Measuring Quality of Life in Deprescribing Trials: A Scoping Review.

BACKGROUND: Quality of life (QoL) is an important outcome to capture in clinical trials evaluating deprescribing interventions. OBJECTIVE: We aimed to conduct a scoping review to examine how QoL has been measured in deprescribing trials among older people and identify potentially relevant QoL scales, to better inform QoL measurement in future deprescribing trials. METHODS: We searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, Google Scholar, Epistemonikos, ClinicalTrials.gov, and reference lists of eligible studies (from inception to October 2023). We included randomized and non-randomized comparative studies with a control group that evaluated deprescribing and polypharmacy reduction interventions in people ≥ 65 years of age and measured QoL as an outcome. We also included studies describing the development and validation of QoL scales related to deprescribing, polypharmacy, or medication burden in adults ≥ 18 years of age. Two independent reviewers screened titles and abstracts, then full texts. Two independent reviewers extracted data from 25% of eligible studies in order to verify agreement, then a single reviewer extracted data from the remaining studies, which a second reviewer cross-checked. We critically appraised scales based on the COSMIN checklist. RESULTS: We retrieved 7290 articles, of which 52 were eligible for inclusion, including 44 deprescribing trials and eight scale development studies. From these studies, we found 21 scales that have been used in the context of deprescribing/polypharmacy (12 generic scales used in clinical trials and nine medication-specific scales). Variations of the generic EQ-5D were the most used scales. The measurement properties of scales for capturing changes in QoL from deprescribing were uncertain. Medication-specific QoL scales have not been employed in deprescribing clinical trials and thus, their performance in this context is also not clear. CONCLUSIONS: Several existing QoL scales have been applied to the context of deprescribing/polypharmacy clinical trials, and new scales specific to the problem have been proposed. If deprescribing does impact QoL, our findings suggest it is uncertain whether existing QoL scales can practically and reliably capture such a change or whether any scale is best. However, this review compares various aspects of the scales that researchers and clinicians can consider in decisions about measuring QoL in deprescribing trials, and in planning future research. PROTOCOL REGISTRATION: Open Science Framework: osf.io/aez6w.

'I think we could probably do more': an interview study to explore community pharmacists' experiences and perspectives of frailty and optimising medicines use in frail older adults.

BACKGROUND: Community pharmacists potentially have an important role to play in identification of frailty and delivery of interventions to optimise medicines use for frail older adults. However, little is known about their knowledge or views about this role. AIM: To explore community pharmacists' knowledge of frailty and assessment, experiences and contact with frail older adults, and perceptions of their role in optimising medicines use for this population. METHODS: Semi-structured interviews conducted between March and December 2020 with 15 community pharmacists in Northern Ireland. Interviews were transcribed verbatim and analysed thematically. RESULTS: Three broad themes were generated from the data. The first, 'awareness and understanding of frailty', highlighted gaps in community pharmacists' knowledge regarding presentation and identification of frailty and their reluctance to broach potentially challenging conversations with frail older patients. Within the second theme, 'problem-solving and supporting medication use', community pharmacists felt a large part of their role was to resolve medicines-related issues for frail older adults through collaboration with other primary healthcare professionals but feedback on the outcome was often not provided upon issue resolution. The third theme, 'seizing opportunities in primary care to enhance pharmaceutical care provision for frail older adults', identified areas for further development of the community pharmacist role. CONCLUSIONS: This study has provided an understanding of the views and experiences of community pharmacists about frailty. Community pharmacists' knowledge deficits about frailty must be addressed and their communication skills enhanced so they may confidently initiate conversations about frailty and medicines use with older adults.

Improving medication dispensing and counselling for patients with vision impairment: a qualitative study of pharmacist-reported barriers and facilitators.

BACKGROUND: People with vision impairment encounter many difficulties when it comes to medicines use. However, evidence indicates that there are major gaps in pharmaceutical care service provision worldwide and limited research on interventions to optimise medication use for this patient population. The Theoretical Domains Framework (TDF) provides a method for theoretically understanding individuals' behaviour and informing development of interventions. The aim of this research was to (a) identify the barriers and facilitators to the provision of medication dispensing and counselling services by pharmacists to patients with vision impairment, and (b) identify key TDF domains to be targeted in a future intervention. METHODS: Semi-structured interviews were conducted with pharmacists from different pharmacy practice settings/areas in Saudi Arabia. The 14-domain TDF was utilised as the theoretical lens through which pharmacists' behaviours were examined. Interviews were conducted in Arabic or English, either face-to-face or over the telephone based on the participant's preference. Following transcription, interviews conducted in Arabic were translated into English before analysis. Data analysis involved using the framework method and content analysis to identify important barriers and facilitators to the provision of dispensing and counselling services to those with vision impairment. Key TDF domains that could be targeted in a future intervention were then identified using a consensus-based approach. RESULTS: Twenty-six pharmacists were interviewed. Pharmacists' experience in pharmacy practice ranged from two to 28 years. A range of barriers and facilitators were highlighted as important in providing services to those with vision impairment. Eight domains were identified as 'key domains' including: 'Knowledge', 'Skills', 'Beliefs about capabilities', 'Goals', 'Memory, attention, and decision processes', 'Environmental context and resources', 'Social influences', and 'Behavioural regulation'. CONCLUSIONS: Barriers and facilitators identified by pharmacists will inform the development of an intervention to ensure its applicability to everyday practice. Future research will focus on the process of developing the proposed intervention through targeting key TDF domains to improve medication dispensing and counselling by pharmacists to patients with vision impairment.

Potentially inappropriate prescribing for people with dementia in ambulatory care: a cross-sectional observational study.

BACKGROUND: Studies have shown that potentially inappropriate prescribing (PIP) is highly prevalent among people with dementia (PwD) and linked to negative outcomes, such as hospitalisation and mortality. However, there are limited data on prescribing appropriateness for PwD in Saudi Arabia. Therefore, we aimed to estimate the prevalence of PIP and investigate associations between PIP and other patient characteristics among PwD in an ambulatory care setting. METHODS: A cross-sectional, retrospective analysis was conducted at a tertiary hospital in Saudi Arabia. Patients who were ≥ 65 years old, had dementia, and visited ambulatory care clinics between 01/01/2019 and 31/12/2021 were included. Prescribing appropriateness was evaluated by applying the Screening Tool of Older Persons Potentially Inappropriate Prescriptions (STOPP) criteria. Descriptive analyses were used to describe the study population. Prevalence of PIP and the prevalence per each STOPP criterion were calculated as a percentage of all eligible patients. Logistic regression analysis was used to investigate associations between PIP, polypharmacy, age and sex; odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Analyses were conducted using SPSS v27. RESULTS: A total of 287 PwD were identified; 56.0% (n = 161) were female. The mean number of medications prescribed was 9.0 [standard deviation (SD) ± 4.2]. The prevalence of PIP was 61.0% (n = 175). Common instances of PIP were drugs prescribed beyond the recommended duration (n = 90, 31.4%), drugs prescribed without an evidence-based clinical indication (n = 78, 27.2%), proton pump inhibitors (PPIs) for > 8 weeks (n = 75, 26.0%), and acetylcholinesterase inhibitors with concurrent drugs that reduce heart rate (n = 60, 21.0%). Polypharmacy was observed in 82.6% (n = 237) of patients and was strongly associated with PIP (adjusted OR 24.1, 95% CI 9.0-64.5). CONCLUSIONS: Findings have revealed a high prevalence of PIP among PwD in Saudi Arabia that is strongly associated with polypharmacy. Future research should aim to explore key stakeholders' experiences and perspectives of medicines management to optimise medication use for this vulnerable patient population.

Oral prednisolone and warfarin and risk of oesophageal cancer: A case-control study.

BACKGROUND: A recent epidemiological study systematically screened 250 prescription medications for associations with oesophageal cancer risk, using Scottish data, and identified an increased risk with use of prednisolone and warfarin. We investigated whether oral prednisolone or warfarin use was associated with increased oesophageal cancer risk. METHODS: A case-control study was conducted within the Clinical Practice Research Datalink. In the primary analysis oesophageal cancer cases were identified from linked cancer registry records. Up to 5 cancer-free controls were matched to each case (based upon sex, birth year, GP practice and year of GP registration). Prednisolone and warfarin medications were identified from prescribing records. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using conditional logistic regression after adjusting for covariates including demographics, comorbidities and medication use. RESULTS: There were 4552 oesophageal cancer cases and 22,601 matched control participants. Overall, there was no evidence of an increased risk of oesophageal cancer with oral prednisolone use (unadjusted OR=1.16 95% CI 1.06, 1.27 and adjusted OR=0.99 95% CI 0.89, 1.11) or warfarin use (unadjusted OR=1.12 95% CI 0.99, 1.28 and adjusted OR=1.08 95% CI 0.92, 1.27). CONCLUSIONS: In this large population-based study, oral prednisolone and warfarin were not associated with oesophageal cancer risk.

Decision-making about changing medications across transitions of care: Opportunities for enhanced patient and family engagement.

BACKGROUND: Older patients often have complex medication regimens, which change as they move across transitions of care. Engagement of older patients and families in making medication decisions across transitions of care is important for safe and high-quality medication management. AIMS: To explore decision-making between health professionals, older patients and families about medication changes across transitions of care, and to examine how patient and family engagement is enacted in the process of decision-making in relation to these medication changes. METHODS: A focused ethnographic design was undertaken with semi-structured interviews, observations, and reflective focus groups or interviews. Reflexive thematic analysis was conducted on transcribed data. The study was undertaken at a public teaching acute care hospital and a public teaching community hospital in Australia. RESULTS: In all, 182 older patients, 44 family members and 94 health professionals participated. Four themes were conceptualised from the data: different customs and routines, medication challenges, health professional interactions, and patient and family involvement. Environments had differences in their customs and routines, which increased the potential for medication delays or the substitution of unintended medications. Medication challenges included health professionals assuming that patients and families did not need information about regularly prescribed medications. Patients and families were informed about new medications after health professionals had already made decisions to prescribe these medications. Health professionals tended to work in disciplinary silos, and they had views about their role in interacting with patients and families. Patients and families were expected to take the initiative to participate in decision-making about medication changes. CONCLUSIONS: Patient movements across transitions of care can create complex and chaotic medication management situations, which lacks transparency, especially for older patients and their families. A greater focus on pre-emptive and planned discussions about medication changes will contribute to improving patient and family involvement in medication decision-making.

Taxonomy development for term standardization in activity resulting from medication review processes: a Delphi study.

BACKGROUND: Medication review (MR) is the systematic assessment of a patient's medications for safety and effectiveness by a healthcare professional. The language used to describe MR activity, such as stopped medicine and increased dose, should be consistent across studies to assist researchers compare how different services operate and identify their mechanism of impact. AIM: To develop an international taxonomy of standardized terms and activity definitions related to medication reviews. METHOD: This was a three-stage Delphi-based consensus study with international medication review experts. A systematic review provided MR activity terms for the survey. Experts rated their consensus on each activity term and its definition on a Likert scale and provided written feedback. The consensus was 75% panel agreement. At each stage, consensus elements were retained, and feedback was used to revise definitions. RESULTS: Seven experts were recruited for the study (response rate 15.2%) from four countries: the United Kingdom (n = 4), New Zealand (n = 1), Australia (n = 1), and Malaysia (n = 1). The following terms achieved consensus: the term Medication as a descriptor for MR terms; discontinue medication, start medication, dose increase, dose decrease, dosage form change, and medication safety and efficacy monitor to describe MR activity; Educate to describe the delivery of healthcare professionals and patients/carers education. CONCLUSION: Standardized medication review activity terms and definitions have been selected for universal adoption in all future MR research to facilitate a meaningful comparison of process evaluations within different settings.

Vaginal Estrogen Therapy Use and Survival in Females With Breast Cancer.

Importance: Genitourinary syndrome of menopause can be treated with vaginal estrogen therapy. However, there are concerns about the safety of vaginal estrogen therapy in patients with breast cancer. Objective: To determine whether the risk of breast cancer-specific mortality was higher in females with breast cancer who used vaginal estrogen therapy vs females with breast cancer who did not use hormone replacement therapy (HRT). Design, Setting, and Participants: This cohort study analyzed 2 large cohorts, one each in Scotland and Wales, of females aged 40 to 79 years with newly diagnosed breast cancer. These population-based cohorts were identified from national cancer registry records from 2010 to 2017 in Scotland and from 2000 to 2016 in Wales and were followed up for breast cancer-specific mortality until 2020. Females were excluded if they had a previous cancer diagnosis (except nonmelanoma skin cancer). Data analysis was performed between August 2022 and August 2023. Exposure: Use of vaginal estrogen therapy, including vaginal tablets and creams, was ascertained from pharmacy dispensing records of the Prescribing Information System for the Scotland cohort and from general practice prescription records for the Wales cohort. Main Outcomes and Measures: The primary outcome was time to breast cancer-specific mortality, which was obtained from national mortality records. Time-dependent Cox proportional hazards regression models were used to calculate hazard ratios (HRs) and 95% CIs for breast cancer-specific mortality, comparing vaginal estrogen therapy users with HRT nonusers and adjusting for confounders, including cancer stage and grade. Results: The 2 cohorts comprised 49 237 females with breast cancer (between 40 and 79 years of age) and 5795 breast cancer-specific deaths. Five percent of patients with breast cancer used vaginal estrogen therapy after breast cancer diagnosis. In vaginal estrogen therapy users compared with HRT nonusers, there was no evidence of a higher risk of breast cancer-specific mortality in the pooled fully adjusted model (HR, 0.77; 95% CI, 0.63-0.94). Conclusions and Relevance: Results of this study showed no evidence of increased early breast cancer-specific mortality in patients who used vaginal estrogen therapy compared with patients who did not use HRT. This finding may provide some reassurance to prescribing clinicians and support the guidelines suggesting that vaginal estrogen therapy can be considered in patients with breast cancer and genitourinary symptoms.

Interventions to improve the appropriate use of polypharmacy for older people.

BACKGROUND: Inappropriate polypharmacy is a particular concern in older people and is associated with negative health outcomes. Choosing the best interventions to improve appropriate polypharmacy is a priority, so that many medicines may be used to achieve better clinical outcomes for patients. This is the third update of this Cochrane Review. OBJECTIVES: To assess the effects of interventions, alone or in combination, in improving the appropriate use of polypharmacy and reducing medication-related problems in older people. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers up until 13 January 2021, together with handsearching of reference lists to identify additional studies. We ran updated searches in February 2023 and have added potentially eligible studies to 'Characteristics of studies awaiting classification'. SELECTION CRITERIA: For this update, we included randomised trials only. Eligible studies described interventions affecting prescribing aimed at improving appropriate polypharmacy (four or more medicines) in people aged 65 years and older, which used a validated tool to assess prescribing appropriateness. These tools can be classified as either implicit tools (judgement-based/based on expert professional judgement) or explicit tools (criterion-based, comprising lists of drugs to be avoided in older people). DATA COLLECTION AND ANALYSIS: Four review authors independently reviewed abstracts of eligible studies, and two authors extracted data and assessed the risk of bias of the included studies. We pooled study-specific estimates, and used a random-effects model to yield summary estimates of effect and 95% confidence intervals (CIs). We assessed the overall certainty of evidence for each outcome using the GRADE approach. MAIN RESULTS: We identified 38 studies, which includes an additional 10 in this update. The included studies consisted of 24 randomised trials and 14 cluster-randomised trials. Thirty-six studies examined complex, multi-faceted interventions of pharmaceutical care (i.e. the responsible provision of medicines to improve patients' outcomes), in a variety of settings. Interventions were delivered by healthcare professionals such as general physicians, pharmacists, nurses and geriatricians, and most were conducted in high-income countries. Assessments using the Cochrane risk of bias tool found that there was a high and/or unclear risk of bias across a number of domains. Based on the GRADE approach, the overall certainty of evidence for each pooled outcome ranged from low to very low. It is uncertain whether pharmaceutical care improves medication appropriateness (as measured by an implicit tool) (mean difference (MD) -5.66, 95% confidence interval (CI) -9.26 to -2.06; I2 = 97%; 8 studies, 947 participants; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the number of potentially inappropriate medications (PIMs) (standardised mean difference (SMD) -0.19, 95% CI -0.34 to -0.05; I2 = 67%; 9 studies, 2404 participants; very low-certainty evidence). It is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PIM (risk ratio (RR) 0.81, 95% CI 0.68 to 0.98; I2 = 84%; 13 studies, 4534 participants; very low-certainty evidence). Pharmaceutical care may slightly reduce the number of potential prescribing omissions (PPOs) (SMD -0.48, 95% CI -1.05 to 0.09; I2 = 92%; 3 studies, 691 participants; low-certainty evidence), however it must be noted that this effect estimate is based on only three studies, which had serious limitations in terms of risk of bias. Likewise, it is uncertain whether pharmaceutical care reduces the proportion of patients with one or more PPO (RR 0.50, 95% CI 0.27 to 0.91; I2 = 95%; 7 studies, 2765 participants; very low-certainty evidence). Pharmaceutical care may make little or no difference to hospital admissions (data not pooled; 14 studies, 4797 participants; low-certainty evidence). Pharmaceutical care may make little or no difference to quality of life (data not pooled; 16 studies, 7458 participants; low-certainty evidence). Medication-related problems were reported in 10 studies (6740 participants) using different terms (e.g. adverse drug reactions, drug-drug interactions). No consistent intervention effect on medication-related problems was noted across studies. This also applied to studies examining adherence to medication (nine studies, 3848 participants). AUTHORS' CONCLUSIONS: It is unclear whether interventions to improve appropriate polypharmacy resulted in clinically significant improvement. Since the last update of this review in 2018, there appears to have been an increase in the number of studies seeking to address potential prescribing omissions and more interventions being delivered by multidisciplinary teams.

Machine learning applications on neonatal sepsis treatment: a scoping review.

INTRODUCTION: Neonatal sepsis is a major cause of health loss and mortality worldwide. Without proper treatment, neonatal sepsis can quickly develop into multisystem organ failure. However, the signs of neonatal sepsis are non-specific, and treatment is labour-intensive and expensive. Moreover, antimicrobial resistance is a significant threat globally, and it has been reported that over 70% of neonatal bloodstream infections are resistant to first-line antibiotic treatment. Machine learning is a potential tool to aid clinicians in diagnosing infections and in determining the most appropriate empiric antibiotic treatment, as has been demonstrated for adult populations. This review aimed to present the application of machine learning on neonatal sepsis treatment. METHODS: PubMed, Embase, and Scopus were searched for studies published in English focusing on neonatal sepsis, antibiotics, and machine learning. RESULTS: There were 18 studies included in this scoping review. Three studies focused on using machine learning in antibiotic treatment for bloodstream infections, one focused on predicting in-hospital mortality associated with neonatal sepsis, and the remaining studies focused on developing machine learning prediction models to diagnose possible sepsis cases. Gestational age, C-reactive protein levels, and white blood cell count were important predictors to diagnose neonatal sepsis. Age, weight, and days from hospital admission to blood sample taken were important to predict antibiotic-resistant infections. The best-performing machine learning models were random forest and neural networks. CONCLUSION: Despite the threat antimicrobial resistance poses, there was a lack of studies focusing on the use of machine learning for aiding empirical antibiotic treatment for neonatal sepsis.

GPs' and pharmacists' views of integrating pharmacists into general practices: a qualitative study.

BACKGROUND: Practice-based pharmacists (PBPs) have been introduced into general practice across the UK to relieve some of the pressures within primary care. However, there is little existing UK literature that has explored healthcare professionals' (HCPs') views about PBP integration and how this role has evolved. AIM: To explore the views and experiences of GPs, PBPs, and community pharmacists (CPs) about PBPs' integration into general practice and their impact on primary healthcare delivery. DESIGN AND SETTING: A qualitative interview study in primary care in Northern Ireland. METHOD: Purposive and snowball sampling were used to recruit triads (a GP, a PBP, and a CP) from across five administrative healthcare areas in Northern Ireland. Sampling of practices to recruit GPs and PBPs commenced in August 2020. These HCPs identified the CPs who had most contact with the general practices in which the recruited GPs and PBPs were working. Semi-structured interviews were recorded, transcribed verbatim, and analysed using thematic analysis. RESULTS: Eleven triads were recruited from across the five administrative areas. Four main themes in relation to PBPs' integration into general practices were revealed: evolution of the role; PBP attributes; collaboration and communication; and impact on care. Areas for development were identified such as patient awareness of the PBP role. Many saw PBPs as a 'central hub-middleman' between general practice and community pharmacies. CONCLUSION: Participants reported that PBPs had integrated well and perceived a positive impact on primary healthcare delivery. Further work is needed to increase patient awareness of the PBP role.

Exposure to weak opioids and risk of gastrointestinal tract cancers: A series of nested case-control studies.

AIMS: There is evidence gastrointestinal (GI) motility may play a role in the development of GI cancers. Weak opioids (codeine and dihydrocodeine) decrease GI motility, but their effect on GI cancer risk has not been assessed. We aim to assess the association between weak opioids and cancers of the GI tract. METHODS: A series of nested case-control studies was conducted using Scottish general practice records from the Primary Care Clinical Informatics Unit Research database. Oesophageal (n = 2432), gastric (n = 1443) and colorectal cancer (n = 8750) cases, diagnosed between 1999 and 2011, were identified and matched with up to five controls. Weak opioid use was identified from prescribing records. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using conditional logistic regression, adjusting for relevant comorbidities and medication use. RESULTS: There was no association between weak opioids and colorectal cancer (adjusted OR = 0.96, CI 0.90, 1.02, P = 0.15). There was an increased risk of oesophageal (adjusted OR = 1.16, CI 1.04, 1.29, P = 0.01) and gastric cancer (adjusted OR = 1.26, CI 1.10, 1.45, P = 0.001). The associations for oesophageal cancer, but not gastric cancer, were attenuated when weak opioid users were compared with users of another analgesic (adjusted OR = 1.03 CI 0.86, 1.22, P = 0.76 and adjusted OR = 1.29 CI 1.02, 1.64, P = 0.04 respectively). CONCLUSIONS: In this large population-based study, there was no consistent evidence of an association between weak opioids and oesophageal or colorectal cancer risk, but a small increased risk of gastric cancer. Further investigation is required to determine whether this association is causal or reflects residual confounding or confounding by indication.

Trends and correlates of concurrent opioid and benzodiazepine and/or gabapentinoid use among Ontario nursing home residents.

BACKGROUND: A concern with long-term opioid use is the increased risk arising when opioids are used concurrently with drugs that can potentiate their associated adverse effects. The drugs most often encountered are benzodiazepines (BZDs) and gabapentinoids. Our study objectives were to examine trends in the concurrent use of opioids and BZDs, or gabapentinoids, in a Canadian nursing home population over an 11-year period, and current resident-level correlates of this concurrent use. METHODS: We conducted a population-based, repeated cross-sectional study among Ontario nursing home residents (>65 years) dispensed opioids between April 2009 and February 2020. For the last study year, we examined cross-sectional associations between resident characteristics and concurrent use of opioids with BZDs or gabapentinoids. Linked data on nursing home residents from clinical and health administrative databases was used. The yearly proportions of residents who were dispensed an opioid concurrently with a BZD or gabapentinoid were plotted with percent change derived from log-binomial regression models. Separate modified Poisson regression models estimated resident-level correlates of concurrent use of opioids with BZDs or gabapentinoids. RESULTS: Over the study period, among residents dispensed an opioid there was a 53.2% relative decrease (30.7% to 14.4%) in concurrent BZD and a 505.4% relative increase (4.4% to 26.6%) in concurrent gabapentinoid use. In adjusted models, increasing age and worsening cognition were inversely associated with the concurrent use of both classes, but most other significantly related covariates were unique to each drug class (e.g., sex and anxiety disorders for BZD, pain severity and presence of pain-related conditions for gabapentinoids). CONCLUSIONS: Co-administration of BZDs or gabapentinoids in Ontario nursing home residents dispensed opioids remains common, but the pattern of co-use has changed over time. Observed covariates of concurrent use in 2019/20 suggest distinct but overlapping resident populations requiring consideration of the relative risks versus benefits of this co-use and monitoring for potential harm.

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.

Development of a core set of clinical skills for pharmacist prescribers working in general practice: A Delphi study.

BACKGROUND: With increasing numbers of pharmacists working in general practices and undertaking patient-facing roles, it has been recognised that they must have the necessary clinical skills. However, previous studies have highlighted that practice-based pharmacists (PBPs) do not feel confident regarding their clinical skills, and it is unclear what skills are needed. OBJECTIVE: To develop a core set of clinical skills (CSs) required for pharmacists who intend to practise as independent prescribers working in general practice/family medicine. METHODS: Based on a previous study, 18 CSs were selected for inclusion in a three-round Delphi consensus questionnaire. These skills were rated by a Delphi panel on a 9-point Likert scale (ranging from 1 = limited importance to 9 = critical). The Delphi panel comprised designated leads of pharmacist independent prescribing programmes in each United Kingdom educational provider listed on the General Pharmaceutical Council website. A CS was included in the core set if 80% or more of participants scored between 7 and 9, and 15% or less scored between 1 and 3. RESULTS: Following Round 1, seven CSs met the criteria for inclusion: 'Measuring heart rate (radial pulse)', 'Assessing respiratory rate', 'Measuring blood pressure (manual, e.g. with aneroid sphygmomanometer)', 'Measuring blood pressure (automated, i.e. electronic blood pressure monitor)', 'Measuring peripheral oxygen saturation (using pulse oximeter)', 'Measuring temperature', 'Measuring Peak Expiratory Flow Rate'. After two further rounds, a further four CSs were included consisting of 'Undertaking a urinalysis', 'Respiratory examination (includes inspection, palpation, percussion and listening to breath sounds)', 'Screening for/assessment of depression and anxiety using a validated questionnaire (e.g. Patient Health Questionnaire-9 [PHQ-9] scoring)', and 'Patient assessment via National Early Warning Score (NEWS)'. No consensus was reached on nine CSs. CONCLUSION: This study has produced a core set of CSs for prescribing pharmacists. This study may contribute to standardisation of training and assessment for pharmacist prescribers working in general practice/family medicine.

Potentially inappropriate prescribing in older adults with cancer receiving specialist palliative care: a retrospective observational study.

BACKGROUND: Older adults (≥ 65 years) with cancer receiving palliative care often have other health conditions requiring multiple medications. AIM: To describe and assess the appropriateness of prescribing for older adults with cancer in the last seven days of life in an inpatient palliative care setting. METHOD: Retrospective observational study of medical records for 180 patients (60.6% male; median age: 74 years; range 65-94 years) over a two-year period. Medication appropriateness was assessed using: STOPPFrail, OncPal deprescribing guideline and criteria for identifying Potentially Inappropriate Prescribing in older adults with Cancer receiving Palliative Care (PIP-CPC). RESULTS: 94.5% of patients had at least one other health condition (median 3, IQR 2-5). The median number of medications increased from five (IQR 3-7) seven days before death, to 11 medications on the day of death (IQR 9-15). The prevalence of PIP varied depending on the tool used: STOPPFrail (version 1: 17.2%, version 2: 19.4%), OncPal (12.8%), PIP-CPC (30%). However, the retrospective nature of the study limited the applicability of the tools. Increasing number of medications had a statistically significant effect on risk of PIP across all tools (STOPPFrail (version 1: 1.29 (1.13-1.37), version 2: 1.30 (1.16-1.48)); OncPal 1.13 (1.01-1.27); PIP-CPC 0.70 (0.61-0.82)). CONCLUSION: This study found that the number of medications prescribed to older adults with cancer increased as time to death approached, and the prevalence of PIP varied with the application of different tools. The study also highlights the difficulties of examining PIP in this patient cohort.