The extent of anticholinergic burden across an older Welsh population living with frailty: cross-sectional analysis of general practice records.

BACKGROUND: Anticholinergic medicines are associated with adverse outcomes for older people. However, little is known about their use in frailty. The objectives were to (i) investigate the prevalence of anticholinergic prescribing for older patients, and (ii) examine anticholinergic burden according to frailty status. METHODS: Cross-sectional analysis of Welsh primary care data from the Secure Anonymised Information Linkage databank including patients aged ≥65 at their first GP consultation between 1 January and 31 December 2018. Frailty was identified using the electronic Frailty Index and anticholinergic burden using the Anticholinergic Cognitive Burden (ACB) scale. Descriptive analysis and logistic regression were conducted to (i) describe the type and frequency of anticholinergics prescribed; and (ii) to estimate the association between frailty and cumulative ACB score (ACB-Sum). RESULTS: In this study of 529,095 patients, 47.4% of patients receiving any prescription medications were prescribed at least one anticholinergic medicine. Adjusted regression analysis showed that patients with increasing frailty had higher odds of having an ACB-Sum of >3 compared with patients who were fit (mild frailty, adj OR 1.062 (95%CI 1.061-1.064), moderate frailty, adj OR 1.134 (95%CI 1.131-1.136), severe frailty, adj OR 1.208 (95%CI 1.203-1.213)). CONCLUSIONS: Anticholinergic prescribing was high in this older population. Older people with advancing frailty are exposed to the highest anticholinergic burden despite being the most vulnerable to the associated adverse effects. Older people with advancing frailty should be considered for medicines review to prevent overaccumulation of anticholinergic medications, given the risks of functional and cognitive decline that frailty presents.

Interventions for reducing anticholinergic medication burden in older adults-a systematic review and meta-analysis.

INTRODUCTION: Anticholinergic medications block the neurotransmitter acetylcholine in the brain and peripheral nervous system. Many medications have anticholinergic properties, and the cumulative effect of these medications is termed anticholinergic burden. Increased anticholinergic burden can have short-term side effects such as dry mouth, blurred vision and urinary retention as well as long-term effects including dementia, worsening physical function and falls. METHODS: We carried out a systematic review (SR) with meta-analysis (MA) looking at randomised controlled trials addressing interventions to reduce anticholinergic burden in older adults. RESULTS: We identified seven papers suitable for inclusion in our SR and MA. Interventions included multi-disciplinary involvement in medication reviews and deprescribing of AC medications. Pooled data revealed no significant difference in outcomes between control and intervention group for falls (OR = 0.76, 95% CI: 0.52-1.11, n = 647), cognition (mean difference = 1.54, 95% CI: -0.04 to 3.13, n = 405), anticholinergic burden (mean difference = 0.04, 95% CI: -0.11 to 0.18, n = 710) or quality of life (mean difference = 0.04, 95% CI: -0.04 to 0.12, n = 461). DISCUSSION: Overall, there was no significant difference with interventions to reduce anticholinergic burden. As we did not see a significant change in anticholinergic burden scores following interventions, it is likely other outcomes would not change. Short follow-up time and lack of training and support surrounding successful deprescribing may have contributed.

Co-designing an intervention to improve the process of deprescribing for older people living with frailty in the United Kingdom.

BACKGROUND: In older people living with frailty, polypharmacy can lead to preventable harm like adverse drug reactions and hospitalization. Deprescribing is a strategy to reduce problematic polypharmacy. All stakeholders should be actively involved in developing a person-centred deprescribing process that involves shared decision-making. OBJECTIVE: To co-design an intervention, supported by a logic model, to increase the engagement of older people living with frailty in the process of deprescribing. DESIGN: Experience-based co-design is an approach to service improvement, which uses service users and providers to identify problems and design solutions. This was used to create a person-centred intervention with the potential to improve the quality and outcomes of the deprescribing process. A 'trigger film' showing older people talking about their healthcare experiences was created and facilitated discussions about current problems in the deprescribing process. Problems were then prioritized and appropriate solutions were developed. The review located the solutions in the context of current processes and procedures. An ideal care pathway and a complex intervention to deliver better care were developed. SETTING AND PARTICIPANTS: Older people living with frailty, their informal carers and professionals living and/or working in West Yorkshire, England, UK. Deprescribing was considered in the context of primary care. RESULTS: The current deprescribing process differed from an ideal pathway. A complex intervention containing seven elements was required to move towards the ideal pathway. Three of these elements were prototyped and four still need development. The complex intervention responded to priorities about (a) clarity for older people about what was happening at all stages in the deprescribing process and (b) the quality of one-to-one consultations. CONCLUSIONS: Priorities for improving the current deprescribing process were successfully identified. Solutions were developed and structured as a complex intervention. Further work is underway to (a) complete the prototyping of the intervention and (b) conduct feasibility testing. PATIENT OR PUBLIC CONTRIBUTION: Older people living with frailty (and their informal carers) have made a central contribution, as collaborators, to ensure that a complex intervention has the greatest possible potential to enhance the experience of deprescribing medicines.

Experiences of patients with heart failure with medicines at transition intervention: Findings from the process evaluation of the Improving the Safety and Continuity of Medicines management at Transitions of care (ISCOMAT) programme.

BACKGROUND: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co-designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient-held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. DESIGN: Twenty one-to-one semi-structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co-analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. RESULTS: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. CONCLUSION: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design, as qualitative data co-analysts and as co-authors.

Process evaluation for the Care Homes Independent Pharmacist Prescriber Study (CHIPPS).

BACKGROUND: Medicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation. METHOD: Intervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework. RESULTS: PCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention. CONCLUSIONS: The intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established. TRIAL REGISTRATION: The definitive RCT was registered with the ISRCTN registry (registration number  ISRCTN 17847169 ).

Interventions to optimise prescribing for older people in care homes.

BACKGROUND: There is a substantial body of evidence that prescribing for care home residents is suboptimal and requires improvement. Consequently, there is a need to identify effective interventions to optimise prescribing and resident outcomes in this context. This is an update of a previously published review (Alldred 2013). OBJECTIVES: The objective of the review was to determine the effect of interventions to optimise overall prescribing for older people living in care homes. SEARCH METHODS: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Specialised Register), MEDLINE, EMBASE and CINAHL to May 2015. We also searched clinical trial registries for relevant studies. SELECTION CRITERIA: We included randomised controlled trials evaluating interventions aimed at optimising prescribing for older people (aged 65 years or older) living in institutionalised care facilities. Studies were included if they measured one or more of the following primary outcomes: adverse drug events; hospital admissions; mortality; or secondary outcomes, quality of life (using validated instrument); medication-related problems; medication appropriateness (using validated instrument); medicine costs. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts, assessed studies for eligibility, assessed risk of bias and extracted data. We presented a narrative summary of results. MAIN RESULTS: The 12 included studies involved 10,953 residents in 355 (range 1 to 85) care homes in ten countries. Nine studies were cluster-randomised controlled trials and three studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of ten studies. Four studies involved multidisciplinary case-conferencing, five studies involved an educational element for health and care professionals and one study evaluated the use of clinical decision support technology. We did not combine the results in a meta-analysis due to heterogeneity across studies. Interventions to optimise prescribing may lead to fewer days in hospital (one study out of eight; low certainty evidence), a slower decline in health-related quality of life (one study out of two; low certainty evidence), the identification and resolution of medication-related problems (seven studies; low certainty evidence), and may lead to improved medication appropriateness (five studies out of five studies; low certainty evidence). We are uncertain whether the intervention improves/reduces medicine costs (five studies; very low certainty evidence) and it may make little or no difference on adverse drug events (two studies; low certainty evidence) or mortality (six studies; low certainty evidence). The risk of bias across studies was heterogeneous. AUTHORS' CONCLUSIONS: We could not draw robust conclusions from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems and improvements in medication appropriateness, however evidence of a consistent effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.

The scale of repeat prescribing--time for an update.

BACKGROUND: The NHS spends billions of pounds annually on repeat prescriptions in primary care, but data on their extent and use is out of date. Understanding the scale of repeat prescribing and for whom it is prescribed is important for the NHS to plan services and develop policies to improve patient care. METHOD: Anonymous data on prescription numbers and practice population demographics was obtained from GP computer systems in a large urban area.Searches were conducted in November 2011 to identify the numbers of repeat items listed on individuals' repeat lists by sex and age.The proportion of all prescription items issued as repeats was identified by conducting searches on items issued as repeat and acute prescriptions. RESULTS: In the year of study 4,453,225 items were issued of which 3,444,769 (77%) were repeats (mean 13 items per patient/annum) and 1,008,456 (23%) acute prescriptions (mean 3.9 items per patient per annum). The mean number of repeat Items per patient was 1.87 (range 0.45 ages 0-9 years; 7.1 ages 80-89 years). At least one repeat medicine was prescribed to 43% of the population (range 20% for ages 0-9; over 75% for ages 60+). CONCLUSION: A significant proportion of the population receive repeat prescriptions and the proportion increases with age. Whilst the proportion of repeat items to acute items has remained unchanged over the last two decades the number of repeat prescriptions items issued has doubled (from 5.8 to 13.3 items/patient/annum). This has implications for general practice workload, patient convenience, NHS costs and risk.

Interventions to optimise prescribing for older people in care homes.

BACKGROUND: There is a substantial body of evidence that prescribing for care home residents is suboptimal and requires improvement. Consequently, there is a need to identify effective interventions to optimise prescribing and resident outcomes in this context. OBJECTIVES: The objective of the review was to determine the effect of interventions to optimise prescribing for older people living in care homes. SEARCH METHODS: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library (Issue 11, 2012); Cochrane Database of Systematic Reviews, The Cochrane Library (Issue 11, 2012); MEDLINE OvidSP (1980 on); EMBASE, OvidSP (1980 on); Ageline, EBSCO (1966 on); CINAHL, EBSCO (1980 on); International Pharmaceutical Abstracts, OvidSP (1980 on); PsycINFO, OvidSP (1980 on); conference proceedings in Web of Science, Conference Proceedings Citation Index - SSH & Science, ISI Web of Knowledge (1990 on); grey literature sources and trial registries; and contacted authors of relevant studies. We also reviewed the references lists of included studies and related reviews (search period November 2012). SELECTION CRITERIA: We included randomised controlled trials evaluating interventions aimed at optimising prescribing for older people (aged 65 years or older) living in institutionalised care facilities. Studies were included if they measured one or more of the following primary outcomes, adverse drug events; hospital admissions;mortality; or secondary outcomes, quality of life (using validated instrument); medication-related problems; medication appropriateness (using validated instrument); medicine costs. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts, assessed studies for eligibility, assessed risk of bias and extracted data. A narrative summary of results was presented. MAIN RESULTS: The eight included studies involved 7653 residents in 262 (range 1 to 85) care homes in six countries. Six studies were cluster-randomised controlled trials and two studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of seven studies, three studies involved multidisciplinary case-conferencing, two studies involved an educational element for care home staff and one study evaluated the use of clinical decision support technology. Due to heterogeneity, results were not combined in a meta-analysis. There was no evidence of an effect of the interventions on any of the primary outcomes of the review (adverse drug events, hospital admissions and mortality). No studies measured quality of life. There was evidence that the interventions led to the identification and resolution of medication-related problems. There was evidence from two studies that medication appropriateness was improved. The evidence for an effect on medicine costs was equivocal. AUTHORS' CONCLUSIONS: Robust conclusions could not be drawn from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems, however evidence of an effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.

Barriers and facilitators of implementing proactive deprescribing within primary care: a systematic review.

OBJECTIVE: Proactive deprescribing - identifying and discontinuing medicines where harms outweigh benefits - can minimise problematic polypharmacy, but has yet to be implemented into routine practice. Normalisation process theory (NPT) can provide a theory-informed understanding of the evidence base on what impedes or facilitates the normalisation of routine and safe deprescribing in primary care. This study systematically reviews the literature to identify barriers and facilitators to implementing routine safe deprescribing in primary care and their effect on normalisation potential using NPT.PubMed, MEDLINE, Embase, Web of Science, International Pharmaceutical Abstracts, CINAHL, PsycINFO and The Cochrane Library were searched (1996-2022). Studies of any design investigating the implementation of deprescribing in primary care were included. The Mixed Methods Appraisal Tool and the Quality Improvement Minimum Quality Criteria Set were used to appraise quality. Barriers and facilitators from included studies were extracted and mapped to the constructs of NPT. KEY FINDINGS: A total of 12,027 articles were identified, 56 articles included. In total, 178 barriers and 178 facilitators were extracted and condensed into 14 barriers and 16 facilitators. Common barriers were negative deprescribing perceptions and suboptimal deprescribing environments, while common facilitators were structured education and training on proactive deprescribing and utilising patient-centred approaches. Very few barriers and facilitators were associated with reflexive monitoring, highlighting a paucity of evidence on how deprescribing interventions are appraised. SUMMARY: Through NPT, multiple barriers and facilitators were identified that impede or facilitate the implementation and normalisation of deprescribing in primary care. However, more research is needed into the appraisal of deprescribing post-implementation.

Person-centred deprescribing for patients living with frailty: a qualitative interview study and proposal of a collaborative model.

OBJECTIVES: (1) Present deprescribing experiences of patients living with frailty, their informal carers and healthcare professionals; (2) interpret whether their experiences are reflective of person-centred/collaborative care; (3) complement our findings with existing evidence to present a model for person-centred deprescribing for patients living with frailty, based on a previous collaborative care model. METHODS: Qualitative design in English primary care (general practice). Semi-structured interviews were undertaken immediately post-deprescribing and 5/6 weeks later with nine patients aged 65+ living with frailty and three informal carers of patients living with frailty. Fourteen primary care professionals with experience in deprescribing were also interviewed. In total, 38 interviews were conducted. A two-staged approach to data analysis was undertaken. KEY FINDINGS: Three themes were developed: attitudes, beliefs and understanding of medicines management and responsibility; attributes of a collaborative, person-centred deprescribing consultation; organisational factors to support person-centred deprescribing. Based on these findings and complementary to existing evidence, we offer a model for person-centred deprescribing for patients living with frailty. CONCLUSIONS: Previous models of deprescribing for patients living with frailty while, of value, do not consider the contextual factors that govern the implementation and success of models in practice. In this paper, we propose a novel person-centred model for deprescribing for people living with frailty, based on our own empirical findings, and the wider evidence base.

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial.

OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received. TRIAL REGISTRATION: ISRCTN 17847169.

Mapping the resilience performance of community pharmacy to maintain patient safety during the Covid-19 pandemic.

BACKGROUND: The first UK wave of the Covid-19 pandemic in 2020 placed unprecedented stress on community pharmacy. Various policies and initiatives were announced during this period to support community pharmacy to continue to perform in a manner that prioritised patient safety. However, little is understood about how these policies and initiatives were implemented by staff working in community pharmacy, and the system adaptions and responses that were initiated to maintain patient safety. OBJECTIVE: The study aimed to investigate how staff working in UK community pharmacy during the first waves of the COVID-19 pandemic in 2020 responded and adapted to system stressors to maintain patient safety. METHODS: We adopted a qualitative interview approach, underpinned by Resilient Healthcare theory, with interview data collected between July 2020 and January 2021. Data were synthesised and analysed using Framework Analysis. RESULTS: 23 community pharmacy staff from England and Scotland were interviewed. We identified five themes supported by between two and six sub-themes: 1. Covid-19, an impending threat to system; 2. Patient safety stressors during the first waves of Covid-19; 3. Altering the system, responding to system stressors; 4. Monitoring and adjusting and 5. Learning for the future. CONCLUSION: Privileging the accounts of community pharmacy staff working on the frontline during the pandemic illuminated how responses and adaptions were developed and deployed, how continual monitoring occurred, and the factors that supported or hindered system resilience. The key learning derived from this study can serve to shorten the gap between 'work as imagined' and 'work as done', and in doing so, support the future resilience performance of community pharmacy during future outbreaks of Covid-19 or similar events.

Enhancing deprescribing: A qualitative understanding of the complexities of pharmacist-led deprescribing in care homes.

The English National Overprescribing Review identified that older people often take eight or more medicines a day. The report recommended pharmacists in primary care should take responsibility for addressing polypharmacy. Overprescribing is a safety concern in care homes as approximately half of older care home residents are prescribed at least one medicine that is unnecessary or now harmful. This predisposes them to adverse outcomes including hospitalisation and mortality. Deprescribing is the planned activity of stopping or reducing a medicine that may no longer be appropriate. Deprescribing, when performed by a pharmacist, is a multidisciplinary activity requiring close communication with general practitioners (GPs) and care home staff. A recently completed trial that integrated pharmacists with prescribing rights into older peoples' care homes found significant variation in proactive deprescribing activity. The aim of the current study was to specifically explore beliefs and practices of deprescribing in care homes. A qualitative approach was adopted to examine individual, social and contextual factors that acted as enablers and barriers to pharmacist deprescribing in care homes. Semi-structured interviews were conducted with participants of the previous study (16 pharmacists, 6 GPs and 7 care home staff from Northern Ireland, Scotland and England). Using thematic analysis, we identified two themes: (a) Structures and systems affecting deprescribing, that is the context in which deprescribing happened, including team involvement and routine practices in GP surgeries and care homes; (b) Balancing risks when deprescribing, that is the perception of individual risk and social barriers were mitigated by understanding the medical background of residents. This supported the clinical understanding that risks from overprescribing were greater than risks from deprescribing. While deprescribing can involve all health professionals in the primary care team, these results suggest the pharmacist is well placed to lead the process; by having both clinical competence and professional willingness to drive this activity forward.

A non-randomised feasibility study of an intervention to optimise medicines at transitions of care for patients with heart failure.

BACKGROUND: Heart failure affects 26 million people globally, and the optimal management of medicines is crucial for patients, particularly when their care is transferred between hospital and the community. Optimising clinical outcomes requires well-calibrated cross-organisational processes with staff and patients responding and adapting to medicines changes. The aim of this study was to assess the feasibility of implementing a complex intervention (the Medicines at Transitions Intervention; MaTI) co-designed by patients and healthcare staff. The purpose of the intervention was to optimise medicines management across the gaps between secondary and primary care when hospitals handover care. The study objectives were to (1) assess feasibility through meeting specified progression criteria to proceed to the trial, (2) assess if the intervention was acceptable to staff and patients, and (3) determine whether amendment or refinement would be needed to enhance the MaTI. METHODS: The feasibility of the MaTI was tested in three healthcare areas in the North of England between July and October 2017. Feasibility was measured and assessed through four agreed progression to trial criteria: (1) patient recruitment, (2) patient receipt of a medicines toolkit, (3) transfer of discharge information to community pharmacy, and (4) offer of a community pharmacy medicines review/discussion or medicines reconciliation. From the cardiology wards at each of the three NHS Acute Trusts (sites), 10 patients (aged ≥ 18 years) were recruited and introduced to the 'My Medicines Toolkit' (MMT). Patients were asked to identify their usual community pharmacy or nominate a pharmacy. Discharge information was transferred to the community pharmacy; pharmacists were asked to reconcile medicines and invited patients for a medicines use review (MUR) or discussion. At 1 month following discharge, all patients were sent three questionnaire sets: quality-of-life, healthcare utilisation, and a patient experience survey. In a purposive sample, 20 patients were invited to participate in a semi-structured interview about their experiences of the MaTI. Staff from hospital and primary care settings involved in patients' care were invited to participate in a semi-structured interview. Patient and staff interviews were analysed using Framework Analysis. Questionnaire completion rates were recorded and data were descriptively analysed. RESULTS: Thirty-one patients were recruited across three sites. Eighteen staff and 18 patients took part in interviews, and 19 patients returned questionnaire sets. All four progression to trial criteria were met. We identified barriers to patient engagement with the intervention in hospital, which were compounded by patients' focus on returning home. Some patients described not engaging in discussions with staff about medicines and lacking motivation to do so because they were preoccupied with returning home. Some patients were unable or unwilling to attend a community pharmacy in person for a medicines review. Roles and responsibilities for delivering the MaTI were different in the three sites, and staff reported variations in time spent on MaTI activities. Staff reported some work pressures and staff absences that limited the time they could spend talking to patients about their medicines. Clinical teams reported that recording a target dose for heart failure medicines in patient-held documentation was difficult as they did not always know the ideal or tolerable dose. The majority of patients reported receiving the patient-held documentation. More than two-thirds reported being offered a MUR by their community pharmacists. CONCLUSIONS: Delivery of the Medicines at Transitions Intervention (MaTI) was feasible at all three sites, and progression to trial criteria were met. Refinements were found to be necessary to overcome identified barriers and strengthen delivery of all steps of the intervention. Necessary changes to the MaTI were identified along with amendments to the implementation plan for the subsequent trial. Future implementation needs to take into account the complexity of medicines management and adaptation to local context.

Development and feasibility testing of an evidence-based training programme for pharmacist independent prescribers responsible for the medicines-related activities within care homes.

INTRODUCTION: The UK pharmacists with independent prescribing rights (pharmacist independent prescribers [PIPs]) are authorised to prescribe within their areas of competence. To enable PIPs to provide pharmaceutical care to residents in care homes and assume responsibility for medicines management, a process for development and assessment of competence is required. The aim of this research was to develop a training and accreditation process (training programme) to enable PIPs to operate safely and effectively within care homes. METHODS: Located in England, Scotland and Northern Ireland across four sites and based on a systematic review, it consisted of four phases: (1) initial stakeholder engagement, (2) uni-professional focus groups and interviews, (3) expert panel consensus and (4) feasibility testing. Four PIPs were trained each to provide pharmaceutical care to 10 care home residents. An expert panel synthesised the evidence at each stage to develop each iteration of the training programme. Content analysis was used throughout. RESULTS: Differences in baseline knowledge of PIPs required inclusion of a Personal Development Framework and the provision of a mentor. Face-to-face training focussed on managing medicines for a complex older person, minimising prescribing costs and supporting people without capacity. Provision of time to understand local context and develop relationships with care homes and general practitioners was identified as a central requirement. PIPs were assessed for competency via viva. Feasibility testing demonstrated that the derived training programme was acceptable, practical and effective. DISCUSSION: The model seemed to work, but due to small numbers, larger-scale testing of the training programme is now required.

Associations Between Anticholinergic Medication Exposure and Adverse Health Outcomes in Older People with Frailty: A Systematic Review and Meta-analysis.

INTRODUCTION: There are robust associations between use of anticholinergic medicines and adverse effects in older people. However, the nature of these associations for older people living with frailty is yet to be established. OBJECTIVES: The aims were to identify and investigate associations between anticholinergics and adverse outcomes in older people living with frailty and to investigate whether exposure is associated with greater risks according to frailty status. METHODS: MEDLINE, CINAHL, EMBASE, Cochrane Database of Systematic Reviews, Web of Science and PsycINFO were searched to 1 August 2019. Observational studies reporting associations between anticholinergics and outcomes in older adults (average age ≥ 65 years) that reported frailty using validated measures were included. Primary outcomes were physical impairment, cognitive dysfunction, and change in frailty status. Risk of bias was evaluated using the Cochrane Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Meta-analysis was undertaken where appropriate. RESULTS: Thirteen studies (21,516 participants) were included (ten community, one residential aged-care facility and two hospital studies). Observed associations included reduced ability for chair standing, slower gait speeds, poorer physical performance, increased risk of falls and mortality. Conflicting results were reported for grip strength, timed up and go test, cognition and activities of daily living. No associations were observed for transitions between frailty states, psychological wellbeing or benzodiazepine-related adverse reactions. There was no clear evidence of differences in risks according to frailty status. CONCLUSIONS: Anticholinergics are associated with adverse outcomes in older people living with frailty; however, the literature has significant methodological limitations. There is insufficient evidence to suggest greater risks based on frailty, and there is an urgent need to evaluate this further in well-designed studies stratifying by frailty.

The recording of drug sensitivities for older people living in care homes.

AIMS: The aims of this study were to determine the recording of drug sensitivities of elderly care home residents, to describe the nature of sensitivities and to identify and describe discrepancies in the documentation of drug sensitivity status in general practices, pharmacies and care homes. METHODS: A random sample of residents within a purposive sample of care homes (nursing and residential) was selected. A clinical pharmacist inspected the GP medical record, the medicines administration record, and the care home record for each resident to identify drug sensitivities and discrepancies between records and to describe the nature of the recorded sensitivities. RESULTS: The records of 121 residents in 31 care homes were studied. Thirty-one (26%) residents had at least one documented drug sensitivity in one of the sources inspected, with 48 sensitivities in total recorded. There was no description of the nature of the sensitivities recorded in 39/48 (81%) cases. The number of sensitivities recorded on the medicines administration record, care home record and the GP record were 3 (6%), 29 (60%) and 35 (73%), respectively. Only two sensitivities were simultaneously recorded on all three records. CONCLUSIONS: It was of concern that over 90% of drug sensitivities were not recorded on the medicines administration record which is the final checking document when administering medication. The reason for this was that the dispensing pharmacy was responsible for generating the medicines administration record; however, drug sensitivity status is seldom shared between the GP and the dispensing pharmacy. Printing sensitivities on prescriptions would help to resolve this.

"Everyone needs to understand each other's systems": Stakeholder views on the acceptability and viability of a Pharmacist Independent Prescriber role in care homes for older people in the UK.

The role of an innovative Pharmacist Independent Prescriber (PIP) for care homes to optimise medications has not been examined. We explored stakeholders' views on issues and barriers that the PIP might address to inform a service specification for the PIP intervention in older people's care homes. Focus groups (n = 72 participants) and semi-structured interviews (n = 13) undertaken in 2015 across four sites in the United Kingdom captured the views of doctors, pharmacists, care-home managers and staff, residents and relatives. Stakeholders identified their expectations of what service should be provided by PIPs, what might affect their support for the role, and barriers and enablers to providing the service. Transcripts were analysed using the Theoretical Domains Framework to identify key components, which were reviewed by stakeholders in 2016. A PIP service was envisaged offering benefits for residents, care homes and doctors but stakeholders raised challenges including agreement on areas where PIPs might prescribe, contextual barriers in chronic disease management, PIPs' knowledge of older people's medicine, and implementation barriers in integrated team-working and ensuring role clarity. Introducing a PIP was welcomed in principle but conditional on: a clearly defined PIP role communicated to stakeholders; collaboration across doctors, PIPs and care-home staff; dialogue about developing the service with residents and relatives, based on trust and effective communication. To embed a PIP service within increasingly complex care-homes provision, the overarching theme from this research was that everyone must "understand each other's systems".

Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial.

INTRODUCTION: A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention. METHODS AND ANALYSIS: The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021. ETHICS AND DISSEMINATION: Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. TRIAL REGISTRATION NUMBER: ISRCTN66212970.

Systematic review and narrative synthesis of pharmacist provided medicines optimisation services in care homes for older people to inform the development of a generic training or accreditation process.

OBJECTIVES: To develop a training programme to enable pharmacists with prescribing rights to assume responsibility for the provision of pharmaceutical care within care homes, a systematic review and narrative synthesis was undertaken to identify reported approaches to training pharmacists and use this literature to identify potential knowledge requirements. METHODS: A PROSPERO-registered systematic review was performed using key search terms for care homes, pharmacist, education, training and pharmaceutical care. Papers reporting primary research focussed on care of the older person within the care home setting were included. No restrictions were placed on methodology. Two researchers independently reviewed titles, abstracts and papers. Agreement on inclusion was reached through consensus. Data on titles, training and activities undertaken were extracted and knowledge requirements identified. Findings were synthesised and reported narratively. KEY FINDINGS: Fifty-nine papers were included, most of which were uncontrolled service evaluations. Four papers reported an accreditation process for the pharmacist. Thirteen papers reported providing tools or specific training on a single topic to pharmacists. The main clinical and therapeutic areas of activity (requiring codified knowledge) were dementia, pain, antipsychotic and cardiovascular medication. Provision of pharmaceutical care, effective multidisciplinary working and care home staff training represented the main areas of practical knowledge. CONCLUSIONS: Information regarding training and accreditation processes for care home pharmacists is limited. This study provides insight into potential codified and practical knowledge requirements for pharmacists assuming responsibility for the provision of pharmaceutical care within care homes. Further work involving stakeholders is required to identify the cultural knowledge requirements and to develop a training and accreditation process.