Table of contents
PC-22 Internal customer satisfaction with pharmaceutical care
PC-27 Treatment of strongyloides stercoralis hyperinfection syndrome in immunocompromised
patients with parenteral ivermectin: two case-reports
PC-32 Improving the quality of consultations for nonprescription medicines (NPMs):
the acceptability of simulated patient (SP) visits and immediate feedback
PC-52 Evaluation of buccal aerosol aequasyal® for xerostomia in geriatric ward
PC-58 Causes of heart failure exacerbation leading to hospital admission: a cross-sectional
study
PC-56 Clinical pharmacist impact in collecting admitted patients medication history
in a rheumatology department: risk reduction and optimization of consecutive hospitalization
orders
PC-159 Pharmacist intervention at the pain clinic
PC-167 Monitoring of repeat prescriptions for asthma by pharmacist and general practitioner
leads to increased control of asthma
PC-168 Pharmaceutical care and drug related problems in internal medicine hospitalized
patients
PC-179 Medication assessment tool to assess quality of prescribing in chronic cardiovascular
disease (MAT-CVD)
PC-205 Self-management of complications in diabetic patients: a pharmaceutical care
program in community pharmacies
PC-265 Development of pharmaceutical seamless care in a university hospital and outpatient
clinic center in switzerland
PK-145 Implementation of a protocol for pharmacokinetic monitoring of high-dose methotrexate
PEC-71 Risk and pharmacoeconomic analyses to improve the safety of the injectable
medication process in the paediatric and neonatal intensive care units
PT-89 Characteristics and reasons associated with non-acceptance of selective serotonin
reuptake inhibitor treatment
EDU-7 Pharmaceutical interventions by pharmacists working within surgery and medicine
departments
PC-280 Knowledge assessment and needs for information of nurses regarding in-patient
treatments
PT-83 Influence of selected drugs on the development of depression in elderly
PT-4 Fcgamma polymorphism as predictor of complete response to rituximab in non-hodgkin
lymphoma
PT-47 Platinum salts, cancer and renal insufficiency. Sub-group analysis of the irma
study
NUTR-21 Stability of antibiotics used in portable pumps: a synthesis for the prescriber
NUTR-54 Clinical pharmacist interventions in patients on total parenteral nutrition
NUTR-114 Impact of pharmaceutical interventions concerning parental nutrition prescriptions
NUTR-236 What place for standardized formulations of parenteral nutrition prescriptions
in our neonatal intensive care unit?
PC-20 Improving communication with elderly patients in the bulgarian pharmacy practice
PC-35 Can a clinical pharmacist contribute in the multidisciplinary team at a paediatric
ward?
PC-44 Iatrogeny and drug dispensations for outpatients: implication of a hospital
pharmacy
PC-60 Effectiveness of a pharmacist intervention for asthma control improvement: a
randomised controlled trial
PC-65 Pharmacotherapeutic follow-up in older inpatients with hip fracture
PC-67 Influences of the sanitary education in the diabetes type 2 and oral antidiabetics
knowledge by patients of two community pharmacies in Gran Canaria, Spain
PC-94 Evaluation of problems with discharge medication on a paediatric ward
PC-115 Pharmaceutical care for type 2 diabetic patients: a randomised controlled trial
PC-141 Adherence to a guideline for the management of drug−drug interactions in Dutch
community pharmacies
PC-147 The role of a pharmacist in safety treatment in the Czech Republic
PC-155 Character of drug related problems identified for clinical centre of serbia
emergency surgery inpatients
PC-156 Validation of policies in a geriatric hospital
PC-160 Assessment and education of asthmatic patients in proper inhaled drug usage
and other aspects of asthma therapy
PC-221 Frequency of adverse drug reactions connected to hospital admissions – a project
implementing clinical pharmacy
PEPI-272 Patients’ report of depressive symptoms in relation with perceptions and
adherence. A cross-sectional study among starters of cardiovascular medication
PC-173 Knowledge and practice regarding crushing medication at an otorhinolaryngology
ward
PC-176 Drug-related problems with new prescriptions – prevalence, nature and management
in community pharmacies
PC-197 Belgian health authorities and clinical pharmacy projects
PC-218 Consensus of the community pharmacists’ referral criteria for the general practitioners
on minor ailments in spain
PC-231 Descriptive analysis of pharmaceutical interventions in surgical inpatients
PEC-23 Clinical pharmacy, a pharmaco-economic benefit in patient care, a literature
review
PEC-125 Valuing hand-foot-syndrome using the time-trade-off and visual analogue scale
PEPI-42 Identification of drug interactions in hospitals – computer screening vs bedside
recording
PEPI-49 Developing consensus around the pharmaceutical public health competencies
for community pharmacists in Scotland
PEPI-120 Application of evidence-based medicine criteria to paediatric off-label drug
utilization
PEPI-181 Role of community pharmacists in health promotion in Khartoum state, Sudan
PT-247 Cotrimoxazole induced agranulocytosis in an AIDS patient: a case report
DI-31 Pregabalin utilization review after its hospital formulary introduction
NUTR-66 Compliance with prescription information sheet of trastuzumab prescriptions
in a tertiary level spanish hospital
PK-182 Vancomycin dosage in critically ill patients undergoing venovenous haemodiafiltration
PK-203 Effect of co-treatment with valproic acid on carbamazepine elimination in epileptic
patients – a population pharmacokinetic study
PT-34 Clinical pharmacist’s intervention to improve the management of potential drug-drug
interactions in a department of internal medicine
PT-95 Sunitinib in advanced metastatic renal cell carcinoma
PT-104 Antibiotic drug monitoring quality assessed by a clinical pharmacist: qualitative
study
PT-106 Impact of the new scientific evidences in the treatment of the anaemia with
erythropoietin
PT-112 Retrospective observation of converting cyclosporin to tacrolimus in renal
transplant patients at middlemore hospital
PT-151 The role of the clinical pharmacist on oncology service: pain management
PT-191 A comparative study of prescribing errors requiring contact with the prescriber
before dispensing in Norway, Estonia and Sweden
DI-70 Eczematous skin reaction of the palm after intravenous immunoglobulin infusion:
a case report
DI-81 Drug herb interactions with oral anticoagulants
DI-103 Non fatal aplastic anaemia due to clopidogrel
DI-141 Pathways of information on antidepressants in flemish psychiatric hospitals:
experiences of health care professionals and patients
DI-157 Management and prevention of intravenous immunoglobulin adverse effects
DI-175 Fludrocortisone 10–50 μg: elaboration of a patient information leaflet and
satisfaction survey
DI-184 Effects of pharmaceutical interventions in geriatrics: limitations of prescription
software
DI-194 Hazardous drugs handling in hospital: a standardized toxicological screening
method to evaluate occupational risks
DI-204 Guidelines for the handling of drugs instilled directly through the bronchoscope
into the bronchial tree during flexible bronchoscopy
DI-211 The profile of drug information enquiries of nurses in the last ten years
DI-269 Standard procedures to answer clinical questions on negative effects to fetus
conceived under paternal medication exposure
EDU-30 A comparison of the perceptions of pharmacists and dispensing technicians about
the causes of medication error in a community pharmacy
EDU-68 Training pharmacists to implement pharmaceutical care (PC) in pharmacies in
community pharmacies
EDU-69 Implementation of the clinical pharmacy in the National university of La Plata
EDU-98 Prescription errors and dispensing errors in clinical trials
EDU-107 The role of the university of khartoum towards the implementation of pharmaceutical
care practice in Sudan
EDU-121 To modify the behaviour: who does it matter?
EDU-146 Investigation on assessment and treatment of painful neuropathy in diabetic
patient
EDU-171 Pharmaceutical care and clinical pharmacy in undergraduate education at University
of Buenos Aires
EDU-229 Counselling on patient’s adherence to tuberculosis therapy in Depok, Indonesia
EDU-233 Development of a tool to support continuous professional development in community
pharmacy
EDU-241 Usage and level of relevance of intravenous immunoglobulin prescriptions in
a French university hospital – Chu Bordeaux
EDU-260 evaluation of a hypertension/diabetes screening campaign
EDU-275 Evaluation of an educational package for pharmacists working in palliative
care
EDU-284 Fourth-grade pharmacy students prefer kinesthetic learning
EDU-285 Prescriptions of antidepressants: analysis in a psychiatric department
EDU-286 Oncology pharmacy training program in Al-Amal Hospital in Qatar
NUTR-46 Ensuring phosphorus adequacy of human-milk-fed preterm babies
NUTR-192 Dietetary management of acute metabolic decompensation in leucinosis: implication
of the pharmacy
NUTR-192 Jejunal feeding tolerance in pancreatic carcinoma
PC-5 Evaluation of the medical service provided to outpatient clinics with hypertension
in two different healthcare systems in Egypt
PC-9 Effect of propofol on myocardial protection after regional ischemic-reperfusion
injury at in vivo rat heart model
PC-11 Barriers to the implementation of clinical pharmacy in psychiatry hospital in
K.S.A
PC-16 Intravenous immunoglobulin utilization in a tertiary care teaching hospital
in Saudi Arabia
PC-28 Compliance with treatment guideline targets in an academic hemodialysis center
PC-29 Action of a working group depending on our drug commission for the use of a
computerized physician order entry (CPOE)
PC-40 Analysis of the activity in a dispensing unit aimed to external patients
PC-50 The patient–pharmacist communication in a community pharmacy chain in Romania
PC-51 Pharmaceutical care level in Romania community pharmacies
PC-61 Medication administration in nursing homes: can pharmacists contribute to error
prevention?
PC-63 Assessment of the off-label use of intravitreal bevacizumab therapy for macular
edema
PC-64 Implementation of a clinical helpline service in the entire hospital
PC-74 Frequency and nature of drug related problems in psychiatry: 10 years later
PC-75 Information fact sheet: Is it the best tool to spread information? Study about
intravenous acetaminophen (IVA) administration
PC-76 Activity assessment and patient survey by outpatient pharmaceutical care unit
PC-78 Implementation of an intervention to reduce long-term benzodiazepine use in
Dutch community pharmacies
PC-84 Awareness and knowledge of the pharmacists about pharmacovigilance in Turkey:
a descriptive pilot study
PC-86 Global versus individual drug dispensing: clinical impact of the intercepted
dispensing errors
PC-88 Evaluation of drugs prepared by nurses in pediatric care units
PC-109 Implementation of dadér methodology for pharmacotherapy follow-up in hospitalized
geriatric patients
PC-111 Analyze antibiotherapy in a surgical intensive care unit
PC-113 Comparative study and optimisation of the mode of administration of proton
pump inhibitors by paediatric nasogastric tubes
PC-116 Do products used to unblock nasogastric tubes alter the inner surface of them?
PC-118 Assessment of administration practices of extemporaneous formulation pediatric
capsule preparations
PC-128 Patients’ expectations and their satisfaction with outpatient pharmacy services
in a Nigerian hospital
PC-131 Anemia management in chronic renal failure in an haemodialysis unit: clinical
audit
PC-137 Implementation of clinical pharmacy in intesive care unit
PC-140 Study of conformity of prescriptions and their retranscriptions
PC-142 Assessment of antibacterial prescriptions for bronchopulmonary infections in
a pneumology department
PC-148 Mouthwashes and mucositis oral prevention: a possible consensus?
PC-161 Comparative bioavailability study of two olanzapine formulations administered
orally in healthy male volunteers
PC-169 Clinical pharmacists impact on validation orders: application to innovative
drugs
PC-178 Challenge for clinical pharmacist in education of patients with type 2 diabetes
PC-183 Evaluation of pharmaceutical care at hospital admission
PC-189 Comparison of the administration of esomeprazole and lansoprazole through nasogastric
tubes in the presence of nutrition mixture
PC-190 Pharmacological interactions in a spinal cord injury unit
PC-196 Pharmacist intervention at the lipid clinic
PC-223 Risk-adjusted monitoring of veno-occlusive disease following bayesian individualization
of busulfan dosage for bone marrow transplantation in paediatrics
PC-228 Determination of geriatric patients’ drug profile and identify their pharmaceutical
care requirement
PC-230 Emergency contraception: change of user’s profile 2003–2006
PC-234 Development and validation of the socioeconomic impact profile (SEIP)-factor
analysis
PC-244 Impact on the medical follow-up of inr in a 200-bed geriatric hospital with
a computerized control (pharmacist developed)
PC-245 Four years experience of fondaparinux use in a French university hospital
PC-248 Pharmacists’ experience in a small village dispensary in Senegal
PC-253 Evaluation of a rapid streptococcus testing service in the community pharmacy
PC-254 Anti-D Ig prescriptions in Rh(D)-incompatible platelet transfusion at montpellier
hospital
PC-257 Pharmacist’s interventions in three medical care units: analysis and impact
on the physicians’ prescriptions
PC-258 Evaluation of the effectiveness of sliding scale insulin for glycemic control
in the home care setting
PC-263 The impact of different schedules on the outcome of vap caused by pseudomonas
aeruginosa
PC-276 Use of recombinant activated factor vii (rFVIIa) in patients with uncontrolled
bleeding: an evaluation of professional practices
PC-277 Pharmaceutical care contribution in health teams in the portuguese integrated
health care system – between the hospital and the community pharmacy
PC-281 Pharmaceutical care in elderly patients with hip fracture: a prospective pilot-study
PC-282 Hospital pharmacists and community pharmacists: an experiment of pharmaceutical
information transmission carried out in an anticancer center
PC-290 Proposal a software for analysis of clinical relevance of antiretroviral drug
interactions
PC-291 Evaluation of a pharmaceutical care model in a pediatric intensive care unit
PEC-126 Evaluation of the professional practices in cardiac surgery: application to
the use of biological and synthetic glues
PEC-92 Economic impact of the modification of zoledronic acid refunding on hospital
budget
PEC-127 Evaluation of the implementation of automated medication-dispensing system
in an intensive care ward
PEC-202 Intracranial stents: an evaluative and cost impact study in Paris hospitals
PEC-216 Feasibility of economical impact of management of cytotoxic remainders in
a centralized cytotoxic unit
PEC-232 Measuring the activities of a clinical pharmacist on sequential treatment
on the emergency department
PEC-235 Analysis and economic impact of utilization of medicinal product for
PEC-288 The vacuum-assisted closure (VAC) therapy: a 17-months medico-economic retrospective
study
PEPI-48 Epidemiology of adverse drug reactions in an intensive care unit
PEPI-122 The incidence of dry cough in angiotensin-converting enzyme inhibitor users
PEPI-138 Evaluation of pain and analgesic usage in Turkish population
PEPI-164 The role of community pharmacist on oral and dental health: prevention of
diseases and toothache management
PEPI-165 Cardiovascular drugs: prescription profiles and the economic impact of a
generic-based reimbursement system
PEPI-198 Folic acid awareness and intake survey in the Iran
PEPI-199 Pre-diabetes screening program: a proactive study in istanbul community pharmacies
PEPI-207 Awareness among pregnant women of the effects of drugs on the fetus and mother
PEPI-210 Pediatric drug intoxications and the experiences of hacettepe drug and poison
information center
PEPI-226 Analysis of clinical trials in montpellier teaching hospital: what’s new
in biomedical research?
PEPI-242 Assessment of drug utilization profiles, attitudes and knowledge on “performance
enhancing drugs” among players of the amateur football league
PEPI-243 How prevalent are opioid misuse and affective disorders in patients with
fibromyalgia?
PEPI-246 Second-generation antipsychotics and metabolic syndrome
PEPI-255 Companies submission strategies and regulatory approval times greatly influence
patient access to medicine
PEPI-256 Quality of life assessment with a portuguese hypertension health status inventory
(hyper 27)
PEPI-264 Proton pomp inhibitor (PPI) prescription in a medicine unit of a university
hospital: indications and part of off-label use
PEPI-266 Can systematic use of scorecards be of value in the evaluation of the quality
of industry submissions and their regulatory review?
PEPI-289 Lack of knowledge of ICS’ actions in patients who discontinued early with
inhaled corticosteroids
PK-102 Antibiotic drug monitoring quality assessed by a clinical pharmacist: observational
study
PK-129 Evaluation of needs for pharmacokinetic monitoring of carbamazepine and digoxin
in tertiary hospital
PK-153 Amikacin – vancomycin: is it possible to design initial dosage regimen from
their respective pharmacokinetic parameters? A retrospective study
PK-172 Single dose of clarithromycin leads to toxic tacrolimus levels
PK-209 Pharmacokinetics of oral taurine in healthy volunteers
PK-268 Effect of human immunodeficiency virus-1 protease inhibitors on itraconazole
metabolism in V79 Chinese hamster cells expressing human cytochrome P450 3A4
PK-293 Prevention of chemotherapy related errors one step toward
PT-8 Compliance with recommendations on length of treatment with interferon plus ribavirine
depending on viral response in patients with hepatitis C
PT-12 Zidovudine induced anemia in patients received HAART
PT-18 Post-operative pain management in opioid naïve and opioid tolerant patients
after orthopedic surgery
PT-26 Evaluation of the compliance of clinical practice with approved prescription
information for Rituximab
PT-43 Clinical pharmacist intervention in nephrology ward in an Iranian academic health
center
PT-53 Topical mitomycin 0.02% as an adjunct to surgical repair of choanal atresia
PT-57 Adherence to clinical guidelines for upper respiratory and ear infections in
out-of-hours primary care – a retrospective study
PT-85 One year of experience with bortezomib in patients with diagnostic of multiple
myeloma
PT-90 Evaluation of the time interval between admission on the emergency department
and administration of the first dose of antibiotics
PT-91 Compassionate use of mitomycin C in the management of laryngeal papillomas.
A case report
PT-93 Effectiveness of Rituximab in rheumatoid arthritis
PT-96 Use of low molecular weight heparin in venous tromboembolic disease prophylaxis
in general surgery
PT-97 Alternatives in the treatment of refractory dermatomyositis
PT-132 Multi-field evaluation of antibiotherapy quality in a university hospital
PT-134 Care givers’ assessment of the sedation drug use in an adult intensive care
unit (ICU)
PT-135 Breast cancer: analysis of different treatments (2005–May 07)
PT-143 Dose efficiency observed with darbepoetin alfa in renal patients previously
treated with epoetin: a meta-analysis
PT-150 An evaluation of systemic and topical treatments of otitis media: a hospital
study in Turkey
PT-152 Antineoplastic chemotherapies monitoring: sampling method optimization
PT-158 Audit of cardiovascular risk management in diabetic outpatients in Kuwait
PT-180 Pediatric use of infliximab: retrospective study
PT-187 An assessment of professional practices about antifungal agents prescriptions
in the department of conventional hematology at Nantes University Hospital
PT-188 Pharmacotherapy of first-episode psychosis in the psychiatry clinics of the
north estonia regional hospital (NERH) and the Tartu University Hospital (TUH)
PT-195 Assessment of rituximab use in refractory autoimmune cytopenia
PT-200 Is aprepitant useful in high dose chemotherapy regimen in hematology?
PT-201 Use of anti-TNF-alfa in rheumatoid arthritis
PT-217 Topical cidofovir for the treatment of plantar warts: case report
PT-227 Safety of platinum salts skin testing
PT-237 Measuring compliance with antibiotic prophylaxis guidelines at a Belgian university
hospital
PT-240 Non-specific immunoglobulins for immune neonatal thrombopenia
PT-262 Sildenafil use evaluation for pulmonary hypertension in paediatric patients
PT-271 Treatment of an eye-disseminated invasive aspergillosis
PT-273 Security and effectiveness of tenofovir/didanosine associated to a protease
inhibitor
PT-278 Evaluation of drotrecogin alfa use for severe sepsis in an intensive care unit
of a portuguese general hospital
PT-279 Clinical practice: dosage reduction of anticancer chemotherapy
PT-294 Interdisciplinary approach to dose adjustment in patients with renal impairment
in secondary care
DI-37 Patinfo-rheuma: development of web-based patient information leaflets about
drugs used in rheumatic diseases – a multidisciplinary approach
PC-22 Internal customer satisfaction with pharmaceutical care
Canadell Laura1, Cañete Carmen
1, Gallart Mª Jesus1, Pardo Rocio1, Monfort Mª Pau1, Aguilella Teresa1
1Pharmacy Service, Hospital Universitari Joan XXIII, Tarragona, Spain
Background and Objective: To establish a periodic evaluation procedure of doctors
and nurses’ opinions of hospital pharmacy activity in order to measure user perceived
quality of care.
Design: A self-administered anonymous questionnaire was distributed to all physicians,
nurses and assistants working at three units of the hospital (Internal Medicine, Orthopedics
and Traumatology surgery, and Paediatric Service) in December 2006.
We used two different surveys with ten questions each one with a four point response
scale (1 to 4) then, there was a question to give an overall global score on the pharmaceutical
service. A third part of free comments to suggest aspects to improve was included.
Setting: Pharmacy service of a third level hospital.
Main Outcome Measures: This instrument provides information to evaluate customer’s
satisfaction with pharmaceutical assistance, accessibility, competence, friendly service
and prescription counselling as well as satisfaction with dispensing systems.
Results: A total of 115 responses were received, yielding a response rate of 87.3%.
Doctors’ survey showed the followings results: professionalism: 3.7, solving therapy
related problems: 3.6, competence: 3.4, friendly service and prescription counselling
3.6, availability of pharmacist: 2.6. The global score obtained for pharmaceutical
attention was 8.3 in a scale of 10.
Nurse’s opinions were the followings: professionalism: 3.4, friendly service: 3.3,
administration counselling: 3.1, availability of pharmacist: 2.4, items relating to
the quality of distribution system 2.6.
The global score obtained for pharmacy service was 6.7 in a scale of 10.
Continuous attention and increasing the opening hours of the Pharmacy service are
the two issues more requested, both in doctors’ and nurses’ surveys
Conclusions: Customers’ evaluation of attention is a prominent method of assessing
the quality of central health care services as Pharmacy.
From the results obtained it became remarkable that Pharmacy service gives a satisfactory
attention to internal customers. The results showed the need to improve our drug dispensing
systems and the demand for longer opening hours at the pharmaceutical service.
Keywords: Customers satisfaction, Survey, Pharmaceutical care
PC-27 Treatment of strongyloides stercoralis hyperinfection syndrome in immunocompromised
patients with parenteral ivermectin: two case-reports
Anne Lise Pouliquen
1, Cecile Raignoux1, Marie Helene Fievet1, Robert Farinotti1
1Pharmacy, Groupe Hospitalier Pitié Salpétrière, Paris, France
Background and Objective: Strongyloides stercoralis infects each year millions of
persons worldwide. In immunocompromised patients, this intestinal nematode can disseminate
and cause a fulminant fatal illness: hyperinfection syndrome. Oral ivermectin is the
principal treatment. Since one of the features of S. stercoralis hyperinfection is
the development of an ileus and small bowel obstruction, the drug absorption is impaired
and thus a reduced efficacy is noted. No parenteral antihelminthic drug is licensed
for human use, but parenteral ivermectin is commonly used in veterinary medicine.
We report two cases of S. stercoralis hyperinfection syndrome that were refractory
to oral drugs and, as a life saving therapy, were treated with a veterinary formulation
of parenteral ivermectin (Ivomec®, Merial) after agreement from the French drug administration
(AFSSaPS).
Design: Case report.
Setting: Pneumology and Neurochirurgical Intensive Care Units, University Hospital,
Paris, France.
Main Outcome Measures: case report.
Results: Patient 1
A 44-year-old African man has been hospitalized in August 2006 for a degradation of
his condition in neurosarcoidosis with hydrocephalus, associated with Enterococcus
faecalis meningitis. He underwent ventriculo-peritoneal shunt and was treated with
corticosteroids (prednisone 65 mg/day). His condition worsened on September 2006,
with the diagnosis of a disseminated strongyloidiasis with paralytic ileus. He was
initially treated with ivermectin (12 mg bid) via the nasogastric tube. Antibiotics
were added on day 2 to control the sepsis. On day 5 albendazole (400 mg/day) was added.
Subcutaneous ivermectin was then obtained and administered on day 6 (200 μg/kg) in
association with ivermectin via nasogastric tube while albendazole was discontinued.
The patient’s condition improved during the following days. He completed 8 days of
Ivomec® and 30 days of oral ivermectin. He returned home 2 months later.
Patient 2
A 49-year-old African man was hospitalized in November 2006 because of a 30 kg weight
loss. He was diagnosed with HIV, meningeal tuberculosis, urinary and pulmonary infections
and S. stercoralis hyperinfection treated with oral ivermectin. On 29 January 2007
he was admitted in Pneumology Intensive Care Unit with melena on severe immunodepression.
On 6 February he developed a septic shock with ARDS on an important bowel obstruction.
Therefore, among other antiinfectious therapies, a veterinary formulation of subcutaneous
ivermectin was administered (200 μg/kg/day). The sepsis was controlled, but on 11
February he died of an acute haematological deterioration.
Conclusions: As the occurrence of malabsorption is a frequent complication of disseminated
strongyloidiasis, a parenteral formulation of ivermectin would be really helpful,
especially as the efficacy of the subcutaneous form has been proved in the literature.
Keywords: Strongyloides stercoralis, Hyperinfection, Parenteral ivermectin
PC-32 Improving the quality of consultations for nonprescription medicines (NPMs):
the acceptability of simulated patient (SP) visits and immediate feedback
Margaret Watson
1, Jennifer Cleland1, Christine Bond1
1General Practice and Primary Care, University of Aberdeen, Aberdeen, United Kingdom
Background and Objective: SPs have been used extensively to assess pharmacy practice.
There has been limited use of SP visits combined with immediate feedback, as a method
of improving the quality of consultations for NPMs. This method was introduced in
Australia to improve advice provision in pharmacies, and demonstrated that immediate
feedback from pharmacy educators (PEs) was effective in changing professional practice.
The objective of this study was to determine whether SP methodology is a suitable
educational tool for use in British community pharmacies.
Design: Pilot study, conducted in 2006, using a randomised controlled trial (RCT)
design. Pharmacies were randomised to one of two trial groups:
SP visit with SP feedback;
SP visit with PE feedback.
Each pharmacy received three covert SP visits over six weeks. Verbal and written feedback
was provided to the pharmacy staff after each SP visit. No pharmacy was visited by
the same SP more than once. Each pharmacy was visited by the same PE throughout the
study.
Setting: Twenty community pharmacies in Grampian, Scotland.
Main Outcome Measures: Acceptability of SP visits with immediate feedback was assessed
using a questionnaire, focus groups and semi-structured interviews. Participants from
each pharmacy were invited to attend one of two focus groups. Semi-structured interviews
(face-to-face or telephone) were conducted with participants who were unable to attend
the focus groups.
The effect of the visits with feedback on practice was measured using data derived
from:
Audiotapes of the consultations;
Data collection forms (completed by the SPs).
Results: Twenty-two pharmacists and 34 Medicine Counter Assistants (MCAs) participated.
Sixty SP visits were completed.
Questionnaire
Nineteen questionnaires (86.4%) were returned by pharmacists, most (>90%) of whom
considered the visits to be: an effective method of improving the quality of NPM consultations;
and acceptable as a future method of education and training.
Focus groups and Semi-Structured Interviews
Eighteen participants attended two focus groups: 13 pharmacists and five MCAs. Six
interviews were completed, five of which were with pharmacists. Overall, participants
were satisfied with the provision of feedback, and particularly appreciated the positive,
non-judgemental manner in which feedback was appreciated.
Conclusions: Simulated patient visits with immediate feedback were acceptable to pharmacists
and support staff as an educational method in British community pharmacies.
Keywords: Simulated patient, Feedback, Medicines, Nonprescription
PC-52 Evaluation of buccal aerosol aequasyal
®
for xerostomia in geriatric ward
Céline Mongaret
1, Julien Rambaud1, Xavier X. L. Arrault1, Nathalie Faucher2, Philippe P. h. Arnaud1
1Clinical Pharmacy, 2Geriatry, Bichat Claude Bernard Hospital, Paris, France
Background and Objective: To evaluate a new medical device Aequasyal®, a mixture of
oxidized glycerol triesters (TGO) in oral dryness of old patients in palliative care.
This hyposalivation is mainly caused by medical treatment or radiotherapy. The consequence
is xerostomia involving a deterioration of the quality of life in these patients.
TGO have lubricating, adhesive and protective characteristics against local aggressions
by respect of the pH and reduction of the local inflammatory process.
Design: To establish and analyse different evaluation criteria for this device in
a prospective study.
Setting: Geriatric unit in an academic hospital.
Main Outcome Measures: The study begins on March 2006 and finish in marsh 2007. Medical
device is dispensed for each patient with evaluation form. It was used four times
per day. Different criteria with score 1 (very well) to 4 (bad) were assessed by nurses:
facility of use, appreciation of tastes, reestablishment of the moisturizing of the
mucous membrane after several days of treatment, improvement felt in the difficulties
of speaking, of chewing, of swallowing, loss of taste and burn feelings, and also
tolerance of the device.
Results: 19 patients were included in this evaluation. Average age is 84, 2 years
old and sex ratio (F/M) is 0, 6. The spray presents a facility of use (84%), a pleasant
taste (94%); buccal moisturizing is restored at 100% of the patients. An improvement
in the difficulties of speaking (88%) is underlined like improvement in chewing (92%)
and swallowing (94%). Burn feelings are also improved (81%). Since the beginning of
the study, no undesirable event has been notified.
Conclusions: This study shows a real improvement in the quality of life for these
patients. A better therapeutic observance of this polymedicamented population could
be expected. Nevertheless it should be noted that the presentation of this device,
a vial of 400 doses, is not adapted for a hospital use. In the same way an applicator
would be necessary in order to reach the various zones of the buccal cavity.
Keywords: Medical device, Xerostomia, Hyposalivation
PC-58 Causes of heart failure exacerbation leading to hospital admission: a cross-sectional
study
Elin C. Lehnbom
1, Anna C. Bergkvist2, Klas Gränsbo3
1Department of Pharmaceutical Sciences, Division of Pharmacokinetics and Drug Therapy,
Uppsala; 2Hospital Pharmacy, 3Department of Internal Medicine, Malmö University Hospital,
Malmö, Sweden
Background and Objective: Heart failure (HF) is a common disease with an estimated
prevalence of 0.4 to 2% in Europe. Patients with HF have frequent episodes of exacerbation.
Non-compliance to medical and dietary advice is a significant clinical problem as
is suboptimal treatment. One example of factors influencing the ability to comply
with a treatment plan is impaired comprehension. The objectives were to construct
a medication assessment tool and to establish face validity for its use in this project,
to construct an interview schedule in order to identify non-compliance, poor patient
comprehension and suboptimal treatment, to conduct a survey and to report the findings
to the clinic.
Design: A cross-sectional study performed during April 2007–May 2007.
Setting: The emergency department and medical wards at Malmö University Hospital.
Main Outcome Measures: Comparison of compliance, comprehension and optimal treatment
on a population basis between men and women, younger (<75 years) and elderly (>75 years)
patients, and patients in different New York Heart Association (NYHA) classes, in
order to assess if exacerbation could have been caused by any of these factors.
Results: Of the 47 patients included, 60% reported high compliance. In the subgroup
analysis, women and elderly patients reported a significant higher compliance than
men and younger patients. Comprehension on self-care was poor. Only 30% weighed themselves
regularly and 45% did not limit the amount of fluids. No more than 28% reported they
would contact a health care provider in case of experiencing more symptoms. Suboptimal
treatment was also found to be a great concern with only 47% being treated with angiotensin-converting
enzyme inhibitors (ACEI) or angiotensin II receptor blocker (ARB), 66% with beta blockers,
and 51% with aldosterone receptor antagonists, but no consideration to other co-morbidities
has been taken into account. The majority treated with recommended agents had not
achieved target dose as recommended in guidelines.
Conclusions: Poor patient compliance and comprehension as well as suboptimal treatment
could contribute to HF exacerbation and efforts should be made to improve these factors
in order to reduce HF exacerbation.
Keywords: Heart failure, Compliance, Sub-optimal treatment
PC-56 Clinical pharmacist impact in collecting admitted patients medication history
in a rheumatology department: risk reduction and optimization of consecutive hospitalization
orders
Emmanuelle Orru Bravo
1, Beatrice Menneglier1, Mathilde Gilet1, Eric Auv1, Delphine Tuil1, Mireille Nang2,
Agnes Certain1, Olivier Meyer2, Philippe Arnaud1
1Pharmacy Department, 2Rheumatology Department, Hospital Bichat Claude Bernard, Paris,
France
Background and Objective: To measure quality improvement of hospitalized patients
orders through clinical pharmacists involvement in systematically reviewing treatments
at admission.
Design: 6-month prospective study, survey on the usual treatment of a patient (clinical
dossier, retail prescriptions, interview with the patient, drugs surrendered by the
patient, contact with the retail pharmacist or GP).
Setting: Rheumatology Department.
Main Outcome Measures: Number of analysed prescriptions, analysis of discrepancies
between the prior treatment of a patient at admission and the hospital prescription,
number pharmacist interventions, number of personal drugs used and of medication errors
avoided.
Results: During a 6 month period 251 questionnaires at entry (70% of the 358 admissions),
were completed, on average one day after admission.
Main sources of information for the treatment prior to admission: patient interview
92.4% (n = 232), drugs surrendered by the patient 55% (n = 139), retail prescriptions
36.2% (n = 139), contact with the retail pharmacist or GP 1.2% (n = 3).
Errors were detected for 24.7% (n = 61) prescriptions at hospital admission mainly
by omission of one or several drugs in 82% cases (n = 50) and/or dosage error 23%
(n = 14). Each error involved a pharmacist for intervention and correction (1 prescription
out of 4).
36% (n = 91) of the patients used one or more personal drugs without always informing
the physician or nurses. Several cases of double intake were avoided.
Conclusions: Difficulties in getting reliable and complete information about prior
treatment of admitted patients lead to high risks of errors in hospital prescriptions.
Clinical pharmacists, practicing with a global approach of treatments, have a key-role
in collecting patient’s drugs histories and thus optimizing quality assurance of hospital
admission prescriptions.
Keywords: Medication history, Clinical Pharmacist, Rheumatology, Medication errors,
Discrepancies, Admission prescriptions
PC-159 Pharmacist intervention at the pain clinic
Lilian M. Azzopardi
1, Anthony Serracino-Inglott1, Maurice Zarb Adami1, Ann-Marie Flores1
1Department of Pharmacy, University of Malta, Msida, Malta
Background and Objective: Patients with chronic pain tend to deviate from advice provided
as often is the case in chronic conditions which require long-term medication. This
leads to non-compliance with chronic pain medication resulting in suboptimal chronic
pain control. The objective of the study was to assess the impact of the pharmacist
intervention at the pain clinic and to assess patient compliance with drug therapy.
Design: Two questionnaires were designed: ‘Knowledge of Pain Medication Questionnaire’
and ‘Assessment of Patient Compliance and Perception of Pain Management Questionnaire’.
Thirty-one patients were recruited for the study and were followed for two months.
During the first visit to the Pain Clinic, the patients received their prescription.
At the second visit (after 4 weeks), the questionnaires were administered and the
pharmacist prepared a treatment chart. This was reviewed at the third visit (after
4 weeks). During this third visit the pharmacist intervention was also assessed. Results
were analysed using the Mcnemar Test of Symmetry and the Wilcoxon Test.
Setting: Pain clinic, Medical Out-Patients, St Luke’s General Hospital.
Main Outcome Measures: Patient compliance with the medication, assessment of pharmacist
intervention, patient sources of knowledge about their condition and medications.
Results: Patient demographics: mean age- 56 years, age range- 28–88 years, gender-
20 female, 11 male. After the pharmacist intervention, the number of patients who
did not comply with the prescribed medication because they forgot to take it decreased
by 11% (p = 0.0082). There was a decrease in number of patients who did not comply
with the prescribed medication, because they felt they could do without (3%), were
not bothered (1%), who felt that the dosage schedule did not fit with their lifestyle
(1%) and who experienced side effects (1%). As regards pharmacist intervention, 18
patients (58%) found the treatment chart very useful and 25 patients (81%) were very
satisfied with the services provided by the pharmacist. Patients stated that their
main sources for information about their medication were their family doctor (25,
81%) and their pharmacist (12, 39%).
Conclusions: The study indicates that the pharmacist intervention at the pain clinic
leads to an improved patient compliance and was favourably assessed by the patients.
Once this service is established a larger study will be undertaken over a longer period
of time to assess patient outcomes following pharmacist intervention.
Keywords: Pain, Pharmaceutical care, Pharmacist intervention
PC-167 Monitoring of repeat prescriptions for asthma by pharmacist and general practitioner
leads to increased control of astma
Henk-Frans Kwint
1, Marcel M. L. Bouvy2, Anne-Margreeth J. M. Krijger-Dijkema3, Just J. Eekhof4, Joost
J. de Kanter4
1Stevenshof Pharmacy and SIR Institute for Pharmacy Practice and Policy, 2SIR Institute
for Pharmacy Practice and Policy, 3Stevenshof Pharmacy, 4GP Practice Stevenshof, Leiden,
Netherlands
Background and Objective: Adherence with inhaled corticosteroids has repeatedly been
reported to be poor. Poor adherence could lead to inadequate control of asthma complaints.
Monitoring of repeat prescriptions by a pharmacist could offer an opportunity to reach
concordance with the patient and improve adherence. The objective of this study is
was to improve asthma control by optimizing use of asthma medicines.
Design: Retrospective follow up study. All pharmacy dispensing records concerning
respiratory medication (R03) from 1st October 2003 to 30th September 2006 were collected.
Between 1st October 2005 to 30th September 2006 monitoring of repeat medication was
conducted by a pharmacist. Pharmacists discussed asthma complaints and use of asthma
medicines with all patients calling for repeat prescriptions. When indicated the pharmacist
proposed adjustments of asthma medicines to the GP after this telephone consultation.
Setting: Community pharmacy and one GP practice (5 GP’s) in Leiden, the Netherlands,
serving a community of 6.000 patients.
Main Outcome Measures: Self-reported use of short-acting beta-agonists (SABA) by intervention
patients.
Defined Daily Doses (DDDs) of short-acting beta-agonists (SABA), long-acting beta-agonists
(LABA) and inhaled corticosteroids (ICS).
Results: 120 consultations were registered for 68 intervention patients. For 29 patients
more than 1 consultation was registered. At the first consultation only 5 of 29 patients
(17%) reported use of SASA 2–3 times a week or less (adequate control of asthma symptoms).
At the last contact 17 of 29 patients (55%) reported adequate control of asthma.
Average Defined Daily Doses (DDDs) of SABA for 68 patients decreased from 133/year
(October 2004–September 2005) to 86/year (October 2005–September 2006): a decrease
of 35%. DDD of ICS for intervention patients decreased from 411 to 342(−17%) and DDD
of LABA increased from 198 tot 212 (+7%)
Conclusions: Monitoring of repeat prescriptions by the community pharmacist resulted
in an increase of patients achieving asthma control. Moreover monitoring resulted
in a decrease in use of short acting sympaticomimetics which was only partly accounted
for by an increase in long acting sympathicomimetics.
Keywords: Asthma control, Repeat prescriptions, Pharmacist
PC-168 pharmaceutical care and drug related problems in internal medicine hospitalized
patients
Salah AbuRuz
1, Kawla M. AbuHamour1
1Departement of Clinical Pharmacy, Faculty of Pharmacy, University of Jordan, Amman,
Jordan
Background and Objective: For most diseases, drug therapy will enhance health- related
quality of life; however, inappropriate use of drugs may be harmful and could evoke
new symptoms. Drug related problems (DRPs) have often been addressed through studies
on databases. The clinical approach—bedside evaluation of patients’ DRPs—has rarely
been applied. More importantly only few randomized controlled trials of the effect
of pharmaceutical care on DRPs in hospitalized patients were done. The primary aim
of this study was to investigate the impact of providing pharmaceutical care on DRPs
in hospitalized internal medicine patients.
Design: The study was a prospective randomized controlled trial. 152 patients were
included and divided between intervention and control group. The research team composed
of 10 clinical pharmacists. Group differences (intervention, control) groups were
examined using independent sample t-test.
Setting: The study was carried out at the internal medicine wards at a teaching hospital
in Jordan.
Main Outcome Measures: 1. Outcomes of pharmaceutical care recommendations during hospitalization.
These were measured in term of the number of recommendations accepted and implemented
2. Outcomes of DRPs during hospitalization. These were measured in term of the number
of DRPs resolved, prevented and improved
3. Number of DRPs upon discharge in the intervention group compared to the control
group.
Results: The average number of the identified DRPs was eight. Ninety-five percent
of the submitted recommendations were accepted by physicians. However, only 67% of
these recommendations were actually implemented. Tow third of DRPs in the intervention
group were either resolved, improved or morbidity prevented, while it was only 14%
in the control group (p < 0.005).
The mean number of DRPs upon discharge for intervention and control group were 1.61
and 6.25 respectively. This represent a three times decrease in the number of DRPs
in the intervention group compared to the control (relative risk reduction).
Conclusions: The number of DRPs in internal medicine hospitalized patients is high.
Clinical pharmacists were able to identify these problems and resolve them or decrease
the associated morbidity. The high acceptance rate by physicians indicates the importance
and high quality of the recommendations and that physicians are starting to accept
the role pharmacist as a health care provider in Jordan.
Keywords: Pharmaceutical care, Clinical pharmacy, Internal medicine
PC-179 Medication assessment tool to assess quality of prescribing in chronic cardiovascular
disease (MAT-CVD)
Tobias Dreischulte
1, John J. McAnaw1, Steve A. Hudson1
1Pharmaceutical Sciences, Strathclyde Institute of Pharmacy and Biomedical Sciences,
University of Strathclyde, Glasgow, United Kingdom
Background and Objective: To test a method to quantify adherence of medication use
to clinical guideline recommendations in a primary care setting.
Design: Retrospective survey to field-test a 51-item instrument (MAT-CVD) based on
earlier studies of quality of medication use in cardiovascular disease (CVD)1.
Setting: A database of 388 patients [45% male, mean (SD) aged 66 (14) years] coded
with circulatory system disease (Read Code ‘G*’) was drawn from computerised records
of all patients receiving care from a single community pharmacist and general medical
practitioner (GP) collaboration (n = 1,703). The pharmacist worked as a supplementary
prescriber and had remote access to the electronic records of the GP. Patients had
diagnoses of diabetes (n = 34), hypertension (HTN; n = 250), ischaemic heart disease
(IHD; n = 60), other ischaemic vascular disease (cerebrovascular n = 27; peripheral
vascular n = 13), heart failure (HF; n = 12), atrial fibrillation (AF; n = 28), were
anticoagulated (warfarin, n = 19) or otherwise identified as potential candidates
for primary prevention of CVD (n = 100).
Main Outcome Measures: Adherence (%) to 51 criteria based on guideline recommendations
on primary and secondary prevention of CVD, treatment of HTN, IHD, HF, AF and warfarin
therapy; overall applicability of criteria and quantification of insufficient data;
inter-rater agreement of application of individual MAT-CVD criteria and of the overall
tool (Cohen’s к)
Results: A total of 2473 criteria were applicable and for 131(5%) of these there was
insufficient data to apply the standard. The guideline adherence (95% CI) overall
was 74 (72–76)%. Highest adherence was to ‘primary/secondary prevention of CVD’ [80
(77–82)% adherence, n = 11 criteria]. Lowest adherence was to ‘treatment of AF’ [43
(25–61)% adherence, n = 3 criteria]. Non-adherences were found to at least one criterion
in 259 (67%) and to ≥4 criteria in 49 (13%) patients. Inter-rater agreement was assessed
on the application of the tool to all patients by two independent raters. All six
sections and the overall tool were found to have inter-rater agreement к > 0.8 and
a percentage agreement >90%. Among the 31 (61%) of 51 individual MAT criteria that
were applicable to ≥10 patients 24 showed к > 0.8. In two of the remaining seven criteria
the base-rate problem2 was responsible for к < 0.8 and when taken into account the
number of individual criteria with acceptable inter-rater agreement was 26 (84%).
Conclusions: The application of the MAT-CVD to routine primary care records in a Scottish
primary care setting is feasible and reliable; the tool has potential use in continuous
quality improvement of prescribing in primary care.
References
Chinwong S, Reid F, McGlynn S, Hudson S, Flapan A. The need for pharmaceutical care
in the prevention of coronary heart disease; an exploratory study in acute myocardial
infarction patients. Pharmacy World and Science 2004; 26: 96–101
Cook RJ. Kappa and its dependence on marginal rates. In: Armitage TG, Colton T, editors.
The encyclopedia of biostatistics. New York: John Wiley; 1998; p 2166–8
Keywords: Pharmaceutical care, Quality of prescribing, Guideline adherence
PC-205 Self-management of complications in diabetic patients: a pharmaceutical care
program in community pharmacies
Ayse Koroglu
1, Asuman Cakiroglu2, Zehra Almila-Oztosun3, Ayse Dundar4, F. Ilkay Alp5, Alper Okyar5,
Gul Baktir5
1Rifat Sargýn Pharmacy, 2Yonca Pharmacy, 3Capitol Pharmacy, 4Pelikan Pharmacy, 5Pharmacology,
Istanbul University Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Diabetes mellitus is a metabolic disorder which causes serious
organ damage such as retinopathy, nephropathy and neuropathy chronically. Diabetes
mellitus could be managed via appropriate pharmacotherapy and regulation of the life
style. The purpose of this study is providing a pharmaceutical care program for diabetic
patients which will help them to minimize the complications of diabetes and increase
the efficiency of pharmacothreapy.
Design: Pharmacists used a structured questionnaire containing questions concerning
demographic data, treatment protocols and characteristics of self monitoring of blood
glucose levels to collect information.
Setting: Four community pharmacies in Istanbul.
Main Outcome Measures: Demographic data and diabetes complications of the patients.
Results: One hundred patients were screened for fasting glucose and postprandial glucose
levels. Despite of receiving medical treatment a large proportion of patients could
not maintain appropriate blood glucose level. According the results of self-monitoring
blood glucose level in diabetics they are guided to the specialist to modify the medication
regimen. Also, it has been observed that a substantial proportion of the patients
are not aware of the serious complications of diabetes.
Conclusions: Community pharmacists could make a useful contribution with a appropriate
pharmaceutical care program to control complications of diabetes mellitus and optimize
the treatment.
Reference
Lindenmeyer A, Hearnshaw H, Vermeire E, Van Royen P, Wens J, Biot Y. J Clin Pharm
Ther 2006;31(5):409–19.
Keywords: Diabetes mellitus, Diabetes complications, Pharmaceutical care
PC-265 Development of pharmaceutical seamless care in a university hospital and outpatient
clinic center in Switzerland
Bertrand Guignard
1, Mapi Fleury1, Arnaud Widmeier2, Emmanuèle Guignard1, OIivier Bugnon1
1Pharmacy, 2General Medicine Unit, University Medical Outpatient Clinic, Lausanne,
Switzerland
Background and Objective: Seamless care refers to continuity of patient care in the
health system across caregivers. The objectives of the present study were (1) to identify
barriers to seamless information between a given hospital and an outpatient clinic
in Switzerland and (2) to propose tools for improving pharmaceutical seamless care.
Design: This is a retrospective study with a convenient sample of patients for mapping
the information flow network. The inclusion criteria were: (1) at least one stay lasting
more than 24 hours in the hospital in 2006, (2) regular checkups with a GP in the
outpatient clinic and (3) medication delivered by the community pharmacy of the outpatient
clinic 6 months prior to 6 months after the hospitalization.
Setting: Both hospital and outpatient clinic are independent and run their own pharmacy.
The hospital pharmacy is implied in drug production and distribution without generalized
pharmaceutical care activities, and the community pharmacy delivers Rx or OTC medication
for outpatients. Geographic and computer proximity between both entities constitutes
an ideal setting for seamless care projects.
Main Outcome Measures: (1) To map medical or administrative information between community
pharmacy, GP and hospital and (2) to find opportunities to improve pharmaceutical
seamless care.
Results: Sixteen patients met inclusion criteria (5 women, 11 men, average 53 years,
mean visits/patient/year with GP: 3, and with community pharmacist: 49, i.e. 16-time
more with pharmacist than GP). We observed that administrative information is computerized
on a common database for both hospital and outpatient clinic. In contrast, clinical
information is mainly handwritten and difficult to share between hospital and outpatient
clinic caregivers. Patient medication database is managed by a community pharmacy
software not linked to medical information. However administrative information flows
in one direction from the administrative to the community pharmacy database. We identified
2 potential tools easily available to the community pharmacy to improve pharmaceutical
seamless care in the center: (1) an alarm through the administrative database connection
if a patient is hospitalized to allow pharmacist to contact hospital physician for
medication history and (2) an access to patient discharge letter and lab results to
improve Rx validation process.
Conclusions: Clinical information is not easily shared between caregivers of the hospital
and the outpatient clinic. If global seamless care still remains a long term goal,
initial actual steps promoted by community pharmacists can be easily implemented.
Keywords: Seamless, Information, Community
PK-145 Implementation of a protocol for pharmacokinetic monitoring of high-dose methotrexate
Beatriz Garcia Robredo
1, Maria Amalia Fernandez Feijoo1, Miguel Angel Calleja Hernandez1
1Hospital Pharmacy Department, Virgen de las Nieves University Hospital, Granada,
Spain
Background and Objective: To quantify the impact of the implementation of a protocol
for the pharmacokinetic monitoring of patients receiving high-dose methotrexate.
Design: Prospective experimental study, in which the Hospital Pharmacy Department
designed a specific protocol for the pharmacokinetics follow-up of these patients
and for gathering the data required for a correct rescue. Results were compared between
three months before and three months after implementation of this new protocol.
Setting: 24-hr infusions of methotrexate at a dose of ≥1 g/m2 were evaluated in adult
patients admitted to the Oncohaematological Area of a tertiary level hospital.
Main Outcome Measures: Number of infusions started at the correct time, number of
missed blood extractions, number of missed leucovorin doses, calculation of the elimination
half-life, and measurement of the urinary pH (dichotomous variables). Degree of compliance
with the leucovorin rescue dosage protocol was measured on a scale of 0–3 points,
with all items carrying the same score (correct loading dose, dosage as function of
body surface area, and dosage as function of the concentrations of methotrexate obtained).
Results: The number of infusions started at the correct time increased from 50% to
60%. The number of missed blood extractions fell from 1.6 to 0.4 extractions per course;
and missed leucovorin doses dropped from 0.25 to 0 per course. The elimination half-life
could be calculated in only 25% of courses in the first study period versus 100% of
courses after protocol implementation. Urinary pH changed from not being measured
in any cycle to being measured in 100% of cycles. Compliance with rescue dosage protocol
was scored with 1.9 points before versus 2.8 points after implementation.
Conclusions: Implementation of a protocol for pharmacokinetics follow-up by the Hospital
Pharmacy Department improved the monitoring of patients receiving high doses of methotrexate
and ensured that data required for a correct rescue treatment were gathered.
Keywords: Protocol, Pharmacokinetic monitoring, High-dose methotrexate
PEC-71 Risk and pharmacoeconomic analyses to improve the safety of the injectable
medication process in the paediatric and neonatal intensive care units
Isabella De Giorgi
1, Béatrice Carredda2, Valérie Mourer2, Laurence Cingria1, Caroline Fonzo-Christe1,
Riccardo Pfister2, Pascal Bonnabry1
1Pharmacy, 2Service of Neonatal and Paediatric Intensive Care Units, University Hospitals
of Geneva, Geneva, Switzerland
Background and Objective: To quantitatively evaluate the safety of the current injectables
medication process, from prescription to administration, in the paediatric and neonatal
intensive care units.
To compare the potential impact of safety measures on the risk.
To classify these measures from a pharmacoeconomic point of view.
Design: Assessment by a prospective risk analysis according to the Failure Modes,
Effects and Criticality Analysis (FMECA) method [1] by a multidisciplinary team: one
physician, two nurses, three pharmacists. Three drugs chosen as models (gentamicin;
morphine; dopamine). Failure modes (FM) defined during brainstorming and criticality
indexes calculated on the basis of their likelihood of occurrence, potential severity
for the patients and detectability. Impact of ten safety measures on the criticality
indexes of the selected three drugs, extrapolation to all drugs injected daily and
calculation for each measure of the investment in Euros per year to improve the safety
by 1 quali (−1 point of criticality) per day.
Setting: University hospital, fifteen NICU beds and ten PICU beds.
Main Outcome Measures: Mean criticality indexes; gain in qualies per day; cost-efficacy
ratios for each safety measure.
Results: In the current situation, the sum of mean criticality indexes of thirty-one
identified FM was 4,540 for the selected three drugs.
We gain 1,292 qualies (46,500 by extrapolation to all drugs injected daily) with CIVAS
(Centralized IntraVenous Additives Services), 1,201 (72,060) with a clinical pharmacist,
996 (59,780) with double check by nurses, 984 (59,040) with CPOE (Computerized Physician
Order Entry), 555 (23,296) with in-line filters, 457 (12,348) with vial of dilution,
408 (17,122) with horizontal laminar airflow hood, 170 (4,590) with intermediate dilution,
144 (6,192) with simple additional measures of asepsis and 98 (951) with a drug planer.
The best cost-efficacy ratios were obtained by a clinical pharmacist (1 quali = 0.54
Euros) or by double check by nurses (1 quali = 0.71 Euros) or by CIVAS (1 quali = 0.72
Euros). The highest ratio was obtained with CPOE, due to the very high costs investment
(1 quali = 22.47 Euros).
Conclusions: The use of a prospective risk analysis allowed us to quantitatively evaluate
the relationship between the medication process of injectables and the paediatric
patient safety and to build a strategy for continuous quality improvement, by selecting
the most appropriate evolutions. Based on the results of the pharmacoeconomic analysis,
development of clinical pharmacy and CIVAS for some drugs will be discussed with the
paediatric department.
Reference
Bonnabry P, et al. Qual Saf Health Care 2005; 14(2):93–8
Keywords: Pediatrics; Risk assessment; Cost-benefit analysis
PT-89 Characteristics and reasons associated with non-acceptance of selective serotonin
reuptake inhibitor treatment
Erica CG van Geffen1, Rolf van Hulten1, Marcel L. Bouvy
2, Antoine C. G. Egberts1, Eibert R. Heerdink1
1Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical
Sciences, Utrecht, 2SIR Institute for Pharmacy and Policy, Leiden, Netherlands
Background and Objective: Studies show that up to 38% of patients starting treatment
with antidepressants fill only a single prescription at the pharmacy, apparently not
accepting treatment. The aim of this study was to determine characteristics and reasons
associated with non-acceptance of SSRI treatment.
Design: Retrospective questionnaire study. Patients presenting a GP prescription for
a newly started SSRI treatment to a community pharmacy were selected. ‘Non-accepters’
were defined as those patients filling only a single SSRI prescription, and patients
who received at least three prescriptions were defined as ‘accepters’.
Setting: 37 community pharmacies in The Netherlands.
Main Outcome Measures: Characteristics evaluated included socio-demographic (e.g.
level of education), disease (e.g. reason for use) and treatment (e.g. type of SSRI)
characteristics. ‘Non-accepters’ were also asked for the reason not filling a second
prescription.
Results: 57 ‘non-accepters’ and 128 ‘accepters’ were included in the analysis. ‘Non-acceptance’
was more common among patients with a low level of education (OR 2.6; CI 1.1–5.9)
and in patients who reported aspecific symptoms like fatigue, stress and restlessness
as the reason for SSRI use (OR 2.7; CI 1.4–5.5). In addition, there was a trend that
‘non-acceptance’ was more common among patients over 60 years of age (OR 2.5; CI 0.8–7.9).
Of all ‘non-accepters’, 29.8% (n = 17) did not start SSRI use, while 70.2% (n = 40)
discontinued SSRI use within two weeks. Fear of side effects and the actual occurrence
of side effects are main reasons for not accepting SSRI treatment. In addition, a
considerable number of ‘non-accepters’ indicated that they felt an aversion towards
medicine use, were feeling better meanwhile or disagreed the GP’s diagnosis. Of the
‘non-accepters’, 55.0% discontinued treatment without informing the GP.
Conclusions: Acceptance of SSRI treatment is a decisive moment in compliance to treatment
initiated by GPs, and deserves more attention. GPs and pharmacists should address
issues related to the use of SSRIs especially in groups who are at risk for non-acceptance.
Keywords: Antidepressants, Discontinuation, Nonadherence
EDU-7 Pharmaceutical interventions by pharmacists working within surgery and medicine
departments
Julie Prince
1, Stephanie Diallo1, Eric Grandsire1, Anne Lecoeur1, Caroline Fijalkowski1, Michelle
Lebas-Certain1, Franck Le Mercier1
1Pharmacy, Ambroise Pare Hospital AP-HP, Boulogne-Billancourt, France
Background and Objective: Since 1995, our pharmacy department set up a nominative
daily drug distribution system without computarization. In each pharmaceutical unit
localized in clinical departments, the prescriptions are screened daily by a pharmacist,
then the drugs are delivered by a technician.
Our objective was to compare the frequency and content of pharmaceutical interventions
in surgery and medicine departments.
Design: During four weeks (Jan–Feb 2007), the pharmacists indexed their interventions
on forms using the French Society of Clinical Pharmacy (SFPC) codification.
2992 lines of prescription were analysed in surgery and 2899 in medicine.
Setting: Three daily drug distribution units working for six hospitalization departments
(92 beds for orthopaedic and vascular surgeries and 102 for internal medicine, pneumology
and endocrinology).
Main Outcome Measures: Percentage of interventions and of each type (7) based on analysed
lines.
Results
More interventions in surgery than in medicine: 435 and 190 i.e. 14.10% vs 6.55% (p < 0.005).
Most interventions are substitutions: 60% of all interventions in surgery, 40% in
medicine.
More clinical and biological monitoring in surgery (1.04% vs 0.24%, p < 0.005), mainly
monitoring for heparin and kaliemia.
More pharmacokinetics advice in surgery (1.44% vs 0.62%, p < 0.005), for example:
iron and quinolones.
More dosage adaptations in surgery (0.50% vs 0.14%, p < 0.005), for example: paracetamol
and buflomedil overdosages.
Better acceptance in medicine than in surgery: 70% of all interventions vs 41%.
Conclusions: The presence of a pharmacist in surgical and medical wards is justified
by the number and relevance of pharmaceutical interventions, even though the acceptance
remains insufficient in surgery because of the problem of surgeons availability.
References
Conort O, Bedouch P et al. Validation of an instrument for the codification of clinical
pharmacy interventions. J Pharm Clin. 2004 Jul–Aug–Sep; 23(3): 141–7
Société Française de Pharmacie Clinique (SFPC). Standardisation et valorisation des
activités de pharmacie clinique. http://sfpc.adiph.asso.fr/admin/ (last viewed 10-04-2007)
Keywords: Pharmaceutical interventions, Daily drug distribution, Evaluation
PC-280 Knowledge assessment and needs for information of nurses regarding in-patient
treatments
Magali Adam1, Mikael Daouphars
1, Elisabeth Bertrand2, Sylvie Violette3
1Pharmacy, 2Haematology, 3Nurses’ management, Cancer centre Henri Becquerel, Rouen,
France
Background and Objective: While several studies have evaluated the frequency and the
consequences of medication errors, few have explored their causes. In particular,
knowledge of nurses regarding treatment of their patients has been scarcely studied.
This survey has been carried out to determine how nurses master medications prescribed
to the patients they care for, and how often they access drugs database.
Design: This work is a prospective study carried out from February to April 2007.
We have decided to focus on the clinical audit method, following French health authorities
recommendations. A questionnaire has been elaborated and submitted to nurses during
semi-structured interviews.
Setting: French cancer centre: 9 nurses from an oncology department and 17 from a
Haematology Department.
Main Outcome Measures: Data collected were: nurses’ profile (age, length of service,
competencies’ self-assessment), knowledge on drugs prescribed to their patients (usage,
administration, side-effects, drug interactions…), use of existing tools (i.e. drugs
database) and possible tools to be developed by the pharmacy ward to help them in
their daily practice.
Results: Twenty out of twenty six nurses (mean age: 27, mean length of service: 4 years)
consider their medical knowledge as intermediate level. 54% of pharmaceutical classes
are quite well known (95% of the indications are known). Only 32% of drugs’ INN are
given and more than half of the generic drugs’ names are not mastered. Administration
conditions and conservation are known for respectively 98% and 96% of the products.
However, side-effects (48%), contraindications (37%) and drug–drug interactions (18%)
are not acquired. In their daily routine, nurses face problems mainly related to:
drug administration (20%), drug conservation (24%), and dealing with generic drugs
and therapeutic equivalence (28%). 46% of nurses refer to a drug database several
times a week when only 4% more than once a day. Pharmacy ward is considered to give
information on drugs on a ‘regular’ basis. Three tools have been identified for their
potential to help nurses: summarized data on drugs (card format), drugs administration
and conservation tables.
Conclusions: This study has helped to define nurses’ difficulties regarding patients’
treatment, and their needs for information on drugs. It is also useful for the pharmacy
ward to improve its relationships with clinical wards and feedback on treatments.
Training sessions will shortly be organised to improve the above results.
Keywords: Medication errors, Clinical audit, Information, Nurses
PT-83 Influence of selected drugs on the development of depression in elderly
Martina Anditsch1, Gudrun Lang2, Rosa Lemmens-Gruber
2, Majidreza Kamyar2, Peter Fischer3
1Hospital Pharmacy, Donauspital, 2Pharmacology and Toxicology, University of Vienna,
3Ludwig Boltzmann Institute for Aging Research, Ludwig Boltzmann Gesellschaft, Vienna,
Austria
Background and Objective: To evaluate the role of long-term medication with selected
drugs on the development of depression in order to allow risk assessment of pharmacotherapy
in elderly.
Design: Literature review; basic examination of cognitive status and depression, two
re-examinations at 2.5 years intervals (first re-examination completed); 11 drug classes;
statistical evaluation (Chi square and exact Fisher test).
Setting: Co-operation of the Ludwig Boltzmann Institute for Aging Research (Vienna,
Austria) with the 1000-bed general hospital Donauspital (Vienna, Austria) and the
Department of Pharmacology and Toxicology at the University of Vienna.
Main Outcome Measures: Categorisation of drug classes with statistically significant
correlation to the development of depression during long-term medication.
Results: The aim of the VITA (Vienna Transdanubia Aging) Study is the early detection
of Alzheimer dementia and the discovery of its risk factors. At basic examination,
dementia was diagnosed in 21 out of 606 patients (4%) at an age of 75 years. In 89%
of these cases dementia was classified as Alzheimer disease. In addition, a clinically
relevant depression was diagnosed in 17% of patients at basic examination, but only
32% of them were treated accordingly. The first re-examination after 2.5 years included
those patients, who showed no or only mild signs of cognitive disorders at basic examination.
19% of these patients developed dementia within the period of 2.5 years. The first
re-examination also revealed a rapid increase of patients with depression (17% vs.
28%). The incidence for the development of dementia was 11% in patients, who have
never suffered from depression. However, in patients with the diagnosis depression
at basic examination, the risk for dementia was doubled. We aimed to prove whether
there is a statistically significant correlation between long-term medication with
selected drugs and the development of depression. Eleven classes of drugs were investigated,
including calcium channel blockers, beta- and alpha-blockers, corticoids, statines,
non-steroidal anti-inflammatory drugs, H2-blockers, neuroleptic drugs, benzodiazepines,
levodopa and opiates. Medication was documented from those 285 patients (122 male,
163 female) without dementia and depression at basic examination, and without dementia
at first re-examination. At first re-examination 86 of them were depressive (26% male,
33% female), and 199 had no depression (control group). For each class of drug, patients
were divided into 6 groups according to gender and duration of medication. A statistically
significant (P < 0.05) correlation was found between the treatment with benzodiazepines
(≥3 months) as well as beta-blockers (≥30 months) and the development of depression
in both male and female.
Conclusions: In elderly long-term therapy with benzodiazepines and beta-blockers can
aggravate the development of depression.
Keywords: Dementia, Depression, Pharmacotherapy
PT-4 Fcgamma polymorphism as predictor of complete response to rituximab in non-hodgkin
lymphoma
Márcia Paiva
1, Herlander Marques2, Paula Ferreira1, Raquel Catarino1, Rui Medeiros1
1Unit of Molecular Oncology, 2Onco-Haematology Department, COV, Instituto Português
de Oncologia Francisco Gentil, Porto, Portugal
Background and Objective: Pharmacogenomic studies aim to elucidate the genetic bases
for interindividual differences and use such genetic information to predict the efficacy,
response rate and safety of a selected drug. To date, the prognostic value of FcγR
polymorphisms as markers to predict treatment outcome in NHL is still being studied.
Our goal was to determine whether there is any correlation between FcγRIIa polymorphisms
and clinical response to rituximab in patients with NHL.
Design: In the present study we analysed FcγRIIa polymorphisms in the genomic DNA
isolated from peripheral blood of 64 patients with NHL who have undergone immunotherapy
with rituximab. Genotype analysis was based on a polymerase chain reaction (PCR) method
followed by a restriction fragment length polymorphism (RFLP) study.
Data were analysed using the computer software SPSS for Windows (Version 13.0) and
treatment outcomes of the patients were compared using Chi-square or Fisher’s exact
test. A cut-off p-value of 0.05 was adopted for all the statistical analysis. Survival
estimates were calculated using the Kaplan-Meier method. The curves were examined
by the log-rank test.
Setting: Unit of Molecular Oncology of Instituto Português de Oncologia, Porto, Portugal.
Main Outcome Measures: The response to therapeutics with rituximab was evaluated according
to physical examination and computed tomography images. Responses were scored according
to International Working Group Consensus.
Overall response rate (ORR) was considered as complete response (CR), unconfirmed
complete response (CRu) and partial response (PR). Overall survival (OS) duration
was defined as the period of time between 1st treatment with rituximab and either
death or the last clinical evaluation of the patient. Event-free survival (EFS) was
defined as the time interval between 1st treatment with rituximab and the occurrence
of an event (recurrence or death) or the time of the last clinical evaluation of the
patient.
Results: The ORR for HH genotype was 100% and for R allele was 87% (p = 0.251). However,
our results demonstrate that all patients carrying the HH genotype had complete responses
to rituximab therapy. Complete response rate for HH genotype was 100% and for R allele
was 63% (p = 0.028).
When comparing the FcγRIIa genotypes, HH genotype or R allele does not have a significant
impact on OS at 3-year (p = 0.338) or on EFS at 3-year (p = 0.449).
Conclusions: This study demonstrates that FcγRIIa polymorphism is predictive of complete
response to regimens containing rituximab in NHL patients, but is not predictive of
overall or event-free survival. Based on the current observation, rituximab has in
some way an FcγRIIa-dependent mechanism of action which is ameliorated in patients
with HH genotype. We hypothesize that HH genotype increases affinity of FcγRIIa receptor
not only for naturally occurring IgG2, via antibody-dependent cellular cytotoxicity
but also ameliorate connection with chimeric IgG1 rituximab.
Keywords: Non-Hodgkin lymphoma, Rituximab, Pharmacogenomics
PT-47 Platinum salts, cancer and renal insufficiency. Sub-group analysis of the IRMA
study
Xavier Pourrat
1, Nicolas Janus2, Stéphane Oudard3, Isabelle Ray-Coquard4, Jean-Philippe Spano5,
Jospeh Gligorov6, Jean-François Morere7, Philippe Beuzeboc8, Gilbert Deray2, Vincent
Launay-Vacher2
1Pharmacy, Hôpital Trousseau, Tours, 2Nephrology, GH Pitié-Salpêtrière, 3Medical Oncology,
Hôpital Européen Georges Pompidou, Paris, 4Medical Oncology, Centre Léon Bérard, Lyon,
5Medical Oncology, GH Pitié-Salpêtrière, 6Medical Oncology, Hôpital tenon, Paris,
7Medical Oncology, Hôpital Avicenne, Bobigny, 8Medical Oncology, Institut Curie, Paris,
France
Background and Objective: The IRMA study reported the high prevalence of renal insufficiency
(RI) in 4684 solid tumour patients: mean age 58.1, mean weight 67.8 kg (84.2% between
50 and 90 kg), glomerular filtration rate (GFR) < 90 mL/min for 50–60% [1]. We present
the results for IRMA patients who received a platinum salt (PS) as part of their chemotherapy.
Design: Data were retrospectively collected for in and outpatients with cancer presenting
over two periods in 2004 (February 1st–15th and October 1st–15th).
Setting: 15 anticancer centers in France.
Main Outcome Measures: Subgroup analysis of IRMA patients who received PS. Data collected:
sex, age, weight, serum creatinine (SCR), type of tumor and anticancer drugs. The
prevalence of SCR > 110 μmol/L was assessed. GFR was estimated with Cockcroft-Gault
(CG) [2] and aMDRD [3] formulae. Chi-square test was used to compare the prevalence
of RI between patients who received PS and patients who did not.
Results: 990 patients were included: mean age 60.2 and weight 66 kg, 525 men. The
prevalence of SCR > 110 μmol/L was 9.5%. GFR < 90 mL/min was 63.1% with CG and 55%
with aMDRD. The prevalence of RI was significantly higher in patients who received
PS as compared to patients who did not receive PS (p = 0.0005). There were 993 prescriptions:
38.1% carboplatin, 31.5% cisplatin and 30.4% oxaliplatin. 69.6% of patients received
carboplatin or cisplatin, the two drugs of this class needing dosage adjustment and
being nephrotoxic.
Conclusions: RI is highly frequent in cancer patients receiving PS. Appropriate evaluation
of renal function necessitates CG or aMDRD calculation. In addition, two third of
those patients with pre-existing RI are at risk for iatrogenic acute renal failure
still receive nephrotoxic PS. Consequently, appropriate methods for the nephrotoxicity
prevention of those drugs should be used as recommended for cisplatin by the ESCP
Special Interest Group on Cancer Care [4].
References
Prevalence of renal insufficiency in cancer patients and implications for anticancer
drugs management: The IRMA study. Cancer 2007 (in press).
Prediction of creatinine clearance from serum creatinine. Nephron, 1976; 16: 31–41.
A simplified equation to predict glomerular filtration rate from serum creatinine
[Abstract]. J Am Soc Nephrol 2000; 11: 828–828.
Prevention of Cisplatin Nephrotoxicity: State of the Art and Recommendations from
the ESCP Special Interest Group on Cancer Care. Pharmacy World & Science (under submission).
Keywords: Renal insufficiency, Cancer, Platinum salts
NUTR-21 Stability of antibiotics used in portable pumps: a synthesis for the prescriber
Nicolas Arlicot
1, Déborah Schlecht1, Jacqueline Grassin1, Sophie Marchand2, Daniel Antier1
1Pharmacy, Trousseau University Hospital, 2Pediatrics R, Clocheville University Hospital,
Tours, France
Background and Objective: Treatment of cystic fibrosis (CF) patients subjected to
bronchial superinfection is based on continuous antibiotics infusion performed with
portable elastomeric pumps. The purpose of this work was to check out the stability
of antibiotics in those portable pumps when no data relative to their stability was
available in literature.
Design: Drugs stability study.
Setting: Quality control laboratory – Department of Pharmacy.
Main Outcome Measures: Stability over 72 h in portable pumps stored at 35°C (average
temperature measured in real condition) of: i) piperacillin + tazobactam; ii) cefsulodin;
iii) ticarcillin + clavulanic acid and; iv) cefepim was checked out according to antibiotic
concentrations used in clinical practice. Stability was assessed by pH and drug concentration
measurements by High Performance Liquid Chromatography (HPLC) and organoleptic parameters
inspection. All parameters were measured at T0; T24; T48 and T72 h.
Results: Piperacillin + tazobactam and ticarcillin + clavulanic acid showed good stability
at T24 for all tested concentrations but the highest one for piperacillin (90 mg/ml)
with a degradation rate over 15%. At T72, both tazobactam and ticarcillin degradation
remained about 10% and 12%, respectively, while clavulanic acid and piperacillin degradation
rate reached 20 and 26%, respectively, the drug degradation appearing to be concentration-dependent
for both antibiotics. At last, cephalosporins also showed degradation rate over 10%
at T24 then reaching 50% at T72.
Conclusions: These results may be useful for clinicians when prescribing continuous
antibiotics infusion to ambulatory CF patients through elastomeric portable infusion
pump. Collected stability data measured at 35°C allowed us to recommend the use of
a cold accumulator to ensure drug stability during infusion over 24 h and more, especially
with cephalosporins (cefepime and cefsulodin).
References
Viaene E et al. Antimicrob Agents Chemother. 2002; 46(8): 2327–2332.
Zhang Y et al. Ann Pharmacother. 2001; 35(11): 1360–1363.
Xu QA et al. J Am Pharm Assoc. 2002; 42(3): 428–431.
Keywords: Cystic fibrosis, Portable pumps, Antibiotic, Stability
NUTR-54 Clinical pharmacist interventions in patients on total parenteral nutrition
Jose Luis Sanchez Serrano1, Carmen Fraile Clemente
1, Marta Suarez Gonzalez1, Itamar Gonzalez Perera1, Pilar Diaz Ruiz1, Matilde Chafer
Rudilla1
1Pharmacy, Hospital La Candelaria, Tenerife, Spain
Background and Objective: To describe an quantify the pharmaceutical interventions
in patients on total parenteral nutrition (TPN)and the drug related problems (DRP)in
patients on this type of nutritional support.
To know the acceptance degree of the interventions and its relevance on patients’
care and quality of life.
Design: Prospective longitudinal study for four months (from January 2007 to April
2007). All patients on TPN were included.
The registered data were: patients number, hospital departments, type of interventions
and modifications on the TPN.
Setting: The pharmaceutical interventions were classified in: indication, effectiveness,
safety and adherence according to the Cipolle and cols methodology in order to identify
de DRP related to the TPN and/or to the drugs.
Main Outcome Measures: All interventions were recorded both in the patient medical
record and in a excel database in the pharmacy department.
Results: 135 patients were evaluated and 2190 interventions were recorded. That means
an average of 16 interventions per patient and a duration average per nutrition of
7.5 ± 5.6 days.
The DRP were: indication 11.6%, safety 12.9%, effectiveness 58% and adherence 17.5%,
being the DRP5 the most representative. The DRP were listed in: nutritional assessment
(14.2%), monitoring (70.9%) and individualized TPN (14.9%). A total of 89 patients
(65.9%) was favoured through some type of pharmaceutical intervention, being the most
implicated hospital departments the Neonatology and Digestive Surgery departments.
A 90% of the interventions were focus on monitoring and optimization of nutritional
support and 10% on drugs (diuretics, insulin, digoxine, enalaprile, and propofol).
The acceptance degree of the interventions was 95%.
Conclusions: The individual monitoring of the patients with TPN represents an improvement
of their clinical outcome and a lower incidence of DRP. Therefore, with this method
we contribute to a lower hospital stay and it also may prevent the appearance of new
adverse effects.
References
Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice. New York. Mac Graw-Hill,
1998
Climente Marti M, Font Noguera I, Jimenez Torres NV. Procedimientos para la practica
clinica orientada a problemas farmacoterapéuticos.Rev.Calidad Asistencial 2001;16:343–53
Levy DB. Documentation of clinical and cost-saving pharmacy interventions in the emergency
room. Hosp.Pharm 1993; 28:624–53
Marti-Bonmati E. y cols.Estudio multicéntrico de prevalencia de hiperglucemia en pacientes
hospitalizados con nutrición parenteral. Farm. Hosp. 2006;1(30):12–19
Keywords: Nutrition, Interventions, Drug related problems
NUTR-114 Impact of pharmaceutical interventions concerning parental nutrition prescriptions
Helene Richard
1, Cyril Breuker1, Audrey Castet1, Anne Jalabert1, Sylvie Hansel-Esteller1
1Pharmacy unit, Lapeyronie and Arnaud de Villeuneuve Hospitals, Montpellier, France
Background and Objective: To assess the impact of interventions based on pharmaceutical
analysis of parenteral nutrition prescriptions.
Design: Pharmaceutical analysis of prescriptions with the aid of biological results,
exhaustive list of interventions and their acceptance for one month, from 5 March
2007 to 6 April 2007.
Setting: Pediatric units: neonatal intensive care, pediatric intensive care, pediatric
oncology-hematology unit, gastropediatric unit, and pediatric visceral surgery.
Main Outcome Measures: The number of interventions carried out and accepted, items
concerned: regulation problems, nitrogenous and calorie intake, electrolytic intake,
prescription omissions and eventually other fields.
Results: Altogether, 569 parenteral nutrition prescriptions were analyzed for one
month in five pediatric units.
The pharmaceutical analysis, which consumes 2 hours a day for 2 pharmacists, generated
58 interventions for prescribers: 67% concerned electrolytic intake, more than half
of which concerned potassium and sodium, the main dangerous electrolytes; 19% were
prescriptions omissions; 7% about nitrogenous and calorie intake; 7% about other fields
(weight error, incompatibility of lipids with divalent ions).
Of these 58 interventions, which concern exactly 54 prescriptions, 30 were accepted
by prescribers, that is 52%, leading to prescription modifications.
Conclusions: Putting in place a systematic pharmaceutical analysis of parenteral nutrition
prescriptions has ensured the detection and the correction of prescription errors.
These errors concern mainly non adjustment of electrolytes to the biological results
of the child. Pharmaceutical interventions are important for safety of the patient
and represent a privileged way to communicate with prescribers and their acceptance
is, on the whole, satisfactory.
Keywords: Pharmaceutical interventions, Parenteral nutrition prescriptions, Electrolytes
PC-20 Improving communication with elderly patients in the Bulgarian pharmacy practice
Valentina B. Petkova-Dimitrova1, Doroteya Naboko
2, Zlatka D. Dimitrova1
1Social Pharmacy, Faculty of Pharmacy, 2Marketing Department, Sopharma PLC, Sofia,
Bulgaria
Background and Objective: The number of elderly intensively increases and the fact
that they consume a great amount of POM and OTC drugs makes them a significant group
of patients that need pharmacy care. Unfortunately pharmacists often find their interaction
with elderly clients very difficult and determined by many factors such as the sensory
and physical limitations that accompany the aging process.
To test the readiness of the elderly patients to communicate with the pharmacist,
to assess the barriers that hinder the proper communication process and to provide
a communication skills training in order to be improved the communication process.
Design: An experimental design involving two stages – assessment and education.
Setting: Setting: The elderly patient center (hospice) and 15 private community pharmacies
both situated in the city of Sofia, Bulgaria.
Participants: 110 patients aged 65+ (80 community pharmacy patients and 30 patients
from the elderly center).
Main Outcome Measures: An initial interview with the patients and questionnaire with
the selected pharmacists to assess the level of communication and to clarify the hinders.
Communication skills training leaflets provided to the pharmacists. Test of the newly
received skills. Final interview with the patients to be assessed the level of their
satisfaction.
Results: The trained pharmacists that have passed the education process are more facilitated
in providing pharmaceutical care that leads to the elderly patients’ satisfaction
(about 70%). Additionally, the elderly patients obtained significantly more information
from their pharmacists that leads to better care and avoidance of nearly half of the
drug-related problems (DRPs) for this age.
Conclusions: Pharmacist communication skills’ training appears to be an effective
means of enhancing the communication process in the pharmacy.
Keywords: Pharmaceutical care, Elderly, Quality of life, pharmacy, Education
PC-35 Can a clinical pharmacist contribute in the multidisciplinary team at a paediatric
ward?
Cathrine Kjeldby
1, Anna A. B. Bjerre2
1Hospital services, The Hospital Pharmacy at Rikshospitalet University Hospital, 2Department
of Paediatrics, Rikshospitalet University Hospital, Oslo, Norway
Background and Objective: As the hospital has no pharmacists working in the multidisciplinary
teams on the wards, we wanted to introduce and evaluate a clinical pharmacy service.
Design: A 14 month prospective pilot study with three aims:
Identify drug related problems (DRPs) (data collecting period of eight months).
Design drug related information sheets and teach nurses.
Evaluate the service by questionnaire.
Suggest cost-effective measures.
Setting: Paediatric ward with 16 beds, National University Hospital.
Main Outcome Measures: The acceptance rate of the DRPs identified and suggested by
the pharmacist, the number of drug information sheets introduced and lectures given
to nurses. Physicians’ and nurses’ views on the service.
Results: The pharmacist identified 162 DRPs in 121 (32%) of the 384 charts that was
screened. Immediate action was taken in 94 (59%) of the 162 cases, the physician considered
42 (26%) of the suggestion rational but no immediate action was taken due to various
reasons, and 26 (16%) of the suggestions were not approved by the physician. The most
commented DRP was “dosage” (33%), which included too low or too high dose, non-optimal
administration time or inappropriate formulation.
The pharmacist designed six drug information sheets and gave five lectures. Cost-effective
measures were suggested for drug handling and specific drugs. Seven out of eight physicians
and all nurses (n = 15) considered the pharmacist a natural participant in the multidisciplinary
team.
Conclusions: Quality assurance of drug treatment may be performed by a clinical pharmacist,
not only by the traditional way of identifying DRPs, but also by designing drug information
sheets and teaching. The clinical pharmacist is also capable of suggesting cost-effective
measures. Physicians and nurses considered the clinical pharmacist a natural participant
in the multidisciplinary team. As a result of this project, the clinical service will
continue and also be introduced to one of the other paediatric wards.
Keywords: DRP, Paediatrics, Quality assurance
PC-44 Iatrogeny and drug dispensations for outpatients: implication of a hospital
pharmacy
Emilie Degris
1, Isabelle Peyranne1, Anne Laure Sarda1, Nadine Malric1, Brigitte Bellon1
1Pharmacie, Hôpital Paule de Viguier, CHU Toulouse, Toulouse cedex 9, France
Background and Objective: In France, some drugs are not available in community and
outpatients have to go to hospital to obtain their treatment. Our objective was to
assess the role of the pharmacist in prevention of iatrogeny when dispensing drugs,
in particular medication errors at high risk for the patient.
Design: a 6 month retrospective study, from December 2006 to May 2007
Setting: Pharmacy of Paule de Viguier, Teaching hospital of Toulouse, France
Main Outcome Measures: Each error encountered was recorded and analysed. First, we
determined the number of errors avoided and the number of errors effective (divided
into 2 groups: non avoided and created by pharmacy). Then, we quantified the frequency
(1 = once, 2 = from twice to ten times, 3 = more than ten times) and the severity
(0 = no risk, 1 = weak, 2 = moderate, 3 = high) of each error. The multiplication
of those two parameters gave us the level of the risk of error for the patient (0 = no
risk, 1 to 3 = weak risk, 4 and 6 = moderate risk, 9 = high risk). Finally, for each
type of error we noted the actors.
Results: We made 6543 dispensations during the period of the study. We recorded 125
errors (1.9%): 92 (14 for 1000 dispensations) were avoided by the evaluation of the
pharmacist, 8 were not avoided (1 for 1000 dispensations) and 25 were created (4 for
1000 dispensations). Among the avoided errors, 36 (5.5 for 1000) were at high risk
(9), 26 (4 for 1000) at moderate risk (6 or 4), 30 (4.5 for 1000) at weak risk (2
or 3). The actor of 87 of them was the prescriber (mainly lack of information on the
prescription like no dosage). Among the 33 effective errors, 24 (3.7 for 1000) were
at moderate risk (6 or 4), 5 (0.7 for 1000) at weak risk (1 to 3), 4 (0.6 for 1000)
had no risk (0). The actor of 31 of them was the pharmacy.
Conclusions: The errors for the activity “retrocession” are not numerous. The majority
of them are stopped by the evaluation of the pharmacist, in particular those at high
risk for the patient. We implemented curative and preventive measures to decrease
the number of errors made both by prescribers and pharmacy.
Keywords: Iatrogeny, Risk, Retrocession
PC-60 Effectiveness of a pharmacist intervention for asthma control improvement: a
randomised controlled trial
Els Mehuys
1, Luc Van Bortel2, Leen De Bolle1, Inge Van Tongelen1, Jean-Paul Remon1, Lieven Annemans3,
Guy Brusselle4
1Pharmaceutical Care Unit, 2Heymans Institute of Pharmacology, 3Department of Public
Health, 4Department of Respiratoy Diseases, Ghent University, Gent, Belgium
Background and Objective: Despite improved treatments and guidelines, asthma control
remains suboptimal. In a recent observational study, we described the Asthma Control
Test® (ACT) as an easy tool to measure asthma control of patients presenting at community
pharmacies (1). The present randomised controlled trial was set up to study the hypothesis
that a pharmacist intervention, focused on optimal use of asthma medication and tailor-made
to the patient’s current asthma control, would result in improved asthma control in
adult patients.
Design: A 6-month randomised controlled trial in 201 asthma patients: 94 patients
in the control group (C) and 107 patients in the intervention group (I). Patients
in the control group received usual care. Patients in the intervention group received
a protocol defined pharmacist intervention, mainly focusing on inhaler technique and
adherence to controller medication.
Setting: 66 randomly selected community pharmacies in Flanders (the Dutch speaking
part of Belgium).
Main Outcome Measures: Primary outcome was the level of asthma control, as measured
by the Asthma Control Test®. Secondary outcomes included rescue medication use, night-time
awakenings due to asthma, patients’ peak expiratory flow, inhalation technique, adherence
to controller medication, quality of life, knowledge on asthma and smoking behaviour.
Results: Mean ACT scores did not change from baseline for both study groups (ACT at
baseline for C: 19.3, I: 19.7 – ACT at 6 months for C: 19.7, I: 20.3). However, a
predefined subgroup analysis of patients having insufficiently controlled asthma at
baseline showed that the intervention significantly increased ACT scores during the
course of the study compared with usual care (p = 0.019). The intervention also significantly
reduced reliever medication use (p = 0.012) and the frequency of night-time awakenings
due to asthma (p = 0.044). Inhalation technique (p = 0.004) and adherence to controller
medication (p = 0.016) were significantly better in the intervention group. These
findings suggest that the more effective use of asthma medication is responsible for
the improvements in symptom control.
There were no differences between control and intervention group in peak expiratory
flow, quality of life, knowledge on asthma and smoking behaviour.
Conclusions: A pharmacist intervention can significantly improve outcomes for asthma
patients (ClinicalTrials.gov number NCT00263159).
Reference
Mehuys et al. Respir Med 2006; 100:1407–14
Keywords: Asthma, Asthma control, Community pharmacy
PC-65 Pharmacotherapeutic follow-up in older inpatients with hip fracture
Amparo Torres
1, Isabel M. I. Baena2, Paloma P. C. Fajardo2, Jose Maria J. M. Araujo3, Maria José
M. J. Faus3, Ramon R. Antelo4
1Pharmaceutical Care Research Group, 2Research Group on Pharmaceutical Care, 3Pharmaceutical
Care Research group, University of Granada, 4Physician, University Hospital San Celicilio,
Granada, Spain
Background and Objective: Patients admitted to surgery departments receive multiple
drugs before, during and after surgical procedures. Drug-related problems (DRP) are
the most common cause of injury to hospitalized patients. In Pharmacotherapeutic Follow-up
(PTF) a pharmacist is responsible for drug-related patient needs by detecting, preventing
and solving drug-related problems (DRP) aiming at specific results to improve patient
quality of life. DRP are pharmacotherapy negative outcomes leading to failed therapeutic
goals or undesirable events. When a DRP appears, it affects not only older hip fracture
patient health, but also the effectiveness of hospital health care.
The general objective of this study was to demonstrate that PTF improves the hip fracture
assistential process quality, comparing some quality indicators of this process between
patients in study group (SG) and control group (CG).
Design: Cuasi-experimental study with control group. PTF was the intervention.
Setting: Two Traumatology wards in a large teaching hospital, “Hospital San Cecilio”,
Granada, Spain.
The period of study was from January to July 2005 (SG) and the same period but in
2004 (CG).
Main Outcome Measures: Incidence and types of DRP; DRP solved in SG; differences in
lengh of stay, six-months mortality and three-months readmissions between study and
control groups.
Results: The incidence of DRP was 74% in SG (n = 112) and 53.8% in CG (n = 119). In
SG, more than 80% of DRP were resolved. In SG and CG the 53% and 41% of DRP were related
to medication need, 26% and 50% to effectiveness, and 21% and 9% to safety, respectively.
Mean length of stay was 15 days in SG and 13.7 in CG. In general, patients with DRP
had a significative longer length of stay (15.6 d) than those without DRP (12 6 d);
but in SG, patients in which DRP were solved had the same length of stay than those
without DRP. Six-months mortality was 7.6% in SG and 11.7% in CG, and readmissions
was 1.9% and 7.7% respectively.
Conclusions: Pharmacotherapy follow-up permitted most of the DRP detected in the SG
were solved. In this patients group, two of the most important hip fracture care process
quality indicators like readmissions and six-months mortality were lower than in CG.
Keywords: Pharmacotherapy follow-up, Hip fracture, Drug related problems
PC-67 Influences of the sanitary education in the diabetes type 2 and oral antidiabetics
knowledge by patients of two community pharmacies in Gran Canaria, Spain
Garcia Rosana
1, Paloma P. C. Fajardo2, Daniel D. Sabater2, Antonio A. Pintor2, Maria Isabel M.
I. Baena2, Diego D. Barbero2, Maria Pilar M. P. Garcia- Delgado2, Fernando F. Martínez2
1Pharmaceutical Care Research Group, 2Pharmaceutical Care Research group, University
of Granada, Granada, Spain
Background and Objective: Evaluating knowledge of oral antidiabetics users about their
medicines and their health problem before and after a session of sanitary education
in two community pharmacies in Gran Canaria, Spain.
Design: Cuaxiexperimental research pre-post intervention. Intervention is defined
as a session of oral and written sanitary education distributed by the pharmacist
about the medicines that the patient uses and its problem of health. The analysis
of the information obtained has been made by a comparison of average for related samples.
Setting: Two community pharmacies with similar characteristics in Las Palmas de Gran
Canaria, Spain
Main Outcome Measures: Knowledge of medicines and health problem before and alter
the sanitary education.
Results: Sixteen patients were included in the study, where 8 were women. 3 patients
did not want to collaborate but they did not show any different characteristics. Regarding
the independent variables of participants, the average age was of 68 years (min 40,
max 81). 13 of the 16 patients did not have studies or had primary studies. The average
of oral antidiabetics taken by patient was of 2. The total number of oral antidiabetics
studied was of 25. Before the intervention, the level of knowledge of the oral antidiabetics
was as follows: optimal knowledge 17, tolerable knowledge 1 and insufficient knowledge
8. After the session of sanitary education about all the oral antidiabetics studied
the knowledge of them became optimal. Concerning the knowledge of the diabetes before
the intervention, it was as follows: optimal knowledge for 7 patients, tolerable in
1 patient and 8 patients had an insufficient knowledge. After the sanitary education,
3 patients remained with an insufficient knowledge on the diabetes and all the rest
obtained an optimal knowledge.
Conclusions: The sanitary education distributed by the pharmacist improves the knowledge
in patients of the oral antidiabetics and of the diabetes itself. Although the study
population is not very significant, this research could open a line of investigation
in sanitary education and in the knowledge of medicines and health problems.
PC-94 Evaluation of problems with discharge medication on a paediatric ward
Christophe Indevuyst1, Katrien Cosaert1, Ludo Willems
1
1Pharmacy, University Hospital Leuven, Leuven, Belgium
Background and Objective: A previous study in our hospital revealed discrepancies
between a child’s medication history and the in-patient drug-chart.[1] This led to
a new study to evaluate patients’ and parents’ knowledge of discharge medication and
to identify the main problems in the discharge medication process.
Design: During one month, medication charts of patients to be discharged were compared
to information obtained from the discharge letter and a structured interview.
Setting: A paediatric oncology and infectious diseases ward (38 beds) in a 1900-bed
university hospital.
Main Outcome Measures: Discrepancies between the intended discharge medication regimen
and the medication regimen displayed in the discharge letter, corrected for information
obtained from the parents and the patient himself.
Results: 24 patients were interviewed about their medication at discharge, which consisted
of a total of 126 drugs. In 87.5% (n = 21/24) of cases, one or both parents were interviewed.
In all other ones, we interviewed the patient himself. In 54.2% (n = 13/24) of patients,
one or more discrepancies were detected. This result is comparable to other results
described in literature (60%)[2]. Omissions accounted for 4.8% (n = 6/126) of errors.
Other inconsistencies were related to dose (4%, n = 5/126), frequency (1.6%, n = 2/126)
and intake with or without food (3.2%, n = 4/126). The clinical pharmacist was asked
to give extra information on various topics of the medication, including indication
(13.5%, n = 17/126), drug–nutrient interactions (10.3%, n = 13/126), dosing (4%, n = 5/126)
and storage (3.2%, n = 4/126).
Conclusions: A high discrepancy rate was found between actual and intended discharge
medication regimens. Our results were comparable to other results published in literature
[1]. Strategies for reducing medication discrepancies at discharge should focus on
omissions, dosing, frequency and intake with/without food. Patients require extra
information on indication, drug–nutrient interactions, dosing and storage.
References
Mertens S, Cosaert K, et al. Discrepancies between a child’s medication history and
the in-patient drug chart. Presented at 35th ESCP Symposium, Vienna, Austria. Abstract
PC-117, p. 48
Vira T, Colquhoun M et al. Reconciliable differences: correcting medication errors
at hospital admission and discharge. Qual. Saf. Health Care 2006;15;122–126.
Keywords: Discharge, Medication, Paediatrics
PC-115 Pharmaceutical care for type 2 diabetic patients: a randomised controlled trial
Els Mehuys
1, Valerie Loomans2, Leen De Bolle1, Luc Van Bortel3, Lieven Annemans4, Inge Van Tongelen1,
Jean-Paul Remon1, Mimi Giri5
1Pharmaceutical Care Unit, Ghent University, 2KOVAG, KOVAG, 3Heymans Institute of
Pharmacology, 4Department of Public Health, 5Department of Endocrinology, Ghent University,
Gent, Belgium
Background and Objective: Type 2 diabetic patients often underestimate the seriousness
of their disease and neglect essential aspects of their treatment. For this reason,
(inter)national treatment guidelines recommend patient education as an important element
of diabetes care. In Belgium (as in other European countries), the majority of type
2 diabetic patients are treated in primary care with the general practitioner as the
central caretaker. However, also the community pharmacist could play a valuable role
in the education of type 2 diabetic patients, by motivating patients towards correct
medication use, better medication adherence and healthy lifestyle.
Design: A 6-month randomised controlled trial in 288 type 2 diabetic patients: 135
patients in the control group (C) and 153 patients in the intervention group (I).
Patients in the control group received usual care. Patients in the intervention group
received a protocol defined pharmacist intervention, mainly focusing on correct medication
use, medication adherence and healthy lifestyle promotion.
Setting: 66 volunteering community pharmacies in Flanders (the Dutch speaking part
of Belgium).
Main Outcome Measures: Primary outcome was glycaemic control, i.e. fasted plasma glucose
(FPG) and HbA1c. Secondary outcomes included medication adherence, knowledge on diabetes
and level of self-management.
Results: In both study groups, FPG levels were significantly decreased from baseline
(C: −8.1 mg/dl, p = 0.004; I: −14.1 mg/dl, p = 0.000). However, the reduction in the
intervention arm was not significantly greater than the reduction in the control arm
(p = 0.193). The percentage of patients having a FPG between 90 and 130 mg/dl (ADA
glycaemic target) was increased significantly more in the intervention group (C: +5.3%;
I: +19.8%) (p = 0.001). There was also a significant study group-effect on HbA1c (p = 0.009):
HbA1c was decreased with 0.63% in the intervention group versus a decrease of 0.14%
in the control group. Interpreting the results of this study, it is important to note
that the pharmacotherapy, i.e. type and daily dose of the oral hypoglycaemic agents,
was changed by the general practitioner during the study period in 24.8% of the control
group patients and 41.4% of the intervention group patients. This implies that the
observed intervention effect on glycaemia could possibly be the result of these pharmacotherapeutic
changes. Extra analyses revealed that for patients whose medication had not changed
during the study, FPG remained status quo (irrespective of study group). For patients
whose medication was changed, FPG decreased significantly more in patients of the
intervention group, compared with patients of the control group (I: −32.1 mg/dl; C:
−12.8 mg/dl) (p = 0.022). These results suggest that a joint action of general practitioner
and pharmacist has the largest impact on glycaemia.
Conclusions: Pharmaceutical care can contribute to an improved glycaemic control of
type 2 diabetic patients.
Keywords: Type 2 diabetes, Pharmacist, Pharmaceutical care
PC-141 Adherence to a guideline for the management of drug–drug interactions in Dutch
community pharmacies
Henk Buurma
1, Tom Schalekamp2, Toine C. G. Egberts2, Peter A. G. De Smet3
1SIR Institute for Pharmacy Practice and Policy, Leiden, 2Dept. of Pharmacoepidemiology
and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University,
Utrecht, 3Scientific Institute of Dutch Pharmacists, (WINAp), The Hague, Netherlands
Background and Objective: Pharmacists contribute to the detection and prevention of
certain drug therapy-related problems including drug–drug interactions (DDIs). Little
is known about adherence to pharmacy practice guidelines for the management of DDI
alerts. The objectives of this study were to measure the adherence of community pharmacists
to a Dutch guideline for the management of DDIs and to determine patient-related and
prescriber-related determinants for non-adherence.
Design: In a cross-sectional study sixteen clinically relevant DDIs were included
in the study based upon certain described criteria. The clinical relevance had to
be classified as C or higher, according to the classification system developed and
maintained by a working group of the Scientific Institute of Dutch Pharmacists (WINAp)
that has been described in detail elsewhere.[1] In other words, all the included DDIs
had to have potentially harmful consequences.
Setting: From June to August 2005, Dutch pharmacists (n = 149) collected alerts occurring
in daily patient care for these interactions as well as information related to the
patient, the alert itself, the prescriber and the management of the alert.
Main Outcome Measures: Non-adherence was measured by comparing the management executed
by the pharmacy with the national guideline.
Results: The overall adherence to the guideline amounted to 69.3% (n = 423) with large
differences between the various DDIs. Adjusted for all variables, male gender (OR
2.25; 95%CI 1.52–3.31), the highest age category (>75 yr) (OR 1.97; 95%CI 1.03–3.75)
and current use of more than seven medications (OR 2.35; 95%CI 1.46–3.80) were associated
with a higher probability for non-adherence to the guideline by pharmacists. Prescriber-related
variables had no significant influence on guideline adherence. The degree of adherence
varied not only with the nature of the DDI, but also with its management characteristics.
Substitution of one of the involved agents, recommended for most of the DDIs, was
only executed in a small minority of cases. The outcome of interaction management,
such as a substitution, a dose reduction, or a temporary stop of one of the agents,
was frequently inconsistent with the guideline.
Conclusions: Non-adherence to a Dutch guideline for the management of DDI alerts is
common in community pharmacies. There are several reasons for non-adherence, for instance
the ultimate decision made by the prescriber in some instances. Further research into
underlying reasons is warranted to guide efforts to improve this situation.
Reference
Van Roon EN, Flikweert S, le Comte M, Langendijk PN, Kwee-Zuiderwijk WJ, Smits P,
et al. Clinical relevance of drug–drug interactions: a structured assessment procedure.
Drug Saf 2005;28:1131–9.
Keywords: Drug interactions, Guidelines, Implementation
PC-155 Character of drug related problems identified for clinical centre of serbia
emergency surgery inpatients
Zorica Boberic-Blazic
1, Svetlana R. S. Ristic2
1Central Pharmacy, Clinical Centre of Serbia, 2Pharmacy, Teching hospital for obstetrics
ang gynecology Narodni Front, Belgrade, Serbia
Background and Objective: Clinical pharmacy service has been introduced in hospital
pharmacy setting in Serbia few years ago. Clinical pharmacist can contribute to better
use of medicines by providing safe, rational and evidence based drug therapy. Clinical
pharmacist reviews medication order lists and in the context of individual patients
data and identify drug related problems (DRPs). The objectives were to: characterize
identified DRPs and drugs involved after review of medication order lists in 5-week
period; to identify drugs or drug group with a greater potential to cause DRPs.
Design: Prospective observational study of general surgery inpatients medication order
lists. DRPs were identified and categorized using Pharmaceutical Care Network Europe
2006 classification and drugs using ATC (WHO 2003) classification.
Setting: Clinical Centre of Serbia Emergency Centre General Surgery Unit, four general
surgery wards include 80 inpatients beds and satellite hospital pharmacy.
Main Outcome Measures: Category of DRPs was presented using PCNE V 5.00 classification.
Drugs and drug group involved in DRPs was classified using, ATC WHO 2003 classification.
Results: Pharmacist identified one problem in every five patients (143/660). Drug
choice problems were the most often involved in DRP (92/143). No clear indication
for drug use was identified 29.37% of all DRPs. Drug–drug interactions were often
21/43 (14.69%). We did not identify any adverse drug reactions. The drug most often
involved in DRP was ketorolac inj. 16/143 and antibiotics were the group of drug most
often involved in drug choice problems (30/143) and dosing problems (13/143).
Conclusions: The first research of pharmacist’s interventions for EC General surgery
inpatients in Serbia has shown that DRPs are frequent and that drug choice is the
most common problem identified, antibiotics most often involved. Clinical pharmacist
should promote responsible, safe and rational drugs use.
References
Pharmaceutical Care Network Europe Foundation. 2003. PCNE Classification for Drug
Related Problems V.5. [online] Zuidlaren: Pharmaceutical Care Network Foundation.
Available from: http://www.pcne.org [Accessed 10 August 2005]
World Health Organization. (2003). Anatomical Therapeutic Chemical Codes system. WHO
Collaborating Centre for Drug Statistics Methodology, Geneva.
Keywords: Clinical pharmacy, Drug related problems, Hospital pharmacy
PC-156 Validation of policies in a geriatric hospital
Lilian M. Azzopardi
1, Anthony Serracino-Inglott1, Maurice Zarb Adami1, Melissa Smith1
1Department of Pharmacy, University of Malta, Msida, Malta
Background and Objective: Policies provide consistency and basis for standardisation
of professional services. The policies should be regularly reviewed to reflect the
requirements of the ever changing healthcare settings. The aim was to validate pharmacy
policies and identify required amendments.
Design: Four pharmacy policies were identified: Dispensing of Medications for Patients
Admitted on the Wards (DMA), Dispensing of Medications for Discharged Patients (DMD),
Amendments in Medications (AM) and Checking of the Emergency Trolley (ET). Tools were
developed to validate the policies. The investigator used the tools and observed the
procedure followed when dispensing medications to patients admitted on the wards,
dispensing medications to discharged patients and changing medications to hospitalized
patients for thirty times. The procedure followed when checking the emergency trolley
was observed for eighteen times. Twenty-eight out of 55 nurses practising at the hospital
were interviewed about their knowledge on the ET policy.
Setting: Zammit Clapp Hospital, St Julians, a 60-bed acute geriatric hospital where
a unit-dose dispensing system is adopted.
Main Outcome Measures: Pharmacists’ compliance with the policies, nurses’ compliance
with the ET policy, nurses’ knowledge on the ET policy.
Results: Pharmacists showed full compliance with the DMD, AM and ET policies. Pharmacists
failed to comply with two steps of the DMA policy. The overall compliance achieved
with DMA policy was 92%. Pharmacists showed a 67% compliance with the step requiring
checking of drug interactions and 93% compliance with the step requiring checking
for other drug-related problems. In addition a step that is included in the DMA policy
where the doctors contact pharmacists to inform them of the new admission to prepare
required drugs showed an 83% non-compliance. From the study it transpired that the
steps required to be carried out by nurses for the ET policy were not being followed.
The mean nurses’ knowledge about the ET policy was 72% with a range of 51–91%. Documentation
of the checking of the emergency trolley was missing.
Conclusions: Following this study, the policy on Checking of the Emergency Trolley
was amended and implemented. The steps which showed low compliance in the other policies
were discussed with the pharmacy personnel to emphasise requirements of the policies.
Keywords: Policies, Validation, Hospital pharmacy
PC-160 Assessment and education of asthmatic patients in proper inhaled drug usage
and other aspects of asthma therapy
Erdal Demir
1, Bahadir Cekic1, Cetin Yilmaz1, Philip M. Clark1
1Clinical Pharmacy, School of Pharmacy, Yeditepe University, Istanbul, Turkey
Background and Objective: To investigate asthmatic patients’ knowledge of disease
state, drug therapy and proper inhalator usage. To provide oral and written education
according to meet patients’ educational needs.
Design: Case control pilot study using.
Guided questionnaire
Assessment of patient inhalor technique
asthma education: oral education including demonstration of proper inhalator usage;
and
Written education using illustrated brochures explaining asthma, trigger factors,
and asthma treatment with an emphasis on the different usage of preventor and relievers;
illustrated brochures explaining correct usage of turbohalers, discus and metered
dose inhaler
Setting: Asthma Out-patient Clinic; Süreyyapaşa Centre for Respiratory Diseases and
Thoracic Surgery, Maltepe-Istanbul
Main Outcome Measures: Questionnaire evaluation; success of patients in optimized
guideline for proper inhalator usage
Results: 20% of 30 (n = 6) patients either did not know what the term asthma meant
or defined it as a cough.
23.3% of patients (n = 7) are smokers who know cigarettes can and do trigger their
asthma attacks; 10% (n = 3) of patients are smokers who claim cigarettes don’t trigger
their asthma.
13.3% (n = 4) of patients reported an aspirin allergy that triggers their asthma attacks.
26.6% (n = 8) had never used aspirin before and did not know whether they had any
sensitivity to aspirin.
6.6% (n = 2) of subjects could correctly describe and distinguish between preventor
and releiver drugs. 3.3% (n = 1) confused the terms, while 90.1% (n = 27) had no idea
about these terms.
70% (n = 21) of asthmatics had received previous inhaler usage education from a specialist
(doctor, nurse or pharmacist). 7 of these 21 patients had ineffective inhalator usage
although they had ostensibly received education. The inhaler technique of the remaining
14 who had been previously educated was accepted as succesful.
30% (n = 9) of the patients had never received inhaler usage education before a specialist.
2 of these 9 patients demonstrated successful technique but 7 of 9 failed.
Conclusions: The results of this pilot study indicate that some asthmatics are ignorant
of their condition. In addition most of them seem to have no comprehension of the
concepts of preventor or reliever therapy. Despite prior education about half (n = 14)
were unable to demonstrate successful technique. Furthermore cigarette smoking may
be a detremental factor to the lives of asthmatic patients.
This results of this study suggest the potential benefit of an innovative pharmacist
led patient education service among asthmatic patients in Turkey.
References
Barker AF, Strategies in managing asthma. West J Med. 1989; 150: 303–308
Keywords: Asthma, Education, Pharmacist, Inhaler technique
PC-221 Frequency of adverse drug reactions connected to hospital admissions – a project
implementing clinical pharmacy
Christina Dueckelmann
1, Jochen Schuler2, Wolfgang Beindl1
1Pharmacy Department, Landesapotheke am St. Johanns Spital, 2Cardiology Department,
Salzburger Landeskliniken, Private Paracelsus Medical University, Salzburg, Austria
Background and Objective: According to a recent meta-analysis, drug-related morbidity
leads to 3.7% of preventable hospital admissions causing enormous expenditures.1 In
Austria, there are only data on the incidence of adverse drug reactions (ADRs) of
psychiatric drugs. Clinical pharmacy is not widely practised at hospital ward level.
With this study, we aim to evaluate and document ADRs leading to or occurring during
hospital admissions. To improve the co-operation of doctors and pharmacists in an
Austrian hospital, to enhance doctors′ sensitivity in detecting drug-related morbidity,
to increase patient safety and lower costs by reducing hospital admissions.
Design: Two study nurses especially instructed about typical symptoms of ADRs identify
and document these cases prospectively in cooperation with doctors on selected internal
wards for a period of three months. These cases are evaluated by a clinical pharmacist
by means of a computer tool and data-base specialised on detecting causality and severity
of ADRs. Results and outcomes form the basis for structured feedback to doctors.
Setting: University Teaching Hospital.
Main Outcome Measures: Quantity and quality of ADRs connected with hospital admission.
Results: During the first six weeks, 958 patients were screened. Sixty three ADRs
(41 female) were identified (6.6% of admissions). More than 50% of ADRs occurred in
patients more than 75 years old. Reasons: Polypharmacy (mean number of drugs on admission
8.5) and reduced renal function (mean creatinine clearance 48.6 ml/min). Diuretics,
oral anticoagulants, NSAIDs, digoxin and antibiotics were most frequently associated
with drug-related problems. Water-electrolyte imbalance, overantigoagulation with
or without bleeding, gastrointestinal problems and bradycardia are some of the most
common problems. Results concerning the severity of ADRs will be available in September
2007.
Conclusions: ADRs are frequent in Austria. Incidences are comparable to numbers given
in the literature. Mainly older patients are affected. The impact on clinical practice
is yet unknown.
Reference
Howard RL, Avery AJ, et al. Which drugs cause preventable admissions to hospital?
A systematic review. Br J Clin Pharmacol. 2007; 63: 136–147.
Keywords: Adverse drug reactions, Hospital admissions, Clinical pharmacy
PEPI-272 Patients’ report of depressive symptoms in relation with perceptions and
adherence. A cross-sectional study among starters of cardiovascular medication
Tanja T. Menckeberg
1, Natascha S. Bechan1, Rene M. Bergsma2, Marieke Keuning3, Alex Sefa4, Wendy Woei
A Sioe5, Sandra Woudstra6, Marcel L. Bouvy7
1Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical
Science, Utrecht, 2Schiphol Apotheek, Pharmacy, Amstelveen, 3Apotheek Overhees, Pharmacy,
Soest, 4Lloyds Apotheek Middenwaard, Pharmacy, Amstelveen, 5Doornse Apotheek, Pharmacy,
Doorn, 6Noorder Apotheek, Pharmacy, Bilthoven, 7Division of Pharmacoepidemiology and
Pharmacotherapy, Utrecht Institute for Pharmaceutical Science, SIR Institute for Pharmacy
Practice and Policy, Leiden, Netherlands
Background and Objective: Adherence to cardiovascular treatment, particularly in the
first year, is low and can result in serious complications. Depression is associated
with a 3 fold increased risk of nonadherence with medical treatment. Therefore, our
aim was to investigate whether illness and treatment perceptions were associated to
depressive symptoms in patients starting treatment for cardiovascular diseases.
Design: Cross-sectional study with mailed questionnaire.
Setting: Patients, who were dispensed at least a first prescription for a cardiovascular
disease (anti-thrombotics excluded), were selected from 5 pharmacies in the Netherlands.
Main Outcome Measures: The questionnaire comprised the Illness Perception Questionnaire-Brief
(IPQ-B), Beliefs about Medicines Questionnaire (BMQ), the Medication Adherence Report
Scale (MARS) and the Centre for Epidemiological Studies Depression Scale (CES-D).
Descriptive statistics and associations between depressive symptoms and the other
study variables were assessed by bivariate correlations.
Results: Sixty two (37.1%) of 167 eligible patients returned our questionnaire. The
mean age was 62.9 yr ± 11.9 (range 40–90) and 51.6% was female. Patients reported
to have hypertension (51.6%), cardiac arrhythmia (21.0%) and hypercholestereamia (38.7%).
The mean score on CES-D was 8.15 ± 6.7 and median self-reported adherence (MARS) was
25.
Reports of depressive symptoms increased with emotional response (IPQ-B Emotional
response, r = 0.51), the perceived consequences (IPQ-B Consequences, r = 0.38) and
increased experience of symptoms (IPQ-B Identity, r = 0.49) attributed to their cardiovascular
disease. Depressive symptoms correlated with concerns about medication (BMQ, r = 0.39),
but not with self-reported adherence.
Adherence was relatively high, as 65.6% of the sample had the maximum MARS score of
25.
Conclusions: In patients who started cardiovascular treatment, perceptions about cardiovascular
disease and concerns about medication are associated with report of depressive symptoms.
Depressive symptoms did not correlate with self-reported adherence. The majority of
patients reported excellent medication taking behaviour, which might reflect their
awareness of the importance of adherence or reluctance to report deviant behaviour
rather than their actual behaviour. Further research is needed to clarify this finding.
Keywords: Depressive symptoms, Perception, Adherence, IPQ, BMQ, CES-D
PC-173 Knowledge and practice regarding crushing medication at an otorhinolaryngology
ward
Nathalie Moerman1, Sarah Mertens
1, Ludo Willems1
1Pharmacy, University Hospital Leuven, Leuven, Belgium
Background and Objective: On an otorhinolaryngology ward many patients have swallowing
difficulties or require feeding tubes, which can frequently lead to problems related
to oral ingestion of solid drugs. Opening capsules or crushing tablets can be necessary.
However, certain solid dosage forms should not be crushed because this may alter the
intended pharmacokinetics leading to adverse events. Nurses’ knowledge about these
pharmaceutical aspects of drugs is often limited.
Design: Assessment of nurses’ knowledge about certain aspects of crushability by using
a 7-question survey, previously validated by a panel of clinical pharmacists.
Setting: Otorhinolaryngology ward, University hospital, Leuven, Belgium.
Main Outcome Measures: Nurses’ knowledge and practice regarding crushing and opening
of solid oral drugs.
Results: Fifteen nurses completed the questionnaire.
93% of the nurses were aware of the purpose of controlled release formulations. Pharmaceutical
codes added to brand names such as UNO, ZOK, LA and OCAS related to prolonged activity
were not recognised in 47% of cases. In contrast, RETARD and CR were linked to slow
release by 67% of the responders. The purpose of enteric coated (EC) drugs was only
known by 26%.
In general, the nursing staff did not pay a lot of attention towards the prevention
of drug-nutrient and/or drug–tube interactions. The recommended time interval between
administration of enteral feeding and drugs was not respected.
84% of the responders would crush drugs together (in the same mortar) when multiple
drugs are prescribed.
Based on the results of the survey, an intervention plan has been developed. This
consisted of information rounds, a poster related to the topic and implementation
of the use of a website dedicated to crushing medication developed by the Flemish
Association of Hospital Pharmacists.1
Conclusions: Knowledge about crushability of solid oral drugs is often limited. Adverse
events related to incorrect crushing or opening drugs can be avoided with recognition
of the problem as well as improvements in health care provider knowledge.
Reference
www.pletmedicatie.be
Keywords: Crushing drugs
PC-176 Drug-related problems with new prescriptions – prevalence, nature and management
in community pharmacies
Patrick M. Eichenberger
1, Markus L. Lampert2, Irene Vogel-Kahmann3, Seraina Mengiardi1, J. W. Foppe van Mil4,
Kurt E. Hersberger1
1Institute of Clinical Pharmacy, University of Basel, 2Institute of Clinical Pharmacology
and Toxicology, University Hospital Basel, Basel, 3Clinical & Hospital Pharmacy, Kantonsspital
Schaffhausen, Schaffhausen, Switzerland, 4van Mil Consultancy, Margrietlaan 1, Zuidlaren,
Netherlands
Background and Objective: The detection and solution of drug-related problems is an
important activity within pharmaceutical care. This study focused on drug-related
problems (DRPs) detected during dispensing of new prescriptions in community pharmacies
and aimed to explore frequency as well as nature and the pharmacist’s management of
them.
Design: During their pharmacy internships fifth-year pharmacy students collected consecutively
5 hospital discharge and 5 primary care prescriptions. After training, they documented
DRPs and interventions on an adapted PCNE classification form. Inclusion criteria
were: age over 18, at least one new medication, at least 2 prescribed drugs.
Setting: 64 Swiss community pharmacies affording the opportunity of internships for
fifth year pharmacy students.
Main Outcome Measures: Prevalence, nature and management of DRPs in community pharmacies
assessed with an adapted PCNE classification form.
Results: The patient’s median age was 56 years (IQR 32) and they received a median
of 3 (IQR 2; range 2–19) different drugs. Prescriptions of 618 patients (285 (43.9%)
discharged from hospital) were analysed. In 129 (20.9%) of all prescriptions at least
one DRP was detected. The most frequent DRPs were potential interactions (28.7%),
wrong/improper application or time of drug intake (17.1%), inappropriate drug (8.5%)
or inappropriate drug form for indication (5.4%), no clear indication for drug use
(7.8%) and too high or too low dosage (4.7%).
These DRPs led to a total of 409 interventions (multiple answers): patient counselling
(194); request of information from prescriber (56); change of drug (15; there from
1 after consultation with physician), drug form (10), dosage (15), instruction for
application (17) or deliverable drug amount (16); drug stopped (7); start with new
drug (2); referral to a physician (3); others (74).
Out of all interventions 78.7% could be managed by the pharmacist without any contact
to the prescriber. There were no differences between hospital discharge and primary
care prescriptions.
Conclusions: In the delivery process of new prescribed drugs DRPs are frequently observed
prompting many interventions. Most DRPs can be managed by the pharmacy. Further studies
are needed to analyse relevance of the problems and impact of according interventions.
Keywords: Drug-related problems, Community pharmacies, Classification
PC-197 Belgian health authorities and clinical pharmacy projects
Hugo Robays
1, Ludo Willems2
1Pharmacy, Gent University Hospital, 9000, 2Pharmacy, Leuven University Hospital,
Leuven, Belgium
Background and Objective: Improving rational use of drugs and patient safety in the
Belgian Hospitals by clinical pharmacists.
Design: To improve rational use of drugs, a project on clinical pharmacy was launched
by the Federal Ministry of Social Affairs and Health Care in Belgium. A total budget
of approx. 1,250,000 € is available in order to finance different initiatives on pharmaceutical
care.
Setting: Belgian hospitals.
Main Outcome Measures: The main selection criteria were clinical relevancy (patient
centred initiatives) reproducibility of clinical and economical outcome, outcome indicators
and multidisciplinary approach. An approval by the hospital board and medical council
must underline the willingness to integrate the clinical pharmacy in the patient care
team.
Results: 80 projects has submitted (on a total of 112 hospitals). A total number of
28 hospitals were selected to receive funding for clinical pharmacy activities. 13
projects were quoted for a full time equivalent and 15 projects for a half time clinical
pharmacist.
The projects described different fields or a combination of different aspects of pharmaceutical
care like e.g. the transfer of information on medication use on admission and discharge
Conclusions: The funding of the Belgian Health Authorities triggered a very high response
rate, which proves the increasing attitude from the Belgian hospitals to the positive
impact of clinical pharmacy. The funding was complementary to other national projects
to improve overall safety of medical treatment. Also, many hospital administrators
took the opportunity to enhance more economical and rational use of drugs.
Financial support by the Belgian authorities of clinical pharmacy and the results
of the projects could trigger a further integration of the hospital pharmacies into
a patient care team.
Reference
www.mfc-cmp.be
Keywords: Health authoriies, Clinical pharmacy, Project funding
PC-218 Consensus of the community pharmacists’ referral criteria for the general practitioners
on minor ailments in Spain
Ocaña Ana Maria
1, Pedro Amariles2, Loreto Sáez-Benito3, Vicente Baos4, Maria Isabel Baena3, María
José Faus3, Federico Plaza5
1Pharmacist Research Group on Pharmaceutical Care GIAF-UGR, Faculty of Pharmacy, Granada,
Spain, 2Pharmacist. Research Group on Pharmaceutical Care (GIAF-UGR), Proffesor of
University of Antioquia, Medellin, Colombia, 3Pharmacist. Research Group on Pharmaceutical
Care (GIAF-UGR), Faculty of Pharmacy, Granada, 4General practitioner, Spanish Society
of Family and Community Medicine (SEMFYC), 5Pharmacist, Spanish Society of Community
Pharmacists (SEFAC), Madrid, Spain
Background and Objective: The task of assisting patients in self-medication practice
is an important component of pharmaceutical care in Spain. In order to provide appropriate
self-medication counselling pharmacist should be able to distinguish between a minor
ailment and one that it is not, and should, consequently, refer patients as necessary
to GPs. Nevertheless, there are no criteria for referral to GP in Spain. The objectives
were:(1)To identify the most relevant minor ailments, agreeing on the specific criteria
for referral to the GP.(2)To select the non-prescription drugs, with evidence of safety
and effectiveness, for the treatment of the identified minor ailments
Design: Qualitative study with an expert panel which was made up of 2 primary care
physician from SEMFYC and six community pharmacists (two members of SEFAC and four
members of GIAF-UGR). The expert panel held two meetings, of five hours each. It was
established which minor ailments were considered most relevant within the framework
of community pharmacy in Spain. Subsequently, the expert panel, reach an agreement
on the general content that should be included in the protocols for the management
of each selected minor ailment. Finally, a working team composed of 4 GPs and three
community pharmacists prepared the protocols, which were compiled into a guide for
self-medication counselling.
Setting: University of Granada, Spain during 2007.
Main Outcome Measures: Identified minor ailments, content of the protocols for each
minor ailment, non prescription drugs selected.
Results: It was selected 27 minor ailments, allocated as follows; respiratory (rhinitis,
cough, cold, flu), pain (period pains, sore throat, headache, backache, toothache),
gastrointestinal (heartburn, diarrhea, constipation, vomiting, hemorrhoids), skin
and mucous membrane (aphthae, acne vulgaris, cutaneous wounds, burns, stings, urticaria,
herpes labialis, eczema lesions) and others (vaginitis, varicose veins, fever, conjunctivitis,
insomnia).
The following sections were specified in each protocol: Banal and serious reasons
or conditions that can lead to the symptom (including drugs); referral criteria according
to the duration of the symptom and associated signs; drug treatment and non-pharmacologic
therapies. It was selected a total of 31 different non prescription drugs.
Conclusions: A total of 27 minor ailments were identified as the most frequently demanded
in community pharmacies in Spain. Referral criteria were based mainly in the duration
of the symptom and other associated symptoms that are indicative of illness. For the
treatment of these minor ailments, 31 different non prescription drugs were selected.
Keywords: Non-prescription drugs, Minor ailment, Community pharmacy services
PC-231 Descriptive analysis of pharmaceutical interventions in surgical inpatients
Mareike Kunkel
1, Matthias Ganso1, Irene Kraemer1
1Pharmacy, Johannes-Gutenberg-University Hospital, Mainz, Germany
Background and Objective: In 2004 clinical pharmacy service was implemented in three
surgical clinics (inclusive ICU). Drug related problems (DRP) were identified by medication
review and discussed with the physicians. From January to June 2005 all pharmaceutical
interventions (PI) from pharmacists (2 FTE) were recorded (paper based) and classified
according to DRP (with the PI-Doc®-System, which was modified to comply the requirements
for hospital use1), intervention type, outcome and clinical relevance. The PIs were
documented and evaluated with an Access® database.
Design: Retrospective study of PIs in surgical patients, identification of DRP by
medication review.
Setting: Departments of Neurosurgery, Accident Surgery and General/Abdominal Surgery
(70, 73 and 71 beds, respectively), university hospital.
Main Outcome Measures: DRP, intervention type, outcome, clinical relevance, drugs
and admission diagnoses being at risk for DRPs.
Results: Within six month 3679 patients were admitted. DRPs were identified in 17%
(n = 610) of the patients. Patients with DRPs were older (mean = 67 y SD ± 14 vs.
56 y SD ± 19) and had an increased length of stay (mean = 24 d SD ± 18 vs. 10 d SD ± 9).
970 PIs were made. The acceptance by the physicians was 95.8%. 175 PIs were classified
to the outcome subcategory patient safety and clinical relevance was estimated as
major (n = 6) or moderate (n = 169) by pharmacists.
Further data are based on these 175 PIs.
The most often addressed DRPs categories were overdose (34%), no or insufficient drug
monitoring, when necessary (10%), untreated indication (7%) and increased risk of
an adverse drug reaction (6%). The type of recommended intervention varied: change
dose/time of application (34%), stop drug (26%) and conduct drug monitoring (15%).
DRPs related with the outcome patient safety and at least moderate clinical relevance
were caused by 185 drugs (100%). The most affected drugs were vancomycin (13%), diclofenac
(8%), potassium (4%), acetaminophen (3%), digitoxin (3%), phenytoin (3%) and theophylline
(3%).
The incidence of the most frequently admission diagnoses of patients with relevant
DRP differed from the incidence of diagnoses of all admitted patients (incidence ICD-10
with DRP vs. all patients): M48.06 Spinal stenosis (5.8% vs. 2.2%), M51.2 Other vertebral
disc displacement (5.0% vs. 2.9%), S72.01 Fracture of neck of femur (5.0% vs. 1.1%)
and I60.9 Subarachnoid haemorrhage, unspecified (3.6% vs. 0.6%).
Conclusions: Medication review was a useful method for detecting DRPs in surgical
patients. Analysis of PI allows the identification of drugs and patients being at
risk for DRPs, which might be involved in negative outcome of pharmacotherapy.
Reference
Ganso, M. et al. (2007) Reliability of a coding system for pharmaceutical interventions.
Krankenhauspharmazie 28(7), 273–283.
Keywords: Drug related problem, Pharmaceutical intervention, Inpatient
PEC-23 Clinical pharmacy, a pharmaco-economic benefit in patient care, a literature
review
Thomas De Rijdt
1, Ludo Willems1, Steven Simoens2
1Pharmacy, University Hospitals Leuven, 2Research Centre for Pharmaceutical Care and
Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium
Background and Objective: During the last decades clinical pharmacy services developed
around the world and evidence of their (cost-)effectiveness has started to emerge(1).
A literature review was carried out that a) summarized the findings of pharmaco-economic
studies; b) evaluated the methodology employed by studies; and c) suggested how future
research has to be designed to meet the requirements of a pharmaco-economic analysis.
Design: Studies to be included are identified by searching electronic databases. Due
to limited relevance of older studies, the scope is limited to studies published between
1996 and 2006. Mainly three techniques can be used to conduct an economic evaluation:
cost-effectiveness analysis, cost-utility analysis and cost-benefit analysis.(2) All
studies are reviewed regarding results and methodological quality. Nineteen out of
312 studies met our eligible criteria.
Setting: Clinical pharmacy services provided in a hospital setting.
Main Outcome Measures: Results were analyzed in terms of number of preventable adverse
drug events (ADE), length of stay (LOS) and financial savings. Methodological quality
was assessed with respect to perspective, scope and measurement of costs and consequences,
sources of data on costs and consequences, and application of an incremental analysis.
Results: a) Nearly all studies conclude a financial benefit based on direct cost saving
and estimated cost avoidance as a measure of prevented ADE or shortened LOS. b) Methodologically
there are a number of shortcomings: e.g. not including the wage of the personnel,
lack of control groups, use of expert panels to estimate savings and costs, possible
selection bias, no valorization of health effects. c) A methodology for conducting
a prospective economic evaluation of an observational study is proposed.
Conclusions: It is not obvious to calculate the net savings of a clinical pharmacy
program or to compare different programs because there are no common guidelines for
this type of assessment. The ideal protocol is hard to achieve, so best practice will
be more realistic. Addition of direct cost saving, labor cost and economic value of
prevented ADE and shorter LOS results in a lucrative service. These savings are higher
for specific inverventions (like preventing ADE, switch therapy) or disciplines (e.g.
intensive care unit versus geriatrics). When a new clinical pharmacy service is started
one can influence the results by carefully choosing the units and type of interventions
to focus on.
References
P.J. Kaboli et al. Clinical pharmacists and inpatient medical care. Arch Intern Med.
2006;166:955–964
M.F. Drummond et al. Methods for the economic evaluation of health care programs.
Third edition. Oxford university press 2005. ISBN 019–852945–7.
Keywords: Clinical pharmacy, Pharmaco-economic analysis, Review
PEC-125 Valuing hand-foot-syndrome using the time-trade-off and visual analogue scale
Dorothee Güney
1, Susanne Roth1, Sven Simons1, Nele Reineking1, Eva-Susanne Dietrich2, Ulrich Jaehde1
1Institute of Pharmacy, Clinical Pharmacy, University of Bonn, Bonn, 2TK, Scientific
Institute for Benefit and Efficiency in Health Care, Hamburg, Germany
Background and Objective: The aim of this study was to obtain utility values for the
three different severity grades of hand-foot-syndrome (HFS) which is a dose-limiting
adverse effect associated with anticancer drugs such as capecitabine and docetaxel.
The clinical symptoms of HFS can vary from numbness and tingling (grade 1) to pain,
desquamation, blistering and ulceration (grade 3).
Design: Utility values were derived from face-to-face interviews of randomly chosen
subjects using the time-trade-off-method (TTO) and the visual analogue scale (VAS).
The participants were informed on the different severity grades of HFS using cards
consisting of a clinical definition, citations of patients and pictures showing affected
hands and feet. To determine utility values by TTO the interviewed persons were asked
to consider two alternatives: living with the particular grade for the next ten years
followed by death versus living in perfect health for a shorter period of time which
was varied until the respondent became uncertain between the options. The proportion
of time in perfect health and ten years in the particular state was defined as TTO
value. Using the VAS the subjects were asked to mark a cross on a vertical scale ranging
from 0 (worst imaginable health state) to 100 (best imaginable health state).
Setting: The interviews took place in a German community pharmacy.
Main Outcome Measures: Utility values for the different severity grades of HFS.
Results: The interrogation of 53 adults (30 females = 56.6%, 23 males = 43.4%) with
a mean age of 50.8 years (median: 49.0 years, SD: 18.5, range: 18–86 years) led to
the following mean utility values for the different severity grades: grade 1: TTO = 0.97,
VAS = 0.70, grade 2: TTO = 0.72, VAS = 0.37, grade 3: TTO = 0.34, VAS = 0.09. All
differences among the grades were statistically significant (p < 0.001).
Conclusions: HFS was considered to have major impact on the health state and quality
of life of cancer patients, particularly grade 2 and 3. Therefore HFS requires attention
and awareness by health care professionals. The health state utility values for HFS
assessed in this study may be applied in proximate cost-utility studies.
Keywords: TTO, Utility, Hand-foot-syndrome
PEPI-42 Identification of drug interactions in hospitals – computer screening vs bedside
recording
Hege Salvesen Blix
1, Kirsten K. Viktil2, Tron A. Moger3, Åsmund Reikvam4
1Lovisenberg Diakonale hospital and Department of Pharmacotherapeutics, 2Diakonhjemmet
hospital pharmacy and Department of Pharmacotherapeutics, Faculty of Medicine, University
of Oslo, 3Department of Biostatistics, 4Department of Pharmacotherapeutics, University
of Oslo, Oslo, Norway
Background and Objective: Managing drug interactions in hospitalised patients is challenging
but important. The objective of the study was to compare two methods for identification
of drug interactions (DDIs) – computerised screening and prospective bedside recording
– with regard to capability of identifying DDIs.
Design: By bedside evaluation drug-related problems, including DDIs, were prospectively
recorded by pharmacists and evaluated in multidisciplinary teams. A computer screening
programme was used to identify DDIs retrospectively – dividing DDIs into four classes:
A avoid, B avoid/take precautions, C take precautions, D no action needed.
Setting: Patient characteristics were recorded for patients admitted to five hospitals.
Main Outcome Measures: Proportion of patients with DDIs; number and types of DDIs.
Results: Among 827 patients computer screening found DDIs in 544 patients (66%); 351
had DDIs introduced in hospital. The 1513 computer identified DDIs had the following
distribution: type A 78; type B 915; type C 38; type D 482. By bedside evaluation,
DDIs were found in 73 patients (9%), with a total of 99 DDIs. The proportions of computer
recorded DDIs which were also identified bedside were: 5%, 8%, 8%, 2% of DDIs type
A, B, C, D, respectively. In 10 patients, DDIs not registered by computer screening
were identified bedside. By computer screening, the drugs most frequently involved
in DDIs were acetylsalicylic acid, warfarin, furosemide and digitoxin and by bedside
evaluation warfarin, simvastatin, theophylline and carbamazepine.
Conclusions: Despite active prospective bedside search for DDIs, this approach identified
only a small proportion – less than one in ten – of the DDIs recorded by computer
screening. This also pertained to DDIs reported by the computer screening to be hazardous.
Computer screening overestimates considerably when the objective is to identify clinically
relevant DDIs.
Keywords: Drug interactions, Drug-related problems, Computer screening
PEPI-49 Developing consensus around the pharmaceutical public health competencies
for community pharmacists in Scotland
Lorna W McHattie
1, David E. Pfleger1, Lesley H. Diack1, Dorothy J. McCaig1, Derek C. Stewart1
1School of Pharmacy, The Robert Gordon University, Aberdeen, United Kingdom
Background and Objective: The contribution of pharmacists to the delivery of public
health in Scotland is recognised in national policy1,2. The new community pharmacy
contract with its emphasis on public health will provide a new framework in which
the contribution of community pharmacy to improving health in Scotland can be delivered.
The Objective was to define the core public health competencies applicable to community
pharmacy practise, using the ‘Skills for Health Public Health Practice competency
framework’3.
Design: A web based Delphi methodology4 was used to achieve consensus on which competencies,
from the ‘Skills for Health Public Health Practice competency framework’, should be
met or aspired to by practising community pharmacists using a multidisciplinary group
of expert stakeholders. Two rounds took place.
Setting: Primary and secondary healthcare and academia.
Main Outcome Measures: Panel members rated their extent of agreement/disagreement
that each community pharmacist should achieve or be striving to achieve that particular
competency. Consensus was defined as ≥90% rating a competency as strongly agree/agree.
Results: Ten organisations (83% of those invited) and 30 organisation members (88%
of those invited) agreed to participate. Responses were received from 25 (83%) individuals
in round 1 and 22 (73%) in round 2. Consensus was achieved for 25/68 (37%) competencies
in round 1 and a further 8/68 (12%) in round 2. Competencies achieving consensus predominantly
focused on health improvement activities at individual and local community levels
and ethical management of self, rather than those relating to surveillance and assessment,
strategic leadership or research and development.
Conclusions: This research has identified that many of the competencies in the ‘Skills
for Health’ document can be applied to community pharmacy. Research has since been
carried out, using focus group and questionnaire methodology, to investigate the views
of practising community pharmacists.
References
Scottish Executive. The Right Medicine: A strategy for pharmaceutical care in Scotland.
Edinburgh: The Scottish Executive, 2002.
Public Health Institute of Scotland, Pharmacy for Health: The way forward for pharmaceutical
public health in Scotland. Glasgow: PHIS 2003.
The Sector Skills Council for Health. Skills for Health: Public Health Practice Competences.2005.
http://www.skillsforhealth.org.uk/tools/view_framework.php?id=53 [accessed 26 June
2007]
Jones J, Hunter D. Qualitative research: consensus methods for medical and health
services research. British Medical Journal 1995; 311: 376–380.
Keywords: Pharmacy, Competencies, Delphi
PEPI-120 Application of evidence-based medicine criteria to paediatric off-label drug
utilization
Begoña Feal Cortizas
1, Luis Margusino Framiñan1, Isabel Martin Herranz1
1Pharmacy Department, Juan Canalejo Hospital, La Coruña, Spain
Background and Objective: In Spain, off-label drug utilization (non-approved indications,
patient population, doses, administration route, association), must be derived to
compassionate use, which requires a prior National Health Authorities (NHA) approval
and a monitoring plan and follow up information provided to them. Request to NHA includes
circumstances of case and patient protection measures, including: physician assessment,
informed consent and institutional clearance. The objective of this study is to analyse
the strength of recommendation, strength of evidence and clinical efficacy of drugs
prescribed outside the terms of product licence (off-label) in paediatric patients
of our hospital.
Design: Literature review to evaluate the evidence level: Micromedex Healthcare Series,
Cochrane Library, Pub-Med, Embase, expert opinion or consensus. Sample: 100% off-label
drugs used in at least 2 paediatric patients (prior Spanish NHA treatment approval
required for every patient). 10 years, retrospective observational study (1997–2007).
Setting: Paediatric hospital (300 beds) and Pharmacy Department (1 pharmacist) in
a large general teaching hospital (1450 beds, 15 pharmacists).
Main Outcome Measures: Categorisation of evidence-based medicine according to Thomson
ratings of recommendation (class I–III), evidence (category A-C) and efficacy (class
I–III).
Results: 191 paediatric patients (3% total patients: adults and paediatrics) used
85 off-label drugs (27% total drugs: adults and paediatrics). Out of this 85 off-label
drugs, 48% (41/85) only approved for adults, 35% (30/85) outside of license in terms
of indication for adults and paediatric patients and 17% (14/85) both causes. 26 off-label
drugs for 29 indications were used in at least 2 paediatric patients: 17% anti-infective
agents, 14% haematopoietic growth factors, 14% cytokines, 10% hormone therapy, 7%
anti-arrhythmics, 38% other 9 therapeutic groups. The categorisation according to
evidence-based medicine was: a) strength of recommendation class: 3% I, 24% IIa; 52%
IIb, 7% III and 14% indeterminant; b) strength of evidence category: 7% A, 55% B,
28% C and 10% no evidence; c) clinical efficacy class: 2% I, 65% IIa, 21% IIb and
7% indeterminant.
Conclusions: A higher proportion of off-label prescriptions is observed among paediatric
patients, most of them related to non-approved indications in this population. There
is a broad range of therapeutic groups involved. The evidence of most off-label therapies
are based on meta-analyses of randomized controlled trials with conflicting conclusions,
small numbers of patients or significant methodological flaws or nonrandomized studies
and, although the weight of evidence favors efficacy of the treatment for a specific
indication, the therapy may be useful and indicated in some, but not most, cases.
Keywords: Medicine-based evidence, Off-label, Paediatrics
PEPI-181 Role of community pharmacists in health promotion in Khartoum state, Sudan
Abdelmoneim Awad
1, Ezeldein S. Ahmed2
1Pharmacy Practice, Faculty of Pharmacy, Kuwait, Kuwait, 2Public and Tropical Health,
University of Medical Sciences and Technology, Khartoum, Sudan
Background and Objective: There is an increasing demand towards the involvement of
the community pharmacists in health promotion. It has been reported that community
pharmacists have a successful role in providing services, which help to improve and
promote health with regard to smoking cessation, coronary heart disease, skin cancer
prevention, drug misuse, sexual health, immunization, mental health, diabetes, nutrition
and physical activity [1]. The aims of this study were to describe the current practice
of community pharmacists with regard to their provision of health promotion activities,
identify their willingness to participate in health promotion and identify the barriers
that may limit their participation.
Design: A descriptive cross sectional study, which included 186 community pharmacies
that selected via stratified and systematic random sampling. Data were collected via
face-to-face structured interview of the respondents using a pre-tested questionnaire.
Setting: Community pharmacies in Khartoum State.
Main Outcome Measures: The extent of the pharmacists’ involvement in counselling patients
about health promotion topics, their preparation to counsel patients in health promotion
topics, and their success in changing the patients’ health behaviour.
Results: The response rate was 88.2%. Seventy five (45.7%) of the study participants
were strongly involved in counselling patients on health promotion related to medications,
but less involved in counseling them on the other personal health behaviours such
as tobacco use (14.0%), alcohol use (9.1%) and exercise habits (7.9%). Seventy two
(43.9%) of the respondents perceived themselves as very prepared to counsel patients
on taking drugs and less very prepared to counsel them on other personal health behaviours.
Fifty two (31.7%) claimed a high level of success in helping patients to change their
behaviour with regard to medications, but not in relation to other personal health
behaviours. Ninety eight percent of respondents indicated their willingness to participate
in continuing education programs to gain more knowledge and skills about health education
and promotion. The main barriers facing the community pharmacists’ participation in
health promotion as perceived by respondents were lack of information and/or training
(75.6%) and lack of pharmacists’ time (27.9%).
Conclusions: Community pharmacists reported to achieve considerable success in helping
patients to change their behaviours in relation to medications, but were less successful
of their ability to change personal health behaviours. The majority of the respondents
have the interest and willingness to be a prime source of advice and support on health
promotion.
Reference
Anderson C, Blenkinsopp A & Armstong M. (2001). Evidence relating to community pharmacy
involvement in health development: A critical review of the literature 1999–2001.
www.pharmacyhealthlink.org.uk
Keywords: Community pharmacists, Health promotion, Khartoum State, Sudan
DI-31 Pregabalin utilization review after its hospital formulary introduction
Damien Galvez
1, Julien Fouque1, Axèle Reberga1, Agnès Certain1, Philippe Arnaud1
1Pharmacy Unit, AP-HP, Hospital Bichat Claude Bernard, Paris, France
Background and Objective: To describe initial period of clinical use of pregabalin,
since its admission in the hospital therapeutic formulary compared with official use
recommendations according to clinical trials (Diabetic Neuropathic Pain (DNP) and
Post-Herpetic Neuralgia(PHN)).
Design: Literature review. 4 months retrospective and descriptive study: September–December
06. Datas from prescription/dispensation computerized circuits in 8 clinical units.
Datas from archived patients files. Study of doses prescribed during 1 month, 10 months
after pregabalin admission.
Setting: Clinical units, mainly rheumatology.
Main Outcome Measures: Population characteristics and indications. Prescriptions’
adherence to recommended therapeutic strategies. Evolution of doses and titrations.
Results: 56 patients (20 males, 60 ± 16 yo), 42(75%) issued from rheumatology unit.
Pregabalin was prescribed only for neuropathic pain as indication, and only 3 patients
were concerned by DNP in Bichat, none by PHN. The mean initiation dose was 150 mg
(n = 43 patients, 77%). The maintenance daily dose (>1 week) 150 mg (n = 41/70.59%),
300 mg (n = 13/70.19%), 75 mg(n = 10/70.10%), 600 mg (n = 5/70.7%), 225 mg (n = 2/70.3%),
450 mg and 375 mg (n = 1/70.1%). Every patient could have several maintenance daily
dose during treatment. 20 patients required dose adjustments and almost 48% (n = 13/27)
of those adjustments didn’t follow the recommended titration rules: Augmentation delay
too short(n = 3.11%), unrecommended titration’s levels(n = 10.37%). Every patient
could have several titration’ levels during treatment. Only 1 patients out of 4 with
impaired renal function had a 75 mg reduction to 50 mg after dizziness complain. VAS(visual
analogic scale) was used to assess clinical efficacy but pregabalin was associated
most of the time with antalgic polymedication, so its clinical efficacy was difficult
to establish. 5 patients (9%) stopped treatment for adverse effects (AE) (4 dizzinesses
and 1 cytolytic hepatitis); but incomplete data probably underestimated AEs. Nevertheless,
dose reduction since January 07 (initiation and maintenance) consecutive of AEs, was
confirmed thanks to 1 month study (May 07)(n = 7/14.50%), less than 150 mg/day when
beginning the treatment).
Conclusions: Preliminary data issued from this drug use review demonstrate pregabalin
utility and interest. Doses and safety profiles appear quite different from published
recommendation. Further dose studies are required to optimize pregabalin dose strategies
for neuropathic pain.
References
R. Freynhagen. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week,
randomised, double blind, multicentre, placebo-controlled trial of flexible and fixed-dose
regimen. PAIN 2005;115(3):254–63
RH. Dworkin. Pregabalin for the treatment of postherpetic neuralgia: a randomized,
placebo-controlled trial. Neurology. 2003 Apr 22;60(8):1274–83
Keywords: Pregabalin, Neuropathic pain, Clinical study
NUTR-66 Compliance with prescription information sheet of trastuzumab prescriptions
in a tertiary level Spanish hospital
Jaime Vargas1, Beatriz Garcia
1, Maria Conde1, Alberto Jimenez1, Jorge Hernandez1, Maria A. Fernandez1
1Pharmacy Service, Virgen de las Nieves University Hospital, Granada, Spain
Background and Objective: To determine the degree of compliance of medical prescriptions
of Trastuzumab with conditions of use described in the Prescription Information Sheet
(PIS) before its approval in Spain for Early Breast Cancer (EBC).
Design: Prospective study of the utilization of Trastuzumab during a 6-month period
(January–June 2006). Data were collected from medical prescriptions after their validation
by the pharmacist of the Centralized Cytostatic Unit (CCU). Other data required were
gathered from the Clinical Records. Official indications were taken from the PIS:
Herceptin should only be used in patients whose tumours have HER2 overexpression at
a 3+ level as determined by immunohistochemistry: a) monotherapy in third-line or
subsequent treatments, b) in combination with taxanes in first-line treatments. Compliance
with PIS was stratified into Grade I (Tumour localization, HER2, intention-to-treat,
line and association), Grade II (Tumour localization, HER2, intention-to-treat and
line), Grade III (Tumour localization, HER2 and intention-to-treat), Grade IV (Tumour
localization and HER2) and Grade V (Tumour localization).
Setting: Patients starting Trastuzumab treatment in the Breast Unit of a tertiary
Spanish hospital during the study period.
Main Outcome Measures: Tumour localization, HER2 overexpression, intention-to-treat,
line and association.
Results: Fifty-four regimens were analyzed in 33 patients: 10 regimens (18.51%) were
assessed as grade 1 compliance, 21 (38.88%) as grade II, 27 (50%) as grade III, and
32 (59.25%) as grade IV, with all regimens (100%) achieving grade V compliance. Grade
I results were due to: 40.7% of regimens corresponding to tumours with ++ rather than
+++ overexpression of HER2; utilization of 16 non-indicated associations; and 31 regimens
in non-approved treatment lines. Trastuzumab was used in 10 cases of EBC (18.5%).
Conclusions: Only 18.51% of regimens met all indications. Trastuzumab was used in
EBC before its authorization on the basis of existing evidence. It was used only in
breast cancer and, in some cases, without the mandatory criterion of +++ HER2 overexpression.
Keywords: Degree of compliance, Prescription information sheet, Trastuzumab
PK-182 Vancomycin dosage in critically ill patients undergoing venovenous haemodiafiltration
Ana Soler
1, Rosa Farré1, Antoni Roglan2, Maria Goretti Lopez-Ramos1, Maria Antonia Mangues1
1Pharmacy Department, 2Intensive Care Unit, Hospital de la Santa Creu i Sant Pau,
Barcelona, Spain
Background and Objective: Vancomycin is usually prescribed in intensive care units
to treat infections caused by gram positive bacilli. Vancomycin requirements in patients
with acute renal failure undergoing continuous venovenous haemodiafiltration (CVVHDF)
have shown a large variability.
Objectives:
To study the pharmacokinetic parameters of vancomycin in critically ill adult patients
undergoing CVVHDF.
To identify vancomycin dosage required to achieve plasma concentrations within the
therapeutic range (Cmin 5–15 mg/L).
Design: Retrospective study in critically ill adult patients with acute renal failure
undergoing CVVHDF and requiring vancomycin therapy from January 2005 to June 2007.
The study included 29 patients (19 men and 10 women). Age ranged from 29 to 83 years
(mean 62.5 ± 13.8). Serum levels were determined by Fluorescence Polarization Immunoassay
(TDX, Abbott). Individual vancomycin pharmacokinetic parameters were estimated by
a Bayesian method (two-compartment model) applying the PKS program (Abbott Base PK
System Version 1.10). An individualized dosage schedule was designed according to
the pharmacokinetic parameters for each patient.
Setting: Intensive Care Unit and Clinical Pharmacokinetics Section, in a 723-bed tertiary-care
university hospital.
Main Outcome Measures: 1. Pharmacokinetic parameters of vancomycin. 2. Vancomycin
dosage requirements.
Results: The mean central volume of distribution (Vc, L/Kg) and elimination half-life
(h) (X ± SD) were 0.23 ± 0.03 and 33.7 ± 18.5, respectively. The mean daily dose of
vancomycin required to reach the specified target concentrations, after dosage individualization,
was 8.5 ± 3.3 mg/kg/day. The dosing interval was every 24 h for 18 of 29 patients
(62.1%), and every 48 h for 9 of 29 patients (31.0%). The long half-life suggests
the appropriateness of a loading dose.
Conclusions: An initial dose of 15 mg/kg, followed by a maintenance dose of 8–10 mg/kg/24 h
can achieve levels within the therapeutic range in 2/3 of patients. Therapeutic drug
monitoring is also advisable in view of the wide variability in these patients, probably
due to daily replacement fluids and residual renal function.
Keywords: Vancomycin, CVVHDF, Pharmacokinetics
PK-203 Effect of co-treatment with valproic acid on carbamazepine elimination in epileptic
patients – a population pharmacokinetic study
Katarina Vucicevic1, Branislava Miljkovic
1, Marija Petronijevic1, Milena Pokrajac1, Ales Mrhar2, Iztok Grabnar2
1Department of Pharmacokinetics, Faculty of Pharmacy, University of Belgrade, Belgrade,
Serbia, 2Department of Pharmacokinetics, Faculty of Pharmacy, University of Ljubljana,
Ljubljana, Slovenia
Background and Objective: Many factors contribute to interindividual variability in
response to carbamazepine (CBZ) therapy in epileptic patients. There are controversial
reports regarding effect of valproic acid (VPA) on CBZ pharmacokinetics. Therefore,
the objective of this study was to investigate the possible effect of VPA on CBZ elimination.
Design: In total 379 epileptic outpatients’ data were retrospectively collected from
routine therapeutic drug monitoring. Patients were on stable dosage regimen for at
least 14 days, mono or polytherapy, and 1–2 concentrations per patient were available.
In the model building set, 28.3% of patients were co-treated with VPA (average dose
1039 ± 442 mg/day), while model validation set included 17% of patients on VPA co-therapy
(average dose 1219 ± 432 mg/day). Pharmacokinetic analysis was performed by a population
modelling approach using NONMEM and Visual-NM, assuming one-compartmental model with
first-order absorption and elimination. FOCE method was used.
Setting: The study was conducted at the Institute of Mental Health, Belgrade, Faculty
of Pharmacy University of Belgrade, Faculty of Pharmacy University of Ljubljana.
Main Outcome Measures: CBZ was best described by one-compartmental model. The model
included an estimate of the interindividual variability for CBZ clearance (CL/F).
Results: Observation of the plots of posterior Bayesian estimates of CBZ CL/F obtained
by the base model versus VPA daily dose, indicated a step-like increase when VPA dose
was greater than 750 mg/day. Therefore, the influence of VPA on CBZ CL/F was tested
by the following equation: TVCL = THETA(1)*(THETA(2))**VPA, where VPA is 1 if dose
VPA > 750 mg/day or 0 otherwise. Interindividual variability of CBZ CL/F was best
described by exponential error model (CV was 36.5(31.6–40.7)%), while additive error
model most adequately characterized residual variability in CBZ concentration (1.18(0.98–1.36) microg/mL).
The effect of VPA on CBZ CL/F was 1.18(1.03–1.33) in the final multiplicative model.
Conclusions: Since total CBZ concentration was measured, and due to the fact that
VPA is highly bound to plasma proteins (90%), this slight increase in CBZ CL/F might
be caused by displacement from plasma proteins. In order to support this assumption
data on unbound CBZ concentrations is required. Hence, the results in this study showed
that during VPA co-therapy CBZ CL/F is increased by 18% if dose VPA > 750 mg/day,
and CBZ concentration (unbound fraction, and its active metabolite) should be monitored
in order to evaluate clinical importance of VPA-CBZ interaction.
Keywords: Epilepsy, Carbamazepine, Valproic acid, Pharmacokinetics, NONMEM
PT-34 Clinical pharmacist’s intervention to improve the management of potential drug-drug
interactions in a department of internal medicine
Priska Vonbach
1, André Dubied2, Jürg H. Beer3, Stephan Krähenbühl4
1Hospital Pharmacy, University Children’s Hospital, Zürich, 2Hospital Pharmacy, 3Department
of Medicine, Cantonal Hospital of Baden, Baden, 4Clinical Pharmacology and Toxicology,
Universitiy Hospital Basel, Basel, Switzerland
Background and Objective: The aim of this study was to improve the clinical management
of potential drug-drug interactions (pDDIs) by pharmacist interventions during hospitalization
and at hospital discharge.
Design: During the first study period inpatients in three medical wards and during
the second study period patients discharged from three medical wards were screened
for major and moderate pDDIs using the drug interaction screening program Pharmavista.
After assessment for clinical relevance of the detected pDDIs by a pharmacist, written
recommendations and information about the pDDIs were sent to the physicians. Feedback
from the physicians and their subsequent implementations were analyzed.
Setting: Department of internal medicine at the Cantonal Hospital of Baden.
Main Outcome Measures: Improvement of the clinical management of pDDIs.
Results: During the first study period, 502 inpatients were exposed to 567 major or
moderate pDDIs. 419 (74%) of these pDDIs were judged clinically relevant by the pharmacist.
349 recommendations including pDDI information, and 70 simply information leaflets
were handed out to the physicians. 80% (278 of 349) of the recommendations were accepted.
At hospital discharge, in 78% (47 of 60 reviewed instances, which were accepted) the
drug changes due to the recommendations were implemented.
During the second study period, 792 patients at hospital discharge were exposed to
392 major and moderate pDDIs. 258 (66%) pDDIs were assessed as clinically relevant
by the pharmacist. 247 recommendations including pDDI information, and 11 simply information
leaflets were sent to the physicians. 73% (180 of 247) of the recommendations were
accepted. One year after hospital discharge, 11 of 13 drug changes due to recommendations
were still existent.
Overall, in 50% and 46%, respectively, of all major and moderate pDDIs detected by
Pharmavista, clinical management was adapted accordingly.
Conclusions: The management of clinically relevant pDDIs can be improved by physicians’
advice of clinical pharmacists. Changes in medication due to pDDIs were found to persist
up to one year after hospital discharge.
Keywords: Potential drug–drug interactions, Intervention study, Clinical management
PT-95 Sunitinib in advanced metastatic renal cell carcinoma
Diana González
1, Gema Casado1, Ana Sierra1, Angeles M. Tacoronte1, Alicia Herrero1, Pilar Zamora2,
Esperanza Jimenez1
1Pharmacy, 2Oncology, La Paz University Hospital, Madrid, Spain
Background and Objective: Current treatment options for metastatic renal cell carcinoma
(mRCC) are limited and there is a need to identify novel and effective therapies.
Sunitinib is an oral multitargeted tyrosine kinasa inhibitor, which has shown activity
in cytokine-refractory metastatic RCC patients. This agent inhibits vascular endothelial
grown factor receptor and platelet derived growth factor receptor. The purpose of
this study is to analyse the efficacy and safety profile of this agent in patients
with mRCC.
Design: Retrospective assessment in seven patients treated with sunitinib as second-line
treatment in mRCC. Data were obtained from clinical histories and informatic records
from the oncology pharmacy department.
Setting: Oncology and Pharmacy Department. La Paz University Hospital. Madrid. Spain.
Main Outcome Measures: Assessment of clinical response and adverse events.
Results: Seven patients were evaluated (4 men, 3 women), median age was 57 (41–77).
Six of them presented bone, lung, brain or liver metastases, all patients were treated
with vinblastine and IFN-alpha as first-line therapy. Patients received sunitinib
at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks
followed by 2 weeks off treatment. They started therapy with sunitinib because of
progressive disease in 3 patients and adverse events in 4 patients on previous therapy.
Sunitinib was discontinued in four of them, causes were: adverse events (1 patient),
volunteered dropout (1 patient) and progressive disease (2 patients). The median progression-free
survival was 6.2 months. The median number cycles received was six and 3 of the 7
patients are still in treatment at the time of data analysis.
Dosage was reduced 25 mg daily because of unacceptable toxicity: hand-foot syndrome(1
patient) and hypothyroidism (1 patient). The most common adverse events experienced
were: asthenia (6 patients), diarrhea (3 patients), damaged nails(2 patients), insomnia
(2 patients), dermatitis (3 patients)and dehydration (2 patients).
Conclusions: In our experience, sunitinib has demonstrated an acceptable efficacy
and safety profile as a single agent in second-line therapy for patients with mRCC.
References
Motzer RJ et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA
2006 Jun 7;295(21):2516–24.
Wong BY, Vogelzang NJ. Do patients with metastatic renal cell carcinoma benefit from
sunitinib? Nat Clin Pract Oncol. 2007 Feb;4(2):72–3.
Keywords: Sunitinib, Carcinoma renal, Metastatic
PT-104 Antibiotic drug monitoring quality assessed by a clinical pharmacist: qualitative
study
E. Ampe
1, A. Spinewine1, Y. Glupczynski2, B. Delaere3, J.M. Feron4, J. Pierart5, C. Bouland6,
J.D. Hecq7, P.M. Tulkens1
1Centre for Clinical Pharmacy, Université catholique de Louvain, Brussels, 2Laboratoire
de Biologie Clinique, 3Service d’Infectiologie, Cliniques universitaires de Mont-Godinne,
Yvoir, 4Centre universitaire de Médecine Générale, Université catholique de Louvain,
Brussels, 5Unité d’anthropologie et de sociologie, Université catholique de Louvain,
Louvain-la-Neuve, 6Institut Bruxellois de Gestion de l’Environnement, IBGE, Brussels,
7Pharmacie, Cliniques universitaires de Mont-Godinne, Yvoir, Belgium
Background and Objective: (i) gaining insight in issues causing poor performance of
antibiotic therapeutic drug monitoring (TDM) revealed by an observational study (companion
abstract) (ii) collecting the perception of health care professionals and laboratory
personnel on current TDM practice (iii) exploring approaches for optimizing TDM (collaboration
with a clinical pharmacist).
Design: Focus group interviews with independent moderators with: (i) representative
sampling of involved health care providers; (ii) validated questionnaire to guide
discussion; (iii) fostering group interaction to generate data; (iv) post-interview
analysis of verbatim transcripts with specialized software (QSR Nvivo 1.2 for Windows®),
based on the grounded theory approach (classification of emerging themes).
Setting: 3 groups: prescribing physicians (7), nurses (10), and laboratory technicians
(6), all involved in antibiotic TDM as performed in orthopaedic surgery, general surgery,
neurosurgery, vascular surgery, haematology, and pulmonary wards in a 400 beds teaching
hospital.
Main Outcome Measures: (i) issues causing poor antibiotic overall TDM performance,
(ii) approaches for optimizing TDM performance supported by group consensus
Results: Key identified Issues: (i) nursing work overload; (ii) insufficient education
to pharmacokinetics and lack of specific training; (iii) insufficient information
communication and lack of coordination and involvement of all stakeholders; (iv) conflicting
guidelines; (v) lack of perception of positive benefit/risk ratio.
Approaches for optimization (consensus): (i) continuous education of all stakeholders;
(ii) daily multidisciplinary collaboration with infectious disease physicians and
clinical pharmacists; (iii) simplification and uniformization of guidelines and procedures;
(iv) implementation of a simpler administration scheme (v) increased staffing.
Conclusions: Correct performance of TDM and its implementation in routine clinical
care needs to be critically assessed and appears to be mainly dependent on non laboratory-related
parameters.
Keywords: Therapeutic drug monitoring, Qualitative study, Clinical pharmacist
PT-106 Impact of the new scientific evidences in the treatment of the anaemia with
erythropoietin
Juan Hidalgo1, Juan Abellón
2, Raquel Mariscal1, Encarnación Atienza1, Rocío Gavira1, Paloma Fajardo3, Elsa Montilla4,
Isabel Baena3, Pilar Gómez1
1Hospital Pharmacy, Hospital General de Jerez de la Frontera, Jerez de la Frontera,
2Hospital Pharmacy, Hospital Reina Sofía, Córdoba, 3Pharmaceutical Care Research Group,
University of Granada, Granada, 4Community Pharmacy, Community Pharmacy, Algeciras,
Spain
Background and Objective: New data published at the end of 2006 and the beginings
of the 2007, suggest not to exceed a haemoglobin level of 12 g/dL to avoid cardiovascular
morbility-mortality in patients with anaemia and chronic kidney disease (CKD) treated
with recombinant human erythropoietin (rHuEPO). Before these evidences the optimal
target haemoglobin levels was greater than 12 g/dL.
Our aim is to evalue if these new published evidences have changed the clinical practice
in pre-dialysis CKD patients.
Design: Retrospective observational study. All the pre-dialysis patients who received
rHuEPO were including. In order to evaluate the possible changes in clinical practice,
we measured the levels of haemoglobin prior to the publication of evidences (March–May
of 2006: group 1) and after the publication of these evidences (March–May of 2007:
group 2). We made a descriptive analysis of independent data.
Setting: Department of hospital pharmacy.
Main Outcome Measures: The main outcome measures were: age, sex, mean Glomerular Filtration
Rate (GFR), mean haemoglobin level, mean haematocrit and type of rHuEPO used.
Results: We studied 196 patients (95 in group 1 and 101 in group 2). Patients age
ranging between 23 to 96 years (median = 73 years). The proportion of women was 61.2%.
Mean GFR for both years located around 25 ml/min and the most frequent stages of renal
injury were 4 and 3. The most rHuEPO used was Darbepoetin alfa (71.4% of patients).
Mean haemoglobin level for group 1 was 11.25 g/dL (SD = 1.43) and 11.61 g/dL (SD = 1.43)
for group 2. Mean haematocrit was 34.98% (SD = 4.53) and 35.9% (SD = 4.42) for group
1 and 2, respectively.
Conclusions: Our nephrologist are cautious about of prescribing rHuEPO, not only after
the publication of the new scientific evidences on this subject, but before this too.
It′s worth questioning if clinical practice in ours hospital is different from the
published evidences.
References
Steinbrook R. Haemoglobin concentrations in chronic kidney disease. The Lancet 2006;368:2191–93.
Phrommintikul A et al. Mortality and target haemoglobin concentrations in anaemic
patients with chronic kidney disease treated with erythropoietin: a meta-analysis.
The Lancet 2007;369:381–88.
Drüeke TB et al. Normalization of hemoglobin level in patients with chronic kidney
disease and anemia. N Engl J Med 2006;355:2071–84.
Singh AK et al. Correction of anemia with epoetin alfa in chronic kidney disease.
N Engl J Med 2006;355:2085–98.
Keywords: Anaemia, Erythropoietin, Chronic kidney disease
PT-112 Retrospective observation of converting cyclosporin to tacrolimus in renal
transplant patients at middlemore hospital
Sanja Mirkov
1, Sharad Ratanjee2, Andrew Knox2
1Pharmacy Department, 2Renal Department, Middlemore Hospital, Auckland, New Zealand
Background and Objective: Tacrolimus (TAC)-based immunosuppression is effective in
adult renal transplant patients with acute or chronic rejection or cyclosporin (CYA)-related
toxicity. The conversion from CYA to TAC resulted in improved cardiovascular risk
profile and increased prevalence of post-transplant diabetes mellitus (PTDM)compared
with treatment with CYA.
The aim of this study was to review clinical documents for renal transplant patients
and assess patients’ outcomes.
Design: A retrospective review of clinical data. Excluded from the study were patients
converted to TAC less than 3 months post-transplantation.
Statistical analysis (one sample paired 2-tailed t test) was performed using Microsoft
Office Excel 2003. The graft survival was analysed with Kaplan-Maier survival curve
using XL Stat software.
The study was approved by the Northern Ethics Committee, Auckland, New Zealand.
Setting: Tertiary care setting.
Main Outcome Measures: Mean serum creatinine, incidence of PTDM, mean total cholesterol,
HDL cholesterol, LDL cholesterol, Total/HDL cholesterol ratio, mean blood pressure
and antihypertensive scores, graft survival censored for death.
Results: Forty-four patients were converted to TAC more than 3 months post-transplantation
from 1998 to June 2006.
Mean serum creatinine (SCr) increased in the 3 months prior to conversion from 149 μmol/L
(95% CI 143–155) to 167 μmol/L (95% CI 159–174) at 12 months post conversion to TAC
(p-value = 0.44). Thirty-four patients were taking CYA for more than 12 months. The
mean SCr increased from 143 μmol/L (95%CI 138–148) at the 12 months prior to conversion
to 172 μmol/L (95%CI 164–180) at 12 months post conversion (p-value 0.04). If SCr
for seven patients who had an acute rejection episode were excluded, the mean SCr
did not show any change in slope after conversion and showed a tendency to gradually
increase from 148 μmol/L (95%CI 142–153) to 159 μmol/L (95%CI 151–167) 12 months post
conversion (p-value 0.32)
Eleven out of 44 patients were affected by diabetes mellitus. Six patients were diabetic
pre transplantation and remained diabetic post transplantation and post conversion
to TAC. Two patients developed new onset PTDM post transplantation and two became
glucose intolerant. After conversion to TAC, glucose intolerance resolved in one patient
and one patient (2%) developed new onset PTDM.
In 34 patients converted to TAC more than 12 months post transplantation, mean total
cholesterol was reduced from 5.3 to 4.5 mmol/L (p-value 0.02) and mean LDL cholesterol
from 2.9 to 2.5 mmol/L (p-value 0.004).
In June 2006, 35/44 patients (79.5%) were taking TAC with a mean SCr of 158 +− 56 μmol/L.
Four patients (9%) lost their grafts. Mean graft survival time was 81.2 months. 5-year
graft survival was 80.8%.
Conclusions: Conversion from CYA to TAC was beneficial with respect to renal function
and cardiovascular risk profile. The conversion had no added benefit on renal function
in patients with stable renal function taking CYA more than 12 months post transplantation.
The reported incidence of PTDM was found to be low (2%).
Keywords: Renal transplantation, Cyclosporin, Tacrolimus
PT-151 The role of the clinical pharmacist on oncology service: pain management
Divin Sevgen
1, Fikret Vehbi Izzettin2, Serdar Turhal3
1Clinical Pharmacy Service, Yeditepe University Hospital, 2Clinical Pharmacy Department,
Marmara University – Faculty of Pharmacy, 3Oncology Division, Department of Internal
Medicine, Marmara University Hospital, Istanbul, Turkey
Background and Objective: Most of the cancer patients suffer from severe pain especially
during the terminal phase of the disease. It is essential to monitor these patients
to achieve adequate and successive pain management, not just because of the importance
of the effects, side effects and overdose problems; but also to improve quality of
life. The aim of the study was to evaluate oncology pharmacist interventions on pain
management.
Design: Numeric pain scales was conducted prospectively among the 58 cancer patient
who were over 18 years old and were selected randomly. Patients were separated into
two groups: 29 of the patients was control group, pharmacist had been effectively
included to the rest 29 patient’s pain management strategies, which was pharmacist
intervention group. All of the patients had been evaluated by numeric pain scales
(time 0). The patients who were on pharmacist intervention group were monitored by
pharmacist on treatment effectiveness and side effect profile every three days during
the study. After one month, numeric scales were repeated (time 1). The interventions
that pharmacist done were pain evaluation, suggestion on appropriate pain reliever,
dose management, patient education and patient monitoring. Our therapy recommendations
were made on the basis of the World Health Organization’s analgesic ladder following
the results of assessments.
Setting: Oncology Outpatient Unit of a university hospital
Main Outcome Measures: The demographic and diagnostic information of the patients
were collected. The results of the evaluations via numeric pain scales were calculated
by using arithmetic mean value.
Results: The mean of pain intensity was significantly decreased in pharmacist intervention
group when compared with control group (2.35 ± 1.85 vs. 4.04 ± 2.10, p = 0.003) and
between time 0 and time 1 (3.68 ± 1.93 vs. 2.35 ± 1.85, p = 0.011). The mean of pain’s
effect on daily activity was significantly decreased in pharmacist intervention group
when compared with control group (3.34 ± 2.79 vs. 6.00 ± 2.57, p = 0.010) and between
time 0 and time 1 (5.23 ± 3.01 vs. 3.34 ± 2.79, p = 0.019). The mean of drug effectiveness
was significantly increased in pharmacist intervention group when compared with control
group (86.30 ± 16.4 vs. 73.52 ± 26.6, p = 0.040) and between time 0 and time 1 (58.45 ± 36.9
vs. 86.30 ± 16.4, p = 0.001).
Conclusions: The harmonious working of the pharmacist with the other health care staff
working in oncology unit, helped patients to achieve more effective pain management.
In this study; pain intensity was decreased, pain interfered less with daily activities
was, and the reported effectiveness of drugs was increased in the pharmacist intervention
group compared to the control group. All these outcomes show that the clinical pharmacists
have an important role in oncology services, especially pain management.
PT-191 A comparative study of prescribing errors requiring contact with the prescriber
before dispensing in Norway, Estonia and Sweden
Svein Haavik
1, Daisy Vollmer2, Anders Ekedahl3
1Institute for Pharmacy Practice Research, University of Bergen, Bergen, Norway, 2University
of Tarttu, Tarttu, Estonia, 3Apoteket AB, University of Kalmar, Kalmar, Sweden
Background and Objective: To investigate and compare the frequency and nature of prescrbing
errors requiring contact with the prescriber at community pharmacies in Norway, Estonia
and Sweden.
Design: A protocol, based on a scheme originally presented by Rupp (1), revised and
developed by Kennedy (2) and translated and transformed to the Nordic context by Haavik
(3), was used in all three settings. In Norway the protocol was self-completed by
the pharmacists; in Sweden and Estonia observers (trained students) recorded and classified
the interventions.
Setting: Norway – 9 community pharmacies in southern and western Norway; Estonia –
4 community pharmacies in three cities; Sweden – 6 community pharmacies in 6 Swedish
cities and 6 public pharmacies at 6 hospitals in Sweden.
Main Outcome Measures: Prescriptions with errors or ambiguities where the pharmacist
decided to contact the prescriber to correct, clarify or complete the information
on the prescription.
Results: The total numbers of dispensed prescriptions were: Norway 69,315, Estonia
13,221, Sweden 49,657 (community pharmacies) and 36,840 (public pharmacies at hospitals).
The proportion of handwritten prescriptions and prescriptions where pharmacists contacted
the prescriber was higher in Estonia than the other countries. Administrative problems
– reimbursement issues; prescriber data and distribution and licensing issues – were
the reason for more than one third (34–43%) of all contacts with the prescribers in
all settings. However, the patterns of prescription problems with potential clinical
hazards varied – in Estonia and Norway, errors concerning strength, administration
form and number of doses were the most common errors and constituted 31 and 24% of
the problems. In Sweden, errors concerning the prescribed dosage were the most common
reasons.
Conclusions: The proportion of problem prescriptions requiring a clarifying contact
with the prescriber was higher in Estonia compared to Norway and Sweden. The main
reason may be that most prescriptions in Estonia were handwritten. Administrative
problems (reimbursement and availability of prescribed products) constituted a similar
large portion in the three countries. However, prescription problems with potential
clinical consequences for the patients, varied.
References
Rupp MT, DeYoung M, Schondelmeyer SW. Prescribing problems and pharmacist intervention
in community practice. Med Care 1992; 30(10): 926–40.
Kennedy AG, Littenberg B. A dictation system for reporting prescribing errors in community
pharmacies. Int J Pharm Pract 2004; 12:13–9
Haavik S, Svane Mellbye K, Horn AM, Kjönniksen I, Granås AG. Forskrivningsfeil – omfang
og oppklaring. Tidsskr Nor Lægeforen 2006; 126: 296–8
Keywords: Prescribing errors, Pharmacists interventions, Community pharmacy
PT-247 Cotrimoxazole induced agranulocytosis in an AIDS patient: a case report
Inge Sluyts
1, Sandrina von Winckelmann1, Isabel Spriet1, Ludo Willems1
1Pharmacy, University Hospital Leuven, Leuven, Belgium
Background and Objective: Cotrimoxazole is a frequently used antibiotic in AIDS patients
to treat life-threatening infections, such as toxoplasmosis or Pneumocystis jiroveci
pneumonia. The mechanism of action of both trimethoprim and sulfamethoxazole is based
on interference with the folic acid pathway of the micro-organism. Rare, severe adverse
drug reactions have been associated with cotrimoxazole, including dermatologic and
hepatotoxic reactions and agranulocytosis. Our case report describes agranulocytosis
related to the administration of a high dose of co-trimoxazole in an AIDS patient.
Design: Case report and literature review.
Setting: Medical intensive care unit, University Hospital Leuven, Belgium.
Main Outcome Measures: Evaluation of cotrimoxazole as a possible cause for agranulocytosis.
Results: A 60-year old man, with a new diagnosis of AIDS (CD4 count 20/mm3), presenting
with Salmonella bacteremia and neurological deterioration due to cerebral toxoplasmosis
was admitted to the intensive care unit. He was immediately intubated. To treat toxoplasmosis,
cotrimoxazole was started in a dose of 1600 mg SMX/320 mg TMP QD. 6 days later the
patient developed leucopenia (absolute wbc count: 1.57 × 109/L, neutrophils: 1.4 × 109/L).
Folinic acid 15 mg OD was associated to restore white blood cell count. Neutrophils
further dropped to attain its nadir (0.4 × 109/L) on day 8 of cotrimoxazole therapy.
Cotrimoxazole was stopped and clindamycin 600 mg TD was used instead. Neutrophil count
restored, normalizing on day 2 after stopping cotrimoxazole.
This event was attributed to the administration of cotrimoxazole. The time relation
between the administration of cotrimoxazole and the onset of neutropenia as well as
the normalisation of neutrophils was clear. Other explanations, such as the contribution
of concomitant medication (ranitidin, ceftriaxon, ethambutol, isoniazid, rifampicin,
aciclovir, amphotericin B, enoxaparin)could be ruled out. The Naranjo score, which
estimates the probability of adverse drug reactions, is 6.
The use of folinic acid as rescue therapy in association with cotrimoxazole is controversial,
as it can theoretically antagonise the anti-infective action of cotrimoxazole. Therapeutic
failure in AIDS patients, receiving this combination for Pneumocystis jiroveci pneumonia,
has been reported. Nevertheless, we decided to start folinic acid to further prevent
nosocomial infections in this severe immunocompromised host. We don’t know whether
folinic acid contributed to quick recovery of neutrophil count in our patient. Further
studies are necessary to clarify its role as rescue agent during treatment with folic
acid antagonists.
Conclusions: This case report illustrates that cotrimoxazole, frequently used in opportunistic
infections, can be associated with agranulocytosis. This dangerous complication in
immunocompromised patients with severe infections must be prevented, although the
effectiveness of folinic acid as rescue therapy is still a matter of debate.
References
Andersohn F et al. Ann Intern Med. 2007; 146:657–665
Safrin S et al. J Infect Dis. 1994; 170: 912–917
Naranjo CA et al. Clin Pharmacol Ther 1981;30:239–244
Keywords: Cotrimoxazole, Agranulocytosis
DI-70 Eczematous skin reaction of the palm after intravenous immunoglobulin infusion:
a case report
Claire Chapuis
1, Nathalie Sylvoz1, Céline Villier2, Pierrick Bedouch1, Gérard Besson3, Benoît Allenet1,
Jean Calop1
1Pharmacy, 2Pharmacovigilance, 3Neurology, University Hospital, Grenoble, France
Background and Objective: Intravenous immunoglobulin (IVIG) therapy is increasingly
used in inflammatory and autoimmune disorders, because of its therapeutic benefit
and its good safety profile. Cutaneous adverse events are rare and include prurit,
rash, alopecia and eczema. In the literature, about 40 cases of eczematous skin reactions
have been reported. Most of the cases were treated for a neurological or neuromuscular
disease. Erythematous eruptions on hands and feet have been notably reported after
high-dose infusion. In most of the cases, the eruption was progressively extending
to involve the entire body. When IVIG were readministered, eruptions were more rapid
and more intensive. We report an eczematous skin reaction of the palms after IVIG
infusion without extensive eruption, in spite of three administrations.
Design: Case report.
Setting: Neurology ward, University Hospital, Grenoble, France.
Main Outcome Measures: A 57-year-old man was treated with IVIG (Tegeline®, LFB, France)
for an inclusion body myositis. He developed a skin reaction, 8 days after the end
of a 5 days IVIG infusion (dose of 0.4 g/kg was given daily for 5 consecutive days).
The eruption was a non-pruriginous erythematous maculopapulovesicular rash located
on the palms. This reaction occurred 8th day after completing the second therapy and
did not extend. The lesions regressed progressively with topical application of fatty
ointment. Three days after the third infusion, the same lesions reappeared, and regressed
the same way.
Results: Clinical Pharmacist with the help of pharmacovigilance experts and Doctor
worked collaboratively: because of the chronology of exposure to other treatments,
intrinsic imputability and recurrence on reintroduction, we ruled out an adverse drug
reaction to any other medication. We decided not to interrupt the infusion. We advised
the patient to continue fatty ointment application and to tell the healthcare team
if the reaction became more serious.
Conclusions: Dermatologic adverse reactions such as eczematous skin reactions are
rare and usually mild. There is no reason to limit the use of IVIG in a case like
this one, as long as the treatment is effective. However, a narrow clinical and biological
follow-up is required. If necessary, this adverse effect can be prevented by anti-histamines
or even steroids.
Keywords: Eczema, Intravenous immunoglobulin, Palms
DI-81 Drug herb interactions with oral anticoagulants
Joan Peris
1, Begoña Pascual2, Laura García2, Nieves Muro2, Gemma Surra1, Teresa Vinuesa1
1Hematology Department, 2Pharmacy Department, Municipal Hospital of Badalona, Badalona,
Spain
Background and Objective: The vitamin-K antagonists are drugs widely used as thrombosis
therapy and its prophylaxis. The use of anticoagulants must be monitored closely by
physicians, because this products have a narrow therapeutic index. Numerous interactions
with herbs are documented, either increasing or decreasing the anticoagulant effect.
Our main objective is to identify this interactions in our surgery and if they are
clinically significant.
Design: Six months observational study; interviewing patients with their INR alterated
about herbs that they were taking at that moment. Literature review.
Setting: The anticoagulant oral treatment surgery.
Main Outcome Measures: The two oral anticoagulant drugs available in Spain are acenocoumarol
and warfarin.
The international normalized ratio (INR) is the laboratory test used to measure therapeutic
efficacy and safety of vitamin-K antagonists. A control test is done every four weeks
and if necessary it can be done earlier.
Results: Among 621 patients with INR > 4, six of them were taking herbs at the same
time, and we could relate the increase of the effect of oral anticoagulants to those
products.
One of this patients who was taking dandelion (Tarxacum officinale) had a 4 INR. An
other one who was taking chamomille (Matricaria capensis) and passion flower (Passiflora
incarnata) had a 7.8 INR. All of these products have coumarins compounds.
Two patients who were taking equinacea (Equinacea purpurea, Equinacea angustifolia)
also had their INR test altered: one had a 5.2 INR and the other one 4.9. An other
one was taking bilberry (Vaccinium myrtillus) and had a 16.16 INR. Both, equinacea
and bilberry inhibit different isoenzimes of cytochrome P450.
The last patient was taking garlic oil (Allium sativum) and had a 4 INR. Garlic increases
the anticoagulant effect.
Conclusions: It is commonly believed that herbal products are inofensive, that is
the reason why mainly of the patients do not take medical advise before starting a
treatment with them. However, there can appear interactions with the usual treatment.
If we fix on the vitamin-K antagonists the risk resides on the hemorragic or strokes
events.
In conclusion, we believe that patients should be educated about the potential risk
of using herbal products while being treated with vitamin-K antagonists.
References
Merrily A Kuhn. Herbal remedies: drug-herb interactions. Critical Care Nurse. 2002;
22:22–31
Holbrook AM, Pereira JA, Labiris R, et al. Systematic overview of warfarin and its
drug and food interactions. An-It Intent Med. 2005; 165:1065–1106
Wittkowsky AK. A systematic review and inventory of supplement effects on warfarin
and other anticoagulants. Thomb Res. 2005; 117:81–86
Noelle E Daugherty, Kelly M Smith. Dietary supplement and selected food interactions
with warfarin. Orthopedics. 2006; 29: 309–14
Keywords: Vitamin-K antagonists, Herbs, Interactions
DI-103 Non fatal aplastic anaemia due to clopidogrel
Nicolas Simon
1, Marc Wetterwald2, Frédérique Bonnevie2, Maxime Bemba2, Marie Beaumont2, Jean-Michel
Pignon2, Caroline Muller1, Marie Perrinet1, Frédérique Barrier-Danicourt1, Sandrine
Horrent1, Sébastien Hochart1, Bertrand Décaudin1, Jean-Pierre Résibois1, Pascal Odou1
1Pharmacy Department, 2Haematology Department, Dunkerque Hospital, DUNKERQUE, France
Background and Objective: Haematological side effects with clopidogrel are considered
rare. Three cases of fatal aplastic anaemia (AA) were reported in the literature,
We report here the first case of non fatal AA possibly due to clopidogrel,
Design: Case report and analysis based on clinical data and literature review,
Setting: Pharmacy and Haematology departments, Dunkerque Hospital
Main Outcome Measures: clopidogrel side-effect, co-morbidities, pharmacovigilance
Results: A 41 year-old man, treated with clopidogrel after coronary stenting, is hospitalized
for AA (Neutrophils: 0G/l (1.7–7G/l); haemoglobin: 10.8 g/dl (12–16 g/dl); platelets:
6G/l (150–450G/l)). His permanent medications were insulin, perindopril, omeprazole,
atorvastatine, bisoprolol, and acetylsalicylic acid. Clopidogrel (75 mg/d) was prescribed
3 weeks before AA occurence. Clopidogrel is withdrawn and AA therapy is started, consisting
in the sequential association of anti-thymocyte globulin therapy (15 mg/kg) and ciclosporin
(5 mg/kg/d) in a filtered-air room. But the severe co-morbidities lead to early stop
ciclosporin, then relayed by androgen therapy (norethandrolone). Finally, at 12 weeks
from the diagnosis, the evolution ends to a resolution of AA, but with platelet-transfusion
dependance.
After the elimination of the other aetiologies, iatrogenic cause is envisaged. To
blame clopidogrel is difficult with regard to the other drugs, especially perindopril
and omeprazole known to induce bone marrow failures. Four arguments lead to target
clopidogrel: (i) the length of treatment by perindopril and omeprazole without complications,
(ii) the timing between the onset of AA and the addition of clopidogrel to treatment,
(iii) the resolution of AA whereas neither perindopril nor omeprazole were withdrawn,
and (iv) the support of the literature.
Conclusions: Clopidogrel seems to be responsible of this side effect. We unfortunately
lack in specific biological tests to prove it.
Keywords: Clopidogrel, Side-effects, Pharmacovigilance
DI-141 Pathways of information on antidepressants in flemish psychiatric hospitals:
experiences of health care professionals and patients
Franciska Desplenter
1, Gert Laekeman1, Steven Simoens1
1Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit
Leuven, Leuven, Belgium
Background and Objective: Informing patients on their medicines is a patient right.
What does current information provision on antidepressants to patients with a depression
admitted to a psychiatric hospital look like? What is the current practice of health
care professionals? What are the experiences of patients? This study aims to explore
current practice on drug information provision in psychiatric hospitals.
Design: A qualitative study consisting of semi-structured interviews with separate
interview guides for health care professionals and for patients. Interviews were tape
recorded, verbatim transcribed and analyzed using NVivo7 software.
Setting: Eight Flemish psychiatric hospitals.
Main Outcome Measures: Identification and evaluation of current approaches to drug
information provision on antidepressants from the point of view of health care professionals
as well as patients.
Results: Patients get information on antidepressants, firstly, through psychiatrists
and, secondly, through nurses. Hospital pharmacists have a supporting role.
The approach in giving information depends on patient characteristics and his/her
mental state. Information is provided mainly orally. Leaflets are not frequently distributed
to patients. Patients also get information on antidepressants during psycho-educational
sessions. On request, patients can read a package insert under supervision of a health
care professional.
Health care professionals consider non-verbal cues of patients to verify if information
has been understood. Information is repeated when the first instruction was not clear
for patients.
There are no systematic interdisciplinary contacts on information interventions.
Patients as well as health care professionals are satisfied with current practice
on information provision. Health care professionals reported lack of time and lack
of interdisciplinary contacts as negative aspects. Patients indicated that health
care professionals take too little initiative to give information about medicines.
Positive aspects reported by health care professionals are the hospitals’ openness
and the opportunity for patients to ask their questions to psychiatrists as well as
nurses. Suggestions for improving practice are: providing more medication information
to patients, in particular on side-effects; enhancing the availability of easy readable
information; and organizing continuing education for nurses on medicines.
Conclusions: Patients are informed about their antidepressants through various pathways.
However, there seems to be room for improvement as a number of suggestions were formulated
to support these pathways of drug information.
Keywords: Medication information, Antidepressant, Psychiatry
DI-157 Management and prevention of intravenous immunoglobulin adverse effects
Claire Chapuis
1, Christine Chevallier1, Céline Villier2, Pierrick Bedouch1, Benoît Allenet1, Jean
Calop1, Gérard Besson3
1Pharmacy, 2Pharmacovigilance, 3Neurology, University Hospital, Grenoble, France
Background and Objective: The use of intravenous immunoglobulin (IVIG) is expanding.
The risk for adverse effects can be minimized by taking some precautions. There are
yet no standardized practice guidelines for prevention and management of adverse effects
occurring during the infusion, and there is a need for it. The purpose was to conduct
a study of their knowledge among the nurse community and to make a review of the best
practices.
Design: We search in Medline and carried out a questionnaire for nurses. We evaluated
knowledge and practices of 14 nurses in Neurology, Pneumology and Haematology units,
experienced in intravenous immunoglobulins administration, in order to define their
role and the prescribers role in ensuring patients safety during therapy. We used
all information and synthesized it in a table. For every type of adverse reaction,
we indicated mechanism, frequency, seriousness, risk factors, practical guidelines
of management and prevention and actor. The guidelines were reviewed by experts (pharmacist
in charge of human derivative products, pharmacovigilance experts and neurologists).
Setting: University Hospital, Grenoble, France.
Main Outcome Measures: Formalisation of practical guidelines on prevention and management
of intravenous immunoglobulin adverse effects, for prescribers and nurses in the local
hospital network and possibly other hospitals.
Results: Nurses always checked the doses before administration (14/14), always prepared
the product aseptically (14/14), warmed up the product until it reached room temperature
(12/14), but only few recorded the patients tolerability during the infusion (9/14),
and very few knew that most adverse events could be minimized first by slowing down
the rate of infusion (4/14). All nurses called a doctor as an adverse effect appeared.
Conclusions: Nurses must be involved in the management of adverse effects, even if
the prescriber remains the one who makes the prevention by evaluating risk factors,
co-medications, dosing and frequency of treatment and the one who makes the decision
to interrupt the treatment if an adverse effect occurs. The Clinical Pharmacist in
care units works collaboratively with both prescriber and nurse. He plays a central
role for preventing drugs’ adverse effects while counselling every member of the healthcare
team
References
Murphy E, Martin S, Patterson JV. Developing Practice Guidelines for the Administration
of Intravenous Immunoglobulin. J Infus Nurs. 2005; 28: 265–272
Orbach H, Katz U, Sherer Y, Shoenfeld Y. Intravenous immunoglobulin: adverse effects
and safe administration. Clin Rev Allergy Immunol. 2005; 29: 173–184
Keywords: Adverse effects, Intravenous immunoglobulin, Management, Prevention
DI-175 Fludrocortisone 10–50 μg: elaboration of a patient information leaflet and
satisfaction survey
Assia Fseil
1, Lila Khazai1, Stephanie Weber1, Yvette Brasseur2, Marie Pierre Berleur2, Christian
Doreau1
1Pharmacy Outpatient Unit, 2Regulation Unit, Agence Générale des Equipements et Produits
de Santé AP-HP, Paris, France
Background and Objective: Fludrocortisone tablets 10–50 μg (F) is mainly used in the
treatment of adrenocortical insufficiency. It may also be used in treatment of orthostatic
hypotension. F is manufactured by AGEPS (public special-order manufacturer) and dispensed
to outpatients by hospital pharmacies, as a “hospital preparation”.
In order to follow GMP guidelines, a patient information leaflet for F was elaborated
in our pharmacy outpatient unit. The leaflet was approved by our Regulation Unit.
To evaluate the usefulness of this leaflet and to improve its quality, we performed
a patient satisfaction survey.
Design: During 14 days, for every dispensation of F, a leaflet was presented to the
patient and an anonymous satisfaction survey was performed.
Setting: Pharmacy Outpatient Unit, Agence Générale des Equipements et Produits de
Santé (AGEPS) (AP-HP), Paris, France.
Main Outcome Measures: The questionnaire consisted of three items: general information
about patient and its treatment; patient’s knowledge of F before reading the leaflet
(uses, precautions, adverse events, storage); patient satisfaction of leaflet (general
presentation, language simplicity, information volume, utility).
Results: 70 patients answered the questionnaire. The mean age was 47 years (3–88 years).
Mean F treatment duration was 17 years (2 months–43 years).
40% of patients were already informed about F: 96% by physicians and 4% by associations
and internet. 97% knew the indication (90% adrenocortical insufficiency and 10% orthostatic
hypotension).79% knew about precautions, 56% knew about side effects, and 76% knew
about storage conditions.
4% of patients did not read the leaflet and had no opinion about satisfaction items.
96% were satisfied of general presentation. Language was understandable for 94%, and
non understandable for 2%. Information volume was sufficient for 88%, insufficient
for 4%, and too large for 4%. Leaflet was useful for 93% of pts. Patients who found
the information insufficient suggested the following items: results of clinical trials,
management of acute situations due to disease or F, and contacts of qualified centres
in case of serious events.
Conclusions: Nearly half of the patients were informed about F by their physicians,
but information is communicated orally without written support. The majority of patients
treated by F knew about precautions, side effects, and storage conditions. However,
patients were satisfied of our information leaflet and find it useful.
Leaflet appears to be a good tool to communicate information from the pharmacist to
the patient when not available in the packaging.
Keywords: Fludrocortisone, Leaflet
DI-184 Effects of pharmaceutical interventions in geriatrics: limitations of prescription
software
Véronique Duhalde
1, John Toft2, Karine Maréchal2, Marie-claire Farjou2
1Pharmacy, University Hospital PURPAN, Geriatric Hospital Casselardit, 2Pharmacy,
University Hospital PURPAN, Geriatric Hospital Casselardit, Toulouse, France
Background and Objective: As the Pharmaceutical team of the geriatric unit, we ensure
an analysis of the prescriptions with a computer prescription program, optimised by
the presence of pharmacy students in the wards, who gather and send us information
on the patients. A function included in the software allows us to write down recommendations.
Aim of the study: to evaluate the effect of our interventions and to determine the
best vehicle for the transmission of information.
Design: 3 week prospective study. Were analysed: drugs, problems, interventions (coded
according to the SFPC*’s pharmaceutical interventions form) and their consideration
by the clinicians.
*SFPC: French society of clinical pharmacy.
Setting: Geriatric wards in a large teaching hospital.
Main Outcome Measures: Categorisation into types of pharmaceutical interventions.
Results: 161 pharmaceutical interventions were formulated concerning 98 patients (150-bed
hospital), of an average age of 84 ± 7 years [63–97], and a sex-ratio of 0.53. According
to the ATC classification, the main therapeutic classes concerned were: Nervous System
(30%), Cardiovascular (19%) and Haematology (16%).
Dosage adaptation (to creatinine clearance) represent 29% of pharmaceutical interventions,
drug introductions (14%), withdrawals (16%) and substitutions (14%). 9% of our interventions
concerned an inappropriate use of the software.
The prescribing clinicians agreed to: 28 dosage adaptations (out of 47 recommended),
18 substitutions (out of 23), 15 withdrawals (out of 25), 13 introductions (out of
23), 8 treatment optimisations (out of 16), 9 drugs monitoring (out of 14) and 11
recommendations about the use of the computer system (out of 12).
Of these 102 recommendations taken into account (63%), within a period of 2 days for
most (n = 84), 53 involved the intervention of a pharmacy student, 33 were given only
via the computer software, and 16 via a telephone call.
Conclusions: Computerisation of prescriptions is an indispensable tool in order to
make the pharmaceutical distribution circuit safer.
However, its use as a vehicle for pharmaceutical interventions is limited, as shown
by this study. It is impossible to analyse a non-response of our recommendations:
is our advice even red, is it considered as inadequate? A discussion with the clinician
(via pharmacy students or on the telephone) allowing a constructive exchange of knowledge,
leads to a better transmission of recommendations.
Keywords: Pharmaceutical interventions, Geriatrics
DI-194 Hazardous drugs handling in hospital: a standardized toxicological screening
method to evaluate occupational risks
Laure-Zoe Kaestli
1, Caroline Fonzo-Christe1, Jules Desmeules2, Pascal Bonnabry1
1Pharmacy, 2Clinical Pharmacology and Toxicology, HUG, Geneva, Switzerland
Background and Objective: In hospital setting, employees may be exposed to hazardous
drugs. Risks and protective measures needed when handling parenteral cytotoxic drugs
are well described, whereas information related to drugs like monoclonal antibodies
or antivirals are lacking. We developed a standardized method to evaluate drugs potential
toxicity and occupational risks taking into account the pharmaceutical forms of the
drugs to balance the risks.
Design: Development of an algorithm for toxicity evaluation using Material Safety
Data Sheet (Risk and Safety phrases), International Agency for Cancer Research (IARC)
classification and official manufacturers’ data.
Evaluation of chronic toxicity (mutagenicity, carcinogenicity), acute toxicity (sensitisation
or irritation in contact with skin, eyes or by inhalation) and toxicity to reproduction
Balancing of toxicity according to the pharmaceutical forms
Assessment of protective measures (centralization of drug preparation in the pharmacy,
wearing of mask, gloves and/or glasses)
Centralization of drug preparation in the pharmacy is recommended only in case of
documented mutagenicity and carcinogenicity and when there is a risk of respiratory
or cutaneous exposure related to the pharmaceutical form.
Setting: University Hospital (2000 beds).
Main Outcome Measures:
Chronic (R45, R46, R49 or IARC group 1, 2A or 2B), acute toxicity (R20–28, 34–38,
41–43; S22–28, 36–39) and toxicity to reproduction (R60–63; cat.D,X)
Pharmaceutical forms associated with a risk of respiratory (e.g. tablets crushing),
cutaneous (e.g. drug in solution) or ocular contact (e.g. inhalation)
Results: Occupational risks of 14 parenteral monoclonal antibodies, 8 oral and 5 parenteral
antivirals, 12 oral cytotoxics and 43 other drugs forms were analysed. According to
our algorithm, crushing of 36% of the 33 tablets forms should be done in the pharmacy
(e.g. valganciclovir). Only 1 parenteral antiviral should be reconstituted at the
pharmacy (ganciclovir). Monoclonal antibodies were found not to be at risks of mutagenicity
or carcinogenicity and only gloves will be recommended for their manipulation. No
“class-effect” has been pointed out (e.g. only a few antivirals were found to be hazardous).
31 products were at risks for pregnant women. Protective measures to be taken by pregnant
nurses or those wishing to have a baby will be discussed institutionally.
Conclusions: Toxicity evaluation of hazardous drugs handling in hospital should take
the pharmaceutical forms into account as some toxic drugs may not be associated with
occupational risks (e.g. coated tablets). Our method allows a standardized way to
evaluate whether a drug should be treated as hazardous or not. Results will be discussed
institutionally in order to implement applicable policies and procedures.
Keywords: Hazardous drugs, Occupational risks, Toxicology
DI-204 Guidelines for the handling of drugs instilled directly through the bronchoscope
into the bronchial tree during flexible bronchoscopy
Julie Scholler
1, Anne A. C. Gairard-Dory1, Anita A. Molard1, Romain R. Kessler1, Leonardo L. Donato1,
Laurence L. Beretz1
167, Hôpital Universitaire de Strasbourg, strasbourg, France
Background and Objective: Flexible bronchoscopy in adults and children has become
a common procedure in clinical respiratory practice. During the intervention, some
drugs are instilled in off-label use, in particular anesthetics, haemostatics and
mucolytics. The aim was to provide guidelines for handling those drugs in the different
units where bronchoscopies are performed.
Design: Observation of the nurses’ practice and literature review
Setting: Department of Pulmonary Medicine and Pediatrics.
Main Outcome Measures: Studies on stability and maximal doses; Good practices for
the handling of drugs.
Results: Lidocaine 1% injectable solution is indicated for tracheo-bronchial anesthesia,
via bolus of 20 mg in adults, and 5 to 10 mg in children. The maximal dose is restricted
to 9 mg/kg in adults and 5–7 mg/kg in children.
Epinephrine is indicated in hemorrhagic complications occurring during interventions;
the solution is diluted to 1 mg/10 ml with NaCl 0.9%; a 200 μg bolus is injected and
can be repeated up to 1 mg.
Terlipressine can be used in heavy bleedings; the powder should be reconstituted with
NaCl 0.9%, at 1 mg/5 ml; 1 mg is injected, repeated if necessary.
Mesna is used to dissolve mucous plugs, especially in patients with cystic fibrosis.
The solution is diluted to 30 mg/ml with NaCl 0.9%; bolus of 10 ml are injected to
allow visibility in the lower airways. There are no data available on the maximal
dose.
All preparations have to be compounded aseptically and extemporaneously by the nurse
when requested by the physician, because of the lack of stability studies in those
ranges of concentrations.
Conclusions: These guidelines are intended to standardize flexible bronchoscopy procedures
between the different units, in order to minimize the occurrence of medication errors.
Reference
British Thoracic Society guidelines on diagnostic flexible bronchoscopy, Thorax 2001;
56; 1–21
Keywords: Flexible bronchoscopy, Guidelines, Drugs
DI-211 The profile of drug information enquiries of nurses in the last ten years
Ayce Celiker1, Gulru Ozkaya
1, Nergiz Nemutlu1
1Hacettepe Drug and Poison Information Center, Hacettepe University, Ankara, Turkey
Background and Objective: Pharmacists have linked medical and pharmaceutical literature,
growing day by day enormously, to all components of health care team. Thus, the emergence
of drug information centers has provided a valuable tool in patient – oriented pharmacy
practice. Nurses, also, have asked advice of drug and/or poison information centers
in order to get updated information they need. Being a pioneer in Turkey, Hacettepe
Drug and Poison Information Center (HIZBIM) is in service for 15 years with 3 pharmacists
in working-hour basis.
Objective
To describe and analyze the extent and characteristics of consultations to HIZBIM
by nurses.
Design: The enquiries directed from nurses between January 1, 1996 and December 31,
2005 were selected retrospectively and analyzed with SPSS 11.5®.
Setting: Hacettepe Drug and Poison Information Center is affiliated to Hacettepe University,
Faculty of Pharmacy.
Main Outcome Measures: Categorization and comparison of data of nurses’ calls of HIZBIM
during the study period.
Results: The percentage of overall nurse calls’ was 5.3 (1044 calls) in the last ten
years’ drug and poison information enquiries. Annual distribution showed a steady
increase beginning from 2002. Calls received mostly (28.4%) between 13:30–15:30 hours.
The 83.5% of the calls received from Hacettepe University Hospitals’ nurses. Almost
half of the enquiries (49.7%) were about stability and incompatibility in intravenous
(iv) admixtures. The frequency of these calls was significantly higher than the calls
came from other health professionals (p < 0.05). The following types of enquiries
were about dosage (9.1%) and availability of pharmaceutical products (8.0%). While
76.5% of enquiries were answered by HIZBIM in less than 5 minutes, in 1% of all calls
took more than 1 day to gather and tailor which requires more literature search. The
mostly (50.0%) used references in retrieving information was general references followed
by Micromedex CCIS Inc. with 41.0%.
Conclusions:
HIZBIM has been consulted by nurses in a rising pattern. This means that this service
is of importance for them because of its rapidity, accuracy and currency
The preparing iv admixtures that has been left to nurses’ responsibilities in practice
in our country can be reconsidered by pharmacists since this service has been fulfilled
by “drug experts”, namely pharmacists in many countries.
Drug information centers can provide not only emergent information for nurses but
also education such as seminars and conferences in some topics they need. The establishment
of drug information centers in hospital settings will be of use to stimulate the frequency
of consultations by nurses and to improve patient care provided by them.
Keywords: Drug information, Nurse, Stability, Incompatibility
DI-269 Standard procedures to answer clinical questions on negative effects to fetus
conceived under paternal medication exposure
Ana Ribeiro-Rama1, Renata Barbosa1, Ana M. Sobral1, Miguel Morais1, Odete Isabel1,
Joana Migueis2, Jose Zagalo-Cardoso2, Franscisco Tavares-Silva2, Ana T. Almeida-Santos2,
Cristina Silva3, Fernando Fernandez-Llimos4, Isabel V. Figueiredo5, Margarida Caramona
5
1Pharmacy, 2Prenatal Diagnosis, University Hospital, Coimbra, 3Faculty Pharmacy, University,
Porto, 4Faculty Pharmacy, University, Lisbon, 5Faculty Pharmacy, University, Coimbra,
Portugal
Background and Objective: Men’s exposure to medications, before/during conception,
can induce fetal abnormalities by spermatogenesis. Mechanisms inducing reproductive
toxicity: Non-genetic-medication on semen; Genetic-mutation or chromosome abnormality;
Epigenetic-effect on gene expression or DNA fragmentation. Evidence literature is
sparse and contradictory. Counselling parents is a dilemma. Lack of literature outcomes,
justifies reporting, follow evidence-based-practice methods and guidelines for reporting
adverse events.
1-Analyze questions to “Medicines-Information-Service”. 2- Application of standard
operation procedures (SOP) developed to answer questions in pharmaceutical-care.
Design: 1-Evaluation: 9 cases- disease/medications exposure. 2-Study case SOP: Clinical
data collection. Integration with Patient/Intervention/Comparison/Outcomes, PICO’s
methodology. Medline/Pubmed as source of answer, search strategies based on PICO,
combining MeSH-terms, subheadings and text-words. Answer and fetal/pregnancy outcomes
follow-up.
Setting: Medicines-Information-Service, Pharmaceutical-Department; Prenatal Diagnosis.
Coimbra University Hospital. Portugal.
Main Outcome Measures: Answer validity, utility and physician’s decision. Pregnancy/neonatal
outcomes follow-up.
Results: 1-Hepatitis-C Cases:3/9; Medications: ribavirin/interferon. 2.1-Patient/Population:
Mother 11th/weeks pregnancy, medicated: levothyroxine; Fetus: no echographic evidence
of malformation at 12;15;18th/weeks; Father at conception: former toxicodependent,
negative serology; Hepatitis-C. Intervention: Ribavirin/Interferon last year; Outcomes:
Reproductive toxicity; Spermatogenesis alteration; Pregnancy development complications;
2.2-Search strategy exemples: P- MeSH-terms: Paternal exposure-Disease; Embryonic
Structures; I-Ribavirin/Interferon; O: Pregnancy Complications; Congenital, Hereditary,
and Neonatal Diseases and Abnormalities; Chromosome Aberrations. Subheadings: abnormalities;
adverse effects; chemically induced. Text-words: Oligozoospermia. Study-types found:
case-reports; case–control; case-series. 2.3-Expected outcomes contradictory: No arm
detected; Disease and antiviral induces spermatic morphologic alterations. 2.4-Answer
considered valid, used to support physician’s decision. 2.5-Observed outcomes: Born
38th/week; 3700 g; Apgar-9:10:10; hypospadias. No major congenital abnormalities,
during 3/days neonatal-period.
Conclusions: These clinical questions are generally complex, with multiple levels.
Evidence-based approach to collect good patient history, PICO’s methodology to focus
and search strategy, must be used to evaluate and follow-up each case, contributing
to more supported decisions and to generate evidence.
Keywords: Paternal-exposure, Ribavirin/interferon, Pharmaceutical-care
EDU-30 A comparison of the perceptions of pharmacists and dispensing technicians about
the causes of medication error in a community pharmacy
Hannah Hesselgreaves
1, Ailsa Power1, Murray Lough2
1Pharmacy, 2Medicine, NHS Education for Scotland, Glasgow, United Kingdom
Background and Objective: Pharmacy dispensing technicians are invariably overlooked
in medication error research. The objective of this research is firstly to explore
the perceptions of pharmacists and pharmacy dispensing technicians in Greater Glasgow,
about the causes of errors relating to a number of specific drugs known to be commonly
involved in errors. Secondly this research will establish either consistency or inconsistency
between the staff groups.
Design: Iterative design; review of literature; interviews with pharmacists were content
analysed; used themes from interviews (n = 11) to survey dispensing staff (n = 64).
Univariate analysis of survey data using means, standard deviations, and frequencies.
Setting: Community pharmacies within Great Glasgow.
Main Outcome Measures: Categorisation of themes from interviews relating to identified
causes of errors.
Results: Themes from interviews with pharmacists were arranged into five thematic
categories relating to their perceptions about medication errors: the work environment;
learning from errors; tasks performed in the dispensary; attaining information from
other health professionals; and participant recommendations for solutions. Pharmacists
and dispensing staff agreed that work load, patient interruptions, and unclear GP
requests were significant sources of medication error. However, dispensing technicians
strongly disagreed about a relaxed atmosphere perceived by pharmacists in the dispensary
causing errors. Unfamiliarity with the drugs resulting from generic buying policies
was only partially supported by dispensers as a cause of errors. All suggestions from
pharmacists about how the causes of errors could be addressed were supported by dispensers,
particularly, “reporting quickly after the event” and “marking changed does on prescriptions”.
Conclusions: Dispensing technicians, who are invariably overlooked in medication error
research, only partially supported pharmacists’ perceptions about the causes of medication
errors relating to a number of high risk drugs. However, some perceptions were congruent
between groups. This highlights some causes that future research may address on a
practice level, for example, managing workload and improving GP requests on prescriptions.
Other causes that were perceived differently by pharmacists and dispensers highlight
profession-specific perceptions about how errors occur in community pharmacy.
Keywords: Medication error, Dispensing technicians, Qualitative
EDU-68 Training pharmacists to implement pharmaceutical care (pc) in pharmacies in
community pharmacies
Ester Filinger
1, Andrea Paura2, Alicia Consolini3, Horacio de Belaustegui4, Ana Tambussi2
1Pharmaceutical Tecnology, Faculty of Pharmacy and Biochemistry. University of Buenos
Aires, Buenos Aires, 2Department of Pharmaceutical Care of the Pharmacy College of
the Province of Buenos Aires., Pharmacy College of the Province of Buenos Aires.,
3National University of La Plata, National University of La Plata, 4Biosphere Foundation,
Biosphere Foundation, La Plata, Argentina
Background and Objective: The concept of Pharmaceutical Care (PC) is capturing the
attention of a growing number of pharmacists. The strategy followed by us to spread
out the implementation of PC in pharmacies involves the utilization of internet tool
as an innovation of traditional education.
Design: To do so, we designed an on line PC Course with interactive cases. The specific
goals of the course are:
The enhancement of the pharmacy practice.
The promotion of practice research.
The personal and professional development of pharmacists.
Setting: Department of Pharmaceutical Care of the Pharmacy College of the Province
of Buenos Aires, the University of Buenos Aires, the National University of La Plata
and Biosphere Foundation.
Main Outcome Measures: The course is carried out by tutorial system. It was established
a virtual class modality for training pharmacists in the field of PC. The design of
the course is of five modules. Every module has a duration of one month and the activity
structured in four weeks:
First week: introduction to each module
Second week: a study of real case
Third week: identification of the problem
Fourth week: resolution of real cases.
The issues of the modules are the following:
Module I: introduction to pharmaceutical care.
Module II: adherence to the treatment.
Module III: habits incorporate in the life’s style and the influence in pharmacological
treatment.
Module IV: drug adverse effect
Module V: drug interaction
Results
The development of on line PC postgraduate course 2002–2005
Total amount of postgraduated registered 664, included 135 foreign postgraduated.
This course was attended by 4 professors and 15 tutors.
Four hundred and ninety-three postgraduated complete the course. Only 9% didn’t take
the final examination.
Conclusions: This PC course that we developed on line, is an useful tool for training
pharmacists in the process of PC and allows the acquisitions of abilities in this
area.
References
Hepler, C.D., Strand, L.M. Opportunities and responsibilities in pharmaceutical care,
Am. J. Pharm. Educ. 1989; 53:7s–14s
Burton S., Anderson C. Using the Internet to develop an international learning community
of pharmacists. Pharmacy World & Science 2002;24:172–174
Keywords: Pharmaceutical care, Training pharmacists, Community pharmacy
EDU-69 Implementation of the clinical pharmacy in the National University of La Plata
Andrea Paura
1, Maria J. Petroni1, Susana Gomez1
1Department of Biological Sciences, Clinical Pharmacy. Faculty of Exact Sciences.
National University of La Plata, La Plata, Argentina
Background and Objective: The Department of Education, Science and Technology of Argentina
by Resolution N 566/2004, with agreement of the Council of Universities, introduced
in the minimum contents of the career of pharmacy the concept of Clinical Pharmacy.
For this reason the universities must modifies the curricula. The new plan of study
developed for the Career of Pharmacy in the Faculty of Exact Sciences of the National
University of La Plata, included since 2005 the teaching of Clinical Pharmacy in the
Department of Biological Sciences.
The objective was to analyse the evolution of the program, whose pedagogical design
was based in a process of teaching-learning in the field of the clinical pharmacy
and pharmaceutical care that permit the training of the future pharmacists in the
use of medicines.
Design: All the classes were designed with practical-theoretical modality including
workshops, reading and analysis of the bibliography, discussion of cases and utilization
of virtual simulators.
Setting: Clinical Pharmacy. Department of Biological Sciences
Main Outcome Measures: Students evaluation was carried out by tests of the general
contents, degree of active participation during the workshops, resolution exposition
and discussion of the cases.
Results: The development of Clinical Pharmacy education began in 2005. The students
appreciated this experience and the 97% of them are satisfied with the process of
teaching-learning employed. This teaching system improved them the adequate and rational
use of the medicines. In these two years the 100% of the students has approved the
examination.
The students also realized two poster presentations during this period, namely:
1. “Comparative study of the information supplies in the leaflet of tablets of omeprazol
20 mg”, in 2005 and 2. “Study of the information supplied by the pharmaceutical laboratories
in the television media” in 2006.
Conclusions: We consider the importance of the incorporation of Clinical Pharmacy
in the new pharmacy curricula, because the students have major task about the practical
education involvement patients and related to their professional future.
References
Popocivh NG. The educational care of Pharmacy. Am J. Pharm. Educ. 1991; 55:349–355
Quinones AC, Mason HL. Assessment of Pharmacy graduates educational outcomes. Am J.
Pharm. Educ. 1994; 58:131–136.
Holdford D, Reinders TP. Development of an instrument to assess student perception
of the quality of Pharmaceutical Education. Am J. Pharm. Educ. 2001; 65:125–131
Keywords: Pharmacy education, Clinical pharmacy, Pharmacy practice
EDU-98 Prescription errors and dispensing errors in clinical trials
Nathalie Do-Van-Lanh
1, Julie Pouzoulet1, Emmanuel Jaccoulet1, Amine Lalhou1, Nathalie Ortiz1, Alain Astier1,
Muriel Paul1
1Pharmacy Department, University Hospital, Creteil, France
Background and Objective: Clinical Trials’ managing and dispensation is one of the
obligatory missions of a hospital pharmacy. The respect of good clinical practices
is necessary to ensure proper trial performance and to be aware of errors in prescription
and in drugs dispensation. The aim of our study was to analyse the nonconformities
in the steps of prescription and dispensation and to evaluate their severity.
Design: The pharmacy department manages 240 clinical trials for all clinical wards
with a pharmacist and a technician who change every four months. There is no specific
computerized system but an excel software for data filing. We realized a retrospective
study of ongoing 67 clinical trials. All the prescriptions were reviewed and we focussed
on all the items required for the prescription (e.g., identification of the protocol,
the patient, the investigator, the dosage) and for the dispensation (e.g., identification
of the drug, the quantity dispensed, batch number, expiry date)
Setting: A French acute university hospital of 950 beds.
Main Outcome Measures: Prescription and dispensation errors, checked by our pharmacy
department, were defined according to a potential clinical severity scale elaborate
by the pharmacist of the clinical trials unit. This scale defined 4 groups of severity
according to the clinical risk for the patient and to the protocol’s set of rules:
with the group A (severe errors with the possibility of the exclusion of the patient),
group B (potentially serious errors), group C (potentially significant errors), and
the group D, with missing information on the prescription without consequence for
the patient and the compliance of the study protocol.
Results: 2312 orders were analysed concerning 67 ongoing clinical trials. We found
one error per order on average (2315/2312) and the most frequent errors were name
omission 44% (1011/2315), signature omission 15% (355/2315) and the wrong prescription-writing
11%.(264/2315). On the prescriptor part, 0.37 (856/2312) errors per order were detected
and 1% of them (12/856) would have severe consequences (group A), mainly related to
the wrong treatment number or the wrong protocol. Concerning the dispensing part,
0.63 (1459/2312) errors per order were detected and 0.54% (8/1459) of them were classified
in group A. Those errors were mainly related to the wrong treatment dispensing to
the patient in a blink study or missing dispensing drug.
Conclusions: Among these errors, 0.8% would cause the exclusion of the patient. Even
if the majority of these errors (67.8%) have no consequences (group D), such as biased
results, most of them are avoidable with a regular information of the investigators
meeting prior to trial start. Regular evaluation of internships and technicians and
specific computerized software could also improve the working clinical practices for
an optimal organization in conducting clinical trials.
Keywords: Clinical trials, Prescription, Dispensation
EDU-107 The role of the university of khartoum towards the implementation of pharmaceutical
care practice in Sudan
Sumia Sir Elkhatim Mohamed
1
1Department of Pharmaceutics, Faculty of Pharmacy, University of Khartoum, Khartoum,
Sudan
Background and Objective: Sudan, the largest country in Africa, has 12 Faculties of
Pharmacy (4 governmental and 8 private). The awareness of the new role of the pharmacist;
pharmaceutical care practice (PCP) was investigated. This new role, which is different
from the traditional current role of dispensing is not yet implemented in Sudan. The
University of Khartoum, the oldest and largest University in the country, assumed
responsibility of changing this. The aim is: a) To describe the attempts of the Faculty
of Pharmacy, University of Khartoum in paving the way for patient-focused teaching
and training. b) To show the efforts exerted towards the transition in pharmacy practice
that must occur to establish PC in both community and hospital settings in Sudan.
Design: A descriptive study using Face to Face interviews, Structured questionnaires
and Steering Committees and experts’ views and opinions to provide data on current
situation of pharmacy teaching and practice in Sudan and possible future changes.
Setting: University of Khartoum, Soba Hospital and community pharmacies in Khartoum.
Main Outcome Measures: Public and pharmacists awareness of PCP, assessment of current
pharmacy undergraduate curriculum, the efforts and means provided to change to Patient-centered
teaching and training and to raise the attention of the authorities towards the implementation
of PCP in Sudan.
Results: Public awareness of PCP is very low. While awareness among pharmacists is
high, they lack appropriate training on use of their knowledge, skills and attitudes.
Number of pharmacy hours taught in 4 years is 3960; 1680 hours theory (42.4%) and
2280 hours practical (57.6%). Although some sporadic clinical aspects are taught,
the teaching and practical training are mainly product-focused. Development of the
curriculum has been recommended to provide an educational programme that will appropriately
address contemporary and foreseeable future changes in the practice of pharmacy. This
needs appropriate trainers and modern pharmacies. The Faculty of Pharmacy established
a two years postgraduate degree in clinical pharmacy by courses in 2004 and started
the refurbishment of the Pharmacy at Soba Hospital to pave the way for implementation
of clinical pharmacy teaching and training and the introduction of clinical pharmacy
services at hospital setting and in-service training. Master and PhD degrees by research
are currently in progress investigating the possibility of implementing PCP at community
setting using different models. Plans for future collaboration with regulatory authorities
and the role of Leadership were envisaged.
Conclusions: Pharmacy curricula need to be revised to accommodate the concepts of
clinical pharmacy. The intention is to provide means to inform the authorities and
debate in the process of establishing acceptable standards for PCP in Sudan. The role
of the regularity authorities and the leadership must be activated.
Keywords: Clinical pharmacy, Pharmaceutical care practice, Sudan
EDU-121 To modify the behaviour: who does it matter?
Daniela Scala
1, Santolo S. C. Cozzolino1, Antonio A. M. Mancini1, Laura L. Z. Zeuli1, Barbara B.
A. Andria1, Rosaria R. O. Orsini1, Ornella O. G. Gallinaro1, Maria M. D. D’Avino2,
Giuseppe G. C. Caruso2, Alessandra A. I. Izzo2, Domenico D. C. Caruso2
1Centre of Biotechnologies, 2Centre for the Diagnosis and Treatment of Hypertension,
Cardarelli Hospital, Naples, Italy
Background and Objective: Patients are often asked to modify lifestyle and adopt healthier
behaviour for disease prevention and long-term disease management. Many people find
it difficult because it means deep and wide life change. But how patients can modify
lifestyle if health care professionals don’t modify first their attitude towards patients?
The Hypertension Working Group of Cardarelli Hospital of Naples, Italy in the view
of “transferring” “Dieciannidivitainpiù” (life ten years longer) from the hospital
to the community, made a survey whose aim was to determine the meaning that General
Practitioners (GPs) ascribe to the patient-centred approach and to identify the important
concepts and issues inherent to this approach. “Dieciannidivitainpiù” is an educational
programme aimed at reducing blood pressure (BP) in patients with hypertension through
a lifestyle modification, and it has got its preliminary positive results.
Design: qualitative survey.
Setting: General Practitioners’ cooperatives of Benevento’s community.
Main Outcome Measures: GPs opinion on the main concepts of a patient-centred approach
assessed by a six question five-point Likert scale questionnaire. Simple descriptive
statistics, median and interquartile range (IQR) were performed using SPSS version
10.0.
Results: 57 GPs participated to the survey. They agreed (median = 4, IQR = 5–4) that
the following concepts are crucial in a patient-centred approach: the need of a specific
training in counselling in under and post graduate education; the necessity of working
with patients to develop mutually agreed-upon goals; the role of information in the
decision making process, the ability to understand patients readiness to make change,
and to identify barriers to change, the importance to recognize that patients are
the experts when it comes to their own behaviour related issues. For only one item
(time dedicated to the consultation) IQR changed (IQR = 4–2) indicating some difficulty
in implementing this aspect in practice.
Conclusions: For Benevento community GPs, a patient-centred approach is a useful way
to help change and promote behaviour. Knowing how to support it is an important skill
for all care professionals, but education is needed to shift from theory to practice.
References
Burke V, Beilin LJ, Cutt HE, Mansour J, Wilson A, Mori TA. Effects of a lifestyle
programme on ambulatory blood pressure and drug dosage in treated hypertensive patients:
a randomized controlled trial. J Hypertens. 2005 Jun;23(6):1241–9.
Scala D., Mancini A., Cozzolino S., Andria B., Lombardi S., Uomo I., DAvino M, Caruso
G, Izzo A., Tajana G., Caruso D. “Dieciannidivitainpiù” (ten years more of life) for
hypertensive patients: preliminary results. Clinical Pharmacy Europe, 5:37–39, winter
2006
Patient centred approach may help in hypertension. BMJ. 2003 Jan 11;326(7380):103.
Keywords: Patient centred care, Health behaviour, Patient education
EDU-146 Investigation on assessment and treatment of painful neuropathy in diabetic
patient
Emilie Prevost
1, Anne Claire Buire1, Anne Laure Lepetit1, Catherine Mennesson1, Jean Caron2, Bertrand
Gourdier1
1Pharmacy, 2Diabetology/Endocrinology, Reims University Hospital, Reims, France
Background and Objective: Diabetes is frequently associated to complications such
as diabetic neuropathy, characterized by neuropathic pain. There is no consensus for
this type of pain management and those are difficult to diagnose.
The aim of this study was to :
diagnose a neuropathic pain among diabetic patients
assess the proportion of diabetic patient with neuropathic pain
analyse the treatments received by these patients
Design: This prospective study took place over a two-months period (from March to
April 2007).
All diabetic patient hospitalised in two units of the diabetology/endocrinology department
have been examined and interrogated by the physicians according to a questionnaire,
based on a new diagnosis instrument: DN4 questionnaire (1). We retrospectively searched
in the patient’s file if they were treated for their pain. Questionnaire results and
treatments have been discussed with the physician.
Setting: 2 medicine wards of 19 and 22 beds each in Reims University Hospital.
Main Outcome Measures: pain characteristics; DN4 questionnaire score; treatment strategies
and tolerability.
Results: 87 diabetic patients have been interrogated: 65 type I, 16 type II and 6
gestationnal diabetes. The average age was 60 years and for the half of these patients,
the pathology developed since more than 10 years. 27 patients were painful and 14
patients presented a positive score to DN4 questionnaire. Symptoms frequently observed
were: pins and needles, prickles, and numbness.
Among these 14 patients, 9 were treated by antidepressants (amytriptiline) or antiepileptics
(clonazepam, gabapentine, tegretol, carbamazepine or pregabaline) or both. The average
number of molecules received by patients was 2.44. The average number of lines of
treatment was: 2.44. First intention treatment insisted of an anti-epileptic monotherapy
in 7 patients. Second line treatment involved the introduction of another anti-epileptic
or an anti-depressant drug. The drugs have been well tolerated except a respiratory
depression under clonazepam.
Among the 5 not-treated patients, only one benefitted from a treatment initiation.
Conclusions: Patients are treated by “old” molecules with a large prescription of
clonazepam but their efficacy is very variable.
The physicians have been sensibilised to DN4 questionnaire and they concluded that
it is easy to use.
However there is a lack of physician’s informations about the management of neuropathic
pain; besides they are hesitant to initiate a treatment. The relationship between
pharmacists and physicians and the development of clinical pharmacy seems important
to optimize the management of this pain.
Reference
Bouhassira D et al The DN4 questionnaire: a new tool for the diagnosis of neuropathic
pain. Pain 2005; 6: 297–300
Keywords: Neuropathic pain, DN4 questionnaire, Diabetic patient
EDU–171 Pharmaceutical care and clinical pharmacy in undergraduate education at University
of Buenos Aires
Ester Filinger
1, Patricia Kanenguiser1, Estela Izquierdo2
1Clinical Pharmacy, 2Pharmaceutical Technology, Faculty of Pharmacy and Biochemistry.
University of Buenos Aires, Buenos Aires, Argentina
Background and Objective: Pharmacy education in the Faculty of Pharmacy and Biochemistry
of the University of Buenos Aires is taught as a product-oriented profession with
a focus on the basic sciences. However in 1997 Pharmaceutical Care and Clinical Pharmacy
was integrated as an optional course into the pharmacy curriculum by resolution CD
707/97.
The object of the emphasis was on the students’ ability to provide Clinical Pharmacy
and Pharmaceutical Care upon graduation. Hence, therapeutic plays a significant role
in building students’ knowledge and skills in preparation for clinical practice.
Design: Theoretical education and program for students and collaborative implication
in the hospital activity or in the community pharmacy. The development of the program
is carried out in two phases. In the first phase the clinical activities of the pharmacists,
the unidose drug distribution, the role of the drug information centers, pharmacoepidemiology
and surveillance studies are explained. In the second phase the concept of Pharmaceutical
Care is introduced and its implementation in different pathologies is developed.
An active approach of the patient and contact with the treating physician was considered
as tool in a strong learning environment.
Setting: Undergraduate pharmacy students at University of Buenos Aires.
Main Outcome Measures: The students find them abilities to identify drug related problems
and to assess patient care and follow-up.
Results: More than 300 students have attended Pharmaceutical Care and Clinical Pharmacy
to: 97% passed and 3% failed. Students option was that the strongest aspect are the
case discussion and the weakest the very few number of hours not enough to discuss
other important illnesses. They also say that many topics should be taught sooner
in the career and it was not considered an emphasis an the clinical and patient oriented-aspects
of the profession.
Conclusions: An approach to clinical pharmacy education in which the integration of
teaching and learning are collaborative creates an atmosphere that is conducive to
effective student learning. Moreover the Clinical Pharmacy is a valued and important
tool of the general practice team regarding quality improvement in drug therapy.
References
Popovich NG. The educational care of Pharmacy. Am J. Pharm. Educ. 1991; 55:349–355
Quinones AC, Mason HL. Assessment of Pharmacy graduates educational outcomes. Am.
J. Pharm. Educ. 1994; 58:131–136.
Barber N. Towards a philosophy of clinical pharmacy. Pharmaceutical J; 1996, 257:289–291
Holdford D, Reinders TP. Development of an instrument to assess student perception
of the quality of Pharmaceutical Education. Am. J. Pharm. Educ. 2001; 65:125–131
Keywords: Clinical pharmacy, Pharmaceutical care, Undergraduate education
EDU-229 Counselling on patient’s adherence to tuberculosis therapy in Depok, Indonesia
Retnosari Andrajati
1, Wati Husnawati1, H Harianto1
1Pharmacy, University of Indonesia, Jakarta, Indonesia
Background and Objective: Tuberculosis is an important health problem in Indonesia.
Adequate and effective treatment is essential, both clinically for patients and to
control the spread of tuberculosis. The objective of this study was to evaluate the
influence of counselling on patient’s adherence.
Design: This study was quasi experiment design (non randomized control group pretest–posttest
design). The study subjects were fifty two people with tuberculosis who took antituberculosis
medicines from February–May 2007. Subjects were divided into intervention and control
group. Both of groups were given questionnaire. Counselling were given to intervention
group. A month later both of groups were given a similar questionnaire. Data was statistically
analyse.
Setting: Depok, West Java, Indonesia.
Main Outcome Measures: Profile of subjects, antituberculosis drugs, the influence
of counselling.
Results: Most of subjects were men, low education, unemployee and at the productive
age. The tuberculosis drug use were isoniazid, Rifampycin, pirazinamid, and ethambutol.
There was significant difference of adherence to tuberculosis therapy between intervention
and control group (p value = 0.007).
Conclusions: There was influence of counselling on patient’s adherence to tuberculosis
therapy.
Keywords: Counselling, Tuberculosis therapy adherence, Depok Indonesia
EDU-233 Development of a tool to support continuous professional development in community
pharmacy
Ailsa Power
1, Susan McKellar2, Muna Al Juma2, Steve A. Hudson2
1Pharmacy, NHS Education for Scotland, 2Institute of Pharmacy and Biomedical Sciences,
University of Strathclyde, Glasgow, United Kingdom
Background and Objective: To investigate the use of a competency based continuous
professional development (CPD) workbook as part of a CPD support package.
Design: 6 month prospective study; Quantitative collation of workbook entries; Qualitative
one to one interviews.
Setting: 27 community pharmacists. The workbook is composed of 5 competence categories.1
Within those categories is a total of 46 associated pharmacy activities, established
from previous research.2
Main Outcome Measures: Collation of the number of each competency and associated pharmacy
activity identified as a CPD need. Pharmacists expressions of priorities in identifying
competencies.
Results: 13 (48.1%) chose to use the CPD workbook. The mean (SD) number of pharmacy
activities with identified CPD needs was 17.4 (9.3).
All of the most popular CPD linked pharmacy activities were from the competency- ‘Participation
as a member of the multidisciplinary team’. Telephone interview findings showed pharmacists
cited ‘priority for their service development’ as the principle reason for CPD identification.
No pharmacist identified a CPD need for: ‘Supporting patient/family motivation’; ‘ecording
problems in blood glucose control requiring balancing food intake and insulin dose’;
‘Sharing reflections of where your performance leaves room for improvement within
a pharmacists group’ and ‘Taking part in a local multi-disciplinary mentoring group.’
Conclusions: Currently CPD workbooks appear not to be widely used within the pharmacy
profession in the UK3 although there are examples of successful use of reflective
portfolio.4,5 Almost half of the participants chose the workbook as a means of support
leading to a substantial number of identified CPD issues. For community pharmacists
to deliver high quality care for diabetes, more attention is required to forms of
training and to both uniprofessional and multiprofessional peer support.
References
NHS Education for Scotland. A competency framework for the care of a person with diabetes.
Edinburgh, 2003.
Power A, Mc Kellar S, Hudson S. Pharmaceutical care of the patient with type 2 diabetes
mellitus: A consensus model for delivery of structured pharmaceutical care by community
pharmacists in Scotland. In Press IJPP.
McMillan F, Power A, Watson A, Brailey A, Parr RM, Ellis R, Mullen A. Development
of a leadership course tailored for pharmacists in Scotland. Pharm J 2007; 278:528–531.
Ashcroft DM, Hall J. Pharmacy students attitudes and views about portfolio-based learning:
a questionnaire survey. Pharmacy Education 2006;6:77–89.
Ashcroft DM, Hall J. Using portfolios to learn about prescribing: qualitative insights
into students experiences. Pharmacy Education 2006;6:91–95.
Keywords: Diabetes, Continual professional development, Community pharmacy
EDU-241 Usage and level of relevance of intravenous immunoglobulin prescriptions in
a French university hospital – Chu Bordeaux
Bénédicte Lahille
1, S. Pédeboscq1, M. Saliège1, M. Delacre2, M. Longy-Boursier2, J.P. Pometan1
1Pharmacy, 2Infectious disease, Saint-André, Bordeaux, France
Background and Objective: Consumption of intravenous immunoglobulins (IVIG) has increased
in Saint-André Hospital (CHU Bordeaux) since the last 2 years. This increase seems
to be related to the extension of the possible indications. Within the contract of
good use of medications, we evaluated the pattern of usage of IVIG in the goal to
estimate the respect of the guidelines.
Design: Retrospective data were collected at the hospital pharmacy between January
2006 and March 2007.
Setting: We retrospectively reviewed all prescriptions of IVIG issued from three infectious
disease departments (50 beds) in a French 500-bed university hospital.
Main Outcome Measures: For each IVIG prescription, the following data were collected:
patient identification, name of IVIG product, quantity of IVIG issued, date of IVIG
release, indication for treatment and level of relevance. These levels are determined
as follows. Level 1: indications approved by health authorities or for which comprehensive
guidelines have been published (high level of proof). Level 2: relevant indications
based on scientific publications. Level 3: off-label indications more difficult to
prove on a scientific basis (few or no high quality randomized controlled clinical
trials).
Results: During the studied period, 25 715 grams of IVIG were administered for a total
of 68 patients and 296 prescriptions. 88.9% IVIG used saccharose as a stabilizing
agent, other products contain either glucose (10.4%), or maltose (0.8%). 1.6% of IVIG
delivered was deprived of IgA. The total cost reached 856,760 €.
Level 1: 52 patients (76.5%), 224 prescriptions (75.7%).
Level 2: 12 patients (17.6%), 58 prescriptions (19.6%) including 43% of Still’s disease,
27.5% of ANCA-associated vascularitis, 15.5% of autoimmune hemolytic anemia and 10.3%
of cortico-resistant polymyositis.
Levels 1 and 2 represent more than 95% of the prescriptions.
Level 3: 4 patients (5.9%), 14 prescriptions (4.7%) including 50% of uveitis and 36%
of Hashimoto’s encephalopathy.
Conclusions: Despite a huge increase of IVIG consumption, we observed that 95% of
prescriptions respect the criteria of published guidelines or high quality clinical
trials.
Meanwhile, 25% of prescriptions corresponded to level 2 or 3. Consequently, the pharmacist
has to be watchful concerning the scientific relevance of these off-label indications
which, moreover represents a non negligible cost.
Keywords: Intravenous immunoglobulin, Level of relevance, Prescription
EDU-260 evaluation of a hypertension/diabetes screening campaign
Esperanca Silva
1, Margarida Caramona2, Tiago Maricoto3, Vera Cruz e Silva3, Rita Rocha3, Emanuel
Costa3, Barbara Oliveiros4, Emanuel Ponciano4
1Community Pharmacy, Farmacia Rocha, 2Pharmacology, Faculty of Pharmacy, 3Medicine,
4Ibili, Faculty of Medicine, Coimbra, Portugal
Background and Objective: The risk of developing Diabetes type 2 increases with family
history of diabetes, age, obesity and lack of physical activity. Risk factors of cardiovascular
diseases must be screened in adults. Smoking, obesity, hypertension and high cholesterol
increase the risk of developing cardiovascular diseases.
The purpose of this study is to produce an evaluation focus on the risk profile and
counselling activities concerning therapeutic and lifestyle change.
Design: Descriptive study. Individual measurements were recorded by pre graduation
students on a standardized datasheet. Blood pressure was measured using a digital
wrist device. Blood glucose monitoring systems of two different brands were used.
Setting: The screening was made in the street using passer-by volunteers. In the course
of a single day in May 2007, a total of 293 subjects (48.8% males and 52.2% females,
mean age 62.37 years, SD = 15.62) had glycaemia and blood pressure measured.
Main Outcome Measures: Age, gender, medication taken, cigarette smoking, body mass
index (BMI), blood pressure, capillary blood glucose
Results: 70.31% of the sample presented BMI > 25Kg/m. 53.24% had elevated systolic
blood pressure values and 13.99% elevated diastolic blood pressure values. 11.95%
had elevated occasional blood glucose. 12.30% are cigarette smokers.
Systolic (t = −1.97; p = .05) and diastolic (t = −2.09; p = .04) blood pressure values
were significantly higher in smokers than in non-smokers.
Concerning patients taking diabetes medication, fewer patients with blood glucose
controled and more patients blood glucose uncontrolled were found than those expected,
suggesting either low compliance or lack of efficiency of medication (χ2 = 31.74;
p < .001).
Concerning the hypertension medication, similar results were found. More patients
under therapy with blood pressure uncontrolled were found than expected.
The concordance within the two measures of the blood glucose with different monitorizing
system was found to be strong and significant (k = .86; p < .001).
Positive and significant correlation between BMI and diastolic blood pressure was
found. However, no significant correlation between BMI and systolic blood pressure
was found.
Conclusions: Events such as this screening improves the quality of education, as well
as develops the interests and opinions of students. As well as it shows face to face
were can be apply their knowledge of clinical pharmacy
Furthermore, events such as these are found by the students to be invaluable in acquiring
training in similar-to-professional setting and expertise in field work.
Keywords: Students, Screening, Hypertension, Blood glucose monitoring systems
EDU-275 Evaluation of an educational package for pharmacists working in palliative
care
Anne Watson
1, Annamarie McGregor2, Janet Trundle3, Alison MacRobbie3, Aileen Scott-Aiton3, Helen
Moulsdale3, Joe Harrison3
1Pharmacy Directorate, NHS Education for Scotland, Glasgow, 2Pharmacy Directorate,
Scottish Executive Health Department, Edinburgh, 3Pharmacy Directorate, Scottish Palliative
Care Pharmacists` Association, Scotland, United Kingdom
Background and Objective: NHS Education for Scotland (NES) has worked with the Scottish
Executive Health Department (SEHD) to develop training packages to support the use
of validated Needs Assessment Tools (NAT) for several longterm conditions. Consequently
a specific training package was then developed to support and standardise needs assessment
and pharmaceutical care delivery by Palliative Care pharmacists in the local networks
set up in Scotland. Additional support materials (trainers package) was developed
for representatives from the Scottish Palliative Care Pharmacists’ Association to
deliver the training to their local network pharmacists in a consistent manner.
Design: Development and evaluation of a training package and course for palliative
care pharmacists.
Evaluation of the outcomes from using a NAT for delivery of care.
Setting: NHS Scotland
Main Outcome Measures
Development and evaluation of a standard training package for palliative care pharmacists
Development and evaluation of a standard training course for palliative care pharmacists
Outcomes from the use of a standard NAT on palliative care patients in community pharmacies
Results
NHS Boards involved 15; pharmacists involved 200; Quality 97%; Relevance 97%.
Comments: Pre-reading comprehensive, informative and not too much; These packs are
excellent!; CDROM of the presentation allowed you to go back over bits difficult to
understand; Resources useful.
NHS Boards involved 14; pharmacists involved 180; Quality 93%; Relevance 98%; Objectives
met 90%
Comments: Good organisation and appropriate time for each session; Excellent, very
interesting and informative lecture; cases relevant and found NAT easy to use.
Identification of issues 100%; Relevance of questions 100%; Time to complete NAT 10–20
mins; barrier – time; benefits – care issues identified by NAT; Care issues – counselling
and compliance issues, side-effects identified (nausea, dry mouth, constipation),
pain relief not adequate.
Conclusions: NES are proactively supporting national policy and practice through a
process of identifying and meeting the educational needs through direct and self-directed
learning for Continuing Professional Development (CPD). The needs of Palliative care
patients are seen as an appropriate target group for pharmaceutical care. The evaluation
and feedback from the courses, training pack and outcomes from the use of the NAT
in practice have been very positive and amendments will be made for further implementation
in Scotland.
Keywords: Education, Palliative, Pharmaceutical care needs
EDU-284 Fourth-grade pharmacy students prefer kinesthetic learning
Sule Apikoglu Rabus
1, Fikret V. Izzettin1
1Clinical Pharmacy Department, Marmara University Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Pharmacy students represent a broad spectrum of learning
preferences and styles. This diversity presents a responsibility for the lecturers
and instructors to meet the educational needs of all students. In order to develop
appropriate learning approaches the instructors need to know the students learning
preferences. Therefore, the aim of this study was to identify the learning preferences
of pharmacy students.
Design: The visual, auditory, reading/writing, kinesthetic (VARK) questionnaire identifies
student’s preferences for particular modes of information presentation. The VARK questionnaire
is freeware that can be completed online. However, we administered the VARK questionnaire
as a hard copy at the end of the ‘clinical pharmacy practices’ final exam to the fourth-grade
pharmacy students.
Setting: Marmara University – Faculty of Pharmacy.
Main Outcome Measures: The frequency of students’ preference for modes of information
presentation.
Results: We administered the VARK questionnaire to 108 students and 106 (98%) returned
the completed questionnaire. Almost half of the students (48.1%) preferred a single
mode of information presentation. Among these students, 2% preferred visual (learning
from graphs, charts, and flow diagrams), 19.6% preferred auditory (learning from speech),
and 29.4% preferred printed words (learning from reading and writing), and 49% preferred
using all their senses (kinesthetics: learning from touch, hearing, smell, taste,
and sight). The other half (51.9%) preferred multiple modes [2 modes (44.3%), 3 modes
(4.8%), or 4 modes (2.8%)] of information presentation. A total of 63 (59.4%) students
preferred ‘kinesthetic’ learning solely or in a multimodal combination.
Conclusions: The students represented a variety of learning styles. Student motivation
and performance improves when instruction is adapted to student learning preferences
and styles; so, it is the responsibility of the instructor to address this diversity
of learning styles and develop optimum learning approaches.
EDU-285 Prescriptions of antidepressants: analysis in a psychiatric department
Olivier Galvez
1, Patrick P. Gentes1, Dominique D. Vallet2, Olivier O. Bourdon3
1Pharmacy Department, 2Psychiatric, HIA Val de Grâce, 3Clinical Pharmacy, Université
Paris Descartes, Paris, France
Background and Objective: To carry out in a psychiatric department a descriptive analysis
of antidepressant use. To estimate the appropriateness of guidelines1,2,3 of therapeutic
strategies and to optimize in the future the medicinal treatment with decision-making
tools.
Design: Retrospective study applied to the prescription of antidepressants in psychiatry.
The data were collected in a retrospective way during three months.
Setting: Psychiatric department, pharmacy department.
Main Outcome Measures: The prescriptions and patient files of 47 patients were analyzed:
therapeutic strategies, posology, taking plan, dosage adjustment, duration before
increasing the doses and drug interactions.
Results: The average age of the individuals in the group was 46 years old. The men
represented 57% of the population, the women 43%. Venlafaxine represented the most
used antidepressant (47%), followed by citalopram, paroxetine and sertraline (15%
each). Escitalopram, fluoxetine and mirtazapine were rarely prescribed.
The posology and taking plan were generally respected. However, some improvements
in terms of treatment optimization could have been brought. They could have lead to
32 actions of clinical pharmacy within the framework of prospective study: 9 posology
optimizations and 23 taking plan optimizations. Nineteen patients (40%) had an adjustment
in their antidepressant treatment: nature and dosage. For all the antidepressants,
a sufficient duration was respected before increasing the doses. An average number
of interactions by prescription were 4.8 but none was clinically significant.
Conclusions: Therapeutic strategies corresponded to guidelines recommendations. The
Dosage adjustments and duration before increasing the doses respected the indication
of antidepressants.
In the future, to optimize the medicinal treatment, decision-making tools carried
out could facilitate psychiatrists’ prescriptions. The pharmaceutical validation of
prescriptions will be facilitated by complying with them within the framework of clinical
pharmacy activity.
References
Practice guideline for the treatment of patients with major depressive disorder (revision).
American Psychiatric Association. Am J Psychiatry. 2000; 157 (4 suppl.): 1–45.
NICE guidelines for the management of depression (6 décembre 2004). www.nice.org.uk
bon usage des antidépresseurs au cours des troubles dépressifs de l adulte (avril
2005) www.afssaps.fr
Keywords: Antidepressant, Therapeutic strategy, Treatment optimization, Evaluation
practices.
EDU-286 Oncology pharmacy training program in Al-Amal Hospital in Qatar
Manal Zaidan
1
1Pharmacy, Al-Amal Hospital, Hamad Medical Corporation, Doha, Qatar
Background and Objective: Al-Amal Hospital is a 51 bed oncology/hematology hospital.
Al-Amal hospital is now the first hospital in Qatar to be accredited by the Joint
Commission International (JCI), the worldwide leader in improving the quality of healthcare.
The objective is to implement clinical pharmacy services in Al-Amal Hospital in the
state of Qatar by training the pharmacists about clinical pharmacy services.
Design: A pharmacist designed the training program and took the initiative and responsibility
for training other pharmacists in AAH about clinical pharmacy. The department of Medical
Oncology/Hematology, the hospital administration and the pharmacy department agreed
that the pharmacists should have central responsibility for antineoplastic agents
and other drugs related problems. Pharmacists for the program were selected from the
existing staff. The Healthcare team is consisting of two pharmacists rotating every
2 months. Each pharmacist join 2 teams consisting of a pharmacists, a consultant,
a specialist, a resident, a rotating resident, 2 nurses, a dietitian, physiotherapist,
social worker and a psychologist. We used to have 3 oncology teams and 1 hematology
team. Both pharmacists participate in the medical rounds and morning report 3 days
per week. The pharmacists provide clinical pharmacy services including chart review,
pharmacy patient profile review, laboratory tests, therapeutic drug monitoring, antibiotics
monitoring, interviews with patients and/or relatives. Drug related problems were
identified, resulting in interventions.
Setting: In patient wards, Al-Amal Hospital, Qatar.
Main Outcome Measures: To identify Drug Related Problems, which well result in interventions
and to help the medical team and the patients to reach their treatment goals. Patient
outcomes were evaluated by follow up with the medical team or by patient interview.
We refer patients to the dietitian, physicians, the clinical psychologist as needed.
Results: More time is needed to evaluate the clinical pharmacy services provided by
the pharmacists as the program was just started. Patient and physicians were satisfied
by starting the training program.
Conclusions: Hematology/Oncology setting provides an excellent opportunity to involve
pharmacists.
References
Caselnova DA, et al. Implementing clinical pharmacy services in an outpatient oncology
clinic. Am J Hosp Pharm. 1985 Jun; 42(6):1348–52.
Christina Hising, et al. An evaluation of pharmacist contribution in oncology ward
in a Swedish hospital. J Onc Pharm Pract. Vol. 12, No.2, 75–81 (2006).
Shah S. et al. Evaluation of clinical pharmacy services in a hematology/oncology outpatient
setting. Ann Pharmacother. Sep; 40(9):1527–33.2006.
Keywords: Clinical pharmacy, Al-Amal Hospital
NUTR-19 Dietetary management of acute metabolic decompensation in leucinosis: implication
of the pharmacy
Céline Mechin
1, Christelle Landy1, Pierre Dechelotte2, Aude Coquard1, Bernard Dieu1
1Pharmacy, 2Nutrition, Hospital Charles Nicolle CHU ROUEN, Rouen, France
Background and Objective: Maple Syrup Urine Disease (M.S.U.D.) or leucinosis is an
autosomal recessive disorder caused by an enzyme defect in the catabolic pathway of
branched-chain amino acids (B.C.A.A.): leucine, isoleucine and valine. Accumulation
of these 3 A.A. leads to encephalopathy and progressive neurodegeneration in the infant
who is not treated. Early diagnosis and dietary management can prevent complications
and may allow for normal intellectual development. However, neurologic function may
deteriorate rapidly at any age because of acute metabolic decompensation. These severe
episodes are caused by catabolism of endogenous protein, which may be provoked by
physiological stress (infections, post-surgery). During these crisis, the patient
must have immediately intravenous glucose infusion and enteral nutrition free of B.C.A.A.
Design: Case report.
Setting: Department of Pharmacy, Hospital Charles Nicolle, Rouen.
Main Outcome Measures: Case report
Results: One patient with classical M.S.U.D. is followed in our establishment since
many years. His disease has been diagnosed in neonatal period. A diet free of B.C.A.A.
has been instaured. This diet is successful, now this patient is 34 years old and
had a normal development except myalgia and hypoesthesy of the left leg. However,
when the diet is not well followed or when he’s infected, acute episode occurs (on
average 3 or 4 times per years). As the crises starts, the patient is sleepy and confused.
In order to be able to treat him very quickly, the medical staff decided to set up
an emergency protocol, which include an adapted enteral nutrition formulation. The
pharmacy is implicated in this protocol to prepare the mixture. The formula includes:
M.S.U.D mix, dextrin maltose, oligoelements, ions, lipids (sunflower oil), vitamins
and water. The pharmacy must be able to carried out the preparation at any time and
the components must be always available.
Conclusions: Because M.S.U.D is an unherited disease, published report of treatment
are rare and they are no consensus for the treatment of acute decompensation. Since
6 years, this protocol is successful: B.C.A.A. levels decrease between 2 to 4 days
after the setting-up and the patient always recovered rapidly. This formula is administrated
by nasogastric tube and avoid the use of hemodialysis which is the last solution to
remove B.C.A.A. This is an example that a personnal follow-up program (with plan for
clinical and metabolic evaluations) during common intercurrent illnesses can have
optimal outcomes.
Keywords: Leucinosis, Metabolic decompensation, Adapted enteral nutrition
NUTR-46 Ensuring phosphorus adequacy of human-milk-fed preterm babies
Canadell Laura1, Cañete Carmen1, Pardo Rocio
1, Albujar Mar2, Valldeperez Cinta2, Carretero Juan2, Gallart M Jesus1, Closa Ricardo2
1Pharmacy service, 2Neonatology, Hospital Universitari Joan XXIII, Tarragona, Spain
Background and Objective: Human milk is the feed of choice for preterm infants both
for nutritional and non-nutritional reasons.
Phosphorus levels in human milk are insufficient for most premature infants. This
deficit is the major cause of osteopenia in prematurity. Fortification with a commercial
multinutrient product should only be considered after 2 weeks of mother’s milk feeding,
however, phosphorus supplement must be given initially.
To describe a standardized scheme for early nutritional support with phosphorus of
very preterm infants (<1250–1500 g)and describe the phosphorous oral solution we use
as a supplement is the aim of this study.
Design: Clinically relevant reports were reviewed to establish a standardized scheme
for early nutritional support with phosphorus of the very preterm infants.
A standardized formula of oral phosphorous was established to diminish the medical
errors when the addition of this mineral is required.
Setting: Pharmacy service and Neonatology Unit of a third level hospital.
Main Outcome Measures: To describe the scheme of adding phosphorous to human milk
as well as the standardized formula we use, “phosphorous oral solution” (10 mg P/100 mL).
Results: Phosphorous oral solution procedure: composition, stability and the scheme
of addition to human milk to ensure the requirements for bone substrate needs in preterm
infants to avoid osteopenia of prematurity.
Conclusions: Various methods have been tested to decide when additional supplements
must be given. Individual adjustment is not possible due to the delay of laboratory
results on milk analysis and the fast changes in infants’ requirements. Therefore,
it is necessary to make a standard adjustment scheme on the dose of the fortifier
that needs to be added.
Keywords: Phosphorous oral solution, Osteopenia of prematurity
NUTR-192 Jejunal feeding tolerance in pancreatic carcinoma
Cristina Vazquez
1, Juliana J. Alvarez1, Jose Manuel J. M. Sierra2, Maria M. Noguerol3, Eva E. Campelo1,
Maria Teresa M. T. Inaraja1
1Pharmacy, 2Endocrine, Hospital Meixoeiro, Vigo, 3Pharmacy, Hospital Leon, Leon, Spain
Background and Objective: Evaluation of nutritional management of a patient undergoing
cephalic pancreaticoduodenectomy for adenocarcinoma of the head of the pancreas.
Design: Case report, evaluation and discussion based on clinical data and literature
review
Setting: Pharmacy Department and general teaching hospital, Spain
Main Outcome Measures: Detection and correction of complications associated to jejunal
feeding and to improve nutritional parameters
Results: Male, age 47, weight 86 kg and BMI 28. Daily energy requirements (using adjusted
weight): 1978 kcal/d, 14.5 gr N2. Hydric needs: 2250–2625 mL.
Shortly to the pancreaticduodenectomy, total parenteral nutrition (TPN) was started
(1500 kcal in progress until reaching his energy requirements). In addition to parenteral
nutrition, supplementation enteral nutrition was delivered via jejunostomy along four
postoperative days. On post day 8, transition to a complete enteral formula was achieved
(standard formula, 1 mL = 1 kcal: 2000 kcal/d). On day 12, patient complained of colic
pain in upper hemiabdomen. An emergency TC revealed presence of liquid in the abdominal
cavity from anastomosis pancreatogastric. With the suspect of a leak from jejunostomy,
the catheter was removed. TPN was reintroduced and kept as the only way of nutrition
until 15 later when oral tolerance was started.
During hospital stay (37 days) periodic blood controls were performed. Main methabolic
complication was high blood sugar, needing the administration of insuline. From day
2 to 28, mean plasma levels of albumin (2.4 vs 3.1 g/dL), total proteins (4.4 vs 6.2 g/dL),
total serum cholesterol (88 vs 106 mg/dL), total lymphocite count (6.9 vs 12.9%) and
prealbumin (10.5 vs 16.1 mg/dL) increased significantly
Conclusions: The leak of artificial nutrition to the abdominal space in patients with
jejunal feeding is a frequent complication of NE. Its incidence is probably related
to the length of the tube inserted into the lumen. Protocols are need to prevent complications
like tube displacement and to encourage early enteral nutrition.
Increase in plasma concentrations of nutritional parameters suggests effective uptake
NUTR-236 What place for standardized formulations of parenteral nutrition prescriptions
in our neonatal intensive care unit?
Aurelie Gresser
1, Aurore Steinmetz1, Anne Cecile Michallat1, Pierre Kuhn2, Dominique Astruc2, Laurence
Beretz1
1Pharmacy, 2Pediatric Intensive Care Unit, University Hospital of Strasbourg, Strasbourg,
France
Background and Objective: Parenteral nutrition (PN) is often used in newborns who
are unable to tolerate sufficient enteral feeding. Admixtures might be either prescribed
and made “a la carte” according to the newborn’s needs or provided by pharmaceutical
companies as standard formulations. The aim of the study is to review individual PN
prescriptions in a neonatology care unit in order to assess the potential for using
standardized PN instead.
Design: Prospective study one day per week during 8 weeks.
Setting: Neonatal intensive care unit, Strasbourg University Hospital.
Main Outcome Measures: the major criteria for the comparison are carbohydrate concentration
and then amino acid intake.
Results: 57 prescriptions were analysed and compared with a standardized formulation,
Pediaven® (Fresenius Kabi). The first point of comparison based on carbohydrate concentration
resulted in an exclusion of 65% (37/57) of the total prescriptions because their carbohydrate
concentration was less than 8 g/100 ml or more than 12 g/100 ml (Pediaven® glucose
concentration, 10 g/10 ml). Among the 20 prescriptions retained, only prescriptions
whose amino acid concentration was less than 0.25 g/100 ml were included (Pediaven®:
0.2 g/100 ml). The other nutrient intakes were similar between PN prescriptions and
standardized formulation. Finally, only 3.5% PN prescriptions (2/57) were similar
to the standardized formulation and could have been substituted without adding extra
aminoacids.
Conclusions: This standardized formulation doesn’t fit the needs of our newborns in
terms of carbohydrate and amino acid intakes, unless excessive fluid and/or extra
aminoacids are provided. Currently, PN “a la carte” remain the preferential alternative
for the physicians in our hospital for the newborns on unstable metabolic condition.
Keywords: Newborn standardized or individualised parenteral nutrition
PC-5 Evaluation of the medical service provided to outpatient clinics with hypertension
in two different healthcare systems in Egypt
Manal El-Hamamsy
1
1Clinical Pharmacy, Faculty of Pharmacy, Cairo, Egypt
Background and Objective: Hypertension represents a major public health concern. Large
benefits, in terms of avoided cardiovascular diseases, are expected from the treatment
of hypertension.
Objective:
The aim was to asses and compares the effectiveness of treating hypertension in two
healthcare systems.
Design: 1. design of questionnaire, 2. administration of questionnaire, 3. data analysis
Setting: Medical out patient’s clinic located in Ain Shams University Hospitals and
different National Health Insurance Hospitals in Cairo, Egypt. from April 2006 to
Dec. 2006.
Main Outcome Measures: 1. counseling about life style modification, 2. number of drugs
used for the treatment of hypertension, 3. frequency of follow up, 4. rate of side
effects, 5. compliance rate, 6. emergency room visits relating to hypertension, 7.
complications rate from hypertension.
Results: The following results were obtained:
Regarding to the medical services provided to out patient clinics with hypertension
in:
Ain Shams University Hospitals the following remarks were noticed:
More care about life style modifications,
More respect is concerned to patient desire and their opinion about medication regimen
and dosage form,
Little care about patient history or compliance
Most of physicians did not use thiazides as the first line of treatment
National Health Insurance Hospitals the following remarks were noticed:
The advantage of health insurance; it is free
The disadvantages of health insurance are; routine, inefficient examination of the
patient, little or no counseling at all, the unavailability of most drugs
Little care about patient history or compliance.
Most of physicians did not use thiazides as the first line of treatment
Conclusions: Regarding to the medical services provided to out patient clinics with
hypertension in: Ain Shams University Hospitals the following remarks were noticed:
More respect is concerned to patient desire and their opinion about medication regimen
and dosage form, Little care about patient history or compliance. National Health
Insurance Hospitals are: routine, inefficient examination of the patient, little or
no counseling at all, the unavailability of most drugs. Little care about patient
history or compliance. Most of physicians did not use thiazides as the first line
of treatment
References
Wolf-Maier K, Cooper RS, Banegas JR, Giampaoli S, Hense HW, Joffres M, et al. Hypertension
prevalence and blood pressure levels in 6 European countries, Canada, and the United
States. JAMA 2003;289: 2363–9.
Guidelines Committee. 2003 European Society of Hypertension-European Society of Cardiology
guidelines for the management of arterial hypertension. J Hypertens 2003;21: 1011–53.
Keywords: Hypertention, Heathcare system, Outpatient clinics, Clinical pharmacy
PC-9 Effect of propofol on myocardial protection after regional ischemic-reperfusion
injury at in vivo rat heart model
Ilwoo Shin
1, Heon Keun Lee1, Ju Tae Sohn1, Young Kyun Chung1
1Department of Anesthesiology, Gyeongsang National University Hospital, Jinju, South
Korea
Background and Objective: It is known that propofol protect myocardial tissue against
global myocardial ischemic-reperfusion injury in the isolated rat heart model. The
aim of this study was to investigate whether propofol, at a clinically relevant concentration
infused during both preischemia and reperfusion (peri-ischemic) period, also provide
protective effect against regional myocardial ischemic-reperfusion injury in vivo.
Design: Mail SD rats weighing between 230 and 270 g were anesthetized with 50 mg/kg
of Ketamine and 3 mg/kg of Xylazine. A haparinized 24 G catheter was placed in the
left femoral vein. The trachea was intubated and then mechanically ventilated with
room air using a volume-controlled rodent ventilator. A left thoracotomy was performed,
and the pericardium was opened. For the ischemia-reperfusion experiments, a snare
was passed around a left anterior coronary artery territory to induce regional myocardial
ischemia. Coronary occlusion was produced by pulling the snare and clamping it with
a mosquito hemostat. Reperfusion was produced by releasing the clamp.
Setting: Rats were subjected to 25 minutes of coronary artery occlusion followed by
24 hours of reperfusion. Propofol or intralipid was administrated during 35 minutes
starting 5 minutes before the onset of ischemia until 5 minutes after the onset of
reperfusion.
Main Outcome Measures: The micro-manometer catheter was advanced into the left ventricle
via right internal carotid artery and hemodynamic function was checked after 24 hours
of reperfusion. Infarct size was determined by triphenyltetrazolium staining after
24 hours of reperfusion.
Results: Propofol administration during both preischemia and reperfusion (peri-ischemic)
period showed protective effects on myocardial function and infarct reduction. In
the control group, the peak rate of ventricular pressure rise (+dP/dtmax) and the
peak rate of intraventricular pressure decline (-dP/dtmin) significantly decreased
than sham group. In the propofol group, the +dP/dtmax and -dP/dtmin significantly
improved than conrol group. Infarct size was 50.6% of the area at risk in control
group, and was reduced markedly by administration of propofol during peri-ischemic
period to 20.4% in the propofol group (P < 0.001). Infarct size of intralipid group
was 43.8% of the area at risk, intralipid had no effect on infarct size compared with
the control group.
Conclusions: Propofol, at a clinically relevant concentration infused during peri-ischemic
period, provided protective effect after regional myocardial ischemic-reperfusion
injury at in vivo rat heart model.
References
Approaches to the prevention of perioperative myocardial ischemia. Anesthesiology.
2000; 92:253–9.
The role neutrophils in myocardial ischemia-reperfusion injury. Cardiovascular Research
43(1999)869–878.
Keywords: Ischemic-reperfusion injury, Myocardial protection, Propofol
PC-11 Barriers to the implementation of clinical pharmacy in psychiatry hospital in
K.S.A
Khalaf Aljumaah
1, Jawza J. S. Alsabhan,2, Zeinab Z. J. Jaglit2
1Pharmacy, AlAmal Complex for Mental Health Care, Riyadh, 2Pharmacy, Alamal Complex
for Mental Health, Riyadh, Saudi Arabia
Background and Objective: Background:
The application of clinical services in psychiatric hospital is difficult due to many
cause which are not be assessed in previous studies
Objective:
To study the barriers of clinical services for Saudi pharmacist who working in psychiatric
hospital
Design: Method:
The information collecting from all pharmacists working in ministry of health psychiatric
hospital through our designed Arabic questioner that composed of 7 sections. Section 1
gathered demographic information, section 2 to 6 respectively asked likert-type questions
about resources barriers, attitude and opinions barriers, skills barriers, education
barriers, environment barriers, and culture barriers. The questioners were distributed
to the pharmacists in all the Kingdom of Saudi Arabia by the fax-machine.
Setting: all Psychiatric hospital in the Kingdom of Saudi Arabia.
Main Outcome Measures: questioners.
Results: Result:
Eighty-five pharmacists participated in our survey. The majority of pharmacists 88%
agreed or strongly agreed with the statement that lack of clinical information for
mentally patients, followed by 85% of pharmacist agreed or strongly agreed with the
statement that lack of financial support are the most resources barrier. The attitude
of pharmacist toward psychiatric patients in implementing pharmaceutical care was
60%. Half of the pharmacist participated in our survey agreed that lack of communication
skills and lack of documentation can affect the performance during the application
of pharmaceutical care. The most educational barriers were lack of education in psychopharmacology
and lack of education in psychiatric disorder (78–72%). Several environmental factors
were associated with barriers to providing pharmaceutical care for psychiatric patients.
80% pharmacist agree that patients culuter, stigmatization and language difficulty
associated with the barriers for efficient practice during application of pharmaceutical
care.
Conclusions: Pharmacists expressed positive attitudes toward both psychiatric patients
and the providing pharmaceutical care to psychiatric patients.
PC-16 Intravenous immunoglobulin utilization in a tertiary care teaching hospital
in Saudi Arabia
Abdullah Alangari1, Mohammed Abutaleb
2, Ahmad Albarraq3, Abdullatif Al-Dhowailie2
1Department of Pediatrics, College of Medicine, King Saud University, 2Clinical Pharmacy
Department, College of Pharmacy, King Saud University, 3Pharmaceutical Services Department,
King Khalid University Hospital, KSU, Riyadh, Saudi Arabia
Background and Objective: Background: Intravenous immunoglobulin (IVIG) is a plasma
product that has many important therapeutic uses. There are only 6 FDA approved indications
for IVIG use. However, it is used to treat a wide variety of other clinical conditions.
Many studies showed high rate of off-label IVIG utilization.
Objectives: To evaluate IVIG utilization at King Khalid University Hospital, an 850
bed tertiary care academic center, over 3 years period.
Design: Methods: Patients who received IVIG in the period from January 2003 to December
2005 were identified retrospectively using the hospital computer system. Their charts
were subsequently reviewed. We collected data about patients demographics, indication
of IVIG, dose regimen and physician specialty. Based on recent evidence, indications
were categorized into 4 different categories: FDA-labeled; off-label recommended as
first line; off-label recommended as alternative; and not recommended.
Setting: King Khalid University Hospital.
Main Outcome Measures: inappropriate uses of IVIG and its costs.
Results: Results: A total of 305 patients were identified. IVIG was given to 109 (35.7%)
patients for FDA-labeled indications, 29 (9.5%) patients for off-label recommended
as first line indications, 97 (31.8%) for off-label recommended as alternative indications,
and 70 (23%) for not recommended indications. The amount of IVIG consumed during the
study period was 43.65 Kgs with an estimated cost of $1.75 million, 24.4% of which
was considered inappropriate use. In terms of the prescribing physician, hematologists
were the most frequent prescribers followed by neurologists.
Conclusions: Conclusions: Significant amount of IVIG was prescribed for inappropriate
indications. This had a large financial burden on an already strained hospital budget.
References
Clinical and Experimental Immunology 2005;142:1–11.
Trasfusion Medicine Reviews 2003;17(4):241–251.
Molecular Immunology 2004;42:839–848.
Transfusion 2003;43:1460–1480.
Ann Pharmacother 2000;34(3):295–9.
JAMA 1995;273(23):1865–1870.
Transfusion 2006;46:741–753.
J Allergy CIin Immunol 2006;117:S525–553.
Archives of Allergy and Immunology 2006;140:185–198.
N Z Med J 1998;110:48–50.
The European Journal of Hospital Pharmacy Science 2006;12(4):67–71.
Am J Hosp Pharm 1994;51(6):801–5.
Can J Clin Pharmacol 2003;10(1):11–6.
Vox Sang 2005;89(3):150–60.
Eur J Clin Pharmacol 1997;52(4):255–60.
Keywords: Intravenous immunoglobulin, IVIG, Immunoglobulin intravenous, IGIV, Utilization,
Cost
PC-28 Compliance with treatment guideline targets in an academic hemodialysis center
Simin Dashti-Khavidaki
1, Hossein Khalili1, Seyedeh-Maryam Vahedi1
1Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic
of)
Background and Objective: Patients with chronic renal disease (CRD) suffer several
complications including metabolic disorder (hyperphosphatemia, hyperkalemia…), anemia
and so on. There are several reports from various countries that show suboptimal metabolic
and hypertension control in CRD patients. This study was designed to assess the achivement
of treatment guidelines targets in controlling the complications of CRD in an academic
hemodialysis center in IRAN.
Design: During a cross-sectional study in the hemodialysis (HD) center of Imam Referral
Hospital affiliated to Tehran University (Medical Sciences), 94 patients on routine
maintenance HD for three sessions per week and four hours in each session were evaluated
for metabolic (calcium (Ca), phosphorus (P), albumin (Alb)), anemia and secondary
hyperparathyroidism control according to National Kidney Foundation-Kidney Disease
Outcomes Quality Initiative (K/DOQI) guidelines.
Setting: Hemodialysis (HD) center of Imam Referral Hospital affiliated to Tehran University
(Medical Sciences).
Main Outcome Measures: metabolic (calcium (Ca), phosphorus (P), albumin (Alb)), anemia
and serum parathyroid hormone control according to National Kidney Foundation-Kidney
Disease Outcomes Quality Initiative (K/DOQI) guidelines.
Results: The results showed hemoglobin level of less than 10 g/dL in 52.2% of the
subjects, transferrin saturation (TSAT) of less than 20% in 77.2% of the HD patients,
TSAT < 20% and ferritin < 100 ng/mL in 7.6% of the patients, serum Alb level of less
than 4 g/dL in 37% of the patients, serum P level of more than 5.5 mg/dL in 57.6%
of the subjects, Ca × P product of more than 55 in 38% of the patients, Parathyroid
hormone (PTH) < 150 pg/mL (adynamic bone disease) in 23.9% of the subjects and serum
PTH concentration of more than 300 pg/mL (uncontrolled secondary hyperparathyroidism)
in 48.9% of the subjects.
Conclusions: The results showed that more than half of the HD patients need erythropoietin
and ferrous dose adjustment or follow up for resistant anemia, more than half of the
subjects need phosphate binders dose adjustment or replacement and about 20% of he
patients need rocaltrol dose adjustment.
We are planning to compare these results with the findings following the participation
of a clinical pharmacist in this HD center rounds and monitoring of HD patients.
Since enough management of complications of CRD patients and their drugs monitoring
are necessary to improve quality of life of HD patients, clinical pharmacist may have
a major role in HD centers.
Reference
www.kidney.org/proffesionals/kdoqi/guidelines
Keywords: Hemodialysis, Anemia, Treatment targets
PC-29 Action of a working group depending on our drug commission for the use of a
computerized physician order entry (CPOE)
Catherine Bouiri
1, Frédérique Bouchand1, Coralie Lepage1, Violette Pincemail1, Annie Merlin1, Djillali
Annane2, Maryvonne Villart1
1Pharmacy, 2Intensive Care Unit, Hopital Raymond Poincaré, AP-HP, Garches, France
Background and Objective: Computerization of our drug circuit has been deployed gradually
to every hospitalisation units of our hospital since 2003. Pharmacists coordinated
the extension, the installation and the support for starting. They were the first
interlocutors to analyze dysfunctions and to help solving them. Difficulties encountered
by nurses were often notified to head nurses and transmitted to pharmacists. The objective
was to study as a whole difficulties of users and to bring a workable solution to
their problems.
Design: A working subgroup depending on the drug commission was created. It was composed
with 12 nurses from different departments (intensive care, infectious, pediatric and
rehabilitation departments), 4 head nurses and 2 pharmacists. Several meetings, organized
between October and December 2006, made it possible to the participants to announce
their difficulties. Reports were written and diffused for validation.
Setting: Pharmacy and hospitalization units of Raymond Poincaré university hospital,
AP-HP, Garches, France.
Main Outcome Measures: Correct knowledge and appropriate use of the CPOE nurse module
were analysed thanks to questions and remarks of the members of the working group.
Results: It appeared that uncorrect use of the CPOE nurse module caused dysfunctions.
Because some dysfunctions repeated several times (uncorrect ordering support, uncorrect
reading of dosage units, registration of infusion settings…), it appeared necessary
to compile a document named “Good practices for the use of CPOE nurse module”. This
document pointed out several stages to be respected from prescription of a treatment
to validation of its administration: 11 points, including, amongst others, checking
of the ordering support documents, dosage units, methods of administration, … were
then diffused to each head nurse of computerized units.
Conclusions: This working method made it possible to highlight the central role of
our drug commission and the transverse role of its working groups, the exhaustiveness
of analysis in collecting difficulties of use of a common software. The created document
succeeded in helping nurses to solve the main dysfunctions.
Additional working subgroups could be created to analyse each other stage of the drug
circuit (orders, protocols, safeguards, patient files, etc…), to carry out the study
of its development and to take part in its appraisal.
Keywords: Drug commission, Drug circuit, CPOE, Good practices
PC-40 Analysis of the activity in a dispensing unit aimed to external patients
Elvira Gea
1, Maria Dolores García1, Esperanza Gil1, Nuria Barral1
1Pharmacy Department, Nostra Senyora de Meritxell, Escaldes-Engordany, Andorra
Background and Objective: Analyse the evolution of the supporting activity and the
economic impact of the dispensed medicines in a unit of pharmaceutical attention to
external patients (UPAEP).
Design: Observational and retrospective study during three years (2004–2006) carried
out in a UPAEP.
Setting: UPAEP. 200 bedded hospital that covers all the country’s population (84.000
inhabitants).
Main Outcome Measures:
The measurement unit for the supporting activity is: number of patients assisted.
The descriptive study has been carried out by pathology and per year.
The economic impact has been worked out based on the medicines consumption of each
treated pathology applying the retail price. This has been related to the total consumption
of the unit per year.
Results: Number total of patients in 2004:165, 2005:208, 2006:207.
Classification by pathology and per year:
2004: Chronic Kidney Failure (CKF): 44 patients (26.6%), others: 32 (19.4%), Human
Immunodeficiency Virus (HIV): 27 (16.4%), Rheumatic Illness (RI): 27 (16.4%), Multiple
Sclerosis (MS): 21 (12.7%), Hepatitis C (HC): 14 (8.5%).
2005: CFK: 57 (27.4%), Others: 51 (24.5%), RI: 37 (17.8%), HIV: 27 (13.0%), MS: 22
(10.6%), HC: 14 (6.74%).
2006: CFK: 52 (25.2%), RI: 47 (22.7%), Others: 39 (18.8%), HIV: 27 (13.0%), MS: 23
(11.1%). HC: 19 (9.2%).
Classification by economic impact and per year:
2004: RI: 247,105 € (26.7%), MS: 243,184 € (26.2%), HIV: 230,076 € (24.8%), HC: 89,760
€ (9.7), Others: 63,657 € (6.9%), CFK: 52,618 € (5.7%). Total economic impact (TEI):
926,399 €.
2005: RI: 398,264 € (31.7%), HIV: 263,625 € (20.9%), MS: 233,593 € (18.6%), HC: 167,499
€ (13.3%), Others: 107,837 € (8.6%), CFK: 86,509 € (6.9%). TEI: 1,257,328 €.
2006: RI: 401,833 € (33.5%), HIV: 230,621 € (19.3%), MS: 222,770 € (18.6%), HC: 156,461
€ (13.1%), Others: 94,197 € (7.9%). CFK: 91,764 € (7.6%). TEI: 1.197,647 €.
Conclusions
The UPAEP undergoes a growth (25%) in total supporting activity in 2005 which stables
in 2006.
The growth in the supporting activity of RI and CKF is paralleled to the growth in
the economic cost.
Decrease the economic cost in MS because of a decrease in medicines’ retail prices.
The economic variations occurred in HIV is due to the treatment changes.
Keywords: External patients, Economic impact, Activity impact
PC-50 The patient–pharmacist communication in a community pharmacy chain in Romania
Diana Simona Negru
1, Ana Maria Petculescu2, Aurelia Nicoleta Cristea1
1Pharmacology and Clinical Pharmacy, University of Medicine and Pharmacy, 2Marketing,
SC SIEPCOFAR SA, Bucharest, Romania
Background and Objective
To evaluate the pharmacist – patient communication and the level of counseling for
OTC and prescription drugs dispense;
to improve the professional relationship between the patient and the community pharmacist;
to assess the effect of clinical pharmacist intervention over those parameters.
Design: interventional study (visits done by clinical pharmacists, especially employed
for), repeated after 2 weeks and again after 6 months.
Setting: 37 chain pharmacies from Bucharest, Romania.
Main Outcome Measures: The investigation was conducted using a multiple sections protocol.
The assessed parameters were: pharmacist’s attitude toward the patients, his/her availability
to communication and the level of counseling when OTC or prescription medication is
released.
Results: During the first visit, in sixteen pharmacies only (43%) the pharmacists
greet the patients. Two weeks later after the intervention, this number increased
to 28 (75%), although after six moths it decreased to 23 pharmacies (62%).
In more than 60% of the chain pharmacies, the professionals had a positive attitude
toward the patients. As an example, an empathic approach has been encountered initially
in 25 pharmacies (68%), then in 28 pharmacies (75%) and finally raised up to 30 pharmacies
(81%) after 6 months.
Although the clinical pharmacist’s intervention (therapeutic counseling) had positive
impact, the extent of minimal counseling at OTC or prescription drugs dispensing was
found to be low at the first visit, since it increased from 7 to 12 pharmacies (20
to 32%) only, during the study period.
Conclusions: The processed data showed a very low level of minimal counseling (32%
at the end of surveillance period). By considering the patients benefits (quality
of life, better control and management of chronic diseases, reduction of medication
costs), the pharmacist interventions are imperatively needed in Bucharest chain community
pharmacies.
Keywords: community pharmacy, Counseling, Communication
PC-51 Pharmaceutical care level in Romania community pharmacies
Diana Simona Negru
1, Ioana Delia Cosma2, Ana Maria Petculescu3, Aurelia Nicoleta Cristea1
1Pharmacology and Clinical Pharmacy, University of Medicine and Pharmacy, Bucharest,
2Community Pharmacy, SC ALDEDRA SRL, Cluj Napoca, 3Marketing, SC SIEPCOFAR SA, Bucharest,
Romania
Background and Objective: to compare the level of minimal consultation services in
chain community pharmacies located in city center or district of Bucharest (capital
city) vs. independent pharmacy in a country town (Cluj-Napoca).
Design: prospective, 3 months, multicenter study.
Setting: 5 pharmacies accepted to fill in the study protocols. Both shifts were covered,
Monday to Friday (week-end days not included).
Main Outcome Measures: The investigation was conducted using a multiple sections protocol.
The assessed parameters were: the level of minimal consultation when OTC and prescription
medications are dispensed and the extent of chronic medication release without a medical
prescription. At the end of trial period, the results were centralized on weekly and
monthly protocols. The interpretation of the collected data was done using percentile
calculations.
Results: To evaluate the minimal consultation, the percentage of counseled patients
from the monthly total was calculated, separately for OTC and for prescription drugs
dispense. The period of the study (from June 2006 to January 2007) was divided in
various slices of 3 consecutive months, when certain pharmacies were compared.
The level of OTC medication counseling in the five studied pharmacies is different
and varies from 25 to 70% (maximum level reached in the country town pharmacy). The
counseling level for medication on prescription varied from 40 to 100%.
By counting separately, the percentage of patients who requested chronic medication
without presenting a prescription is as high as up to 30%.
Conclusions: The level of counseling, especially for OTC drugs (recommended or auto-medication),
was generally low in the studied pharmacies and may threat the health state of the
patients, due to improper administration. As a third of patients come in pharmacy
and request chronic medication without a physician’s prescription, this commonly leads
to complications which aren’t discovered and treated in time.
Keywords: Minimal consultation, Counseling
PC-61 Medication administration in nursing homes: can pharmacists contribute to error
prevention?
Charlotte Verrue
1, Nele Verhaeghe1, Annemie Somers2, Mirko Petrovic3, Els Mehuys1
1Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences – Ghent University,
2Department of Pharmacy, 3Department of Geriatrics, Ghent University Hospital, Gent,
Belgium
Background and Objective: The quality of medication use in nursing homes (NHs) is
subject to growing concern. Focus should not only be on appropriateness of prescribing,
but also on correct administration of the medication. The aim of this study was to
investigate 1) the type and frequency of medication administration errors in NHs,
2) their clinical relevance and 3) whether a training session by a pharmacist on good
medication administration practices can contribute to the prevention of the detected
errors.
Design: The study had a pre-post design. During the first phase (pre), medication
administration was observed during 5 days per ward by 2 pharmacists (Barker method).
Phase 2 (intervention) consisted of a general information session on good medication
administration principles provided by the 2 pharmacists to the nursing staff. Moreover,
the observed errors were discussed with the head nurse of each ward. Phase 3 (post)
took part one month after the intervention and consisted again of a 5-day observation
on each ward. Finally, in the last phase (phase 4), the clinical relevance of the
detected errors was scored by an expert panel (geriatrician and clinical pharmacist).
Setting: 2 volunteering NHs with different medication distribution systems. In total,
medication administration was observed for 122 residents.
Main Outcome Measures
Results: The number of detected errors was considerably lower in NH2 than in NH1.
However, the type of errors did not differ. Besides the unnecessary or forgotten preparation
of medication, most problems occurred during the administration stage. 23.6% of crushed
medications indeed were not suitable for crushing. The same applied to 43.5% of the
opened capsules. Moreover, the crushing hygiene was problematic: all medications for
one resident were crushed together and the crushing device was not cleaned between
different residents. Inhalation techniques were inadequate in almost all cases (insufficient
inhalation by the resident, coordination problems or expiration in the device). Furthermore,
specific administration moments were not taken into account. For example, the administration
of alendronate (Fosamax®) was observed in a horizontal position after breakfast, while
it should be administered 30 minutes prior to breakfast in a vertical position. The
nursing staff experienced the training course by the pharmacists as very interesting.
53.6% of the attendants found that the discussed topics were not sufficiently covered
during their education. Preliminary results of phase 3 showed a considerable diminution
of detected errors in NH2, as well as on 1 ward of NH1. The clinical relevance of
the observed errors still has to be scored. These results are expected by September
2007.
Conclusions: The quality of medication administration in nursing homes is potentially
problematic, independently of the distribution system. Pharmacists can possibly contribute
to the prevention of medication administration errors, but the impact of such intervention
highly depends on the goodwill of the nursing staff.
Keywords: Nursing homes, Medication administration, Error prevention
PC-63 Assessment of the off-label use of intravitreal bevacizumab therapy for macular
edema
Yolanda Castellanos
1, Rafael Carpio2, Mario García1, Ana Ontañón1, Beatriz Candel1, Francisco J. Farfán1
1Pharmacy Department, 2Ophthalmology Department, Fuenlabrada University Hospital,
Madrid, Spain
Background and Objective: The off-label use of intravitreal injection of bevacizumab
(IIB) for the treatment of macular edema (ME) requires the approval of its use by
Health authorities. Pharmacy Department (PD) participates in that process, assessing
each treatment request and preparing a sterile syringe for intravitreal administration.
Our aim is to evaluate the short term anatomic and visual acuity (VA) response after
IIB in patients affected of ME due to diabetic retinopathy or retinal vein thrombosis.
Design: Retrospective study of patients treated with IIB during a period of 7 months
(December 2006–June 2007).
Setting: Ophthalmology Department and PD in a general hospital.
Main Outcome Measures: VA and central retinal thickness (CRT).
Results: Of 13 eyes of 13 patients with ME who where treated with IIB 1.25 mg, we
excluded 7 eyes of the study due to: 5 eyes had a VA that could not be measured by
decimal scale (patients were unable to read the letter chart at any distance and they
had to be tested using counting fingers and hand motion) and the other 2 eyes had
suffered other ophthalmologic interventions at the time they received IIB. Therefore,
only 6 patients were included. All eyes received one IIB, except one eye that received
two. Most of the eyes had undergone previous treatments, such as laser therapy (50%),
vitrectomy (33%) and intravitreal triamcinolone (50%). At baseline, mean VA of the
eyes which received one IIB was 0.25 (range, 0.15–0.4) and one week after IIB increased
to 0.48 (range, 0.2–0.8), excluding one patient who has a VA = 0.05 which decreased
and had to be tested using counting fingers. Considering mean CRT of the previous
5 yes, it decreased from 373.8 μm (range, 267–703 μm) to 233.4 μm (range, 148–431 μm).
Regarding to the eye which received two IIB, VA increased from 0.3 to 0.5 and CRT
decreased from 650 to 596 μm.
Conclusions
IIB resulted in a decrease in CRT, therefore, a decrease in ME, and in an improvement
in VA, except in one patient who had a reduced VA before the treatment.
Although the number of patients included in the study and the follow-up period were
too short to provide specific treatment recommendations, the results are hopeful and
encourage further studies considering a longer follow-up.
Keywords: Intravitreal bevacizumab therapy, Macular Edema
PC-64 Implementation of a clinical helpline service in the entire hospital
Sara Bink
1, Elke De Troy1, Caroline Devolder1, Jaak Damiaans1
1Pharmacy, Virga Jesseziekenhuis, Hasselt, Belgium
Background and Objective: The objective of this project is to spread clinical pharmacy
services over the entire hospital without having a clinical pharmacist on every ward.
At this moment we have three pharmacists for four wards. The clinical helpline should
be easy and simple to contact by e-mail.
Design: The questions are collected on a central e-mail address: klinischefarmacie@virgajesse.be.
Three pharmacists take care of answering the questions day by day, on a continuous
base.
The aim is to give an answer within 24 hours.
Setting: All three pharmacists are working in the Virga Jesse Hospital, a large peripheral
hospital of 600 beds in Belgium.
Main Outcome Measures: Implementation of the clinical helpline in the entire hospital.
To make sure clinical pharmacy services are known by every physician and nurse and
are easy to contact.
Results: We made an e-mail address and a schedule, so every day another clinical pharmacist
is responsible for answering the questions.
To let the physicians and nurses on the ward know we exist, we made flyers with the
address and the explanation of the service. On a patient safety congress in the hospital,
the clinical pharmacists presented a lecture concerning the advantages of clinical
pharmacy services.
The main aim is to explore other ways of delivering clinical pharmacy services. In
Belgium, the hospitals don’t have a tradition of clinical pharmacy and there is no
governmental support for this pharmaceutical function. With the clinical helpline
we try to spread our services without having a clinical pharmacist on every ward.
In the pharmacy we prepare the question thoroughly on paper. The clinical pharmacist
has computerized access to all necessary medical information and pharmaceutical data.
Afterwards the pharmacist goes to the ward, to see the patient and to have a discussion
with the physician. The physician can decide if he agrees with the given pharmaceutical
advice or not. The clinical pharmacist has only an advisory function and doesn’t do
any therapeutic changes in the prescription.
By collaboration of several caregivers, the patient receives a more complete and optimal
therapy in our hospital.
Conclusions: By implementation of a clinical helpline, by an e-mail address, it is
possible to spread our clinical pharmacy services over the entire hospital, without
having a clinical pharmacist on every ward. The aim is to make an advice and go to
the ward to discuss it with the doctor.
Not only physicians can use this e-mail address, also nurses can ask their questions.
In this way we reach every caregiver.
Keywords: Helpline, Pharmaceutical advice, e-mail Address
PC-74 Frequency and nature of drug related problems in psychiatry: 10 years later
Akram Barrak
1, Isabelle De Beauchamp1, Marie-Christine Alberto1
1Pharmacy, Saint Egrève Hospital Center, Saint Egrève, France
Background and Objective: In hospital, medication of psychiatric pathology is very
complex, because comorbidities and risk factors in one hand and therapy resistance
in the other hand. That leads to potential drug related problems (DRP) increasing
the role of pharmacist in order to improve medication appropriateness.
Design: During 3 months, we undertook a retrospectif review of pharmacist’s interventions
(PI). Then, we classified it according to standardized classification suggested by
the SFPC (French society of Clinical Pharmacy).
Setting: A review of prescriptions after PI was made in order to evaluate the impact
of our interventions.
Main Outcome Measures: To identify frequency and nature of DRP and the impact of PI
on patient’s medications.
Results: 5269 prescriptions were analysed by pharmacists. The rate of PI was 4%.
67% of these PI was followed by modification of the prescription few days later.
This study showed that 47% of the opinions were related to psychotropic drug overdose
(often confirmed by psychiatrists after PI), especially neuroleptics, the most prescribed
therapeutic class on the establishment.
21.1% of the PI was related to inappropriateness to available guidelines. We note
an important proportion of no respect of correct use recommendations of long-Acting
rispéridone injection: no respect of posological equivalence, patients not stabilized
by oral way, insufficient period of co-administration oral/IM during the initialization
of treatment…
2.16% of PI was guiding to drug management and to clinical and biological monitoring.
Drug related problems still under estimated without clinical and biological data accessible
to pharmacists.
However, PI may identify the risks related to therapeutic, to prevent potential problems,
to reinforce the clinical and biological monitoring.
Comparison with a similar retrospectif study in 1998 shows that the number of prescriptions
was increased (4030 in 1998 Vs 5269), and number of PI doubled.
However, nature and type of PI are virtually the same.
Conclusions: In order to reduce DRP of overdose (the most frequent problem), an information
strategy targeted to psychiatrists was developed and a updated list of maximal psychotrops
posology was diffused and put on line.
Our study doesn’t include problem of second –generation atypical antipsychotics association,
this association still increasing despite fewer evidence and lucid guidelines;
A second study will be soon conducted to identify PI having a significant clinical
impact.
References
Peter J. Kaboli et al. “Clinical Pharmacists and Inpatient Medical Care. A Systematic
Review”. Arch Intern Med/vol 166, May 8, 2006
Hanlon JT, Schmader KE et al. “A method for assessing drug therapy appropriateness”.
J Clin Epidemiol. 1992;45:1045–1051
“Valorisation of clinical pharmacy activities: validation of a standard tool for routine
interventions quotation in French hospitals”. SFPC; June 2004
Keywords: Drug related problems, Pharmacist’s interventions, Clinical pharmacy
PC-75 Information fact sheet: Is it the best tool to spread information? Study about
intravenous acetaminophen (IVA) administration
Afroun Amina
1, Benameur N. B. Neila1, Menneglier B. M. Beatrice1, Nguyen-Kim L. N. Luc1, Casimir
N. C. Nadine1, Antignac M. A. Marie1, Farinotti R. F. Robert1
1Pharmacy, Hospital pitié salpetriere, Paris, France
Background and Objective: Serious episodes of air embolism (with death cases) were
recorded due to intravenous acetaminophen administration (IVA) in a central catheter
without electric syringe (linked to the glass packaging).
Results of a previous study performed in 2005 showed that guidelines set up by Drug
Regulatory Agency (AFSSAPS) about IVA weren’t known and followed by clinical units.
Information fact sheet was sent to all physicians about guideline’s recall. In 2006
a second prospective study was designed with aim to evaluate the impact of this information
fact sheet.
Design: The Acetaminophen IV consumption expressed on days of treatment was studied.
Questionnaire was designed to record data on patient to which IVA was prescribed.
Items were: Clinical indication, opportunity of an oral route, criteria of choice
for the route of injection, prevalence of peripheral route in comparison to central
administration, presence of an electric syringe if central route is chosen. Pharmacy
students were asked to fulfil the questionnaire during two weeks.
Setting: Sixteen clinical units in a large teaching hospital (2000 beds) were prospected.
Main Outcome Measures: Prescriptions of Acetaminophen IV: number, oral intake opportunity.
Results: 46 prescriptions were analyzed and 145 administrations were recorded. No
decrease of Acetaminophen IV consumption values were observed in comparison to 2005
study. In 65% of IVA prescriptions, oral route was possible vs 44% in 2005. 20% of
cases were in clinical trials. The main reason to choose IV administration was the
presence of another infusion prescription (33% vs 48%). Only 13% of infusion intake
switched to oral intake before the end of treatment. No electric syringe was used
when central administration was chosen (5 cases).
Conclusions: This study showed that clinical practices don’t change even after reminding
guidelines. Information by fact sheet is not the best tool to spread guidelines. Study’s
results will be submitted to an interactive presentation in medical staff, and clinical
trials with IVA are discussed and changed with Acetaminophen oral route.
Reference
Guidelines set up by the Drug Regulatory French Agency (AFSSAPS) about IVA
Keywords: Acetaminophen, Guidelines afssaps, Information, Prescriptions
PC-76 Activity assessment and patient survey by outpatient pharmaceutical care unit
Gonzalo Rodriguez Torne
1, Maria Carmen Iranzu Aperte1, Beatriz Gonzalez Joga1, Maria Antonia Berrocal Javato1,
Milagros Gomez-Serranillos Reus1
1Pharmacy Service, Hospital Nuestra Senora del Prado, Talavera de la Reina, Spain
Background and Objective: To assess quantity and quality of care by an outpatient
pharmaceutical care unit from patient satisfaction regarding the unit’s activities.
Design: 5 months transversal study using a patient survey. Analyses of the Pharmaceutical
care using activities register data. Literature review.
Setting: Outpatient pharmaceutical care unit. Pharmacy Service.
Main Outcome Measures: The pharmaceutical care was evaluated regarding six points
that were registered in a database: drug interaction, adverse reaction, drug information,
daily dose and frequency, psychological support and drug manipulation. Patient satisfactions
were obtained using a patient survey according to eight points: communication, interaction
with professionals, unit location, waiting time, intimacy of the unit, timetable,
information delivered and overall satisfaction.
Results: 970 activities of pharmaceutical care were realized, of which 231 (23.81%)
were daily dose and frequency, 306 (31.54%) adverse reaction, 133 (13.71%) drug information,
14 (1.44%) psychological support and 66 (6.80%) drug interaction. 278 surveys (74%
of patient) were provided. Best assessment included communication (4.68 points over
5), overall satisfaction (4.44 points) and, intimacy of the unit (4.46 points). Worst
assessment included timetable (3.93 points) and information delivered (4.41 points).
Mean values and standard deviation in this study were 4.02 ± 0.79, whereas median
were 4.40 points.
Conclusions: A high number of patients needs explanation of dose and frequency as
well as warning of possible adverse reactions. The high scores suggest us a good benefit
of pharmaceutical care in this kind of patient. Bad assessments were very useful to
identify areas of improvement.
References
Ventura Cerdá JM. HIV-infected patients’ perceived satisfaction with an outpatient
pharmaceutical care unit (OPCU). Farm Hosp 2005; 29: 134–140.
A. Montero et al. Quality perceived by outpatients at the pharmaceutical care clinic.
Farm Hosp 2006; 30: 65–67.
Keywords: Pharmaceutical care, Patients’ satisfaction, Outpatient
PC-78 Implementation of an intervention to reduce long-term benzodiazepine use in
Dutch community pharmacies
Caroline van de Steeg-van Gompel
1, Michel J. P. Wensing1, Peter A. G. M. de Smet2
1Centre for Quality of Care Research WOK, 2Department of Clinical Pharmacy, Radboud
University Nijmegen Medical Centre, Nijmegen, Netherlands
Background and Objective: Although guidelines recommend limited prescription of benzodiazepines,
long-term use still is a problem. An informative letter is effective in reducing it.
It is not known which implementation strategy is efficient in implementing this intervention
in community pharmacies. The aim of this study was, to compare two strategies for
implementing the intervention.
Design: A cluster randomized trial. Control group pharmacies received an educational
manual and electronic version of the letter. Supplementary, the intervention group
had an educational meeting and at least one telephone call by an individual coach.
Setting: 90 community pharmacies participated in the study: 43 in the control, 47
in the intervention group. Patients were selected if they had at least 4 prescriptions
for benzodiazepines for at least 91 dose units in total in the previous year, and
for at least 60 dose units in the previous three months (n = 25.673). The general
practitioner (GP) reviewed the patient selection for patient exclusion.
Main Outcome Measures: The proportion of GP’s that received, reviewed and returned
the patient selection to the pharmacist, and the proportion of long-term users that
received the informative letter.
Results: Substantially more pharmacists in the intervention (77%) than in the control
group (51%) handed over the patient selection to their GP’s. 52% resp. 36% of the
GP’s received (n.s.), and 38% resp. 30% of the GP’s reviewed and returned the list
(n.s.). Substantially more pharmacies in the intervention group got back any lists
(70% vs 49%) and sent any letters (66% vs 40%). 20% and 13% of all long-term users
received the informative letter in the intervention resp. control groep (n.s.).
Conclusions: The maximal implementation strategy was effective in getting the pharmacists
started. The main outcome measures were not significantly different in both groups,
though the realized effect on a large scale was relevant in practice.
References
Gorgels WJ et al. Discontinuation of long-term benzodiazepine use by sending a letter
to users in family practice: a prospective controlled intervention study. Drug Alcohol
Depend 2005 Apr 4;78(1):49–56.
Bero LA et al. Closing the gap between research and practice: an overview of systematic
reviews of interventions to promote the implementation of research findings. BMJ 1998
Aug 15;317(7156):465–8.
Grimshaw JM et al. Effectiveness and efficiency of guideline dissemination and implementation
strategies. Health Technol Assess 2004 Feb;8(6):iii–72.
van Mil JW. Pharmaceutical care in community pharmacy: practice and research in the
Netherlands. Ann Pharmacother 2005 Oct;39(10):1720–5.
Keywords: Implementation study, Community, Pharmacy services, Benzodiazepines, Therapeutic
use
PC-84 Awareness and knowledge of the pharmacists about pharmacovigilance in Turkey:
a descriptive pilot study
Aygin Bayraktar
1, Pinar T. Kocagul1, Nihan E. Mistepe1, Kutay Demirkan1
1Faculty of Pharmacy, Hacettepe University, Ankara, Turkey
Background and Objective: To identify pharmacists’ awareness, knowledge and their
attitudes towards ‘pharmacovigilance’, which is a new term for Turkish pharmacists
in reporting adverse drug reactions (ADRs), after the National Regulations comes into
force by the Turkish Ministry of Health in June 2005.
Design: Descriptive pilot study, comparison of the questionnaire results at the different
time periods.
Setting: Randomly selected academician, community and hospital pharmacists in Ankara/Turkey.
Main Outcome Measures: Awareness of pharmacists about pharmacovigilance.
Results: The questionnaire was undertaken during a week, both in October 2004 (period-1)
and in October 2006 (period-2) and a total of sixty pharmacists participated (30 pharmacists
in each time period) in the study. The pharmacists were randomly selected and 10 pharmacists
from each pharmacy profession (hospital, community and academia) were interviewed
at the each time period.
Of the participants, total of 6.7% has heard of the term ‘pharmacovigilance’ in the
period-1, which is entirely the academicians, while it is increased to 66.7% in the
period-2 (chi-square test with Yates correction, p < 0.05), which are mainly expressed
by the hospital (33.3%) and academician (23.3%) pharmacists.
During the period-1, only 20% of the participants know where to report any ADRs (13.3%
academicians and 6.7% hospital pharmacists), whereas during the period-2, this figure
is increased to 40% (13.3% academicians, 20% hospital and 6.7% community pharmacists)
(p > 0.05).
The participants preferred to report any ADRs mainly by the internet (66.7% vs 50%)
and by the telephone (30% vs 46.7%) at the period-1 and the period-2, respectively
(p > 0.05).
In terms of having reported any ADRs among the participants, it is indicated that
none of the pharmacists reported ADRs at the period-1, but only three hospital pharmacists
reported an ADR at the period-2.
Conclusions: By the National Regulations for pharmacovigilance, the pharmacists are
entitled to report any ADRs to the Turkish Pharmacovigilance Centre. Although this
study is limited by the small number of pharmacists and location, it shows that there
is an increased awareness and knowledge about pharmacovigilance. By the provision
of pharmaceutical care, pharmacists’ involvement in detecting and reporting ADRs will
improve, mainly in hospital and in community settings.
Keywords: Pharmacovigilance, Pharmaceutical care
PC-86 Global versus individual drug dispensing: clinical impact of the intercepted
dispensing errors
Déborah Schlecht
1, Céline C. F. Flattet1, Sebastien S. B. Bauer1, Xavier X. P. Pourrat1, Jacqueline
J. G. Grassin1
1Pharmacy, University hospital of tours, TOURS, France
Background and Objective: In France, global drug dispensing (GDD) is the common way
to dispense drug inpatient. After an experience of implementation of individual drug
dispensing (IDD) the objective of the department of pharmacy was to prove the benefit
offered by this system in comparing the clinical impact of the intercepted dispensing
errors of both dispensing system.
Design: Thirty days prospective study.
Setting: Orthopaedic surgical care unit; department of pharmacy.
Main Outcome Measures: Data related to drug preparation were collected by two pharm
D students over a 30 days period and analysed. Identified preparation errors were
classified in four groups: discordance between prescription and drug administration,
exceeding or missing treatment and, unidentified delivered drugs. Then errors were
classified in potential or effective errors. At last, pharmacist and prescriber have
quote this errors. Preparation errors were classified according to their clinical
impact from 0 (no clinical impact) to 3 (life threatening).
Results: 1 631 drugs units were prepared with GDD vs 1 446 with IDD. Eighty effectives
errors (4.90%) were observed with GDD and 11 (0.76%) with IDD. Clinical impact were
0 (34%), 1 (36%), 2 (30%) for GDD and 0 (90%), 1 (10%) and 2 (0%) for IDD. A Khi 2
test highlight a difference between the 2 dispensing system for clinical impact 0
and 2 (p < 0.05). Moreover, the mean value of weighting was about 0.95 with GDD vs
0.09 with IDD (p < 0.001).
Conclusions: This study shows the major benefit offered by IDD versus GDD. Errors
weighting represent a relevant parameter for physicians. The results provided by this
study highlight the role of the pharmacy staff, to reduce the incidence of medication
errors and to promote a rational use of medicines. This work was the second step of
our quality medication process; the next step will be the development of IDD in several
care unit by use and test automated process for preparing doses.
Keywords: Individual drug dispensing, Preparation errors
PC-88 Evaluation of drugs prepared by nurses in pediatric care units
Marie-Odile Duzanski
1, Anne-Cécile Michallat1, Juliette Kern1, Anne A. C. Gairard-Dory1, Laurence Beretz1
1Pharmacy, University Hospital of Strasbourg, Strasbourg, France
Background and Objective: Lack of pediatric drug formulations can cause medication
mistakes.
The main issue of our study was to assess the difficulties faced by nursing staff
in preparation, administration of pediatric medications and to propose adapted solutions.
Design: We conducted a prospective study to assess how drugs are prepared and administrated
by nurses.
Setting: Pediatric Department of Strasbourg University Hospital.
Main Outcome Measures: Review of prescriptions from five care units (101 beds) every
morning for a 3-week period from December 2006 to January 2007. For each prescription
we collected information about the patient, the prescribed drug, the steps involved
in its preparation and its administration.
Results: We collected 279 prescriptions (126 different drugs) concerning 77 children
(average age: 6 years). Sixty-two percent of medications were oral forms: 49% liquids,
25% tablets, 19% capsules. Thirty-two percent of the tablets were cut; only 30% of
those were authorized. Due to the age, 44% of the tablets were crushed to facilitate
administration whereas grinding was allowed in only 31% of the cases. Most of the
capsules were opened (71%) and 6% fractionated for an adapted dose. Opening of capsules
was possible in 92% of the cases. Intravenous drugs represented 29%, the average injection
was 71.5% of the vial; in 14%, less than a quarter was given.
Conclusions: About 20% of pediatric preparations were inappropriate. The results of
this study highlight the need to provide drugs adapted to pediatric care, which is
one of the main tasks of the pharmacy. We are thus developing more appropriate pharmaceutical
formulations for children, such as oral suspensions. A comparative statement of solubilization
rates in liquid of crushed tablets or capsules after opening has to be established.
Moreover if a pharmacist is present in the care units, most medication error will
be avoided.
Keywords: Drugs, Preparation, Paediatry
PC-109 Implementation of dadér methodology for pharmacotherapy follow-up in hospitalized
geriatric patients
Nadine Ribeiro1, Patricia Cavaco
1, Fatima Falcao2
1Pharmacy Department, Hospital de Sao Francisco Xavier, CHLO, 2Faculty of Pharmacy
of Lisbon University, Pharmacy Department of CHLO, Lisbon, Portugal
Background and Objective: The world’s population is aging. The elderly have many chronic
disorders and consequently use more drugs than any other age group. Safe, effective
pharmacotherapy is one of the greatest challenges in clinical geriatrics. Among the
many assessment tools that combined structured review criteria and implicit judgment
that appeared with the advance of pharmaceutical care, Dáder Method is a tool designed
for pharmacotherapeutic follow-up. This methodology consists in identifying, preventing
and resolving Drug Related Problems (DRP) in a continuous, systematic and documented
approach, considering three scaled domains to measure inappropriate prescribing: necessity,
efficacy and safety. In order to optimize the elderly hospitalized patients pharmacotherapy,
our Pharmacy Department applied Dadér methodology to review their prescriptions.
Design: Eight months retrospective study of pharmacotherapy follow-up by Dáder method.
Setting: Internal Medicine Ward of S. Francisco Xavier Hospital, CHLO (general hospital).
Main Outcome Measures: Evaluation of Health Problems (HP), pharmacotherapy reviews,
identification of DRP and clinical outcomes from the pharmacist’s interventions.
Results: Analysed patients have a mean age of 71.9 years, and an average of 4.8 HP
and 18.5 drugs/patient. Application of Dáder’s criteria found that 18.3% of the 698
elderly patients evaluated have at least one serious health problems related to their
pharmacotherapy, presenting an average 1.15 of DRP that needed the pharmacist intervention
(total of 143 DRPs). 52% of those DRPs were safety related, 39% were about necessity
and 7% about efficacy. In relation to the degree of acceptance upon the pharmacist’s
interventions, from the 143 interventions made, 80 were accepted and 63 refused by
the doctor. Nevertheless, 88% of the detected real or potential HP were resolved or
never happened.
Conclusions: Elderly are a very needed patient’s group for pharmaceutical care: they
have multiple chronic diseases, are polimedicated and are especially vulnerable to
the adverse effects of medications. With Dáder Methodology for pharmacotherapy follow-up,
clinical pharmacists can provide valuable services to the elderly, achieving maximum
affectivity from their pharmacotherapy, decreasing the rate of preventable ADRs, improving
compliance, simplifying drug regimens, and producing direct cost savings. The final
purpose is to achieve definite patient outcomes by promoting rational use of drugs,
as it happened in the elderly patients analysed.
Keywords: Pharmacotherapy follow-up, Dáder, Geriatrics
PC-111 Analyze antibiotherapy in a surgical intensive care unit
Christelle Landy
1, Isabelle Tiret1, Céline Méchin1, Benoit Weber2, Bernard Dieu1
1Pharmacy, 2Surgical intensive care, University Hospital Rouen, Rouen, France
Background and Objective: In spite of the multiplication of recommendations, the over
consumption of antibiotics and their misuse lead to the emergence of resistances while
new antibiotics get rare. The objective of the study is to analyze the prescription
of antibiotics in the surgical intensive care unit of Rouen hospital.
Design: An analysis of all patients entering in the unit and receiving antibiotics
was conducted over 2 months (from November to December 2006). The required informations
about the antibiotics prescribed (indication, posology, duration, monitoring) were
collected in files (report of hospitalization, biological and bacteriological results).
Setting: Surgical intensive care unit in Rouen hospital
Main Outcome Measures: We determined the number of prophylactic, probabilistic and
curative treatments, their duration and the molecules prescribed, in connection with
the germs responsible for the treated infections.
Results: Fifty patients received antibiotics according to several schemes.
Nineteen patients received prophylactic treatments during 3.3 days on average. The
employed molecules were mostly part of beta-lactams’ family (84.2%) including 87.5%
of Co-amoxiclav. The prophylactic treatment seemed to be effective in 73.7% of case
because it wasn’t followed by other treatment.
Thirty-one patients received probabilistic treatment: 19.3% of them received quadruple
therapies, 22.6% received triple therapies, 35.5% bitherapies, and 22.5% monotherapies
(only beta-lactams). The average duration of the probabilistic treatment was 3 days.
Twenty-three patients got curative treatment. Compared with the probabilistic treatment
or with the treatment at the entry, the curative treatment corresponded to a reduction
of the spectrum in 75% of cases with mainly an arrest of the vancomycin (55%). Monotherapy
was the most prescribed (69.6%) and especially beta-lactams (68.2%). Then came bitherapies
(27.3%) and triple therapies (4.3%). The most frequent isolated germs were Escherichia
Coli (12 cases), Staphylococcus aureus (5 cases), Pseudomonas aeruginosa (4 cases)
and Pneumococcus sp. (3 cases) alone or associated, including 8.7% of multiple-drugs-resistant
bacterias.
The monitoring of aminosids and vancomycin was globally well carried out. Only 17.6%
of vancomycin’s dosages and 22.2% of aminosides’ dosages were not done.
Thirty-two patients increased their transaminases and/or their creatininemy. These
increases were often physiopathological, related to multiviscérales failures or to
septic shocks. The antibiotics could be clearly blamed in only one case.
Conclusions: In the surgical intensive care unit, antibioprophylaxy is longer than
in recommendations. The probabilistic treatments used often associate active molecules
on multiple-drugs-resistant bacterias. This can be explained by the gravity of infections,
and the increased risk of bacteriologic resistances due to former treatments. Moreover,
bacteriological tests are systematically done, so antibiotics can quickly be adapt
to the germs’ resistances.
Keywords: Used of antibiotics, Surgical intensive unit
PC-113 Comparative study and optimisation of the mode of administration of proton
pump inhibitors by paediatric nasogastric tubes
Marie-Pierre Ponrouch1, Valérie Sautou-Miranda
2, Anne Grand-Boyer2, Jean Chopineau2
1Pharmacy, G Montpied Hospital, Clermont-Ferrand, 2Laboratory of clinical pharmacy,
Faculty of pharmacy, Clermont-Ferrand, France
Background and Objective: Most of proton pump inhibitors (PPIs) do not have legal
mention for a paediatric use. However these drugs are largely prescribed to children.
One disadvantage resides in the absence of liquid form which causes problems for their
administration in nasogastric tubes. Indeed, the absence of use recommendations involves
many misuses responsible for inefficiency and/or tube obstruction. We tried to evaluate
if PPIs can be administered through paediatric nasogastric tubes.
Design: To quantify the transit of different PPIs through paediatric nasogastric tubes
and to optimise their modes of administration.
Setting: Laboratory of Clinical Pharmacy and Biotechnics. Faculty of Pharmacy.
Main Outcome Measures: We administered four PPIs (Mopral®, Ogast®, Inexium®, Ogastoro®)
through nasogastric tubes by respecting their positioning in a child in a 30° elevation.
For each PPI a study plan was drawn up to assess the influence of different variables:
the volume of water to dissolve or put in suspension the PPIs (2 or 5 ml), the rinse
volume (2.5 or 10 ml), the length (50 or 125 cm) and the diameter (6 or 8 French)
of the polyurethane tubes. For every tests (n = 134) we carried out an analysis of
each active ingredient at the tube outlet by UV spectrometry.
Results: All 6 F tubes were obstructed by PPIs. Through 8 F tubes, we observed a mean
recovery of active ingredient of 86% for Ogastoro®, 36.9% for Inexium® but only 7.1%
for Ogast® and 3.9% for Mopral®. The length of the tubes had no significant influence
on the loss of PPI at the outlet of the tube. A water volume of 5 ml instead of 2 ml
increased only the final concentration of Inexium® (+26%). A rinse volume of 10 ml
improved significantly the transit of Mopral®, Ogast® and Ogastoro® (+4.8%, +2.7%,
+19.5% respectively). This rinse volume allowed to obtain a 94.5% recovery of lanzoprazole
for
Ogastoro® whatever the water volume employed for its administration.
Conclusions: The most satisfactory results were obtained with Ogastoro®: an administration
volume of 5 ml and a rinse volume of 10 ml allowed a near-complete transit of lanzoprazole.
Under these conditions only 45% of Inexium® was recovered. It is disadvised using
Mopral® and Ogast® through 8F nasogastric tubes because no condition ensure the transit
of an efficient concentration of active ingredient.
Keywords: Nasogastric tubes, Proton pump inhibitors, Children
PC-116 Do products used to unblock nasogastric tubes alter the inner surface of them?
Pierre-Adelin Rucart1, Anne Boyer-Grand2, Valérie Sautou-Miranda
2, Corinne Bouteloup3, Claire-Lise Pastre1, Jean Chopineau2
1Pharmacy, G. Montpied Hospital, 2Laboratory of clinical pharmacy, Faculty of pharmacy,
3Gastroentereology, Hôtel Dieu Hospital, Clermont-Ferrand, France
Background and Objective: Feeding tube occlusion is a frequent problem. Practices
to make the clogging off are very varied and are not the subject of any consensus.
No study have assessed the impact of the different products on the inner surface of
the tubes. In this context, it seams to be important to evaluate if these products
are safe in order to rationalize the practices.
Design: To study the inner surface of nasogastric feeding tubes after contact with
various products used to unblock them.
Setting: Laboratory of Clinical Pharmacy and Biotechnics. Faculty of Pharmacy.
Main Outcome Measures: we have put in contact 12 F nasogastric tubes made of silicone
or polyurethane with the following products: water, 1.4% sodium bicarbonate, orange
juice, pineapple juice, cola, papain syrup, pancreatic enzymes. An analysis of the
inner surface of the tubes was carried out after 7, 15 and 30 days by scanning electron
microscopy (SEM). Photos of unexposed tubes were used as negative controls. Photos
of tubes exposed to heat, ether or sodium hydroxide were used as positive controls.
Results: The analysis by SEM shows that the silicone tubes are not altered by the
different products tested. On the other hand, the surface of polyurethane tubes is
modified in the presence of 1.4% sodium bicarbonate and pancreatic enzymes. The papain
syrup seems to settle on the surface of the tubes without altering it. Water, fruit
juices and cola do not modify the biomaterial whatever the exposure time.
Conclusions: 1.4% sodium bicarbonate, pancreatic enzymes and even papain syrup should
not be used in practice to unblock the feeding tubes. The orange and pineapple juices
as well as cola can be recommended because of their harmlessness with biomaterials.
Keywords: Nasogastric feeding tubes, Occlusion, Scanning electron microscopy
PC-118 Assessment of administration practices of extemporaneous formulation pediatric
capsule preparations
Helene Richard
1, Anne Jalabert1, Sylvie Hansel-Esteller1
1Pharmacy unit, Lapeyronie and Arnaud de Villeuneuve Hospitals, Montpellier, France
Background and Objective: To assess administration practices of pediatric capsules
made as an extemporaneous formulation preparation by the laboratory of the pharmacy
unit, in pediatric units.
Design: A questionnaire was designed and filled in by asking questions directly to
nurses about their administration practices, from February to April 2007.
Setting: Altogether, six pediatric units were consulted, corresponding to the units
for which the laboratory carries out the most pediatric extemporaneous formulation
preparations.
Main Outcome Measures: The questionnaire concerned the ten most made up pediatric
preparations, which are: amiodarone, warfarine, captopril, propranolol, ursodesoxycholic
acid, omeprazole, fludrocortisone, spironolactone, hydrocortisone and calcium carbonate.
Items filled in were: hygiene rules, the existence of administration procedures in
units, preparation conservation, and practical administration details.
Results: In 3 months, 40 questionnaires were filled in. Concerning hygiene rules,
nurses wash their hands before every manipulation, 21% wear gloves, 10% wear a mask
or a mobcap. No administration procedures were available in units and more than 80%
of nurses would like to have one. In every unit, preparations were conserved at room
temperature, in a dry place, and 87% in a light-free place.
For amiodarone, propranolol, fludrocortisone, spironolactone and hydrocortisone capsules,
nurses use sweetened water (G5%) to dilute capsule contents, sometimes milk (especially
in newborns units). For the other drugs, the vehicules the most used were: sweetened
water (55%), solid vehicules like yogurt, apple sauce, jam (17%), fruit juice or syrup
(15%), milk (14%), and coca-cola (7%).
The vehicule volume used fluctuates between 1 ml and 2 cl. Nurses administer capsules
by syringue into the mouth (38%), per os (33%), or by enteral nutrition (29%).
Conclusions: Most of the administration practices of pediatric preparations are homogeneous
in the different units (except the vehicule volume used). In the absence of administration
procedures, the administration of preparations is more adapted to the child than to
the drug. The aim of this study is to provide pediatric units with guidelines about
good use of extemporaneous formulation pediatric preparations.
Keywords: Extemporaneous formulation preparations, Pediatric capsules, Administration
practices
PC-128 Patients’ expectations and their satisfaction with outpatient pharmacy services
in a Nigerian hospital
Uche M. Ochei
1, Azuka C. Oparah1, Rose N. Mafiana1
1Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Benin City, Nigeria
Background and Objective: An introduction of novel services may derive from patients’
reported outcomes including patient expectation of services and their satisfaction
with existing services in the absence of novel ones. Pharmaceutical care is a novel
practice that merits priority consideration in all settings.
The objectives to assess patients’ expectations of pharmaceutical care and their satisfaction
with existing services compared to a pharmaceutical care model.
Design: Cross-sectional observational study. Respondents completed 12-item expectations
and 22-item satisfaction Likert-type questionnaires. Descriptive statistics on sample
characteristics including means and frequency distribution was computed. Principal
component analysis employed Varimax rotation with Kaiser normalization. Inferential
statistics was performed using Students’ t-test and one-way ANOVA.
Setting: A Nigerian city public hospital
Main Outcome Measures: Patients’ reported expectations of pharmaceutical care and
their satisfaction with the existing pharmacy services compared to a pharmaceutical
care model. Items pertaining to pharmacists’ communication with the patient and the
physician as well as the pharmacists potential to manage drug therapy were assessed.
Results: Of the 1000 patients approached, 720 (72%) response rate was achieved. Cronbach’s
alpha = 0.7084 (expectations) and 0.950 (satisfaction). Females were 367 (51%), married
(75%) and 52% had post-secondary education. Some 83% expect accurate dispensing of
their medications, 78% expect pharmacists to simplify their medications and 52% expect
the pharmacist to spend as much time as possible with them. Expectations were resolved
into 3 components: humaneness, friendly attitude and professional competence. Only
51% were satisfied with the professional appearance of the pharmacy, the rest of the
items received dissatisfaction rating. Two principal components of satisfaction were
identified as humaneness and professional competence. Marital status and level of
education were associated with satisfaction scores.
Conclusions: Patients’ expectations of pharmaceutical care services were high but
the satisfaction with current services compared to pharmaceutical care was below average.
Professional competence and humaneness were important dimensions of both patient expectations
and satisfaction. There is a need to introduce pharmaceutical care.
References
Kucukarslan S, Schommer JC. Patients’ expectations and their satisfaction with pharmacy
services. J Am Pharm Assoc 2002;42:489–496.
Larson LN, Rovers JP, Mackeigan LD. Patient satisfaction with pharmaceutical care:
update of a validated instrument. J Am Pharm Assoc 2002;42:44–50.
Volume CI, Farris KB, kassam R, Cox CE, Cave A. Pharmaceutical care research and education
project (PERP): patient outcomes after provision of pharmaceutical care. J Am Pharm
Assoc 2001;41:411–420.
Keywords: Expectations, Patients, Satisfaction, Patients, Pharmaceutical care
PC-131 Anemia management in chronic renal failure in an haemodialysis unit: clinical
audit
Anne-Laure Lepetit
1, Emilie Prevost1, Nathalie Herment1, Catherine Mennesson1, Bertrand Gourdier1, Sylvie
Lavaud2, Philippe Rieu2
1Pharmacy, 2Nephrology, Reims Teaching Hospital, Reims, France
Background and Objective: The primary cause of anemia for patients with End-Stage
Renal Disease (ESRD) is insufficient production of erythropoetin by the kidneys.
Recombinant human erythropoetin is the standard therapy for anemia for ESRD patients.
Moreover, intravenous iron has been shown in the increase of the haemoglobin response
to erythropoetin.
The objective of this study was to compare anemia management in an haemodialysis unit
with the European Renal Association and the AFFSSAPS guidelines.
Design: Clinical audit. All patients receiving their first haemodialysis between October,
1st, 2005 and April, 1st, 2006 were included. Dead or transplanted patients were excluded.
The end of the study was December, 31st 2006.
Setting: Haemodialysis centre in a teaching hospital.
Main Outcome Measures: For each patient included, a series of data was studied: hemoglobin
concentration, iron status (ferritin, transferrin saturation, injection of intravenous
iron), monitoring of hemoglobin levels and rate of increase in hemoglobin levels during
correction phase and maintenance phase, erythropoetin dose and its adjustement, erythropoetin
injection tracability.
Results: Fourteen criteria were defined. A yes, no or not applicable answer has been
given to each criterion according to the guidelines. Drawing lots have been realised
to set up a representative sample of twenty patients among those included in the study:
six males, fourteen females, average age: 74.9 years old.
Two patients are below the average. The average mark of the patients is 56.3%.
Hemoglobin level of 40% patients is inferior to the targeted hemoglobin level (11 g/dl)
at the end of the study.
Six criteria obtain a score superior or equal to 80%. Five criteria obtain a score
under 50%.
The three criteria which obtain the best results concern the monitoring of the hemoglobin
levels during correction phase and maintenance phase, and the maximum weekly dose
of erythropoetin.
The three criteria which obtain the lowest results concern the assessment of iron
status before erythropoetin therapy starts (0%), the rate of increase in hemoglobin
levels which should be 1–2 g/dl per month (25%) and the adjustment of total weekly
erythropoetin dose.
Conclusions: The average grade obtained by the patients highlights the deviation from
the guidelines. This indicates the needs of improving the anemia management in our
haemodialysis unit.
So it is necessary to make another time the team of doctors and nurses aware of the
problem and to reinforce the pharmaceutic implication into the haemodialysis unit.
A re-evaluation of practices (in the guise of clinical audit) must be planned in order
to estimate the impact of the setting up of correctional measures.
Keywords: Anemia, Erythropoetin, Audit
PC-137 Implementation of clinical pharmacy in intesive care unit
Kutay Demirkan
1
1Faculty of Pharmacy, Hacettepe University, Ankara, Turkey
Background and Objective: To determine the role of a clinical pharmacist in the intensive
care unit (ICU), where clinical pharmacy practices have been implemented first time
at the hospital. Since only few clinical pharmacists are available and clinical pharmacy
practices are not routinely performed in hospitals in Turkey, most of the physicians
are not familiar with clinical pharmacy practices.
Design: Descriptive study for clinical pharmacist’s activities in ICU during the period
of December 2001 and May 2002 (89 working days). Data were recorded daily about the
clinical pharmacist’s interventions and the questions from other health care professionals
answered during the ward round. The clinical pharmacist visited ICU almost all week-days
and was available on call when needed.
Setting: Nine-bed medical intensive care unit at the Hacettepe University Hospital
in Ankara, Turkey.
Main Outcome Measures: Number of the clinical pharmacist’s interventions accepted
by the physicians and types of drug related problems that requires clinical pharmacist’s
interventions were the main outcomes.
Results: Total of 297 interventions were made and a total of 40 questions were answered
by the clinical pharmacist. Only 36 (%12) of the interventions were not accepted by
physicians. Majority of the interventions were related with therapeutic drug level
monitoring (44.4%) and dosage adjustment in renal failure (22.6%). Furthermore, the
clinical pharmacist provided three educational seminars on therapeutic drug monitoring
(TDM) to the physicians during study period.
Conclusions: ICU patients routinely receive more therapies than the patients on a
general medical or surgical ward, so it will be a good place to start for the implementation
of the clinical pharmacy in hospital setting. Clinical pharmacist could have a significant
impact in improving patient care and providing optimum therapy in ICU by implementation
of clinical pharmacy services and being active member of the health care team.
Keywords: Clinical pharmacy, Intensive care unit
PC-140 Study of conformity of prescriptions and their retranscriptions
Anne-Claire Buire
1, Emilie Prevost1, Corinne The1, Bertrand Gourdier1, Roland Jaussaud2
1Pharmacy, 2Infectiology, Reims Teaching Hospital, REIMS, France
Background and Objective: Medication errors most commonly occur at the prescribing
stage. Prescriptions are often not written according to the regulations. The retranscriptions
of the original prescriptions by nurses are also source of errors. The aim of the
study was to access the conformity of prescriptions and their retranscriptions.
Design: A retrospective study was conducted in 3 wards, one day given in May 2006.
Setting: 3 wards (internal medicine, infectiology and week hospital) with 70 beds
in Reims University hospital.
Main Outcome Measures: In the one hand, we have assessed if all regulation’s variables
were present on prescriptions. These variables were related to the prescribers (name,
signature quality), the prescriptions (date, hour, ward), the patients (name, surname,
age, weight and height) and drugs (readable, International Non-proprietary Name (INN),
dosage, pharmaceutical form, dosage of unit, administration route and hour). In the
second hand, we have compared the retranscriptions with the original prescriptions
(statement of the variations). Inclusion criteria were: oral and injectable drugs’
prescriptions concerning patients who were present in the ward since more than 24
hours.
Results: 27 medical records were analyzed. Patient age varied from 51 to 74 years
old and the average duration of the hospitalisation from 4.5 to 13 days. Omitted variables
were: patient’s weight in all cases, prescriber’s quality in 93% of cases, prescription’s
hour in 63% and prescriber’s signature in 59.3%. For each patient, all drugs prescribed
since the beginning of the hospitalization in the unit was studied i.e. 334 lines
of drugs. We have noted the INN was absent in 90% of the cases, pharmaceutical form
in 74% and administration route in 57%. Only one prescription had all variables. Thus,
the global rate of prescription conformity was 0%. In the 3 wards, nurses write the
original prescriptions on a card-index (CI). Then, drugs administrations are written
on a temperature chart (TC) and on pharmacy’s book (PB) for drugs order. We have compared
documents one by one, for each drug. Conformity rates are 60.5% (prescription/CI),
70.4% (CI/TC) and 0% (CI/PB). The noted differences are multiple(modification of the
administration or hour route, increase or dicrease of dosage…). The clinical relevance
of non conformity was not studied.
Conclusions: From this study, it can be concluded that many prescriptions do not comply
to the regulation and many retranscriptions are not identical to original prescriptions.
It constitutes of course a potential iatrogenic impact. The development of Computerized
Physician Order Entry (CPOE) in our hospital should be a corrective measure. The next
stage will consist of realizing this study with CPOE and compared the 2 studies.
Keywords: Conformity, Prescription, Retranscription errors
PC-142 Assessment of antibacterial prescriptions for bronchopulmonary infections in
a pneumology department
Anne-Claire Buire
1, Emilie Prevost1, François Lebargy2, Bertrand Gourdier1
1Pharmacy, 2Pneumology, Reims Teaching Hospital, Reims, France
Background and Objective: Assessment of antibacterial prescriptions regarding community-acquired
lower respiratory tract infections and comparison with national guidelines.
Design: Patients treated with antibiotics were included each day, during the analysis
of the computerized prescriptions in the pharmacy. Then, a report sheet was indicated
in the unit with the prescribers for each patients with pneumonia or exacerbation
of chronic obstructive lung disease. One month prospective study (in April 2007) included
all patients hospitalised for pneumonia or exacerbation of chronic obstructive pulmonary
disease (ECOPD) in a unit of the Pneumology Department and treated with antibiotics.
Setting: Pneumology Department – Reims University Hospital.
Main Outcome Measures: For each patient the following data were assessed: age, hospitalization
duration, diagnosis, severity factors, co-morbidities and antibiotic prescriptions
were analyzed. Treatments were thought consistent when following the national guidelines
[1; 2].
Results: 63 new patients were hospitalized during this month. 44 (70%) were treated
with antibiotics: 4 with no pulmonary pathology and 40 with pulmonary infection (19
patients with pneumonia, 4 with ECOPD, 5 with pleurisy, 4 with exacerbation of asthma,
4 with chest secondary infection, 2 with acute respiratory infection, 2 with thoracic
pain and 1 with cough).
Then, the study focused on 23 patients: 19 pneumonia and 4 ECOPD (M/F = 13/10, mean
age: 61 years old). Hospitalization duration was about 10 days. 18 patients (78%)
had at least one co-morbidities factor (the majority: 9 with pulmonary antecedents)
and 13 (57%) a severity factor (the majority: 10 with an attack of the vital functions).
12 antibiotic treatments were initiated in the unit and 11 out (9 in emergency department
and 2 by general practitioner). All treatments initiated in the unit were consistent
with the recommendations and revaluated with the bacterial results (except one treatment)
or changed because of bad tolerability. Bacteriological documentation was always researched
and the results were significant for 6 patients (26%): 3 Streptococcus pneumoniae,
1 Pseudomonas aeruginosa, 1 Proteus mirabilis with Morganella morganii and 1 Haemophilus
influenzae. When it was possible, per os relay was realized in the 24 at 48 hours,
except for 2 patients (relay in the 3 days).
Conclusions: In this survey, the management of pneumonia and ECOPD was globally consistent
with the national guidelines. Nevertheless, the bacterial documentation is poor and
the antibiotics prescriptions for bronchopulmonary infections are difficult and need
using molecules with large spectrum.
References
AFSSAPS. Antibiothérapie par voie générale en pratique courante au cours des infectons
respiratoires basses de l’adulte et de l’enfant. Recommandations. Octobre 2005.
SPILF. 15 éme conférence de consensus en thérapeutique anti-infectieuse. Revue des
maladies respiratoires. Mars 2006.
Keywords: Antibacterial prescriptions, Pneumonia, Exacerbation of chronic obstructive
pulmonary disease
PC-147 The role of a pharmacist in safety treatment in the Czech Republic
Josef Maly
1, Michal Hojny2, Martina Marikova3, Jiri Vlcek1
1Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove,
Charles University in Prague, Hradec Kralove, 2Hospital pharmacy, Institute of Clinical
and Experimental Medicine, Prague, 3Hospital pharmacy, Teaching Hospital, Hradec Kralove,
Czech Republic
Background and Objective: Occurrence and clinical relevancy of adverse drug events
and medication errors were described by many quality studies. To prevent the medication
errors it is necessary to collaborate with all of the health care professionals and
patients and to identify causes of errors. The unique position and possibilities of
a pharmacist enable him to follow up the errors, from a fact that he is an expert
on medication properties and is basically the last in a row who deals with drugs before
their administration to the patients. The aim of this study was to describe and evaluate
the role of pharmacist in identification and dealing with medication errors in Czech
pharmacy.
Design: 30 pharmacists identified and recorded all medication errors over a period
of six months of pharmaceutical care. Basic characteristic of pharmacists: mean age
35.0 years; mean length of pharmaceutical practice 9.7 years; 16 of them worked in
the hospital pharmacy. 19 of them got the first grade of attestation in pharmacy (by
4 years of working experience in pharmacy and by passing exams). Pharmacists collected
the following data: types and causes or errors, their interventions, drugs and time
concerning errors, subjects making errors and patient’s characteristics as age, gender,
other drugs used and co-morbidities. All the data were processed by descriptive statistics.
Setting: Hospital and community pharmacies in the Czech Republic
Main Outcome Measures: Type, frequency and clinical importance of medication errors
and relevancy of pharmacist’s interventions
Results: During a six-month period there were identified 698 interventions of pharmacists,
out of 110750 prescriptions. We evaluated the following errors: 49 cases of incorrect
indication or contraindicated drugs, 266 cases of dosage of drugs – such as insufficient
dosing, overdosing or other problem with dosages, 45 cases of potential drug interactions,
37 cases of duplications of therapy, 40 cases of wrongly prescribed drugs, 111 cases
of wrongly or inappropriately prescribed strength of medication, 24 cases of inappropriate
dosage forms, 59 cases of prescribed drugs unavailable on the Czech market, 27 cases
of possible instabilities of specific dosage forms as dividing sustained release tablets
and 40 cases of the other types of medication errors. Pharmacists most frequently
consulted with prescribing physician their interventions (in 263 cases).
Conclusions: This study highlighted medications errors that pharmacist can identify,
and are relevant to adverse drug events, originating mainly during prescription of
drugs. It seems that Czech pharmacist could contribute to improvement of safety treatment.
Keywords: Medication errors, Pharmaceutical care, Pharmacy
PC-148 Mouthwashes and mucositis oral prevention: a possible consensus?
Marie Antignac1, Malik Berhoune1, Bertrand Billemont2, Laura HASSAN1, Annick Datry3,
Sylvain Choquet4, Robert Farinotti1, Agnès Bellanger
1
1Pharmacy, 2Medical Oncology, 3Infectious Disease, 4Hematology, Pitié-Salpétrière
Hospital Group, Paris, France
Background and Objective: There is no standard of care to prevent oral mucositis for
patients with cancer treated by chemotherapy. Most common treatment is local (mouthwashes).
No commercial mouthwash solution is available. Special preparations are compounded
by clinical units. A new 1.4% sodium bicarbonate solution presentation was recently
proposed for local treatment. Our hospital drug committee decided to evaluate the
clinical practices of oral mucositis prevention related to anti-neoplasic agents.
Design: An observational study conducted in Pitié-Salpétrière Hospital. Interview
of nurses and physicians by Pharmacy students about mouthwashes prescription and practice.
Data recorded on pre-established questionnaire and analyzed in pharmacy department
using Microsoft Excel®.
Setting: Study performed in oncology, hematology and radiotherapy clinical departments
and in clinical units with oncologic activity (gastroenterology…). During one year,
more than 2600 patients received anticancer chemotherapy.
Main Outcome Measures: Questionnaire items were: use of a specific mouthwash procedure
within the service, use of a single agent or in combination. Data collected from the
nurse point of view were: preparation and administration practices; from the physicians’
perspective: circumstances of prescription and duration of the treatment.
Results: 31 questionnaires were analyzed (nurses: 10, physicians: 21) from 7 clinical
units. There was a standard written procedure in only one clinical unit. Several formulations
were used: each physician proposed his own, including antifungal prophylaxis (amphotericin
B, nystatin), antimicrobial agents (povidone, chlorhexidine), mucosal surface protectant
(sucralfate), alkalin solution (sodium bicarbonate), anti-inflammatory agent (aspirin),
anaesthetic drugs (lidocaïn) and other agent (glycothymoline).
Preparations were not systematically labelled with patients name, formulation, date
of preparation and stability duration. These were administered from 2 to 4 times daily
regardless the stability compounding. For physicians, prescriptions of mouthwashes
were done for patients with specific toxic anticancer drugs (5-FU, anthracyclin, capecitabin
and sunitinib), were concomitant with chemotherapy and systematic after radiotherapy.
Conclusions: There are variations among clinical units in terms of mouth care regimen
used. Treatment efficacy was never evaluated. Drug committee worked on guidelines
in order to prescribe antifungal therapy only for curative aim or avoid anaesthetic
drugs (swallowing difficulties). Good practices included, before chemotherapy, dental
hygiene. Maintenance is realized by the patient himself (mouthrinses with alkalin
solution or chlorhexidine). Analgesics can be taken orally in case of mouth pain.
Keywords: Oral mucositis, Prevention, Mouthwash
PC-161 Comparative bioavailability study of two olanzapine formulations administered
orally in healthy male volunteers
Parvin Zakeri-Milani
1, Hadi Valizadeh1
1Pharmaceutics, Tabriz University of Medical Sciences, Tabriz, Iran (Islamic Republic
of)
Background and Objective: The bioavailability of a new olanzapine tablet preparation
was compared with the reference preparation of the drug in 24 healthy male volunteers.
Design: The open, randomized, single-blind two-sequence, two-period crossover study
design was performed.
Setting: Under fasting conditions, each subject received a single oral dose of 10 mg
olanzapine tablet as a test or reference formulation on 2 treatment days. The treatment
periods were separated by a one-week washout period.
Main Outcome Measures: The plasma concentrations of drug were analyzed by a rapid
and sensitive HPLC method with UV detection.
Results: The pharmacokinetic parameters included AUC0-24 h, AUC0-infinity, Cmax, t1/2,
and Ke. The mean AUC0-infinity of olanzapine was 570.76 and 558.66 ng h/ml for the
test and reference formulation, respectively. The maximum plasma concentration (Cmax)
of olanzapine was on average 15.82 ng/ml for the test and 15.73 ng/ml for the reference
product. No statistical differences were observed for Cmax and the area under the
plasma concentration-time curve for test and reference tablets. 90% confidence limits
calculated for Cmax and AUC0-infinity of cefixime were included in the bioequivalence
range (97.3–109.2%).
Conclusions: Therefore, the two tablet formulations were considered to be bioequivalent.
References
Simultaneous determination of olanzapine, clozapine and demethylated metabolites in
serum by on-line column-switching high-performance liquid chromatography, Journal
of Chromatography B, 759 (2001) 63–71.
Disposition and Metabolism of Olanzapine in Mice, Dogs, and Rhesus Monkeys, Drug Metabolism
and Disposition, Vol. 25, No. 5, 573–583.
Keywords: Olanzapine, Bioequivalence, Bioavailability, AUC, Cmax
PC-169 Clinical pharmacists impact on validation orders: application to innovative
drugs
Sarah Berdot
1, Julie Rouprêt1, Etienne Guillard1, Hanna Chaouch1, Agnès Certain1, Philippe Arnaud1
1Pharmacy, Teaching Hospital Bichat-Claude Bernard, Paris, France
Background and Objective: Hospital including 22 clinical services with satellite pharmacies
including pharmacy technicians and clinical pharmacists and a central pharmacy department.
To ensure drug dispensing process in order to obtain a 100% clinical pharmacists validation
before dispensation.
Focus on drugs that do not belong to Diagnosis-Related Group (DRG) created by French
rules related to rational good use of drugs.
Design: Process analysis in an healthcare providers practices audit.
Prospective study over 5 months (January–May 2007) including 100 successive computerised
and non-computerised prescriptions. Data were collected by a pharmacist resident.
Setting: Pharmacy department and all clinical units of the hospital.
Main Outcome Measures: Number of prescription validations compared to the total number
of these prescriptions.
Identification of process dysfunctions.
Results: Of 100 prescriptions, validation before dispensation was effective by clinical
pharmacists for 43% and by basement pharmacists for 57%.
Identified reasons for 57 prescriptions not validated by clinical pharmacists, were
:
no contact between pharmacy technician and clinical pharmacists: 10/57 (17.5%)
no clinical pharmacists available: 11/57 (19.3%)
direct transmission of prescriptions from clinical units to central pharmacy: 8/57
(14%)
night and week-end dispensation: 16/57 (28.1%)
clinical services without clinical pharmacists: 12/57 (21.1%)
Conclusions: Clinical pharmacists effectively validate 43% of these prescriptions
but one third of prescriptions will inevitably remain validated by pharmacist residents
during night and week-ends.
Performance criteria must be proposed to measure impact of pharmaceutical improvement
initiatives (validation procedures writing, continuous education for example). We
suggest to test clinical pharmacy activities related to economic indicators and to
medication events reduction.
Keywords: Clinical pharmacist, Innovative drug, Practices audit, Indicators
PC-178 Challenge for clinical pharmacist in education of patients with type 2 diabetes
Oksana U. Hrem
1, Andrij B. Zimenkovsky1, Oksana U. Hrem1
1Department of Clinical Pharmacy, Pharmacotherapy and Medical Standardization, Danylo
Halytsky Lviv National Medical University, Lviv, Ukraine
Background and Objective: Education of patients with type 2 diabetes is a key point
of non-medical management of that disease. Thus objective was evaluation of patients’
knowledge about their disease and its management for further development of pharmaceutical
care protocols.
Design: Prospective cohort control study. Total 100 patients casually were divided
in two equivalent groups: study group (n = 50), age 64.4 ± 8.93, diabetes duration
9.02 ± 6.74 who were questioned by face-to-face technique and received pharmaceutical
care during the interview; control group (n = 50), age 61.6 ± 8.89, diabetes duration
6.97 ± 5.63 and filled in questionnaires without clinical pharmacist. Inclusive criteria
were: presence of type 2 diabetes mellitus, duration of the disease was not considered
as criteria. Patients were inquired once following standardized questionnaire. All
included patients could read and write. Two groups controlled their diabetes mostly
by oral antidiabetics, only n = 6 in study group and n = 2 in control used insulin.
Setting: Out-patient setting of Lviv Clinical hospital No4, endocrinologist’s office.
Main Outcome Measures: Assessment of patients’ knowledge about diabetes and self-monitoring
in study and control groups.
Results: Only 32.0% and 30.0% of inquired patients in both groups respectively stated
that they possess good knowledge about diabetes. But as it was shown by evaluation
of their level of knowledge through assessment of keeping to diet, regular physical
activity, self monitoring it didn’t conform completely. Diet was implemented by almost
70% of patients in two groups, while regular physical activity was declared only by
14.0% in study and 46% in control groups. Smoking was reported by 14.0% and 16.0%
respectively. Next step was evaluation of self-monitoring. It has been revealed that
only 12.0% and 10.0% of patients in two groups performed blood glucose monitoring
at home; body weight was controlled by 58.0% and 50.0% respectively; blood pressure
by 50.0% and 58.0% as well. Target level of blood pressure was achieved by 42.9% of
subjects in study group and in 40.9% – in control. In study group foot examination
was performed everyday by 70.0% of patients when in control only by 18.0%. No one
from both groups evaluated glycated haemoglobin regularly as it is recommended by
American Diabetes Association, those they couldn’t state their present or previous
parameter.
Conclusions: It was estimated that knowledge about necessity of diet following, regular
physical activity, and particularly – self-monitoring was very poor in diabetic patients,
no regarding compliance which possibly also will be low. Even if patients stated good
knowledge about the disease they had problems with self-monitoring. It is obvious
that patients of this out-patient setting require adequate education, which should
be a component of pharmaceutical care program implemented by the clinical pharmacist.
Protocols of pharmaceutical care for these patients must be developed and include
standard procedure of type 2 diabetes patients’ education.
Keywords: Education of diabetic patients, Pharmaceutical care protocols
PC-183 Evaluation of pharmaceutical care at hospital admission
Miriam Maroto
1, Elena Florensa1, Ferran Sala2, Pilar Lalueza3, J. Carlos Juarez3, Lourdes Girona3
1Pharmacy Department, Hospital Universitari Vall d’Hebron, 2Pharmacy Department, 3Pharmacy
department, Hospital Universitari Vall Hebron, Barcelona, Spain
Background and Objective: Patients who are admitted for a programmed orthopedic surgery
in a tertiary hospital are usually elderly and present high co-morbidity which makes
therapy complexity increase. The objective is to evaluate whether a pharmaceutical
care is necessary before patients hospital admission.
Design: We analysed the domiciliary treatment in 1000 patients who attended to a pre-surgery
visit. A form designed by the Pharmacy department and validated by Anaesthesiology
Unit was delivered to the patient to fill in with domiciliary therapy.
Our data base included information about patients epidemiological dates and the pharmacological
treatment. Drugs were classified following the protocols of two hospitals and the
Protocol published by Catalonian Society of Anaesthesiology.
Setting: Pharmacy Department and Traumatology Hospitalization Unit of a tertiary teaching
hospital.
Main Outcome Measures: Evaluate how many patients require a pharmaceutical care in
our hospital before undergoing surgery.
Results: We revise 1,000 patients treatments, 654 women and 246 men. 611 patients
were over 64 (61.1%). We analysed 4660 different drugs prescriptions, which included
495 active ingredients (AI)
The average of prescribed drugs was 4.66 per patient, being this reduced to 3.9 drugs
in patients younger than 65 and increased to 5.13 in patients older than 65. Over
one third of patients (340/1000) were taken orally NonSteroidal Anti-Inflammatory
Drugs (NSAIDs).
From 495 AI, 122 would need a pharmacological evaluation in the preoperative. Those
were included in 1998 drugs, meaning the 42.8% of the different drugs prescriptions.
This percentage belonged to 860 patients.
Conclusions: The fact that a high percentage of patients over 64 with an orthopedic
pathology take a considerable amount of drugs at home makes it necessary to monitories
the therapy in order to minimise the iatrogenic problems during the admission. We
have seen that this situation is so frequently (86%) in our study, so the
Pharmacy Department has established a collaborative job with Anaesthesiologist Unit
to reduce as much as possible therapy problems.
Keywords: Pharmaceutical care, Hospital and surgery
PC-189 Comparison of the administration of esomeprazole and lansoprazole through nasogastric
tubes in the presence of nutrition mixture
Marie-Pierre Ponrouch1, Valérie Sautou-Miranda
2, Anne Boyer-Grand2, Jean Chopineau2
1Pharmacy, G. Montpied Hospital, 2Laboratory of clinical pharmacy, Faculty of pharmacy,
Clermont-Ferrand, France
Background and Objective: Nasogastric tubes are medical devices which first role is
the administration of enteral nutrition to patients when oral way is not functional.
These devices also authorize drug administration like protons pump inhibitors (PPIs).
The reduced diameter of tubes used for children increases the risk of obstruction
when these drugs are administered. Some studies (1.2) showed that the esomeprazole
is the only PPI presenting a sufficient transit through adult nasogastric tubes. Is
it the same with paediatric tubes particularly in the presence of nutrition mixture?
Does orally disintegrating tablet of lansoprazole behave like esomeprazole under these
conditions of administration?
Design: to compare the transit of esomeprazole and lansoprazole through nasogastric
tubes at the time of a concomitant administration of a nutritive solution.
Setting: Laboratory of clinical pharmacy and biotechnics.
Main Outcome Measures: We used 8 French polyurethane nasogastric tubes French set
to mimic their position in a child in a 30° elevation. Through each tube, a 1500 ml
nutritive solution was delivered on 24 h each day during one week. After dissolution
in 5 ml water the PPIs were administered once a day after stopping of the enteral
nutrition and rinsing of the tube with 5 ml of water. The tubes were then rinsed with
10 ml of water and the nutrition was started again. During each administration of
PPI the suspension was collected at the tube exit in order to quantify the PPI by
UV-spectrometry.
Results: No tube was obstructed. The enteral nutrition mixture did not adversely affect
the transit of lansoprazole through 8F nasogastric tubes. The transit of lansoprazole
through the tube was complete and regular during the 7 days of the study (100.4 ± 4.2).
For esomeprazole the mean recovery of active ingredient was of 79.2 ± 17.4 (coefficient
of variation: 22%) This variability can be explained by the incomplete and inconstant
dissolution of esomeprazole because of the low volume of water usable in paediatry.
Conclusions: Orally disintegrating tablet of lansoprazole can be administered through
8F nasogastric tubes in a concomitant way to an enteral nutrition mixture. For esomeprazole
there is a variability of the administered active ingredient. However enteral nutrition
doesn’t seem to affect the esomeprazole transit. Low volumes of water used in paediatry
seem to be responsible for the variability.
References
Messaouik D., Sautou-Miranda V., Bagel-Boithias S, Chopineau J. Comparative study
and optimisation of the administration mode of three proton pump inhibitors by nasogastric
tube. Int J Pharm. 2005 Aug 11;299(1–2):65–72.
Messaouik D., Sautou-Miranda V., Balayssac D., Bagel S, Chopineau J. Is the administration
of esomeprazole through a nasogastric tube modified by concomitant delivery of a nutrition
mixture? EJHP, 2006, 12(5), 67–71
Keywords: Lansoprazole, Esomeprazole, Enteral nutrition, Nasogastric tubes, Paediatry
PC-190 Pharmacological interactions in a spinal cord injury unit
Berta Renedo
1, Miriam Maroto1, Ramon Arroyo2, Lucrecia Ramirez2, Pilar Lalueza1, Juan Carlos Juárez1,
Lourdes Girona1
1Pharmacy, 2Rehabilitation, Hospital Universitari Vall Hebron, barcelona, Spain
Background and Objective: The current complexity of pharmacological interactions (PI)
forces to a special pharmaceutical care. The aim of this study is to analyse possible
PI, and its clinical repercussion, in patients admitted in a Spinal Cord Injury (SCI)
Unit.
Design: A prevalence study of PI, described and observed, in patients admitted in
the SCI unit was performed. The following variables were registered: clinical patients
characteristics, pharmacological treatment and PI defined and classified according
to their severity in 3 different sources: Medinteract, Lexi-Comp and iMedicins.
Setting: Pharmacy department and SCI Unit of a tertiary hospital.
Main Outcome Measures: Pharmacological treatment, PI and their clinical repercussion.
Results: We analyzed pharmacological treatment in 14 patients, with a mean age of
46 years old (27–77). The average of drugs per patients was 11 (7–17).
After checking the sources we detected 63 possible PI (4 severe, 40 moderate and 19
slight), observed 73 times. PI were detected in 9 of 14 patients and mean per patient
was 5.2 (0–19).
The following PI were described: increase of sedation (9 patients), risk of bleeding
(2 patients), serum potassium levels alteration (3 patients), hypotension (1 patients),
risk of hepatotoxicity (1 patients), increase of creatin kinase levels and risk of
myopathy (1 patients). From all these, only two were observed: sedation which was
observed in all patients and hypotension which permitted the reduction of patient
antihypertensive treatment.
Conclusions: The most frequent PI was sedation which is considered beneficial in order
to reduce anxiety in SCI patients. Arterial tension, electrolytic balance, hepatic
and renal function, as well as risk of bleeding, are regularly controlled in the SCI
unit. This way, if one of these parameters was altered it would be easily detected.
To conclude, it would be important to carry out regular checking to detect PI, especially
for those drugs that are not usual and for those symptoms that are not controlled
regularly in the SCI unit.
Keywords: Pharmacological interactions, Spinal cord injury
PC-196 Pharmacist intervention at the lipid clinic
Anthony Serracino-Inglott
1, Lilian M. Azzopardi1, Maurice Zarb Adami1, Annelise Sapiano1
1Department of Pharmacy, University of Malta, Msida, Malta
Background and Objective: Pharmacists’ individualized counselling of patients has
positive impacts on the management of hyperlipidaemia, including improved compliance
and better treatment endpoints. The objective was to evaluate patient knowledge on
hypercholesterolemia and its treatment and to assess impact of pharmacist intervention
at the Lipid Clinic.
Design: One hundred and fifty statin-treated patients were recruited by convenience
sampling. Following completion of a scored pre-intervention questionnaire, the pharmacist
provided education on hypercholesterolaemia and the use of statins. A leaflet was
prepared, evaluated and distributed to the patients. The patients completed again
the same questionnaire after the intervention (post-intervention).
Setting: Lipid Clinic, Out-Patient Department, St Luke’s General Hospital.
Main Outcome Measures: The pre-intervention questionnaire indicated patients’ baseline
knowledge and the post-intervention questionnaire assessed patient knowledge following
the pharmacist intervention.
Results: Patient demographics: 42% (63) were males, 58% (87) were females, mean age
was 59 years (range 32–76 years). A response rate of 71% was achieved with 98 patients
completing both questionnaires. Following the educational intervention by the pharmacist,
knowledge regarding the correct action to be taken if muscle pain or tenderness occur
during statin therapy increased by 34% (p = 0). The awareness regarding the normal
total blood cholesterol level increased by 22% (p = 0.0001) and the knowledge regarding
the need for low-fat diet consumption during statin therapy increased by 27% (p = 0).
Face and content validity of the patients’ leaflet were strong. The average Gunning
FOG Index obtained for the leaflet was 11.6 indicating good readability for individuals.
The leaflet was endorsed by the local Health Promotion Department and 10 000 copies
were printed and distributed to patients.
Conclusions: The pharmacist intervention at the Lipid Clinic resulted in an increased
patient knowledge on hypercholesterolemia and on the use of statins.
Keywords: Hypercholesterolaemia, Pharmaceutical care, Patient counselling
PC-223 Risk-adjusted monitoring of veno-occlusive disease following bayesian individualization
of busulfan dosage for bone marrow transplantation in paediatrics
Valerie Bertholle
1, Brice Kitio1, Valerie Mialou2, Claire Galambrun2, Yves Bertrand2, Gilles Aulagner3,
Nathalie Bleyzac1
1Pharmacy, 2Paediatric Immuno-haematology and Bone Marrow Transplantation, Hospices
Civils de Lyon – Debrousse Hospital, LYON, 3Henry Poincarré University, Henry Poincarré
University, Nancy, France
Background and Objective: In order to assess the performance of Bayesian individualization
of busulfan (BU) dosage regimens, veno-occlusive disease (VOD) rate was monitored
for paediatric patients undergoing allogeneic bone marrow transplantation (BMT).
Design: Consecutive patients undergoing allogeneic BMT with BU as conditioning regimen
during five years period (January 2000 to Febuary 2006) were retrospectively reviewed
(66 patients).
Setting: VOD was major outcome variable. Preconditioning risk of VOD was estimated
for each patient using a scoring system that included type of transplant, recipient
CMV-positive status and total parenteral nutrition provided pretransplantation. A
risk-adjusted cumulative sum method was used to compare observed versus predicted
outcome by assigning a risk score, based on log-likelihood ratios, to each patient.
Main Outcome Measures: The cumulative scores were sequentially plotted with preset
control limits for “signalling” where results were substantially different than expected
(doubling or halving of odds ratio).
Results: Sixty-six children received BMT after oral busulfan-based conditioning regimen
with median age 3.9 years, 63.6% of male. Median preconditioning risk of VOD was 0.34
range (0.23–0.84). Observed VOD rate was 16.7% (n = 11) which was 60.7% (17 patients)
fewer than the expected number estimated by the risk score. The resulting risk-adjusted
score for each patient was plotted sequentially. This plot adopted early a negative
slope, crossing the lower control limit twice, after 27 and 66 patients, indicating
improved results compared to those expected.
Conclusions: Bayesian individualization of oral busulfan dosage regimens is useful
to reduce VOD rate in children undergoing allogeneic BMT.
Keywords: Busulfan, Bayesian pharmacokinetic monitoring, Risk-adjusted cumulative
sum
PC-228 Determination of geriatric patients’ drug profile and identify their pharmaceutical
care requirement
Betul Yalcin1, Mesut Sancar2, Fikret Vehbi Izzettin
2
1Clinical Pharmacy Service, Yeditepe University Hospital, 2Clinical Pharmacy Department,
Marmara University – Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Geriatric patients use numerous drugs; because they have
several concurrent diseases. 85% of those 65 years old and over have at least one
chronic disease, 30% have 3 or more chronic diseases (1). The purpose of this study
is to evaluate data on the geriatrics’ drug usage, assess the appropriateness of their
drug treatment and identify their pharmaceutical care requirements.
Design: Patients, who were 65 years old and over and live in a nursing home in the
Anatolian part of Istanbul, were included in our study. By interviewing the patients,
individualized information was obtained regarding the drugs they used, dose and frequency
of drugs, the purposes of medication use and side effects, and who suggested or prescribed
the drug. The patients at risk of drug induced problems were defined and a risk map
was developed. Patients who have 4 or more risk factors were accepted as being in
a high risk category.
Setting: A nursing home.
Main Outcome Measures: The demographic, clinical and drug data of the patients were
recorded. The pills count that patients used daily and totally; side effects of the
drugs; knowledge of patient’s diseases and drugs; risk category of patients were assessed.
Results: Polypharmacy was identified in 44% of those included in the study (total
of 146 patients who take drug therapy). Generally it was observed that the drugs were
prescribed at an appropriate dosage and time; however 80% of the patients didn’t know
for what they were taking drugs. Just 2 (1.4%) of the patients were aware of the conditions
under which they should take drugs. 88 of the patients (60.3%) were not aware on how
to and when they should receive their drugs. 24 patients (16.4%) were using their
drugs by self-administration. The drugs of 122 patients (83.6%) were administered
by their nurse. 8.75% of the patients were receiving no medication. Mean of number
of drug used by patients was 5.89 ± 3.61. 24.65% of patients were in a high risk category.
Conclusions: As a result, drug effects alter due to polypharmacy, physiological and
psychological changes. Drug treatment should be individualized and monitored in geriatrics.
According to our results, patients have lack of knowledge on drug use and they have
never been educated in this matter. It is necessary to begin meeting their pharmaceutical
care needs with education. We believe that this study will help bring together specialist
geriatric teams consisting of physician, pharmacist, nurse and other health professionals,
and contribute to the development and spread of patient oriented pharmacy services.
References
Katz MS, Gerety MB, Lichtenstein JM: Gerontology and geriatric medicine. Ed: Stein
JH, Internal Medicine. Mosby Year Book Inc., USA, 1994.
PC-230 Emergency contraception: change of user’s profile 2003–2006
Kurt E. Hersberger
1, Tanja Bodenmann1, Seraina Mengiardi1, Patrick Eichenberger1, Elisabeth Zemp Stutz2,
Brigitte Frey Tirri3
1Institute of Clinical Pharmacy, 2Institute of Social and Preventive Medicine, University
of Basel, 3Women’s Hospital, University Clinic, Basel, Switzerland
Background and Objective: In 2002, Levonorgestrel was introduced in Switzerland for
emergency hormonal contraception (EC) without prescription (‘pharmacist only’). In
2003, a first analysis of requests of EC showed that the dispensing of EC through
pharmacies could successfully be implemented (Lemke et al 2004). This study was repeated
three years later with the aim to explore whether the user’s profile has changed over
time.
Design: Retrospective analysis of requests of EC using pharmacy protocols registered
in 2003 and 2006.
Setting: Selected Swiss community pharmacies with enlarged opening hours and providing
access to their protocols on EC.
Main Outcome Measures: Age, reason for request of EC, contraceptive method used, report
of previous use of EC.
Results: Comparison of requests in 2003 (n = 205) vs. 2006 (n = 349) showed a decrease
in mean age of EC users (25.5 ± 7.1 vs. 24.2 ± 6.9 years; p = 0.035), but no significant
difference in report of previous use of EC (48.8% vs. 50.1%; p = 0.869). Women seeking
for EC used mainly condoms as their contraceptive method, in 2003 as well as in 2006
(68.8% vs. 62.8%; n.s.) or a hormonal contraceptive pill (17.1% vs. 24.9%; p = 0.031).
Conclusions: Four years after introduction of a low threshold access to EC through
pharmacies, besides a slight decrease of the age of EC-users, no major trends in user’s
profile were observed, especially no increase of reported previous use of EC.
References
Lemke S et al. Supply of emergency hormonal contraception without prescription in
Swiss community pharmacies. Proceedings of 2nd ACCP-ESCP Congress, Pharm World Sci
2004; 26:A66, abstract PC-090
Keywords: Pharmacy practice, Emergency hormonal contraception, Trend
PC-234 Development and validation of the socioeconomic impact profile (SEIP)-factor
analysis
Adetomilola Aderounmu
1, Sam M. Salek2
1Centre for Socioeconomic Research, Welsh School of Pharmacy, Cardiff University,
2Centre for Socioeconomic Research, Welsh School of Pharmacy, Cardiff University,
Cardiff, United Kingdom
Background and Objective: As part of development process of a measurement technique,
it is vital to carry out factor analysis to explore the statistical confirmation of
the new instrument domains. Factor analytical technique can be either exploratory
or confirmatory. Exploratory factor analysis (EFA) remains one of the standard and
most widely used methods to demonstrate construct validity of new instruments. It
is used to help development of the instrument by revealing items that may be made
redundant from the questionnaire because they contribute little to the presumed construct.
The SEIP consists of 24 items in five domains and is scored on a four-to-five-point
Likert scale. The aim of the study was to assess further psychometric property of
the SEIP using principal component factor analysis (PCA). The strength of the inter-correlations
among the items will be assessed by the presence of coefficients greater than 0.30
in the correlation matrix. If few correlations above this level are found, then factor
analysis may not be appropriate.
Design: Factor analysis was executed by an exploratory principal components analysis
(PCA) on the correlation matrix of the 24 SEIP items with orthogonal rotation using
the varimax procedure. Items with strong loadings (above 0.40) on each factor were
retained and those with weak loadings (below 0.40) were eliminated. The intercorrelations
among the factors and between factors and items were assessed by internal consistency
reliability tests.
Setting: Community pharmacies in South Wales, United Kingdom.
Main Outcome Measures: The Kaiser–Meyer–Olkin (KMO) measure of sampling Adequacy for
suitability of factor analysis and cronbach’s coefficient alpha values for the internal
consistency reliability tests to establish final domains of the SEIP and their components.
Results: Three-factor models were produced: 1) the impacts of statins on healthcare
services use; 2) emotional distress and impacts on productivity; and 3) socio-emotional
symptoms and use of healthcare services. The correlation matrix for SEIP revealed
the presence of some coefficients of 0.3 and above (KMO value was 0.82) therefore
confirming the suitability of the SEIP data set for factor analysis. The alpha coefficients
for internal reliability ranged between 0.62–0.77.
Conclusions: The factor analysis results have clearly supported the clinical and statistical
meaningfulness of the SEIP domains. Although the SEIP awaits full validation, encouraging
results of pilot studies and the supporting evidence from this analysis indicate that
it may become the gold standard for socioeconomic evaluation of medication – related
problems in particular of cardiovascular drugs.
Keywords: Socioeconomic impact, Medication-related problems, Factor analysis
PC-244 Impact on the medical follow-up of inr in a 200-bed geriatric hospital with
a computerized control (pharmacist developed)
Emmanuelle Orru Bravo
1, Celine Moreau1, Bruno Baune1
1Pharmacy Department, Hospital Bretonneau, Paris, France
Background and Objective: Elderly patients are at high risk of over-anticoagulation
when treated with oral anticoagulant therapy (OAT). To reduce this risk a regular
control of INR is required. However scheduling the follow-up of several patients with
OAT is complex with a risk of failure of INR regular control. The purpose of the study
is to evaluate a systematic pharmaceutical computerized method of INR follow up.
Design: It is a 6-month prospective study. A Access® database was developed by the
hospital pharmacists in order to extract a computerized prescription named GENOIS®
of all the patients with OAT.
For every patient, an Excel® record is set up and updated with the INR results and
dosage modifications of OAT, then filed in a folder corresponding to the day of the
week the INR should be checked.
The INR control dates are based upon the recommandations of the Specific Product Characteristics
of the anticoagulant
If necessary, the pharmacist sends an alert to the prescribor concerning the INRs
follow-up.
Setting: Pharmacy Department and Clinical Units of the hospital
Main Outcome Measures: Number of patients with OAT/patient records in Excel/INR data
base/number of identified follow-up issues
Results: Out of 83 patient receiving OAT, 86% (71/83) were registered (79% female,
mean age = 86 years) in Excel. 14% patients were not recorded due to the time to fine
tune the follow-up method. Within 2 months 100% patients were recorded.
A total of 477 INR was analysed (mean = 4/patient). 48% (34/71) and 11% (8/71) have
an INR between 3–5, and INR between 5–9, respectively.
193 issues were identified including 101 related to INR controls not performed and
27 due to a poor/no adjustement of the OAT dosage. 91% of the issues resolved following
the pharmacist recommandations
Conclusions: Computerized follow-up system allows to check INRs at the right date
and to reduce the loss of results. Pharmacists’ recommendations were well accepted
by physicians. The impact of the follow-up on the reduction of the overdose incidence
will have to be evaluated.
Keywords: Oral anticoagulant therapy, INR, Computerized follow-up, Pharmacist, Geriatric
PC-245 Four years experience of fondaparinux use in a French university hospital
Charlotte Trento1, Chloe Dupont
1, Aurelie Barrail-Tran1, Isabelle Vincent1, Anne-Marie Taburet1
1Pharmacy, Bicetre, Le Kremlin Bicetre, France
Background and Objective: Fondaparinux is an antithrombotic agent approved for prophylaxis
of thromboembolism events, following orthopaedic or abdominal surgery or in medical
situation, and for deep vein thrombosis or pulmonary embolism treatment. Recently,
the AFSSaPS (French Drug Agency) has notified haemorrhagic complications due to inappropriate
or off label use of fondaparinux and has published guidelines of good practice. The
objective of this study is to evaluate the fondaparinux use in regard with these recommendations.
Design: Retrospective analysis of fondaparinux prescriptions for four years (June
2003–June 2007).
Setting: One thousand beds in a French university hospital with surgical (orthopaedic
and abdominal) and medicine wards.
Main Outcome Measures: Patient characteristics, type of surgery or indication, duration
of treatment, were recorded. Haemorrhagic risks factors were age > 75 years, weight < 25 kg
and inflammatory disease.
Results: During the study period 120 patients received fondaparinux (57 male). At
least one of the 3 extra risks factor for thrombosis was recorded in 79 (66%) of them.
Mean [range] demographic and biological characteristics of these patients were: 66 years
old [4–94], body weight 77 kg [20–110], n = 81, creatinine clearance 93 ml/min [30–254],
n = 72. Mean duration of treatment is 11 days [1–62] at the dose of 2.5 mg qd for
prophylaxis excepted for one patient at 7.5 mg qd in pulmonary embolism treatment.
Indications were hip (n = 72) and knee (n = 24) total replacement, other orthopaedic
surgery of lower limbs (n = 13) and pulmonary embolism treatment (n = 1). Indications
were “off label” for 7 patients with allergic reaction to heparine and 3 were not
documented.
At least one of the 3 haemorrhagic risks factors was identified in 42 patients (35%).
Conclusions: Fondaparinux is mainly used in approved indications. Within the 42 patients
with haemorrhagic risks factors, no haemorrhagic accident was notified in the pharmacovigilance
records of our hospital. Nevertheless, fondaparinux has to be administred cautiously
in this population of patients for whom the 1.5 mg dose will be necessary and hopefully
available in a few month.
Keywords: Fondaparinux, Haemorrhagic risks factors, Good practice
PC-248 Pharmacists’ experience in a small village dispensary in Senegal
Ana Soler1, Ainhoa Rodriguez-Arias
1, Maria Antonia Mangues1
1Pharmacy Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Background and Objective: The Guerlé dispensary is an initiative of a Spanish non-governmental
organization set up to optimise health resources in the Sadio rural community (Senegal).
Every year, a team of doctors and nurses travel to a community dispensary to support
the local nurse and a pharmacy technician. This visiting team provides the dispensary’s
essential drugs. In 2006, two pharmacists were included in this team.
This study describes the clinical activities undertaken by hospital pharmacists in
a dispensary in this setting over a 3-week period.
Design: Descriptive study of activities developed by pharmacists in a community pharmacy
dispensary in Senegal.
Setting: Guerlé village, Sadio rural community, Senegal.
Main Outcome Measures: Evaluation of the contribution of two pharmacists in a multidisciplinary
health team in a developing country.
Results: A mean of 35 patients per day were attended at the dispensary from 8 am to
6 pm. The activities developed by the pharmacists were:
Organisation of the dispensary’s pharmacy, providing support for the reorganization
of drugs and disposal of expired medication.
Pharmacological advice to clinical personnel (interventions about indications and
dosage)
Dispensation of medicines, providing information to patients in French or Wolof and
adapted to their sociocultural level. We dispensed the exact number of pills to complete
a treatment and explained how to take it. In case of oral solutions for children,
we taught mothers how to give the correct volume for the prescribed dose.
Local medical staff training in pharmacology and consulting sources.
Detection and resolution of medication dosing errors. This problem was found especially
in paediatric patients.
Health promotion campaigns.
Conclusions: Improving organisation and medicine management and providing patient
information about drug use were the two main contributions of pharmacists. Local and
Spanish medical teams evaluated the pharmacists’ contribution as positive. Pharmacists
can play an important role offering support to the medical team and improving global
healthcare quality.
PC–253 Evaluation of a rapid streptococcus testing service in the community pharmacy
Sam Salek
1, Jigna Patel1, Catrina Schwartz2
1Centre for Socioeconomic Research Welsh School of Pharmacy, Cardiff University, Cardiff,
United Kingdom, 2Jones Pharmacy, Cardiff University, Spokane, United States
Background and Objective: Jones Pharmacy is one of the first American community pharmacies
piloting a testing service to diagnose Group A Streptococcal (GAS) Acute Pharyngitis.
This study aimed to evaluate the service; examine whether current clinical records
were adequate; and test hypotheses investigating the association between clinical
prediction rules (Center Criteria, CC), Rapid Antigen Detection Tests (RADT) and antibiotic
prescription.
Design: Initially, a semi-structured interview was conducted to gain an insight into
the service. Data was retrospectively obtained from a standardised template (APEF),
completed by a pharmacist at the time of each patient visit. Patient demographics
and symptoms, RADT results, CC scores and follow up rates were analysed. Chi squared
analyses were performed to investigate the aforementioned hypotheses.
Setting: Jones Pharmacy, Spokane, Washington DC.
Main Outcome Measures: Establishing adequacy and effectiveness of clinical records
and relationships between clinical prediction rules, RADT and the antibiotic prescription.
Results: Out of a total of 76 patients (mean age = 22; male = 33) there were 38 children
(mean age = 9.9; male 16) and 38 adults (mean age = 33; male = 17). Ten (47.6%) of
the 21 negative RADT results amongst children were referred to a primary healthcare
provider. Out of 72 patients, 58 (80.6%) needed a RADT to be performed. Only 25 (34.7%)
out of 72 patients were followed up. Significant association existed between RADT
outcomes and the prescription of antibiotics (p = 0.001, p < 0.05).
Conclusions: The findings from this study indicate that pharmacists need to be educated
on the importance of a comprehensive clinical record. Inconsistent practices occur
amongst pharmacists due to the conflict between US guidelines, particularly relating
to the referral of children with negative RADT results to a primary care provider.
The template was an efficient tool for data collection. Jones did not tailor their
data collection for the purpose of the study: with improved data collection, Jones
can yield information demonstrating the value of this service in future studies.
Keywords: Rapid streptococcus testing service, Rapid Antigen Detection Tests (RADT),
Community pharmacy
PC-254 Anti-D Ig prescriptions in Rh(D)-incompatible platelet transfusion at Montpellier
Hospital
Cyril Breuker1, Gaëlle de Barry1, Audrey Castet
1, Morgane Lebeschu1, Anne Jalabert1, Sylvie Hansel1
1Pharmacy, Lapeyronie University Hospital, Montpellier, France
Background and Objective: Rh(D)-positive platelet transfusion to a Rh(D)-negative
recipient may induce alloimmunization which can be dramatic for woman in childbearing
age. Alloimmunization is linked to the immunologic status of the patient together
with the red blood cell content in the platelet concentrate (PC) (1). In France, the
100 μg Ig anti-D NATEAD was replaced by RHOPHYLAC 200 or 300 μg (July 2005). The doses
recommended are 20 μg of Ig per ml of Rh(D)-positive transfused erythrocyte concentrate
whereas AFSSAPS (French Health Products Safety Agency) advocate to administer a dose
of 100 μg for the female recipient of 10 apheresis PC, in childbearing age and without
strong immunosuppression (2).
The aim of this study was to evaluate the quality of anti-D Ig prescriptions and the
respect of the AFSSAPS recommendations.
Design: Descriptive retrospective study of anti-D Ig prescriptions during the 2005
and 2006 years.
Setting: Pharmacy, pediatric and adult hematology oncology units, various hospitalization
units.
Main Outcome Measures: Identity of the patient, unit, sex, age, indication, drug,
posology and dose administered.
Results: For the adults, 89 prescriptions were collected concerning 66 patients (81%
from hematology oncology unit, 42 males, 24 females of whom 7 under 45 years). Among
22 NATEAD prescriptions, 73% were well specified (name and dosage or posology mentioned)
and only 9% of the 67 RHOPHYLAC prescriptions. 100 μg of anti D Ig were administered
when NATEAD was available, whereas 200 μg with RHOPHYLAC excepted 4 times where 300,
400 or 600 μg were administered. 5 times the pharmacist has induced a modification
of the posology. However, none prescription was made according to the AFSSAPS recommendations.
15 prescriptions were made for children in hematology unit concerning 4 boys and 2
girls. Among 8 prescriptions of 100 μg NATEAD, 100% were correct and 29% for the 7
RHOPHYLAC. The dose administered was not standard (200, 100 or 25 μg) and none prescription
was conformed to the recommendations.
Conclusions: This study shows that since RHOPHYLAC was commercialized (more expensive
than NATEAD), the doses administered have doubled and the national recommendations
(existent for adults only) are not followed. The reason is that hematologic patients
may have a lot of transfusions so they want to protect them from any immunization,
despite they are immunocompromised patients. New recommendations are needed, more
applied to the practice and precising doses for children. The role of the pharmacist
is then to remind physicians good practices of prescription.
References
Lozano M, Cid J, The clinical implications of platelet transfusions associated with
ABO or Rh(D) incompatibility. Transfus Med Rev. 2003 Jan;17(1):57–68.
AFSSAPS recommendations, Platelet transfusion: products, indications. 2003 June.
Keywords: Rh(D)-incompatible platelet transfusion, Anti-D Ig
PC-257 Pharmacist’s interventions in three medical care units: analysis and impact
on the physicians’ prescriptions
Guillaume Hache1, Aurélie Barrail-Tran1, Muriel Bocquentin1, Isabelle Vincent
1, Anne-Marie Taburet1
1Pharmacy, CHU Bicêtre, Le Kremlin Bicêtre, France
Background and Objective: Computerized prescriptions are settled in clinical wards
of our hospital. As pharmacist we have to validate those prescriptions and make recommendations
to change part of the prescription such as dose, drug drug interactions. The objective
of this study is to evaluate what kind of pharmaceutical interventions physicians
really pay attention to.
Design: The prescriptions had been analysed for three months in three medical care
units by two pharmacists. One of them take part in the physician round in order to
integrate particular medical practices. Pharmacist’s interventions were recorded and
categorized. The ratio of accepted interventions by the physicians was assessed.
Setting: Three medical care units: 2 internal medicine services (acute care unit:
10 beds and long term hospitalisation: 18 beds) and acute geriatric unit (12 beds)
in a 1000-bed French university hospital.
Main Outcome Measures: Description and analysis of pharmacist’s interventions in clinical
wards.
Results: We analysed 944 prescriptions. 104 interventions were performed and categorized.
It should be noticed that 35% of pharmaceutical interventions were for misused of
the new software: wrong selection of unit (75%) and redundant order (25%). The other
65% interventions were related to the prescription, our suggestions were as follow:
time of administration (29%), adequate drug formulation (18%), dose adjustment (17%),
therapeutic drug monitoring or biologic follow up (16%), to stop treatment (13%),
route of administration (7%). Among these recommendations, 32% were the consequence
of drug–drug interaction. 57% of the interventions led to change in the prescription.
34% of the physicians maintained their prescription despite the recommendations, mainly
for staggered administration to avoid drug interaction.
Conclusions: This work evaluated pharmacist’s interventions. First, physicians training
to use this new prescription software has to be improved. Then we identify what kind
of pharmaceutical interventions are accepted by physicians. Pharmacists should be
well-educated to be as persuasive as possible. Even though physicians are reluctant
to change their prescription, they are willing to be warned to improve their practice.
Keywords: Clinical pharmacy, Computerized prescriptions, Pharmaceutical interventions
PC-258 Evaluation of the effectiveness of sliding scale insulin for glycemic control
in the home care setting
Sam Salek
1, Navneet Gill1, Brian Gates2, Luke Rice2, Douglas Weeks2
1Centre for Socioeconomic Research Welsh School of Pharmacy, Cardiff University, Cardiff,
United Kingdom, 2Department of Pharmacy, Washington State University, Spokane, United
States
Background and Objective: Sliding scale insulin therapy (SSI) is a commonly used method
of adjusting insulin in an attempt to control a patient’s blood glucose levels. Previous
research investigating SSI use in the hospital setting has determined that SSI therapy
leads to poor glycaemic control and poor patient outcomes. Therefore, a Corrective
Schedule for SSI therapy is recommended by The American Diabetes Association (ADA).
The aims of this study were therefore to determine, for the first time whether SSI
recipients experience problems in the home care setting and whether ADA guidelines
on SSI use are being adhered to.
Design: Eligible patients were identified through electronic records of patients admitted
from 1st January to 31st December 2006. The list was utilised to obtain medical charts
of the patients. Relevant information including patient demographics, blood glucose
readings and documented problems were recorded using a standardised data collection
form. Chi-squared statistical analysis was determined using SPSS Version 14.0.
Setting: The Visiting Nurses Association (VNA) home care agency, Spokane, Washington
State, USA.
Main Outcome Measures: Use of ‘traditional SSI therapy’ versus ‘corrective’ version
recommended by ADA.
Results: Of the total 117 (male = 45, female = 72; mean age = 67.37, age range = 34–96)
patient medical records examined in this study, 36.75% (n = 43) had at least one problem
documented with their insulin regimen. The most common problem that affected over
a quarter of the population, 25.64% (n = 30) was ‘lack of control’ which included
any hyper- and hypoglycemic events. More than a third of sliding scale recipients,
37.61% (n = 44) had pre-prandial blood glucose levels above 150 mg/dl. In total 70.94%
(n = 83) of patients were prescribed the non-recommended Traditional SSI therapy and
only 29.06% (n = 34) were using the recommended Corrective SSI therapy.
Conclusions: The findings of this study support previous concerns that SSI use is
prone to problems and poor glycaemic control. Furthermore, this study has established
the lack of adherence to the ADA recommended use of the Corrective SSI schedule in
the home care setting. It is hoped that this study will influence use of SSI in hospital
and home care agencies as well as national and international guidelines.
Keywords: Sliding scale insulin therapy, Home care setting
PC-263 The impact of different schedules on the outcome of vap caused by pseudomonas
aeruginosa
Dinamene D. M. Santos1, Anabela A. G. Gusmão1, Armando Alcobia
1
1Pharmacy, Hospital Garcia de Orta, Almada, Portugal
Background and Objective: Prolonged (more than 48 hours) mechanical ventilation (MV)
is the most important factor associated with nosocomial pneumonia (1). Nosocomial
pneumonia (NP) is differentiated in to ventilator-associated pneumonia (VAP) if the
process arose after the patient has been receiving at least 24 h of MV (2). VAP is
defined as an inflamation of the lung parenchima caused by infectious agents not present
or incubating at time MV was started (1).
Design: Longitudinal, prospective and observational study.
Setting: We made a prospective evaluation of the clinical files of a patient population
of 14 cases with VAP diagnosed between April 2006 and December 2006, who were assisted
in Hospital Garcia de Orta. A total of 14 patients, 57% male and 43% female, aged
62 ± 15 years were diagnosed with VAP. VAP was defined as new positive respiratory
culture after at least 24 hours of MV.
Main Outcome Measures: These data sugest that the increase of PCR for documented VAP
caused by Pseudomonas aeruginosa ocurred more frequently with ceftazidim than other
antibiotics.
Results: In all VAP episodes, an aetiologic microrganism, was isolated from 26 hemocultures
and 22 bronchic secretions. The gram-negative bacteria were the most commonly isolated
microorganisms (68%).
We collected PCR and leucocytes data of seven documented schedules (n = 7) for erradication
of Pseudomonas aeruginosa: (1) ceftazidime (2 g q8 h) + gentamicin (5 mg/Kg qd), (2)
ceftazidime (2 g q8 h) + ciprofloxacin (200 mg q12 h), (3) Piperacillin-tazobactam
(4 g/500 mg q6 h) + aztreonam (2 g q8 h), (4) Piperacillin-tazobactam (4 g/500 mg
q6 h) + gentamicin (5 mg/Kg qd), (5) Piperacillin-tazobactam (4 g/500 mg q6 h) + amikacin
(15 mg/Kg qd), (6) imipenem-cilastatine (500 mg q6 h) + gentamicin (5 mg/Kg qd), (7)
meropenem (1 g q8 h) + gentamicin (5 mg/Kg qd). The mean duration of antibiotic therapy
was 10 days. There was an increase of the PCR values of the patients who were scheduled
with ceftazidim but in the other groups there was a decrease of this parameter. The
number of leucocytes didn’t have any impact of the PCR variation (p > 0.05, t-test).
Considering the group of the 14 patients, 75% (6) of the positive cultures for Pseudomonas
aeruginosa which were sensitive to either Ceftazidim or a carbapenem or piperacillin-tazobactam
were treated with ceftazidim instead.
Conclusions: This approach provides useful information on the relation of host defenses
and the clinical outcome. It is also useful to study the prevalence of acquired resistance
to several antibiotics that may be used in documented antibiotherapy for Pseudomonas
aeruginosa.
References
Chastre, Jean; Fagon, Fagon, Jean-Yves; Ventilator-associated pneumonia. Am J Respir
Crit care Med, 2002; 165: 867–903.
Kollef, Marin; Shorr, Andrew; Tabak, Ying et al. Epidemiology and outcomes of health-care-associated
pneumonia. Chestjournal, 2005; 128: 3854–3862.
Keywords: Pseudomonas aeruginosa, Antibiotherapy, VAP (ventilator-associated pneumonia)
PC-276 Use of recombinant activated factor vii (rFVIIa) in patients with uncontrolled
bleeding: an evaluation of professional practices
Sophie Langevin
1, Amélie Liou1, Estelle Bignon1, Elisabeth Vaissier2, Alexandre Ouattara2, Robert
Farinotti1
1Pharmacy, 2Cardiac Surgery, Pitié Salpêtrière Hospital, Paris, France
Background and Objective: rFVIIa is increasingly used as rescue therapy in uncontrolled
bleeding, however little information is available regarding its safety and efficacy
in this indication. Inadequate administration or dosage can induce severe adverse
effects. Therefore, we elaborated standardized guidelines for physicians in December
2006. The aim of this study was to evaluate the impact of these recommendations on
professional practices and to identify what should be improved.
Design: Retrospective study for patients treated in 2006 and prospective study in
2007 (6 months); drawing up of a form based on updated guidelines, validation of this
form and data-gathering in patient’s medical file.
Setting: Different departments using rFVIIa in our hospital, in particularly cardiac
surgery department.
Main Outcome Measures: To measure the conformity of medical practice regarding the
guideline in especially the following points:
indication for use: massive bleeding when first-line treatment (surgical control of
bleeding, use of blood products) has failed;
to achieve the correction of factors that may interfere with coagulation (hypothermia,
severe acidosis, hypocalcemia);
before administration of rFVIIa the patient or his family should be informed about
the treatment;
the prescription of FVIIa should be initialized by a referent physician
to conform the dose of 60 mu/kg in cardiac surgery patient.
Results:
17 patients received rFVIIa in cardiac surgery department (12 in 2006 and 5 in 2007);
indication is respected in 100% of the cases;
factors that may interfere with coagulation are rarely corrected (80% of patients
are in acidosis in 2007 which represents a decrease of 3% in comparison with 2006);
patient is never informed about the type of treatment that he has received (off-label
use);
rFVIIa is systemically prescribed by a referent physician in 2007 (72.6% in 2006);
in 2007, dose is still wrong in 60% of cases.
Conclusions: Several solutions have been proposed to the physicians to improve their
professional practices: to develop an algorithm for use of rFVIIa, to fill in a checklist
before administration of rFVIIa to be sure to follow the guidelines, … This study
will be extended in others departments using rFVIIa as gastroenterology and traumatology.
References
Vincent JL, Rossaint R, Riou B, Ozier Y, Zideman D, Spahn DR: recommandations on the
use of recombinant activated factor VII as an adjunctive treatment for massive bleeding
– a European perspective. Critical Care 2006, 10(4): R120
Keywords: Recombinant activated factor VII, Massive bleeding, Guidelines
PC-277 Pharmaceutical care contribution in health teams in the Portuguese integrated
health care system – between the hospital and the community pharmacy
Rita Lucas
1, Ana Paula Abreu2, Miriam Capoulas2, Fátima Cimadeira2, Ondina Martins2
1Pharmacy, Administração Regional de Saúde de Lisboa, 2Pharmacy, Administração regional
de saúde de lisboa, Lisboa, Portugal
Background and Objective: The pharmacist can contribute to the maintenance and recovery
of population health conditions participating in patient house visit′ s health teams.
Pharmaceutical care at this level may also have a real impact on the health system
costs.
The aim of this project is to establish a pathway at this care level in which all
aspects of pharmaceutical care are explained and defined.
Design: Program description.
Participation of the pharmacist in health care teams. Definition of field areas, between
the pharmaceutical hospital care and the community pharmacy and health care centers.
Articulation between the hospital pharmacist, the health care center pharmacist and
this new “home pharmacist”. Definition of the different types of pharmaceutical care
to be implemented in this setting.
Setting: The implementation of this project in the Portuguese Integrated Health care
System.
Main Outcome Measures: The implementation in near future by the governement.
Results: Non applicable at the moment.
Conclusions: The role of the pharmacist in the health system is well defined. Rational
drug use promotion is an important tool to minimize adverse effects and maximize efficacy
of medicines. Pharmaceutical Care should be implemented in all types of health care,
including recovery care, for governmental and population benefits.
Keywords: Pharmacist, Health promotion, Pharmaceutical care, Health teams
PC-281 Pharmaceutical care in elderly patients with hip fracture: a prospective pilot-study
Miriam Maroto
1, Berta Renedo1, Pilar Lalueza1, Carmen Pilar Simeon2, Juan Carlos Juarez1, Lourdes
Girona1, Josep Monterde1
1Pharmacy, 2Internal Medicine, Hospital Universitari Vall Hebron, Barcelona, Spain
Background and Objective: Hip fracture is a major public health problem with a high
incidence and prevalence in people aged 65 years and older. Changes in body composition
and organ function, drug-drug interactions, and co-morbidities should be taken into
account in the pharmaceutical care of this group of patients. The aim of this study
is to analyse pharmacological treatment of elderly patients ongoing hip fracture in
order to improve pharmaceutical care in this group of patients.
Design: A prospective pilot-study was performed during one month, (May–June 2007)
in 14 patients admitted in a tertiary hospital ongoing hip fracture. These variables
were recorded for each patient: sex, age, body mass index (BMI), diseases antecedents,
serum creatinine and creatinine clearance estimated by Cockroft-Gault formula, serum
albumin levels, lymphocytes count, sodium and potassium levels. Drug treatment was
recorded from pharmacy database.
Setting: Patients with hip fracture admitted in a tertiary hospital.
Main Outcome Measures: Prescription profile in elderly patients with hip fracture.
Results: Of 14 patients, 9 were female. Mean age was 80.4 years old (68–96). Mean
BMI was 27.6 (n = 10, range 21–35). Albumin levels were lower than 3.4 g/dL in 10
patients. Sodium levels were out of the normal range in 7 patients. Five patients
had creatinine clearance lower than 50 ml/min, 2 of them less than 30 ml/min.
We analysed 119 prescriptions which included 50 drugs. They were classified in 5 categories:
not adjustment required (16 drugs), adjustment required (12), inappropriate based
in Beer’s criteria (1), precaution in elderly people (10) and not enough information
available in geriatric population (11). Mean number of drugs per patient was 9 (5–15).
Of 119 prescriptions revised, 22 required adjustment and 15 of them were correctly
adjusted. Of 24 prescriptions in precaution group 18 were correctly prescribed.
Conclusions: Dosage adjustment or precaution was required in 40% of prescriptions.
Of these, 75% (33/46) needed dosage adjustment according to renal function. Besides,
36% of patients had renal function alteration. Thus, it is important to improve pharmaceutical
care in this group of patients specially for those drugs that need dosage adjustment
in renal failure.
Keywords: Pharmaceutical care, Hip fracture, Elderly patients
PC-282 Hospital pharmacists and community pharmacists: an experiment of pharmaceutical
information transmission carried out in an anticancer center
Anne Lebreton
1, Erwin Raingeard1, Christelle Audeval1, Sophie Rochard1
1Anticancer Center, Centre René Gauducheau, Nantes, France
Background and Objective: To evaluate a programme of pharmaceutical information transmission
from hospital pharmacists to the community pharmacists about drugs, particularly anticancer
drugs, dispensed until then by hospital pharmacy and now distributed by them.
Design: While doing the last dispensation by the hospital pharmacy, an informative
fax was sent to the community pharmacists indicating the name of the patient, prescribed
drug and its posology, date and quantity dispensed, approximate date of the next dispensation
and general information about the delivered drug. One month later a questionnaire
was sent to the pharmacists to get their appreciation about this document. In the
case of having no answer from them, the same questionnaire was re-sent.
Setting: Pharmacy of French Anticancer Center, Centre René Gauducheau, Nantes.
Main Outcome Measures
Appropriateness of the way of transmission
Pertinence of information sent
Efficiency of the programme
Results: Out of 49 patients treated (11 vinorelbine oral, 10 erlotinib, 12 sorafenib,
16 sunitinib), 34 (69.4%) were registered in this study, involving 32 pharmacists.
Six pharmacists (18.8%) answered after the first sending of the questionnaire and
14 (43.8%) answered after they received the remainder. Fourteen pharmacists (43.8%)
did not answer. All the pharmacists were satisfied with the way of transmission. However,
one of them suggested having the information sent by E-mail. Seventeen professionals
(85%) thought information was useful and 9 (45%) thought that it was sufficient for
their practice. Only 6 pharmacists (30%) encouraged us to continue the programme;
the others did not express any opinion about its efficiency. Moreover, none of them
called us even though we suggested so.
Conclusions: This experiment seems to be interesting and to correspond to the needs
of the pharmacists. It would also be an easy way to make dispensation safe. Nevertheless,
many problems appeared: much time spent and the difficulty making an exhaustive follow-up
of all the patients thus limiting the application of this kind of programme to larger
cohort.
Keywords: Community pharmacists, Pharmaceutical information transmission, Evaluation,
Dispensing safe
PC-290 Proposal a software for analysis of clinical relevance of antiretroviral drug
interactions
Pedro Amariles
1, Newar Giraldo1, Maria Jose Faus2, Francisco Javier Gutierrez1
1Pharmacy, University of Antioquia, Medellin, Colombia, 2Research Group on Pharmaceutical
Care (GIAF-UGR), University of Granada, Granada, Spain
Background and Objective: To make a proposal of software that facilitates the analysis
of clinical relevance of antiretroviral drug interactions, in the medical prescription,
dispensation and Dader methodology of pharmaceutical care study phase.
Design: Pubmed and other databases evaluate revision. Antiretroviral drug interactions
were classified in four levels according to probability and severity of the interaction.
The probability was grouped in 3 categories: defined, probable and possible. So, severity
was grouped in 3 categories: serious, moderate, and slight. The levels are: Level
1 (serious and defined or probable); Level 2 (serious and possible, moderate and defined
or probable); Level 3 (moderate and possible, slight and defined or probable) and
Level 4 (slight and possible). We used the PubMed and database review for identified
and organized the information to software elaboration.
Setting: University of Antioquia, Medellin – Colombia.
Main Outcome Measures: Interactions distribution by: level of clinical relevance,
type, pharmacodinamic interactions, pharmacokinetics interactions, enzymatic inhibition,
enzymatic induction and pharmacologic groups that interact with antiretroviral drugs.
Results: 3694 drug interactions were classified. The clinical relevance distribution
by level was: level 1: 191 (5.2%), level 2: 1152 (31.2%), level 3: 2309 (62.3%), and
level 4: 46 (1.2%). The type interactions distribution was: 3694 (94%) drug–drug interactions,
90 (2.7%) drug–disease interactions, 29 (0.8%) drug–food interactions, 22 (0.6%) drug–nutrient
interactions, 43 (1.2%) drug–laboratory test interactions, and 27 (0.7%) drug–herbal
product interactions. Of 3694 interactions, 213 (5.8%) were pharmacodinamic interactions
and 3481 (94.2%) pharmacokinetics. 715 (20.5%) pharmacokinetics interactions were
mediated by enzymatic induction, whereas 2727 (78.3%) were by the enzymatic inhibition.
Antiarrhythmics, antihistaminics, ergot alkaloids, prokinetics, benzodiazepins, statines,
calcium channels antagonists, phosphodiesterase inhibitors, azoles antifungics, selective
serotonin reuptake inhibitors, opioid analgesic, immunosuppressants, macrolides, classic
anticonvulsivants, and riphamicins were the most common drug therapeutic groups with
anti-retroviral drug interactions.
Conclusions: 3694 interactions were classified, which 94% were drug–drug interactions;
as well, 94.2% were pharmacokinetics interactions and in their majority (78.3%) were
mediated by the enzymatic inhibition. About 36.7% of interactions were level 1 and
2, this levels of greater clinical relevance and whose the alert generated by software
are contributions that help to analyze and take decisions with respect to the handling
from the same ones.
References
Amariles P, Giraldo NA, Faus MJ. Clinical relevance of drug interactions. Med Clin
(Bar) 2007;129:27–35.
Keywords: Drug interactions, Anti-retroviral drugs, Software
PC-291 Evaluation of a pharmaceutical care model in a pediatric intensive care unit
A. Robelet
1, Jean-françois Bussieres1, Annie Lavoie1, Christopher Marquis1, Denis Lebel1
1Pharmacy, Sainte-Justine Hospital, Montreal, Canada
Background and Objective: To develop a structured and reproducible approach to evaluate
the pharmaceutical care model in a pediatric intensive care unit. The approach should
allow a revision of the pharmacist task description on the unit in order to optimize
pharmaceutical care. The evaluation conducted in a Canadian setting will be tested
in a similar French context.
Design: Descriptive study of pharmaceutical care.
Setting: Pediatric intensive care unit in a 500 bed teaching hospital.
Main Outcome Measures: A literature search and review conducted to describe the impact
of clinical pharmacist on a selected clinical outcomes (e.g. mortality, morbidity,
adverse drug reactions.); a profile of patients and clinical activities; an update
of task description based on evidences and context.
Results: Studies demonstrate that pharmacists have an impact on selected clinical
outcomes following clinical pharmacy activities (e.g. drug therapy monitoring, pharmacokinetics
and education for medical and paramedical professional). Patients admitted in the
intensive care unit have a higher level of complexity of care than average patients
in the hospital, but a similar length of stay. For pharmacy services, their drug cost
per admission is higher (503$CAD vs 380$CAD), as the number of pharmacist paid hours
per admission (1.1 vs 0.88) and the number of pharmaceutical interventions per admission
(2.05 vs 1.74). The approach helped us to identify solutions to problems like the
non-participation to the cardiology patient’s round, the absence of a medication reconciliation
process or the inconstant documentation of interventions. A revised task description
will be tested by both clinicians.
Conclusions: This study illustrates an approach for the evaluation of a pharmaceutical
care model in a pediatric intensive care unit.
Keywords: Pharmaceutical care, Evaluation, Intensive care unit
PEC-126 Evaluation of the professional practices in cardiac surgery: application to
the use of biological and synthetic glues
Ameslant Sandra
1, Capucine Delgove2, Tramier Blaise3, Lescoat Halima4, Caus Thierry4, Petit Abir2,
Desablens Françoise2
1Pharmacy, CHU Amiens, Amiens, France, 2Pharmacy, 3Medical Information, 4Cardiology
Background and Objective: From 2005, an increase in the consumption of biological
and synthetic glues was noted in the cardiac service of surgery. These are drugs and
expensive medical devices, which represent an expenditure of more than 80 K€.
The impact of their use was evaluated on the post-operative bleedings, the duration
and the cost of stay by the way of a economic medical study.
Design: An observational exploratory study was carried out between January and March
2007. All the operated patients were included.
Setting: The computerized consultation of the patient files made it possible to identify
the following criteria of judgement: indication, surgeon, type of glue used, catch
of platelet aggregation inhibitors or oral anticoagulants, volume of drainage, number
blood transfused, duration of hospitalization.
The statistical analysis related to two groups of patients, treated or not by glues,
with a stratification on the hemorrhagic factors of risk.
Main Outcome Measures: The comparison of the averages of the various parameters was
carried out by tests of Student, for the large samples presenting comparable variables,
and of Fisher in the other cases. The cost of each hospitalization was calculated
from the numbers of stays.
Results: During the three months of study, 154 patients, whom average age was 70 years
[35–90], were operated. The two principal indications were the valvular replacement
(45.5%) and aorto-coronary bridging (39%). On all six surgeons, 70% of the interventions
were dealt with by three. On the whole, 57 patients receive a glue (37%), of biological
type with Tissucol® (32.5%), and synthetic with Bioglue® (4%), Arista® (2%) and the
GRF® (1%). Some patients received two types of glues (3.5%). No significant difference
between the two groups appeared in the total analysis.
Among the 120 patients who received a pre-operative anticoagulant treatment (78%),
only 37% were treated by a glue, for which the number of transfused globular bases
and the duration of stay in reanimation were significantly lower (p < 0.05; p < 0.01),
compared to untreated patients.
Conclusions: In general, the use of glues in cardiac surgery does not decrease the
post-operative bleedings, but increases the cost of the stay. It however finds its
utility with patients at the hemorrhagic risk.
A standardization of the local practices of the surgeons is in progress because there
is not any national consensus. These results should be confirmed by randomized studies
on a large scale.
Keywords: Glues, Cardiac surgery, Economic medical study, Evaluation of the professional
practices
PEC-92 Economic impact of the modification of zoledronic acid refunding on hospital
budget
Isabelle Alleman
1, Sophie Gensollen1, Christelle Labrande1, Sylvie Laurent2, Philippe Monges1, Marion
Gaudry3, Albert Darque1, Marie Claude Bongrand1
1Pharmacy, 2Management Control, 3Medical Information, CHU Conception, Marseille, France
Background and Objective: Pamidronic (PA) and zoledronic (ZA, Zometa®) acids are the
intravenous biphosphonates (BP) referred for use in our hospital. Until March 2007,
these drugs were not part of the “activity-based tariffing” system (T2A) which provides
for a global refunding fare for an “homogeneous group of patients” (GHS) pooled by
pathology and cost, and involves extra refunding of expensive drugs used in addition
to the standard of care. Since then, GHS fare has increased and now includes BP which
are no more extra refunded.
Although ZA is 5 times more expensive than PA, it seems more effective with a shortened
administration time (20 minutes vs 2–4 hours).
In respect of the contract of good use (CBU), our objective was to evaluate the real
cost of a daily hospital (HDJ) session per patient treated with BP, and to compare
it with the one obtained from the national study of costs (ENC) in order to determine
if whether our hospital gained or loosed benefit from this new refunding status.
Design: Retrospective study.
Setting: Conception Hospital, 147 Bd Baille, 13385 Marseille Cedex5, France.
Main Outcome Measures: For every HDJ session, we accounted pharmacy direct expenditures
(including implants, medical devices or drugs), medical technical acts, and structure
and logistic supports costs. Moreover, we evaluated matching of prescriptions with
the CBU criteria. We analyzed data together with the Public Health and Medical Information
ward and the Department of Management Control.
Results: Real costs of HDJ session amounted to 327 € without BP, and increased to
368 € and 537 € with PA and ZA administration, respectively. According to ENC results,
each session including intravenous BP was refunded for 459.39 €.
In 2005, on a total of 5242 HDJ sessions (2085 patients), 712 sessions had BP administration
(13.58%) and concerned 243 patients (11.65%). Real costs of HDJ were 302914 € (172960
€ and 129954 €, for 470 and 242 HDJ sessions with PA and ZA, respectively). If BP
administrations were integrated in the GHS at this time, the 712 sessions would have
been refunded for 327086 € (215913 € and 111172 € with PA and ZA, respectively) resulting
in a profit of 24171 € for the hospital.
Among BP prescriptions, 32% matched approved indications, 4.6% were part of temporary
protocol of use and 63.4% were medical publication-based. Internal medicine ward initiated
37% of the prescriptions.
Conclusions: Using pamidronic acid compensates the deficit generated by zoledronic
acid use. In respect with the CBU, zoledronic acid use will be restrained to approved
indications in outpatients and pamidronic acid will be preferred in all others indications.
Keywords: Biphosphanate, Refund, Economy
PEC-127 Evaluation of the implementation of automated medication-dispensing system
in an intensive care ward
Gregory Gaudillot
1, Marie Antignac1, Fabien Heck1, Nadine Casimir1, Robert Farinotti1
1Pharmacy, Groupe Hospitalier Pitié-Salpétrière, Paris, France
Background and Objective: The development of the implementation of automated medication-dispensing
system in French hospitals is the main aim, defined in the “Good Use” Contract voted
in 2005. The purpose is to improve the safety around the drug dispensing by the nurses.
The objective of this work was to evaluate this implementation in 3 thrusts: safety,
economic and organization.
Design: Comparison between two different organization ways: before the implementation
(pharmacy order by nurses chief) and 6 months afterwards (automated order and arrangement
by a chemist assistant).
Setting: Surgery intensive care unit (8 beds) in the Pitie-Salpétrière Hospital (GHPS),
a large teaching hospital.
Main Outcome Measures: Study “Before and after”: Follow up of prescribing and dispensing
matches, analysis of time repartition between nurses and chemist assistants, follow
up of line of emergency order, analysis of the results of a nurses satisfaction survey
and costs study of drug consumption and drug storage.
Results: This study, performed over 50 days, showed very small differences between
prescribing and administered medications (1% before versus 4% afterwards = no significant
difference). Organization: Implementation of automated device allowed a better division
of activities, the management by nurses chief of the pharmacy order decreased (from
9% to 2% of their weekly working time), because this part was attributed to the chemist
assistant (15% of their weekly working time). Satisfaction: 70% of nurses preferred
the automated system and especially because they find that this system was safe. In
the same time, 80% of them appreciate with the new relationship with the Pharmacy
Department. Costs Study: a huge decrease of the storage: −34% of cost (14,819 € versus
9,806 €) and −13% of references number (296 versus 230). In the same time, over 2 months,
the drug consumption of the unit has been reduced by 30% (−11,680 €).
Conclusions: Even if the study did not demonstrate a decrease of the number of medication
errors (due to the tiny number of them as much before than afterwards the implementation),
this automated system allowed a safety access to the drugs (biometric system) and
contributed to reduce the risk of medication errors. The other great interest is the
real involvement of the pharmacy in the clinical wards. The presence of the chemist
assistant ensures a better management of drug storage (decrease of emergency order),
a direct follow up and allowed a contact with nurses.
PEC-202 Intracranial stents: an evaluative and cost impact study in Paris hospitals
Serry Géraldine
1, Maubert Marie-Anne2, Naud Carole2, Goeury Dominique2, Doreau Christian2
1GIEAP, AP-HP, Paris, France, 2GIEAP, AP-HP, Paris
Background and Objective: Since 2005, manufacturers develop a new class of implantable
medical device: intracranial stents. It can be used for intracranial angioplasty or
in endovascular management of intracranial aneurysm. The aim of this study is, firstly
to review the different stents available in France, their technical characteristics
according to indications and, secondly to estimate the cost impact of those new devices
uses for 2007.
Design: Descriptive and cost evaluating study, literature review, manufacturers sales,
neuroradiologists and manufacturers interviews.
Setting: 3 Neuroradiology departments of Paris hospitals, Evaluation and purchase
of medical device unit of Paris hospitals.
Main Outcome Measures: Technical description of intracranial stents, quantitative
analysis of stent implantations in Paris hospitals and in France, cost.
Results: In 2007 in France, 5 intracranial stents with various technical characteristics
are available (steel or nitinol, learning curve: 2 to 5 procedures, follow-up of patients
is from 6 months to 2 years).
Stents with a hight radial force are used for intracranial artery angioplasty. More
precisely, those devices are implanted in patients with recidive stroke, with an intracranial
stenosis ≥50% and who had failed medical therapy. Two stents are identified in this
therapeutic use: Wingspan® (Boston) and Pharos® (Micrus). About 120 implantations
are estimated for 2007 in France, whom 35 implantations (cost = 105,000 €) in Paris
hospitals. The need is not actually clearly identified: the number of eligible patients
is not already known and not systematically searched by neuroradiologists. So number
of implantations will evolve.
4 intracranial stents are used in combination with detachable coils embolization in
patients with wide-necked cerebral aneurysms: Léo® (Balt), Neuroform 3® (Boston),
Entreprise® (Cordis) and Pharos® (Micrus, double therapeutic use). For 2007, about
230 to 300 implantations are estimated in France (10 to 25% of endovascular treatment
of intracranial aneurysm), whom 40 implantations (cost = 116 000 €) in Paris hospitals.
Those data might increase. Indeed, there is evidence of the effectiveness of stent
implantation in intracranial aneurysm which generates lower rate of aneurysm recanalisation.
Conclusions: 5 intracranial stents has been identified in 2 precise therapeutic uses.
However, an exact quantitative assessment can not be realised: those medical devices
are innovating and are actually changing the management of patients concerned. Those
quantitative results might evolve. Further similar studies will be necessary in order
to follow up those innovating therapeutic uses in neuroradiology departments and to
estimate their cost impact, actually negligible.
Keywords: Stent, Intracranial angioplasty, Intracranial aneurysm, Implantable medical
device, Cost evaluation
PEC-216 Feasibility of economical impact of management of cytotoxic remainders in
a centralized cytotoxic unit
Hélène Corneau
1, Déborah Schlecht1, Sébastien Bauer1, Sylvie Froger1, Jacqueline Grassin1
1Pharmacy, University Hospital of Tours, Tours, France
Background and Objective: The French law forecasts to reimburse the most expensive
cytotoxic drugs to the real quantity administered to the patient. So to set up a secured
procedure to use remainders of cytotoxic drugs in a centralized cytotoxic preparation
unit in order to conform to the French law.
Design: Prospective study.
Setting: Clinic unit of oncologic pharmacy.
Main Outcome Measures: This procedure was tested during ten weeks and had concerned
the three most expensive cytotoxic drugs used in digestive cancers. Generated remaining
quantities are conditioned inside isolator in radio-sterilized bags, and identified
with the number of register of prescriptions, the drug’s name, the remaining quantity,
the conservation’ conditions, the opening date, the duration of physico-chemical stability
according to the data of the literature. Bags are joined when they are gone out of
the isolator. A theoretical differential is daily established between the doses which
are prepared with or without management of remainders.
Results: The management of remainders involves that a rigorous manipulation during
the conditioning and a daily management of the out-of-dates. The average of realized
savings 800 € a week, that represents 41,600 € extrapolated to one year and a decrease
of 7.5% of expenses for these three drugs.
Our software of the preparations of drugs is adapted for the use of the remainders.
But the invoice-software allows only one invoice for one flask, which involves with
the management of the remainders an unequal invoicing system for the patients
Conclusions: The management of remainders generates a real financial profit. But the
really administered quantity cannot be imputed to the patient because the software
of inventory control and invoicing does not manage the fraction of flasks. Nevertheless,
according to the French law we must express under fractional shape the quantities
of cytotoxics, which are administered by stay to the patients for the most expensive
drugs.
Reference
Ordinance n°2005–1023 of August 24th 2005
Keywords: Expensive cytotoxic drugs, Savings, Remainders
PEC-232 Measuring the activities of a clinical pharmacist on sequential treatment
on the emergency department
Sabrina De Winter1, Sandrina von Winckelmann1, Isabel Spriet1, Daniel Knockaert2,
Ludo Willems
1
1Pharmacy Dpt, 2Emergency Dpt, University Hospital Leuven, Gasthuisberg, Leuven, Belgium
Background and Objective: Since July 2006, financing of drugs in Belgian hospitals
is based on a lump-sump system. This decision favours efforts leading to more rational
use of medication like for example the sequential treatment. Efforts like posters,
recommendation letters and information rounds were part of the strategy. Since 01–11–2007
a clinical pharmacist puts also attention on this subject by contacting physicians
and nurses regarding individual drug therapies. Documenting the results of interventions
suggested by a clinical pharmacist is often quite difficult. The number of DDD of
intravenous administered drug versus the total amount of DDD [oral + IV] of the particular
drug administered has been described. This parameter can be disturbed by the use of
the oral form over a long period of time or by the early discharge of patients combined
with a continuation of the therapy at home. To follow up the sequential treatment
on the emergency department, this parameter seems to be accurate by the fact that
the stay of the patient here is between 1 and 2 days.
Design: A clinical pharmacist attends daily patient rounds and gives advice to physicians
and nurses about the route of administration of drugs. Retrospective evaluation of
the administration of levofloxacin and paracetamol to patients at the emergency department
between January 2006 and May 2007.
Setting: Emergency department, University Hospital, Leuven, Belgium
Main Outcome Measures: DDD-IV versus DDD total of levofloxacin and paracetamol over
time.
Savings by orally administered paracetamol and levofloxacin were calculated.
Results: The start of the activities of the clinical pharmacist is well documented
with the described method showing a drop of DDD IV/DDD total. The average of DDD IV/DDD
total of paracetamol respectively levofloxacin between January 2006 and June 2006
is 91% and 85% which is decreased to 87% and 79% between July 2006 and December 2006
and further dropped to 84% and 62% between January 2007 and June 2007.
Cost savings by sequential treatment of paracetamol and levofloxacin were 1274 euro
and 2025 euro, calculated from the start of the activities the clinical pharmacist
(for 8 months).
Old habits are difficult to change among them the administration of drugs by intravenous
route. Almost every medical and surgical patient admitted to the emergency department
receives an intravenous line, so the threshold for intravenous administration is low.
Furthermore a wide variety in patients’ medical conditions added to a rapidly changing
timetable for technical examinations and surgery necessitates an individual approach
of the most suitable route of drug administration. Official letters and posters may
be useful. However this report confirms the importance of a clinical pharmacists’
permanent presence on the ward for maintaining awareness of sequential treatment.
Conclusions: The number of IV-DDD’s versus the number of total-DDD’s of a particular
drug enables the documentation of sequential treatment by a clinical pharmacist on
the emergency department.
Keywords: Sequential treatment, Paracetamol, Levofloxacin
PEC-235 Analysis and economic impact of utilization of medicinal product for compassionate
use
Carolina Apezteguia-Fernández
1, Maria del Pilar Vicente-Sanchez1, Nuria Ibañez-Heras1, Marta Arteta-Jimenez1
1Pharmacy, Hospital Universitario de Getafe, Getafe, Spain
Background and Objective: To analize utilization of drugs for compassionate use and
economic impact in a 600 bed hospital with an attended population of 319,000 inhabitants.
Design: Retrospective study of applications of drugs for compassionate use during
2006.
Setting: Hospital Universitario de Getafe.
Main Outcome Measures: From each application following data were collected: medicinal
product arranged as compassionate use, clinical unit which requested the application,
indication and price.
Results: 303 applications for compassionate use treatment were processed (0.95 processings/1000
inhabitants). The higher number of applications has corresponded to Gynecology Unit,
154 processings of misoprostol to use in delayed curettage. Secondly, botulinum toxin
was processed in 81 cases, 96.3% of them corresponding to Anaesthesic and Reanimation
Unit for miofascial pain. Active substance that has caused a higher impact on the
hospital′s budget was inhalated tobramicin, processed for a total of 5 patients with
bronchiectasias colonized by Pseudomonas aeruginosa. The expenses for this indication
has added up to 35,000 € during 2006.
Secondly, as regards to economic impact we found botulinum toxin which raised up to
26,300 €, expenses that were attributed in 95% to Anaesthesic and Reanimation Unit.
The highest cost/treatment by patient during 2006 corresponded to inhalated tobramicin
that has increased up to 14,000 €, followed by infliximab approved for hydrosadenitis
treatment which accounted for 11,000 €. Total cost of treatments for compassionate
use has involved approximately 0.7% of total consumption for drugs during 2006.
Conclusions: The higher number of processings in 2006 corresponds to misoprostol requested
by Gynecology Unit although its economic impact on the consumption of medicinal products
for compassionate use is very low.
Inhalated tobramicin utilization for colonized bronchiectasias involves the highest
global cost and the highest cost/treatment on total medicinal products for compassionate
use.
The percentage accounted for medicinal products for compassionate use on total consumption
of medicinal products is low. It would be interesting to perform a multicenter study
in order to value economic impact in last years of medicinal products for compassionate
use.
PEC-288 The vacuum-assisted closure (VAC) therapy: a 17-months medico-economic retrospective
study
Stéphanie Roche
1, Nathalie Herment2, Sandrine Havet2, Amélie Pruvost2, Willemin Jean-Claude2, Frances
Carole2
1PHARMACIE, Reims teaching hospital, Reims, France, 2PHARMACIE, Reims teaching hospital,
Reims
Background and Objective: In the management of wounds care, spectacular results have
been achieved through the application of negative pressure wound therapy. This approach
known as Vacuum-Assisted Closure (VAC) involves the use of a defined controlled negative
pressure (delivered by an ambulatory motor) over a polyurethane or polyvinyl sponge
(which are considered as consumables) placed in the wound. In our hospital, this therapy
was first introduced for acute traumatic wounds. In June 2005, the interdisciplinary
wound and cicatrisation group decided to extend indications to chronic wounds. To
improve management regarding this larger and complex use through all units, a specific
prescription form associated with recommendations was set up. This document is available
as well as paper or electronic form.
The purpose of this study was to evaluate conditions of use and global costs of VAC
therapy.
Design: A 17-months retrospective study was based on the analysis of nominative prescriptions
of VAC consumables (canisters with gel, small, medium or large foam dressing kits
and Y connectors). All patients treated with VAC therapy from June 2005 to October
2006 were included.
Setting: care units.
Main Outcome Measures: Demographic data, indications, type of consumables, hospitalisation
units.
Results: Among the 89 patients (49 male, 40 female; mean age 58.2 ± 19.8 years), 21
(23.6%) were treated for acute wounds, 27 (30.4%) for subacute wounds, 32 (36.0%)
for chronic wounds and 9 (10%) for others indications. We identified 4 mainly users
departments: Departments of Traumatology (22 patients), Vascular Surgery (22 patients),
Dermatology (20 patients) and Digestive Surgery (13 patients). The average treatment
duration was 23.6 days [3–60]. The cost of consumables was estimated to 28.8 euros
per day per patient. Total cost over the study period amounted to 171366 euros, including
the hiring of the VAC system (52.73 euros per day). These data indicate that the use
seems to be appropriate and optimized without overuse.
Conclusions: Facing the high cost of this technical therapy, its use must be closely
managed. This study suggests that the multidisciplinary collaboration in our hospital
between medical staff and pharmacist unit contributes to guarantee the optimal use
of this specific therapy.
Keywords: VAC therapy, Wound, Cost
PEPI-48 Epidemiology of adverse drug reactions in an intensive care unit
Canadell Laura1, Pardo Rocio
1, Gilabert M Carmen2, Ruiz M Angeles3, Alonso Santiago2, Pérez Enrique4, Gallart
M Jesus1, Rello Jordi2
1Pharmacy service, 2Intensive Care Unit, 3Internal Medicine, 4Database service, Hospital
Universitari Joan XXIII, Tarragona, Spain
Background and Objective: To evaluate the prevalence and characteristics of adverse
drug reactions (ADRs) in an Intensive Care Unite (ICU) from January to May 2007.
To analyze the effectiveness of an educational programme to increase the ADRs reports
during this period.
Design: Clinically relevant events possibly caused by exposure to drugs have been
analysed in a retrospective study for a period of five months. We analysed the prevalence
of ADRs reported, the medical conditions of the patients, the relationship between
ADR and the suspected drug using Karch–Lasagne algorithm and the severity of the reaction
using WHO criteria.
During this period, we implemented a pharmacovigilance programme in order to increase
the reports and to estimate the prevalence of ADR in this unit.
Setting: Pharmacy service and Critical care service of a general hospital
Main Outcome Measures: To evaluate prevalence, characteristics, nature and severity
of ADRs in UCI.
To measure the effectiveness of an educational programme to improve the awareness
and detection of ADRs.
Results: A total of 243 patients were hospitalized during this period, 24 ADRs were
detected (9.9%).
Severe sepsis and cardiac arrest were the most frequent diagnosis in this group of
patients. 66.6% males and 33.3% females, 65.1 years in average.
Dermatologic effects as urticaria rashes and haematological effects as pancytopenia
were the most frequently noted, with more than 20% each. Therapies most often associated
with the reported events were antibiotics (piperacillin/tazobactam, ertapenem, azitromicin)
in 41.7% of cases and nitroglycerin in 8.3% of them.
The ADR reported were classified as low severity in 29.2% of cases, medium in 45.8%
and high severity in 25% of them. Level of causality more frequent was “probable”
in a 62.5% of the reports followed by “possible” in 37.5% of them.
Since the implementation of the educational programme the number of reports of ADR
have increased from 3.2% to 13.7%. The high level severity of ADRs reported has increased
in this period from 0% to 41%.
Conclusions: Communication and educational programmes should be implemented to promote
detection, identification, reporting and evaluation of ADRs. The analysis to determine
the probability, causality and severity of ADR is necessary to establish the measures
needed to improve the security and the quality of health attention.
Keywords: Adverse drug reaction, Intensive care unit
PEPI-122 The incidence of dry cough in angiotensin-converting enzyme inhibitor users
Mustafa Ozyalcin1, Mesut Sancar
1, Fikret Vehbi Izzettin1
1Clinical Pharmacy Department, Marmara Univ. Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: ACE inhibitors are used for controlling blood pressure,
treating heart failure and preventing kidney damage in people with hypertension or
diabetes. Although ACE inhibitors are generally well-tolerated by the most individuals,
they are not free of side effects. Dry cough is one of the most common side effects
seen in patients during ACE inhibor therapy. In this study, we have evaluated the
incidence of dry cough that appears during the ACE inhibitors therapy and relationships
with the other coughing factors and the other side effects that may appear.
Design: The questionnaire was applied on 304 ambulatory patients (144 m/160 f) who
have used or been using ACE inhibitors and 100 hypertension patients as control group
who use also anti-hypertensive drugs except ACE inhibitors.
Setting: The study was conducted in 25 different pharmacies located in The West Blacksea
Region of Turkey between June 2006 and May 2007.
Main Outcome Measures: The demographic characteristics and the chronic problems of
the patients on ACE inhibitors, the side effects of ACE inhibitors, and the reactions
against the dry cough were determined by pharmacist’s questionnaire on the patients
who come to the community pharmacy.
Results: Dry cough was observed on the 65 patients out of 304, during their using
of ACE inhibitors (21%). 24% of male patients and 19% of female patients were having
a cough. The 5 patients out of 100 (5%) from control group were having a cough. The
incidence of dry cough that appears on the patients who use ACE inhibitors were; silazopril
28%, ramipril 26%, lisinopril 21%, fosinopril 17%, qinapril 14%, perindopril 13%,
enalapril 11% and trandolapril 10%. The treatments of 32 patients out of 65 who complain
from coughing during the therapy of ACE inhibitors were changed with angiotensin receptor
antagonists and calcium antagonists by their physician. Treatment changes were resulted
in increasing in the cost by 382.08 YTL monthly if it was calculated on the base of
generics.
Conclusions: As a conclusion, the incidence of dry cough from ACE inhibitors was found
to be 21% in The Blacksea Region of Turkey. The pharmacist can play an important role
in determining side effects such as dry cough and refer the these patients to physician.
Patient counselling and drug therapy monitoring in the community pharmacies will increase
the compliance and provide better outcomes in many chronic diseases.
Keywords: ACE inhibitors, Dry cough, Side effects, Community pharmacy
PEPI-138 Evaluation of pain and analgesic usage in Turkish population
Filiz Cevik
1, Sibel Cýrak2, Philip M. Clark2
1Clinical Pharmacy, Yeditepe University, School of Pharmacy, 2Clinical Pharmacy, Yeditepe
University, School of Pharmacy, Istanbul, Turkey
Background and Objective: To evaluate analgesic drugs usage in community, the assessment
of pain and the role of pharmacists for people while taking drugs
Design: Litarature review and consultation with Anesthesia & Algology departments
in faculty of medicine in Istanbul (Çapa and Cerrahpaşa) and Marmara Universities
in order to create a valid questionnaire. The questionnaire consisted of 15 questions
derived from these sources. Two months randomised study.
Setting: Community in İstanbul
Main Outcome Measures: Visual Analouge Scale (VAS) was used for assessment of pain.
The universe of the study consisted of randomly selected 210 women and 190 men (n = 400).
A pilot study was run on 15 individuals from different occupation groups to determine
the validity and intelligibility of the questionnaire.
Results: The data were analyzed using a SPSS 10.0 program. The level of significance
was accepted as p < 0.05. The results show that women experience more intense pain
than men; their mean VAS score is higher than men (6 vs 4). Headache is the most common
type of pain (41.5%) and also its VAS scores reached the highest level (9–10). This
pain is especially caused by migraine and hypertension. In addition, 56% of questionees
prefer to take an analgesic drug in order to manage their pain problem. It was recorded
that especially Non-steroidal Antiinflammatory Drugs (NSAIDs) and preparations containing
paracetamol are the first choice in pain management. Most respondees took analgesics
when pain begun (37.5%), when pain increased (39.5%) or when was intolerable (20.5%).
Conclusions: The majority of those who participated in the study took their analgesic
medication without consulting a health professional. This indicates a high level of
self medication in our population. This gives rise to a number of potential drug problems
such as NSAIDs usage in gastrointestinal disorders, hypertension and renal failure.
Although many participants used their drugs in a rondom and improper way, unfortunately
the pharmacist was rated second to last as a drug consultant.
References
Carlsson, Anna Maria: Assessment of chronic pain. I. Aspects of the reability and
Validity of the Visual Analogue Scale: Pain, 1983;16:87–101
Keywords: Pain, Analgesic, VAS score, Pharmacist
PEPI-164 The role of community pharmacist on oral and dental health: prevention of
diseases and toothache management
Sabriye Tunc1, Mesut Sancar1, Pelin Sarica
1, Fikret Vehbi Izzettin1
1Clinical Pharmacy Department, Marmara Univ. Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Many patients visit the pharmacy for their oral problems
like toothache and ask for appropriate pain relievers. The purpose of this study is
to examine the attitude and role of pharmacists, dentists and non-health workers towards
solving of dental and oral health (like management of toothache).
Design: 3 different questionnaires were applied randomly on 30 pharmacists, 30 dentists
and 30 non-health workers.
Setting: Canakkale – Turkey.
Main Outcome Measures: Dentists’ and pharmacists’ approach to patients with toothache,
drug usage evaluation in dental problems, the type of information given by pharmacists,
patient behaviors.
Results: 30% of non-health workers (n = 30) indicated that if they complain about
toothache they choose their pharmacist as their consultant. 50% of non-health workers
(n = 30) indicated that they use various medications without consulting a dentist
(44% naproxen sodium, 21% paracetamol, 7% methimazole, 7% flurbiprofen, 7% amoxicillin,
7% carnation essence). The most common suggested antibiotics was amoxicillin (66%)
by pharmacists and amoxicillin-clavulanate (21%) by dentists. The most common suggested
pain relievers were naproxen sodium by both pharmacists (59%) and dentists (36%).
Only 28% of dentists declared that they consult with a pharmacist about drug usage.
41% of dentists indicated the importance of consultation of patients by pharmacists.
Conclusions: According to our results; pharmacists must take an important role in
prevention and management of oral and dental health problems including informing the
patients about convenient drug usage. Also collaboration between dental staff and
pharmacists need to be improved.
Keywords: Oral health, Toothache, Pharmacist, Drug usage
PEPI-165 Cardiovascular drugs: prescription profiles and the economic impact of a
generic-based reimbursement system
Nuha B. Cinemre-Solmaz1, Kutlay Burat1, Sule Apikoglu Rabus
2
1Biochemistry Department, Ankara University Faculty of Pharmacy, Ankara, 2Clinical
Pharmacy Department, Marmara University Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Cardiovascular drugs are among the most frequently prescribed
drugs and account for a high percentage of medical expenditure. The aim of this study
is to assess the prescription profiles and the economic impact of a generic-based
reimburesement system for the cardiovascular drugs.
Design: The study was performed in three community pharmacies, each from a different
district of Ankara (the capital of Turkey). Each district represented a different
socio-economic level expressed as “low; middle and high” socioeconomic levels. The
study used 100 consecutive prescriptions collected from each pharmacy during the spring
season. Percentage of cardiovascular prescriptions (prescriptions containing at least
one cardiovascular drug item) and number of cardiovascular drug items calculated for
each pharmacy.
Setting: Three community pharmacies.
Main Outcome Measures: The percentage of cardiovascular prescriptions and number of
cardiovascular drug items for each pharmacy. Monetary savings that would have been
achieved if the generic drug with the lowest-price had been substituted for each cardiovascular
drug item in the cardiovascular prescriptions was calculated.
Results: The percentage of cardiovascular prescriptions and number of cardiovascular
drug items calculated for each pharmacy were as follows: 8% (26 items) in the low;
7% (35 items) in the middle; and 17% (60 items) in the high socioeconomic levels.
Monetary savings if a generic-based reimbursement system had been used was calculated
as 269.99 YTL -new Turkish liras- (€ 145). This amount was equal to the total cost
of an average of 4 cardiovascular prescriptions. In this study 4 cardiovascular prescriptions
could be supplied by the money saved when a generic-based reimbursement system was
applied to 65 cardiovascular prescriptions.
Conclusions: In the developing countries generic-based reimbursement systems can help
optimizing medication related health-care expenditures, especially in chronic conditions
like cardiovascular diseases.
PEPI-198 Folic acid awareness and intake survey in the Iran
Simin Mashayekhi
1, Maryam Dilmaghanizadeh2, Zahra Fardi-azar3, Roghayeh Bamdad-Moghadam4
1Pharmaceutics Department, Tabriz Medical University, 2Pharmaceutics Department, Tabriz
Medical university, 3Faculty of Medicine, Tabriz Medical University, 4Private, Private,
Tabriz, Iran (Islamic Republic of)
Background and Objective: In 1965 Hibbard and Smithells suggested a link between inadequate
maternal intake of folic acid and neural tube defects in their offspring (1). Consequently,
it has been recommended that all women planning to become pregnant should consume
additional folic acid before conception and during the first 12 weeks of pregnancy.
Despite these recommendations, periconceptional intake of additional folic acid is
still low in many developed countries and a substantial percentage of women are not
aware of its benefits (2).
Design: A questionnaire was used in a face-to-face encounter.
Setting: Postnatal wards of a teaching and a private hospital in Iran.
Main Outcome Measures: Awareness of the effects of folic acid on the fetus was evaluated
among 400 women.
The questionnaire included questions about demographic information, folic acid supplementation
before and during pregnancy, its effects and the most susceptible periods in pregnancy
and the source of information regarding the drug’s effects during pregnancy.
Results: The mean age of women was 26.4 (± 5.2) years old. The majority of the subjects
had more than high-school education (53% vs.47%).
Out of 400 subjects, 359 (89.8%) took folic acid supplement before and during pregnancy.
Only 2.5% believed that its usage was unnecessary, 81.5% believed in its positive
effects. In the subjects’ opinion, the most important time for taking this supplement
was the first trimester (32.5%), then prior to pregnancy (19.5%). The second and third
trimester were noted important by 4.0%. 7.8% believed in the importance of this supplement
during all nine months.
The advisor for taking this supplement was doctors (74.4%), health visitor (23.3%),
self-medication (2.7%), TV and Radio (1.8%), family members and friends (1.8%) and
pharmacist (0%).
Conclusions: Awareness of the value of periconceptional folic acid was high among
women of Iranian nationality compare to similar studies (3). The majority of the participants
believed in the positive effects of folic acid. The advices provided by doctors and
pharmacists had the greatest and least effect on the use of this medication. Regarding
the best time of usage of this supplement, the most emphasis was on the first trimester
and next on prior to pregnancy.
References
Hibbard E.D. and S. R.W., Folic acid metabolism and human embryopathy. Lancet, 1965.
1: p. 1254–6.
Gisondi, P., et al., Folic acid in general medicine and dermatology. J Dermatolog
Treat, 2007. 18(3): p. 138–46.
Abdulrazzaq, Y.M., et al., Folic acid awareness and intake survey in the United Arab
Emirates. Reprod Toxicol, 2003. 17(2): p. 171–6.
Keywords: Pregnancy, Folic acid, Neural tube defects
PEPI-199 Pre-diabetes screening program: a proactive study in istanbul community pharmacies
Asuman Cakiroglu
1, Ayse Koroglu2, Zehra Almila-Oztosun3, Ayse Dundar4, Alper Okyar5, F. Ilkay Alp5,
Gul Baktir5
1 Yonca Pharmacy, 2 Rifat Sargin Pharmacy, 3 Capitol Pharmacy, 4 Pelikan Pharmacy,
5Pharmacology, Istanbul University Faculty of Pharmacy, Istanbul, Turkey
Background and Objective: Diabetes mellitus type-II is a metabolic disorder that is
primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia.
Before type II diabetes stage, people almost always have “pre-diabetes”; in which
blood glucose levels are higher than normal but not yet high enough to be diagnosed
as diabetes. While some people with type-II diabetes have symptoms, the majority may
go 7–10 years without apparent symptoms. Because some of the symptoms for diabetes
mimic other diseases or conditions, makes it harder to predict an precise diagnosis
without any additional information. The purpose of this study is early diagnosis of
pre-diabetes, prevention or delay of the complications with a collaboration of community
pharmacists and patients.
Design: Pharmacists used a structured questionnaire containing questions concerning
demographic data and informations which indicate prediabetes symptoms.
Setting: Four community pharmacies in Istanbul.
Main Outcome Measures: Data: age, gender, body mass index (BMI), genetic predisposition,
blood pressure, pysical activity and hypoglycemia symptoms.
Results: One hundred people were screened for undiagnosed diabetes. and the risk for
pre-diabetes is evaluated according fasting plasma glucose (FPG) and total oral glucose
tolerance (OGTT) test results. Blood glucose level between 100 and 125 mg/dl with
the FPG test and 140 and 199 mg/dl with OGTT test are considered as pre-diabetes.
Conclusions: Diagnosis of pre-diabetes can prevent the development of type II diabetes
and making changes in nutrition and increasing the level physical activity may even
be able to return the elevated blood glucose levels to the normal levels.
References
Irons BK, Mazzolini TA, Greene RS. Pharmacotherapy 2004, 24(3):362–71.
www.diabetes.org
Keywords: Type-II diabetes, Prediabetes, Pharmacy based study
PEPI-207 Awareness among pregnant women of the effects of drugs on the fetus and mother
Maryam Dilmaghanizadeh
1, Simin Mashayekhi1, Masoud Naghizadeh2, Zahra FardiAzar2, Roghaiieh Bamdad Moghaddam2
1Pharmaceutics Department, 2The faculty of Medicine, Tabriz university of medical
sciences, Tabriz, Iran (Islamic Republic of)
Background and Objective: Since the talidomide catastrophy [1] concern about the safety
of drugs in pregnancy has been increasingly evident. Studies have revealed that pregnant
women continue to take considerable quantities of drugs. However, all pregnant women
worry about whether to take any medications. Because of an estimated 10% of birth
defects resulted from maternal drug exposure [2], this fear is well justified.
Little is known about the knowledge of pregnant women regarding the safety of medications
during pregnancy. To our knowledge the present study is the first performed in Iran.
Design: A questionnaire was used in a face-to-face encounter.
Setting: Postnatal wards of a teaching and a private hospital in Iran.
Main Outcome Measures: Awareness of the safety of drug use during pregnancy among
400 women. The questionnaire included questions about demographic information, drugs
use before and during pregnancy, information regarding the safety of drugs during
pregnancy and the most susceptible periods in pregnancy, the source of information
regarding drugs’ safety during pregnancy.
Results: The mean age of women was 26.4 years old. Only an 18.85% and 22.25% used
conventional medications and herbal remedies during pregnancy, respectively. A great
percentages (87.5%) believed in harmfulness of drugs during pregnancy, but only a
38.3% believed in harmfulness of herbal remedies. The first trimester and the second
trimester were believed to be the most and the least susceptible period, respectively
(60.8% vs. 3.0%).
The sources of information for the subjects regarding the safety of medications was
specialist doctors (53.8%), general practitioner (9.3%), pharmacist (5.8%), midwives
(1.3%), health center (17.5%), media and books (9.5%) and friends and family member
(1%).
Discussion: A common concern about the care of pregnant women involves the medications,
which led us to establish a special initiative to review available knowledge among
our general population. The present study highlights weakness of the role the pharmacists
play in providing the information to this vulnerable and eligible group of people,
who nourishing our next generation.
Conclusions: A common concern about the care of pregnant women involves the medications,
which led us to establish a special initiative to review available knowledge among
our general population. The present study highlights weakness of the role the pharmacists
play in providing the information to this vulnerable and eligible group of people,
who nourishing our next generation.
References
Benegbi M, 45 years later…where do we stand? Can J Clin Pharmacol, 2007. 14(1): p.
e37–9.
Black RA and H. DA., Over-the-counter medications in pregnancy. Am Fam Physician,
2003. 67(12): p. 2517–24.
Keywords: Pregnancy, Drugs, Fetus, Mother, Awareness, Herbal
PEPI-210 Pediatric drug intoxications and the experiences of hacettepe drug and poison
information center
Ayce Celiker1, Nergiz Nemutlu1, Gulru Ozkaya
1
1Hacettepe Drug and Poison Information Center, Hacettepe University, Ankara, Turkey
Background and Objective: Poisoning casualties require be approached with utmost attention
due to their “medico-social emergency” nature. Children are more vulnerable because
of their inherent interests for knowing the environment besides ignorance and carelessness
of adults. Drugs are among the leading offending agents in children poisonings.
The services of drug and/or poison information centers have been regarded as one of
the main challenge areas of clinical pharmacy practice. Being a pioneer in Turkey,
Hacettepe Drug and Poison Information Center (HIZBIM), has been run for 15 years in
working hours basis.
Objective: The objective is to evaluate the demographic and epidemiological characteristics
of drug poisonings in children, thus, to contribute to clarify the actual “intoxication
profile” and identify necessary measures for the children in Turkey.
Design: The data of childhood (aged < 17 years) poisoning enquiries received by HIZBIM
between January 1, 1996 and December 31, 2005 were collected retrospectively and analyzed
with SPSS 11.5®
Setting: HIZBIM is affiliated to Hacettepe University, Faculty of Pharmacy
Main Outcome Measures: Categorization and comparison of data of children intoxicated
with drugs during ten years
Results: Children were involved in 54% of all poisoning cases and 63% of those cases
were due to drugs. There was no gender difference among very young children, however,
girls dominated as the age increases (p < 0.05). 88% of the cases were accidental,
and analgesics were involved in 40% of the accidental poisonings (p < 0.05). While
the most offending agent group was analgesics in children younger than 12 years (p < 0.05),
multiple drug ingestions were the main causes of the cases involved older children
(p < 0.05). Multiple drugs were mostly encountered (63%) in suicidal attempts where
the dominant gender was girls (75%) (p < 0.05). The most frequently reported symptoms
indicated central nervous system involvement almost in all intoxication cases and
in all age groups.
Conclusions: Pediatric poisonings are rather high in Turkey like many other countries
and drugs are accounted for mostly in those injuries whether accidental or suicidal
exposures. Some regulations, the attitudes of physicians, pharmacists, and parents
and other care givers make contributions to that outcome.
In the prevention of childhood drug intoxications it is essential to make cooperation
between drug manufacturers, regulatory authorities, health professionals, and families,
besides increasing social awareness.
Drug and/or poison information centers stimulate rational drug use through providing
accurate and rapid information to health care providers, educating people directly,
documenting current epidemiological data.
Keywords: Poison information center, Childhood poisoning, Drug poisoning, Drug intoxication
PEPI-226 Analysis of clinical trials in Montpellier teaching hospital: what’s new
in biomedical research?
Marlene Ester
1, Laetitia Guillon1, Pierre-Jean Aragon1, Sylvie Hansel-Esteller1
1Pharmacy, Lapeyronie-Arnaud de Villeneuve Teaching Hospital, Montpellier, France
Background and Objective: 130 clinical trials are managed by Lapeyronie-Arnaud de
Villeneuve pharmacy in Montpellier. Recently, we noticed a great interest of pharmaceutical
companies in drugs such as monoclonal antibodies or in diseases such as inflammatory
rheumatism. The aim of this study is to put in evidence the orientations of biomedical
research. We particularly analysed the pathologies concerned, the type and the target
of the experimental drugs, and the aim of the biomedical researches.
Design: Analysis of the protocols and of the investigator’s brochures of the ongoing
clinical trials in January 2007.
Setting: Clinical trials sector of Lapeyronie-Arnaud de Villeneuve hospital, Montpellier.
Main Outcome Measures: Methodological aspects were first analysed: aim of the study,
phase, type of sponsor, type of binding, inclusion rate.
Then, we focused on the experimental drugs involved: type of drug, target, therapeutic
area concerned.
Results: 84% of clinical trials are promoted by pharmaceutical companies. 68% are
phase 3 trials, 56% are open-label trials. 5 objectives can be found: testing a new
molecule on a new target (17%), testing a new molecule in an known pharmacological
group (19%), testing a new formulation (7%), testing an known molecule in a new indication
(24%), evaluating a therapeutic strategy (33%).
20% concern rheumatology, 20% pneumology, 11% infectiology, 8% haematology, and 8%
nephrology. The most frequent pathologies concerned are inflamatory rheumatism (23%),
malignancies (17%), asthma/COBP (10%), HIV infection (11%), and post renal transplantation
immunosuppression (6%). The percentage of patients included (Number of patients in
the trials concerned/Total number of included patients) and the inclusion rate (Real
number of inclusions/Number of expected inclusions)are respectively 16% and 126% in
rheumatology, 32% and 174% in pneumology, 10% and 48% in haematology, 9% and 80% in
infectiology and 19% and 113% in nephrology.
50% of experimental drugs are injectable. 54% are little molecules obtained by chemical
synthesis, and 46% are issued from biotechnologies: monoclonal antibodies (34%), peptide
(10%), and gene therapy (2%). The new targets (17% of clinical trials) are receptors
(57%), enzymes (29%), gene transcription (9%), cytokines (5%).
Conclusions: This analysis gives an idea of the future commercialized drugs. It puts
in evidence the development of drugs in therapeutic areas which concern a lot of patients
and whose financial rentability is high. Furthermore, only 17% of clinical trials
concern new drugs and new targets. Development of me-too and optimization of therapeutic
strategies are the most frequent clinical trials.
PEPI-242 Assessment of drug utilization profiles, attitudes and knowledge on “performance
enhancing drugs” among players of the amateur football league
Banu Ayca
1, Sule Apikoglu Rabus2
1Department of Sports and Health Sciences, Marmara University, School of Physical
Education and Sports, 2Clinical Pharmacy Department, Marmara University Faculty of
Pharmacy, Istanbul, Turkey
Background and Objective: The increasing use of performance-enhancing substances and
methods in sport threatens not only the meaning and the ethical value of the sport
itself, but also the health of the athletes. This study aims to assess the drug utilization
profiles of the amateur football players, as well as their attitudes and knowledge
on “performance enhancing drugs”.
Design: This study was conducted on 62 male players of the amateur football league.
The players were asked to fill in a standard questionnaire, where information about
their drug utilization profiles as well as their attitudes and knowledge on “performance
enhancing drugs” were sought through various questions.
Setting: Various amateur football clubs in Turkey.
Main Outcome Measures: Drug consumption rates of the players. Answers to the pre-prepared
questions.
Results: The age of the players ranged between 16 and 30 years. Forty-four (71%) players
thought that drugs have a positive impact on sports performance; while 29% did not
share this idea. The resource of this idea was a team-member for 45.2%, the trainer
for 25.8%, sports magazines for 25.8% and a family-member for 3.2%.
The players were asked to name the drugs that could be used for performance enhancement
and 80.6% replied as vitamins, while 51.6% replied as central nervous system (CNS)
stimulants and 25.8% replied as anabolic steroids.
Thirty-six players (58.1%) reported that they use various drugs with the aim of performance
enhancement. The drug utilization profile was as follows: vitamins were consumed by
54.8% of the players; where CNS stimulants, anabolic steroids, diuretics and growth
hormone were consumed by 48.4%, 16.1%, 12.9% and 6.5% of the players, respectively.
The players reported the reasons referring them to drug-use as follows: 1. Drugs always
have a positive impact on sports performance (83.3% of the drug-users); 2. Drugs are
necessary in case of inadequate training (33.3% of the drug-users); 3. Performance
enhancement leads to individual success in the team and this brings prices and rewards
in return (11.1% of the drug-users).
About 40% of the players thought that CNS stimulants have the main effects of increasing
the heart rate, endurance and strength. The main potential adverse effects of the
CNS stimulants were reported as gastrointestinal problems, dependency and tachycardia.
About 40% of the players thought that anabolic steroids increase muscle volume, endurance
and strength. The main potential adverse effects of the anabolic steroids were reported
as hypertension, hepatotoxicity and dependency.
Conclusions: The results of the questionnaire suggests that drug-use with the aim
of performance-enhancement was common among the amateur football players; and the
players were not adequately and properly informed on the effects and adverse effects
of the (so called performance-enhancing) drugs. This reality yields new responsibilities
in this challenging area of practice, for the clinical pharmacist.
PEPI-243 How prevalent are opioid misuse and affective disorders in patients with
fibromyalgia?
Sam Salek
1, Rosalind E. Lewis-Smith1, Timothy J. Ives2, Kristen M. Rake2
1Centre for Socioeconomic Research Welsh School of Pharmacy, Cardiff University, Cardiff,
United Kingdom, 2School of Pharmacy, University of North Carolina, Chapel Hill, United
States
Background and Objective: Psychiatric disorders and opiate misuse are associated with
chronic pain syndromes, but their incidence in fibromyalgia (FMS) is unknown. The
aim of this study was to identify if the incidence of affective disorders, and opioid
misuse, was more common in patients with FMS than those with other forms of non-malignant
chronic pain.
Design: A prospective, cohort study was carried out involving 66 patients, who were
internally referred to a chronic pain management program. Subjects with a working
diagnosis of FMS were matched by age (mean = 53) and sex (82% female) and compared
to a control group of patients with alternative forms of non-malignant chronic pain.
Individuals were compared using urine toxicological screens, drug-related criminal
convictions, diagnoses of affective disorders, and responses to the following inventories:
Screener and Opioid Assessment for Patients in Pain, the Pain Disability Index, the
Personal Health Questionnaire and the Fibromyalgia Impact Questionnaire. Patients
also underwent a standardised physical examination using American College of Rheumatology
(ACR) guidelines to diagnose FMS.
Setting: This was a quantitative, hypothesis-testing cohort study, conducted in an
academic general internal medicine practice.
Main Outcome Measures: Diagnosis of fibromyalgia, clinician’s awareness of ACR guidelines,
pain intensity and impact of fibromyalgia on physical and psychosocial activity.
Results: Response rate was 67% (n = 44; mean age = 53, median = 52, age range = 35–80;
male = 8); the most common affective disorders were mood (42%) and anxiety disorders
(27%) and there was a correlation between them (rs = 0.45; p = 0.01). Mean incidence
of affective disorders was 2.3 (±1.4) in the FMS group and 2.0 (±1.5) in the control
group but the only significant difference (P < 0.05) between the two populations was
the mean number of tender points; FMS 5.8 (±4.6), control 3.1 (±2.1).
Conclusions: Three (14%) FMS patients fulfilled the diagnostic criteria revealing
that FMS is a commonly misdiagnosed pain syndrome and clinician awareness of ACR criteria
for FMS requires promotion.
Keywords: Opioid misuse, Fibromyalgia, Affective disorders
PEPI-246 Second-generation antipsychotics and metabolic syndrome
Magali Farines
1, Marie-Christine M. C. Alberto-Gondouin1
1Pharmacy, Saint Egreve Hospital, Saint Egreve, France
Background and Objective: The increase in the frequency of the metabolic syndrome
and its implication, in the development of ischemic cardiovascular disease and type
II diabetes mellitus, represent a real public health problem and of much interest
in the medical field.
Otherwise, the cardiovascular pathologies are twice more frequent among chronics psychotics
patients, for that reason we were interested in the prevention of these pathologys.
This phenomena have been accentuated with the arrival of second generation antipsychotic
drugs which were associated with weight gain, disorders of glycemia and lipidemia.
In the aim to elaborate recommendations, at first we proceeded to the assessment of
biological and clinical follow-up of the patients hospitalized in the Saint-Egreves
hospital.
Design: Literature review, 6 months prospective study.
Setting: We asked 2 doctors of each unit (13) to answer 5 questionaries corresponding
to 5 patient files. We worked out a general questionary to avoid revealing our objective.
Main Outcome Measures: Blood pressure, body weight, height, abdominal perimeter, glycemia,
total cholesterol, triglyceridemia, cholesterol’s fractions(HDL and LDL).
Results: Our results showed a good clinical follow-up but the frequency of biological
control was not sufficient. The blood pressure and weight were evaluated respectively
in 85 and 69% of the patients, the total cholesterol, glycemia and triglyceridemia
were in 40% of patients. On the other hand, cholesterol’s fractions (HDL and LDL)
were rarely evaluated. As for the abdominal perimeter, where the increase is predictive
of cardiovascular disease, is never measured.
Conclusions: It seems difficult to evaluate the risk of either cardiovascular disease
or metabolic syndrome of these patients or to determine if there is any possible relationship
between the nombre of cardiovascular risk factors and the apparition of this syndrome.
These findings imply to identify these high risk subjects and to define the optimal
preventive, or curative, management strategy of metabolic syndrome and this, through
simple measurements to realize in clinical practice.
References
American Diabetes Association, American Psychiatric Association, American Association
of Clinical Endocrinologists, North American Association for the study of obesity.
Consensus development conference on antipsychotic drugs and obesity and diabetes.
J clin Psychiatry 2004; 65 (2): 267–72.
Newcomer JM. Second-Generation (atypical) Antipsychotics and Metabolic Effects. A
comprehensive literature review. CNS Drugs 2005; 19 (suppl 1): 1–93.
Keywords: Metabolic syndrome, Second-generation antipsychotic, Biological and clinical
follow-up
PEPI-255 Companies submission strategies and regulatory approval times greatly influence
patient access to medicine
Sam Salek
1, Laura Morgan1, Neil McAuslane2, Kate Read2, Stuart Walker2
1Centre for Socioeconomic Research Welsh School of Pharmacy, Cardiff University, Cardiff,
2CMR Institute for Regulatory Science, Novellus Court, Epsom, United Kingdom
Background and Objective: Availability of a medicine in Western markets can be delayed
either due to differential submission strategies of companies or differences in review
process between countries. The aim of this study was to examine delays in patient
access to medicines for compounds approved by two or more authorities (US FDA, EU
EMEA, Australian TGA, Health Canada and SwissMedic), by characterising potential drivers
for new active substances (NAS) approved between 1997 and 2006, from both a company
and regulatory agency perspective.
Design: 310 NASs approved by FDA since 1997 were compared to NASs approved by the
other agencies. This data was analysed comparing the difference between submission
and approval dates and characterised by; type of approval route, company size, and
therapy area.
Setting: Data on NAS’s approved by the Authorities was collected from agencies and
from public domain sources.
Main Outcome Measures: The difference in patient access to new medicines in different
countries and factors influencing such differences.
Results: 170 NASs have been approved by FDA and one or more of the agencies studied.
The median time ranged between submissions to FDA and another authority from 20 days
at EMEA to 99 days at TGA. The difference between approval dates ranged from a median
of 230 days at EMEA to 331 at Health Canada. However these differ depending on company
size, therapy area and approval route.
Conclusions: Availability of a new medicine is a mixture of company submission strategies
and approval process, although therapeutic profile of submissions and company size
are also influencing factors. In Europe the main driver to patient access is review
timelines rather than delay in submission by companies.
Keywords: Review process, Patient access to medicines, FDA
PEPI-256 Quality of life assessment with a portuguese hypertension health status inventory
(hyper 27)
Esperança Silva
1, Margarida Caramona2, Barbara Oliveiros3, Emanuel Ponciano3
1Community Pharmacy, Farmacia Rocha, 2Pharmacology, Faculty of Pharmacy, 3Ibili, Faculty
of Medicine, Coimbra, Portugal
Background and Objective: Hypertension is one of the major factors for many chronic
diseases, playing an important role affecting the quality of life of many patients.
The aim of this work is to validate a quality of life in adult hypertensive patients
scale – Hypertension Health Status Inventory (Hyper).
Design: Patients over 18 years old and with a history of antihypertensive treatment
for at least 6 months were invited at the pharmacy to complete the 45 items version
of the original Hyper, the Beck Depression Inventory, 2nd edition (BDI-II) and the
Beck Anxiety Inventory (BAI) as well as a sociodemografic questionnaire. The scales
were self administered or filled by the pharmacist when necessary.
Setting: A sample of 1512 subjects was gathered in over 300 Portuguese Community Pharmacies
were involved in the study following the previously defined criteria.
Main Outcome Measures: Validity of the Hyper was evaluated using exploratory factor
analysis (principal axis factoring with varimax and promax rotation). Depressive and
anxiety symptoms being important components of quality of life, concurrent validity
was evaluated using BDI-II and BAI. Reliability was assessed using Cronbach′s alpha
and item remainder correlations.
Results: After factoring the 45 items of the Hyper, 27 items were retained using as
criteria salient loadings >.30. Further analysis were performed on 27 items of 1512
questionnaires showing a two factor structure labelled Emotion/Physical (15 items)
and Daily (12 items). Cronbach′s alpha for the subscales was .87 and .76 respectively.
Item remainder correlations for Emotional/Physical subscale have a maximum and a minimum
value of .71 and .30 respectively with a median value of .59. Values of .60, .27 and
.39 were found for the Daily subscale.
Concurrent validity: Correlations with BDI-II and BAI were −.68 and −.65.
No significant correlations between Emotion/Physical and Daily Hyper27 subscales and
blood pressure, duration of hypertension after diagnosis where found.
No significantly differences in mean values on Hyper 27 total and subscales scores
of controlled and uncontrolled blood pressure of hypertensive patients where found.
Conclusions: The final version of Hyper (27 items) has good construct and concurrent
validity as well as good internal consistency. In Portuguese language Hyper 27 seems
to be a promising scale in the evaluation of a chronic disease-related quality of
life, which is becoming an increasingly important goal for health professionals.
Keywords: Quality of life, Community pharmacy, Hypertension, Hyper 27
PEPI-264 Proton pomp inhibitor (PPI) prescription in a medicine unit of a university
hospital: indications and part of off-label use
Emmanuel Gasperi1, Philippe Mougenot
1, Bénédicte Giroux Le Prieur2, Paul Escure2, Axele Reberga1, Agnès Certain1, Thomas
Papo2, Philippe Arnaud1
1Pharmacy, 2Internal Medicine, Chu Bichat-Claude Bernard AP-HP, Paris, France
Background and Objective: The aim of this study was to analyse the indication of PPI
prescription during hospitalization to determinate the part of off-label use in a
department of internal medicine.
Design: All patients were consecutively hospitalized in February and March 2007 in
the department of internal medicine.
Setting: Department of internal medicine in a teaching Hospital.
Main Outcome Measures: Data on sex, age, origin of PPI prescription and indication
were collected by a standardized questionnaire and were retrospectively analysed.
Results: 76 men and 84 women were reviewed. The median age was 68 years (range, 20–99).
54% of patients received PPI therapy by pantoprazole (available in our hospital) when
hospitalized. 77% of patients received daily 40 mg of pantoprazole and 23% received
20 mg a day. 21% of the prescriptions were validated. The main off-label indications
were prevention of hemorrhagic risk of anti-platelet agent (23%), hemoglobin decrease(16%),
anticoagulant co-prescription(13%), steroids co-prescription(6%).
Conclusions: This prospective study confirms the large prescription of PPI therapy
in a department of internal medicine. Nevertheless, this study highlights the difficulties
to interrupt this well tolerated therapy after the first prescription by family physicians.
Clinical pharmacist interventions in the department consist of explaining the difference
of indications between pantoprazole 20 mg and pantoprazole 40 mg, he makes physicians
aware of prescribing PPI therapy with a cautious reweighted cost/benefit consideration.
Reference
Vidal 2007 Dictionary, Vidal Edition.
Keywords: PPI, Indication, Internal medicine
PEPI-266 Can systematic use of scorecards be of value in the evaluation of the quality
of industry submissions and their regulatory review?
Sam Salek
1, Andrea Mallia-Milanes1, Neil McAuslane2, Stuart Walker2
1Centre for Socioeconomic Research Welsh School of Pharmacy, Cardiff University, Cardiff,
2CMR Institute for Regulatory Science, Novellus Court, Epsom, United Kingdom
Background and Objective: To develop and validate a system for regulatory authorities
to provide feedback to companies on the quality of their submissions while companies
report to authorities on the quality of the review. A standardised report format will
allow performance comparisons within and across companies and agencies.
Design: Draft scorecards were tested in a study on the same four compounds, each reviewed
recently by the agencies in Australia, Canada and Switzerland. The agencies provided
feedback on the quality of submissions and sponsors, AstraZeneca, GSK, Novo Nordisk
and Pfizer gave views on the conduct of reviews.
Setting: Four pharmaceutical companies and three regulatory authorities (Europe, Australia
and Canada).
Main Outcome Measures: Development of scorecards for companies to evaluate the quality
of the regulatory review of their new compound and regulatory authorities to assess
quality of dossiers submitted by companies.
Results: The companies and agencies responded openly and without reserve to requests
for ratings and commentary on the quality of performance by the other parties. The
data gave insights into different perceptions of quality in relation to submitted
data, review procedures and the assessment of benefit-risk.
Conclusions: This study demonstrated the value, relevance and effectiveness of the
proposed scorecard framework for reviewing the quality of submissions and their assessment.
Agencies and companies all responded positively to the proposed extension to a wider
pilot study on current and future applications.
Keywords: Regulatory review, Scorecards, Regulatory authorities
PEPI-289 Lack of knowledge of ICS’ actions in patients who discontinued early with
inhaled corticosteroids
Tanja T Menckeberg
1, Marcel L. Bouvy1, Madelon Bracke1, Jacqueline G. Hugtenburg2, Jan-Willem J. Lammers3,
Jan A. M. Raaijmakers1
1Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical
Science, Utrecht, 2Department of Clinical Pharmacology & Pharmacy, Section Pharmacotherapy,
VU Medical Centre, Amsterdam, 3Department of Pulmonary Diseases, University Medical
Centre Utrecht, Utrecht, Netherlands
Background and Objective: Adherence with chronic medication such as inhaled corticosteroids
(ICS) has repeatedly been reported to be low. Non-adherence could be related to inadequate
knowledge of ICS’ actions and lack of ICS’ instructions on the use of inhalers. This
has not been reported previously to our knowledge among new users of ICS who discontinued
ICS treatment early.
The aim of the study is therefore to describe, among new users of ICS that discontinued,
their knowledge of ICS’ actions and whether they were instructed on the use of their
inhaler.
Design: A cross-sectional study among new users of ICS that discontinued use. Patients
were interviewed by telephone and their GP received a mailed questionnaire. Automated
dispensing records of all patients were retrieved.
Setting: 15 community pharmacies in the Netherlands.
Main Outcome Measures: By use of conditional logistic regression the association between
knowledge and study variables was assessed.
Results: From 287 eligible patients, 230 (78.2%) were interviewed. The majority (83.5%)
of these new users of ICS who discontinued ICS early was not aware of the anti-inflammatory
actions of ICS. Most patients (79.6%) were instructed on the use of their inhaler,
predominantly by the GP (27.8%). After adjusting for symptom experience by ACQ, asthma
diagnosis, having persistend asthma or use of medication only age (OR 1.03 95% CI
0.99–1.07) and male gender (OR 0.04 95% CI 0.03–0.91) were associated with unawareness
of anti-inflammatory actions.
Conclusions: This study shows that a substantial number of new patients that did not
refill their ICS prescriptions, were unaware of ICS’ inflammatory actions. Surprisingly
only age and gender seemed associated with awareness of ICS actions. Most patients
were instructed on the use on their inhaler by a health care provider. Physicians
and pharmacists could cooperate in identifying and motivating these patients to continue
ICS use.
Keywords: Asthma, Epidemiology, Pharmacy, Inhaled corticosteroids, Discontinuing treatment,
Disease control, ACQ
PK-102 Antibiotic drug monitoring quality assessed by a clinical pharmacist: observational
study
E. Ampe
1, A. Spinewine1, Y. Glupczynski2, B. Delaere3, J.D. Hecq4, P.M. Tulkens1
1Centre for Clinical Pharmacy, Université catholique de Louvain, Brussels, 2Laboratoire
de Biologie Clinique, 3Service d’Infectiologie, 4Pharmacie, Cliniques universitaires
de Mont-Godinne, Yvoir, Belgium
Background and Objective: To assess the quality of Antibiotic Therapeutic Drug Monitoring
(TDM) in routine hospital practice and establish baseline status for rationally defining
future actions aimed at improving it (by implementation of clinical pharmacy services).
Design: 4 months prospective observational study with validated data collection form
using predefined criteria for TDM quality assessment. Descriptive statistics performed
with SPSS 13.0 for Windows®.
Setting: Orthopaedic surgery, general surgery, neurosurgery, vascular surgery, haematology
and pulmonary wards of a 400 beds teaching hospital, using vancomycin twice daily
and amikacin once daily administration schemes.
Main Outcome Measures: Adherence to predefined criteria for sample timing, information
transmission, and follow up of dose adjustment recommendations. Criteria: (i) sampling
time: less than ±15 min (amikacin) and ±30 min (vancomycin) deviation from preset
time for peak levels; less than ±30 min for trough levels; (ii) information transmission:
patient’s full name, dose, schedule of administration, time of previous and current
dose, actual time of peak and trough level sampling; (iii) quality of the analysis
[internal and external controls]; (iv) acceptance of dose adjustment (more than 10%)
recommendations.
Results: Inclusion: 94 patients (46 vancomycin and 65 amikacin courses). Correct sampling
times: (i) peak levels: 39% (n = 15) for vancomycin and 11% (n = 9) for amikacin,
(ii) trough levels: 63% (n = 51) for both antibiotics. Correct information transmission:
55% (n = 83). No issue noted for the quality of the laboratory analyses. Implementation
of recommendations: 32% (n = 66) for vancomycin and 18% (n = 17) for amikacin.
Conclusions: Incorrect sampling times and deficiencies in communication between the
ward and the laboratory are key factors affecting the quality of TDM, leading to dosage
adjustment recommendations that are only infrequently implemented. The companion abstract
examines the underlying reasons for such poor performance of the TDM process using
a qualitative approach.
Keywords: Therapeutic drug monitoring, Clinical pharmacist, Quality
PK-129 Evaluation of needs for pharmacokinetic monitoring of carbamazepine and digoxin
in tertiary hospital
Justina Penkauskaite
1, Omar Mneimneh1, Romaldas Maèiulaitis1, Birute Varanavièiene2, Birute Tarutiene3
1Pharmacy, Kaunas University of Medicine, 2Pharmacy, 3Hematology laboratory and Medicinal
Chemistry, Kaunas University of Medicine Hospital, Kaunas, Lithuania
Background and Objective: Tendencies in Drug Use (DU) of highly toxic drugs-such as
Digoxin (D)and Carbamazepin (C) and level of Rational Drug Use (RDU) is unknown in
Lithuania. Our goal was to evaluate the first experiences in serum concentration (Sc)
measurements of D and C. We tried to discover practical consumption tendencies of
D and C using defined daily dose (DDD) in our measuring.
Design: DU study is based on hospital pharmacy and hospital administrative databases;
consumption is in DDD per 100 occupied bed daily (100OBD) during 2004–6; highest consumers
of C and D in 2006. Evaluation of all Sc in 2005 and 2006. Data were processed with
SPSS 16.0 using descriptive and comparative statistics for nonparametric values (Mann
Whitney test).
Setting: Tertiary hospital, 2600 beds, 63 departments. Information about the population
studied: tertiary level requiring patients; age- paediatric and adults.
Main Outcome Measures: Annual consumptions according to DDD/100OBD; Sc intensity of
Digoxin & Carbamazepine (as per number of DDDs) and proportions of abnormal Sc.
Results: Values of Carbamazepin:
In 2004: mean (±SD) DDD/100OBD 1.02 ± 1.93 (median 0.13; CI95% 0.50–1.54);
In 2005: mean 0.90 ± 1.79 (median 0.13; CI 95% 0. 45–1.35);
In 2006: mean 1.11 ± 2.21 (median 0.18; CI95% 0.56–1.65).
Corresponding values of D were:
In 2004: mean 1.73 ± 2.48 (median 0.92; CI95% 1.07–2.39);
In 2005: mean 1.07 ± 1.44 (median 0.54; CI95% 0.7–1.44);
In 2006: mean: 1.90 ± 3.26 (median 0.59; CI 95%1.08–2.71).
Intensity of Sc measurements were: for C 1/125 DDDs in 2005, 1/74 DDDs in 2006; for
D 1/147 DDDs in 2005; 1/309 in 2006. Sc of C in 2005: 12/57 (21%) too low, 32/57 (56%)
normal, and 13/57 (23%) too high; C in 2006 42/122 (34%) too low, 61/122 (50%) normal,
19/122 (16%) too high; Sc of D in 2005: 22/58 (38%) too low, 24/58 (41%) normal, 12/58
(21%) too high, in 2006 5/31 (16%) too low, 16/31 (50%) normal, 10/31 (32%) too high.
In 2006 the highest consumer of C were Head &brain surgery, Head brain traumas, Psychiatry,
Face&jaw surgery (71.47% of total DU), for D- Cardiology II, Palliative oncology,
Endocrinology, Neurology and other 16 departments (64.28% of total DU).
Conclusions: The consumption of C did not change essentially during last 3 years,
the consumption of D decreased in 2005. Sc measurements in 2006 vs 2005 increased
for C and decreased for D. Clear insufficiency in Sc. of C and D reveals high need
for intensifying Sc starting from highest consumers.
Reference
Kaunas University of Medicine Hospital databases
Keywords: Rationality, Defined daily dose, Occupied bed daily
PK-153 Amikacin – vancomycin: is it possible to design initial dosage regimen from
their respective pharmacokinetic parameters? A retrospective study
Sandra Fontanals
1, Dolors Soy1, Josep Ribas1
1Pharmacy, Hospital Clinic i Provincial de Barcelona, Barcelona, Spain
Background and Objective: To evaluate the relation between vancomycin and amikacin
pharmacokinetic (PK) parameters in an intensive care unit population.
Design: Data from intensive care unit patients were collected over a 48-month period,
through a retrospective review of medical records and Therapeutic Drug Monitoring
(TDM) reports. Patients were included only if at least two blood samples, at steady
state conditions, had been drawn. Data were first evaluated for completeness and consistency
of recorded sampling and dosing times.
Individual PK parameters were estimated (Bayesian analysis) using a one-compartmental
PK model for amikacin and a two-compartmental PK model for vancomycin (PKS® Abbot).
Phase I of the study determined relationships between vancomycin and amikacin pharmacokinetic
parameters, mainly clearance and volume of distribution. For that purpose, linear
regression analysis of data from 63 out of 83 patients (analysis dataset) was performed.
Phase II tested the predictability of the developed equations in an additional sample
of 20 patients (validation dataset) by comparing predicted PK parameters from equations
(PREDEQ) to those estimated by Bayesian analysis (PREDBAY). T-test between PREDEQ
and PREDBAY from each antimicrobial was performed. Bias and precision were evaluated
calculating the mean prediction error (MPE) and mean absolute error (MAPE), respectively
(S-plus 5).
Setting: Intensive Care Units. Tertiary University Hospital.
Main Outcome Measures: Patients demographics, clinical and TMD records, creatinine
clearance by Cockcroft-Gault, vancomycin and amikacin blood levels and PK parameters.
Results: Eighty-three critically ill patients (33 females, 48 males)were recruited
for the study (Mean values: Age 59.30 yr, Weight: 71.63 kg, Cr: 0.92 mg/dL).
A correlation between vancomycin and amikacin regarding their CL was found (CLvancomycin = 0.5678
CLamikacin + 0.7648; R = 0.811). However, no correlation was observed for Vd (R = 0.114).
Concerning Phase II, differences in demographic data from both datasets were not statistically
significant. No significant differences were observed when performing PREDEQ versus
PREDBAY T-test. Nevertheless, boxplot graphs for PREDEQ and PREDBAY residuals showed
a wide variability of the values distribution and a lack of precision for both antimicrobials.
Conclusions: In our patient population this studied approach reveals an existing relation
between amikacin and vancomycin PK parameters (or vice versa). However, the poor precision
and large bias of residual values prevents us from recommending the use of these equations
as PK parameters predictors (or regimen dose predictors) in intensive care patients.
Further studies with larger samples are definitely required in such an heterogeneous
population.
Reference
Predictive Performance of a Vancomycin-Aminoglycoside Population Model. Paul M Beringer,
Annie Wong-Beringer and Jay P Rho
Keywords: Amikacin, Vancomycin, Pharmacokinetic
PK-172 Single dose of clarithromycin leads to toxic tacrolimus levels
Sarah Mertens
1, Isabel Spriet1, Sandrina von Winckelmann1, Ludo Willems1
1Pharmacy, University Hospital Leuven, Leuven, Belgium
Background and Objective: Tacrolimus is widely used as a potent immunosuppressive
agent. However, it has a small therapeutic window and toxic levels are possibly leading
to severe side effects such as nephrotoxicity, neurotoxicity and QT prolongation.
Tacrolimus is nearly completely metabolised in the liver by CYP3A4; drug interactions
are hence expected with potent CYP3A4 inhibitors.
Design: Case report.
Setting: Medical Intensive Care Unit.
Main Outcome Measures: Toxic tacrolimus levels after administration of a single dose
of clarithromycin.
Results: A 22-year old woman with a medical history of heart-lungtransplantation for
multiple major aortic pulmonary collateral arteries, was admitted with fever and progressive
dyspnea. Her immunosuppressive therapy consisted of tacrolimus (5–4 mg PO) and methylprednisolone
4 mg PO. Meropenem was started empirically to treat pneumonia. On day 3, the patient
was transferred to the ICU because of progressive respiratory insufficiency, where
she was immediately intubated. Ganciclovir and SMX-TMP were associated to cover possible
opportunistic infections by CMV and Pneumocystis jiroveci. Clarithromycin 500 mg BD
IV was also associated, because Legionella pneumoniae as causative agent was not yet
ruled out. However, Legionella antigen was negative and treatment could be stopped
after administration of a single dose of clarithromycin. Tacrolimus (0.5 mg/24u IV)
was daily monitored, trough level was 14 μg/L on day 3 after admission but increased
on day 4 up to 24 μg/L after association of clarithromycin. Concomitant treatment
on day 4 was azathioprine, methylprednisolone, meropenem, ganciclovir, SMX-TMP, piritramide
and midazolam. We believe that clarithromycin is the causative agent leading to toxic
levels as the time-relationship between administration and toxic levels is clear.
Other causative factors could be ruled out: no other potent CYP3A4 inhibitors were
administered and renal function did not change (serum creatinine 0.84 (day3) and 0.64 mg/dL
(day4). We calculated the DIPS score, which assesses the causation of potential drug
interactions, and concluded that the interaction is at least probable.1 A Medline
search revealed other case reports describing the same interaction in renal, bone
marrow and heart transplant patients.2,3,4,5 Clarithromycin is a potent inhibitor
of CYP3A4, leading to competitive inhibition and toxic levels of tacrolimus. It is
remarkable that even one single dose of clarithromycin results in plasma concentrations
that are capable of blocking CYP3A4. In this patient, the interaction did not have
clinical consequences.
Conclusions: This case illustrates that even one single dose of clarithromycin can
lead to toxic tacrolimus levels. We believe that other antibiotics, such as azithromycin
or fluoroquinolones, should be used if patients on tacrolimus have to be treated for
Legionella pneumoniae. These drugs do not have the potential to interact with tacrolimus.
References
Horn J. Ann Pharmacother 2007;41:674–80
Gomez G. Transplant Proc 1999;31:2250–1
Wolter K. Eur J Clin Pharmacol 1994;47:207–8
Ibrahim RB. Ann Pharmacother 2002;36:1971–2
Kunicki P. Ther Drug Monit 2005;27:107–8
Keywords: Tacrolimus, Clarithromycin, Interaction
PK-209 Pharmacokinetics of oral taurine in healthy volunteers
Mohammadreza Ghandforoush-Sattari
1, Siminozar Mashayekhi2
1Pharmacology and Toxicology, Tabriz University of Medical Sciences, Tabriz, 2Clinical
Pharmacy, Iran (Islamic Republic of)
Background and Objective: Taurine is a relatively non-toxic substance and a normal
constituent of the human diet. Protective effects of taurine on cells against different
toxic agents have already been established. Little is known of the pharmacokinetics
of taurine in man after oral administration.
Design: Eight healthy male volunteers (median age 27.5, range 22–45) were recruited
from the general population. Taurine 4 g was administered orally to each volunteer
in the fasting state in the morning.
Setting: The study was performed in the Cardiff Poisons Unit, Llandough Hospital,
Cardiff, Wales, UK.
Main Outcome Measures: Blood samples were taken (3 ml each time) at regular intervals
and Plasma taurine concentration was measured by a modified HPLC method. Pharmacokinetic
analysis was performed by WinNonlin (Version 1.5) software package.
Results: Maximum plasma taurine concentration (Cmax) was 86.1 ± 19.0 mg/L, time of
maximum concentration (Tmax) between 1 and 2.5 hours (1.5 ± 0.6 hr), plasma elimination
half-life (T1/2) 1.0 ± 0.3 hr, and the ratio of clearance/bioavailability (Cl/F) was
21.1 ± 7.8 L/hr.
Conclusions: All pharmacokinetic parameters were significantly different from the
only one previous study which was studied following an IV injection of 200 mg bolus
dose on six hypertensive human patients and six healthy volunteers. This was probably
because they were examining an alpha phase which was obscured by the absorption phase
for taurine after oral absorption.
References
Eslami, M., J. Stuart and R. Dean: Analysis of Taurine in Blood Plasma of Epileptic
Patients Using an Improved Isocratic HPLC Method for Amino Acids. Journal of Liquid
Chromatography 1987, 10, 977–995.
Huxtable, R. and L. Sebring. Cardiovascular actions of taurine. In: Sulfur amino acids
Biochemical aspects. K. Kuriyama, R. Huxtable and H. Iwata. Alan R. Liss, Inc. New
York, 1983. 5–37.
Zhang, Y., Z. Sun and X. Shi: Pharmacokinetics and pharmacodynamics of the effects
of taurine on human blood pressure and heart rate. Chin J Hosp Pharm (Yiyuan Yaoxue
Zazhi) 1998, 18, 106–107.
Keywords: Taurine, Pharmacokinetics, Oral administration
PK-268 Effect of human immunodeficiency virus-1 protease inhibitors on itraconazole
metabolism in V79 Chinese hamster cells expressing human cytochrome P450 3A4
Estelle Huet
1, Bijan Ghaleh2, Anne Hulin1, Alain Astier1
1Laboratory of Pharmacology and Toxicology, Henri Mondor Hospital, 2Laboratory of
Pharmacology, Faculty of Medecine, CRETEIL, France
Background and Objective: Liver cytochrome P450 3A4 (CYP3A4) is involved in the metabolism
of about 60% of drugs, notably all human immunodeficiency virus-1 protease inhibitors
(PIs), and itraconazole (ITRA), an antifungal azole. Coadministration of ITRA with
PIs may lead to serious drug–drug interaction (DDI) by increasing ITRA concentration
because of CYP3A4 inhibition properties of PIs. The aim of this study was to investigate
the effect of PIs on ITRA metabolism in a Chinese hamster V79-derived cell line, stably
expressing human CYP3A4.
Design: Studies monitoring CYP3A4-mediated ITRA metabolite formation with time, in
the presence of increasing concentrations of each PI were used to obtain in vitro
Ki values. Kinetic parameters of ITRA hydroxylation were determined by incubating
for 3 h at 37°C the V79 cells in 6-well plates in 1 mL of complete culture medium
containing increasing concentrations of ITRA (0.14 to 3.5 μM) with or without PIs.
ITRA metabolite (hydroxy-itraconazole) concentrations in culture medium were measured
using validated reverse-phase high-performance liquid chromatography (HPLC) coupled
with fluorescence detector.
Setting: Laboratory of Pharmacology and Toxicology, Henri Mondor Hospital.
Main Outcome Measures: Enzyme inhibition by PIs (Ki) were estimated using a non linear
least square regression with proportional weighting (1/v2) with SigmaPlot® Enzyme
Kinetics Module. The data were fitted using conventional relationships for competitive,
noncompetitive or mixed-type inhibition.
Results: Lopinavir, indinavir PIs used at maximal plasma concentrations inhibit ITRA
hydroxylation competitively for lopinavir, indinavir, amprenavir with a Ki values
of 0.37, 0.54 and 0.66 μM, respectively, non-competitively for ritonavir, saquinavir,
atazanavir and tipranavir with a Ki value of 0.31, 3.3, 1.10 and 32.1 μM, respectively
and with a mixed-type inhibition mechanism for nelfinavir, with apparent Ki equal
to 2.4 μM. All PIs, except saquinavir, are expected to inhibit in vivo ITRA hydroxylation
with predicted inhibition percentage from 74.4% for atazanavir to 98% for ritonavir.
Conclusions: In clinical settings, this suggests obvious potential of significant
DDI for all of the PIs, except for nelfinavir which is also metabolized by others
CYP450. Finally, a close therapeutic drug monitoring of ITRA plasma concentrations
for these patients is recommended.
Keywords: CYP3A4, Protease inhibitor, Drug interaction
PK-293 Prevention of chemotherapy related errors one step toward
Catarina Oliveira
1, Filipa Duarte-Ramos1, José Cabrita1
1Social-Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
Background and Objective: Several strategies have been proposed to minimize cytotoxic
medication errors. Different guidelines identify items that must be filled-in in prescriptions
and cytotoxics identification labels aiming to prevent these errors.
Objective: Define a national consensus document concerning chemotherapy error prevention.
Evaluate the extent of agreement with the consensus document of chemotherapy prescriptions
and identification labels.
Design: Consensus Document: Delphi Technique. Prescriptions evaluation: descriptive,
retrospective study. Labels evaluation: descritive, prospective study.
Main Outcome Measures: Consensus Document: Hospital pharmacists that manipulate cytotoxics
were identified (n = 67) from all national hospitals and invited to participate in
a 2 round Delphi Technique. They were asked to identify which items of the ASHP Guidelines
and GEDEFO they considered that must be filled in, in a prescription or in an identification
label. Consensus was defined as an agreement rate ≥66%.
Prescriptions/Labels evaluation: All breast or colon intravenous chemotherapy prescriptions,
from a central hospital, have been evaluated from January to December 2004 (n = 920),
based on the parameters identified in the consensus document. A two month analysis
of identification labels was performed.
Results: Consensus Document: A total of 49 hospital pharmacists (73.1%) completed
the 2 rounds of the Delphi. Consensus was obtained for 84.6% of the prescription items
and for 90.9% of the labels items.
Prescriptions/Labels evaluation: More than 2/3 of the analysed prescriptions were
for breast cancer (69%) and the rest for colon. None of the analysed prescriptions
had all the consensus items filled-in. Information that allowed the validation of
the prescription by the pharmacist (ex: height, weight, body surface or number of
cycle) was present in less then 10% of the prescriptions. No one had the prescriptor
telephone, or the justification for dose reduction (when appropriate).
Only 68.8% (110/160) of the labels mentioned the full identification of the solvent
(96% miss the concentration) used and none of them stressed out the need for filter
use when applicable.
Conclusions: Consensus was obtained about a large number of items, which may constitute
a difficulty in daily practice The evaluation of prescriptions highlights the lack
of information that could allow confirmation by the pharmacist. Labels do not seem
to alert about special administration conditions.
References
American Society of Health-System Pharmacists. ASHP guidelines on preventing medication
errors with preventing medication errors. Am J Health-Syst Pharm 2002; 59: 1649–69;
Grupo Espaňol para el desarrollo de la Farmacia Oncológica (GEDEFO). Prevención de
errores de medicación en quimioterapia. En: http://www.amgen.es/amgen2/grupos/Errores_medicacion.htm
Keywords: Preventing medication errors, Consensus document, Chemotherapy error prevention
PT-8 Compliance with recommendations on length of treatment with interferon plus ribavirine
depending on viral response in patients with hepatitis C
Sanchez Azhara
1, Murgadella A. M. Anna1, Gurrera T. G. Teresa1, Agustí C. A. Clara1, Fàbregas X.
F. Xavier1, Castellví J. C. Josep2
1Pharmacy, 2Digestive, Mataro Hospital, Mataro, Spain
Background and Objective: Background: The Ministerial advisor on Hepatitis C in Catalonia
has established a series of recommendations concerning Hepatitis C treatment distinguishing
between two groups: viral genotypes 1 and 4, and viral genotypes 2 and 3.
In genotypes 1 and 4 it is necessary to evaluate treatment continuity after 12 and
24 weeks, depending on viral load and it is also necessary to prolong the treatment
to 48 weeks if there is viral response. In genotypes 2 and 3 it has not to be longer
than 24 weeks regardless of viral load.
Objective: To evaluate the adequacy of Hepatitis C treatment and analytic monitoring,
following the recommendations of the catalonian Ministerial advisor.
Design: Observational and retrospective study.
Setting: Patients that started treatment with PEG-interferon plus ribavirine in this
hospital during 2005.
The information obtained was: viral genotype, the beginning and the end of treatment,
quantitative basal RNA (in all genotypes), quantitative RNA (12 weeks) and qualitative
RNA (24 weeks) in genotypes 1 and 4 and at the end of the treatment in all genotypes.
Main Outcome Measures: The application of global advices ranges from 59% to 100% according
to viral genotype and established recommendation.
Results: The compliance degree in genotypes 1 and 4: 100% application of quantitative
basal RNA and 59% after 12 weeks. 60% of treatments were discontinued with quantitative
RNA positive after 12 weeks, 78% with qualitative RNA positive after 24 weeks and
6% the treatment was continued longer than 48 weeks.
In genotypes 2 and 3: 100% application of quantitative basal RNA, 65% application
of qualitative RNA after 24 weeks and 20% the treatment was continued longer than
24 weeks.
Conclusions: Following the recommendations on viral response evaluation after 12 and
24 weeks allows the early suspension of therapy in non-responsive patients. This leads
to and improvement in patients’ quality of life, a reduction in adverse side-effects
and savings in medical care costs.
Treatment monitoring by Hospital Pharmacist provides medical decision support. In
consequence these patients constitute a target group to establish pharmacy care programs
focused on hospital outpatients.
References
Criteris d’indicació en el tractament de les hepatitis víriques. Direcció General
de Recursos Sanitaris, instrucció 1 2004. Generalitat de Catalunya.
Stephanos J. Hadziyannis, md; Hoel Sette Jr., MD; Timothy R. Morgan, MD; et al. Peginterferon-alpha2a
and Ribavirin combination therapy in chronic hepatitis c. Ann Intern Med. 2004;140:346–355.
Keywords: Hepatitis C, Treatment, Genotype
PT-12 Zidovudine induced anemia in patients received HAART
Hossein Khalili
1, Simin Dashti-Khavidaki1, Mahbobeh Hajiabdolbaghi2, Atefeh Etghani1
1Clinical Pharmacy, Tehran University of Medical Sciences, 2Infectious Disease, Iranian
AIDS Research Center, Tehran, Iran (Islamic Republic of)
Background and Objective: Zidovudine (ZDV) is the first drug that approved for treatment
of HIV infected patients and now has wide use in HAART regimens. This drug can cause
hypoproliferative anemia bone marrow toxicity. The object of this study is evaluation
of incidence of anemia in Iranian HIV positive patients that received ZDV in HAART
regimens.
Design: In a prospective study, 162 HIV positive patients were referred to Iranian
HIV Research Center that start ZDV in HAART combination were entered the study and
have followed for at least one year. Baseline and monthly hematological parameters
were recorded.
Setting: Iranian HIV Research Center.
Main Outcome Measures: patients Demographic parameters, Route of Infection exposure,
stage of Disease, CD4 counts, CBC, and Hematological Parameters.
Results: Twenty nine (29) patients were excluded from the study because of impossible
follow-up. From 133 patients, 77 of them have anemia (Hemoglobin less than 12 g/dl
for female and less than 13 g/dl for male). Thirty there (33) patients have anemia
before starting HAART. Thirty four (34) patients have showed anemia following received
ZDV. Twenty (12) patients have improved anemia after were changed ZDV to stavudine.
Conclusions: About 34% of HIV positive patients that were received ZDV have experienced
anemia.
References
Ssali F, Stöhr W, Munderi P, et al. Prevalence, incidence and predictors of severe
anaemia with zidovudine-containing regimens in African adults with HIV infection within
the DART trial. Antivir Ther. 2006;11(6):741–9
Mildvan D, Creagh T, Leitz G; The Anemia Prevalence Study Group. Prevalence of anemia
and correlation with biomarkers and specific antiretroviral regimens in 9690 human-immunodeficiency-virus-infected
patients: findings of the Anemia Prevalence Study. Curr Med Res Opin. 2007 Feb;23(2):343–55.
Koduri PR, Parekh S. Zidovudine-related anemia with reticulocytosis. Ann Hematol.
2003 Mar;82(3):184–5.
Keywords: Zidovudine, Anemia
PT-18 Post-operative pain management in opioid naïve and opioid tolerant patients
after orthopedic surgery
Asad E. Patanwala1, Brian Erstad
1, Donna Jarzyna2, Michael Miller3
1Pharmacy Practice and Science, University of Arizona College of Pharmacy, 2Nursing,
University Medical Center, 3Orthopedic Surgery, Arizona Health Sciences Center, Tucson,
United States
Background and Objective: To compare post-operative opioid requirements in opioid
naïve and opioid tolerant patients after orthopedic surgery. Secondary endpoints included
comparisons of pain scores, sedation scores, and adverse effects between the two groups
Design: Prospective observational study design. Patient’s ≥18 years of age that were
scheduled for elective total knee arthroplasty between October 2005 and June 2007
were included in the study. Patients were classified into one of two categories based
on their daily opioid consumption during the week prior to surgery; 1) opioid naïve
(≤10 mg of oral morphine equivalent); 2) opioid tolerant (≥30 mg of oral morphine
equivalent).
Setting: Academic medical center in the United States.
Main Outcome Measures: Post-operative opioid consumption, pain scores and sedation
scores were compared between the two groups during three different time periods: 1)
Time in the post-anesthesia care unit (PACU), 2) 24 hours after discharge from the
PACU and 3) 24–48 hours after discharge from the PACU.
Results: A total of 29 patients satisfied criteria for inclusion into the study (20
opioid naïve, 9 opioid tolerant). Post-operative opioid consumption (intravenous morphine
equivalent) was significantly greater in the opioid tolerant group in the PACU (median
56 vs. 8.2 mg, p = 0.0013); during the first 24 hours after discharge from the PACU
(108 vs. 20.5 mg, p = 0.0004) and 24 to 48 hours after discharge from the PACU (152.3
vs. 25 mg, p = 0.0001). Pain scores (verbal numeric scale from 0–10) were significantly
greater in the opioid tolerant group during the first 24 hours after discharge from
the PACU (5.9 vs. 4.1, p = 0.03). There was no difference in pain scores during the
other time periods studied. Sedation scores and adverse effects were similar between
the groups during the study.
Conclusions: Opioid tolerant patients have significantly greater opioid requirements
in the PACU and up to 48 hours after discharge from the PACU compared to opioid naïve
patients after orthopedic surgery.
Keywords: Pain, Opioid, Surgery
PT-26 Evaluation of the compliance of clinical practice with approved prescription
information for Rituximab
Mari Carmen Conde
1, Beatriz Garcia1, Jaime Vargas1, Maria Amalia Fernandez1
1Pharmacy, Cytostatic Unit CCU, Virgen de las Nieves University Hospital, Granada,
Spain
Background and Objective: To evaluate the compliance of clinical practice with conditions
of use in the Prescription Information Sheet in relation to the utilization of Rituximab
between July 1 2006 and December 31 2006.
Design: Prospective, observational, single-centre study of all patients who started
treatment with Rituximab at the Virgen de las Nieves University Hospital between July
1 2006 and December 31 2006, with follow-up to April 30 2007.
Setting: Department of Pharmacy Cytostatic Unit and Medical Departments of Oncology,
Rheumatology, Internal Medicine and Day-Hospital.
Main Outcome Measures: Degree of compliance of clinical practice with the indications,
regimen, line of treatment, dose, and frequency and number of courses established
in the Prescription Information Sheet.
Results: Out of the 31 treated patients, 7 (23%) received Rituximab for a disease
not included in the Prescription Information Sheet, i.e., in practically a quarter
of cases, approval is required for compassionate use. Only 65% of the drug regimens
accorded with the Prescription Information Sheet. Among the patients receiving Rituximab
for an approved indication and with an appropriate regimen, the correct dose and treatment
line were used in 100% of cases, whereas recommendations for the frequency and number
of courses were only followed in 86% and 42% of cases, respectively.
Conclusions: A very high proportion of patients are being treated with Rituximab for
an indication that is not approved in the Prescription Information Sheet, meaning
that there are no conclusive data on the efficacy and safety of this drug in these
cases. Indications for Rituximab treatment were completely followed in only four (12.9%)
of the patients in this sample.
PT-43 Clinical pharmacist intervention in nephrology ward in an Iranian academic health
center
Talia Mazidi
1, Simin Dashti Khavidaki1, Hossein Khalili1
1Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic
of)
Background and Objective: Patients with chronic kidney disease have several complications
which necessitate drug therapy. Because of polypharmacy in this population, risk of
drug interactions and adverse drug effects (ADEs) will increase. It is established
that clinical pharmacist have critical role in the treatment safety and reducing healthcare
cost by monitoring patients for ADEs, appropriate dose and rational drug administration
and identification of prescription errors. So we decided to evaluate the impact of
pharmacist intervention in drug safety in our hospital.
Design: During an ongoing activity in an academic nephrology ward, we have visited
61 patients till now and did some interventions for the first 2 months. Interventions
were about dose adjustment, adverse effects alert, drug interactions, IV to PO conversion,
drug information, drug administration,…
Setting: Nephrology Ward in Imam Referral Hospital affiliated to Tehran University,
Tehran, Iran.
Main Outcome Measures: For treatment monitoring we have used NKF/DOQI guidelines in
chronic kidney disease: Hg = 11–12, Hct = 33–36%, Ca-P < 55, 2.5 < P < 5.5.
Results: We did 1.2 intervention per patient during this time. Among these patients,
11.4% needed treatment interchange (drug replacement), 9.8% drug discontinuation,
29.5% dose adjustment, 6.6% IV to PO conversion, 32.8% recommendation about drug administration,
11.4% adding a drug to previous order, 4.9% ADEs alert, 21.3% monitoring for drug
interactions and in 3.3% of cases there was a prescription error.
Conclusions: As it is clear, by clinical pharmacist interventions, in addition to
giving better healthcare services, reducing healthcare cost will be achievable as
well.
References
http://www.kidney.org/professionals/kdoqi/guidelines_updates.
Catherine Christen. Clinical Pharmacy and Medication Safety. Ann. Pharmacother. 2006;40:2020–2021.
Keywords: Clinical pharmacist, Chronic kidney disease, Treatment safety
PT-53 Topical mitomycin 0.02% as an adjunct to surgical repair of choanal atresia
Canadell Laura1, Pardo Rocio1, Aviles Francisco J2, Cañete Carmen
1, Figuerola Enric2, Gallart M Jesus1
1Pharmacy service, 2Otorhinolaryngology, Hospital Universitari Joan XXIII, Tarragona,
Spain
Background and Objective: To evaluate the use of topical mitomycin 0.02% used as an
adjunct to choanal atresia surgical repair to reduce the development of granulation
tissue and cicatrix.
Design: Description of results of two patients with either unilateral and bilateral
congenital choanal atresia who were under transnasal endoscopic surgical repair.
Topical application of mitomycin 0.02% during two minutes and postoperative stenting
for a period of four-ten weeks were used, no second application of mitomycin was used.
The follow-up was 2 years in bilateral case and six months for the unilateral case.
Setting: Pharmacy and Otorhinolaryngology Service. Hospital Universitari Joan XXIII
de Tarragona. Spain.
Main Outcome Measures: The success of the repair was measured according to the following
items: endoscopic evaluation of the patency of the choanae, respiratory distress and
nasal drainage.
Results: Bilateral membranous choanal atresia was surgical repaired five days after
birth, using transnasal endoscopic approach and topical mitomycin 0.02% during de
proceeding. No operative complications occurred and stents were removed four weeks
after repair. The choanae was inspected endoscopically to asses healing and no presence
of re-estenosis was found. No clinical symptomatology.
Unilateral mixted atresia on the left side was diagnostic at six years old and surgical
repaired because of association of respiratory distress and nasal mucus drainage symptomatology.
No restenosis has appeared and syntomatology has improved.
Nome patient required surgical revision.
Conclusions: Although, the exact role of the topical application of mitomycin 0.02%
must to be further investigated, the use of this drug as an adjunct to the surgical
repair of choanal atresia may offer decreased need for revision surgery due to re-estenosis.
Keywords: Mitomycin 0.02%, Choanal atresia
PT-57 Adherence to clinical guidelines for upper respiratory and ear infections in
out-of-hours primary care – a retrospective study
Sara Claesson
1
1Biofarmaci, Uppsala University, Täby, Sweden
Background and Objective: Infections in the upper airways and ears are a frequently
occurring reason for patients to visit primary care settings. Prescribing adherence
to local guidelines for handling infections of ears and upper airways and antibiotic
prescribing is of both local and national concern. Increasing antibiotic resistance
is one reason, cost and patient quality of care are others. The objective of this
study was to investigate physician adherence to clinical guidelines at the out-of-hours
primary care clinic in Täby.
Design: A retrospective study. Clinical case notes were scrutinised for all patients
seeking care for problems with ear, nose, throat, fever, cough or cold between January
1 and March 31 2007. Data was analysed for patients who were diagnosed with specified
ear or upper respiratory infections. Laboratory tests taken and antibiotic prescriptions
were anonymously documented. Antibiotic prescription filling dates were investigated.
Setting: Husläkarjouren, the out-of-hours primary care clinic in Täby.
Main Outcome Measures: Adherence to and fulfillment of local therapeutic guidelines
and professional quality criteria was defined with respect to immediate, delayed or
no prescription, drug choice, dose and duration and the use of diagnostic tests. Adherence
was defined as complete or not, and deviations from the guidelines were separately
analysed. Prescription filling was analysed with respect to time from clinic visit
to pharmacy visit.
Results: Data from 1077 patient visits were analysed. Adherence to local guidelines
was disappointingly low. General treatment of infections was only according to guidelines
in 44% of the cases and only laboratory testing met the quality criteria. Adherence
to antibiotic prescribing guidelines was even lower, only 22% of antibiotic prescriptions
were completely according to local guidelines. 93% of all antibiotic prescriptions
were filled within one day from the visit to the clinic.
Conclusions: Communicating guidelines to prescribers and continuous follow up of prescribing
behaviour is essential for improving patient care and decreasing the risk of antibiotic
resistance in the community. This study exposes gaps in the quality of care that may
not be picked up by traditional follow up measurments. Studies with a wider scope
and in depth analysis of reasons for nonadherence to guidelines are warranted if antibiotic
use is to be improved.
Keywords: Infection, Antibiotics, Adherence, Guidelines, Quality of care, Resistance,
Primary care
PT-85 One year of experience with bortezomib in patients with diagnostic of multiple
myeloma
Alexandra Reis1, Patricia Cavaco
1, Nadine Ribeiro1, Fernando Lima2, Isabel Ribeiro2, Fátima Falcão3
1Pharmacy, 2Haematology, CHLO, 3Pharmacy, CHLO, Pharmacy Faculty, Lisbon, Portugal
Background and Objective: To evaluate one year of experience with bortezomib in patients
with diagnostic of Multiple Myeloma (MM), according with the NCCN guidelines and their
clinical outcomes.
Design: One year retrospective study, review of NCCN guidelines in MM.
Setting: Haematology Ward and Day Hospital of CHLO (general hospital).
Main Outcome Measures: Number of therapeutic according NCCN guidelines, effectiveness
of bortezomib’s therapeutics established according to immunoglobulin values.
Results: From the 8 patients with the diagnostic of Multiple Myeloma, one had a diagnostic
of MM IgG K, five MM IgA K and one MM IgGλ. Three were male and five female. The mean
age was 57.25 ± 10.99 years. The Bortezomib was initiated 3.14 lines after other therapies.
Before bortezomib one patient received therapeutic with thalidomide/dexametasone,
one VAD, one cyclophosphamide (CTX), three followed by VAD, one MP followed VAD and
followed CTX, and another with VAD followed by CTX. The therapeutic selection followed
the NCCN guidelines in all patients. The average number of cycles with bortezomib
has 4.14. From the 8 patients, 2 stopped, one had a generalized face oedema bortezomib
related, although the disease was in remission, and another died by sepsis not related
with this drug. In relation to bortezomib’s effectiveness, 6 (75%) patients had a
very good response, since the immunoglobulin decreased and three (25%) of these patients
are actually at consolidation cycles (7th and 8th).
Conclusions: The use of Bortezomib in our hospital was according the NCCN guidelines
and the experience was very positive. Nevertheless, and considering also the high
cost of this therapeutic, we consider very important to continue to follow up this
group in order to evaluate the rate of response to bortezomib during time.
Reference
NCCN Clinical Practice Guidelines in Oncoloy for Multiple Myeloma 2007; Nice guidence
by tipe on Multipe Myeloma; Paul G. Richardson, et al., A Phase 2 Study of Bortezomib
in Relapsed, Refractory Myeloma; Velcade RCM.
PT-90 Evaluation of the time interval between admission on the emergency department
and administration of the first dose of antibiotics
Saskia Vandenput1, Ludo Willems
1, Sabrina De Winter1, Sandrina von Winckelmann1, Daniel Knockaert2
1Pharmacy, 2Internal medicine, University Hospital Leuven, Gasthuisberg, Leuven, Belgium
Background and Objective: When patients are admitted with a proven or suspected infection
on the emergency department, adequate antibiotic treatment must be started as soon
as possible. Literature reveals that the time between admission and administration
of the first dose of antibiotics can reach about 5 hours and this can influence the
prognosis of the patient. International guidelines for community acquired pneumonia
(CAP) and bacterial meningitis define this time interval of 4 hours(1) and less than
2 hours(2) respectively. To evaluate the practice on the emergency department of our
hospital, with an average daily admission of 136 patients, a study on this interval
was carried out.
Design: Prospective observational study during a 3-week period
Setting: Emergency Department, University Hospital, Leuven, Belgium.
Main Outcome Measures: – Mean time interval between admission of patients on the emergency
department and administration of the first doseof antibiotics – Adherence to local
guidelines.
Results: 76 patients were included in the study. The mean time interval is 2 h 52 min
(range 3 min–14 h 07 min). The mean time intervals measured at night and during the
day are 2 h 16 min and 3 h 17 min respectively. For bronchopulmonar infections (44
patients) the mean time interval is 2 h 35 min, skin and soft tissue infections (13
patients) 1 h 50 min, urogenital infections (4 patients) 2 h 54 min, sepsis (4 patients)
4 h 25 min, abdominal infections (8 patients) 5 h 34 min and bacterial meningitis
(1 patient) 1 h 15 min. Specifically for CAP (28 patients) the mean time interval
is 2 h 56 min.
80.3% of all administered antibiotics is in adherence to the local guidelines; however
this was only evaluated by the clinical pharmacist.
A possible explanation for the relatively short time intervals could be that the antibiotics
which are frequently used are available at the emergency department and that the guidelines
are at all time available on our hospital intranet. The time intervals of CAP and
bacterial meningitis are shorter than the defined international guidelines.(1, 2)
Conclusions: The time interval, found in our study, between admission on the emergency
department and administration of the first dose of antibiotics is short, compared
with similar conducted studies.(3, 4)
References
Schouten J, et al. CID 2005; 41: 450–460
Lala HM, et al. J infect 2006; abstract
Natsch S, et al. J Clin microbial infect dis 1998; 17: 681–684
Buyle F, et al. ASHP 2005; dec.: 640
Keywords: Antibiotics, Emergency department
PT-91 Compassionate use of mitomycin C in the management of laryngeal papillomas.
A case report
Ana Such-Diaz
1, Carmen Sanchez-Gil1, Maria del Puy Goyache-Goñi1, Pilar San Miguel1, Rodrigo Monge-Jodra2,
Alberto Herreros de Tejada1
1Pharmacy, 2Otolaryngology, 12 de Octubre University Hospital, Madrid, Spain
Background and Objective: A woman diagnosed with laryngeal papillomatosis. Treatment
consisted of laser excision of the granulomatous lesions, followed by mitomycin C
instillation over the surgical bed.
Description of the preparation and utilization of mitomycin C instillation over the
surgical bed for the treatment of laryngeal papillomatosis.
Design: Request by the ENT Service for compassionate use of mitomycin C.
Following authorization from the health authorities, a literature search was made.
After determining the dose/day for the patient, elaboration was carried out according
to the literature references.
Setting: Vials of 10 mg of mitomycin C were used as starting material, with 1-ml syringes
to facilitate instillation in the operating room. Dilution was made to double the
standard in our centre (20 ml).
Main Outcome Measures: Two 1-ml syringes were prepared per cycle, with a mitomycin
C solution of 0.5 mg/ml for instillation, though finally in all cases only one of
them was used.
Stability was established as 24 hours at room temperature, without special considerations
regarding light exposure, as specified by the literature.
The entire procedure was carried out in a laminar flow chamber, in compliance with
the specifications for manipulating cytostatic agents.
Results: The patient received a total of three cycles of mitomycin C, the last two
being maintenance cycles.
The patient has experienced no papilloma relapse, and only right vocal cord hyperaemia
is observed, probably secondary to surgery.
Conclusions: Collaboration between the Service of Pharmacy and the ENT Service allowed
adequate treatment and recovery of the patient, without apparent adverse effects.
References
Hamza AH, Nasr MM, Deghady AA. The use of mitomycin-C for respiratory papillomas:
clinical, histologic and biochemical correlation. Saudi Med J. 2005 Nov;26(11):1737–45.
de Mones E, Lagarde F, Hans S, Menard M, Laccourreye O, Brasnu D.
Mitomycin C: prevention and treatment of anterior glottic synechia. Ann Otolaryngol
Chir Cervicofac. 2004 Sep;121(4):229–34.
Rahbar R, Valdez TA, Shapshay SM. Preliminary results of intraoperative mitomycin-C
in the treatment and prevention of glottic and subglottic stenosis. J Voice. 2000
Jun;14(2):282–6.
Hueman EM, Simpson CB. Airway complications from topical mitomycin C. Otolaryngol
Head Neck Surg. 2005 Dec;133(6):831–5.
Keywords: Mitomycin C, Laryngeal papillomatosis, Papillomas
PT-93 Effectiveness of Rituximab in rheumatoid arthritis
Marta Martí-Navarro
1, Carmen Frías-López2, Toni Gómez-Centeno3, Begoña Campos4, Sarai Humbert1, Roger
Salvador1, Joan Altimiras-Ruiz1
1Pharmacy, Corporació Sanitària Parc Taulí, 2Pharmacy, Corporacio Sanitaria Parc Tauli,
Sabadell, Spain, 3Rheumatology, 4Medicine, Universitat de Barcelona, Barcelona, Spain
Background and Objective: To assess the response to Rituximab in patients with rheumatoid
arthritis (RA) who were refractory to anti-TNF treatment.
Design: Observational, cross-sectional study. Performed on patients diagnosed of RA
according to ACR criteria (American College of Rheumatology), undergoing treatment
with Rituximab due to their refractoriness to at least two differents anti-TNF drugs.
All patients who had been receiving treatment with Rituximab for at least 3 months
before beginning of study were included.
Setting: Performed in a level II teaching Hospital.
Main Outcome Measures: The main variables used to assess clinical evolution were:
decrease in DAS28-ESR, considering the number of swollen and tender joints over 28
joints evaluated, and the value of erythrocyte sedimentation rate, comparing the DAS28
from one patient on two different time points; EULAR response, that classifies patients
in 3 groups according to treatment response, and decrease in MHAQ (Modified Health
Assessment Questionnaire), that indicates patient’s awareness of disability. Data
were recollected at beginning and at 12 weeks of initiating treatment with Rituximab.
Differences between B-lymphocyte count at beginning and at 2 weeks was of initiating
treatment was used as a secondary variable.
Results: We collected data of 6 patients, all being females, 1 was RF positive and
5 were anti-CCP positive. At 2 weeks, all the patients presented B-lymphocyte depletion.
Mean DAS28 basal rate was 6.55 and MHAQ was 2.29.
At 12 weeks, mean DAS28 was 4.86 and mean MHAQ was 1.98. Assessment of disease evolution
was performed with these values during this period according to EULAR criteria, obtaining
83.3% moderate response and 16.7% no response.
The difference in the decrease of DAS28 between the 1st and 2nd visit was 1.69 CI95
[0.63, 2.74] p = 0.009 statistically significant and difference in MHAQ between 1st
and 2nd visit was 0.35 CI95 [−0.41, 1.11] p = 0.268 not statistically significant.
Conclusions: These results suggest that Rituximab is an effective treatment in patients
affected by RA refractory to 2 or more current anti-TNF. Although patients did not
realise this improvement, the decrease in DAS makes Rituximab an interesting option
in this type of patients. However a higher number of patients is required to confirm
these results.
Keywords: Rituximab, Refractory arthritis, DAS28
PT-96 Use of low molecular weight heparin in venous tromboembolic disease prophylaxis
in general surgery
Marta Gallego
1, Elena Fuentes2, Jesus Llorente2, Marian Campos Fernandez de sevilla2, Francisco
Moreno2, Esperanza Jimenez-Caballero2
1Pharmacy, Hospital La Paz, 2Pharmacy, Hospital la Paz, Madrid, Spain
Background and Objective: Evaluate compliance of low molecular weigh heparin (LMWH)
to Guidelines of Clinical Practice published in 7th Conference of ACCP antitrombotic
therapy for prevention of venous thromboembolism in general surgery.
Design: Prospective study, three months duration (January–March 2007). Medical histories
of patients hospitalized in surgery department, either with or without LMWH prescription
were revised daily. The collected data were: Patient identification along with th
number of medical history, sex, age, date and reason of admission to hospital, surgery
(major or minor, duration and kind anesthesia), risk factors (prior history venous
tromboembolism, prolonged immobilisation, cancer, obesity, varicose veins, estrogens
use, haemodynamic state, serious infection), LMWH prophylactic prescription or not
(posology, start date and end of prophylaxis) and adverse events related.
Setting: General and Diegestive Surgery department of tertiary Hospital.
Main Outcome Measures: From elaborate database, the LMWH prescription habits and their
compliance with Guidelines of Clinical Practice published in 7th Conference of ACCP
in 2004, were analyzed. Proceeded analysis of 2 surgeries with greater prevalence,
being these, pathologies related to cholédoco (cholelythiasis, cholecystitis) and
cancer (colon, rectum, cecum, esophagus, breast, stomach, thyroid, pancreas, liver
metastasis, mouth) representing 15.5% and a 17.9% respectively, of a total of 168
patients recruited.
Results: Pathologies related to cholédoco (26 surgeries, 13 men, 13 women) a 65.38%
of patients received adjusted prophylaxis to their degree of risk (76.5% with heparin
prescription and 23.5% without it) from all 11.53% of inadequate prescription (100%
of the patients with LMWH prescription); 6 patients lost follow up. Patients submitted
to cancer surgery (30 surgeries, 17 men, 13 women), 40% received apropiate prophylaxis
(83.3% with LMWH and 16.6% without it). Same percentage of patients (40%) was not
adapted to correct prophylaxis (100% patients with LMWH); 6 patients lost follow up.
Conclusions: There is a greater percentage of choledoco surgery patients with LMHW
prescription in compliance with published guidelines than oncology surgery patients,
however it will be necessary carry out a better implementation
among healthy professionals in order to increase this percentage of patientes.
References
Vilar Fernandez I y col. Evaluación de la utilización de heparinas de bajo peso molecular
como profilaxis de tromboembolismo venoso en pacientes de medicina interna. Farmacia
hospitalaria 28;6.402–409.
The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based
Guidelines. Evidence-Based Guidelines. CHEST 2004; 126(Supplement 3)
Keywords: Heparin low molecular weith, Thromboembolism, Prophilaxis
PT-97 Alternatives in the treatment of refractory dermatomyositis
Francisco Moreno
1, Diana Gonzalez1, Elena Fuentes1, Marta Gallego1, Angeles M. Tacoronte1, Yolanda
Larrubia1, Esperanza Jimenez1
1Pharmacy, La Paz University Hospital, Madrid, Spain
Background and Objective: Effectiveness of infliximab and rituximab in a patient diagnosed
of refractory dermatomyositis (DM). The idiopatic inflammatory myopathies constitute
a group of disorders characterized by muscle weakness, increased of muscle enzymes
levels, dermatologic features and abnormalities found in muscle biopsy and electromyography.
Most patients respond to corticosteroids.
Design: Retrospective study of a case of refractory dermatomyositis.
Setting: Rheumathology, Dermatology and Pharmacy Departments. University hospital
La Paz. Madrid. Spain.
Main Outcome Measures: Creatine phosphokinasse (CPK), aspartate aminotransferase (AST),
alanine aminotransferase (ALT) and lactate dehydrogenase (LDH).
Results: A 40-year-old female diagnosed of DM in October 1997. She firstly presented
a rash on her hands and knees, the laboratory studies revealed an elevation of muscle
enzymes, and the patient had dysphagia and respiratory failure requiring mechanical
ventilation. CPK of 164 UI/L; AST of 28 UI/L; ALT of 22 UI/L; LDH of 459 UI/L. During
seven years, the treatment consisted of different doses of corticosteroids and methotrexate(10 mg/week)
and was changed to cyclosporine (50 mg/12 h) and azathioprine (50 mg/7 days) since
the patient showed esteroid myophaty and progressive muscular weakness. No significant
improvements were observed, so a new treatment with infliximab 5 mg/Kg is begun as
off-label use. Nevertheless, after the fourth infusion the patient developed an infusional
reaction and infliximab was withdrawn. To date, the patient has received 2 doses of
rituximab(1000 mg) as off-label use without any complication, being the current levels:
CPK of 135 UI/L; AST of 19 UI/L; ALT of 15 UI/L; LDH of 334 UI/L.
Conclusions: B-cell depletion therapy with rituximab may be a viable option in patients
with dermatomyositis refractory to current therapies. More studies are needed to determine
the efficacy of anti-TNF (infliximab) and rituximab in DM
References
Noss EH et al. Rituximab as therapy for refractory polymyositis and dermatomyositis.
J. Rheumatology 2006 May; 33(5): 1021–6.
Sylvia D. et al. Treatment of early and refractory dermatomyositis with infliximab:
a report of two cases. Clinical Rheumatology(2007)26: 1186–1188.
Keywords: Dermatomyositis, Rituximab, Infliximab
PT-132 Multi-field evaluation of antibiotherapy quality in a university hospital
Coralie Lepage1, Frédérique Bouchand1, Rachel Favreau1, Anne-Claude Crémieux2, Christine
Lawrence3, Catherine Bouiri
1, Jean-Charles Nicoulaud1, Maryvonne Villart1
1Pharmacy, 2Infectiology department, 3Bacteriology, Hopital Raymond Poincaré, APHP,
Garches, France
Background and Objective: Bacterial resistances, compromising antibiotics efficiency,
constitute a major problem of public health. Their emergence is related on overconsumption
and misuse of antibiotics. Checking the use of antibiotics could help to prevent this
phenomenon. In May 2007, the anti-microbial drug commission of the hospital set up
a study in order to evaluate the appropriateness of prescriptions of 5 broad-spectrum
antibiotics: vancomycin, teicoplanin, ceftazidim, piperacillin/tazobactam, imipenem/cilastatin.
Design: A multi-field team, composed with infectious disease physicians, pharmacists
and bacteriologists, was involved in this study. An evaluation schedule was mapped
out. This work presents the preliminary results, based on 1 month.
Setting: Every care units, including orthopaedic surgery, intensive care, medicine
and rehabilitation departments.
Main Outcome Measures: Relevance of indications, choice of the antimicrobial agents,
duration of the treatment, dosing and adjustment of treatment regarding bacteriological
results were analysed by members of the multi-field team.
Results: 55 prescriptions of these broad-spectrum antibiotics were collected and analysed.
58% of the prescriptions were initiated by residents, 42% by senior physicians. Vancomycin
was the most prescribed antibiotic (53%), mainly in the orthopaedic surgery unit.
The indications of antibiotics were osteomyelitis (31%), septic arthritis (15%), prosthetic
joint infections (13%) and pneumonia (11%). Only 13% of antibiotic doses were not
correctly adapted to creatinine clearances or to plasmatic vancomycin rates. The initial
choice of antibiotic was considered appropriate in 90% of cases. Regarding bacteriological
results (bacteria, antibiogram), the continuation of the treatement was acceptable
in 80% of cases. However in 20% of prescriptions, an adjustment of therapy with a
more narrow spectrum antibiotic could have been done.
Conclusions: These results have to be extended with further investigation (at least
3 months). The improvement of the quality of antibiotherapy in health care establishments
go through a decrease of prescriptions and optimization of the treatments. This clinical
study, carried out by a multi-field team, gives a reliable evaluation of antibiotherapy
practices in the establishment. Corrective actions are considered.
Keywords: Broad-spectrum antibiotic, Multi-field evaluation, Antibiotherapy quality
PT-134 Care givers’ assessment of the sedation drug use in an adult intensive care
unit (ICU)
Pierre Voirol
1, Anne Laure Blanc1, Valia Humbert Delaloye1, Laurence Van Tulder2, Laurent Gattlen2,
Rene Chiolero2, Andre Pannatier1
1Dept of Pharmacy, 2Adult ICU, University Hospital CHUV, Lausanne, Switzerland
Background and Objective: Sedation and analgesia are crucial therapies in ICU but
few guidelines for their use are available. A recent retrospective local study showed
that the drugs and doses used in the local adult ICU are similar to reports in the
literature. Propofol, morphine, fentanyl and midazolam are the most prescribed drugs.
This study aimed at measuring the nurses’ and physicians’ global assessment of the
patient sedation and at comparing the results with those of the retrospective study.
The final aim was to evaluate the need for local guidelines on ICU sedation.
Design: Two anonymous 10-item questionnaires were developed for this protocol. The
first one, sent to the 36 physicians of the ICU, included also 4 additional clinical
cases to discuss. The second one was send to the 207 nurses. 6 questions were the
same in both questionnaires.
Setting: 34-bed adult ICU of a university hospital
Main Outcome Measures: Physicians’ and nurses’ perception of sedation.
Results: 47 percent of physicians and 15% of nurses returned the questionnaire despite
3 reminders. 47% physicians and 50% nurses considered the sedation adequate in 50–75%
cases and 47% and 27% respectively considered it adequate in 75–90% cases. When the
sedation was rated as inadequate, 80% of the nurses thought that patients were under-sedated
while over-sedation was mentioned by 65% of the physicians. The vast majority of physicians
(76%) and nurses (93%) mentioned using the sedation agitation scale (SAS) on a regular
basis and 87% of physicians said that they prescribed a daily interruption of sedation.
However, a daily interruption was observed in only 20% of cases during the retrospective
study. This discrepancy could partly be explained by the lack of response from medical
residents. Moreover, in practice, the sedation level is sometimes just decreased to
allow a clinical evaluation of the patient without a formal interruption of the administration
of esdatives. This could also explain the very low percentage observed. The discussion
of the 4 clinical cases showed a large variability in the choice of sedative drugs.
This demonstrated a lack of consensus among the prescribers. The implementation of
local guidelines for the sedation was requested by nurses and physicians.
Conclusions: This study demonstrated a large diversity among prescribers in the management
of sedation. Hence, the need for guidelines exists. Such a document also requested
by nurses and physicians. Once the new guidelines will be available, teaching to the
nurses and to the medical residents has to be provided. The enhancement of the communication
between physicians and nurses about the level of sedation and its goal has to be promoted.
The pharmacist will contribute to the elaboration and implementation of the guidelines.
Keywords: Sedation, Guidelines, ICU
PT-135 Breast cancer: analysis of different treatments (2005–May 07)
Gisela Costa
1, Armando Alcobia1
1Pharmacy, Garcia de Orta Hospital, Almada, Portugal
Background and Objective: Breast cancer is the most common malignancy in women in
Portugal. The treatment of breast cancer includes the surgery, radiation therapy or
both, cytotoxic chemotherapy, endocrine and biological therapy or combinations of
these. The aim of this study was to analyse the drugs use in breast cancer (chemotherapy
schemes and hormonal agent) and haematopoietic growth factors needs.
Design: A retrospective study was carried out of women with breast cancer diagnosis
who received chemotherapy/hormone therapy during 2005–May 2007. Data collected included:
age, sex, stage disease, type of treatment, treatment line. Data was obtained from
a computer application (SONHO) and medical order. A statistical evaluation was made
with SPSS 11.0.
Setting: Oncology Day Hospital and Pharmacy Department of Garcia Orta Hospital.
Main Outcome Measures: Evaluation of different combinations of cytotoxics used in
treatment of breast cancer.
Results: The study included 192 patients, 190 female and 2 male. The mean age was
55.59 ± 12.96 years. In this study 19.8% patients had metastatic disease. Sixteen
combinations of cytotoxics in first line treatment were identified. The most common
regimens was the FEC scheme (5-Fluorouracil, Epirubicin, Cyclophosphamide), used in
39.6% of patients. In second line treatment 36.5% received docetaxel. In third line
20% of patients used G + VNB scheme (Gemcitabine, Vinorelbine). In first line treatment
taxanes-based therapy was used in 25.7% of patients in 2005, 20.8% in 2006 and 12.1%
in 2007. The anthracycline-containing therapy was used in first line in 45.9% (2005),
70.8% (2006) and 72.7% (2007). In early stage disease, the taxanes was used in 17.4%
of patients in 2005, 50% in 2006 and 53.8% in 2007. In metastatic breast cancer the
most used regimens are Docetaxel, Gemcitabine + Vinorelbine, Capecitabine, Doxorubicin
Liposomal and Trastuzumab + Paclitaxel. In relation to endocrine therapy, tamoxifen
was used in 34.4%, letrozol in 19.8% and 18.7% of patients change the hormonal agent
prescription. The therapy with filgrastim was used in 47.9% of patients and 6.8% received
darbepoetin. The patients with filgrastim prescription 51.1% received FEC scheme.
The mean of units used was higher in TAC scheme (Docetaxel, Doxorubicin, Cyclophosphamide)
23.14 ± 9.15 units.
Conclusions: The therapeutic options for patients with breast cancer are complex and
varied. The use of taxanes-containing regimens in first line decrease in 2006 and
increasing the use in early stage disease. In literature taxanes are not recommended
as an option for the treatment of early breast cancer. The increasing use of taxanes
treatment will potentially alter treatment strategies of patients with metastatic
breast cancer. The state-of-the-art treatment of metastatic breast cancer depending
on disease-associated and biological variables.
References
National Comprehensive Cancer Network, Practice Guidelines in Oncology, 2007.
Keywords: Breast cancer, Chemotherapy, Analysis
PT-143 Dose efficiency observed with darbepoetin alfa in renal patients previously
treated with epoetin: a meta-analysis
X Bonafont
1, M Iskedjian2, M Machado2, R Aziziyeh2, T Einarson3, S Robbins4, B Molemans5, B
Dehmel5
1Pharmacy, Hospital Universitari Germans Trias Pujol, Badalona, Spain, 2, PharmIdeas,
Oakville, 3Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada,
4Health Economics, 5Medical Affairs, Amgen Europe GmbH, Zug, Switzerland
Background and Objective: Anemia is a common complication in patients with chronic
kidney disease undergoing dialysis. Erythropoeisis stimulating agents (ESAs) such
as epoetins alfa and beta (rHuEPO) and darbepoetin alfa (Aranesp®; DA) are effective
treatments of anemia. DA is a longer-acting ESA that can be administered less frequently.
Previous studies have suggested that when patients are converted from rHuEPO to DA
using an initial rHuEPO:DA conversion ratio of 200:1 (Aranesp® EU label), the DA dose
can be reduced while maintaining Hb levels. In this study, we estimated the relative
doses of DA required to maintain comparable Hb levels in dialysis patients switched
from rHuEPO.
Design: Medline (1956–2007) and Embase (1980–2007) were systematically reviewed to
retrieve prospective trials describing ESA doses in dialysis pts who converted from
rHuEPO to DA. Search words included: “epoetin, darbepoetin, ESRD, CKD, and dialysis.”
The inclusion criteria required a study to have dose data available during the evaluation
period for both rHuEPO and DA. Study selection and data extraction were performed
by 2 independent reviewers and verified by a 3rd. Relative doses and dose changes
after conversion from rHuEPO to DA were estimated using an initial rHuEPO:DA 200:1
conversion ratio (Aranesp® EU label). Study quality assessment was performed using
the Downs-Black checklist, a standard method used to assess the quality of a study
using EBM principles.
Setting: Meta-analysis.
Main Outcome Measures: Dose efficiency.
Results: The search yielded 34 studies meeting the inclusion criteria. Upon further
review, 19 studies were excluded (14 had unextractable data, 3 were retrospective
analyses, and 2 had predialysis pts). The remaining 15 studies were analyzed: 3 RCTs
with parallel control groups, 3 cross-over trials, and 9 observational conversion
studies (table). The studies yielded data on 3,380 rHuEPO and 3,164 DA pts, with a
mean treatment duration being 21 weeks. We found the average study quality was 70%,
with RCTs (n = 663) having a higher quality score (87%) than crossover (72%; n = 497)
or observational (66%; n = 5384) studies. There was a notable dose efficiency observed
when pts were converted to DA from rHuEPO. This effect was greater in the RCTs (27.5%)
than in crossover (19.1%) or observational (12.1%) studies.
Conclusions: We found a notable DA dose efficiency (up to 27%) in pts who were converted
from rHuEPO to DA using a 200:1 conversion ratio. Additionally, studies with the highest
quality scores (eg RCTs) had the greatest observed dose efficiency while non controlled
studies scored lowest in both quality and dose efficiency.
Keywords: Darbepoetin, Epoetin, Dose efficiency
PT-150 An evaluation of systemic and topical treatments of otitis media: a hospital
study in Turkey
Mert Eken1, Betul Okuyan
1, Mesut Sancar1, Mehmet Eken2, Fikret Vehbi Izzettin1
1Clinical Pharmacy Department, Marmara University – Faculty of Pharmacy, 22nd ENT,
Kartal Training and Research Hospital, Istanbul, Turkey
Background and Objective: The purpose of this study is to evaluate the frequency of
otitis media and the assessment of its relationship to patients’ socio-demographic
characteristics and determination of systemic and topical drug profiles in otitis
media.
Design: This retrospective study included the assessment of patients diagnosed with
otitis media, who admitted to the study hospital during a 3 months period (March–May
2006). Demographic, clinical and prescription data of these patients were collected
and analyzed.
Setting: The ear-nose-throat out-patient clinic of a states hospital.
Main Outcome Measures: The socio-demographic data of patients; the frequency of otitis
media; type and percentage of prescribed drugs; the most used treatment regimens.
Results: 216 patients (122 women and 94 men), who were diagnosed with otitis media,
were included in our study. Patients were diagnosed as chronic otitis media or serous
otitis media or acute otitis media or external otitis media at rates of 37.5%, 30.5%,
20.4%, and 11.6%; respectively.
In children, the acute and serous otitis media were seen more often than in adults
(p < 0.05). However, chronic otitis media were seen more frequently in adults (p < 0.05).
All patients were administered drug therapy for their diseases.
It was observed that antibiotics (oral and/or topical), analgesics, decongestants,
and topical corticosteroids were prescribed at rates of 99.1%, 88.0%, 76.8%, and 7.4%;
respectively. Prescribed oral antibiotics were cephalosporins [cefixime (17.6%), cefuroxime
axetil (15.6%) and cefaclor (8.3%)], amoxicillin-clavulanate, and floroquinolones
[levofloxacin (10.7%) and ciprofloxacin (9.8%)] at rates of 41.5%, 38%, and 20.5%
respectively. Rifampin and ciprofloxacin were prescribed as topical antibiotics at
rates of 87.5%, 12.5% respectively. When the number of drug used by the patients was
evaluated, 38 were on quadri-therapy, 126 on tri-therapy, 46 on dual-therapy and 6
on mono-therapy. 89 patients were treated with the combination of antibiotic-analgesic-decongestants.
Conclusions: Our study indicated that the most frequently prescribed drugs were antibiotics
in otitis media. Clinical pharmacists have a potential role in rational antibiotic
use by providing clinical pharmacy services such as antibiotic selection, drug monitoring
and patient education; so that they would reduce both antibiotic resistance and treatment
costs.
PT-152 Antineoplastic chemotherapies monitoring: sampling method optimization
Christophe Bazin
1, Bruno Cassard1, Marie-Christine Gerain1, Isabelle Frazier1, Brigitte Bonan1, Patrice
Prognon1, Laurent Havard1
1Pharmacy, Hôpital Européen Georges Pompidou, Paris Cedex, France
Background and Objective: The sampling method is crucial for the physical and chemical
quality control of antineoplastic chemotherapies. This step acts upon the dosage correctness
and may lead to risk of needle-stick or cytotoxic drug projection during its achievement.
Beyond, the sampling time must be as short as possible and the sample be directly
placed on the analysis machine. This work evaluates a new and improved sampling method,
specially worked out for this application.
Design: This study was designed to ensure the vial airtightness and the volume sampling.
A cost and time study was also performed.
Setting: The vial is an HPLC type, Chromacol® 2 mL, 12 × 32 mm DP = 500 hPa, (Interchim®,
Montluçon, 03). The vial is airtight thanks to a PTFE silicon septum set with an aluminium
collar. The vials are vacuum-packed in a PVC bag (DIDOP®, Compiègne, 60). A void test
was led on unpacked vials up to 3 months, to ensure a maximum conservation, and showed
a filling volume of 448 ± 90 μL, very close of the 500 μL target.
Main Outcome Measures: One week samples have been weighed to calculate the filling
volume in real conditions of use. This volume is 747 ± 17 μL ranging from 220 to 1130
μL. Since this sampling method has been set up, the percentage of refusal for insufficient
volume is lower than 0.1%. This technique was compared to the previous method in terms
of cost: vial, sampling adjuncts, handling-time and waste. The vials are filled with
a secured double-needle Eclipse®, 32 mm, 7/10 (Becton-Dickinson®, Le-Pont-de-Claix,
38).
Results: About 10,000 chemotherapies controls are made each year in the hospital.
The vial and the sampling device costs are higher than the previous (1 € versus 0.25
€, and 0.29 € versus 0.05 €). On the contrary, the handling-time for sampling was
estimated 1 minute lower (which corresponds to 0.388 € less per sample). Furthermore,
the waste weight is 1 gram lighter with the new devices, which costs 0.003 € less
in the waste disposal. The total cost difference is 0.60 € higher per sample. An estimation
of a needle-stick accident has been carried out, with the human cost (pharmacist technician’s
compensation and medical consulting) and the equipment including gloves, sterilization
devices and post-sterilization check; the lowest estimation cost of an accident is
274.58 €.
Conclusions: The secured needle makes the sampling operation easier for the workers
and it lowers the risk of needle-stick. Besides, this closed system avoids completely
the antineoplastic contact for the manipulators during the confection and the control.
Moreover, this system allows to secure the sample library.
Keywords: Chemotherapy, Monitoring, Sampling, Quality control
PT-158 Audit of cardiovascular risk management in diabetic outpatients in Kuwait
Phillip Capps
1, Ahmed S. Abdelmoneim1
1Faculty of Pharmacy, Kuwait University, Jabriya, Kuwait
Background and Objective: The prevalence of diabetes mellitus in Kuwait ranks amongst
the highest in world at about 15%. Diabetes is a well recognized independent risk
factor for cardiovascular disease (CVD). The increased prevalence of several other
known risk factors for CVD in Kuwaiti diabetics further increases the risk. Since
CVD is the leading cause of death in Kuwait, the high incidence of diabetes has major
social and economic impact. Diabetics aged 40 years or older have, in general, an
increased 10-year risk of developing CVD compared to younger patients but there have
been no audits involving this group of patients in Kuwait. The objective of this study
was therefore to audit achievement of CVD risk factor goals according to JBS2 guidelines
(1).
Design: Retrospective audit of patient medical notes.
Setting: Patients aged 40 years or older scheduled to attend the diabetic outpatient
clinic at a major hospital in Kuwait during the period September 2006 to March 2007
were included in the study.
Main Outcome Measures: Percentage of patients achieving optimum and minimum audit
standards for serum total cholesterol, LDL-C, glycosylated haemoglobin (HbA1C), BP
and take up of aspirin.
Results: Out of the 201 patients included in the study, 51.2% were men, 92% were Kuwaiti
nationals, mean age was 58.13 years (SD ± 9.795; median = 57), 89.5% had type 2 diabetes
and 39.8% were obese (≥30 Kg/m2). Clinical CHD, CVD and PVD were present in 24.9%
(n = 50), 1.5% (n = 3) and 3% (n = 6), respectively.
Hypertension was diagnosed in 133 patients. Of these, only 28.6% (n = 38) had achieved
the optimum treatment standard of <130/80 and 95.5% (n = 127) of patients were receiving
at least one antihypertensive. Values for total cholesterol and LDL-C were documented
for 153 and 157 patients, respectively. Of these, optimum treatment standards for
total cholesterol (<4 mmol/L) and LDL-C (<2 mmol/L) were achieved by 34.6% (n = 53)
and 23.6% (n = 37), respectively. Patients within the minimum audit goal for total
cholesterol (<5 mmol/L) and LDL-C (<3 mmol/L) were 74.5% (n = 114) and 65.6% (n = 103),
respectively.
HbA1C values were documented for 185 patients. Of these, the optimum treatment standard
(HbA1C 6.5% or less) and minimum audit goal (HbA1C 7.5% or less) was met by 9.7% (n = 18)
and 33.5% (n = 62), respectively. Male patients were significantly more likely than
females (P < 0.05) to be within the minimum audit goal for HbA1C. Patients meeting
this standard were also more likely to meet the minimum audit goal for cholesterol
(<5 mmol/L). 111 of 177 patients who fulfilled the JBS2 criteria for antiplatelet
therapy were receiving aspirin. One patient was taking clopidogrel.
Conclusions: Although achievement of key treatment goals compares favourably with
studies from other countries, a high percentage of patients still did not achieve
optimum goals for BP, cholesterol and glycaemic control. Documentation for some parameters
could be improved.
Reference
JBS2: Joint British Societies’ guidelines on prevention of cardiovascular disease
in clinical practice. Heart 2005;91(suppl_5):v1–v52
Keywords: Audit, Diabetes, CVD
PT-180 Pediatric use of infliximab: retrospective study
Vanida Brunie
1, Sandrine Roy2, Ariane Blanc1, Francoise Brion1, Olivier Bourdon1
1Pharmacy, Robert DEBRE, 2Pharmacy, AP-HP – Robert DEBRE, Paris, France
Background and Objective: In June 2007, the use of infliximab has been approved by
EMEA for the treatment of severe active Crohn’s disease in pediatric patients aged
6 to 17 years old, who have not responded to conventional therapy (corticosteroid,
immunomodulator and nutrition therapy). However, pediatricians were already using
infliximab for patients with inflammatory bowel syndrome (IBD) such as Crohn’s disease
(CD), ulcerative colitis (UC) and indeterminate colitis (IC). The goal of the study
was to analyze infliximab prescriptions for children and to evaluate changes in prescriptions
of corticosteroid due to the introduction of infliximab.
Design: Retrospective study in 33 IBD patients in a pediatric teaching hospital.
Setting: Gastroenterology unit and pharmacy department.
Main Outcome Measures: Indications, infliximab dosage, anterior treatments, reason
of therapeutic change (non-tolerance or inefficiency of anterior treatment and/or
cortico-dependance), evolution of corticosteroid dosage 3 and 6 months after the introduction
of infliximab.
Results: Thirty-three children were treated by infliximab: 20 CD, 3 UC and 10 IC.
Age for diagnosis was an average of 11 years old (5.2–16.5) and 13.5 years old (7–17)
for the beginning of infliximab. Previous treatment to infliximab was immunomodulators,
single therapy for 31 patients (azathioprine n = 23, mercaptopurine n = 3, methotrexate
n = 5) or dual therapy (n = 2 azathioprine + methotrexate), with corticosteroids (n = 32)
and/or mesalazine (n = 6). Various etiologies justified infliximab administration:
corticodependance (n = 31), corticoresistance (n = 1), non compliance to corticotherapy
(n = 1), insufficient efficacy of previous treatment (n = 23), non tolerance to previous
treatment (n = 2). At the beginning, dosage of infliximab was 5 mg/kg. Dosages were
increased (10 mg/kg) for 6 patients due to insufficient clinical results. One patient
also had to be switched for adalimumab because he developed human antichimeric antibody
(HACA). Among corticodependant patients (31), corticosteroids have been stopped after
3 or 6 months, 9 (29%) and 19 patients (61%) respectively. For 12 patients, corticosteroids
were continued without reduction of dosages, six months after the introduction of
infliximab.
Conclusions: Infliximab is the only therapeutic alternative for children who are non
tolerant or non respondent to conventional treatment. Moreover, this treatment permits
the use of decreased dosage of corticosteroids, limiting their side effects, especially
on children growth. However, HACA occurrence could limit its use in a long-term disease.
Keywords: Infliximab, Inflammatory bowel syndrome, Pediatrics
PT-187 An assessment of professional practices about antifungal agents prescriptions
in the department of conventional hematology at Nantes University Hospital
Véronique Sylvestre-Baron
1, Bénédicte B. B. Bernadac1, Sylvie S. J. Jaccard1, Laurent L. F. Flet1, Philippe
P. M. Moreau2, Patrick P. T. Thomare1
1Hôtel Dieu Pharmacy, 2Conventional Hematology, Nantes University Hospital, Nantes,
France
Background and Objective: Invasive fungal infections represent a major threat for
patients with haematological malignancies, with an important rate of morbidity and
mortality. New triazole antifungal agents have recently been introduced to treat them
but some resistances emerge. The aim of this study was to assess professional practices
about antifungal drugs prescriptions according to Hematology Department guidelines
and French recommendations.
Design: Three-month period (2006) retrospective observational cohort study including
all patients treated with an antifungal agent.
Setting: Conventional Hematology Department, Nantes University Hospital.
Main Outcome Measures: Data were collected on patient medical files: pathology, antifungal
treatments, dosage, treatment length, nephrotoxic associated drugs, clinical and biological
parameters as weight, creatininemy, previous fungal infections, previous treatments
with triazole antifungal drugs.
Results: Fifty-three patients (29 men and 24 women) received antifungal drugs (mean
age: 53 years [22–68]) for 11.6 +/– 9.5 days. A hundred and four prescriptions were
studied. Five patients died during this period (two deaths because of a Fusarium sp.
and Aspergillus sp. septicaemia).
Chemotherapy indication was autologous Bone Marrow Transplant (BMT) (54%), leukaemia
chemotherapy induction or consolidation (15%), leukaemia intensive chemotherapy (21%),
myeloblastic allogeneic BMT (2%) and mini allogeneic BMT (8%).
Treatments were prophylactic (60%), empirical (13%) or curative (15% for Aspergillus
sp but no for Candida sp infections); 8% of the prescriptions related to local candidosis
and 4% remained unknown.
Although 66% of prescriptions were in accordance with internal guidelines concerned
antifungal drug indication, 26% had wrong dosages e.g. no loading dose for voriconazole.
Moreover, only 22% of the prescriptions were in accordance with French recommendations:
neither voriconazole is approved in prophylaxis of aspergillosis in patients with
autologous BMT nor antifungal drugs associations (ten prescriptions). Nevertheless,
it may be a good way of medical management as hopeful patients outcomes have been
obtained.
Conclusions: Hematology Department guidelines should be reviewed in accordance with
French recommendations, department’s ecology and the state-of-the-art about treatment
of fungal infections in patients with haematological malignancies. The accordance
to further recommendations should be regularly assessed as well as resistance emergence.
Reference
French guidelines for assumption of responsibility of Candida sp. and Aspergillus
sp. invasive infections. French Society of Anesthesia and Reanimation, French Society
of Infectious Pathology and French Society of Reanimation. May 2004
Keywords: Assessment, Antifungal agents, Hematology
PT-188 Pharmacotherapy of first-episode psychosis in the psychiatry clinics of the
North Estonia Regional Hospital (NERH) and the Tartu University Hospital (TUH)
Jana Lass
1, Agnes Männik2, Simon J. Bell3
1Pharmacy Department, North Estonia Regional Hospital, Tallinn, 2Institute of Pharmacy,
University of Tartu, Tartu, Estonia, 3Faculty of Pharmacy, University of Helsinki,
Helsinki, Finland
Background and Objective: Treatment guidelines provide recommendations for the evidence-based
treatment of schizophrenia. Adherence to these guidelines is often sub-optimal. Our
aim was to compare and contrast the pharmacotherapy of first-episode psychosis at
the NERH and TUHs, with respect to both treatment location and evidence-based guidelines.
Design: Retrospective study. Case notes for consecutive patients with schizophrenia,
schizotypal or delusional disorders (ICD-10) admitted to the NERH and TUH between
September 2005 and September 2006 were retrospectively reviewed.
Setting: Psychiatry clinics of two tertiary care hospitals – NERH and TUH.
Main Outcome Measures: Outcome measures included the choice and daily dose of antipsychotics,
incidence of antipsychotic polypharmacy and reasons for changes in therapy plan.
Results: 113 patients form NERH and 29 from TUH were included in the final analyses.
Median age (SD) of the patients was 35(13.8) in the NERH and 39(15.2) in the TUH Patients
were hospitalised for longer in the NERH than in the TUH, 31 (17.4) vs. 23(17.2).
The most frequently prescribed antipsychotic was risperidone at both study locations
– 37% of prescriptions in the NERH and 57% in the TUH. Conventional antipsychotics
were administered twice often in the NERH than in the TUH. In the TUH olanzapine was
administered in higher prescribed daily doses than in the NERH. The number of antipsychotics
prescribed per patient was higher in the NERH than in the TUH −1.7 vs 1.3. The prevalence
of antipsychotic polypharmacy was 13.3% among the patients in the NERH, whereas only
one patient was treated with antipsychotic polypharmacy in the TUH.
Conclusions: Analyses revealed significant differences in the pharmacotherapy of first
episode psychosis at the NERH and the TUH. Mechanisms to facilitate improved adherence
to the evidence-based treatment guidelines should be investigated.
References
Bowers L, Callaghan P, Clark N, Evers C. Comparisons of psychotropic drug prescribing
patterns in acute psychiatric wards across Europe. Eur J Clin Pharmacol 2004; 60:
29–35.
Kiivet RA, Llerena A, Dahl MA, Rootslane L, Vega JS, Eklundh T, Sjöqvist F. Patterns
of drug treatment of schizophrenic patients in Estonia, Spain and Sweden. Br J Clin
Pharmacol 1995; 40: 467–476
Keywords: Pharmacotherapy, Mental health
PT-195 Assessment of rituximab use in refractory autoimmune cytopenia
Marisol Ucha1, Inés Castro1, M. Teresa Inaraja1, Manuel Lite2, Amelia Troncoso
1, Ramón Cuíña1
1Pharmacy Department, 2Haematology Department, Meixoeiro Hospital, Vigo, Spain
Background and Objective: To evaluate the efficacy and safety of rituximab (RTX) for
the treatment of refractory autoimmune cytopenia, including autoimmune hemolytic anemia
(AHA) and immune-mediated thrombocytopenia (idiopathic thrombocytopenic purpura ITP
and thrombotic thrombocytopenic purpura TTP)
Design: Descriptive, retrospective study based on rituximab prescriptions analysis.
Patients were identified through medical reports delivered by compassionate use program.
Data collection was made through the pharmaco-therapeutic profile and medical chart
review
Setting: General Teaching Hospital (420 beds)
Main Outcome Measures: Patients who received any course of RTX for refractory immune
cytopenia from January 2004 to May 2007 were evaluated. Data recorded included patients
details, diagnosis, previous treatment, RTX schedule, number of courses and baseline
hemoglobin (Hb) and platelet count (PQ) values. Effectiveness and tolerance were also
considered. Response was evaluated according to criteria found in the literature:
clinical symptoms resolution and a normal PQ count of 100.000/mm3 for ITP/TTP or an
Hb level >10 g/dL achieved and maintained for at least 3 months for AHA. Additional
response criteria for AHA was an Hb increase >1.5 g/dL 1 month after the last dose
of RTX.
Results: 11 patients (4 men), 54 doses RTX; average age 65 years (range 31–85). Diagnosis:
AHA 7 (2 cases cold agglutinin disease), 3 ITP and 1 TTP. In 3 patients cytopenia
(AHA) was associated with chronic lymphocytic leukemia. All patients had been previously
treated with steroids and 8 had received 2 or more other treatment modalities (4 splenectomy,
7 immunosupressive agents, 7 intravenous immunoglobulin). Patients received 4–6 RTX
infusions at a standard dose of 375 mg/m2 once per week, in combination with steroids
therapy in 10 cases. No serious infusion-related effects occurred, but 2 patients
reported hematologic toxicity (fever and infection). All patients with AHA (7/7) and
2 patients with ITP (2/3) responded to the first course of RTX. One patient AHA had
relapse after 29 months and responded to retreatment. ITP responders achieved durable
response (16 and 3 months) and were offered second course of RTX after relapse (1
patients did not respond to retreatment). After 28 months follow-up, patient with
TTP remained with acceptable PQ counts. Hb levels increased by a median of 3.5 g/dL
(range 2–7,6) among the AHA responders. ITP + TTP responders achieved a median increase
in PQ count of 172.500/mm3 (range 67–188). Only responders who reached a 3 months
follow-up were considered for response duration assessment: 5 AHA, 1 TTP, 3 ITP (1
retreatment). Median response duration was 17 months (range 4–29) for AHA and 16 months
(range 3–31) for ITP + TTP
Conclusions: Most of the literature findings for RTX in this setting were related
to small series or isolated case descriptions. Despite the common limitation of the
number of patients, our results showed that RTX appears to be a promising agent for
the treatment of refractory autoimmune cytopenia.
Keywords: Rituximab, Autoimmune hemolytic anemia, Immune-mediated thrombocytopenia
PT-200 Is aprepitant useful in high dose chemotherapy regimen in hematology?
Marion Lafaurie
1, Clément Hubert1, Carole Fontenoy1, Muriel Menanteau1, Philippe Moreau2, Patrick
Thomaré1
1Unité de Pharmacie Clinique Oncologique, 2Hématologie clinique, CHU Hotel Dieu, NANTES,
France
Background and Objective: Chemotherapy-induced vomiting (emesis) can significantly
affect patient’s quality of life, leading to poor adherence with further chemotherapy
treatment. 2006 ASCO’s guidelines recommend the use of aprepitant associated with
ondansetron and corticosteroid for emesis induced by high-dose chemotherapy regimen
including cisplatin. The main purpose of this study is to determine if this antiemetic
strategy could be effective on acute and delayed emesis in patients undergoing a high
dose chemotherapy regimen in hematology.
Design: Prospective study among 30 patients receiving: melphalan 200 mg/m² or BEAM
(carmustine 300 mg/m², etoposide 200 mg/m² for 4 days, cytarabine 400 mg/m² for 4 days,
and melphalan 140 mg/m²) both highly emetic chemotherapy.
Design of a scale to score personal risks factors (6 to 7: standard risk, 8 to 13:
high risk)
Design of a therapeutic scheme following 2006 ASCO’s guidelines, as follow.
Day 1: Aprepitant 125 mg per os 1 h before chemotherapy
Ondansetron 8 mg IV 30 min before chemotherapy
Methylprednisolone (MP) 90 mg IV 30 min before chemotherapy
Days 2 and 3: Aprepitant per os 80 mg
Methylprednisolone per os 12 mg b.i.d.
For the BEAM strategy, this treatment is given on day 1 (carmustine) and on day 6
(melphalan).
The course of corticosteroid was reduced on purpose for, in hematology, patients have
previously received large doses of corticosteroids.
Setting: Hematology ward in Nantes teaching hospital.
Main Outcome Measures: Strategy was considered efficient if no vomiting or emesis
grade 1 or 2 occurred, according to the Common Terminology Criteria for Adverse Events
v.3.0 of the National Cancer Institute (USA) from day 1 to day 5.
Results: Primary results are promising. Of 22 patients (12 scored high risk, 6 standard
risk), 13 followed BEAM course, 9 melphalan high dose. No acute emesis occurred. Only
one patient (scored 10) vomited on days 2 and 3 after MP tablets were given (midday).
Even if our study does not focus on nausea, we notice that eleven patients required
additional treatment (metoclopramide 10 mg up to t.i.d) to control delayed nausea
from day 2 of aprepitant course.
Conclusions: The association of aprepitant, ondansetron and methylprednisolone seems
to be efficient in preventing high-dose chemotherapy-induced emesis (acute and delayed)
used in hematology as well as in oncology.
References
American Society of Clinical oncology guideline for antiemetics in oncology: update
2006. Kris and coll., J Clin Oncol, 2006: 24 (18);2932–2947
Keywords: Aprepitant, Emesis, Hematology
PT-201 Use of anti-TNF-alfa in rheumatoid arthritis
Maria Del Pilar Vicente-Sanchez
1, Carolina Aurora Apezteguía-Fernández1, Nuria Ibañez-Heras1, Noelia Garrido-Peño1,
Marta Arteta-Jimenez1
1Pharmacy, Hospital Universitario de Getafe, Getafe, Spain
Background and Objective: To analyze the use of TNF-alfa inhibitors in rheumatoid
arthritis diagnosed patients in a 600 bed hospital.
Design: Retrospective study of patients with anti-TNF-alfa during year 2006. The following
data were compiled: age, sex and anti-TNF-alfa prescription including dosage and duration
of treatment.
Setting: Hospital Universitario de Getafe.
Main Outcome Measures: Dosage and duration of treatment.
Results: A total of 69 patients were included. 51 patients (73.91%) received just
one anti-TNF-alfa drug, 17 (24.64%) needed two lines of treatment and 1 (1.45%) of
them needed three.
Patients who were treated with just one drug had a median age of 46.5 years and those
who required two lines of treatment had a median of 55.5 years.
The first line drug was etanercept in 37.68%, infliximab in 31.19% and adalimumab
in 30.43% of patients. Second option was etanercept in 37.68%, adalimumab in 31.88%
and infliximab in 30.43% of patients.
The average duration of treatment with etanercept as forward edge was 463 days. The
treatment was suspended in 42.31% of patients.
When infliximab was used as first line, average duration was 578 days, and treatment
was interrupted in 22.7%. With adalimumab, average duration was 435 days and treatment
was interrupted in 33% of patients.
Conclusions: Those of our patients who need an only one treatment line are younger
than those who need 2 or 3, due to the chronic and progressive course of the disease.
Etanercept is used as much in first option (followed by infliximab) as in second one
(followed of adalimumab), although these differences are not statistically significant
and it would be necessary to make a study including more patients.
The duration of treatment with infliximab is the longest, as this was the first drug
available. Regarding treatment failure, etanercept shows the greatest percentage.
This should be taken into account when establishing first line treatment.
PT-217 Topical cidofovir for the treatment of plantar warts: case report
Amelia Troncoso
1, Ramon Cuiña1, Juliana Alvarez1, Cristina Vazquez1, Maria Teresa Inaraja1, Francisco
Allegue2
1Pharmacy, Hospital Meixoerio, 2Dermatology, Hospital Meixoeiro, Vigo, Spain
Background and Objective: Plantar warts are hyperkeratotic lesions on the plantar
surface caused by infection with Human papillomavirus. Lesions caused by warts are
commonly refractory to therapy and may become large and painful in immunodeficient
patients. Cidofovir is a cytidine analogue with activity against a broad spectrum
of DNA viruses. It is indicated for the treatment of cytomegalovirus retinitis in
patients with acquired immunodeficiency syndrome and without renal dysfunction.
We describe a case of plantar warts that was treated with topical cidofovir in a highly
immunodeficient patient.
Design: Case report, evaluation and discussion based in clinical chart and literature
review.
Setting: Pharmacy department, General Teaching Hospital.
Main Outcome Measures
Plantar warts regression, which was evaluated on the basis of change in overall surface
area of the treated lesions compared with baseline.
To evaluate the organoleptics properties of the galenic formulation.
Results: A 29 years old woman, who received kidney transplant in 1996, presenting
plantar warts refractory to conventional therapy since last four years. She was treated
with topical 3% cidofovir cream twice daily. The treatment was authorised as compassionate
use by the national regulatory agency on drugs. The glomerular filtration rate (GFR)
was monitored in order to detect nephrotoxicity due to cidofovir.
The 3% cidofovir ointment was compounded as follows:
Cidofovir 75 mg/ml 5 ml vial .…….. 20 ml
Anhydrous Lanolin ……………………….. 5 g
Beeler base …..sufficient to produce 50 g
It was packaged and labelled in a light-resistant containers and we assumed an expiration
date of 3 months based on the duration of treatment and published studies. The quality
controls of organoléptics properties were made according to the Good Manufacturing
Practice (GMP)
After 10 weeks of therapy the patient did not show any improvement and developed severe
local erosion, so treatment with cidofovir was withdrawn. Two weeks later this local
erosion disappeared spontaneously. No systemic side effects were observed.
The colour, texture and smell organoleptics characters were complied with GMPs.
Conclusions: There are not formal studies of optimal formulations or treatment regimens
and further studies are needed to elucidate the role of cidofovir in treatment of
plantar warts. The immunodeficiency of the patient and the large wart area could be
related with the failure to the treatment.
Reference
Alonso Diez M, de Miguel Cascón M, Sánchez Moreno H, González Mielgo FJ. Cidofovir
tópico para tratamiento de lesiones cutáneas por Molluscum contagiosum y Papilomavirus
humano. XLIV SEFH Congress.1999; 156–57
PT-227 Safety of platinum salts skin testing
Julie Fillon
1, Francoise Baud1, Berangere Belmonte1, Annie Becker1, Francisque Leynadier2, Isabelle
Debrix1
1Pharmacy Department, 2Allergology Department, Hopital Tenon, Paris, France
Background and Objective: Hypersensitivity reactions (HR) to platinum salts can be
serious and should lead to interrupt chemotherapy regimen. Skin tests may be used
to confirm diagnosis of HR. Usually, these tests are prick tests and intradermal tests
performed with diluted solutions of platinum salts. There is no standard solutions
for these drugs, which local toxicity depends on concentration.
The main objective of this study was to assess the safety of platinum salts skin tests
performed in our hospital.
The secondary objective was to assess their efficacy to verify the allergic nature
of the reactions observed.
Design: Pilot study of skin tests preparations between January 2004 and June 2007.
These preparations were dilutions (1/10, 1/100, 1/1000) of a primary platinum salt
solution, which concentration was roughly the one used in the chemotherapy regimen
of most patients. The compatibility of platinum salts with dilution solvent was checked,
and all solutions were prepared extemporaneously in a centralised cytotoxic drug preparation
unit, in order to protect handlers.
Setting: Allergology department and pharmacy department in a university Hospital.
Main Outcome Measures: Skin tests results: positive if a papule appeared, negative
if there was no reaction, local toxicity if an irritative reaction happened.
Results: 11 patients with clinical symptoms of HR with a chemotherapy regimen containing
platinum salts were explored by skin tests.
Drugs assessed were: oxaliplatin (9 patients), cisplatin (4), and carboplatin (1).
No patient developed local toxicity.
Tests results were positive in 5 cases (4 oxaliplatin and 1 cisplatin), and negative
in 6 cases.
3 patients received both cisplatin and oxaliplatin skin tests: 2 patients had a single
positive reaction with no cross reaction between the two drugs, and the third had
no reaction.
In 4 cases, tests results and clinical history of hypersensitivity mismatched.
Conclusions: This study shows that these skin test solutions were safe. Their efficacy
was judged correct: 5 positive reactions confirmed the diagnosis of hypersensibility
for 5 patients. The main limit of the results is the absence of control subjects.
These tests allowed to explore 11 patients’ HR, and to help oncologists to choose
the more appropriate treatment for them. Stability studies are still needed to assess
the pharmaceutical quality of these diluted solutions. These preparations have now
been standardized in our hospital.
Keywords: Platinum salts, Hypersensitivity reaction, Skin tests
PT-237 Measuring compliance with antibiotic prophylaxis guidelines at a Belgian university
hospital
Lien Huenaerts1, Steven Simoens1, Bart Meyns2, Freddy Penninckx3, Ludo Willems
4
1Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit
Leuven, 2Division of Cardiac Surgery, 3Division of Abdominal Surgery, 4Hospital Pharmacy,
University Hospitals Leuven, Leuven, Belgium
Background and Objective: Guidelines regarding appropriate use of prophylactic antibiotics
have been implemented at University Hospitals Leuven. However, the degree of compliance
with these guidelines is unknown. The aim of this study is to develop a method to
quantify compliance with antibiotic prophylaxis guidelines and to apply this method
to the clinical areas of appendectomy and heart valve surgery.
Design: A retrospective case series was carried out of all prophylaxis episodes related
to appendectomy and heart valve surgery at University Hospitals Leuven between August
2001 and February 2007.
Four grades of compliance with antibiotic prophylaxis guidelines were identified:
grade 1 compliance, reflecting administration of the antibiotic proposed by the guidelines
in a dosage within 80–120% of the recommended dosage; grade 2 compliance, defined
as the administration of the antibiotic proposed by the guidelines in a dosage outside
80–120% of the recommended dosage; grade 3 compliance, referring to the administration
of an antibiotic equivalent to the antibiotic proposed, but not mentioned by the guidelines;
and grade 4 compliance, representing any other antibiotic prophylaxis scheme.
Setting: Divisions of Abdominal and Cardiac Surgery, University Hospitals Leuven.
Main Outcome Measures: The percentage of prophylaxis episodes that satisfy each grade
of compliance with antibiotic guidelines.
Results: Prophylaxis guidelines relating to appendectomy (1,191 episodes) recommend
administration of three times cefazolin 2 g and a single dose of metronidazol 1.5 g.
The proportion of episodes that satisfied grade 1, 2, 3 and 4 of compliance with guidelines
amounted to 5%, 58%, 6%, and 30%, respectively. Cefazolin 2 g and metronidazol 1.5 g
was used in 257 episodes.
Prophylaxis guidelines applying to heart valve surgery (2,182 episodes) recommend
administration of cefazolin 14 g. The proportion of episodes that satisfied grade
1, 2 and 4 of compliance amounted to 68%, 31% and 1%, respectively. Grade 3 does not
apply to heart valve surgery as no equivalent antibiotics were identified.
The difference in compliance with prophylaxis guidelines between both surgical procedures
could be explained by differences in infectious pathology, the peri-operative adaptation
of the antibiotic regimen by the abdominal surgeon, and the use of a second regimen
related to the severity of the appendicitis. A case can be made for combining grade
1–3 compliance with respect to appendectomy, resulting in a higher compliance rate.
Conclusions: Our proposed method to measure compliance needs to be validated by future
research. The method can be applied to different surgical procedures, thereby stimulating
surgeons to explain differences in compliance between procedures and promoting the
development of instruments to enhance compliance. Closer interaction with surgeons
is required to further develop the measurement of compliance with antibiotic prophylaxis.
Keywords: Antibiotic prophylaxis, Compliance, Guidelines
PT-240 Non-specific immunoglobulins for immune neonatal thrombopenia
Nuria Ibañez
1, Maria del Pilar M. P. Bautista1, Ana Maria A. M. Iglesias1, Roberto R. Ortiz2,
Javier J. Sanchez-Rubio1, Maria del Carmen M. C. Giron1, Marta M. Arteta1
1Pharmacy, 2Pediatry, Hospital Universitario de Getafe, Madrid, Spain
Background and Objective: Non-specific human immunoglobulins are being used at the
moment in neonatal population for treatment of immune thrombopenia. The dosis commonly
used varies between 400 mg/kg and 1 g/kg from one to five days. Corticoids and platelet
transfusions can be used jointly.
To study the effectiveness and safety of non-specific human immunoglobulins in a neonatal
unit for treatment of immune thrombopenia.
Design: Retrospective study of neonatal patients diagnosed with immune thrombopenia
during 2006 and treated with non-specific human immunoglobulins. A revision of clinical
histories is made and following data are collected: sex, gestational age, born weight,
age at the moment of infusion, administered dose and duration of treatment, use of
corticoids and platelet transfusions, number of platelets/μL before infusion, at 24,
at 48 hours of initiate the treatment and at discharge. Possible adverse reactions
is also considered.
Setting: Hospital Universitario de Getafe.
Main Outcome Measures: The effectiveness and safety of non-specific human immunoglobulins
for treatment of immune neonatal thrombopenia.
Results: Three children were included in the study, two of them were males. Thrombopenia
was diagnosed from probable alloimmune origin, including positive confirmation study
in one of the cases. Gestational ages ranged from 38 + 2 to 39 + 1 weeks. Born weight
ranged between 1.850 kg and 2.720 kg. Immunoglobulin treatment was initiated between
first and sixth day of life. Administered dose varies between 400 mg/kg/day and 1 g/kg/day
from two to five days. All children needed platelet transfusions, while only one of
them was treated with corticoids. The number of platelets/μL before infusion of immunoglobulins,
at 24 hours, at 48 hours and at discharge was: children 1: 41,000, 23,000, 81,000
and 116,000 platelets/μL. Children 2: 34,000, 22,000, 18,000 and 303,000. Children
3: 19,000 and 25,000 platelets/μL 24 hours after initiation of treatment, there were
no analytical data at 48 hours, but number of platelets at discharge was 355,000.
No adverse effects were observed in any children.
Conclusions: Although eventually the three children recovered the number of platelets,
it can not be concluded that this was due to immunoglobulin treatment, because it
is overlapped with administration of platelet transfusions and corticoids. A higher
number of patients is required
to evaluate efficacy and safety of non-specific human immunoglobulins in treatment
of neonatal thrombopenia.
Keywords: Immunoglobulins, Thrombopenia, Neonatal
PT-262 Sildenafil use evaluation for pulmonary hypertension in paediatric patients
Begona Feal Cortizas
1, Luis Margusino Framinan1, Marta Calvin Lamas1, Ines Raposo Sonnefeld2, Isabel Martin
Herranz1
1Pharmacy Department, 2Paediatric Cardiology Unit, Juan Canalejo Hospital, La Coruna,
Spain
Background and Objective: Pulmonary hypertension (PH) is one of the most difficult
childhood disease to treat. In Spain, oral sildenafil has recently been approved in
adults to treat PH, but it′s an off-label drug for children (its utilization must
be derived to “compassionate use”, which requires a prior National Health Authorities
approval for every children), and an oral suspension must be formulated at the pharmacy
department for them. The objective of this study is to analyse the use of oral sildenafil
for PH in paediatric patients.
Design: 4 years retrospective study. 100% paediatrics patients with oral sildenafil
for PH. Clinical data review.
Setting: Paediatric Cardiology Unit and Pharmacy Department (1 pharmacist) in a paediatric
hospital (300 beds), in a large general teaching hospital (1450 beds, 15 pharmacists).
Main Outcome Measures: Patient data (diagnosis, age, weight). Treatment description
(dose, length of treatment). Treatment effectiveness: peripheral arterial oxygen saturation
and six-minute walk test. Treatment security: side effects registered.
Results: 15 children (8 girls). Age: 3 months to 17 years, median 7.3 years. Diagnosis:
13/15 PH secondary to surgery due to congenital heart disease and 2/15 primary PH.
Sildenafil doses ranged from 0.3 mg/kg/8 h to 50 mg/8 h; median length of treatment
was 19.5 months (1 month–4.3 years). 8 children have used the oral suspension formulated
and monthly dispensed at the Pharmacy Department. Other treatments: spironolactone
(10), furosemide (8), captopril (4), acenocoumarol (2), aspirin (2), ranitidine (2)
and propranolol (1).
9 patients have experimented clinical improvement and are on treatment. Sildenafil
was withdrawn in 3 patients because it was indicated to ameliorate the effects of
inhaled nitric oxide withdrawn. 2 patients died. No data available in 1 patient.
Only 1 patient experimented occasional headache.
Mensual treatment cost range from 40–624 €/patient.
Conclusions: Oral sildenafilo seems to be a safe and effective therapy for paediatric
patients with pulmonary hypertensión. Due to the lack of an oral formulation for paediatrics
patients, it should be elaborated at the pharmacy department.
Keywords: Sildenafil, Pulmonary hypertension, Paediatric patients
PT-271 Treatment of an eye-disseminated invasive aspergillosis
Sonia Martelli
1, Clémence Moiron1, Emmanuelle Papy1, Xavier Arrault1, Philippe Arnaud1
1Pharmacy, Bichat Claude Bernard hospital, Paris, France
Background and Objective: We will describe the case of a bi-pulmonary transplant women
who developed an invasive aspergillosis located in the lungs and the brain. She received
intravenous voriconazole during 14 days. She was then diagnosed with an Aspergillus
endophthalmitis. Even though a dual therapy consisting of caspofungin and posaconazole
was initiated, the patient underwent a partial vitrectomy. This therapeutic failure
could be explained by a late diagnosis and insufficient vitreous and aqueous humor
penetration of the systemic drugs.
Design: A retrospective analysis of an endophthalmitis management.
Setting: Clinical Unit in a French Teaching hospital
Main Outcome Measures: To secure a high ocular concentration, the ophtalmologist recommended
voriconazole intravitreal injections. His prescription was based on several case reports.
Results: We found articles dealing with animal testing: one concluded that voriconazole
was a safe intravitreal agent which may be injected in human eye. Another study described
the successfull use of intra-ocular voriconazole to treat a fungal endophthalmitis:
it allowed a significant improvement in visual acuity and the patient’s recovery.
However, further studies are needed to assess the optimal dosage and frequency of
administration. We prepared voriconazole syringes under a horizontal laminar air flow
hood, as follows:
preparation of a 10 mg/mL solution with 19 mL of water for injection and dilution
in 9 mL of water for injection, to obtain a 1 mg/mL solution
we sampled 0.3 mL of this solution in a 1 mL syringe, which was closed with an occluder,
labelled and refrigerated.
Since we had no data regarding stability, it was administrated extemporaneously.
Conclusions: Intravitreal injections failed to prevent deterioration. Had they been
introduced precociously, they might have been more efficient. An early diagnosis and
prompt management might improve the extremely poor visual prognosis of this devastating
condition. Were are currently studying the preparation stability.
References
Kramer M, et al. Intravitreal voriconazole for the treatment of endogenous Aspergillus
endophthalmitis. Ophthalmology. 2006
Sen P, et al. Intravitreal voriconazole for drug-resistant fungal endophthalmitis:
case series. Retina. 2006 Oct
Yildiran ST, et al. Fungal endophthalmitis caused by Aspergillus ustus in a patient
following cataract surgery. Med Mycol. 2006 Nov
Gao H, et al. Intravitreal voriconazole: an electroretinographic and histopathologic
study. Arch Ophthalmol. 2004 Nov; Erratum in: Arch Ophthalmol. 2005
Breit SM, et al. Management of endogenous fungal endophthalmitis with voriconazole
andcaspofungin. Am J Ophthalmol. 2005
Aliyeva SE, et al, Histological examination of an eye with endogenous Aspergillus
endophthalmitis treated with oral voriconazole: a case report. Graefes Arch Clin Exp
Ophthalmol. 2004 Oct
Schelenz S, Goldsmith DJ, Aspergillus endophthalmitis: an unusual complication of
disseminated infection in renal transplant patients. J Infect. 2003 Nov
Keywords: Fongal endophthalmitis, Intravitreal, Voriconazole
PT-273 Security and effectiveness of tenofovir/didanosine associated to a protease
inhibitor
Maria Eugenia Martínez Núñez
1, Javier Sánchez-Rubio Ferrández1, Noelia Garrido Peño1, Carolina Apezteguía Fernández1,
Belén Hernández Muniesa1, Marta Arteta Jiménez1
1Pharmacy Service, Hospital Universitario de Getafe, Getafe, Spain
Background and Objective: In 2003 professionals were alerted about an elevated frequency
of early virological failure in patients treated with tenofovir (TDF) and didanosine
(ddI) associated to lamivudine. In 2005 similar results related to the administration
of TDF and ddI, in association with a non-nucleoside reverse transcriptase inhibitor
(NNRTI) were notified. Therefore similar events can be observed when TDF and ddI are
co-administered in combination with other antiretroviral classes, such as protease
inhibitors (PI). Subsequent pharmacokinetic studies have shown that TDF when co-administered
with ddI increases ddI plasma concentrations leves by up to 40–60%, with a higher
risk of didanosine-related adverse events, like pancreatitis and lactic acidosis.
The administration of a reduced dose of didanosine (250 mg) to avoid over-exposure
to didanosine may also contribute to a higher rate of virological failure and emergence
of resistance at early stage. The objective of the study is to asses the rate of virological
failure in patients treated with TDF and ddI associated to a PI.
Design: Retrospective study of patients VIH + treated with TDF/ddI/PI in the period
between October of 2003 and April of 2007. The data were collected from clinical records.
The main outcome was the development of virological failure, defined as detectable
plasma viral load (PVL) after 24 weeks, or repeated detection of HIV-RNA after virological
suppression. The determination of the PVL was made following the PCR technique, with
a limit of detection of 200 copies/ml (device COBAS AMPLICOR®).
Setting: Pharmacy Service.
Main Outcome Measures: Development of virological failure.
Results: Seven patients were included (six male) with an average age of 36.4 (SD = 5.6)
years, with 2.4 (SD = 0.78) previous treatments (all treatment-experienced patients),
and an average duration of 22 (SD = 13.9) months with tenofovir/didanosine/ritonavir-boosted
PI. Two cases of virological failure were reported, whose antiretroviral regimens
respectively included a dose of 400 mg and 250 mg of ddI. One of them was associated
to the lack of adherence. No serious adverse events were reported and no treatment
was suspended by this cause.
Conclusions: The combination tenofovir/didanosine/PI can be a safety and effective
alternative in treatment-experienced patients.
Keywords: HIV, Viral load, Antiretroviral therapy, Highly active
PT-278 Evaluation of drotrecogin alfa use for severe sepsis in an intensive care unit
of a Portuguese general hospital
Erica Viegas1, Patricia Cavaco
1, Nadine Ribeiro1, Fatima Falcao2
1Pharmacy Department, S. Francisco Xavier, CHLO, 2Faculty of Pharmacy Lisbon University,
Pharmacy Department CHLO, Lisbon, Portugal
Background and Objective: To audit the use of drotrecogin alfa (activated), considering
the National Institute for Clinical Excellence (NICE) Guidance.
Design: Retrospective study conducted from January 2004 to May 2007; NICE Guidance
on Drotrecogin alfa for severe sepsis review.
Setting: Medical intensive care unit ward in a general hospital
Main Outcome Measures: The patient’s mortality at 28 days; the time of administration
of the treatment in relation to the onset of severe sepsis; whether or not the patient
received the full 96-hour infusion, and if not, why not; the micro-organisms isolated
and the presence of absolute contraindication.
Results: During the study period 27 patients had prescription for drotrecogin alfa
for sepsis syndrome; 48.1% were male and the mean age was 58.7 years (range 16–83 years).
All patients had proven infection: 66.7% had pneumonia (n = 18), 22.2% pyelonephritis(n = 6),
3.7% soft tissue infection(n = 1) and 7.4% abdominal infection(n = 2). The main isolated
micro-organisms were Klebsiella pneumonia(n = 3), Escherichia coli(n = 2), Pseudomonas
aeruginosa(n = 1), Enterococcus faecium(n = 1), Staphylococcus aureus(n = 2), Legionella
pneumophila(n = 1), Proteus vulgaris(n = 1), Enterococcus faecium(n = 1), Klebsiella
oxytoca(n = 1). All patients started treatment within 24 h of the onset of severe
sepsis. The treatment was not completed in one patient due to adverse events. Contraindications
were present in 4 patients: platelet count <30.000 × 106/L (n = 2), age under 18 years
(n = 1) and major surgery (n = 1). The mean organ failures was 3.5 (range 2–5 organs).
Adverse reactions were present in 7 patients: thrombocytopenia (n = 3), pancytopenia
(n = 1), bleeding (n = 1) and elevation of activated partial thromboplastin time (n = 1).
Mortality at 28 days was found to be 37% (n = 10).
Conclusions: Despite the presence of some contraindications, in most patients drotrecogin
alfa was used according to current guidelines. Nevertheless, since APACHE II score
was not determined, the real risk of death is unknown and there can be no extrapolation
to literature results. Upon these findings, a systematic evaluation of APACHE II score
must be implemented in order to optimize patient selection and the risk-benefit ratio,
improving the use of drotrecogin alfa.
Reference
Drotrecogin alfa (activated) for severe sepsis, National Institute for Clinical Excellence
(NICE) Guidance, September 2004
Keywords: Drotrecogin alfa, Sepsis, Audit
PT-279 Clinical practice: dosage reduction of anticancer chemotherapy
Charles Aurélie
1, Fillon Julie1, Japkowicz Maxime2, Becker Annie1, Lotz Jean-Pierre2, Debrix Isabelle1
1Pharmacy, 2Oncology, Hôpital Tenon APHP, Paris, France
Background and Objective: It is necessary to focus on side effects for pharmaceutical
analysis. Dosage reductions are commonly used in cancer chemotherapy. However, little
is known concerning the way these reductions are performed in clinical practice. The
objectives were to evaluate the incidence, the reason and the percentage of dosage
reduction.
Design: Prospective four-week study during which we analysed prescriptions with dosage
reductions.
Setting: Pharmacy and clinical oncology department in a Paris university hospital.
Main Outcome Measures: We focused on prescriptions with dosage reduction and we recorded
:
Patient information
Cancer localisation
Chemotherapy regimen
Dosage reduction characteristics (date, reduction percentage, reason)
The toxicities were classified according to the NCI-CTC criteria (grade 1 to 4).
Individual interviews were performed in order to assess how physicians decided the
reduction ratio.
Results: 406 patients (53% women; mean age 57 years) have been treated during that
period. Diagnosis majority were breast (25%), colorectal (22%) and lung (16%) cancer.
66 patients required a dosage reduction (incidence 16%). Hematological toxicities
were the main cause of reductions (69%). The hematological toxicities observed were
thrombopenia (35%), neutropenia (25%) and neutropenia-thrombopenia associations (40%).
The toxicities observed were grade 3 (48%) or 4 (42%).
The other major causes of reductions were neurological (7%) and gastrointestinal (5%).
The average percentage of reductions was between 15% and 20%.
The individual interviews have shown that physicians didn’t base the dosage reductions
on literature results (established criteria) but on their own clinical practice (experience).
Conclusions: 16% of the prescriptions showed a decrease of the regimen.
Even if there is few literature, clinical trials recommend a decrease of 25% of the
usual dosage of the drugs. The percentage in practice is lower than the one defined
by clinical trials.
The choices of reduction percentage were not standardized. Recommendations for dosage
reductions are still needed.
Keywords: Dosage reduction, Anticancer chemotherapy, Toxicity
PT-294 Interdisciplinary approach to dose adjustment in patients with renal impairment
in secondary care
Liekweg A, Hinnerkort A, Ebeling G, Braband S, Dreischulte T, Heilenkötter K, Sander
S, Schiffmann S, Schrimpff U, Siems M, Wagner K, Weiland T, Zeigermann G, Melzer S
Hospital pharmacy of the Asklepios Kliniken Hamburg GmbH
Background and Objective: As part of a unit dose dispensing system, patient medication
profiles are routinely entered in an electronic database. Medication profile and laboratory
data are accessible online by clinical pharmacists. The project was conducted in order
to optimise pharmacotherapy in patients with renal impairment and to integrate the
clinical pharmacist in the therapeutic team.
Setting: Unit-dose supplied wards (n = 73) in four Asklepios hopitals in Hamburg with
approximately 1800 patients per day. The project was conducted in cooperation with
clinical pharmacists, physicians and the laboratory department over a period of 2.5 months
(12/06–02/07).
Programm description: Clinical pharmacists receive a list of all patients with an
estimated glomerular filtration rate (eGFR) < 30 mL/min/1,73 m2 (MDRD) from the laboratory
department on a daily basis. They screen medication profiles daily with regard to
apparently inappropriate dosing of renally excreted drugs (Qo < 0.5). Critical cases
are reported to physicians by phone or entry in medical case notes. Following an interdisciplinary
discussion with the physician the drug dose or dosing interval is either adjusted,
the medication is stopped or paused or an alternative is started. During the pilot
phase the number of altered medications as a result of pharmacists’ recommendations
was documented.
Results: A prevalence of 5% of patients with a eGFR < 30 mL/min/1.73 m2 was found
in the examined setting. During the pilot phase 1088 of 5013 prescribed drugs (21%)
were renally excreted or considered nephrotoxic. Antibiotics (26%), antidiabetics
(7%), diuretics (25%) or NSAIs (11%) were predominantly involved. Overall, 225 of
318 pharmaceutical recommendations (71%) were accepted and acted upon by physicians.
Conclusion: The number of recommendations demonstrates the importance of this service
in optimising pharmacotherapy. Clinical pharmacists’ contributions in matters of dose
adjustment in patients with renal impairment is well received by physicians especially
in non-nephrologic departments. The new service was found to be feasible in daily
practice and has become part of the clinical routine.
DI-37 Patinfo-rheuma: development of web-based patient information leaflets about
drugs used in rheumatic diseases – a multidisciplinary approach
Kirsten K Viktil
1, Camilla Bjørnstad2, Anne Glennås3, Frank Jørgensen4, Kristin Larssen2, Knut Midthaug5,
Terje Nordengen6, Marianne Wallenius7
1Diakonhjemmet Hospital Pharmacy and Department of Pharmacotherapeutics, Diakonhjemmet
and University of Oslo, Oslo, 2Hospital Pharmacy, Hospital Pharmacy North, Tromsø,
3Department of Rheumatology, Diakonhjemmet Hospital, Oslo, 4Hospital Pharmacy, Hospital
Pharmacy West, Bergen, 5NRF, Norwegian Rheumatism Association, 6NPF, Norwegian Psoriasis
Association, Oslo, 7NTNU, Norwegian University of Science and Technology, Trondheim,
Norway
Background and Objective: The sources and availability of drug information for patients
are growing, e.g. through the internet and official patient information leaflets (PILs).
However, the quality of the information on the internet might be questioned. Furthermore,
PILs are not standardized, the layout is not reader friendly and the information covers
all approved indications for the drug, some of them not relevant for rheumatic patients.
Also, over the years various information leaflets for drugs have been developed in
the departments of rheumatology in Norway. These are not standardized and the accessibility
is limited.
The objective was to develop a system for producing and maintaining reader friendly
patient information leaflets about anti-rheumatic drugs, which takes the quality assurance
aspect into account, and is easily accessible for the users.
Design: Development project, consensus method.
A national multidisciplinary project group was set up in December 2005, with members
from the Social leagues (two members), pharmacists’ organization (four) and rheumatologists’
organization (two). Mandate and regulations were approved by the organizations, as
well as a legal disclaimer.
The pharmacists make a draft for each drug which is e-mailed to all the members of
the group. Based on the comments a revision is made followed by another hearing until
consensus is reached. The rheumatologists approve the leaflet.
Setting: National multidisciplinary consensus including patients associations
Main Outcome Measures: Establishment of a dedicated website. Number of leaflets published.
Results: A web address for publication of the leaflets is set up on the home page
of the Norwegian Society for Rheumatology: www.legeforeningen.no/nrf. There is a link
to this address on the home pages of the Social leagues and the Norwegian Association
of Hospital Pharmacists.
During the first year 60 different drug leaflets have been developed and published
on the web site. It is possible to search by trade name, generic name and groups of
drugs such as “antiinflammatory drugs”, so the numbers of hits adding up to 87.
Conclusions: This national multidisciplinary approach has made it possible to develop
a system for making patient information leaflets about anti-rheumatic drugs, which
are standardized and easily accessible.
Keywords: Patient information leaflets, Drugs in rheumatic diseases, Multidisciplinary