Margaret Watson

A systematic review of the use of simulated patients and pharmacy practice research

Objective The use of simulated patients to assess current practice, or to derive outcome measures for pharmacy practice research, has received much attention in recent years. A simulated patient is an individual who is trained to visit a pharmacy to enact a scenario testing specific behaviour of the pharmacist or pharmacy staff. The aim of this study was to provide a definitive review of the use of simulated patients as a methodological tool for pharmacy practice research.

Simulated patients in the community pharmacy setting. Using simulated patients to measure practice in the community pharmacy setting.

Background: Performance measurement and quality of care in community pharmacy settings is problematic because of the lack of formal patient registration and the resultant risk of selection bias. Although simulated patients have been used for teaching and education purposes, particularly in medical settings, their use as a research tool requires exploration in other health settings. The purpose of this paper is to describe how we used simulated patients to measure professional performance of community pharmacy staff.Method: Sixty pharmacies participated in a randomised controlled trial (RCT) to evaluate the effectiveness and efficiency of two guideline implementation strategies in the community pharmacy setting. The primary outcome measure for the study was derived from assessment forms completed by simulated patients following covert visits to participating pharmacies.Results: Of the 420 simulated patient visits scheduled, 384 (91%) were completed. Nine visits were reported by pharmacy staff using reply-paid postcards, four of which concurred with known SP visits. Each detected visit was made by a different SP. In a post-intervention survey, 26 (52%) pharmacists stated they had been apprehensive about the use of simulated patients as part of the study, however, 41 (82%) pharmacists agreed that SP visits were an acceptable research method to use in a community pharmacy setting.Discussion: Simulated patients are a feasible method of assessing professional performance in community pharmacy settings and overcome the methodological problems of other measurement methods. Further research is needed to assess the reliability and validity of simulated patients.

Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals.

AbstractBackground: In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. Objective: To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS. Design and Setting: Retrospective observational study in the UK. Methods: Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report. Results: In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range IQR] of 3 [2–5] vs 2 [1–3], respectively; p<0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p<0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [27–463] vs 28 [13–75] days respectively; p<0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards. Conclusions: This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.

Does organisational culture influence prescribing in care homes for older people?: a new direction for research

Prescribing in care homes for older people has been the focus of much research and debate because of inappropriate drug choice and poor monitoring practices. In the US, this has led to the implementation of punitive and adversarial regulation that has sought to improve the quality of prescribing in this healthcare setting. This approach is unique to the US and has not been replicated elsewhere. The literature has revealed that there are limitations as to how much can be achieved with regulation that is externally imposed (an ‘external factor’). Other influences, which may be categorised as ‘internal factors’ operating within the care home (e.g. patient, physician and care-home characteristics), also affect prescribing. However, these internal and external factors do not appear to affect prescribing uniformly, and poor prescribing practices in care homes continue to be observed. One intangible factor that has received little attention in this area of healthcare is that of organisational culture. This factor has been linked to quality and performance within other health organisations. Consideration of organisational culture within care-home settings may help to understand what drives prescribing decisions in this particularly vulnerable patient group and thus provide new directions for future strategies to promote quality care.

Factors predicting the guideline compliant supply (or non-supply) of non-prescription medicines in the community pharmacy setting

Background: The reclassification of prescription only medicines to pharmacy and general sales list medicines (also known as non-prescription medicines) provides the public with greater access to medicines that they can purchase for self-care. There is evidence that non-prescription medicines may be associated with inappropriate supply. This study investigated factors predicting evidence-based (guideline compliant) supply or non-supply of non-prescription medicines. Method: Secondary analysis of results from a randomised controlled trial of educational interventions to promote the evidence based supply of non-prescription medicines. Ten actors made simulated patient (customer) visits to 60 community pharmacies using seven scenarios reflecting different types of presentations. The dependent variable was appropriate (guideline compliant) supply of antifungal medication for treatment of vaginal candidiasis. Results: No significant association was shown between guideline compliant behaviour and pharmacy type or location, or with the actor making the visit. The likelihood of guideline compliant outcome was significantly greater with symptom presentations than with condition or product presentations (p<0.001). The likelihood of a guideline compliant outcome increased (a) as more information was exchanged (p<0.001), (b) with the use of WWHAM (a mnemonic frequently used by medicine counter assistants during consultations for non-prescription medicines) (p<0.001); (c) when specific WWHAM questions were used (including “description of symptoms” (p<0.001) and “whether other medication was currently being used” (p<0.001); and (d) in consultations involving solely pharmacists compared with those involving only medicine counter assistants (p = 0.017). After adjustment for presentation type, a significant association persisted between appropriate outcome and consultations with WWHAM scores of 2 and ⩾3, respectively. Conclusions: The nature and extent of information exchange between pharmacy staff and customers has a strong influence on the guideline compliant supply of non-prescription medicines. Future interventions to promote the safe and effective use of non-prescription medicines should address the apparent deficit in communication between pharmacy staff in general, and medicine counter assistants in particular, which may reflect both pharmacy staff skills and customer expectations.

Oral versus intra‐vaginal imidazole and triazole anti‐fungal agents for the treatment of uncomplicated vulvovaginal candidiasis (thrush): a systematic review

Objectives To compare the relative effectiveness, cost effectiveness and safety of oral versus intra‐vaginal anti‐fungal treatments for uncomplicated vulvovaginal candidiasis (thrush) and establish patient preference for the route of anti‐fungal administration

Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial.

Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) completed. Exclusion criteria included: severe mental illness, terminally ill, cancer related pain, history of addiction. Randomisation and intervention Patients were randomised using a remote telephone service to: (1) pharmacist medication review with face-to-face pharmacist prescribing; (2) pharmacist medication review with feedback to GP and no planned patient contact or (3) treatment as usual (TAU). Blinding was not possible. Outcome measures Outcomes were the SF-12v2, the Chronic Pain Grade (CPG), the Health Utilities Index 3 and the Hospital Anxiety and Depression Scale (HADS). Outcomes were collected at 0, 3 and 6 months. Results In the prescribing arm (n=70) two patients were excluded/nine withdrew. In the review arm (n=63) one was excluded/three withdrew. In the TAU arm (n=63) four withdrew. Compared with baseline, patients had an improved CPG in the prescribing arm, 47.7% (21/44; p=0.003) and in the review arm, 38.6% (17/44; p=0.001), but not the TAU group, 31.3% (15/48; ns). The SF-12 Physical Component Score showed no effect in the prescribing or review arms but improvement in TAU (p=0.02). The SF-12 Mental Component Score showed no effect for the prescribing or review arms and deterioration in the TAU arm (p=0.002). HADS scores improved within the prescribing arm for depression (p=0.022) and anxiety (p=0.007), between groups (p=0.022 and p=0.045, respectively). Conclusions This is the first randomised controlled trial of pharmacist prescribing in the UK, and suggests that there may be a benefit for patients with chronic pain. A larger trial is required. Trial registration: www.isrctn.org/ISRCTN06131530. Medical Research Council funding.

Lightening the load? A systematic review of community pharmacy-based weight management interventions

The extent to which community pharmacies can increase capacity for weight management is unknown. Thus, the objective of the present paper was to evaluate the effectiveness and cost‐effectiveness of community pharmacy weight management interventions. This paper used a design of systematic review and narrative synthesis. Electronic databases (1999–2009) were searched, including Medline, EMBASE, CINAHL and Pharm‐line. Weight management studies in community pharmacies were eligible for the inclusion criteria. All languages and study designs were considered. Outcome measures included body weight or anthropometry (at baseline and at least one follow‐up time point). Data were extracted through independent, duplicate data extraction and quality assessment. As a result, 10 studies were included, totalling 2,583 service users and 582 pharmacies from the USA, the UK, Switzerland, Spain and Denmark. One was a randomized controlled trial of a meal‐replacement versus a reduced calorie diet. A non‐randomized controlled before and after study compared community pharmacist treatment using Orlistat with usual care. Eight studies were uncontrolled. Five studies described behaviour change techniques. Long‐term (12 months) mean weight loss measured in three studies ranged from 1.1 to 4.1 kg. Four uncontrolled studies reported statistically significant weight loss. No study reported economic evaluations. Currently, there is insufficient evidence for the effectiveness and cost‐effectiveness of community pharmacy‐based weight management initiatives to support investment in their provision.

The evidence-based supply of non-prescription medicines: barriers and beliefs

Context The reclassification of prescription only medicines (POMs) to pharmacy only (P) and general sale list (GSL) status is ongoing in the UK. Pharmacy staff need support to ensure the appropriate supply of these non‐prescription medicines (NPMs).

Patient versus Healthcare Professional Spontaneous Adverse Drug Reaction Reporting

AbstractBackground: Increasing numbers of national pharmacovigilance schemes are accepting adverse drug reaction (ADR) reports from patients. The extent to which patient ADR reports contribute to pharmacovigilance requires comparisons to be made with reports from healthcare professionals (HCPs). Objective: This systematic review was conducted to identify all comparative studies of patient and HCP ADR reports to national pharmacovigilance schemes. Methods: We conducted a systematic review (which complied with the PRISMA statement) and a narrative synthesis of the results. Electronic databases (1996–2011) were searched, including MEDLINE, EMBASE and PHARM-Line, and supplementary searching of reference lists of included studies, authors’ personal reference lists and internet searches was carried out. Studies that compared patient and HCP ADR reports submitted to national reporting schemes were considered for inclusion. Independent, duplicate data extraction, quality assessment and risk of bias were undertaken. Results: Of the 949 hits generated, three comparative studies were identified and included in this review. These studies were conducted on the national pharmacovigilance schemes in the Netherlands, Denmark and the UK.Considerable variation was observed across the national schemes in terms of the proportion of total ADR reports submitted by patients. Some of this variation may be explained by the duration that the schemes have been in operation. The number of serious ADR reports as a percentage of total reports was similar for patients compared with HCPs within each study, but varied across studies. Similarities were shown with the Netherlands and the UK in terms of drugs reported. Both studies featured statins and proton pump inhibitors in the top five drugs.Clear differences were shown between patients and HCPs in the body systems affected by ADRs as well as the therapeutic categories reported in both the UK and Danish studies. There was considerable similarity when considering the nature of ADRs reported. The Dutch study also showed similarities between patients and physicians in terms of the types of drugs for which ADRs were reported. Conclusions: Despite the large and increasing number of national pharmacovigilance schemes that accept ADR reports from patients, few comparative studies have been undertaken of patient and HCP reporting. Comparison across schemes is challenging because of differences in reporting processes, the inclusion criteria of schemes and different reporter types. The true value of patient ADR reports to pharmacovigilance will remain unknown unless more comparative evaluations are undertaken. This systematic review has highlighted both similarities and differences between reporter behaviour, the implications of which, in terms of signal generation, require further exploration.