The Burden of Managing Medicines for Older People With Sensory Impairment: An Ethnographic-Informed Study.

Background: Older age is associated with increased prevalence of sensory impairment and use of medicines. Objectives: To explore the daily "medicine journey" of older people with sensory impairment. Methods: The study used ethnographic-informed methods (using audio-, photo- and video-recordings, diary notes and semi-structured interviews with researchers) and involved community-dwelling adults (aged > 65) in Scotland, with visual and/or hearing impairment and using >4 medicines. Data analysis used the constant comparative method. Results: Fourteen older people with sensory impairment participated and used a mean of 11.0 (SD 5.0) medicines (range 5-22). Participants reported difficulties with medicine ordering, obtaining, storage, administration and disposal. They used elaborate strategies to manage their medicines including bespoke storage systems, fixed routines, simple aids, communication, and assistive technologies. Conclusion: Older people with sensory impairment experience substantial burden, challenges and risk with medicines management. Tailored medicine regimens and assistive technologies could provide greater support to older people with sensory impairment.

Pharmacy users' perceptions, awareness and future expectations of community pharmacy in England: a focus group study.

OBJECTIVE: To explore pharmacy users' perceptions of current and future provision of community pharmacy services in England. METHODS: Qualitative, reconvened focus groups were conducted with community pharmacy users. An initial focus group explored preliminary views. Participants were then given an evidence brief describing community pharmacy before a reconvened focus group two weeks later. Transcripts were analysed using inductive thematic analysis. KEY FINDINGS: Eleven individuals participated across two reconvened focus groups. Participants valued community pharmacies and staff, but lacked awareness of their services and roles: '… I don't think the general public is aware of all of this … it gives you a very different perspective'. Urgent care and long-term conditions management were identified as suitable for future development, facilitated by training, closer collaboration with general practices, shared access to health records, and premises with more space and confidentiality: 'I still think of it as a retail space more than as a health service'. Concerns were expressed about working conditions in community pharmacy and unplanned closures: 'doesn't sound like a great place to work'. Participants anticipated greater use of technology but did not want this to replace face-to-face contact with pharmacy staff: 'I am not saying it's inaccurate, it is so remote and impersonal'. CONCLUSIONS: Pharmacy users would value a greater role for community pharmacy in addressing the challenges currently faced by the health service in England, provided that their concerns on a range of issues are addressed.

Professional stakeholders' expectations for the future of community pharmacy practice in England: a qualitative study.

OBJECTIVES: To explore the views of professional stakeholders on the future of community pharmacy services in England. Specific objectives related to expectations of how community pharmacy services will be provided by 2030 and factors that will influence this. DESIGN: Qualitative, using semistructured interviews in person or via telephone/Skype. The topic guide was informed by a recent policy review that used the Walt and Gilson policy framework. Transcripts were analysed using inductive thematic analysis. SETTING: England. PARTICIPANTS: External stakeholders were representatives of non-pharmacy organisations, including policy-makers, commissioners and representatives of healthcare professions. Internal stakeholders were community pharmacists or pharmacy organisation representatives. Interviewees were identified using stakeholder mapping RESULTS: In total, 25 interviews were completed (7 external stakeholders and 18 internal stakeholders, of which 10 were community pharmacists). Community pharmacy was recognised as having a key role in expanding health system capacity ('…pharmacy is the obvious person to take on those roles…'), particularly for long-term condition management (eg, adherence, reducing polypharmacy, monitoring), urgent care (eg, minor illnesses) and public health (including mental health). For these contributions to be developed and optimised, greater integration and collaboration with general practices will be needed ('…there is no room for isolationism in pharmacy anymore…'), as well as use of technology in a patient-centred way and full access to health records. These changes will require workforce development together with appropriate commissioning and contractual arrangements. Community pharmacy is currently undervalued ('…the complete misunderstanding by senior Government officials is very scary') and recent investment in general practice pharmacists rather than community pharmacy was seen as a missed opportunity. CONCLUSIONS: Community pharmacy as a sector could and should be developed to increase health service capacity to address its current challenges. Numerous modifications are required from a range of stakeholders to create the environment in which these changes can occur.

Assistive technologies and strategies to support the medication management of individuals with hearing and/or visual impairment: A scoping review.

BACKGROUND: Individuals with sensory impairment (visual and/or hearing) experience health inequalities and increased the risk of medication-related iatrogenic disease compared with the general population. Assistive technologies and tailored strategies could support medication management for individuals with sensory impairment to reduce harm and increase the likelihood of therapeutic benefit. OBJECTIVE: This scoping review identified assistive technologies and strategies to support medication management of/for people with hearing and/or visual impairment. METHODS: Standard scoping review methodology was used to identify studies that evaluated technologies or strategies designed to support people with sensory impairment with independent medicine management. Electronic databases were searched (MEDLINE, Embase, CINAHL, ACM, Cochrane) from inception to 18/07/22. Independent duplicate screening, selection, and data extraction were undertaken. RESULTS: Of 1231 publications identified, 18 were included, reporting 17 studies, 16 of which evaluated technologies to assist people with visual impairment and one study to assist people with hearing impairment. The range of technologies and devices included: applications for android phones (n = 6); eyedrop-assistance devices (n = 5); audio-prescription labelling/reading systems (n = 2); touch-to-speech devices (n = 2); continuous glucose monitoring system (n = 1); magnifying technology (n = 1). Ten studies tested early-stage prototypes. Most participants could operate the technologies effectively and deemed them to be useful. CONCLUSIONS: Despite the increasing number of medicine-related assistive technologies, there has been limited empirical evaluation of their effectiveness for supporting individuals with sensory impairment. Prototypes appear to be useful for people with visual or hearing impairment, however wider 'real-life' testing is needed to confirm the benefits of these technologies.

Professional and governmental policy on community pharmacy: A 10-year policy review and comparative analysis (2008-2017).

Background: An increased role for community pharmacy might bring considerable value to healthcare systems, for example by relieving workload elsewhere in primary care through the provision of medicines-related services. This requires support from appropriate policy. Objectives: To explore the representation of community pharmacy in governmental and professional health policies in England (2008-2017) using the Walt and Gilson policy framework. Methods: Relevant policies were identified using a systematic search. The content of these policies was analysed using thematic analysis. The transparency of evidence use during the policymaking process was scored in four keys areas using a recognised tool: diagnosis; proposal; implementation; testing and evaluation. Key actors involved in the development of each policy were summarised. Results: 18 governmental policies and 7 pharmacy profession policies were included. Convergence between governmental and professional policy content was identified in 6 areas: healthcare workforce; behaviour and collaborations; utilising technology; urgent care; long-term health conditions; service provision. Divergence was identified in 5 areas: enquiry-driven culture; quality in healthcare; cancer care; mental health care; commissioning. Professional policies were less transparent in their use of evidence and had less documentation of the involvement of key actors, such as professionals and the public. Conclusions: The profession has limited influence and/or representation in governmental policies. This may be because professional policies did not reflect concerns expressed in governmental policies and had low credibility due to limited stakeholder involvement and transparency about evidence use.

National initiative to promote public involvement in medicine safety: the use of a cross-sectional population survey to identify candidate behaviours for intervention development in Scotland.

OBJECTIVES: The aim of this study was to explore the public's current awareness of the safe use of medicines in general, and over-the-counter (OTC) analgesics (painkillers) in particular, as well as their information-seeking and advice-seeking, medicine use and disposal. SETTING: General population, Scotland. PARTICIPANTS: Adults (aged >16 years) living in Scotland. INTERVENTIONS: A cross-sectional survey was undertaken in collaboration with Ipsos MORI (a market research company). The content was informed by a multi-stakeholder prioritisation event and supplemented with information from earlier studies. RESULTS: The survey was completed in March 2020 by 1000 respondents, most of whom had used a pharmacy in the previous 12 months to obtain a medicine. Of the 1000 respondents, 39% (n=389) were 55 years and over; 52% (n=517) were women; and 58% were degree-educated.On receipt of a new prescription, up to 29.8% (95% CI 27.0% to 32.7%) of respondents proactively sought specific information or advice from the pharmacist. Few (5.2% (95% CI 4.0% to 6.8%) respondents 'always' discussed their new prescription medicine with pharmacy staff and 28.9% (95% CI 26.2% to 31.8%) reported 'never' engaging in this behaviour. Respondents aged >35 years were less likely to engage in this behaviour.Just over half (53% (95% CI 50.5% to 56.7%)) the respondents reported oral OTC analgesic use at least once in the previous month.In terms of medicine disposal, 29.3% (95% CI 26.6% to 32.2%) of respondents considered waste bin disposal to be of low or no harm. CONCLUSIONS: This study identified low levels of information-seeking and advice-seeking from pharmacy personnel especially on receipt of new prescription medicines. Potentially unsafe behaviours were identified in the use and disposal of medicines. These results will inform the development of interventions to promote advice-seeking and increase awareness regarding safe medicine use.

Audit and feedback interventions involving pharmacists to influence prescribing behaviour in general practice: a systematic review and meta-analysis.

INTRODUCTION: Pharmacists, as experts in medicines, are increasingly employed in general practices and undertake a range of responsibilities. Audit and feedback (A&F) interventions are effective in achieving behaviour change, including prescribing. The extent of pharmacist involvement in A&F interventions to influence prescribing is unknown. This review aimed to assess the effectiveness of A&F interventions involving pharmacists on prescribing in general practice compared with no A&F/usual care and to describe features of A&F interventions and pharmacist characteristics. METHODS: Electronic databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, (Social) Science Citation Indexes, ISI Web of Science) were searched (2012, 2019, 2020). Cochrane systematic review methods were applied to trial identification, selection, and risk of bias. Results were summarized descriptively and heterogeneity was assessed. A random-effects meta-analysis was conducted where studies were sufficiently homogenous in design and outcome. RESULTS: Eleven cluster-randomized studies from 9 countries were included. Risk of bias across most domains was low. Interventions focussed on older patients, specific clinical area(s), or specific medications. Meta-analysis of 6 studies showed improved prescribing outcomes (pooled risk ratio: 0.78, 95% confidence interval: 0.64-0.94). Interventions including both verbal and written feedback or computerized decision support for prescribers were more effective. Pharmacists who received study-specific training, provided ongoing support to prescribers or reviewed prescribing for individual patients, contributed to more effective interventions. CONCLUSIONS: A&F interventions involving pharmacists can lead to small improvements in evidence-based prescribing in general practice settings. Future implementation of A&F within general practice should compare different ways of involving pharmacists to determine how to optimize effectiveness.PRISMA-compliant abstract included in Supplementary Material 1.

What influences the implementation and sustainability of antibiotic stewardship programmes in hospitals? A qualitative study of antibiotic pharmacists' perspectives across South West England.

OBJECTIVES: Antibiotic stewardship programmes (ASPs) are needed at every hospital as they can improve antibiotic use and address antibiotic resistance. Pharmacists are key agents and specialists in these programmes. This study explored antibiotic pharmacists' perceptions of factors that influence the implementation and sustainability of hospital-based ASPs. METHODS: Semistructured interviews were conducted with hospital antibiotic pharmacists face-to-face or by telephone. NVivo V.12 software was used to collate and organise the data grouped within codes. Thematic analysis was undertaken using inductive and deductive approaches to produce overarching themes. RESULTS: Thirteen pharmacists from 13 hospitals were interviewed. Four main themes were identified: (1) 'organisational culture' which highlighted the importance of strong local clinical leadership to help achieve organisational buy-in and address resistance among physicians or clinical hierarchies; (2) 'national influences' including networks, guidance and incentive schemes which were considered to be a driver to bring about changes across organisation; (3) 'continuous monitoring with feedback ASP data, preferably through direct communication' to demonstrate the impact of the programmes which then facilitated ongoing support from local leadership and improved engagement across organisation; and (4) 'resources' which indicated the need of information technology and dedicated personnel with protected time to support ASP activities. CONCLUSIONS: Interventions and strategies should operate at different levels-individual, team, organisational and national-to help implement and sustain ASPs in hospital. This is also the first study to identify and highlight the importance of national initiatives in contributing to the implementation and sustainability of hospital-based ASPs.

User Testing to Improve Retrieval and Comprehension of Information in Guidelines to Improve Medicines Safety.

OBJECTIVE: The aim of the study was to investigate the effectiveness of user testing for improving healthcare professionals' retrieval and comprehension of information in medicines guidelines. METHODS: The United Kingdom's Injectable Medicines Guide was selected as a case study. This gives guidance to nurses on preparing and administering intravenous medicines on hospital wards, in line with standard UK practice. Three rounds of user testing were completed with 10 hospital nurses per round, using the Injectable Medicines Guide for voriconazole and aminophylline. Participants used the guidelines to answer 17 questions related to the administration of these medicines. Answers were scored for "finding" and "understanding" the required information. Semistructured interviews explored participants' opinions of guideline content, design, and wording, with responses analyzed thematically. The guidelines were revised between rounds. RESULTS: In round 1, 8 of 17 questions were answered correctly by all participants. Participants had difficulty with dose, dilution, administration rate, and adverse effects questions. Revisions included new subsections and increased calculation support. In round 2, 14 of 17 questions were answered correctly by all participants. Difficulty persisted with dose and administration rate questions and further revisions made. In round 3, 15 of 17 questions were answered correctly by all participants. Across all rounds, participants considered appropriate subheadings and information order as important for fast location of information. Specific, detailed, and practical instructions were perceived as important to improve understandability and usefulness. CONCLUSIONS: Key information in medicines guidelines may not be found and/or understood by healthcare professionals. User testing increased information retrieval and comprehension and could have an important role in improving the safety of medicines use.

Costs and Cost-Effectiveness of User-Testing of Health Professionals' Guidelines to Reduce the Frequency of Intravenous Medicines Administration Errors by Nurses in the United Kingdom: A Probabilistic Model Based on Voriconazole Administration.

AIM: In the UK, injectable medicines are often prepared and administered by nurses following the Injectable Medicines Guide (IMG). Our earlier study confirmed a higher frequency of correct administration with user-tested versus standard IMG guidelines. This current study aimed to model the cost-effectiveness of user-testing. METHODS: The costs and cost-effectiveness of user-testing were explored by modifying an existing probabilistic decision-analytic model. The adapted model considered administration of intravenous voriconazole to hospital inpatients by nurses. It included 11 error types, their probability of detection and level of harm. Model inputs (including costs) were derived from our previous study and other published data. Monte Carlo simulation using 20,000 samples (sufficient for convergence) was performed with a 5-year time horizon from the perspective of the 121 NHS trusts and health boards that use the IMG. Sensitivity analyses were undertaken for the risk of a medication error and other sources of uncertainty. RESULTS: The net monetary benefit at £20,000/quality-adjusted life year was £3,190,064 (95% credible interval (CrI): -346,709 to 8,480,665), favouring user-testing with a 96% chance of cost-effectiveness. Incremental cost-savings were £240,943 (95% CrI 43,527-491,576), also favouring user-tested guidelines with a 99% chance of cost-saving. The total user testing cost was £6317 (95% CrI 6012-6627). These findings were robust to assumptions about a range of input parameters, but greater uncertainty was seen with a lower medication error risk. CONCLUSIONS: User-testing of injectable medicines guidelines is a low-cost intervention that is highly likely to be cost-effective, especially for high-risk medicines.

Prescribing of direct oral anticoagulants and warfarin to older people with atrial fibrillation in UK general practice: a cohort study.

BACKGROUND: Anticoagulation for stroke prevention in atrial fibrillation (AF) has, historically, been under-used in older people. The aim of this study was to investigate prescribing of oral anticoagulants (OACs) for people aged ≥ 75 years in the UK before and after direct oral anticoagulants (DOACs) became available. METHODS: A cohort of patients aged ≥ 75 years with a diagnosis of AF was derived from the Clinical Practice Research Datalink (CPRD) between January 1, 2003, and December 27, 2017. Patients were grouped as no OAC, incident OAC (OAC newly prescribed) or prevalent OAC (entered study on OAC). Incidence and point prevalence of OAC prescribing were calculated yearly. The risk of being prescribed an OAC if a co-morbidity was present was calculated; the risk difference (RD) was reported. Kaplan-Meier curves were used to explore persistence with anticoagulation. A Cox regression was used to model persistence with warfarin and DOACs over time. RESULTS: The cohort comprised 165,596 patients (66,859 no OAC; 47,916 incident OAC; 50,821 prevalent OAC). Incidence of OAC prescribing increased from 111 per 1000 person-years in 2003 to 587 per 1000 person-years in 2017. Older patients (≥ 90 years) were 40% less likely to receive an OAC (RD -0.40, 95% CI -0.41 to -0.39) than younger individuals (75-84 years). The likelihood of being prescribed an OAC was lower with a history of dementia (RD -0.34, 95% CI -0.35 to -0.33), falls (RD -0.17, 95% CI -0.18 to -0.16), major bleeds (RD -0.17, 95% CI -0.19 to -0.15) and fractures (RD -0.13, 95% CI -0.14 to -0.12). Persistence with warfarin was higher than DOACs in the first year (0-1 year: HR 1.25, 95% CI 1.17-1.33), but this trend reversed by the third year of therapy (HR 0.75, 95% CI 0.63-0.89). CONCLUSIONS: OAC prescribing for older people with AF has increased; however, substantial disparities persist with age and co-morbidities. Whilst OACs should not be withheld solely due to the risk of falls, these results do not reflect this national guidance. Furthermore, the under-prescribing of OACs for patients with dementia or advancing age may be due to decisions around risk-benefit management. TRIAL REGISTRATION: EUPAS29923 . First registered on: 27/06/2019.

Multiplicity and complexity: a qualitative exploration of influences on prescribing in UK general practice.

OBJECTIVES: Despite widespread availability of evidence-based guidelines to inform rational use of medicines, considerable unwarranted variation exists in prescribing. A greater understanding of key determinants of contemporary prescribing in UK general practice could inform strategies to promote evidence-based prescribing. This study explored (1) current influences on prescribing in general practice and (2) the possibility that general practice-based pharmacists (PBPs) may contribute to greater engagement with evidence-based prescribing. DESIGN: Semistructured, telephone interviews and a focus group were conducted, audio-recorded and transcribed verbatim. Thematic analysis was undertaken. PARTICIPANTS: General practice prescribers: general practitioners (GPs), PBPs, nurses.Key informants: individuals within the National Health Service (NHS) with responsibility for influencing, monitoring and measuring general practice prescribing. SETTING: General practices and NHS organisations in England. RESULTS: Interviews with 17 prescribers (GPs (n=6), PBPs (n=6), nurses (n=5)) and 6 key informants, and one focus group with five key informants were undertaken between November 2018 and April 2019. Determinants operating at individual, practice and societal levels impacted prescribing and guideline use. Prescribers' professional backgrounds, for example, nursing, pharmacy, patient populations and patient pressure were perceived as substantial influences, as well as media portrayal and public perceptions of medicines.Prescribers identified practice-level determinants of prescribing, including practice culture and shared beliefs. Key informants tended to emphasise higher-level influences, including NHS policies, availability of support and advice from secondary care and generic challenges associated with medicines use, for example, multimorbidity.Participants expressed mixed views about the potential of PBPs to promote evidence-based prescribing in general practice. CONCLUSION: Prescribing in UK general practice is influenced by multiple intersecting factors. Strategies to promote evidence-based prescribing should target modifiable influences at practice and individual levels. Customising strategies for medical and non-medical prescribers may maximise their effectiveness.

User-testing guidelines to improve the safety of intravenous medicines administration: a randomised in situ simulation study.

BACKGROUND: User-testing and subsequent modification of clinical guidelines increases health professionals' information retrieval and comprehension. No study has investigated whether this results in safer care. OBJECTIVE: To compare the frequency of medication errors when administering an intravenous medicine using the current National Health Service Injectable Medicines Guide (IMG) versus an IMG version revised with user-testing. METHOD: Single-blind, randomised parallel group in situ simulation. Participants were on-duty nurses/midwives who regularly prepared intravenous medicines. Using a training manikin in their clinical area, participants administered a voriconazole infusion, a high-risk medicine requiring several steps to prepare. They were randomised to use current IMG guidelines or IMG guidelines revised with user-testing. Direct observation was used to time the simulation and identify errors. Participant confidence was measured using a validated instrument. The primary outcome was the percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel. RESULTS: In total, 133 participants were randomised to current guidelines and 140 to user-tested guidelines. Fewer moderate-severe IMG-related errors occurred with the user-tested guidelines (n=68, 49%) compared with current guidelines (n=79, 59%), but this difference was not statistically significant (risk ratio: 0.82; 95% CI 0.66 to 1.02). Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60). Median simulation completion time was 1.6 min (95% CI 0.2 to 3.0) less with the user-tested guidelines. Participants who used user-tested guidelines reported greater confidence. CONCLUSION: User-testing injectable medicines guidelines reduces the number of errors and the time taken to prepare and administer intravenous medicines, while increasing staff confidence. TRIAL REGISTRATION NUMBER: researchregistry5275.

Using the behaviour change technique taxonomy v1 (BCTTv1) to identify the active ingredients of pharmacist interventions to improve non-hospitalised patient health outcomes.

OBJECTIVES: The aim of this study was to identify which behaviour change techniques (BCTs) were present in intervention and control groups of randomised controlled trials (RCTs) included in a Cochrane systematic review. SETTING: The RCTs included were conducted in community, primary and/or ambulatory-care settings. PARTICIPANTS: The data set was derived from 86 RCTs from an interim update of the Cochrane review of the effectiveness of pharmacist services on non-hospitalised patient outcomes. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the identification of BCTs scheduled for delivery in intervention and control groups of the RCTs. The secondary outcome measure was to identify which BCTs are not being utilised in intervention and control groups of the RCTs. RESULTS: The intervention and control groups included 31 and 12 BCTs, respectively. The number of identifiable BCTs/study ranged from 0 to 12 in the intervention groups (mean 3.01 (SD 2.4)) and 0 to 6 in the control groups (mean 0.38 (SD 0.84)). The most commonly identified BCTs in the intervention groups were: instruction on how to perform the behaviour (55%, n=47) (also the most common BCT in control groups); problem solving (29%, n=25); information about health consequences (24%, n=21); social support (practical) (24%, n=21); and social support (unspecified) (23%, n=20) (the second most common BCT in control groups). Thirteen trials had no identifiable BCTs in either group. CONCLUSION: The pharmacist interventions presented in this study did not use the full range of available BCTs. Furthermore, the reporting of BCTs was incomplete for both intervention and control groups, thereby limiting the utility and reproducibility of the interventions. Future interventions should be designed and reported using relevant taxonomies and checklists for example, BCT taxonomy and TIDieR (the template for intervention description and replication).

Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis. OBJECTIVES: The primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching. SELECTION CRITERIA: We included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as recommended by Cochrane. MAIN RESULTS: This review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high. There was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%. In terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials. AUTHORS' CONCLUSIONS: Oral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low. The decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.

Use of oral anticoagulants in older people with atrial fibrillation in UK general practice: protocol for a cohort study using the Clinical Practice Research Datalink (CPRD) database.

INTRODUCTION: Warfarin has frequently been underused in older people for stroke prevention in atrial fibrillation (AF). Direct oral anticoagulants (DOACs) entered the UK market from 2008 and have been recommended as an alternative to warfarin. This study aimed to describe any changes in the prescribing of oral anticoagulants (OACs) to people aged ≥75 years in UK general practice before and after the introduction of DOACs, to examine differences in patient characteristics which may influence prescribers' decisions regarding anticoagulation, to evaluate the time people stay on OACs and switching between OACs. METHODS AND ANALYSIS: A retrospective cohort study design will be used. Patients with a diagnosis of AF will be identified from the Clinical Practice Research Datalink (CPRD). The study period will run from 1 January 2003 to 27 December 2017. Patients enter the cohort at the latest date of the start of the study period, first AF diagnosis, 75th birthday or a year from when they started to contribute research standard data. Follow-up continues until they leave the practice, death, the date the practice stops contributing research standard data or the end of the study period (27 December 2017). Exposure to OACs will be defined as ≥1 prescription issued for an OAC of interest during the study period. Patients issued an OAC in the year preceding study entry will be defined as 'prevalent users'. Patients starting on an OAC during the study period will be defined as 'incident users'. Incidence and prevalence of OAC prescribing, patient demographics and characteristics will be described during three time periods: 2003-2007, 2008-2012 and 2013-2017. Persistence (defined as the time from initiation to discontinuation of medication) with and switching between different OACs will be described. ETHICS AND DISSEMINATION: The protocol for this study was approved by the CPRD Independent Scientific Advisory Committee. The results will be disseminated in a peer-reviewed journal and at conferences. TRIAL REGISTRATION NUMBER: EUPAS29923.

Medication safety problems priorities in community pharmacy in Saudi Arabia: a multi-stakeholder Delphi study using the human factors framework.

AIM: To achieve multi-stakeholder consensus and prioritisation of medication safety problems in community pharmacies in Saudi Arabia. DESIGN AND INTERVENTION: A theoretically-underpinned, three-round Delphi study. SETTING: Saudi Arabia. PARTICIPANTS: Patients and public (pharmacy users), pharmacy-related professionals (policymakers, academics, medication safety officers and pharmacy owners) and community pharmacists. METHODS: Round 1 comprised 84 statements derived from a qualitative study. The items were grouped according to the Human Factors Framework (HFF). Rounds 1 and 2 aimed to achieve consensus, 6-point Likert response scale (agreement/disagreement) was used. Round 3 aimed to prioritise the items for which consensus was achieved in Rounds 1 and 2 indicated on a 5-point scale (very important to unimportant). Consensus was predefined as any item that achieved ≥70%. RESULTS: The number of respondents in Rounds 1, 2 and 3 was 161, 120 and 112, respectively. In all three rounds, the majority of respondents were pharmacy users (Round 1 77% (n=124), Round 2 74% (n=89), Round 3 72% (n=81)). Consensus was achieved with 28/84 items. The top five medication safety priorities were: lack of pharmacy facilities such as counselling area, lack of communication between pharmacists and physicians, lack of patient databases, lack of post-registration pharmacist education and pharmacists' long working hours. The professional and pharmacy user groups achieved consensus on similar items through different categories of the HFFs. Community pharmacists had the highest percentage of consensus among the three groups for factors related to work, such as high workload and low salaries. CONCLUSION: This multi-stakeholder study used the HFF to identify and prioritise the main medication safety challenges facing community pharmacy in Saudi Arabia. It indicates the need for changes to practice and policy and further research to address these priorities and promote medication safety at an individual, pharmacy and population level.

Quality indicators and community pharmacy services: a scoping review.

BACKGROUND: Quality indicators are a commonly used improvement tool in health care. There is growing interest and activity in the use of quality indicators to improve community pharmacy practice. OBJECTIVES: To conduct a scoping review of the use of quality indicators for community pharmacy practice, including their methods of development and evaluation. METHODS: Electronic databases (EMBASE and PubMed) were searched to identify papers published between January 2008 and April 2018. No limits were applied for language of publication or country of origin. Studies were included if they reported empirical data regarding the development or evaluation of quality indicators. All study designs were eligible for inclusion. Duplicate independent screening was undertaken of the search results. Data extraction was performed by one reviewer. RESULTS: Of the 988 records identified from the database search, 15 articles were included. The studies were conducted in 12 countries from six continents. Eleven studies described the development of quality indicators, eight of which included the evaluation of the psychometric properties of the indicators developed. Four studies examined the impact of quality indicators on practice all of which reported improvements in some aspects of quality, mainly with structure indicators rather than those relating to process and outcome. CONCLUSIONS: Whilst there is a growing emphasis on promoting improvement in community pharmacy services, evidence is lacking of the effect of indicators on improving quality. Measurable process and outcome indicators are needed. The future development of quality indicators would also benefit from a multi-stakeholder approach.

A Theory Based Intervention to Enhance Information Exchange during Over-The-Counter Consultations in Community Pharmacy: A Feasibility Study.

Background: Management of minor ailments through self-care and self-medication brings both benefits and risks that can be mitigated if consumers and pharmacy personnel engage in information exchange during over-the-counter (OTC) consultations. Objective: Explore the feasibility of interventions using situational cues to promote information exchange between pharmacy personnel and consumers, during OTC consultations. Methods: Intervention tools were developed prior to conducting the study, in two community pharmacies in Perth, Western Australia. The situational cues included two posters and individual position badges. Data were collected from audio-recording OTC consultations, consumer questionnaires and interviews, and pharmacy personnel interviews. Results: Space required for posters and for researchers conducting interviews was challenging in the retail environment. Pharmacy personnel perceived that the badges positively impacted -consumers' ability to identify the position of personnel they engaged with. Data collection methods were deemed practical and acceptable. Conclusions: The proposed interventions and evaluation methods were feasible. The use of posters and badges as situational cues to address the barriers to information exchange during OTC consultations was found to be practical, in a community pharmacy setting. There is potential to use situational cues to address other barriers identified to information exchange, to add to the effectiveness of the intervention. With growing emphasis on self-care and self-medication, effective interventions are necessary to promote information exchange to enhance appropriate management in community pharmacies.