The evaluation of an e-learning prescribing course for general practice.

Prescribed medication may lead to significant morbidity or mortality as a result of these medications causing adverse events, or because of a prescribing error. E-learning is a common tool used in supporting training in prescribing. This paper describes the development of an e-learning course and the subsequent evaluation undertaken by the users with the aim of obtaining an effective e-learning course for prescribing. The e-learning course was developed by general practitioners and pharmacists and focussed on the principles of good prescribing, examined the common reasons for prescribing errors, and was evaluated using self-reported quantitative and qualitative measures. Scores significantly increased on an assessment given before and after the course. The majority of respondents reported that the e-learning course had a positive impact on prescribing knowledge, skills and attitudes, with medication reviews the top area where a change in prescribing practice was reported. Over 90% of the respondents agreed that the e-learning course was easy to use and a useful part of their continuing professional education. This study shows that clinicians recognise the on-going need for training in prescribing, but the lack of training is one of the factors contributing to errors, which suggests that more education is needed, not just for GPs in training, but for qualified GPs as well.

Using sociotechnical theory to understand medication safety work in primary care and prescribers' use of clinical decision support: a qualitative study.

OBJECTIVES: The concept of safety work draws attention to the intentional work of ensuring safety within care systems. Clinical decision support (CDS) has been designed to enhance medication safety in primary care by providing decision-making support to prescribers. Sociotechnical theory understands that healthcare settings are complex and dynamically connected systems of fluid networks, human agents, changing relationships and social processes. This study aimed to understand the relationship between safety work and the use of CDS. DESIGN AND SETTING: This qualitative study took place across nine different general practices in England. Stakeholders included general practitioners (GPs) and general practice-based pharmacists and nurse prescribers. Semi-structured interviews were conducted to illicit how the system was used by the participants in the context of medication safety work. Data analysis conducted alongside data collection was thematic and drew on socio-technical theory. PARTICIPANTS: Twenty-three interviews were conducted with 14 GPs, three nurse prescribers and three practice pharmacists between February 2018 and June 2020. RESULTS: Safety work was contextually situated in a complex network of relationships. Three interconnected themes were interpreted from the data: (1) the use of CDS within organisational and social practices and workflows; (2) safety work and the use of CDS within the interplay between prescribers, patients and populations; and (3) the affordances embedded in CDS systems. CONCLUSION: The use of sociotechnical theory here extends current thinking in patient safety particularly in the ways that safety work was co-constituted with the use of CDS alerts. This has implications for implementation and use to ensure that the contexts into which such CDS systems are implemented are taken into account. Understanding how alerts can adapt safety culture will help improve the efficacy of CDS systems, enhance prescribing safety and help to further understand how safety work is achieved in primary care.

The frequency and nature of prescribing problems by GPs-in-training (REVISiT): a retrospective review.

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.

Development of 2 Short Patient-Report Questionnaires of Patient Safety in Primary Care.

OBJECTIVES: The Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) is a valid and reliable instrument (61 items across 5 domains) of patients' perceptions of safety. Stakeholder feedback has supported shorter versions for improving choice and facilitating uptake of routine patient-centered evaluation. We sought to develop 2 shorter versions of PREOS-PC: one including the shortest possible scales that met established measurement performance standards and a screening version including a single item per domain. METHODS: A total of 1244 patients from 45 general practices across England completed PREOS-PC questionnaires. All scale items in PREOS-PC underwent Item Response Theory analysis, applying standard criteria for the item reduction. Cognitive debriefing from 10 patient interviews allowed for the assessment of the instruments' readability. The instruments' psychometrics properties were reassessed in a validation sample of 1557 patients in 21 English general practices. RESULTS: "PREOS-PC Compact" includes 25 items and 2 open-ended questions across the 5 domains, 44% of the length of the original instrument. "PREOS-PC Screen" consists of 6 items: the best-performing single items for 2 domains, 1 item modified from original items for each of the remaining 3 domains, and 1 open-ended question. The evaluation of the instruments confirmed they were acceptable to patients and met standards for readability; construct, convergent, and divergent validity; and reliability. CONCLUSIONS: PREOS-PC Compact meets high-performance standards while reducing patient burden for routine monitoring of patient safety in primary care. PREOS-PC Screen is a concise tool apt for incorporation into audits and to target more in-depth review as needed.

Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: A qualitative exploration using the Theoretical Framework of Acceptability.

INTRODUCTION: Medication errors are an important cause of morbidity and mortality. The pharmacist-led IT-based intervention to reduce clinically important medication errors (PINCER) intervention was shown to reduce medication errors when tested in a cluster randomised controlled trial and when implemented across one region of England. Now that it has been rolled out nationally, and to enhance findings from evaluations with staff and stakeholders, this paper is the first to report patients' perceived acceptability on the use of PINCER in primary care and proposes suggestions on how delivery of PINCER related care could be delivered in a way that is acceptable and not unnecessarily burdensome. METHODS: A total of 46 participants living with long-term health conditions who had experience of medication reviews and/or monitoring were recruited through patient participant groups and social media. Semi-structured, qualitative interviews and focus groups were conducted face-to-face or via telephone. A thematic analysis was conducted and findings mapped to the constructs of the Theoretical Framework of Acceptability (TFA). RESULTS: Two themes were identified and interpreted within the most relevant TFA construct: Perceptions on the purpose and components of PINCER (Affective Attitude and Intervention Coherence) and Perceived patient implications (Burden and Self-efficacy). Overall perceptions on PINCER were positive with participants showing good understanding of the components. Access to medication reviews, which PINCER related care can involve, was reported to be limited and a lack of consistency in practitioners delivering reviews was considered challenging, as was lack of communication between primary care and other health-care providers. Patients thought it would be helpful if medication reviews and prescription renewal times were synchronised. Remote medication review consultations were more convenient for some but viewed as a barrier to communication by others. It was acknowledged that some patients may be more resistant to change and more willing to accept changes initiated by general practitioners. CONCLUSIONS: Participants found the concept of PINCER acceptable; however, acceptability could be improved if awareness on the role of primary care pharmacists is raised and patient-pharmacist relationships enhanced. Being transparent with communication and delivering streamlined and consistent but flexible PINCER related care is recommended.

Understanding factors influencing uptake and sustainable use of the PINCER intervention at scale: A qualitative evaluation using Normalisation Process Theory.

INTRODUCTION: Medication errors are an important cause of morbidity and mortality. The pharmacist-led IT-based intervention to reduce clinically important medication errors (PINCER) has demonstrated improvements in primary care medication safety, and whilst now the subject of national roll-out its optimal and sustainable use across health contexts has not been fully explored. As part of a qualitative evaluation we aimed to identify factors influencing successful adoption, embedding and sustainable use of PINCER across primary care settings in England, UK. METHODS: Semi-structured face-to-face or telephone interviews, including follow-up interviews and an online survey were conducted with professionals knowledgeable of PINCER. Interview recruitment targeted four early adopter regions; the survey was distributed nationally. Initial data analysis was inductive, followed by analysis using a coding framework. A deductive matrix approach was taken to map the framework to the Normalisation Process Theory (NPT). Themes were then identified. RESULTS: Fifty participants were interviewed, 18 participated in a follow-up interview. Eighty-one general practices and three Clinical Commissioning Groups completed the survey. Four themes were identified and interpreted within the relevant NPT construct: Awareness & Perceptions (Coherence), Receptivity to PINCER (Cognitive Participation), Engagement [Collective Action] and Reflections & Adaptations (Reflexive Monitoring). Variability was identified in how PINCER awareness was raised and how staff worked to operationalise the intervention. Facilitators for use included stakeholder investment, favourable evidence, inclusion in policy, incentives, fit with individual and organisational goals and positive experiences. Barriers included lack of understanding, capacity concerns, operational difficulties and the impact of COVID-19. System changes such as adding alerts on clinical systems were indicative of embedding and continued use. CONCLUSIONS: The NPT helped understand motives behind engagement and the barriers and facilitators towards sustainable use. Optimising troubleshooting support and encouraging establishments to adopt an inclusive approach to intervention adoption and utilisation could help accelerate uptake and help establish ongoing sustainable use.

Strategies supporting sustainable prescribing safety improvement interventions in English primary care: a qualitative study.

BACKGROUND: While the use of prescribing safety indicators (PSI) can reduce potentially hazardous prescribing, there is a need to identify actionable strategies for the successful implementation and sustainable delivery of PSI-based interventions in general practice. AIM: To identify strategies for the successful implementation and sustainable use of PSI-based interventions in routine primary care. DESIGN & SETTING: Qualitative study in primary care settings across England. METHOD: Anchoring on a complex pharmacist-led IT-based intervention (PINCER) and clinical decision support (CDS) for prescribing and medicines management, a qualitative study was conducted using sequential, multiple methods. The methods comprised documentary analysis, semi-structured interviews, and online workshops to identify challenges and possible solutions to the longer-term sustainability of PINCER and CDS. Thematic analysis was used for the documentary analysis and stakeholder workshops, while template analysis was used for the semi-structured interviews. Findings across the three methods were synthesised using the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework. RESULTS: Forty-eight documents were analysed, and 27 interviews and two workshops involving 20 participants were undertaken. Five main issues were identified, which aligned with the adoption and maintenance dimensions of RE-AIM: fitting into current context (adoption); engaging hearts and minds (maintenance); building resilience (maintenance); achieving engagement with secondary care (maintenance); and emphasising complementarity (maintenance). CONCLUSION: Extending ownership of prescribing safety beyond primary care-based pharmacists, and achieving greater alignment between general practice and hospital prescribing safety initiatives, is fundamental to achieve sustained impact of PSI-based interventions in primary care.

The implementation, use and sustainability of a clinical decision support system for medication optimisation in primary care: A qualitative evaluation.

BACKGROUND: The quality and safety of prescribing in general practice is important, Clinical decision support (CDS) systems can be used which present alerts to health professionals when prescribing in order to identify patients at risk of potentially hazardous prescribing. It is known that such computerised alerts may improve the safety of prescribing in hospitals but their implementation and sustainable use in general practice is less well understood. We aimed to understand the factors that influenced the successful implementation and sustained use in primary care of a CDS system. METHODS: Participants were purposively recruited from Clinical Commissioning Groups (CCGs) and general practices in the North West and East Midlands regions of England and from the CDS developers. We conducted face-to-face and telephone-based semi-structured qualitative interviews with staff stakeholders. A selection of participants was interviewed longitudinally to explore the further sustainability 1-2 years after implementation of the CDS system. The analysis, informed by Normalisation Process Theory (NPT), was thematic, iterative and conducted alongside data collection. RESULTS: Thirty-nine interviews were conducted either individually or in groups, with 33 stakeholders, including 11 follow-up interviews. Eight themes were interpreted in alignment with the four NPT constructs: Coherence (The purpose of the CDS: Enhancing medication safety and improving cost effectiveness; Relationship of users to the technology; Engagement and communication between different stakeholders); Cognitive Participation (Management of the profile of alerts); Collective Action (Prescribing in general practice, patient and population characteristics and engagement with patients; Knowledge);and Reflexive Monitoring (Sustaining the use of the CDS through maintenance and customisation; Learning and behaviour change. Participants saw that the CDS could have a role in enhancing medication safety and in the quality of care. Engagement through communication and support for local primary care providers and management leaders was considered important for successful implementation. Management of prescribing alert profiles for general practices was a dynamic process evolving over time. At regional management levels, work was required to adapt, and modify the system to optimise its use in practice and fulfil local priorities. Contextual factors, including patient and population characteristics, could impact upon the decision-making processes of prescribers influencing the response to alerts. The CDS could operate as a knowledge base allowing prescribers access to evidence-based information that they otherwise would not have. CONCLUSIONS: This qualitative evaluation utilised NPT to understand the implementation, use and sustainability of a widely deployed CDS system offering prescribing alerts in general practice. The system was understood as having a role in medication safety in providing relevant patient specific information to prescribers in a timely manner. Engagement between stakeholders was considered important for the intervention in ensuring prescribers continued to utilise its functionality. Sustained implementation might be enhanced by careful profile management of the suite of alerts in the system. Our findings suggest that the use and sustainability of the CDS was related to prescribers' perceptions of the relevance of alerts. Shared understanding of the purpose of the CDS between CCGS and general practices particularly in balancing cost saving and safety messages could be beneficial.

A qualitative evaluation of a prescribing e-learning package for general practice.

BACKGROUND: The GMC PRACtiCe study identified a 1 in 20 error rate in prescriptions issued in general practice and identified a need for further training in prescribing. As a result, an e-Learning prescribing package was designed and launched to healthcare professionals through the Royal College of General Practitioners in January 2014. AIM: This part of the study explored the longer-term impact on prescribing knowledge, attitudes and behaviours of practitioners completing the eLearning prescribing package. METHOD: On completion of the e-Learning package, participants were asked to indicate their willingness to be contacted for a telephone interview. Semi-structured interviews were conducted which were audio recorded, transcribed verbatim and analysed using thematic analysis, aided by NVivo. Interviewees were invited to enter a prize draw to win Stockley's Drug Interaction textbook (provided courtesy of the Royal Pharmaceutical Society). RESULTS: Of the 120 participants who expressed an interest in being followed up for interview, seven prescribers were interviewed in 2014 and 2015. Reasons for completing the course were explored, and interviewees gave examples of changes made to their prescribing practice as a result of completing the e-Learning. This included the adoption of specific strategies to enhance safe practice, and enacting enhanced vigilance in key areas such as renal function monitoring. Some changes to the course content and presentation were also recommended. CONCLUSION: These interviews have highlighted the potential for using e-Learning for prescribing training and to achieve long-term changes in prescribing practice. However, further work is needed to generate substantive evidence of its impact on prescribing.

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

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

A systematic review in select countries of the role of the pharmacist in consultations and sales of non-prescription medicines in community pharmacy.

BACKGROUND: Much has been studied in regard to non-prescription medicines (NPMs), but the impact of greater emphasis toward patient self-selection of such agents is still not well understood, and evidence in the literature might be equivocal. OBJECTIVE: The aim was to examine whether or not pharmacist interventions are important in the sale of NPMs and to summarize the evidence of pharmacists' contribution in maintaining patient safety and improving the quality of consultations involving NPMs. METHODS: Seven online databases were searched to identify the literature on studies conducted within the UK and in countries comparable to the UK reporting on consultations and selling of NPMs published between 1980 and 2013. All study designs except for quantitative surveys were eligible for inclusion into the review. The data extraction and quality assessment were performed according to the National Institute for Health and Care Excellence guidelines. The data extracted from the studies were analyzed and presented qualitatively. RESULTS: Eighty-three studies from an original 12,879 citations were included in this review. Just under half of the studies were published between 2000 and 2009 (n = 38; 46%). Thirty-three (44%) of the studies were conducted in the UK. The review showed that in terms of the contribution of community pharmacy staff in consultations for NPMs, non-pharmacist staff dealt with a large proportion of the consultations and pharmacists were usually involved in the consultation through referral from non-pharmacist staff member. Counseling was not consistently offered to everyone. Where counseling was provided it was not always of sufficient quality. Consultations were performed much better when symptoms were presented compared to when people made a direct product request. Pharmacists were reported to conduct better consultations than non-pharmacist staff. There was evidence to suggest that where counseling was appropriately provided this afforded the person a safe environment to utilize their NPMs. CONCLUSIONS: Seeking methods to develop better engagement with customers accessing pharmacy services for NPMs is necessary to enhance the interaction between these two parties. Efforts to enhance the community pharmacy environment to bring about a more positive experience for people using pharmacy is needed at present and will be important if the model for the selection of NPMs is modified in the UK. More studies are needed to allow a better understanding of the impact self-selection may have on patient safety in the community pharmacy context.

Examination of England's New Medicine Service (NMS) of complex health care interventions in community pharmacy.

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.

Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service.

OBJECTIVE: To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. METHODS: Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7-14 days after presentation of prescription followed by another 14-21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. RESULTS: At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI -£59 to £100, p=0.128) per patient. CONCLUSIONS: The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice. TRIAL REGISTRATION NUMBERS: 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).

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

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

A systematic review of adherence-enhancing interventions in adolescents taking long-term medicines.

PURPOSE: To assess the effectiveness of adherence-enhancing interventions (AEIs) aimed at adolescents (10-19-year-olds). METHODS: An extensive search of seven bibliographic databases was conducted at the end of 2009 to identify comparative studies evaluating AEIs targeting adolescents. Data describing study characteristics and intervention effects on adherence to medicines or health outcomes were extracted and summarized using qualitative and quantitative methods. RESULTS: A total of 17 AEIs were identified: 12 studies (70%) were conducted in the United States, 10 (59%) included adolescents with type 1 diabetes mellitus, and 14 (82%) considered the developmental tasks of adolescence. In all, 12 AEIs successfully improved outcome measures. Features of successful interventions included targeting AEIs to a narrow age range, including family in type 1 diabetes mellitus management, and improving access to care. Poor quality and underpowered studies limit the inferences drawn from this review. CONCLUSIONS: More diverse and robust studies are needed to identify strategies to help adolescents manage medicines.