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      The Care Home Independent Prescribing Pharmacist Study (CHIPPS)—a non-randomised feasibility study of independent pharmacist prescribing in care homes

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          Abstract

          Background

          Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification.

          Methods

          Mixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3 months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥ 65 years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident’s quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants’ views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed.

          Results

          Across the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84 years; 61% (24) were female), and 38 participants remained at 3 months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5 L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload.

          Conclusion

          Implementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

          Electronic supplementary material

          The online version of this article (10.1186/s40814-019-0465-y) contains supplementary material, which is available to authorized users.

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          Most cited references 15

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          A drug burden index to define the functional burden of medications in older people.

          Older people carry a high burden of illness for which medications are indicated, along with increased risk of adverse drug reactions. We developed an index to determine drug burden based on pharmacologic principles. We evaluated the relationship of this index to physical and cognitive performance apart from disease indication. Data from the Health, Aging, and Body Composition Study on 3075 well-functioning community-dwelling persons aged 70 to 79 years were analyzed by multiple linear regression to assess the cross-sectional association of drug burden index with a validated composite continuous measure for physical function, and with the Digit Symbol Substitution Test for cognitive performance. Use of anticholinergic and sedative medications was associated with poorer physical performance score (anticholinergic exposure, 2.08 vs 2.21, P<.001; sedative exposure, 2.09 vs 2.19, P<.001) and cognitive performance on the Digit Symbol Substitution Test (anticholinergic exposure, 34.5 vs 35.5, P = .045; sedative exposure, 34.0 vs 35.5, P = .01). Associations were strengthened when exposure was calculated by principles of dose response. An increase of 1 U in drug burden index was associated with a deficit of 0.15 point (P<.001) on the physical function scale and 1.5 points (P = .01) on the Digit Symbol Substitution Test. These values were more than 3 times those associated with a single comorbid illness. The drug burden index demonstrates that anticholinergic and sedative drug exposure is associated with poorer function in community-dwelling older people. This pharmacologic approach provides a useful evidence-based tool for assessing the functional effect of exposure to medications in this population.
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            Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial.

            to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. randomised controlled trial of clinical medication review by a pharmacist against usual care. sixty-five care homes for the elderly in Leeds, UK. a total of 661 residents aged 65+ years on one or more medicines. clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.
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              Care homes’ use of medicines study: prevalence, causes and potential harm of medication errors in care homes for older people

              Introduction: Care home residents are at particular risk from medication errors, and our objective was to determine the prevalence and potential harm of prescribing, monitoring, dispensing and administration errors in UK care homes, and to identify their causes. Methods: A prospective study of a random sample of residents within a purposive sample of homes in three areas. Errors were identified by patient interview, note review, observation of practice and examination of dispensed items. Causes were understood by observation and from theoretically framed interviews with home staff, doctors and pharmacists. Potential harm from errors was assessed by expert judgement. Results: The 256 residents recruited in 55 homes were taking a mean of 8.0 medicines. One hundred and seventy-eight (69.5%) of residents had one or more errors. The mean number per resident was 1.9 errors. The mean potential harm from prescribing, monitoring, administration and dispensing errors was 2.6, 3.7, 2.1 and 2.0 (0 = no harm, 10 = death), respectively. Contributing factors from the 89 interviews included doctors who were not accessible, did not know the residents and lacked information in homes when prescribing; home staff’s high workload, lack of medicines training and drug round interruptions; lack of team work among home, practice and pharmacy; inefficient ordering systems; inaccurate medicine records and prevalence of verbal communication; and difficult to fill (and check) medication administration systems. Conclusions: That two thirds of residents were exposed to one or more medication errors is of concern. The will to improve exists, but there is a lack of overall responsibility. Action is required from all concerned.
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                Author and article information

                Contributors
                jacqueline.inch@abdn.ac.uk
                fnotman16@aol.com
                c.m.bond@abdn.ac.uk
                d.p.alldred@leeds.ac.uk
                antony.arthur@uea.ac.uk
                A.Blyth@uea.ac.uk
                A.K.DaffuOReilly@leeds.ac.uk
                JOANNA.FORD@nnuh.nhs.uk
                c.hughes@qub.ac.uk
                vivienne.maskrey@gmail.com
                Anna.Millar2@albertahealthservices.ca
                phyo.myint@abdn.ac.uk
                f.poland@uea.ac.uk
                L.Shepstone@uea.ac.uk
                A.G.Zermansky@leeds.ac.uk
                rch23@leicester.ac.uk
                d.j.wright@uea.ac.uk
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                11 July 2019
                11 July 2019
                2019
                : 5
                Affiliations
                [1 ]ISNI 0000 0004 1936 7291, GRID grid.7107.1, Primary Care, Institute of Applied Health Sciences, School of Medicine, Medical Sciences & Nutrition, , University of Aberdeen, ; Foresterhill, Aberdeen, AB25 2ZD Scotland
                [2 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, School of Healthcare, Baines Wing, , University of Leeds, ; Leeds, UK
                [3 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Health Sciences, Faculty of Medicine and Health Sciences, , University of East Anglia, ; Norwich, UK
                [4 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, Norwich Medical School, , University of East Anglia, ; Norwich, UK
                [5 ]GRID grid.240367.4, Older Peoples Medicine, , Norfolk and Norwich University Hospitals NHS Foundation Trust, ; Norwich, UK
                [6 ]ISNI 0000 0004 0374 7521, GRID grid.4777.3, School of Pharmacy, , Queen’s University Belfast, ; Belfast, UK
                [7 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Health Sciences, , University of East Anglia, ; Norwich, UK
                [8 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, School of Healthcare, , University of Leeds, ; Leeds, UK
                [9 ]ISNI 0000 0004 1936 8411, GRID grid.9918.9, Leicester Medical School, , University of Leicester, ; Leicester, UK
                [10 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Pharmacy, , University of East Anglia, ; Norwich, UK
                Article
                465
                10.1186/s40814-019-0465-y
                6625047
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007602, Programme Grants for Applied Research;
                Award ID: RP-PG-0613-20007
                Award Recipient :
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                © The Author(s) 2019

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