Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease: the ALL-HEART RCT and economic evaluation.

Background: Allopurinol is a xanthine oxidase inhibitor that lowers serum uric acid and is used to prevent acute gout flares in patients with gout. Observational and small interventional studies have suggested beneficial cardiovascular effects of allopurinol. Objective: To determine whether allopurinol improves major cardiovascular outcomes in patients with ischaemic heart disease. Design: Prospective, randomised, open-label, blinded endpoint multicentre clinical trial. Setting: Four hundred and twenty-four UK primary care practices. Participants: Aged 60 years and over with ischaemic heart disease but no gout. Interventions: Participants were randomised (1 : 1) using a central web-based randomisation system to receive allopurinol up to 600 mg daily that was added to usual care or to continue usual care. Main outcome measures: The primary outcome was the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes were non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, all-cause mortality, hospitalisation for heart failure, hospitalisation for acute coronary syndrome, coronary revascularisation, hospitalisation for acute coronary syndrome or coronary revascularisation, all cardiovascular hospitalisations, quality of life and cost-effectiveness. The hazard ratio (allopurinol vs. usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis. Results: From 7 February 2014 to 2 October 2017, 5937 participants were enrolled and randomised to the allopurinol arm (n = 2979) or the usual care arm (n = 2958). A total of 5721 randomised participants (2853 allopurinol; 2868 usual care) were included in the modified intention-to-treat analysis population (mean age 72.0 years; 75.5% male). There was no difference between the allopurinol and usual care arms in the primary endpoint, 314 (11.0%) participants in the allopurinol arm (2.47 events per 100 patient-years) and 325 (11.3%) in the usual care arm (2.37 events per 100 patient-years), hazard ratio 1.04 (95% confidence interval 0.89 to 1.21); p = 0.65. Two hundred and eighty-eight (10.1%) participants in the allopurinol arm and 303 (10.6%) participants in the usual care arm died, hazard ratio 1.02 (95% confidence interval 0.87 to 1.20); p = 0.77. The pre-specified health economic analysis plan was to perform a 'within trial' cost-utility analysis if there was no statistically significant difference in the primary endpoint, so NHS costs and quality-adjusted life-years were estimated over a 5-year period. The difference in costs between treatment arms was +£115 higher for allopurinol (95% confidence interval £17 to £210) with no difference in quality-adjusted life-years (95% confidence interval -0.061 to +0.060). We conclude that there is no evidence that allopurinol used in line with the study protocol is cost-effective. Limitations: The results may not be generalisable to younger populations, other ethnic groups or patients with more acute ischaemic heart disease. One thousand six hundred and thirty-seven participants (57.4%) in the allopurinol arm withdrew from randomised treatment, but an on-treatment analysis gave similar results to the main analysis. Conclusions: The ALL-HEART study showed that treatment with allopurinol 600 mg daily did not improve cardiovascular outcomes compared to usual care in patients with ischaemic heart disease. We conclude that allopurinol should not be recommended for the secondary prevention of cardiovascular events in patients with ischaemic heart disease but no gout. Future work: The effects of allopurinol on cardiovascular outcomes in patients with ischaemic heart disease and co-existing hyperuricaemia or clinical gout could be explored in future studies. Trial registration: This trial is registered as EU Clinical Trials Register (EudraCT 2013-003559-39) and ISRCTN (ISRCTN 32017426). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/36/41) and is published in full in Health Technology Assessment; Vol. 28, No. 18. See the NIHR Funding and Awards website for further award information.

The purpose of the ALL-HEART study was to determine whether giving allopurinol to people with ischaemic heart disease (also commonly known as coronary heart disease) would reduce their risk of having a heart attack, stroke or of dying from cardiovascular disease. Allopurinol is a medication usually given to patients with gout to prevent acute gout flares. It is not currently used to treat ischaemic heart disease. We randomly allocated people aged over 60 years with ischaemic heart disease to take up to 600 mg of allopurinol daily (in addition to their usual care) or to continue with their usual care. We then monitored participants for several years and recorded any major health events such as heart attacks, strokes and deaths. We obtained most of the follow-up data from centrally held electronic hospital admissions and death records, making the study easier for participants and more cost-efficient. We asked participants in both groups to complete questionnaires to assess their quality of life during the study. We also collected data to determine whether there was any economic benefit to the NHS of using allopurinol in patients with ischaemic heart disease. There was no difference in the risk of heart attacks, strokes or death from cardiovascular disease between the participants given allopurinol and those in the group continuing their usual care. We also found no difference in the risks of other cardiovascular events, deaths from any cause or quality-of-life measurements between the allopurinol and usual care groups. The results of the ALL-HEART study suggest that we should not recommend that allopurinol be given to people with ischaemic heart disease to prevent further cardiovascular events or deaths.

Evaluating the UK's first national prescribing assessment for GPs in training using an online survey.

BACKGROUND: GP trainees may not have experienced a systematic and comprehensive education in safe prescribing. Therefore, a self-assessment prescribing review was developed. AIM: To determine whether the assessment was feasible, had face validity, and did not disadvantage particular groups of participants. DESIGN & SETTING: An online survey that evaluates the opinions of GPs in training of a prescribing assessment in the UK. All full-time UK trainees who started their final year of GP training in August 2019 undertook the prescribing assessment along with their trainers, after which they completed an online anonymous feedback questionnaire. METHOD: The questionnaire completed by trainees sought their opinions of the assessment, and collected ethnicity and disability data. The trainer questionnaire was similar but did not include any demographic information. RESULTS: The questionnaire was completed by 1741 trainees and 1576 trainers. There was no evidence that ethnic group and disability were related to aspects of the review. Most of the trainees (76.4%, n = 1330) and trainers (82.0%, n = 1293) agreed or strongly agreed that the prescribing review was helpful for assessing and learning about the trainee's prescribing. However, most participants (63.2%, n = 1092) took >4 hours to review their prescriptions. A majority of trainees (90.2%, n = 1571) reported that completing the assessment had resulted in a change in their prescribing practice. CONCLUSION: The majority of trainers and trainees reported that the prescribing assessment was helpful. The study was not able to assess whether there had been an actual change in practice that resulted in an error reduction.

Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. METHODS: We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96. FINDINGS: Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients). INTERPRETATION: H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term. FUNDING: National Institute for Health and Care Research Health Technology Assessment.

Managing medicines at the end of life: a position paper for health policy and practice.

PURPOSE: The impact of population ageing is significant, multifaceted and characterised by frailty and multi-morbidity. The COVID-19 pandemic has accelerated care pathways and policies promoting self-management and home-based care. One under-researched area is how patients and family caregivers manage the complexity of end-of-life therapeutic medicine regimens. In this position paper the authors bring attention to the significant strain that patients and family caregivers experience when navigating and negotiating this aspect of palliative and end-of-life care. DESIGN/METHODOLOGY/APPROACH: Focussing on self-care and organisation of medicines in the United Kingdom (UK) context, the paper examines, builds on and extends the debate by considering the underlying policy assumptions and unintended consequences for individual patients and family care givers as they assume greater palliative and end-of-life roles and responsibilities. FINDINGS: Policy makers and healthcare professionals often lack awareness of the significant burden and emotional work associated with managing and administering often potent high-risk medicines (i.e. opioids) in the domiciliary setting. The recent "revolution" in professional roles associated with the COVID-19 pandemic, including remote consultations and expanding community-based care, means there are opportunities for commissioners to consider offering greater support. The prospect of enhancing the community pharmacist's medicine optimisation role to further support the wider multi-disciplinary team is considered. ORIGINALITY/VALUE: The paper takes a person-focused perspective and adopts a holistic view of medicine management. The authors argue for urgent review, reform and investment to enable and support terminally ill patients and family caregivers to more effectively manage medicines in the domiciliary setting. There are clear implications for pharmacists and these are discussed in the context of public awareness, inter-professional collaboration, organisational drivers, funding and regulation and remote care delivery.

A comparative assessment of two tools designed to support patient safety culture in UK general practice.

BACKGROUND: The NHS has recognised the importance of a high quality patient safety culture in the delivery of primary health care in the rapidly evolving environment of general practice. Two tools, PC-SafeQuest and MapSaf, were developed with the intention of assessing and improving patient safety culture in this setting. Both have been made widely available through their inclusion in the Royal College of General Practitioners' Patient Safety Toolkit and our work offerss a timely exploration of the tools to inform practice staff as to how each might be usefully applied and in which circumstances. Here we present a comparative analysis of their content, and describe the perspectives of staff on their design, outputs and the feasibility of their sustained use. METHODS: We have used a content analysis to provide the context for the qualitative study of staff experiences of using the tools at a representative range of practices recruited from across the Midlands (UK). Data was collected through moderated focus groups using an identical topic guide. RESULTS: A total of nine practices used the PC-SafeQuest tool and four the MapSaf tool. A total of 159 staff completed the PC-SafeQuest tool 52 of whom took part in the subsequent focus group discussions, and 25 staff completed the MapSaf tool all of whom contributed to the focus group discussions. PC-SafeQuest was perceived as quick and easy to use with direct questions pertinent to the work of GP practices providing useful quantitative insight into important areas of safety culture. Though MaPSaF was more logistically challenging, it created a forum for synchronous cross- practice discussions raising awareness of perceptions of safety culture across the practice team. CONCLUSIONS: Both tools were able to promote reflective and reflexive practice either in individual staff members or across the broader practice team and the oversight they granted provided useful direction for senior staff looking to improve patient safety. Because PC SafeQuest can be easily disseminated and independently completed it is logistically suited to larger practice organisations, whereas the MapSaf tool lends itself to smaller practices where assembling staff in a single workshop is more readily achieved.

Evaluation of a pharmacist-led actionable audit and feedback intervention for improving medication safety in UK primary care: An interrupted time series analysis.

BACKGROUND: We evaluated the impact of the pharmacist-led Safety Medication dASHboard (SMASH) intervention on medication safety in primary care. METHODS AND FINDINGS: SMASH comprised (1) training of clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so. It was implemented in 43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK. All practices started receiving the intervention between 18 April 2016 and 26 September 2017. We used an interrupted time series analysis of rates (prevalence) of potentially hazardous prescribing and inadequate blood-test monitoring, comparing observed rates post-intervention to extrapolations from a 24-month pre-intervention trend. The number of people registered to participating practices and having 1 or more risk factors for being exposed to hazardous prescribing or inadequate blood-test monitoring at the start of the intervention was 47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21]). At baseline, 95% of practices had rates of potentially hazardous prescribing (composite of 10 indicators) between 0.88% and 6.19%. The prevalence of potentially hazardous prescribing reduced by 27.9% (95% CI 20.3% to 36.8%, p < 0.001) at 24 weeks and by 40.7% (95% CI 29.1% to 54.2%, p < 0.001) at 12 months after introduction of SMASH. The rate of inadequate blood-test monitoring (composite of 2 indicators) reduced by 22.0% (95% CI 0.2% to 50.7%, p = 0.046) at 24 weeks; the change at 12 months (23.5%) was no longer significant (95% CI -4.5% to 61.6%, p = 0.127). After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%. Study limitations include the fact that practices were not randomised, and therefore unmeasured confounding may have influenced our findings. CONCLUSIONS: The SMASH intervention was associated with reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring in general practices. This reduction was sustained over 12 months after the start of the intervention for prescribing but not for monitoring of medication. There was a marked reduction in the variation in rates of hazardous prescribing between practices.

'New Medicine Service': supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial.

OBJECTIVE: To examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks. METHODS: Pragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective). RESULTS: Unadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: -£104 (95% CI -£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI -0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of -£113.9 (-1159.4, 683.7). The incremental cost-effectiveness ratio was -£2758/QALY (2.5% and 97.5%: -38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY. CONCLUSIONS: At 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high. TRIAL REGISTRATION NUMBER: NCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

Clinical effectiveness and cost-effectiveness of issuing longer versus shorter duration (3-month vs. 28-day) prescriptions in patients with chronic conditions: systematic review and economic modelling.

BACKGROUND: To reduce expenditure on, and wastage of, drugs, some commissioners have encouraged general practitioners to issue shorter prescriptions, typically 28 days in length; however, the evidence base for this recommendation is uncertain. OBJECTIVE: To evaluate the evidence of the clinical effectiveness and cost-effectiveness of shorter versus longer prescriptions for people with stable chronic conditions treated in primary care. DESIGN/DATA SOURCES: The design of the study comprised three elements. First, a systematic review comparing 28-day prescriptions with longer prescriptions in patients with chronic conditions treated in primary care, evaluating any relevant clinical outcomes, adherence to treatment, costs and cost-effectiveness. Databases searched included MEDLINE (PubMed), EMBASE, Cumulative Index to Nursing and Allied Health Literature, Web of Science and Cochrane Central Register of Controlled Trials. Searches were from database inception to October 2015 (updated search to June 2016 in PubMed). Second, a cost analysis of medication wastage associated with < 60-day and ≥ 60-day prescriptions for five patient cohorts over an 11-year period from the Clinical Practice Research Datalink. Third, a decision model adapting three existing models to predict costs and effects of differing adherence levels associated with 28-day versus 3-month prescriptions in three clinical scenarios. REVIEW METHODS: In the systematic review, from 15,257 unique citations, 54 full-text papers were reviewed and 16 studies were included, five of which were abstracts and one of which was an extended conference abstract. None was a randomised controlled trial: 11 were retrospective cohort studies, three were cross-sectional surveys and two were cost studies. No information on health outcomes was available. RESULTS: An exploratory meta-analysis based on six retrospective cohort studies suggested that lower adherence was associated with 28-day prescriptions (standardised mean difference -0.45, 95% confidence interval -0.65 to -0.26). The cost analysis showed that a statistically significant increase in medication waste was associated with longer prescription lengths. However, when accounting for dispensing fees and prescriber time, longer prescriptions were found to be cost saving compared with shorter prescriptions. Prescriber time was the largest component of the calculated cost savings to the NHS. The decision modelling suggested that, in all three clinical scenarios, longer prescription lengths were associated with lower costs and higher quality-adjusted life-years. LIMITATIONS: The available evidence was found to be at a moderate to serious risk of bias. All of the studies were conducted in the USA, which was a cause for concern in terms of generalisability to the UK. No evidence of the direct impact of prescription length on health outcomes was found. The cost study could investigate prescriptions issued only; it could not assess patient adherence to those prescriptions. Additionally, the cost study was based on products issued only and did not account for underlying patient diagnoses. A lack of good-quality evidence affected our decision modelling strategy. CONCLUSIONS: Although the quality of the evidence was poor, this study found that longer prescriptions may be less costly overall, and may be associated with better adherence than 28-day prescriptions in patients with chronic conditions being treated in primary care. FUTURE WORK: There is a need to more reliably evaluate the impact of differing prescription lengths on adherence, on patient health outcomes and on total costs to the NHS. The priority should be to identify patients with particular conditions or characteristics who should receive shorter or longer prescriptions. To determine the need for any further research, an expected value of perfect information analysis should be performed. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015027042. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Cost Effectiveness of Support for People Starting a New Medication for a Long-Term Condition Through Community Pharmacies: An Economic Evaluation of the New Medicine Service (NMS) Compared with Normal Practice.

BACKGROUND: The English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs. METHODS: We developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients' non-adherence. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted life-year (QALY) were calculated from the perspective of NHS England, using a lifetime horizon. RESULTS: NMS generated a mean of 0.05 (95% CI 0.00-0.13) more QALYs per patient, at a mean reduced cost of -£144 (95% CI -769 to 73). The NMS dominates normal practice with a probability of 0.78 [incremental cost-effectiveness ratio (ICER) -£3166 per QALY]. NMS has a 96.7% probability of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. CONCLUSIONS: Our study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost. TRIAL REGISTRATION: ClinicalTrials.gov Trial reference number NCT01635361 ( http://clinicaltrials.gov/ct2/show/NCT01635361 ). Current Controlled trials: Trial reference number ISRCTN 23560818 ( http://www.controlled-trials.com/ISRCTN23560818/ ; DOI 10.1186/ISRCTN23560818 ). UK Clinical Research Network (UKCRN) study 12494 ( http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494 ). FUNDING: Department of Health Policy Research Programme.

Understanding the implementation and adoption of an information technology intervention to support medicine optimisation in primary care: qualitative study using strong structuration theory.

OBJECTIVES: Using strong structuration theory, we aimed to understand the adoption and implementation of an electronic clinical audit and feedback tool to support medicine optimisation for patients in primary care. DESIGN: This is a qualitative study informed by strong structuration theory. The analysis was thematic, using a template approach. An a priori set of thematic codes, based on strong structuration theory, was developed from the literature and applied to the transcripts. The coding template was then modified through successive readings of the data. SETTING: Clinical commissioning group in the south of England. PARTICIPANTS: Four focus groups and five semi-structured interviews were conducted with 18 participants purposively sampled from a range of stakeholder groups (general practitioners, pharmacists, patients and commissioners). RESULTS: Using the system could lead to improved medication safety, but use was determined by broad institutional contexts; by the perceptions, dispositions and skills of users; and by the structures embedded within the technology. These included perceptions of the system as new and requiring technical competence and skill; the adoption of the system for information gathering; and interactions and relationships that involved individual, shared or collective use. The dynamics between these external, internal and technological structures affected the adoption and implementation of the system. CONCLUSIONS: Successful implementation of information technology interventions for medicine optimisation will depend on a combination of the infrastructure within primary care, social structures embedded in the technology and the conventions, norms and dispositions of those utilising it. Future interventions, using electronic audit and feedback tools to improve medication safety, should consider the complexity of the social and organisational contexts and how internal and external structures can affect the use of the technology in order to support effective implementation.

Sources of unsafe primary care for older adults: a mixed-methods analysis of patient safety incident reports.

Background: older adults are frequent users of primary healthcare services, but are at increased risk of healthcare-related harm in this setting. Objectives: to describe the factors associated with actual or potential harm to patients aged 65 years and older, treated in primary care, to identify action to produce safer care. Design and Setting: a cross-sectional mixed-methods analysis of a national (England and Wales) database of patient safety incident reports from 2005 to 2013. Subjects: 1,591 primary care patient safety incident reports regarding patients aged 65 years and older. Methods: we developed a classification system for the analysis of patient safety incident reports to describe: the incident and preceding chain of incidents; other contributory factors; and patient harm outcome. We combined findings from exploratory descriptive and thematic analyses to identify key sources of unsafe care. Results: the main sources of unsafe care in our weighted sample were due to: medication-related incidents e.g. prescribing, dispensing and administering (n = 486, 31%; 15% serious patient harm); communication-related incidents e.g. incomplete or non-transfer of information across care boundaries (n = 390, 25%; 12% serious patient harm); and clinical decision-making incidents which led to the most serious patient harm outcomes (n = 203, 13%; 41% serious patient harm). Conclusion: priority areas for further research to determine the burden and preventability of unsafe primary care for older adults, include: the timely electronic tools for prescribing, dispensing and administering medication in the community; electronic transfer of information between healthcare settings; and, better clinical decision-making support and guidance.

Cognitive behaviour therapy for long-term frequent attenders in primary care: a feasibility case series and treatment development study.

BACKGROUND: Most frequent attendance in primary care is temporary. Long-term frequent attendance may be suitable for psychological intervention to address health management and service use. AIM: To explore the feasibility and acceptability of cognitive behaviour therapy (CBT) for long-term frequent attendance in primary care and obtain preliminary evidence regarding clinical and cost effectiveness. DESIGN AND SETTING: A CBT case series was carried out in five GP practices in the East Midlands. METHOD: Frequent attenders (FAs) were identified from case notes and invited by their practice for assessment, then offered CBT. Feasibility and acceptability were assessed by CBT session attendance and thematic analysis of semi-structured questionnaires. Clinical and cost effectiveness was assessed by primary care use and clinically important change on a range of health and quality of life instruments. RESULTS: Of 462 FAs invited to interview, 87 (19%) consented to assessment. Thirty-two (7%) undertook CBT over a median of 3 months. Twenty-four (75%) attended at least six sessions. Eighteen FAs (86%, n = 21) reported overall satisfaction with treatment. Patients reported valuing listening without judgement alongside support to develop coping strategies. Thirteen (54%, n = 24), achieved clinically important improvement on the SF-36 Mental-Component Scale at 6-month follow-up and improved quality of life, but no improvement on other outcomes. Primary care use reduced from a median of eight contacts in 3 months at baseline (n = 32) to three contacts in 3 months at 1 year (n = 18). CONCLUSION: CBT appears feasible and acceptable to a subset of long-term FAs in primary care who halved their primary care use. With improved recruitment strategies, this approach could contribute to decreasing GP workload and merits larger-scale evaluation.

Harms from discharge to primary care: mixed methods analysis of incident reports.

BACKGROUND: Discharge from hospital presents significant risks to patient safety, with up to one in five patients experiencing adverse events within 3 weeks of leaving hospital. AIM: To describe the frequency and types of patient safety incidents associated with discharge from secondary to primary care, and commonly described contributory factors to identify recommendations for practice. DESIGN AND SETTING: A mixed methods analysis of 598 patient safety incident reports in England and Wales related to 'Discharge' from the National Reporting and Learning System. METHOD: Detailed data coding (with 20% double-coding), data summaries generated using descriptive statistical analysis, and thematic analysis of special-case sample of reports. Incident type, contributory factors, type, and level of harm were described, informing recommendations for future practice. RESULTS: A total of 598 eligible reports were analysed. The four main themes were: errors in discharge communication (n = 151; 54% causing harm); errors in referrals to community care (n = 136; 73% causing harm); errors in medication (n = 97; 87% causing harm); and lack of provision of care adjuncts such as dressings (n = 62; 94% causing harm). Common contributory factors were staff factors (not following referral protocols); and organisational factors (lack of clear guidelines or inefficient processes). Improvement opportunities include developing and testing electronic discharge methods with agreed minimum information requirements and unified referrals systems to community care providers; and promoting a safety culture with 'safe discharge' checklists, discharge coordinators, and family involvement. CONCLUSION: Significant harm was evident due to deficits in the discharge process. Interventions in this area need to be evaluated and learning shared widely.

Primary Care Medication Safety Surveillance with Integrated Primary and Secondary Care Electronic Health Records: A Cross-Sectional Study.

INTRODUCTION: The extent of preventable medication-related hospital admissions and medication-related issues in primary care is significant enough to justify developing decision support systems for medication safety surveillance. The prerequisite for such systems is defining a relevant set of medication safety-related indicators and understanding the influence of both patient and general practice characteristics on medication prescribing and monitoring. OBJECTIVE: The aim of the study was to investigate the feasibility of linked primary and secondary care electronic health record data for surveillance of medication safety, examining not only prescribing but also monitoring, and associations with patient- and general practice-level characteristics. METHODS: A cross-sectional study was conducted using linked records of patients served by one hospital and over 50 general practices in Salford, UK. Statistical analysis consisted of mixed-effects logistic models, relating prescribing safety indicators to potential determinants. RESULTS: The overall prevalence (proportion of patients with at least one medication safety hazard) was 5.45 % for prescribing indicators and 7.65 % for monitoring indicators. Older patients and those on multiple medications were at higher risk of prescribing hazards, but at lower risk of missed monitoring. The odds of missed monitoring among all patients were 25 % less for males, 50 % less for patients in practices that provide general practitioner training, and threefold higher in practices serving the most deprived compared with the least deprived areas. Practices with more prescribing hazards did not tend to show more monitoring issues. CONCLUSIONS: Systematic collection, collation, and analysis of linked primary and secondary care records produce plausible and useful information about medication safety for a health system. Medication safety surveillance systems should pay close attention to patient age and polypharmacy with respect to both prescribing and monitoring failures; treat prescribing and monitoring as different statistical processes, rather than a combined measure of prescribing safety; and audit the socio-economic equity of missed monitoring.

The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: a naturalistic stepped wedge study.

OBJECTIVES: To compare prevalence and types of dispensing errors and pharmacists' labelling enhancements, for prescriptions transmitted electronically versus paper prescriptions. DESIGN: Naturalistic stepped wedge study. SETTING: 15 English community pharmacies. INTERVENTION: Electronic transmission of prescriptions between prescriber and pharmacy. MAIN OUTCOME MEASURES: Prevalence of labelling errors, content errors and labelling enhancements (beneficial additions to the instructions), as identified by researchers visiting each pharmacy. RESULTS: Overall, we identified labelling errors in 5.4% of 16,357 dispensed items, and content errors in 1.4%; enhancements were made for 13.6%. Pharmacists also edited the label for a further 21.9% of electronically transmitted items. Electronically transmitted prescriptions had a higher prevalence of labelling errors (7.4% of 3733 items) than other prescriptions (4.8% of 12,624); OR 1.46 (95% CI 1.21 to 1.76). There was no difference for content errors or enhancements. The increase in labelling errors was mainly accounted for by errors (mainly at one pharmacy) involving omission of the indication, where specified by the prescriber, from the label. A sensitivity analysis in which these cases (n=158) were not considered errors revealed no remaining difference between prescription types. CONCLUSIONS: We identified a higher prevalence of labelling errors for items transmitted electronically, but this was predominantly accounted for by local practice in a single pharmacy, independent of prescription type. Community pharmacists made labelling enhancements to about one in seven dispensed items, whether electronically transmitted or not. Community pharmacists, prescribers, professional bodies and software providers should work together to agree how items should be dispensed and labelled to best reap the benefits of electronically transmitted prescriptions. Community pharmacists need to ensure their computer systems are promptly updated to help reduce errors.

Cost effectiveness of a pharmacist-led information technology intervention for reducing rates of clinically important errors in medicines management in general practices (PINCER).

BACKGROUND AND OBJECTIVE: We recently showed that a pharmacist-led information technology-based intervention (PINCER) was significantly more effective in reducing medication errors in general practices than providing simple feedback on errors, with cost per error avoided at £79 (US$131). We aimed to estimate cost effectiveness of the PINCER intervention by combining effectiveness in error reduction and intervention costs with the effect of the individual errors on patient outcomes and healthcare costs, to estimate the effect on costs and QALYs. METHODS: We developed Markov models for each of six medication errors targeted by PINCER. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. A composite probabilistic model combined patient-level error models with practice-level error rates and intervention costs from the trial. Cost per extra QALY and cost-effectiveness acceptability curves were generated from the perspective of NHS England, with a 5-year time horizon. RESULTS: The PINCER intervention generated £2,679 less cost and 0.81 more QALYs per practice [incremental cost-effectiveness ratio (ICER): -£3,037 per QALY] in the deterministic analysis. In the probabilistic analysis, PINCER generated 0.001 extra QALYs per practice compared with simple feedback, at £4.20 less per practice. Despite this extremely small set of differences in costs and outcomes, PINCER dominated simple feedback with a mean ICER of -£3,936 (standard error £2,970). At a ceiling 'willingness-to-pay' of £20,000/QALY, PINCER reaches 59 % probability of being cost effective. CONCLUSIONS: PINCER produced marginal health gain at slightly reduced overall cost. Results are uncertain due to the poor quality of data to inform the effect of avoiding errors.

A qualitative study identifying the cost categories associated with electronic health record implementation in the UK.

OBJECTIVE: We conducted a prospective evaluation of different forms of electronic health record (EHR) systems to better understand the costs incurred during implementation and the factors that can influence these costs. METHODS: We selected a range of diverse organizations across three different geographical areas in England that were at different stages of implementing three centrally procured applications, that is, iSOFT's Lorenzo Regional Care, Cerner's Millennium, and CSE's RiO. 41 semi-structured interviews were conducted with hospital staff, members of the implementation team, and those involved in the implementation at a national level. RESULTS: Four main overarching cost categories were identified: infrastructure (eg, hardware and software), personnel (eg, training team), estates/facilities (eg, space), and other (eg, training materials). Many factors were felt to impact on these costs, with different hospitals choosing varying amounts and types of infrastructure, diverse training approaches for staff, and different software applications to integrate with the new system. CONCLUSIONS: Improving the quality and safety of patient care through EHR adoption is a priority area for UK and US governments and policy makers worldwide. With cost considered one of the most significant barriers, it is important for hospitals and governments to be clear from the outset of the major cost categories involved and the factors that may impact on these costs. Failure to adequately train staff or to follow key steps in implementation has preceded many of the failures in this domain, which can create new safety hazards.

Description and process evaluation of pharmacists' interventions in a pharmacist-led information technology-enabled multicentre cluster randomised controlled trial for reducing medication errors in general practice (PINCER trial).

OBJECTIVE: To undertake a process evaluation of pharmacists' recommendations arising in the context of a complex IT-enabled pharmacist-delivered randomised controlled trial (PINCER trial) to reduce the risk of hazardous medicines management in general practices. METHODS: PINCER pharmacists manually recorded patients' demographics, details of interventions recommended, actions undertaken by practice staff and time taken to manage individual cases of hazardous medicines management. Data were coded, double-entered into SPSS version 15 and then summarised using percentages for categorical data (with 95% confidence interval (CI)) and, as appropriate, means (± standard deviation) or medians (interquartile range) for continuous data. KEY FINDINGS: Pharmacists spent a median of 20 min (interquartile range 10, 30) reviewing medical records, recommending interventions and completing actions in each case of hazardous medicines management. Pharmacists judged 72% (95% CI 70, 74; 1463/2026) of cases of hazardous medicines management to be clinically relevant. Pharmacists recommended 2105 interventions in 74% (95% CI 73, 76; 1516/2038) of cases and 1685 actions were taken in 61% (95% CI 59, 63; 1246/2038) of cases; 66% (95% CI 64, 68; 1383/2105) of interventions recommended by pharmacists were completed and 5% (95% CI 4, 6; 104/2105) of recommendations were accepted by general practitioners (GPs), but not completed at the end of the pharmacists' placement; the remaining recommendations were rejected or considered not relevant by GPs. CONCLUSIONS: The outcome measures were used to target pharmacist activity in general practice towards patients at risk from hazardous medicines management. Recommendations from trained PINCER pharmacists were found to be broadly acceptable to GPs and led to ameliorative action in the majority of cases. It seems likely that the approach used by the PINCER pharmacists could be employed by other practice pharmacists following appropriate training.

Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England.

BACKGROUND: Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. METHODS/DESIGN: Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. DESIGN: parallel group patient-level pragmatic randomized controlled trial. INTERVENTIONS: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. PRIMARY OUTCOMES: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. SECONDARY OUTCOMES: impact of NMS on: patients' understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice.Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice. SAMPLE SIZE: 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate. DISCUSSION: At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken. TRIAL REGISTRATION: Current controlled trials: ISRCTN23560818. Clinical Trials US (clinicaltrials.gov): NCT01635361.

The causes of prescribing errors in English general practices: a qualitative study.

BACKGROUND: Few detailed studies exist of the underlying causes of prescribing errors in the UK. AIM: To examine the causes of prescribing and monitoring errors in general practice and provide recommendations for how they may be overcome. DESIGN AND SETTING: Qualitative interview and focus group study with purposive sampling of English general practices. METHOD: General practice staff from 15 general practices across three PCTs in England participated in a combination of semi-structured interviews (n = 34) and six focus groups (n = 46). Thematic analysis informed by Reason's Accident Causation Model was used. RESULTS: Seven categories of high-level error-producing conditions were identified: the prescriber, the patient, the team, the working environment, the task, the computer system, and the primary-secondary care interface. These were broken down to reveal various error-producing conditions: the prescriber's therapeutic training, drug knowledge and experience, knowledge of the patient, perception of risk, and their physical and emotional health; the patient's characteristics and the complexity of the individual clinical case; the importance of feeling comfortable within the practice team was highlighted, as well as the safety implications of GPs signing prescriptions generated by nurses when they had not seen the patient for themselves; the working environment with its extensive workload, time pressures, and interruptions; and computer-related issues associated with mis-selecting drugs from electronic pick-lists and overriding alerts were all highlighted as possible causes of prescribing errors and were often interconnected. CONCLUSION: Complex underlying causes of prescribing and monitoring errors in general practices were highlighted, several of which are amenable to intervention.