Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice

Objective: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. Design: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. Setting: Four general practices. Participants: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. Intervention: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. Main outcome measures: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. Results: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference £4.72 per 28 days, -£7.04 to -£2.41); equivalent to £61 per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference -0.2, -0.4 to -0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. Conclusions: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners

Quality of medication use in primary care - mapping the problem, working to a solution: a systematic review of the literature

Background: The UK, USA and the World Health Organization have identified improved patient safety in healthcare as a priority. Medication error has been identified as one of the most frequent forms of medical error and is associated with significant medical harm. Errors are the result of the systems that produce them. In industrial settings, a range of systematic techniques have been designed to reduce error and waste. The first stage of these processes is to map out the whole system and its reliability at each stage. However, to date, studies of medication error and solutions have concentrated on individual parts of the whole system. In this paper we wished to conduct a systematic review of the literature, in order to map out the medication system with its associated errors and failures in quality, to assess the strength of the evidence and to use approaches from quality management to identify ways in which the system could be made safer. Methods: We mapped out the medicines management system in primary care in the UK. We conducted a systematic literature review in order to refine our map of the system and to establish the quality of the research and reliability of the system. Results: The map demonstrated that the proportion of errors in the management system for medicines in primary care is very high. Several stages of the process had error rates of 50% or more: repeat prescribing reviews, interface prescribing and communication and patient adherence. When including the efficacy of the medicine in the system, the available evidence suggested that only between 4% and 21% of patients achieved the optimum benefit from their medication. Whilst there were some limitations in the evidence base, including the error rate measurement and the sampling strategies employed, there was sufficient information to indicate the ways in which the system could be improved, using management approaches. The first step to improving the overall quality would be routine monitoring of adherence, clinical effectiveness and hospital admissions. Conclusion: By adopting the whole system approach from a management perspective we have found where failures in quality occur in medication use in primary care in the UK, and where weaknesses occur in the associated evidence base. Quality management approaches have allowed us to develop a coherent change and research agenda in order to tackle these, so far, fairly intractable problems

England’s Electronic Prescription Service: Infrastructure in an Institutional Setting

We describe the development of the Electronic Prescription Service (EPS), the solution for the electronic transmission of prescriptions adopted by the English NHS for primary care. The chapter is based on both an analysis of data collected as part of a nationally commissioned evaluation of EPS, and on reports of contemporary developments in the service. Drawing on the notion of an installed infrastructural base, we illustrate how EPS has been assembled within a rich institutional and organizational context including causal pasts, contemporary practices and policy visions. This process of assembly is traced using three perspectives; as the realization and negotiation of constraints found in the wider NHS context, as a response to inertia arising from limited resources and weak incentive structures, and as a purposive fidelity to the existing institutional cultures of the NHS. The chapter concludes by reflecting on the significance of this analysis for notions of an installed base

Deprescribing interventions and their impact on medication adherence in community-dwelling older adults with polypharmacy: a systematic review

Background: Polypharmacy, and the associated adverse drug events such as non-adherence to prescriptions, is a common problem for elderly people living with multiple comorbidities. Deprescribing, i.e. the gradual withdrawal from medications with supervision by a healthcare professional, is regarded as a means of reducing adverse effects of multiple medications including non-adherence. This systematic review examines the evidence of deprescribing as an effective strategy for improving medication adherence amongst older, community dwelling adults. Methods: A mixed methods review was undertaken. Eight bibliographic database and two clinical trials registers were searched between May and December 2017. Results were double screened in accordance with pre-defined inclusion/exclusion criteria related to polypharmacy, deprescribing and adherence in older, community dwelling populations. The Mixed Methods Appraisal Tool (MMAT) was used for quality appraisal and an a priori data collection instrument was used. For the quantitative studies, a narrative synthesis approach was taken. The qualitative data was analysed using framework analysis. Findings were integrated using a mixed methods technique. The review was performed in accordance with the PRISMA reporting statement. Results: A total of 22 original studies were included, of which 12 were RCTs. Deprescribing with adherence as an outcome measure was identified in randomised controlled trials (RCTs), observational and cohort studies from 13 countries between 1996 and 2017. There were 17 pharmacy-led interventions; others were led by General Practitioners (GP) and nurses. Four studies demonstrated an overall reduction in medications of which all studies corresponded with improved adherence. A total of thirteen studies reported improved adherence of which 5 were RCTs. Adherence was reported as a secondary outcome in all but one study. Conclusions: There is insufficient evidence to show that deprescribing improves medication adherence. Only 13 studies (of 22) reported adherence of which only 5 were randomised controlled trials. Older people are particularly susceptible to non-adherence due to multi-morbidity associated with polypharmacy. Bio-psycho-social factors including health literacy and multi-disciplinary team interventions influence adherence. The authors recommend further study into the efficacy and outcomes of medicines management interventions. A consensus on priority outcome measurements for prescribed medications is indicated

Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial

People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.Five UK private sector care homes.41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.Problems addressed and changes in medicines prescribed.Information was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22).The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.ISRCTN 48133332

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

When pharmacotherapeutic recommendations may lead to the reverse effect on physician decision-making

For long the medical literature has shown that patients do not always receive appropriate care, including pharmacotherapeutic treatment. To achieve improved patient care, a number of physician-oriented interventions are being delivered internationally in an attempt to implement evidence based medicine in routine daily practice of medical practitioners. The pharmacy profession has taken an active role in the delivery of intervention strategies aimed at promoting evidence based prescribing and improved quality and safety of medicine use. However, the medical literature also supports the notion that valid clinical care recommendations do not always have the desired impact on physician behaviour. We argue that the well-established theory of psychological reactance might at least partially explain instances when physicians do not act upon such recommendations. Reactance theory suggests that when recommended to take a certain action, a motivational state compels us to react in a way that affirms our freedom to choose. Often we choose to do the opposite of what the recommendation is proposing that we do or we just become entrenched in our initial position. The basic concepts of psychological reactance are universal and likely to be applicable to the provision of recommendations to physicians. Making recommendations regarding clinical care, including pharmacotherapy, may carry with it implied threats, as it can be perceived as an attempt to restrict one’s freedom of choice potentially generating reactance and efforts to avoid them. By identifying and taking into account factors likely to promote reactance, physician-oriented interventions could become more effective

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

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

Real-world clinical experience with Idebenone in the treatment of Leber hereditary optic neuropathy

Background: Leber hereditary optic neuropathy (LHON) leads to bilateral central vision loss. In a clinical trial setting, idebenone has been shown to be safe and to provide a trend toward improved visual acuity, but long-term evidence of effectiveness in real-world clinical practice is sparse. Methods: Open-label, multicenter, retrospective, noncontrolled analysis of long-term visual acuity and safety in 111 LHON patients treated with idebenone (900 mg/day) in an expanded access program. Eligible patients had a confirmed mitochondrial DNA mutation and had experienced the onset of symptoms (most recent eye) within 1 year before enrollment. Data on visual acuity and adverse events were collected as per normal clinical practice. Efficacy was assessed as the proportion of patients with either a clinically relevant recovery (CRR) or a clinically relevant stabilization (CRS) of visual acuity. In the case of CRR, time to and magnitude of recovery over the course of time were also assessed. Results: At time of analysis, 87 patients had provided longitudinal efficacy data. Average treatment duration was 25.6 months. CRR was observed in 46.0% of patients. Analysis of treatment effect by duration showed that the proportion of patients with recovery and the magnitude of recovery increased with treatment duration. Average gain in best-corrected visual acuity for responders was 0.72 logarithm of the minimal angle of resolution (logMAR), equivalent to more than 7 lines on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Furthermore, 50% of patients who had a visual acuity below 1.0 logMAR in at least one eye at initiation of treatment successfully maintained their vision below this threshold by last observation. Idebenone was well tolerated, with most adverse events classified as minor. Conclusions: These data demonstrate the benefit of idebenone treatment in recovering lost vision and maintaining good residual vision in a real-world setting. Together, these findings indicate that idebenone treatment should be initiated early and be maintained more than 24 months to maximize efficacy. Safety results were consistent with the known safety profile of idebenone