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      Use of Simulated Patients to Evaluate Combined Oral Contraceptive Dispensing Practices of Community Pharmacists

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          Abstract

          Background

          Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use.

          Objective

          To evaluate the COC dispensing practices of CPs in a developing country.

          Method

          A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21 ® (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients’ medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated.

          Results

          Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., “do you smoke?” (n = 2) and “what is your age?” (n = 1). None of the CPs measured the patient’s blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects.

          Conclusion

          The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure.

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          Most cited references43

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          Risk of ischaemic stroke in people with migraine: systematic review and meta-analysis of observational studies.

          To explore the association between migraine and risk of ischaemic stroke. Systematic review and meta-analysis. Observational studies published between 1966 and June 2004 (identified through Medline and Embase) that examined the association between migraine and risk of ischaemic stroke. 14 studies (11 case-control studies and 3 cohort studies) were identified. These studies suggest that the risk of stroke is increased in people with migraine (relative risk 2.16, 95% confidence interval 1.89 to 2.48). This increase in risk was consistent in people who had migraine with aura (relative risk 2.27, 1.61 to 3.19) and migraine without aura (relative risk 1.83, 1.06 to 3.15), as well as in those taking oral contraceptives (relative risk 8.72, 5.05 to 15.05). Data from observational studies suggest that migraine may be a risk factor in developing stroke. More studies are needed to explore the mechanism of this potential association. In addition, the risk of migraine among users of oral contraceptives must be further investigated.
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            Medication Therapy Management: 10 Years of Experience in a Large Integrated Health Care System

            BACKGROUND: Medication therapy management (MTM) was officially recognized by the federal government in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which requires Medicare Part D plans that offer prescription drug coverage to establish MTM programs (MTMPs) for eligible beneficiaries. Even though the term MTM was first used in 2003, pharmacists have provided similar services since the term pharmaceutical care was introduced in 1990. Fairview Health Services, a large integrated health care system, implemented a standardized pharmaceutical care service system in 1998, naming it a pharmaceutical care-based MTM practice in 2006. OBJECTIVES: To present the clinical, economic, and humanistic outcomes of 10 years of delivering MTM services to patients in a health care delivery system. METHODS: Data from MTM services provided to 9,068 patients and documented in electronic therapeutic records were retrospectively analyzed over the 10-year period from September 1998 to September 2008 in 1 health system with 48 primary care clinics. Patients eligible for MTM services were aged 21 years or older and either paid for MTM out of pocket or met their health care payer's criteria for MTM reimbursement; the criteria varied for Medicaid, Medicare, and commercially insured enrollees. All MTM was delivered face to face. Health data extracted from the electronic therapeutic record by the present study's investigators included patient demographics, medication list, medical conditions, drug therapy problems identified and addressed, change in clinical status, and pharmacist-estimated cost savings. The clinical status assessment was a comparison of the first and most recent MTM visit to measure whether the patient achieved the goals of therapy for each medical condition (e.g., the blood pressure of a patient with diabetes and hypertension will be less than 130/80 millimeters mercury [mmHg] in 1 month; the patient with allergic rhinitis will be relieved of his complaints of nasal congestion, runny nose, and eye itching within 5 days). Goals were set according to evidence-based literature and patient-specific targets determined cooperatively by pharmacists, patients, and physicians. Cost savings calculations represented MTM pharmacists' estimates of medical services (e.g., office visits, laboratory services, urgent care visits, emergency room visits) and lost work time avoided by the intervention. All short-term (3-month) estimated health care savings that resulted from addressing drug therapy problems were analyzed. The expenses of these avoided services were calculated using the health system's contracted rates for services provided in the last quarter of 2008. The return on investment (ROI) was calculated by dividing the pharmacist-estimated savings by the cost of MTM services in 2008 (number of MTM encounters times the average cost of an MTM visit). The humanistic impact of MTM services was assessed using the results from the second patient satisfaction survey administered in 2008 (new patients seen from January through December 2008) for the health systems MTM program. RESULTS: A total of 9,068 patient records were in the documentation system as of September 30, 2008. During the 10-year period, there were 33,706 documented encounters (mean 3.7 encounters per patient). Of 38,631 drug therapy problems identified and addressed by MTM pharmacists, the most frequent were a need for additional drug therapy (n = 10,870, 28.1%) and subtherapeutic dosage (n = 10,100, 26.1%). In the clinical status assessment of the 12,851 medical conditions in 4,849 patients who were not at goal when they enrolled in the program, 7,068 conditions (55.0%) improved, 2,956 (23.0%) were unchanged, and 2,827 (22.0%) worsened during the course of MTM services. Pharmacist-estimated cost savings to the health system over the 10-year period were $2,913,850 ($86 per encounter) and the total cost of MTM was $2,258,302 ($67 per encounter), for an estimated ROI of $1.29 per $1 in MTM administrative costs. In the patient satisfaction survey, 95.3% of respondents agreed or strongly agreed that their overall health and wellbeing had improved because of MTM. CONCLUSIONS: Pharmacist estimates of the impact of an MTM program in a large integrated health care system suggest that the program was associated with improved clinical outcomes and cost savings. Patient satisfaction with the program was high.
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              Counselling quality in community pharmacies: implementation of the pseudo customer methodology in Germany.

              To investigate a new method for evaluating counselling performance of staff in community pharmacies and to assess the quality of patient counselling. Trained pseudo customers, instructed to play their role according to two different self-medication scenarios, visited voluntarily participating community pharmacies in Berlin. After documenting the counselling process, immediately after each visit, outside the pharmacy on an assessment form, the pseudo customer re-entered the pharmacy and gave detailed performance feedback to the counsellor and the pharmacist in charge in order to provide support for improving counselling skills and practice behaviour, when appropriate. This was followed with a written summary of the general performance of all participating pharmacies and additional individual feedback and suggestions for improvement. Educational needs were identified for subsequent performance-based educational strategies such as group-workshops, team-training and on-site team-coaching. Forty-nine community pharmacies in Berlin volunteered to participate in this pilot study. Ninety-eight per cent of the participating pharmacies offered advice. However, in 36% of the cases, advice was only given on request. The different types of scenarios--presentation of a symptom or request for a specific product--made a great difference to the spontaneity of questions and advice. At least one question to check on accuracy of self-diagnosis was asked in 95% of the cases of symptom presentation but in only 47% of the cases of specific product request. Information on appropriate self-medication was provided on at least one item in 74% of pseudo customer visits, but most of the time the information was not sufficient. Communication skills (nonverbal elements, comprehensibility etc.) were very good or good in 54% of the visits. Potential for improvement was mainly in relation to the use of open-ended questions to gain more information and on counselling about appropriate self-medication. Direct feedback was given in 96% of the pharmacies (one person refused to accept feedback and one feedback had to be postponed because of time shortage). All of the participants regarded counselling as an important subject in pharmacy practice. The pseudo customer method was successfully used in this study of German community pharmacies. It was shown that pseudo customer visits and performance feedback following the counselling process, were feasible in daily practice and well accepted by the participants. A training program, focussing on areas in most need of improvement, has been developed. The promising results have led to the Federal Chamber of Pharmacists in Germany adopting this method as part of a continuous quality improvement program in community pharmacies.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                4 December 2013
                : 8
                : 12
                : e79875
                Affiliations
                [1 ]Department of Pharmacology and Therapeutics, State University of Maringa, Maringa, Brazil
                [2 ]Department of Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Sao Paulo, Brazil
                [3 ]Department of Pharmaceutical Sciences, State University of Londrina, Londrina, Parana, Brazil
                [4 ]Department of Clinical Pharmacology, University Hospital Dubrava, Zagreb, Croatia
                [5 ]Laboratory of Teaching and Research in Social Pharmacy, Federal University of Sergipe, São Cristóvão, Sergipe, Brazil
                [6 ]Department of Pharmacy, Faculdades Integradas de Ourinhos, Sao Paulo, Brazil
                [7 ]Chair of Social Pharmacy, University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia
                Groningen Research Institute of Pharmacy, Netherlands
                Author notes

                Competing Interests: The authors declare that they have no competing interests.

                Conceived and designed the experiments: PRO-N LRLP CMG AOB KLA ACMP JDN EG RKNC SM DPL-J MK. Performed the experiments: PRO-N LRLP CMG AOB KLA ACMP JDN EG RKNC. Wrote the manuscript: PRO-N LRLP CMG AOB KLA ACMP JDN EG RKNC SM DPL-J MK.

                Article
                PONE-D-13-17648
                10.1371/journal.pone.0079875
                3853625
                24324584
                c855c19a-6283-49e1-8509-32576c074819
                Copyright @ 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 30 April 2013
                : 26 September 2013
                Funding
                The authors have no support or funding to report.
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                Research Article

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