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Background: Direct reporting of suspected adverse drug reactions (ADRs) to authorities is increasing, but questions remain about how patients identify suspected ADRs and their ability to distinguish between ADRs and other symptoms.Objective: The aim of the study was to determine how reporters to the Yellow Card Scheme (YCS) identify ADRs.Methods: We carried out a qualitative analysis of data from three sources, obtained as part of a larger evaluation of patient reporting to the UK YCS: responses to open questions in postal questionnaires sent to all reporters during March 2008-January 2009 (method 1); telephone interviews with a purposive sample of these reporters (method 2); and the free-text field from completed Yellow Card reporting forms submitted during October 2005-September 2007 (method 3).Results: Method 1 involved 1362 questionnaire respondents (67.8% of the 2008 patient reporters during the study period), 1167 of whom explained how they decided they had experienced an ADR. Temporality was the most common reason for the perceived association, given by 820 (70.2%) respondents. 478 (41.0%) provided information on two or more aspects of temporality, such as onset, changes with dose and re-challenge. A total of 383 (32.8%) respondents used information sources, such as patient information leaflets or discussions with health professionals to confirm associations, including 145 (12.4%) who had also reported a temporal association. Telephone interviews with 27 reporters (method 2) provided detailed explanations of temporal associations, particularly experiences of rechallenge, and data from 230 Yellow Card reports (method 3) showed that, although reporters are not required to explain reasons for their suspicions, 74.8% of submitted reports included a temporal association. These reports also showed evidence of causal theorizing and differential diagnosis.Conclusion: In our study sample, most reporters to the YCS feel able to identify suspected ADRs adequately and describe processes of assessing causality that mirror those in standard algorithms designed for use by health professionals. These findings should help to reduce concerns among health professionals about the ability of patients to identify suspected ADRs when reporting to authorities. [ABSTRACT FROM AUTHOR]

We sought to compare the performance of the EQ-5D and SF-6D with regard to the criteria of practicality, convergent validity, and construct validity, the level of agreement between the two measures was also assessed. Responses from 1865 individuals aged >/= 45 years in one general practice were analysed. Of these, 93.1% completed the EQ-5D, compared with 86.4% for the SF-6D, where individuals who were older, female, of a lower occupational skill level, from an area of lower deprivation, or used prescribed medication were significantly less likely to complete the SF-6D. The performance of both measures was comparable with regard to both convergent and construct validities, as both the EQ-5D and SF-6D scores were closely related to scores on the EuroQol visual analogue scale (VAS) (p<0.001) and able to discriminate between people who did and did not take: (i) analgesics and (ii) other prescribed medication. Despite EQ-5D and SF-6D scores being highly correlated (p<0.001), individuals who were healthier (according to the VAS) had higher mean scores on the EQ-5D (p<0.001), whereas less healthy individuals had higher mean scores on the SF-6D (individuals with knee pain, osteoarthritis, back pain, rheumatoid arthritis, and hip pain had significantly lower mean scores on the EQ-5D, p<0.001). Copyright (c) 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The authors sought to identify ways in which the use of general practice computer systems could be improved to enhance safety in primary care. DESIGN: Qualitative study using semistructured interviews. PARTICIPANTS: Thirty one participants, representing a broad range of relevant disciplines and interest groups. Participants included clinicians, computer system and drug database suppliers, academics with interests in health informatics and members of governmental, professional and patient representative bodies. SETTING: UK. RESULTS: Participants identified deficiencies in current systems that pose serious threats to patient safety. To bring about improvements, providers need to supply clinicians with safe, accurate and accessible information for decision support; be aware of the importance of human ergonomics in the design of hazard alerts; consider the value of audit trails and develop mechanisms to allow for the accurate transfer of information between clinical computer systems. These improvements in computer systems will be most likely to occur if mandated through regulations. Individual practices are in need of improved education and training which focuses, in particular, on providing support with recording data accurately and using call, recall and reminders effectively. CONCLUSION: There are significant opportunities for improving the safety of general practice computer systems. Priorities include improving the knowledge base for clinical decision support, paying greater attention to human ergonomics in system design, improved staff training and the introduction of new regulations mandating system suppliers to satisfy essential safety requirements. [ABSTRACT FROM AUTHOR]

Computerized physician order entry (CPOE) is an application that is used to electronically write physician orders either in the hospital or in the outpatient setting. It is used in about 15% of U.S. Hospitals and a smaller percentage of ambulatory clinics. It is linked with clinical decision support, which provides much of the value of implementing it. A number of studies have assessed the impact of CPOE with respect to a variety of parameters, including costs of care, medication safety, use of guidelines or protocols, and other measures of the effectiveness or quality of care. Most of these studies have been undertaken at CPOE exemplar sites with homegrown clinical information systems. With the increasing implementation of commercial CPOE systems in various settings of care has come evidence that some implementation approaches may not achieve previously published results or may actually cause new errors or even harm. This has lead to new initiatives to evaluate CPOE systems, which have been undertaken by both vendors and other groups who evaluate vendors, focused on CPOE vendor capabilities and effective approaches to implementation that can achieve benefits seen in published studies. In addition, an electronic health record (EHR) vendor certification process is ongoing under the province of the Certification Commission for Health Information Technology (CCHIT) (which includes CPOE) that will affect the purchase and use of these applications by hospitals and clinics and their participation in public and private health insurance programs. Large employers have also joined this focus by developing flight simulation tools to evaluate the capabilities of these CPOE systems once implemented, potentially linking the results of such programs to reimbursement through pay for performance programs. The increasing role of CPOE systems in health care has invited much more scrutiny about the effectiveness of these systems in actual practice which has the potential to improve their ultimate performance. [ABSTRACT FROM AUTHOR]

While medications can improve patients' health, the process of prescribing them is complex and error prone, and medication errors cause many preventable injuries. Computer provider order entry (CPOE) with clinical decision support (CDS), can improve patient safety and lower medication-related costs. To realize the medication-related benefits of CDS within CPOE, one must overcome significant challenges. Healthcare organizations implementing CPOE must understand what classes of CDS their CPOE systems can support, assure that clinical knowledge underlying their CDS systems is reasonable, and appropriately represent electronic patient data. These issues often influence to what extent an institution will succeed with its CPOE implementation and achieve its desired goals. Medication-related decision support is probably best introduced into healthcare organizations in two stages, basic and advanced. Basic decision support includes drug-allergy checking, basic dosing guidance, formulary decision support, duplicate therapy checking, and drug-drug interaction checking. Advanced decision support includes dosing support for renal insufficiency and geriatric patients, guidance for medication-related laboratory testing, drug-pregnancy checking, and drug-disease contraindication checking. In this paper, the authors outline some of the challenges associated with both basic and advanced decision support and discuss how those challenges might be addressed. The authors conclude with summary recommendations for delivering effective medication-related clinical decision support addressed to healthcare organizations, application and knowledge base vendors, policy makers, and researchers. [ABSTRACT FROM AUTHOR]

Our objective was to identify and establish consensus on the most important safety features of GP computer systems, with a particular emphasis on medicines management. We used a two-round electronic Delphi survey, completed by a 21-member multidisciplinary expert panel, all from the UK. The main outcome measure was percentage agreement of the panel members on the importance of the presence of a number of different safety features (presented as clinical statements) on GP computer systems. We found 90% or greater agreement on the importance of 32 (58%) statements. These statements, indicating issues considered to be of considerable importance (rated as important or very important), related to: computerised alerts; the need to avoid spurious alerts; making it difficult to override critical alerts; having audit trails of such overrides; support for safe repeat prescribing; effective computer-user interface; importance of call and recall management; and the need to be able to run safety reports. The high level of agreement among the expert panel members indicates clear themes and priorities that need to be addressed in any further improvement of safety features in primary care computing systems. [ABSTRACT FROM AUTHOR]

General practice computer systems already have a number of important safety features. However, there are problems in that general practitioners (GPs) have come to rely on hazard alerts when they are not foolproof. Furthermore, GPs do not know how to make best use of safety features on their systems. There are a number of solutions that could help to improve the safety features of general practice computer systems and also help to improve the abilities of healthcare professionals to use these safety features. [ABSTRACT FROM AUTHOR]

BACKGROUND: The NHS Plan promises an equitable distribution of resources within primary care. To inform the debate on the extent to which resources should be redistributed we examined the association between primary care activity and deprivation. We used the natural experiment of the organization of primary care in Mansfield, Nottinghamshire, where town centre general practices have patients from electoral wards with a range of socio-economic characteristics who are subject to the same degree of supplier-induced demand and variations in data quality. METHODS: We used one year's prospective data for two practices with 20,106 patients from 15 electoral wards. We performed linear regression analysis of directly age-standardized rates for different types of primary care activity and primary care morbidity-specific contacts against Townsend and Index of Multiple Deprivation 2000 scores. RESULTS: There were 44 per cent more out-of-hours contacts in more deprived areas (95 per cent confidence interval (CI) 17-70 per cent), 18 per cent more surgery consultations (95 per cent CI 8-27 per cent), and 28 per cent more same-day consultations (95 per cent CI 12-44 per cent). Routine visits by doctors and contacts by district and practice nurses did not have substantial associations with deprivation. Morbidity-specific contacts for psychological problems and respiratory problems were associated with deprivation but there was no significant association for contacts for low back pain, asthma or menopausal problems. CONCLUSIONS: Different types of primary care activity and contacts for different morbidities had different associations with deprivation. This makes it difficult to recommend a simple list size adjustment; however, increased activity in deprived wards needs to be recognized in resource allocation, service configuration and performance management in primary care. [ABSTRACT FROM AUTHOR]

Objectives: To document (1) the use of general practice and hospital-based accident and emergency (emergency department) services outside normal general practice office hours for children under 5; (2) the presenting complaints of those children; (3) the proportion of presentations to general practice services that are dealt with by telephone alone. Setting and sample: Six general practices in Nottingham, UK, and the local accident and emergency department; all children aged under 5 registered with the general practices. Methods: Prospective study recording all general practice and accident and emergency (emergency department) out-of-hours contacts over a 6-month period. Results: The overall rate of contacts outside normal office hours was 751 per 1000 children per year. General practitioner services handled 81.2% of contacts compared with 18.8% for the accident and emergency department. Only 41 % of the emergency department contacts were due to accidents and injuries. Overall, 34% of presentations to general practitioners were dealt with by telephone. However, the proportion dealt with by telephone varied for different types of presenting complaint. For example, presentations for shortness of breath, fever or generalized rash were conducted over the telephone in 10, 29 and 40% of cases, respectively. Conclusions: General practice services dealt with the majority of contacts with children under 5 outside normal general practice office hours. Nevertheless, it is possible that some of the presentations to accident and emergency (the emergency department) could have been dealt with outside hospital. The proportion of contacts dealt with by telephone varied for different presenting complaints. [ABSTRACT FROM AUTHOR]

Objective: To investigate the temporal association between the first diagnosis of gout and cardiovascular events in the short term., Methods: We performed a self-controlled case series analysis and a cohort study using data from linked primary care, hospitalization, and mortality records from the United Kingdom's Clinical Practice Research Database-GOLD. We included individuals with a new diagnosis of gout either in the primary care or secondary care between January 1, 1997 and December 31, 2020. The first consultation at which gout was diagnosed was the exposure of interest. The main outcome consisted of cardiovascular events (ie, a composite of fatal and nonfatal myocardial infarction, ischemic or hemorrhagic stroke, and transient ischemic attack)., Results: The 4,398 patients (66.9% male, mean age 74.6 years) had a cardiovascular event within at least two years of their first recorded diagnosis of gout. The incidence of cardiovascular events was significantly higher in the 30 days after the first diagnosis of gout compared to baseline (adjusted incidence rate ratio 1.55, 95% confidence interval [CI] 1.33-1.83). Among 76,440 patients (72.9% male, mean age 63.2 years) included in the cohort study, the incidence of cardiovascular events in the 30 days after the first gout diagnosis (31.2 events per 1,000 person-years, 95% CI 27.1-35.9) was significantly higher than in days 31 to 730 after gout diagnosis (21.6 events per 1,000 person-years, 95% CI 20.8-22.4) with a rate difference of -9.6 events per 1,000 person-years (95% CI -14.0 to -5.1)., Conclusion: Individuals had a short-term increased risk of cardiovascular events in the 30 days following the first consultation at which gout was diagnosed., (© 2024 The Author(s). Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objectives: To quantify prevalence, harms, and NHS costs in England of problematic oral non-steroidal anti-inflammatory drug (NSAID) prescribing in high risk groups., Design: Population based cohort and economic modelling study., Setting: Economic models estimating patient harm associated with NSAID specific hazardous prescribing events, and cost to the English NHS, over a 10 year period, were combined with trends of hazardous prescribing event to estimate national levels of patient harm and NHS costs., Participants: Eligible participants were prescribed oral NSAIDs and were in five high risk groups: older adults (≥65 years) with no gastroprotection; people who concurrently took oral anticoagulants; or those with heart failure, chronic kidney disease, or a history of peptic ulcer., Main Outcome Measures: Prevalence of hazardous prescribing events, by each event and overall, discounted quality adjusted life years (QALYs) lost, and cost to the NHS in England of managing harm., Results: QALY losses and cost increases were observed for each hazardous prescribing event ( v no hazardous prescribing event). Mean QALYs per person were between 0.01 (95% credibility interval (CI) 0.01 to 0.02) lower with history of peptic ulcer, to 0.11 (0.04 to 0.19) lower with chronic kidney disease. Mean cost increases ranged from a non-statistically significant £14 (€17; $18) (95% CI -£71 to £98) in heart failure, to a statistically significant £1097 (£236 to £2542) in people concurrently taking anticoagulants. Prevalence of hazardous prescribing events per 1000 patients ranged from 0.11 in people who have had a peptic ulcer to 1.70 in older adults. Nationally, the most common hazardous prescribing event (older adults with no gastroprotection) resulted in 1929 (1416 to 2452) QALYs lost, costing £2.46m (£0.65m to £4.68m). The greatest impact was in people concurrently taking oral anticoagulants: 2143 (894 to 4073) QALYs lost, costing £25.41m (£5.25m to £60.01m). Over 10 years, total QALYs lost were estimated to be 6335 (4471 to 8658) and an NHS cost for England of £31.43m (£9.28m to £67.11m)., Conclusions: NSAIDs continue to be a source of avoidable harm and healthcare cost in these five high risk populations, especially in inducing an acute event in people with chronic condition and people taking oral anticoagulants., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: Funding from the NIHR; DMA reports research grants from NIHR, AbbVie, Almirall, Celgene, Eli Lilly, Janssen, Novartis, UCB, and the Leo Foundation. AC, EC, BG, DM, LP, and GR report research grants from NIHR. AC reports research grants from NIHR, UKRI, and Industrial Challenge Fund. AJA reports research grants from NIHR and was National Clinical Director for NHS England at the time of the study. RAE reports research grants from NIHR and Abbott., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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., (Copyright © 2023, The Authors.)

Background: Cerebral palsy (CP) is one of the most common neurological disorders in children and results in lifelong physical impairments. Adults with CP have approximately the same life expectancy as their non-disabled peers, so helping them to stay healthy throughout the life course will have long-term cost benefits via reductions in hospital admissions, long-term care, and unemployment rates., Aim: To explore how adults with CP experience ageing., Design & Setting: National online survey given to adults with CP in the UK., Method: The participants were adults with CP. Items for the online survey were taken from existing self-report measures, with additional items developed for the survey. Several domains of functioning were assessed including mobility, dexterity, fatigue, pain, speech, mental health, swallowing and health maintenance/self-care as well as healthcare usage. Data were analysed using χ 2 to examine the relationships between the demographic variables and the survey responses., Results: The survey was completed by 395 participants, of whom 74.2% were female and approximately 59.3% aged <45 years. Responders reported having problems with mobility, pain, and fatigue with older participants reporting higher levels of pain and more mobility problems, although the correlations were fairly small. Healthcare usage was surprisingly low., Conclusion: The study found that age was associated with a decline in mobility and a higher level of pain, although the relationships were weak. It is possible that the low healthcare usage among the responders is owing to services not being available to respond to their needs., (Copyright © 2023, The Authors.)

The interface between primary and secondary care represents a highly complex and heterogeneous system that continues to pose risks to the safety and quality of care. Many issues relate to prescribing activities, and suboptimal information sharing between stakeholders can lead to avoidable harm events and system inefficiencies that increase workload. The framework of a systems approach is used to structure four key interface issues: medicines reconciliation, prescribing at secondary care outpatient appointments, shared records, and quality of communication. We outline opportunities for improved safety and efficiency, and identify key barriers that need to be addressed. Significant further development is required for the measures discussed. We recommend the use of a systems approach to methodologically support this process, particularly due to the inherent system-wide understanding of problems that it generates. We argue such understanding is essential to ensure that risks and workload are not shifted around a system, without overall gain., Competing Interests: AA is national clinical director for prescribing for NHS England., (© Royal College of Physicians 2023. All rights reserved.)

Objective: Previous studies demonstrated that the risk of venous thromboembolism (VTE) is increased in patients with gout, but not whether there was a temporal association between gout flare and VTE. This study was undertaken to evaluate potential temporal associations between gout flare and VTE., Methods: Data were obtained from electronic primary-care records from the UK's Clinical Practice Research Datalink, which links data from hospitalization and mortality registers. Using self-controlled case series analysis adjusted for season and age, we evaluated the temporal association between gout flare and VTE. The 90 days after primary-care consultation or hospitalization for gout flare was designated the exposed period. This was divided into three 30-day intervals. The baseline period was up to 2 years before the start of and up to 2 years after the end of the exposed period. The association between gout flare and VTE was measured using adjusted incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs)., Results: In total, 314 patients met the inclusion criteria (age ≥18 years, incident gout, no presence of VTE or use of a primary-care anticoagulant prescription before the start of the pre-exposure period). Among the 314 patients, VTE incidence was significantly higher in the exposed period than in the baseline period (adjusted IRR 1.83, 95% CI 1.30-2.59). The adjusted IRR of VTE during the first 30 days after gout flare was 2.31 (95% CI 1.39-3.82) relative to the baseline period. No increase in the adjusted IRRs was observed in days 31-60 (adjusted IRR 1.49, 95% CI 0.79-2.81) and days 61-90 (adjusted IRR 1.67, 95% CI 0.91-3.06) relative to baseline. Results were consistent across sensitivity analyses., Conclusion: Among patients with gout, there was a transient increase in the rate of VTE within 30 days after primary-care consultation or hospitalization for gout flare., (© 2023 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Background: Medication reviews in primary care provide an opportunity to review and discuss the safety and appropriateness of a person's medicines. However, there is limited evidence about access to and the impact of routine medication reviews for older adults in the general population, particularly in the UK. We aimed to quantify the proportion of people aged 65 years and over with a medication review recorded in 2019 and describe changes in the numbers and types of medicines prescribed following a review., Methods: We used anonymised primary care electronic health records from the UK's Clinical Practice Research Datalink (CPRD GOLD) to define a population of people aged 65 years or over in 2019. We counted people with a medication review record in 2019 and used Cox regression to estimate associations between demographic characteristics, diagnoses, and prescribed medicines and having a medication review. We used linear regression to compare the number of medicines prescribed as repeat prescriptions in the three months before and after a medication review. Specifically, we compared the 'prescription count' - the maximum number of different medicines with overlapping prescriptions people had in each period., Results: Of 591,726 people prescribed one or more medicines at baseline, 305,526 (51.6%) had a recorded medication review in 2019. Living in a care home (hazard ratio 1.51, 95% confidence interval 1.40-1.62), medication review in the previous year (1.83, 1.69-1.98), and baseline prescription count (e.g. 5-9 vs 1 medicine 1.41, 1.37-1.46) were strongly associated with having a medication review in 2019. Overall, the prescription count tended to increase after a review (mean change 0.13 medicines, 95% CI 0.12-0.14)., Conclusions: Although medication reviews were commonly recorded for people aged 65 years or over, there was little change overall in the numbers and types of medicines prescribed following a review. This study did not examine whether the prescriptions were appropriate or other metrics, such as dose or medicine changes within the same class. However, by examining the impact of medication reviews before the introduction of structured medication review requirements in England in 2020, it provides a useful benchmark which these new reviews can be compared with., (© 2023. The Author(s).)

Objectives: Prisoners use healthcare services three times more frequently than the general population with poorer health outcomes. Their distinct healthcare needs often pose challenges to safe healthcare provision. This study aimed to characterise patient safety incidents reported in prisons to guide practice improvement and identify health policy priorities. Design: We carried out an exploratory multi-method analysis of anonymised safety incidents from prisons., Setting: Safety incidents had been reported to the National Reporting and Learning System by prisons in England between April 2018 and March 2019., Participants: Reports were reviewed to identify any unintended or unexpected incident(s) which could have, or did, lead to harm for prisoners receiving healthcare., Main Outcome Measures: Free-text descriptions were examined to identify the type and nature of safety incidents, their outcomes and harm severity. Analysis was contextualised with subject experts through structured workshops to explain relationships between the most common incidents and contributory factors., Results: Of 4112 reports, the most frequently observed incidents were medication-related (n = 1167, 33%), specifically whilst administering medications (n = 626, 54%). Next, were access-related (n = 559,15%), inclusive of delays in patients accessing healthcare professionals (n = 236, 42%) and managing medical appointments (n =  171, 31%). The workshops contextualised incidents involving contributing factors (n = 1529, 28%) into three key themes, namely healthcare access, continuity of care and the balance between prison and healthcare priorities., Conclusions: This study highlights the importance of improving medication safety and access to healthcare services for prisoners. We recommend staffing level reviews to ensure healthcare appointments are attended, and to review procedures for handling missed appointments, communication during patient transfers and medication prescribing.

Objective: To implement complex, PINCER (pharmacist led information technology intervention) prescribing indicators, on a national scale with general practice data to describe the impact of the covid-19 pandemic on safe prescribing., Design: Population based, retrospective cohort study using federated analytics., Setting: Electronic general practice health record data from 56.8 million NHS patients by use of the OpenSAFELY platform, with the approval of the National Health Service (NHS) England., Participants: NHS patients (aged 18-120 years) who were alive and registered at a general practice that used TPP or EMIS computer systems and were recorded as at risk of at least one potentially hazardous PINCER indicator., Main Outcome Measure: Between 1 September 2019 and 1 September 2021, monthly trends and between practice variation for compliance with 13 PINCER indicators, as calculated on the first of every month, were reported. Prescriptions that do not adhere to these indicators are potentially hazardous and can cause gastrointestinal bleeds; are cautioned against in specific conditions (specifically heart failure, asthma, and chronic renal failure); or require blood test monitoring. The percentage for each indicator is formed of a numerator of patients deemed to be at risk of a potentially hazardous prescribing event and the denominator is of patients for which assessment of the indicator is clinically meaningful. Higher indicator percentages represent potentially poorer performance on medication safety., Results: The PINCER indicators were successfully implemented across general practice data for 56.8 million patient records from 6367 practices in OpenSAFELY. Hazardous prescribing remained largely unchanged during the covid-19 pandemic, with no evidence of increases in indicators of harm as captured by the PINCER indicators. The percentage of patients at risk of potentially hazardous prescribing, as defined by each PINCER indicator, at mean quarter 1 (Q1) 2020 (representing before the pandemic) ranged from 1.11% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 36.20% (amiodarone and no thyroid function test), while Q1 2021 (representing after the pandemic) percentages ranged from 0.75% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 39.23% (amiodarone and no thyroid function test). Transient delays occurred in blood test monitoring for some medications, particularly angiotensin-converting enzyme inhibitors (where blood monitoring worsened from a mean of 5.16% in Q1 2020 to 12.14% in Q1 2021, and began to recover in June 2021). All indicators substantially recovered by September 2021. We identified 1 813 058 patients (3.1%) at risk of at least one potentially hazardous prescribing event., Conclusion: NHS data from general practices can be analysed at national scale to generate insights into service delivery. Potentially hazardous prescribing was largely unaffected by the covid-19 pandemic in primary care health records in England., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare the following: BG has received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; he also receives personal income from speaking and writing for lay audiences on the misuse of science., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: Competing interests: AA has received departmental research grants from AstraZeneca and Oxford Immunotec, speaker bureau fees from Menarini, Cadilla Pharmaceuticals, scientific meeting support from Pfizer, consulting fees from Inflazome and author royalties from UpToDate and Springer, unrelated to this work. The other authors have no conflict of interest to declare.

Background: We previously reported on a randomised trial demonstrating the effectiveness and cost-effectiveness of a pharmacist-led information technology intervention (PINCER). We sought to investigate whether PINCER was effective in reducing hazardous prescribing when rolled out at scale in UK general practices., Methods and Findings: We used a multiple interrupted time series design whereby successive groups of general practices received the PINCER intervention between September 2015 and April 2017. We used 11 prescribing safety indicators to identify potentially hazardous prescribing and collected data over a maximum of 16 quarterly time periods. The primary outcome was a composite of all the indicators; a composite for indicators associated with gastrointestinal (GI) bleeding was also reported, along with 11 individual indicators of hazardous prescribing. Data were analysed using logistic mixed models for the quarterly event numbers with the appropriate denominator, and calendar time included as a covariate. PINCER was implemented in 370 (94.1%) of 393 general practices covering a population of almost 3 million patients in the East Midlands region of England; data were successfully extracted from 343 (92.7%) of these practices. For the primary composite outcome, the PINCER intervention was associated with a decrease in the rate of hazardous prescribing of 16.7% (adjusted odds ratio (aOR) 0.83, 95% confidence interval (CI) 0.80 to 0.86) at 6 months and 15.3% (aOR 0.85, 95% CI 0.80 to 0.90) at 12 months postintervention. The unadjusted rate of hazardous prescribing reduced from 26.4% (22,503 patients in the numerator/853,631 patients in the denominator) to 20.1% (11,901 patients in the numerator/591,364 patients in the denominator) at 6 months and 19.1% (3,868 patients in the numerator/201,992 patients in the denominator). The greatest reduction in hazardous prescribing associated with the intervention was observed for the indicators associated with GI bleeding; for the GI composite indicator, there was a decrease of 23.9% at both 6 months (aOR 0.76, 95% CI 0.73 to 0.80) and 12 months (aOR 0.76, 95% CI 0.70 to 0.82) postintervention. The unadjusted rate of hazardous prescribing reduced from 31.4 (16,185 patients in the numerator/515,879 patients in the denominator) to 21.2% (7,607 patients in the numerator/358,349 patients in the denominator) at 6 months and 19.5% (2,369 patients in the numerator/121,534 patients in the denominator). We adjusted for calendar time and practice, but since this was an observational study, the findings may have been influenced by unknown confounding factors or behavioural changes unrelated to the PINCER intervention. Data were also not collected for all practices at 6 months and 12 months postintervention., Conclusions: The PINCER intervention, when rolled out at scale in routine clinical practice, was associated with a reduction in hazardous prescribing by 17% and 15% at 6 and 12 months postintervention. The greatest reductions in hazardous prescribing were for indicators associated with risk of GI bleeding. These findings support the wider national rollout of PINCER in England., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AJA is the National Clinical Director for Prescribing for NHS England. AJA and RAE hold a NIHR Programme Grants for Applied Research: Avoiding patient harm through the application of prescribing safety indicators in English general practices (acronym: PRoTeCT): RP-PG-1214-10005.MJB is a reviewer for NIHR and Pharmacy Research UK grant awards and is an Editorial Board member for Research in Social and Administrative Pharmacy (RSAP) and Exploratory Research in Clinical and Social Pharmacy (ERCSP). AS is on the editorial board of PLOS Medicine. ANS received funding from the National Institute for Health Research for several unrelated studies listed in publication., (Copyright: © 2022 Rodgers et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischaemic heart disease., Methods: ALL-HEART was a multicentre, prospective, randomised, open-label, blinded-endpoint trial done in 18 regional centres in England and Scotland, with patients recruited from 424 primary care practices. Eligible patients were aged 60 years or older, with ischaemic heart disease but no history of gout. Participants were randomly assigned (1:1), using a central web-based randomisation system accessed via a web-based application or an interactive voice response system, to receive oral allopurinol up-titrated to a dose of 600 mg daily (300 mg daily in participants with moderate renal impairment at baseline) or to continue usual care. The primary outcome was the composite cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death. The hazard ratio (allopurinol vs usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis (excluding randomly assigned patients later found to have met one of the exclusion criteria). The safety analysis population included all patients in the modified intention-to-treat usual care group and those who took at least one dose of randomised medication in the allopurinol group. This study is registered with the EU Clinical Trials Register, EudraCT 2013-003559-39, and ISRCTN, ISRCTN32017426., Findings: Between Feb 7, 2014, and Oct 2, 2017, 5937 participants were enrolled and then randomly assigned to receive allopurinol or usual care. After exclusion of 216 patients after randomisation, 5721 participants (mean age 72·0 years [SD 6·8], 4321 [75·5%] males, and 5676 [99·2%] white) were included in the modified intention-to-treat population, with 2853 in the allopurinol group and 2868 in the usual care group. Mean follow-up time in the study was 4·8 years (1·5). There was no evidence of a difference between the randomised treatment groups in the rates of the primary endpoint. 314 (11·0%) participants in the allopurinol group (2·47 events per 100 patient-years) and 325 (11·3%) in the usual care group (2·37 events per 100 patient-years) had a primary endpoint (hazard ratio [HR] 1·04 [95% CI 0·89-1·21], p=0·65). 288 (10·1%) participants in the allopurinol group and 303 (10·6%) participants in the usual care group died from any cause (HR 1·02 [95% CI 0·87-1·20], p=0·77)., Interpretation: In this large, randomised clinical trial in patients aged 60 years or older with ischaemic heart disease but no history of gout, there was no difference in the primary outcome of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death between participants randomised to allopurinol therapy and those randomised to usual care., Funding: UK National Institute for Health and Care Research., Competing Interests: Declaration of interests ISM reports research grants from Menarini, EMA, Sanofi, Health Data Research UK, the British Heart Foundation, and Innovative Medicines Initiative; institutional consultancy income from AstraZeneca outside the submitted work; and personal income from AstraZeneca and Amgen outside the submitted work. TMM reports grants from Menarini/Ipsen/Teijin and Merck Sharp & Dohme outside the submitted work, and personal income for consultancy from Novartis and AstraZeneca outside the submitted work, and is a trustee of the Scottish Heart Arterial Risk Prevention Society. AGB reports personal income from Novartis, Mylan, AstraZeneca, Bayer, Daiichi-Sankyo, Boehringer, Pfizer, Galderma, Zambon, and Novo-Nordisk outside the submitted work. ADS and the University of Dundee hold a European patent for the use of xanthine oxidase inhibitors in treating chest pain in angina pectoris. AW declares personal income for consultancy from AbbVie, Akcea, Albireo, Alexion, Allergan, Amarin, Apsara, Arena, Astellas, AstraZeneca, Autolus, Bayer, Biocryst, Biogen, Biomarin, Bristol Myers Squibb, Boehringer Ingelheim, Calico, Celgene, Chiesi, Daiichi Sankyo, Diurnal, Elsai, Eli Lilly, Ferring, Galapagos, Gedeon Richter, Gilead, GlaxoSmithKline, GW Pharma, Idorsia, Incyte, Intercept, Ionis, Ipsen, Janssen, Jazz, Jcyte, Kite Gilead, LEK, Leo Pharma, Les Laboratoires Servier, Lundbeck, Merck (Merck Sharp & Dohme), Merck-Serono, Mitenyi, Mundibiopharma, Mustang Bio, Mylan, Myovant, Norgine, Novartis, Novo Nordisk, Orchard, Paion, Pfizer, Pierre Fabre, PTC, RegenXBio, Rhythm, Sanofi, Santen, Sarepta, SeaGen, Shionogi, Sigmatec, SOBI, Takeda, Tanaya, UCB, and Vertex outside the submitted work. JST declares research funding from the UK National Institute for Health and Care Research (NIHR) and NHS England outside the submitted work and membership of a UK National Institute for Health and Care Excellence guideline committee on management of atrial fibrillation. All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Prescribing errors can cause significant morbidity and occur in about 5% of prescriptions in English general practices., Aim: To describe the frequency and nature of prescribing problems in a cohort of GPs-in-training to determine whether they need additional prescribing support., Design & Setting: A primary care pharmacist undertook a retrospective review of prescriptions issued between 9 October 2014 and 11 March 2015 by 10 GPs in their final year of training from 10 practices in England., Method: Pre-existing standards and expert panel discussion were used to classify the appropriateness of prescribing. Data were imported into Stata (version 13) to perform descriptive analysis. An individualised report highlighting prescribing errors, suboptimal prescribing, and areas of good practice identified during the review was shared with the GPs-in-training and their trainers. This report was used to guide discussions during the GP-in-training's feedback session., Results: A total of 1028 prescription items were reviewed from 643 consultations performed by 10 GPs-in-training. There were 92 prescribing errors (8.9%) and 360 episodes of suboptimal prescribing (35.0%). The most common types of error concerned medication dosages ( n = 30, 32.6% of errors)., Conclusion: Personalised review of prescribing revealed an error rate higher than recorded in a previous similar study mainly comprising GPs who had completed postgraduate training, and a substantially higher rate of suboptimal prescribing. A larger intervention study is now required to evaluate the effectiveness of receiving a personalised review of prescribing, and to assess its impact on patient safety., (Copyright © 2022, The Authors.)

Importance: Gout is associated with cardiovascular diseases. The temporal association between gout flares and cardiovascular events has not been investigated., Objective: To investigate whether there is a transient increase in risk of cardiovascular events after a recent gout flare., Design, Setting, and Participants: A retrospective observational study was conducted using electronic health records from the Clinical Practice Research Datalink in England between January 1, 1997, and December 31, 2020. A multivariable nested case-control study was performed among 62 574 patients with gout, and a self-controlled case series, adjusted for season and age, was performed among 1421 patients with gout flare and cardiovascular event., Exposures: Gout flares were ascertained using hospitalization, primary care outpatient, and prescription records., Main Outcomes and Measures: The primary outcome was a cardiovascular event, defined as an acute myocardial infarction or stroke. Association with recent prior gout flares was measured using adjusted odds ratios (ORs) with 95% CIs in a nested case-control study and adjusted incidence rate ratios (IRRs) with 95% CIs in a self-controlled case series., Results: Among patients with a new diagnosis of gout (mean age, 76.5 years; 69.3% men, 30.7% women), 10 475 patients with subsequent cardiovascular events were matched with 52 099 patients without cardiovascular events. Patients with cardiovascular events, compared with those who did not have cardiovascular events, had significantly higher odds of gout flare within the prior 0 to 60 days (204/10 475 [2.0%] vs 743/52 099 [1.4%]; adjusted OR, 1.93 [95% CI, 1.57-2.38]) and within the prior 61 to 120 days (170/10 475 [1.6%] vs 628/52 099 [1.2%]; adjusted OR, 1.57 [95% CI, 1.26-1.96]). There was no significant difference in the odds of gout flare within the prior 121 to 180 days (148/10 475 [1.4%] vs 662/52 099 [1.3%]; adjusted OR, 1.06 [95% CI, 0.84-1.34]). In the self-controlled case series (N = 1421), cardiovascular event rates per 1000 person-days were 2.49 (95% CI, 2.16-2.82) within days 0 to 60; 2.16 (95% CI, 1.85-2.47) within days 61 to 120; and 1.70 (95% CI, 1.42-1.98) within days 121 to 180 after a gout flare, compared with cardiovascular event rates of 1.32 (95% CI, 1.23-1.41) per 1000 person-days within the 150 days before or the 181 to 540 days after the gout flare. Compared with 150 days before or the 181 to 540 days after a gout flare, incidence rate differences for cardiovascular events were 1.17 (95% CI, 0.83-1.52) per 1000 person-days, and adjusted IRRs were 1.89 (95% CI, 1.54-2.30) within days 0 to 60; 0.84 (95% CI, 0.52-1.17) per 1000 person-days and 1.64 (95% CI, 1.45-1.86) within days 61 to 120; and 0.38 (95% CI, 0.09-0.67) per 1000 person-days and 1.29 (95% CI, 1.02-1.64) within days 121 to 180 after a gout flare., Conclusions and Relevance: Among individuals with gout, those who experienced a cardiovascular event, compared with those who did not experience such an event, had significantly higher odds of a recent gout flare in the preceding days. These findings suggest gout flares are associated with a transient increase in cardiovascular events following the flare.