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BackgroundMany mental health conditions are associated with loneliness, which is both a potential trigger and an exacerbating factor in mental health conditions. Richer evidence about how people with mental health problems experience loneliness, and about what exacerbates or alleviates it, is needed to underpin research on strategies to help with loneliness in this context.MethodsOur aim was to explore experiences of loneliness, as well as what contributes to or helps address it, among a diverse sample of adults living with mental health problems in the UK. We recruited purposively via online networks and community organisations. Qualitative semi-structured interviews were conducted with 59 consenting participants by video call or telephone. Researchers with relevant lived experience were involved at all stages, including design, data collection, analysis and writing up of results.FindingsAnalysis led to identification of four overarching themes: 1. What the word “lonely” meant to participants, 2. Contributory factors to ongoing loneliness, 3. Connections between loneliness & mental health, 4. Ways of reducing loneliness. Central aspects of loneliness were lack of meaningful connections with others and lack of a sense of belonging to valued groups and communities. Some drivers of loneliness, such as losses and transitions, were universal, but specific links were made between living with mental health problems and being lonely. These included direct effects of psychiatric symptoms, the need to withdraw to cope with mental health problems, and impacts of stigma and poverty.ConclusionsThe multiplicity of contributors to loneliness that we identified, and of potential strategies for reducing it, suggest that a variety of approaches are relevant to reducing loneliness among people with mental health problems, including peer support and supported self-help, psychological and social interventions, and strategies to facilitate change at community and societal levels. The views and experiences of adults living with mental health problems are a rich source for understanding why loneliness is a frequent experience in this context and what may address it. Co-produced approaches to developing and testing interventions have potential to draw on this experiential knowledge in formulating effective approaches to loneliness.

PurposeWe sought to understand how the experiences of people in the UK with pre-existing mental health conditions had developed during the course of the COVID-19 pandemic.MethodsIn September-October 2020 we interviewed adults with mental health conditions pre-dating the pandemic, whom we had previously interviewed three months earlier. Participants had been recruited through online advertising and voluntary sector community organisations. Interviews were conducted by telephone or video-conference by researchers with lived experience of mental health difficulties, and explored changes over time in people’s experience of the pandemic.ResultsWe interviewed 44 people, achieving diversity of demographic characteristics and a range of mental health conditions and service use among our sample. Three overarching themes were derived from interviews. The first theme “Spectrum of adaptation”: to difficulties in access to, or the quality of, statutory mental health services, through developing new personal coping strategies or identifying alternative sources of support. The second theme is “Accumulating pressures”: from pandemic-related anxieties and sustained disruption to social contact and support, and to mental health treatment. The third theme “Feeling overlooked”: A sense of people with pre-existing mental health conditions being overlooked during the pandemic by policy-makers at all levels. The latter was compounded for people from ethnic minority communities or with physical health problems.ConclusionOur study highlights the need to support marginalised groups who are at risk of increased inequalities, and to maintain crucial mental and physical healthcare and social care for people with existing mental health conditions, notwithstanding challenges of the pandemic.

PurposeThe COVID-19 pandemic has many potential impacts on people with mental health conditions and on mental health care, including direct consequences of infection, effects of infection control measures and subsequent societal changes. We aimed to map early impacts of the pandemic on people with pre-existing mental health conditions and services they use, and to identify individual and service-level strategies adopted to manage these.MethodsWe searched for relevant material in the public domain published before 30 April 2020, including papers in scientific and professional journals, published first person accounts, media articles, and publications by governments, charities and professional associations. Search languages were English, French, German, Italian, Spanish, and Mandarin Chinese. Relevant content was retrieved and summarised via a rapid qualitative framework synthesis approach.ResultsWe found 872 eligible sources from 29 countries. Most documented observations and experiences rather than reporting research data. We found many reports of deteriorations in symptoms, and of impacts of loneliness and social isolation and of lack of access to services and resources, but sometimes also of resilience, effective self-management and peer support. Immediate service challenges related to controlling infection, especially in inpatient and residential settings, and establishing remote working, especially in the community. We summarise reports of swiftly implemented adaptations and innovations, but also of pressing ethical challenges and concerns for the future.ConclusionOur analysis captures the range of stakeholder perspectives and experiences publicly reported in the early stages of the COVID-19 pandemic in several countries. We identify potential foci for service planning and research.

Background Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation. Methods Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff. Results Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety. Conclusions A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.

ObjectiveTo examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.MethodsPragmatic 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).ResultsUnadjusted 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.ConclusionsAt 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 numberNCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

Fatima B Jeragh-Alhaddad,1,2 Mohammad Waheedi,2 Nick D Barber,1 Tina Penick Brock3 1Department of Practice and Policy, University College London School of Pharmacy, London, UK; 2Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait; 3Department of Clinical Pharmacy, School of Pharmacy, University of California, San Francisco, CA, USA Background: Nonadherence to medications among Kuwaitis with type 2 diabetes mellitus (T2DM) is believed to be a major barrier to appropriate management of the disease. Published studies of barriers to medication adherence in T2DM suggest a Western bias, which may not adequately describe the Kuwaiti experience. Aim: The purpose of this study was to explore barriers to medication adherence among Kuwaiti adults with T2DM. Methods: Semi-structured interviews were conducted with 20 Kuwaiti patients with type 2 diabetes. The interviews were digitally recorded, transcribed, and analyzed using thematic analysis. Results: Barriers to medication adherence were identified. Emerging themes were: 1)lack of education/awareness about diabetes/medications, 2) beliefs about medicines/diabetes, 3)spirituality and God-centered locus of control, 4) attitudes toward diabetes 5) perceptions of self-expertise with the disease and body awareness, 6) social stigma, 7) perceptions of social support, 8) impact of illness on patient’s life, 9) perceptions of health care providers’ attitudes toward patients, and 10) health system-related factors, such as access difficulties and inequalities of medication supply and services. Conclusion: Personal, sociocultural, religious, health care provider, and health care system-related factors may impede medication adherence among Kuwaitis with type2 diabetes. Interventions to improve care and therapeutic outcomes in this particular population must recognize and attempt to resolve these factors. Keywords: medication adherence, type 2 diabetes mellitus, Kuwait, qualitative

Objective Government and professional groups within the pharmacy have sought to extend the role of pharmacists from dispensing-focused towards the provision of further pharmaceutical services. The aim of this research was to describe how pharmacists in current English community pharmacy practice spend their time using a work sampling method. Methods Ten community pharmacies across London were purposively selected. Trained observers visited one pharmacy each to record the activities of the responsible pharmacist, using a fixed-interval work sampling technique. Activities were recorded every minute, into one of 18 predefined, piloted and tested activity codes. Data were recorded for 4 h each day for 1 week at each pharmacy during 2011. Key findings A total of 12 306 observations were recorded across the pharmacies. The pharmacists spent the majority of their time assembling and labelling products (median 25.2%; quartiles 19.0, 31.0) and monitoring prescriptions for clinical appropriateness (10.6%; 8.3, 13.0). The next most prevalent activity code was rest, waiting and breaks (8.6%; 6.9, 15.3). They spent more time offering non-prescription medicines advice (6.6%; 3.5, 7.6) than prescription medicines counselling (3.8%; 2.8, 5.6). The provision of pharmaceutical services accounted for 3.2% (0.8, 7.5) of pharmacists' time. Overall, 46.2 % (35.2, 56.2) of their time was spent on activities deemed to be ‘Professional’. Conclusions Despite repeated attempts during the last decade to shift pharmacists' roles towards patient-care activities, on the basis of this research, community pharmacists continue to spend the majority of their time on technical dispensing (as opposed to cognitive patient-centred) tasks.

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.

Non-adherence to medication is a ‘worldwide problem of striking magnitude’.1 It has consequences for the health of patients and is a great concern for healthcare providers in terms of patient outcomes and healthcare costs. Theoretical research has mainly focused on intentional non-adherence: for example, when people choose not to take their medication. However, unintentional non-adherence also accounts for a significant proportion of the problem: when people mean to take their medication in the right way but do not. This area is under-researched. In this paper, we bring a new perspective to this problem by exploring what contribution ‘resilience’ could make to it. Resilience engineering focuses on a system's ability to maintain performance, avoid error, compensate for poor circumstances and cope with disturbances. So, rather than focus on how things go wrong, we propose to exploit and enhance how things go right. The National Health Service in England processed 962 million prescriptions in 2011, which had an ingredient cost of £8.8 billion,2 and it is estimated that 30%–50% of prescribed medication are not taken correctly.3 A report prepared for a summit of European health ministers in 2012 estimated that non-adherence contributes approximately 57% of $500 billion total avoidable costs attributed to suboptimal medicine use globally each year.4 Horne et al 3 provide a broad and comprehensive review of the research in this area. Their report shows that the problem is complex and multifaceted, and they call for more research to tackle this important issue. They argue that improving the effectiveness of adherence interventions could have a greater impact on public health than improvements in specific medical treatments.3 Haynes et al 5 note that current successful interventions for non-adherence are multifaceted, complex, labour intensive and at best have modest effects; they call for innovative approaches to assist …

Background Relatively little is known about prescribing errors in general practice, or the factors associated with error. Aim To determine the prevalence and nature of prescribing and monitoring errors in general practices in England. Design and setting Retrospective case-note review of unique medication items prescribed over a 12-month period to a 2% random sample of patients. Fifteen general practices across three primary care trusts in England. Method A total of 6048 unique prescription items prescribed over the previous 12 months for 1777 patients were examined. The data were analysed by mixed effects logistic regression. The main outcome measures were prevalence of prescribing and monitoring errors, and severity of errors, using validated definitions. Results Prescribing and/or monitoring errors were detected in 4.9% (296/6048) of all prescription items (95% confidence interval [CI] = 4.4% to 5.5%). The vast majority of errors were of mild to moderate severity, with 0.2% (11/6048) of items having a severe error. After adjusting for covariates, patient-related factors associated with an increased risk of prescribing and/or monitoring errors were: age 64 years (OR = 1.68, 95% CI = 1.04 to 2.73, P = 0.035), and higher numbers of unique medication items prescribed (OR = 1.16, 95% CI = 1.12 to 1.19, P Conclusion Prescribing and monitoring errors are common in English general practice, although severe errors are unusual. Many factors increase the risk of error. Having identified the most common and important errors, and the factors associated with these, strategies to prevent future errors should be developed, based on the study findings.

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

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. Electronic supplementary material The online version of this article (doi:10.1007/s40273-017-0554-9) contains supplementary material, which is available to authorized users.

Background Community pharmacies are increasingly commissioned to deliver new, complex health interventions in response to the growing demands on family doctors and secondary health care services. Little is known about how these complex interventions are being accommodated and translated into the community pharmacy setting and whether their aims and objectives are realized in practice. The New Medicine Service (NMS) is a complex medicine management intervention that aims to support patients' adherence to newly prescribed medicines for a long-term condition. Objective This study explores the recent implementation of the NMS in community pharmacies across England. It also seeks to understand how the service is becoming manifest in practice and what lessons can be learned for future service implementation. Methods Structured, organizational ethnographic observations and in situ workplace interviews with pharmacists and support staff were undertaken within 23 English community pharmacies. Additionally, one-to-one, semi-structured interviews were carried out with 47 community pharmacists and 11 general practitioners (GPs). Observational and interview data were transcribed and analyzed thematically and guided by Damschroder's consolidated framework for implementation research. Results The NMS workload had been implemented and absorbed into pharmacists' daily routines alongside existing responsibilities with no extra resources and little evidence of reduction in other responsibilities. Pharmacists were pragmatic, simplifying, and adapting the NMS to facilitate its delivery and using discretion to circumvent perceived non-essential paperwork. Pharmacist understanding of the NMS was found to impact on what they believed should be achieved from the service. Despite pharmacists holding positive views about the value of the NMS, not all were convinced of its perceived benefits and necessity, with reports that many consultations did not identify any problems with the patients' medicines. GPs were generally supportive of the initiative but were unaware of the service or potential benefits. Poorly developed existing pharmacist-GP relationships impeded implementation. Conclusions This study identifies the multifaceted and complex processes involved in implementing a new community pharmacy service in England. Community pharmacy workflow, infrastructure, and public and professional relationships all affect NMS implementation. Greater prior engagement with the pharmacy workforce and GPs, robust piloting and a phased rollout together with ongoing support and updates, are potentials strategies to ensure future implementation of pharmacy services meet their intended aims in practice.

Failure mode and effects analysis (FMEA) is a structured prospective risk assessment method that is widely used within healthcare. FMEA involves a multidisciplinary team mapping out a high-risk process of care, identifying the failures that can occur, and then characterising each of these in terms of probability of occurrence, severity of effects and detectability, to give a risk priority number used to identify failures most in need of attention. One might assume that such a widely used tool would have an established evidence base. This paper considers whether or not this is the case, examining the evidence for the reliability and validity of its outputs, the mathematical principles behind the calculation of a risk prioirty number, and variation in how it is used in practice. We also consider the likely advantages of this approach, together with the disadvantages in terms of the healthcare professionals' time involved. We conclude that although FMEA is popular and many published studies have reported its use within healthcare, there is little evidence to support its use for the quantitative prioritisation of process failures. It lacks both reliability and validity, and is very time consuming. We would not recommend its use as a quantitative technique to prioritise, promote or study patient safety interventions. However, the stage of FMEA involving multidisciplinary mapping process seems valuable and work is now needed to identify the best way of converting this into plans for action.

Objective To explore health care professionals' experiences and perceptions of Failure Mode and Effects Analysis (FMEA), a team-based, prospective risk analysis technique. Methods Semi-structured interviews were conducted with 21 operational leads (20 pharmacists, one nurse) in medicines management teams of hospitals participating in a national quality improvement programme. Interviews were transcribed, coded and emergent themes identified using framework analysis. Results Themes identified included perceptions and experiences of participants with FMEA, validity and reliability issues, and FMEA's use in practice. FMEA was considered to be a structured but subjective process that helps health care professionals get together to identify high risk areas of care. Both positive and negative opinions were expressed, with the majority of interviewees expressing positive views towards FMEA in relation to its structured nature and the use of a multidisciplinary team. Other participants criticised FMEA for being subjective and lacking validity. Most likely to restrict its widespread use were its time consuming nature and its perceived lack of validity and reliability. Conclusion FMEA is a subjective but systematic tool that helps identify high risk areas, but its time consuming nature, difficulty with the scores and perceived lack of validity and reliability may limit its widespread use.

Objectives: To provide baseline data on patterns of antimicrobial usage in dogs and cats through the analysis of data stored in electronic practice management systems. Methods: Clinical data from 11 first opinion veterinary practices were extracted for the year 2007. Descriptive statistical analysis was performed to assess the usage of antimicrobials. Results: Widespread usage of systemic broad-spectrum antimicrobials was observed. Antimicrobials most frequently used in both species were potentiated amoxicillin (44·4% and 46.1% in cats and dogs, respectively) and amoxicillin (14·3% and 20·7%). Cephalexin (13·4%) and cefovecin (15·0%) were also commonly used in dogs and cats, respectively. Systemic critically important antimicrobials in human medicine were widely used in dogs (60·5%) and cats (82·7%). Topical antimicrobials used in both species included fusidic acid (48·4% and 54·8%), framycetin (20·4% and 13·4%), polymyxin B (12·6% and 9·3%) and neomycin (6·5% and 6·6%). Clinical Significance: Inappropriate usage of broad-spectrum antimicrobials may contribute to the development of antimicrobial resistance and loss of efficacy of antimicrobials in veterinary settings. Data recorded in practice management systems were demonstrated to be a practical source for monitoring antimicrobial usage in pets.

Objective To compare the incidence and severity rating of dose prescribing errors before and after the implementation of a commercially available electronic prescribing system at a tertiary care children’s hospital. Methods Dose errors were identified using prescription review to detect errors. Severity rating was determined by five judges using a validated, reliable scoring tool. The mean score for each error was used as an index of severity. Results Dose prescribing errors occurred in 88 of the 3939 (2.2%) items prescribed for outpatients and inpatients, and on discharge prescriptions prior to the implementation of electronic prescribing (EP). After EP, there were 57 dose errors in 4784 (1.2%) items prescribed (1% absolute reduction (p Conclusion Electronic prescribing appears to reduce rates of dosing errors in paediatrics, but larger studies are required to assess the effect on the severity of these errors and in different settings.

We present the findings of a discrete event simulation study of the hospital pharmacy outpatient dispensing systems at two London hospitals. Having created a model and established its face validity, we tested scenarios to estimate the likely impact of changes in prescription workload, staffing levels and skill-mix, and utilisation of the dispensaries' automatic dispensing robots. The scenarios were compared in terms of mean prescription turnaround times and percentage of prescriptions completed within 45 min. The findings are being used to support business cases for changes in staffing levels and skill-mix in response to changes in workload.

INTRODUCTION: Older people in care homes are at increased risk of medication errors and adverse drug events. The effect of formulation on administration errors is not known, that is whether the medicine is a tablet or capsule, liquid or device such as an inhaler. Also, the impact on administration errors of monitored dosage systems (MDS), commonly used in UK care homes to dispense tablets and capsules, is not known. This study investigated the influence of formulation and MDS on administration errors. METHODS: Administration errors were identified by pharmacists (using validated definitions) observing two drug rounds of residents randomly selected from a purposive sample of UK nursing and residential homes. Errors were classified and analysed by formulation and medicine delivery system. RESULTS: The odds of administration errors by formulation, when compared with tablets and capsules in MDS, were: liquids 4.31 (95% CI 2.02 to 9.21; p = 0.0002); topicals/transdermals/injections 19.61 (95% CI 6.90 to 55.73; p < 0.0001); inhalers 33.58 (95% CI 12.51 to 90.19; p < 0.0001). The odds of administration errors for tablets and capsules not in MDS were double those that were dispensed in MDS (adjusted OR 2.14, 95% CI 1.02 to 4.51; p = 0.04). CONCLUSIONS: Inhalers and liquid medicines were associated with significantly increased odds of administration errors. Training of staff in safe administration of these formulations needs implementing. Although there was some evidence that MDS reduced the odds of an administration error, the use of MDS impacts on other aspects of medicines management. Because of this, and as the primary topic of our study was not MDS, a prospective trial specifically designed to evaluate the overall impact of MDS on medicine management in care homes is needed.

Objectives The aim was to adapt a US adverse drug event (ADE) trigger tool for UK use, and to establish its positive predictive value (PPV) and sensitivity in comparison to retrospective health record review for the identification of preventable ADEs, in a pilot study on one hospital ward. Methods An established US trigger tool was adapted for UK use. We applied it retrospectively to 207 patients' health records, following up positive triggers to identify any ADEs (both preventable and non-preventable). We compared the preventable ADEs to those identified using full health record review. Key findings We identified 168 positive triggers in 127 (61%) of 207 patients. Seven ADEs were identified, representing an ADE in 3.4% of patients or 0.7 ADEs per 100 patient days. Five were non-preventable adverse drug reactions and two were due to preventable errors. The prevalence of preventable ADEs was 1.0% of patients, or 0.2 per 100 patient days. The overall PPV was 0.04 for all ADEs, and 0.01 for preventable ADEs. PPVs for individual triggers varied widely. Five preventable ADEs were identified using health record review. The sensitivity of the trigger tool for identifying preventable ADEs was 0.40, when compared to health record review. Conclusions Although we identified some ADEs using the trigger tool, more work is needed to further refine the trigger tool to reduce the false positives and increase sensitivity. To comprehensively identify preventable ADEs, retrospective health record review remains the gold standard and we found no efficiency gain in using the trigger tool.

Objective To compare the incidence and severity rating of dose prescribing errors before and after the implementation of a commercially available electronic prescribing system at a tertiary care children's hospital. Methods Dose errors were identified using prescription review to detect errors. Severity rating was determined by five judges using a validated, reliable scoring tool. The mean score for each error was used as an index of severity. Results Dose prescribing errors occurred in 88 of the 3939 (2.2%) items prescribed for outpatients and inpatients, and on discharge prescriptions prior to the implementation of electronic prescribing (EP). After EP, there were 57 dose errors in 4784 (1.2%) items prescribed (1% absolute reduction (p

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Care home residents are a frail and vulnerable population who are at a high risk of adverse drug reactions. • The recording of drug sensitivities is important to avoid the inadvertent prescribing, dispensing and administration of an offending drug to a sensitive resident. • There have been no studies investigating the recording of drug sensitivities for care home residents. WHAT THIS STUDY ADDS • The recording of drug sensitivities for care home residents is suboptimal and there are large discrepancies between records. • It is concerning that over 90% of sensitivities are not recorded on the care home medicines administration record. • Systems improvements are required, including the sharing of drug sensitivity status with community pharmacists; this could be achieved by printing sensitivities on prescriptions. AIMS The aims of this study were to determine the recording of drug sensitivities of elderly care home residents, to describe the nature of sensitivities and to identify and describe discrepancies in the documentation of drug sensitivity status in general practices, pharmacies and care homes. METHODS A random sample of residents within a purposive sample of care homes (nursing and residential) was selected. A clinical pharmacist inspected the GP medical record, the medicines administration record, and the care home record for each resident to identify drug sensitivities and discrepancies between records and to describe the nature of the recorded sensitivities. RESULTS The records of 121 residents in 31 care homes were studied. Thirty-one (26%) residents had at least one documented drug sensitivity in one of the sources inspected, with 48 sensitivities in total recorded. There was no description of the nature of the sensitivities recorded in 39/48 (81%) cases. The number of sensitivities recorded on the medicines administration record, care home record and the GP record were 3 (6%), 29 (60%) and 35 (73%), respectively. Only two sensitivities were simultaneously recorded on all three records. CONCLUSIONS It was of concern that over 90% of drug sensitivities were not recorded on the medicines administration record which is the final checking document when administering medication. The reason for this was that the dispensing pharmacy was responsible for generating the medicines administration record; however, drug sensitivity status is seldom shared between the GP and the dispensing pharmacy. Printing sensitivities on prescriptions would help to resolve this.

The study, first published in 2006, looks at how we should evaluate electronic prescribing systems in hospitals, particularly to improve patient safety. It provides an evaluation framework, compares methodologies to detect prescribing errors and describes the advantages of approaching evaluation of these systems from a sociotechnical perspective. Two electronic prescribing systems are studied using simultaneous quantitative and qualitative approaches. Electronic prescribing systems can reduce the incidence of prescribing error, however their implementation is not straight forward and they should be considered a constant ‘work in progress’.

Purpose To compare four methods of detecting prescribing errors (PE) in the same patient cohorts before and after an intervention (computerised physician order entry; CPOE) and to determine whether the impact of CPOE is identified consistently by all methods. Methods PEs were identified using (1) prospective detection by ward pharmacist; (2) retrospective health record review; (3) retrospective use of a trigger tool and (4) spontaneous reporting over two separate 4-week periods on one surgical ward in a UK teaching hospital. Results We reviewed 93 patients pre- and 114 post-CPOE. Using all four methods, we identified 135 PE (10.7% of all medication orders) pre-CPOE, and 127 (7.9%) post-CPOE. There was little overlap in PE detected by the different methods: prospective detection identified 48 (36% of all PE) pre- and 30 (24%) post-CPOE; retrospective review (RR) revealed 93 (69%) pre- and 105 (83%) post-CPOE, trigger tool 0 pre- and 2 (2%) post-CPOE and spontaneous reporting 1 (1%) pre- and 1 (1%) post-CPOE. The calculated relative reduction in risk of PE was 50% using prospective data, 12% with RR and 26% using data from all four methods. Conclusions In this study, each method predominantly identified different PE. A combination of methods may be required to understand the true effectiveness of different interventions. Copyright © 2009 John Wiley & Sons, Ltd.

Objective To assess the effect of an electronic prescribing and administration system on the safety and quality of medication administration in a UK hospital. Setting Surgical ward in a teaching hospital. Method Data were collected before and after introducing a closed-loop system comprising electronic prescribing, automated dispensing, barcode patient identification and electronic medication administration records (ServeRx, MDG Medical). We observed medication administration during drug rounds and assessed medication administration error (MAE) rates for ward-stock and non-ward-stock drugs, accuracy of medication administration documentation, timeliness of administration, administration of medication from unlocked areas and supervision of patients taking oral medication by nursing staff. Key findings Pre- and post-intervention MAE rates were 6.4 and 2.3% respectively for ward-stock drugs (95% confidence interval for the difference (CI) −5.8 to −2.4%), and 14.6 and 13.7% for non-ward-stock drugs (CI −6.5 to 4.7%). Excluding omissions due to unavailability, pre- and post-intervention MAE rates were 6.2 and 2.2% respectively for ward-stock drugs (CI −5.7 to −2.3%), and 9.2 and 3.5% for non-ward-stock drugs (CI −9.3 to −2.1%). Pre-intervention, 2086 doses (96.3%) were documented correctly and 1557 (95.9%) post-intervention (CI −1.6 to 0.8%). There were five clinically significant documentation discrepancies pre-intervention (0.2%), and 33 (2.0%) afterwards (CI 1.1 to 2.5%). Timeliness of administration improved post-intervention (P < 0.001; Chi-square test), as did administration of medication from unlocked areas (CI 4.7 to 7.3%) and supervision of patients taking oral medication (CI 17 to 23%). Conclusion Reductions in MAEs, excluding omissions due to unavailability, occurred for both ward-stock and non-ward-stock drugs. The system also improved timeliness and security of drug administration. However, there was an increase in potentially significant documentation discrepancies.

Aim The identification of medication-monitoring errors requires a validated definition. This paper describes the development and validation of a definition which includes criteria for specific medicines to determine whether a medication-monitoring error has occurred in the care home setting. Setting Criteria were developed for older people (aged 65 years or older) living in care homes. Methods Criteria were developed by two clinical pharmacists using published guidelines. The criteria were divided into those relating to initiation of therapy and maintenance monitoring. The study steering group, made up of clinical pharmacists, a general practitioner (GP) and pharmacy academics, then reviewed the criteria and a consensus was achieved. The criteria were then reviewed by a sample of 21 GPs and 11 clinical pharmacists. The threshold for acceptance for each criterion was set at 70% by agreement of all participants. Key findings The definition of a medication-monitoring error was accepted as ‘when a prescribed medicine is not monitored in the way which would be considered acceptable in routine general practice. It includes the absence of tests being carried out at the frequency listed in the criteria for each medicine, with tolerance of +50%’. Seventy per cent agreement was reached on all criteria for the initiation of therapy, except warfarin (69%), and on all criteria for maintenance monitoring, except penicillamine (63%) and potassium (63%). Conclusions To our knowledge, this is the first study to define a medication-monitoring error, and to determine and validate specific criteria to identify such errors in older people living in care homes.

Objective To assess the effect of an electronic prescribing (EP) system on the incidence and type of prescribing errors and the number of error-free visits. Study design This was a before-and-after study conducted in a nephrology outpatient clinic at an acute tertiary care pediatric hospital. Results A total of 520 patients had 2242 items prescribed on 1141 prescriptions during the study period. The overall prescribing error rate was 77.4% (95% confidence interval [CI] = 75.3% to 79.4%) for handwritten items and 4.8% (95% CI = 3.4% to 6.7%) with EP. Before EP, 1153 (73.3%; 95% CI = 71.1% to 75.4%) items were missing essential information, and 194 (12.3%; 95% CI = 10.8% to 14%) were judged illegible. After EP, only 9 (1.4%; 95% CI = 0.7% to 2.6%) items were missing essential information, and illegibility errors were eliminated. The number of patient visits that were error-free increased from 21% to 90% (69% difference; 95% CI = 64% to 73.4%) after the implementation of EP. Conclusions There was a high incidence of errors using handwritten prescriptions in the outpatient setting, with an overall error rate of 77.4%. EP significantly reduced errors related to completeness of prescriptions and eliminated legibility related errors.

Objective The objective of this study was to explore beliefs about medicines, using the Necessity–Concerns Framework, of patients who report adherence, unintentional nonadherence, and intentional nonadherence. Method This study performed a cross-sectional survey of patients starting a new medication for a chronic condition. Self-reported adherence was assessed via telephone interview. The Necessity–Concerns Framework was operationalized using the Beliefs About Medicines Questionnaire, which assesses beliefs about the necessity of and concerns with taking medications. Results Intentional nonadherers, compared to adherers, had lower perceptions of the necessity of their new medication and higher levels of concerns about taking it. Conversely, unintentional nonadherers were not significantly different from adherers. Intentional nonadherers were more likely to rate their concerns as high relative to their need for treatment than both adherers and unintentional nonadherers. Conclusion When patients start a new medication for a chronic condition, intentional nonadherers hold beliefs significantly different from those of adherers and unintentional nonadherers. These findings have implications for practice in helping clinicians to reduce this type of nonadherence.

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

Tara Lamont and colleagues discuss how researchers can help service leaders to evaluate rapidly changing models of care, with a range of approaches depending on needs and resources

Prescription of medicines is a fundamental component of the care of elderly people, and optimisation of drug prescribing for this group of patients has become an important public-health issue worldwide. Several characteristics of ageing and geriatric medicine affect medication prescribing for elderly people and render the selection of appropriate pharmacotherapy a challenging and complex process. In the first paper in this series we aim to define and categorise appropriate prescribing in elderly people, critically review the instruments that are available to measure it and discuss their predictive validity, critically review recent randomised controlled intervention studies that assessed the effect of optimisation strategies on the appropriateness of prescribing in elderly people, and suggest directions for future research and practice.

Objective To assess the impact of a closed-loop electronic prescribing and automated dispensing system on the time spent providing a ward pharmacy service and the activities carried out. Setting Surgical ward, London teaching hospital. Method All data were collected two months pre- and one year post-intervention. First, the ward pharmacist recorded the time taken each day for four weeks. Second, an observational study was conducted over 10 weekdays, using two-dimensional work sampling, to identify the ward pharmacist's activities. Finally, medication orders were examined to identify pharmacists' endorsements that should have been, and were actually, made. Key findings Mean time to provide a weekday ward pharmacy service increased from 1 h 8 min to 1 h 38 min per day (P = 0.001; unpaired t-test). There were significant increases in time spent prescription monitoring, recommending changes in therapy/monitoring, giving advice or information, and non-productive time. There were decreases for supply, looking for charts and checking patients' own drugs. There was an increase in the amount of time spent with medical and pharmacy staff, and with ‘self’. Seventy-eight per cent of patients' medication records could be assessed for endorsements pre- and 100% post-intervention. Endorsements were required for 390 (50%) of 787 medication orders pre-intervention and 190 (21%) of 897 afterwards (P < 0.0001; chi-square test). Endorsements were made for 214 (55%) of endorsement opportunities pre-intervention and 57 (30%) afterwards (P < 0.0001; chi-square test). Conclusion The intervention increased the overall time required to provide a ward pharmacy service and changed the types of activity undertaken. Contact time with medical and pharmacy staff increased. There was no significant change in time spent with patients. Fewer pharmacy endorsements were required post-intervention, but a lower percentage were actually made. The findings have important implications for the design, introduction and use of similar systems.

To review and appraise randomised controlled trials (RCT) and ‘before and after' studies published on clinical decision support systems (CDSS) used to support the use of antibiotics. A literature search was carried out in October 2006 using MEDLINE including Medical Subject Heading (MeSH) terms (1966–2006), EMBASE (Excerpta Medica, 1980–2006) and International Pharmaceutical Abstracts (IPA, 1970–2006) using the combinations of the following terms: (Decision support systems) or (CDSS) AND (antibiotics) or (anti-infectives) or (antibacterials) or (antimicrobials). Only English language papers were selected. Editorials, letters and case reports/series were excluded. The reference sections of all retrieved articles were also searched for any further relevant articles. Forty articles were identified. Five RCT and six ‘before and after' studies were retrieved. In the RCTs, three studies used computer-based CDSS, one paper-based CDSS and one a combination of both. Two studies were conducted in primary care and three within secondary care. The primary outcomes for each study were different and only three studies were significant in the favour of the use of CDSS. ‘Before and after' studies were used where RCT were not feasible. One ‘before and after' study was excluded because it did not include any control group. The remaining five included historical control groups and evaluated the use of computer-based CDSS within secondary care. Their primary outcomes also varied but all concluded significant benefits of CDSS. Only three of ten studies were conducted outside the USA; one in Switzerland and two in Australia. CDSS could be a powerful tool to improve clinical care and patient outcomes. It presents a promising future for optimising antibiotic use. However, it is difficult to generalise as most studies were conducted in the United States. Although RCT are the ‘gold standard' in research, they may not be feasible to conduct. Realising that different study designs answer different questions would allow researchers to choose the most appropriate study design to evaluate CDSS in a specified setting.

The use of informed consent for surgery or research has been widely studied; however, its use in other areas of clinical practice has received less attention. This study investigates how doctors and nurses understand informed consent in relation to the prescription and administration of medicines in secondary care. It uses a qualitative analysis of semi-structured in-depth interviews with 19 doctors and 6 nurses recruited from various specialties in a teaching hospital. The results indicate a striking gap between official and actual standards of practice. Providing information, assuring adherence and communication about potential treatment harms were raised as key issues instead of the principal goals of informed consent. Rather than simply treating these findings as support for a 'deficit' account of professionalism, the paper concludes that we need a richer and more grounded account of exactly when hospital medication decisions need to be subjected to the highest standards of informed consent.

Community pharmacists play a growing role in the delivery of primary healthcare. This has led many to consider the changing power of the pharmacy profession in relation to other professions and patient groups. This paper contributes to these debates through developing a Foucauldian analysis of the changing dynamics of power brought about by extended roles in medicines management and patient education. Examining the New Medicine Service, the study considers how both patient and pharmacist subjectivities are transformed as pharmacists seek to survey patient's medicine use, diagnose non-adherence to prescribed medicines, and provide education to promote behaviour change. These extended roles in medicines management and patient education expand the 'pharmacy gaze' to further aspects of patient health and lifestyle, and more significantly, established a form of 'pastoral power' as pharmacists become responsible for shaping patients' self-regulating subjectivities. In concert, pharmacists are themselves enrolled within a new governing regime where their identities are conditioned by corporate and policy rationalities for the modernisation of primary care.