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ABSTRACT: To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain.
An exploratory randomised controlled trial.
Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3).
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.
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.
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).
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.
BMJ open. 01/2013; 3(4).
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ABSTRACT: Background: 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.
Drug Safety 08/2012; 35(10):807-18. · 3.63 Impact Factor
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ABSTRACT: The extent to which community pharmacists contribute to the management of the global obesity epidemic is unclear. Local, regional and national obesity management schemes need to be informed by existing services which will be influenced by health professionals' attitudes and willingness to engage in service provision. The purpose of this study was to derive an accurate account of community pharmacists' activities and attitudes towards the provision of current and future Healthy Weight Management (HWM) services.
A postal survey was developed and disseminated to all 128 community pharmacies in Grampian, north-east Scotland.
The response rate was 64.8% (83/128). A range of HWM services was already being provided. The most common services offered were the supply of weight-loss medication (n=69, 84.1%) and advice about its use (n=68, 84.0%). Other services commonly offered were dietary advice (n=59, 72.8%), physical activity advice (n=53, 66.3%) and body mass index (BMI) calculation (n=56, 68.3%). Most pharmacists were confident in measuring weight (n=78, 93.9%), height (n=78, 93.9%) and BMI (n=78, 93.9%). Many pharmacists perceived a need for HWM services in their local area (n=56, 67.5%) as well as a need to extend these services within their pharmacies (n=48, 57.9%). Barriers to the provision of HWM services included workload (n=77, 92.8%) and the need for additional reimbursement (n=63, 75.9%) and additional staff (n=49, 59.7%). The pharmacists' perceived training needs included estimation of body fat (n=67, 81.7%), one-to-one consultation skills (n=60, 73.2%), advice on weight-loss products (n=52, 63.4%), measurement of blood cholesterol (n=51, 63%) and advice on weight-loss drugs (n=49, 60.5%).
Community pharmacies could be an ideal setting for the provision of HWM services. The barriers to service provision need to be addressed. Furthermore, the development of appropriate undergraduate and postgraduate training is required to equip pharmacists and their staff with appropriate knowledge and skills to deliver these services effectively.
International Journal of Pharmacy Practice 04/2011; 19(2):106-14.
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ABSTRACT: To describe the characteristics of patient reporters to the UK's Yellow Card Scheme (YCS) and the suspect drugs reported, and to determine patient views and experiences of making a Yellow Card report.
A questionnaire was developed for distribution by the Medicines and Healthcare products Regulatory Agency (MHRA) to all patients reporting through the YCS between March 2008 and January 2009. Associations between reporting method (online, postal and telephone) and questionnaire responses were examined using Pearson's Chi-squared test.
Evaluable questionnaires were returned by 1362 out of 2008 reporters (68%). Respondents' median (IQR) age was 56.5 (43.0, 67.0) years, 910 (66.8%) were female, 1274 (93.5%) were white and 923 (67.8%) had at least a further education qualification. The most frequent reporting method was postal (59.8%), followed by online (32.8%) and telephone (6.3%). Online reporters were younger with a higher education level than those using other reporting methods. Most respondents, 1274 (93.6%), thought that the report was fairly or very easy to complete, although many identified the need for improvements to the system. One third (n = 448; 32.9%) expected feedback from the MHRA and 828 (60.8%) would have liked feedback. Almost all respondents (n = 1302; 95.6%) would report again.
The majority of patients found the current methods of reporting suspected ADRs easy to use and would recommend them to others. Different methods of reporting were used by different demographic subgroups of reporters. Improvements to the system, including the provision of feedback to reporters, could be made.
Pharmacoepidemiology and Drug Safety 02/2011; 20(5):523-31. · 2.53 Impact Factor
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ABSTRACT: 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.
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Retrospective observational study in the UK.
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.
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.
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.
Drug Safety 09/2010; 33(9):775-88. · 3.63 Impact Factor
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ABSTRACT: The supply of over-the-counter (OTC) medicines from community pharmacies should be safe and effective, but there is evidence that appropriate practice is not always achieved. The primary objective of this study was to assess the acceptability of simulated patient (SP) visits combined with feedback, delivered by either SPs or pharmacy educators (PEs), as a method for improving the supply of OTC medicines in community pharmacies.
This feasibility study used a randomized controlled trial design where participating pharmacies were randomized into two groups (SP or PE, feedback). SP visits were audiotaped and questionnaire data collected from participants post-intervention. Each pharmacy received three covert visits from SPs. Feedback was provided immediately after the first and second visits. Data were collected on information gathering and advice provision. The visits were assessed for minimum standards of practice and appropriateness of outcome.
Twenty-two pharmacists and 34 medicine counter assistants (MCAs) from 20 community pharmacies in Grampian, Scotland, participated. Sixty SP visits were completed (three per pharmacy) and were well received, particularly by the pharmacists. Similar results were shown across both study groups in terms of information gathering and information/advice provision during consultations. Few SP consultations achieved the minimum standard of practice although most resulted in an appropriate outcome.
SP visits with feedback were acceptable to pharmacists as a method of improving the quality of consultations for OTC medicines, irrespective of the person giving feedback (SP or PE). The process by which pharmacists and their staff derived their recommendations, in terms of information gathering, could be improved. A large-scale study is needed to assess the effectiveness and cost-effectiveness of SP visits with feedback.
Family Practice 10/2009; 26(6):532-42. · 1.50 Impact Factor
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ABSTRACT: Excessive consumption of alcohol is a major public health concern. The use of community pharmacies and pharmacists as sources of public health information and services is gaining greater recognition. The objective of this review was to provide an overview of the evidence on the feasibility, effectiveness and acceptability of providing community pharmacy-based services to address the excessive consumption of alcohol.
Electronic databases were searched for the period 1996-2007 to identify relevant evidence. Searches were also conducted of relevant pharmacy and addiction journals. Information was sought from key contacts in pharmacy and alcohol research. Studies were included if they were conducted in a community pharmacy setting.
The review comprised three feasibility studies which included 14 pharmacies and 500 customers. Non-significant reductions in alcohol consumption were reported with two studies following brief interventions by pharmacists. Between 30% and 53% of pharmacy customers were identified as having hazardous or harmful drinking behaviour. Customer opinion of the pharmacy-based alcohol services was not reported.
There has been little empirical evaluation of the effectiveness of community pharmacy-based services for alcohol misuse. The evidence presented in this review suggests that community pharmacy-based screening is feasible. Organisations and individuals involved with tackling excessive alcohol consumption should consider the inclusion of community pharmacies and pharmacists as part of their strategies to address this problem. Large-scale studies are needed to evaluate the short- and long-term effects and cost-effectiveness of community pharmacy-based interventions to reduce excessive alcohol consumption, as well as to explore the acceptability of the service to
International Journal of Pharmacy Practice 08/2009; 17(4):199-205.
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ABSTRACT: Neuropathic pain is widely recognized as one of the most difficult pain syndromes to treat and presents a significant challenge for pain clinicians and GPs.
The Self-complete Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire, recently validated for identifying pain of predominantly neuropathic origin (POPNO), was sent to 6000 adults identified from general practices in the UK. The questionnaire also contained items about chronic pain identification, medications and treatments received for pain and the pain relief these provided.
In total, 1420/3002 (48%) of respondents indicated that they suffered with any chronic pain. These were further categorized as those with chronic pain who were S-LANSS negative ['chronic pain (non-POPNO)' group, n = 1179] and those with chronic pain who were S-LANSS positive, indicating the presence of POPNO ('chronic POPNO' group, n = 241). Questions relating to treatments and medications were completed by 88% of the respondents (1244/1420). The chronic POPNO group was more likely to receive multiple pain medications (37% versus 21% took two or more pain medications, P < 0.001) and stronger painkillers [e.g. opioids odds ratio 1.94; 95% confidence interval 1.10, 3.42]. Despite this, they reported less effective pain relief than the non-POPNO chronic pain group.
Patients in primary care reporting chronic pain were found generally to obtain incomplete relief from their medication with chronic POPNO patients reporting less relief. It is important that patients with any chronic pain are identified and managed appropriately according to their distinct treatment needs.
Family Practice 10/2007; 24(5):481-5. · 1.50 Impact Factor
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ABSTRACT: Medicine counter assistants (MCAs) supply the majority of non-prescription medicines (NPMs) to consumers. Suboptimal communication during consultations between consumers and MCAs has been identified as a major cause of inappropriate supply. Evidence from medical consultations suggests that training in specified communication skills can change professional behaviour.
A feasibility study was conducted to evaluate the effect of theory-based communication skills training for MCAs. Thirty MCAs were recruited from 21 community pharmacies in Grampian, Scotland. The intervention comprised 2 4-hour training sessions, held 1 month apart. The sessions were informed by results from previous studies and the Calgary-Cambridge evidence-based model of communication skills training. Strategies for guiding individuals through change were adopted from cognitive behavioural therapy techniques. The theory of planned behaviour was used to assess potential pathways to behaviour change. Recorded data were collected during covert visits to the pharmacies by simulated patients at baseline and 1 month after each training session. Communication performance was measured as the number and type of questions asked.
Compared with baseline measures, the total number of questions asked increased in the intervention group at both time-points. No change was shown in the control group between baseline and follow-up 1, and a decrease was shown in the total number of questions from follow-up 1 to 2. The intervention appeared to have greater effect on consultations involving advice, compared with those concerning product requests.
Communication performance improved following training. Increased information exchange is associated with guideline-compliant supply of NPMs. A substantive randomised, controlled trial is now planned to assess the intervention.
Medical Education 06/2007; 41(5):450-9. · 3.18 Impact Factor
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ABSTRACT: The purpose of this study was to undertake linguistic analysis of consultations between medicine counter assistants (MCAs) and customers for the supply of nonprescription medicines.
The linguistic corpus comprised 168 recorded and transcribed consultations. Utterances were tagged as information eliciting, information or advice giving and other. The analysis focused on triads, beginning and ending with an MCA utterance (MCA(1)-->customer's response-->MCA(2)). The use of the mnemonic, WWHAM (Who for, What symptoms, How long, Any medicine tried, other Medication taken) was also analysed.
A total of 505 triads were identified. Of the 773 utterances, 61% were information eliciting, 13% were information giving, 14% were advice giving and 11% were "other" or unclassifiable. No consultation involved WWHAM in its entirety.
MCAs do not appear to have been made sufficiently aware of the ways in which their exchanges with customers during consultations for nonprescription medicines are crucially different from natural conversation.
In order to help customers decide upon an appropriate nonprescription medicine, the MCA has the role of both informing and advising. Training should focus on informing and advising as distinct functions, and the potential problems caused by combining them.
Patient Education and Counseling 01/2007; 65(1):51-7. · 2.31 Impact Factor
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ABSTRACT: 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.
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.
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.
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.
Pharmacy World amp Science 03/2004; 26(1):32-7. · 1.22 Impact Factor
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ABSTRACT: In the UK, there has been a rapid increase in the reclassification of prescription only medicines (POMs) to pharmacy only (P) and general sales list (GSL) status. This means that community pharmacy staff have a greater range of non-prescription medicines to recommend for the treatment of minor illness. Strategies are needed to promote good professional practice in the supply of non-prescription medicines. Guidelines have been shown to promote quality of care in other health care settings. In this article, we present evidence based guidelines for the treatment of vulvovaginal candidiasis using non-prescription anti-fungal medicines.
Pharmacy World amp Science 09/2003; 25(4):129-34. · 1.22 Impact Factor
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ABSTRACT: The purpose of this study was to develop evidence-based guidelines for over-the-counter (OTC) treatment of vulvovaginal candidiasis with non-prescription anti-fungal medicines purchased from community pharmacies.
A multidisciplinary guideline development group was recruited from the locality where the guidelines were to be tested. A Nominal Group Technique (NGT) was used to achieve formal consensus within the group regarding the issues that the guidelines would address. Guideline recommendations were developed from the results of two systematic literature reviews that assessed which symptoms were predictive of vulvovaginal candidiasis (using data from epidemiological studies) and estimated the relative effectiveness of oral and intra-vaginal anti-fungals using data from randomised controlled trials.
Evidence-based guideline recommendations. The guideline statements were linked to the evidence using a standard hierarchy.
The guideline development group met four times. The use of NGT was an effective way of achieving consensus on guideline content. Two systematic reviews carried out as part of the guideline development process identified evidence for the guidelines on the efficacy of OTC treatments and symptoms suggestive of vulvovaginal candidiasis. The guideline recommendations were presented as a booklet and a laminated algorithm. In summary, the guidelines highlighted symptoms suggestive of vulvovaginal candidiasis, and symptoms associated with other vaginal conditions that should be referred to the GP. The guidelines stated that oral treatment and intra-vaginal treatment are equally effective, and that selection of an anti-fungal should be based upon safety, cost and patient preference. Many of the recommendations were influenced by OTC license restrictions of each antifungal product. Contra-indications to, and special precautions with, antifungals were also listed. In addition, the guidelines stated that the male sexual partner does not require treatment unless symptomatic.
There is sufficient evidence available to develop evidence-based guidelines for the treatment of vulvovaginal candidiasis in the community pharmacy setting. The NGT is a useful component in the guideline development process.
Pharmacy World amp Science 09/2003; 25(4):177-81. · 1.22 Impact Factor
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ABSTRACT: 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.
A systematic review of studies comparing oral and intra-vaginal anti-fungal treatments for uncomplicated vulvovaginal candidiasis. Standard Cochrane Collaboration methods were used.
The following sources were searched: the Cochrane Controlled Trials Register; the Cochrane Sexually Transmitted Disease review group Specialised Register of Controlled Trials; EMBASE (January 1980 to January 2000); and MEDLINE (January 1985 to May 2000). The reference list of each trial was checked for additional references. The manufacturers of anti-fungal treatments in the UK were asked for information on trials fulfilling the inclusion criteria.
There was duplicate, independent examination and selection of the electronic search results followed by duplicate data abstraction. Disagreements regarding inclusion status and data abstraction were resolved by discussion between reviewers and the editor of the Cochrane Sexually Transmitted Disease group. Randomised controlled trials conducted worldwide and published in any language were included. The primary outcome measure was clinical cure. Mycological cure, patient preference and safety were secondary outcome measures.
Seventeen trials were included in the review, reporting 19 oral versus intra-vaginal anti-fungal treatment comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical or mycological cure. All 10 trials that reported a preference favoured oral treatment (compared with intra-vaginal or no preference). No trials presented cost data.
There is no difference between the relativeeffectiveness of oral and intra-vaginal anti-fungal treatment for thrush.
BJOG An International Journal of Obstetrics & Gynaecology 02/2002; 109(1):85-95. · 3.41 Impact Factor
