Title: The practice of over-the-counter medicine sale and supply in community pharmacy: an evidence-based perspective and a case study in musculoskeletal joint pain
Funder: Department of Health and Social Care

Abstract: Research questionHow can we improve the use of effectiveness evidence about over-the-counter (OTC) medicine recommendations for musculoskeletal (MSK) joint pain management in community pharmacy? BackgroundThere are wide variations in OTC supplies and minor ailment management in community pharmacies, with inconsistencies in patient experience and expectations. As a consequence, patients do not get the right care at the right time, resulting in patients returning to their GPs and enervating the already overstretched NHS. MSK conditions are particularly a problem, being experienced by nearly 30% of the UK population, accounting for up to 30% of GP consultations, and causing 30 million working days lost a year.AimsI aim to improve the practice of OTC sale and supply so that patients have the right care in community pharmacies, by developing an intervention to: 1) make the clinical effectiveness of OTC medicines for managing MSK pain easy to comprehend for patients and carers, and 2) better facilitate communication between community pharmacy teams and patients.MethodsFirst, randomised controlled studies examining the effectiveness of OTC medicines for managing MSK joint pain will be identified, appraised, and synthesised systematically according to the Cochrane Handbook of Systematic Reviews of Interventions. Network meta-analysis will be used to compare the clinical effectiveness of OTC medicines with each other and against prescription-only-medicines and physiotherapy, giving a comprehensive view of treatment options for pharmacy teams.Second, the review results will be presented and simplified using visualisation techniques, and then refined by the Experience-Based Design method to develop an intervention to facilitate OTC recommendations. Observations will be conducted in different pharmacies to understand norms in OTC practice. A summary of observations will be discussed and shared with a group of patients and pharmacy teams to identify problems and opportunities for the intervention. Then an iterative co-design process will be followed in workshops to prototype, test and refine the intervention.Last, a feasibility study will be conducted to evaluate acceptability and feasibility of the intervention. A scoping review of potential outcome measures will be performed to determine suitable measures for shared decision-making, communication, patient and staff experience. Additional interviews with staff and patients will be conducted after the study to gain an in-depth understanding for further improvement. Transcripts will be mapped according to the Theoretical Domains Framework and complemented by the Consolidated Framework for Implementation Research. Anticipated impact The findings from this research will inform strategies to improve the quality of practice in community pharmacies. There is a lack of guidelines for OTC medicines. Results of the systematic review could be used to foster thoughts and ideas for such guidelines to guide self-care. Strategies found in this review could be also applied to conditions other than MSK joint pain. DisseminationParticipants involved in this research will be updated about the results regularly. Findings will be published in research articles and presented in conferences, meetings, and websites to reach different audiences, as well as disseminated through personal networks, public engagement team in the university, and social media.

Lay abstract: AimTo improve the practice of over-the-counter (OTC) medicine sale and supply in community pharmacies by: 1) helping patients and community pharmacy teams make better decisions together; and 2) using research findings from clinical trials. I will use muscle and joint pain management as a working example. BackgroundAdvice about the purchase of OTC medicines often focuses on safety, such as contraindications and interactions with other drugs. The effectiveness of these medicines for treating minor ailments is often assumed or based on personal experience. This leads to wide variation in practice, causing patients to return to their GPs, contributing to the long-standing problem of waiting times in an already overstretched NHS. This is particularly problematic for conditions such as muscle and joint pain. Such pain affects nearly 30% of the total UK population, leading to the loss of around 30 million working days a year, and accounts for the third-largest area of NHS spending. Design and methodProduct effectiveness should be part of the patient-pharmacist discussion during community pharmacy visits for muscle and joint problems. Therefore, I will review all relevant, searchable clinical trials to assess the effectiveness of OTC medicines, prescription-only-medicines, and physiotherapy on muscle and joint pain management in primary care settings. The review procedure will follow the same rigorous methodology as Cochrane reviews. This will give patients and pharmacy teams a complete list of treatment options to meet patients' needs and guide patients for self-care or referrals. Second, I will work with patients and community pharmacy teams to design strategies to improve the quality of OTC medicine sale and supply. I will follow an approach called the 'experience-based design' method. I will visit pharmacies to see how they normally practise OTC sales. These observations will help a group of patients and pharmacy staff to identify problems and opportunities for the new strategy. We will work on how to summarise and present complex findings from clinical trials using visualisation. Then patients and pharmacy teams will give feedback and advise on the strategy at workshops until it is ready for real-world application. Last, towards the end of the fellowship I will test the usefulness of the strategy in two community pharmacies. The small study will answer several questions: Can pharmacy teams use the strategy in real practice? Do most patients and customers like it? Do they feel sufficiently supported to make better decisions? Should this design be introduced more widely in other pharmacies? After the study, I will interview patients and staff who have participated in the study to understand why the strategy works or does not work. Patient and public involvementPatients will have significant involvement in this research. First, patients will sit on advisory groups to: 1) contribute to the review protocol, outcomes of interests and final manuscript; 2) oversee the design and workshops; and, 3) advise on the study protocol and evaluation. Second, patients will work on the design, co-lead the process, and identify research priorities as part of the design team alongside pharmacy staff and researchers. Third, patients will be able to join individual workshops to comment on and help develop the strategies if they are unwilling to make a long-term commitment. DisseminationI will regularly update all stakeholders involved in this research on progress and results. I will publish results in research articles and present at conferences, meetings, and websites, and disseminate through personal networks and social media to reach the widest possible audience and seek other opportunities for publicity and public engagement. After the research completes, I will share a lay summary of the research findings with everyone involved in the research.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE;MUSCULOSKELETAL