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.

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study.

BACKGROUND: Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. AIMS AND OBJECTIVES: To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation. OBJECTIVES: 1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff. METHODS: A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service. DISCUSSION: Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions. TRIAL REGISTRATION: ISRCTN17847169. Date registered: 15 December 2017.

Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study.

BACKGROUND: Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within each care home. and shown that a pharmacist independent prescriber service is feasible in this context. AIMS AND OBJECTIVES: To conduct a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of a pharmacist-independent prescribing service in care homes compared to usual general practitioner (GP)-led care. OBJECTIVES: To perform a definitive randomised controlled trial (RCT) with an internal pilot to determine the intervention's effectiveness and cost-effectiveness and enable modelling beyond the end of the trial. METHODS: This protocol is for a cluster RCT with a 3-month internal pilot to confirm that recruitment is achievable, and there are no safety concerns. The unit of randomisation is a triad comprising a pharmacist-independent prescriber (PIP) based in a GP practice with sufficient registered patients resident in one or more care homes to allow recruitment of an average of 20 participants. In the intervention group, the PIP will, in collaboration with the GP: assume responsibility for prescribing and managing residents' medicines including medication review and pharmaceutical care planning; support systematic ordering and administration in the care home, GP practice and supplying pharmacy; train care home and GP practice staff; communicate with GP practice, care home, supplying community pharmacy and study team. The intervention will last 6 months. The primary outcome will be resident falls at 6 months. Secondary outcomes include resident health-related quality of life, falls at 3 months, medication burden, medication appropriateness, mortality and hospitalisations. A full health economic analysis will be undertaken. The target sample size is 880 residents (440) in each arm) from 44 triads. This number is sufficient to detect a decrease in fall rate from 1.5 per individual to 1.178 (relative reduction of 21%) with 80% power and an ICC of 0.05 or less. DISCUSSION: Recruitment is on-going and the trial should complete in early 2020. The trial results will have implications for the future management of residents in care homes and the ongoing implementation of independent pharmacist prescribing. TRIAL REGISTRATION: ISRCTN, ID: 17847169. Registered on 15 December 2017.

Interventions to Reduce Anticholinergic Burden in Adults Aged 65 and Older: A Systematic Review.

INTRODUCTION: Older age is associated with multimorbidity and polypharmacy with high anticholinergic burden (ACB). High ACB is linked to adverse events such as poor physical functioning, dementia, cardiovascular disease, and falls. Interventions are needed to reduce this burden. AIMS/OBJECTIVES: The aim was to systematically review the literature to identify and describe studies of clinical and cost-effectiveness of interventions designed to reduce ACB in adults (≥65 years) on polypharmacy regimes, compared with usual care. The objective was to answer the following questions: What are the contents of the interventions? Were these interventions clinically effective? Were these interventions cost effective?. DESIGN, SETTING, AND PARTICIPANTS: Systematic review of interventions to reduce anticholinergic burden in adults aged 65 and older in any clinical setting. METHODS: Eligible papers reported primary or secondary research describing any type of intervention including systematic reviews, randomized controlled trials (RCTs), controlled clinical trials, or nonrandomized pre-post intervention studies (PPIs) published in English from January 2010 to February 2019. Databases searched included CINAHL, Ovid MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL). RESULTS: The search yielded 5862 records. Eight studies (4 RCTs, 4 PPIs) conducted in hospital (4), community (2), nursing homes (1), and retirement villages (1) met the inclusion criteria. Pharmacists, either individually or as part of a team, provided the intervention in the majority of studies (6/8). Most (7/8) involved individual patient medication review followed by feedback to the prescriber. Two of the 4 RCTs and all non-RCTs reported a decrease in ACB following the intervention. No study reported cost outcome. CONCLUSIONS/IMPLICATIONS: Pharmacists may be well placed to implement an ACB reduction intervention. This is the first systematic review of interventions to reduce ACB in older adults, and it highlights the need for development and testing of high-quality pragmatic clinical and cost-effectiveness trials in community and specific patient populations at high risk of harm from ACB. [PROSPERO registration: CRD42018089764].

New professional roles and patient satisfaction: Evidence from a European survey along three clinical pathways.

This paper reports the results of an empirical analysis exploring the impact of new professions (eg a physician associate) and new professional roles on patient experiences of and satisfaction with care. A sub set of data from a patient survey conducted as part of the MUNROS programme of work was used. The overall survey aim was to describe and quantify the use of new professionals and new roles for established health care professionals other than medical doctors, in primary and secondary care sectors in three care pathways in nine European countries Ordered logit models were used to investigate the association between: (1) patient satisfaction with the last visit; (2) with their care provider; (3) with the information provided and a set of covariates explaining the involvement of new professional roles in three clinical pathways: type 2 diabetes, heart disease and breast cancer. For patients with breast cancer, high levels of satisfaction are associated with the involvement of new professions/professional roles in the provision of conditions specific education and monitoring. For patients with heart disease, the involvement of new professions/professional roles is likely to have a negative impact on satisfaction. For patients with Type 2 diabetes results are ambivalent. Patients belonging to countries experiencing innovative models of healthcare delivery and with high levels of involvement of new professions/professional roles are generally more satisfied. In conclusion, the introduction of new professions does not affect patient satisfaction negatively, therefore introducing new health professional roles is a pursuable strategy from a patient satisfaction perspective, at least for breast cancer and type 2 diabetes.

Pharmacist services for non-hospitalised patients.

BACKGROUND: This review focuses on non-dispensing services from pharmacists, i.e. pharmacists in community, primary or ambulatory-care settings, to non-hospitalised patients, and is an update of a previously-published Cochrane Review. OBJECTIVES: To examine the effect of pharmacists' non-dispensing services on non-hospitalised patient outcomes. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, two other databases and two trial registers in March 2015, together with reference checking and contact with study authors to identify additional studies. We included non-English language publications. We ran top-up searches in January 2018 and have added potentially eligible studies to 'Studies awaiting classification'. SELECTION CRITERIA: Randomised trials of pharmacist services compared with the delivery of usual care or equivalent/similar services with the same objective delivered by other health professionals. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures of Cochrane and the Effective Practice and Organisation of Care Group. Two review authors independently checked studies for inclusion, extracted data and assessed risks of bias. We evaluated the overall certainty of evidence using GRADE. MAIN RESULTS: We included 116 trials comprising 111 trials (39,729 participants) comparing pharmacist interventions with usual care and five trials (2122 participants) comparing pharmacist services with services from other healthcare professionals. Of the 116 trials, 76 were included in meta-analyses. The 40 remaining trials were not included in the meta-analyses because they each reported unique outcome measures which could not be combined. Most trials targeted chronic conditions and were conducted in a range of settings, mostly community pharmacies and hospital outpatient clinics, and were mainly but not exclusively conducted in high-income countries. Most trials had a low risk of reporting bias and about 25%-30% were at high risk of bias for performance, detection, and attrition. Selection bias was unclear for about half of the included studies.Compared with usual care, we are uncertain whether pharmacist services reduce the percentage of patients outside the glycated haemoglobin target range (5 trials, N = 558, odds ratio (OR) 0.29, 95% confidence interval (CI) 0.04 to 2.22; very low-certainty evidence). Pharmacist services may reduce the percentage of patients whose blood pressure is outside the target range (18 trials, N = 4107, OR 0.40, 95% CI 0.29 to 0.55; low-certainty evidence) and probably lead to little or no difference in hospital attendance or admissions (14 trials, N = 3631, OR 0.85, 95% CI 0.65 to 1.11; moderate-certainty evidence). Pharmacist services may make little or no difference to adverse drug effects (3 trials, N = 590, OR 1.65, 95% CI 0.84 to 3.24) and may slightly improve physical functioning (7 trials, N = 1329, mean difference (MD) 5.84, 95% CI 1.21 to 10.48; low-certainty evidence). Pharmacist services may make little or no difference to mortality (9 trials, N = 1980, OR 0.79, 95% CI 0.56 to 1.12, low-certaintly evidence).Of the five studies that compared services delivered by pharmacists with other health professionals, no studies evaluated the impact of the intervention on the percentage of patients outside blood pressure or glycated haemoglobin target range, hospital attendance and admission, adverse drug effects, or physical functioning. AUTHORS' CONCLUSIONS: The results demonstrate that pharmacist services have varying effects on patient outcomes compared with usual care. We found no studies comparing services delivered by pharmacists with other healthcare professionals that evaluated the impact of the intervention on the six main outcome measures. The results need to be interpreted cautiously because there was major heterogeneity in study populations, types of interventions delivered and reported outcomes.There was considerable heterogeneity within many of the meta-analyses, as well as considerable variation in the risks of bias.

What are the current challenges of managing cancer pain and could digital technologies help?

OBJECTIVES: Pain remains a problem for people with cancer despite effective treatments being available. We aimed to explore current pain management strategies used by patients, caregivers and professionals and to investigate opportunities for digital technologies to enhance cancer pain management. METHODS: A qualitative study comprising semistructured interviews and focus groups. Patients with cancer pain, their caregivers and health professionals from Northeast Scotland were recruited from a purposive sample of general practices. Professionals were recruited from regional networks. RESULTS: Fifty one participants took part in 33 interviews (eight patients alone, six patient/caregiver dyads and 19 professionals) and two focus groups (12 professionals). Living with cancer was hard work for patients and caregivers and comparable to a 'full-time job'. Patients had personal goals which involved controlling pain intensity and balancing this with analgesic use, side effects, overall symptom burden and social/physical activities.Digital technologies were embraced by most patients, and made living life with advanced cancer easier and richer (eg, video calls with family). Technology was underutilised for pain and symptom management. There were suggestions that technology could support self-monitoring and communicating problems to professionals, but patients and professionals were concerned about technological monitoring adding to the work of managing illness. CONCLUSIONS: Cancer pain management takes place in the context of multiple, sometimes competing personal goals. It is possible that technology could be used to help patients share individual symptom experiences and goals, thus enhancing tailored care. The challenge is for digital solutions to add value without adding undue burden.

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes.

BACKGROUND: Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). METHODS: A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7-9 and <15% scoring 1-3. Exclusion was defined as ≥70% scoring 1-3 and <15% 7-9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved. RESULTS: A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS. CONCLUSIONS: We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.

It's not what you do it's the way that it's measured: quality assessment of minor ailment management in community pharmacies.

BACKGROUND: Effective management of minor ailments in community pharmacies could reduce the burden on alternative high-cost services (general practices, Emergency Departments). Evidence is needed regarding the appropriateness of management of these conditions in community pharmacies. OBJECTIVE: To explore the appropriateness of minor ailment management in community pharmacies. SETTING: Prospective, observational study of simulated patient (SP) visits to community pharmacies in Grampian (Scotland) and East Anglia (England). METHOD: Eighteen pharmacies (nine per centre) were recruited within a 25-mile radius of Aberdeen or Norwich. Consultations for four minor ailments were evaluated: back pain; vomiting/diarrhoea; sore throat; and eye discomfort. Each pharmacy received one SP visit per ailment (four visits/pharmacy; 72 visits total). Visits were audio-recorded and SPs completed a data collection form immediately after each visit. PRIMARY OUTCOME MEASURE: Each SP consultation was assessed for appropriateness against product licence, practice guidelines and study-specific consensus standards developed by a multi-disciplinary consensus panel. RESULTS: Evaluable data were available for 68/72 (94.4%) visits. Most (96%) visits resulted in the sale of a product; advice alone was the outcome of three visits. All product sales complied with the product licence, 52 (76%) visits complied with practice guidelines and seven visits achieved a 'basic' standard according to the consensus standard. CONCLUSION: Appropriateness of care varied according to the standard used. Pharmacy-specific quality standards are needed which are realistic and relevant to the pharmacy context and which reflect legal and clinical guidelines to promote the safe and effective management of minor ailments in this setting.

The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial.

BACKGROUND: Medication organisation devices (MODs) provide compartments for a patient's medication to be organised into the days of the week and the recommended times the medication should be taken. AIM: To define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs. DESIGN: The feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated. SETTING: Potential participants were identified by medical practices. PARTICIPANTS: Aged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable. INTERVENTIONS: One of three MODs widely used in routine clinical practice supplied either weekly or monthly. OBJECTIVES: To identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation. METHODS: The systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery. RESULTS: Studies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50-60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly. CONCLUSIONS: MOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients. FUTURE WORK: A study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required. STUDY REGISTRATION: Current Controlled Trials ISRCTN 30626972 and UKCRN 12739. FUNDING: This project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial.

OBJECTIVES: To explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT. DESIGN: Regression analysis of costs and effects, using intention-to-treat and expected value of sample information analysis (EVSI). SETTING: Six general practices: Grampian (3); East Anglia (3). PARTICIPANTS: 125 patients with complete resource use and short form-six-dimension questionnaire (SF-6D) data at baseline, 3 months and 6 months. INTERVENTIONS: Patients were randomised to either pharmacist medication review with face-to-face pharmacist prescribing or pharmacist medication review with feedback to general practitioner or treatment as usual (TAU). MAIN OUTCOME MEASURES: Differences in mean total costs and effects measured as quality-adjusted life years (QALYs) at 6 months and EVSI for sample size calculation. RESULTS: Unadjusted total mean costs per patient were £452 for prescribing (SD: £466), £570 for review (SD: £527) and £668 for TAU (SD: £1333). After controlling for baseline costs, the adjusted mean cost differences per patient relative to TAU were £77 for prescribing (95% CI -82 to 237) and £54 for review (95% CI -103 to 212). Unadjusted mean QALYs were 0.3213 for prescribing (SD: 0.0659), 0.3161 for review (SD: 0.0684) and 0.3079 for TAU (SD: 0.0606). Relative to TAU, the adjusted mean differences were 0.0069 for prescribing (95% CI -0.0091 to 0.0229) and 0.0097 for review (95% CI -0.0054 to 0.0248). The EVSI suggested the optimal future trial size was between 460 and 690, and between 540 and 780 patients per arm using a threshold of £30,000 and £20,000 per QALY gained, respectively. CONCLUSIONS: Compared with TAU, pharmacist-led interventions for chronic pain appear more costly and provide similar QALYs. However, these estimates are imprecise due to the small size of the pilot trial. The EVSI indicates that a larger trial is necessary to obtain more precise estimates of differences in mean effects and costs between treatment groups. TRIAL REGISTRATION NUMBER: ISRCTN06131530.

Estimating the burden of minor ailment consultations in general practices and emergency departments through retrospective review of routine data in North East Scotland.

BACKGROUND: Minor ailment attendances in general practices and emergency departments (EDs) place significant burden on health care resources. OBJECTIVES: To estimate the prevalence and type of minor ailment consultations for adults in general practice and ED that could be managed in a community pharmacy. METHODS: Retrospective review of routine data from general practices (n = 2) and one ED in North East Scotland. Two independent consensus panels assessed each consultation summary to determine whether it represented a minor ailment. Outcomes included prevalence of consultations for minor ailments in general practice and ED and frequency of different minor ailment type that could be managed in community pharmacies. RESULTS: In total, of the 494 general practice and 550 ED consultations assessed, 13.2% [95% confidence interval (CI): 18.6-25.9%] and 5.3% (95% CI: 4.0-8.0%), respectively, were categorized as minor ailments suitable for management in community pharmacies. Consensus among panel members was moderate for general practice consultations, but fair to poor for ED consultations. Agreement between uni- and multi-disciplinary panels was good. Applied to national data, these estimates would equate to ~18 million general practice and 6500000 ED consultations that could be redirected to community pharmacy, equating to ~£1.1 billion in resources. CONCLUSION: Minor ailment consultations still present a major burden on higher cost settings. Effective strategies are needed to raise awareness among patients and health professionals regarding conditions that can be managed effectively in pharmacies and to change patient health-seeking behaviour for such conditions.

Are pharmacy-based minor ailment schemes a substitute for other service providers? A systematic review.

BACKGROUND: Pharmacy-based minor ailment schemes (PMASs) have been introduced throughout the UK to reduce the burden of minor ailments on high-cost settings, including general practice and emergency departments. AIM: This study aimed to explore the effect of PMASs on patient health- and cost-related outcomes; and their impact on general practices. DESIGN AND SETTING: Community pharmacy-based systematic review. METHOD: Standard systematic review methods were used, including searches of electronic databases, and grey literature from 2001 to 2011, imposing no restrictions on language or study design. Reporting was conducted in the form recommended in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist. RESULTS: Thirty-one evaluations were included from 3308 titles identified. Reconsultation rates in general practice, following an index consultation with a PMAS, ranged from 2.4% to 23.4%. The proportion of patients reporting complete resolution of symptoms after an index PMAS consultation ranged from 68% to 94%. No study included a full economic evaluation. The mean cost per PMAS consultation ranged from £1.44 to £15.90. The total number of consultations and prescribing for minor ailments at general practices often declined following the introduction of PMAS. CONCLUSION: Low reconsultation and high symptom-resolution rates suggest that minor ailments are being dealt with appropriately by PMASs. PMAS consultations are less expensive than consultations with GPs. The extent to which these schemes shift demand for management of minor ailments away from high-cost settings has not been fully determined. This evidence suggests that PMASs provide a suitable alternative to general practice consultations. Evidence from economic evaluations is needed to inform the future delivery of PMASs.

Pharmacist prescribing in primary care: the views of patients across Great Britain who had experienced the service.

OBJECTIVE To evaluate the views of patients across primary care settings in Great Britain who had experienced pharmacist prescribing. METHODS All Royal Pharmaceutical Society of Great Britain (RPSGB) prescribers (n = 1622) were invited to participate. Those consenting were asked to invite up to five consecutive patients who had experienced their prescribing to participate. Patients were mailed one questionnaire and a reminder. The questionnaire included five sections: demographics; you and your pharmacist prescriber; you and your general practitioner; your views and experiences based on your most recent pharmacist prescriber consultation; and additional views. KEY FINDINGS Of the 482 (29.7%) pharmacists who responded, 92 (19.1%) were eligible to participate, of whom 49 (53.3%) consented. Of those excluded, 193 (49.5%) were prescribing in secondary care and 171 (43.8%) were not prescribing. Between September 2009 and March 2010, 143 patients were recruited. Patient response rate was 73.4% (n = 105/143). Consultation settings were largely general practice (85.7%) or community pharmacy (11.4%). Attitudes were overwhelmingly positive with the vast majority agreeing/strongly agreeing that they were totally satisfied with their consultation and confident that their pharmacist prescribed as safely as their general practitioner (GP). Pharmacists were considered approachable and thorough, and most would recommend consulting a pharmacist prescriber. A slightly smaller majority would prefer to consult their GP if they thought their condition was getting worse and a small minority felt that there had been insufficient privacy and time for all their queries to be answered. CONCLUSIONS Patients were satisfied with, and confident in the skills of, pharmacist prescribers. However, the sample was small, may be biased and the findings lack generalisability.

Cross sectional survey of the Scottish general public's awareness of, views on, and attitudes toward nonmedical prescribing.

BACKGROUND: Nonmedical (ie, nonphysician) prescribing is a key development in the UK that has brought about many changes in prescribing policy and practice. Systematic research into the views of the general public toward such developments is limited. OBJECTIVE: To determine the awareness of, views on, and attitudes of members of the Scottish general public toward nonmedical prescribing, with an emphasis on pharmacist prescribing. METHODS: A questionnaire was mailed in November 2006 to a random sample of 5000 members of the general public in Scotland aged 18 and over, obtained from the UK electoral roll. The questionnaire contained items on awareness of nonmedical prescribing, levels of comfort with specific health professionals, and attitudes toward pharmacist prescribing. RESULTS: Response rate was 37.1%. More than half of the individuals who responded were taking prescribed drugs. Nine hundred and seventy-eight (56.6%) were aware that trained health professionals could write prescriptions for medicines previously only prescribed by physicians. Awareness was associated with: increasing age (p < 0.001), having a health professional in their immediate family (p < 0.001), self-rated general health (p < 0.005), and a higher education level (p < 0.01). In logistic regression, all factors were retained as independent predictors of awareness (p < 0.001). Comfort levels for nonmedical prescribing were highest for pharmacists (median 4, IQR 3-5 [1 = low, 5 = high]), closely followed by nurses, and lowest for radiographers (median 2, IQR 1-4) (p < 0.001). While more than half of the respondents supported pharmacists having a prescribing role, fewer felt that pharmacists should prescribe the same range of drugs as physicians. There were concerns about lack of privacy in a pharmacy, despite acknowledging its enhanced convenience. CONCLUSIONS: Our results indicate that more than half of the respondents were aware of nonmedical prescribing. A higher proportion was more comfortable with prescribing by pharmacists and nurses than with other healthcare professionals. Several issues relating to aspects of clinical governance were highlighted, specifically education and data handling.

Needs assessment study for community pharmacy travel medicine services.

BACKGROUND: Community pharmacists in the UK currently provide limited travel medicine services. An enhanced service could offer the traveling public general advice, provision of immunizations, and malaria prophylaxis. The assessment of need for a travel vaccine service from community pharmacies is key to the decision to develop the service. METHOD: The needs assessment used a questionnaire survey of potential travelers recruited from community pharmacies and the regional travel clinic. RESULTS: In total, 151 completed questionnaires were received (response rate 40%); nearly three times as many replies were from females (74%) than males (26%). Details for 230 different proposed visits abroad and 174 different past visits were analyzed. General medical practice (54.3%) and community pharmacies (36.4%) were rated as providing the most useful advice. Most respondents (76.4%) required advice on vaccines, 53.9% on malaria prophylaxis, and 54.9% on bite prevention. Many (58.9%) agreed, or strongly agreed, that they would use the community pharmacy to provide travel immunizations, while 43% (strongly) agreed that they would be prepared to pay to obtain travel medicine services including immunizations. The median amount that participants were prepared to pay for a full travel assessment was pound 10, pound 13 for the administration of typhoid vaccine, pound 70 for a course of rabies vaccine, and pound 25 for malaria tablets for Kenya. Nearly three quarters (74.8%) agreed, or strongly agreed, that the community pharmacy would provide a convenient location from which to obtain travel services and 70.2% that the pharmacy could provide a one-stop shop for travel medicine services. CONCLUSIONS: Members of the traveling public do visit community pharmacies, and most people are traveling for holiday purposes. The results suggest that travelers would be prepared to use the community pharmacy to provide travel advice and immunizations.

Exploring patients' perspectives of pharmacist supplementary prescribing in Scotland.

AIM: The aim of this study was to explore patients' perspectives and experiences of pharmacist supplementary prescribing (SP) in Scotland. METHOD: A survey in primary and secondary care in Scotland. Pharmacist supplementary prescribers (n = 10) were purposively selected across Scotland. All pharmacists distributed questionnaires to 20 consecutive patients as they attended appointments during October to December 2006. Reminders were mailed to all 20 patients by each pharmacist 2 weeks after initial distribution. MAIN OUTCOME MEASURES: The questionnaire contained items on: attitudes towards pharmacist SP derived from earlier qualitative research; consultation satisfaction derived from a validated scale developed initially for general practitioners, with the term 'doctor' being replaced by 'pharmacist prescriber'; and demographics. Closed and Likert scales were used as response options. RESULTS: One pharmacist withdrew. The patient response rate was 57.2% (103/180). The median age was 67 years (interquartile range 56.5-73 years), with 53.4% being female. Most (76, 73.8%) consulted with the pharmacist in a general practice setting. Patients reported positive consultation experiences with 89.3% agreeing/strongly agreeing that they were satisfied with the consultation, 78.7% thought the pharmacist told them everything about their treatment and 72.9% felt the pharmacist was interested in them as a person. Most patients were positive in their attitudes, agreeing that they would recommend a pharmacist prescriber to others and that they had trust in the pharmacist. However, 65% would prefer to consult a doctor. CONCLUSION: Most patient respondents were satisfied with, and had a positive attitude towards, pharmacist prescribing consultations. However, most patients would still elect to see a doctor given the choice.

Experiential learning as part of pharmacist supplementary prescribing training: feedback from trainees and their mentors.

BACKGROUND: A period of learning in practice (PLP) is an integral part of supplementary prescribing training for pharmacists in Great Britain. During the PLP, a designated medical practitioner (DMP) supervises and supports the trainee to develop competence in prescribing. OBJECTIVE: To evaluate the views and experiences of supplementary prescribing pharmacists and DMPs regarding the PLP and identify their perceived support needs during the PLP. METHODS: Prepiloted questionnaires were mailed in September 2006 to all pharmacists who had started their supplementary prescribing training at The Robert Gordon University, Aberdeen, Scotland (n = 242) and their DMPs (n = 232). Nonrespondents were sent up to 2 reminders. Responses were analyzed using descriptive and comparative statistics; responses to open questions were analyzed thematically. RESULTS: Responses were received from 186 (76.9%) pharmacists and 144 (62.1%) DMPs. Just over half of the pharmacists agreed/strongly agreed that they knew what was expected of them and their DMPs during the PLP, but less than half agreed/strongly agreed that it was important to communicate with pharmacist colleagues in the prescribing course. One hundred twelve (60.2%) pharmacists had their consultation skills reviewed by their DMPs during the PLP. Opportunities for professional development and teamwork were regarded as major positive experiences by both pharmacists and DMPs. Organizational, attitudinal, and time barriers were also reported. There was considerable interest among both pharmacists and DMPs for an Internet-based support network during the PLP. CONCLUSIONS: Information on the roles and responsibilities of pharmacists and DMPs during the PLP should be enhanced. The Internet could be a useful medium for communication during the PLP. Input from a multidisciplinary team of healthcare professionals and review of consultation videos could further enhance the PLP experience.

Preferences for self-care or professional advice for minor illness: a discrete choice experiment.

AIM: To determine the relative importance of factors that influence decision making in the management of minor illness, and how people trade between these factors. DESIGN OF STUDY: Discrete choice experiment. SETTING: Scottish electoral roll. METHOD: Six hundred and fifty-two responders of a previous national survey were invited to complete a discrete choice experiment questionnaire. This was used to measure relative preferences for managing symptoms of minor illness often associated with analgesic use. Three attributes were identified as important to participants: type of management, availability, and cost of managing symptoms. Trade-offs between these attributes were examined. RESULTS: A 57% response rate was achieved (51% valid response rate). People preferred to manage symptoms by self-care and were willing to pay almost pounds 23 to do so. Community pharmacy was the preferred source of advice. Responders preferred less waiting time and paying less money when managing symptoms, and were willing to trade between factors. A less preferred type of management became more attractive when waiting times and cost were reduced. CONCLUSION: Findings suggest that self-care is the preferred method of managing symptoms of minor illness. When developing services to support self-care, policy makers should invest in services that reduce waiting times and incur least cost to users.