Evaluation of a training programme for Pharmacist Independent Prescribers in a care home medicine management intervention.

BACKGROUND: The provision of independent prescribing rights for United Kingdom (UK) pharmacists has enabled them to prescribe within their area of competence. The aim of this study was to evaluate an evidence-based training programme designed to prepare Pharmacist Independent Prescribers (PIPs) to safely and effectively assume responsibility for pharmaceutical care of older people in care homes in the UK, within a randomised controlled trial. METHODS: The training and competency assessment process included two training days, professional development planning against a bespoke competency framework, mentor support, and a viva with an independent General Practitioner (GP). Data on the PIPs' perceptions of the training were collected through evaluation forms immediately after the training days and through online questionnaires and interviews after delivery of the 6-month intervention. Using a mixed method approach each data set was analysed separately then triangulated providing a detailed evaluation of the process. Kaufman's Model of Learning Evaluation guided interpretations. RESULTS: All 25 PIPs who received the training completed an evaluation form (N = 25). Post-intervention questionnaires were completed by 16 PIPs and 14 PIPs took part in interviews. PIPs reported the training days and mentorship enabled them to develop a personalised portfolio of competence in preparation for discussion during a viva with an independent GP. Contact with the mentor reduced as PIPs gained confidence in their role. PIPs applied their new learning throughout the delivery of the intervention leading to perceived improvements in residents' quality of life and medicines management. A few PIPs reported that developing a portfolio of competence was time intensive, and that further training on leadership skills would have been beneficial. CONCLUSIONS: The bespoke training programme was fit for purpose. Mentorship and competency assessment were resource intensive but appropriate. An additional benefit was that many PIPs reported professional growth beyond the requirement of the study. TRIAL REGISTRATION: The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17,847,169 ).

Perinatal fluoxetine exposure results in social deficits and reduced monoamine oxidase gene expression in mice.

Perinatal antidepressant drug exposure increases risk for autism spectrum disorder, yet the molecular and neurobehavioral effects of maternal antidepressant drug use on offspring remain poorly understood. In this study, we administered the selective serotonin reuptake inhibitor (SSRI) fluoxetine non-invasively to female mice throughout gestation and early lactation, and then examined social interaction behaviors in offspring. In addition, we measured whole brain gene expression levels of monoamine oxidase A (MAOA), the primary metabolizing enzyme for serotonin. We found deficits in sociability and social novelty-seeking behavior in the juvenile offspring of SSRI-treated mice, and these behaviors persisted into young adulthood. Furthermore, we found decreased MAOA expression in the brains of offspring of SSRI-treated mice. Our findings suggest that exposure to antidepressants during the prenatal and early postnatal period may negatively affect social development. Moreover, reduced MAOA expression may play a role in the mechanistic pathway linking SSRI exposure and behavioral deficits symptomatic of autism.

Real-time determination of enantiomeric and isomeric content using photoelectron elliptical dichroism.

The fast and accurate analysis of chiral chemical mixtures is crucial for many applications but remains challenging. Here we use elliptically-polarized femtosecond laser pulses at high repetition rates to photoionize chiral molecules. The 3D photoelectron angular distribution produced provides molecular fingerprints, showing a strong forward-backward asymmetry which depends sensitively on the molecular structure and degree of ellipticity. Continuously scanning the laser ellipticity and analyzing the evolution of the rich, multi-dimensional molecular signatures allows us to observe real-time changes in the chemical and chiral content present with unprecedented speed and accuracy. We measure the enantiomeric excess of a compound with an accuracy of 0.4% in 10 min acquisition time, and follow the evolution of a mixture with an accuracy of 5% with a temporal resolution of 3 s. This method is even able to distinguish isomers, which cannot be easily distinguished by mass-spectrometry.

A systematic review of the use, quality and effects of pelvic examination in primary care for the detection of gynaecological cancer.

AIM: This three part systematic review gathered all the current evidence on the use, quality and effects of pelvic examination (abdominal palpation, bimanual vaginal examination ± visualisation of the cervix) in primary care in diagnosing gynaecological cancer. Research questions • Do primary care practitioners perform pelvic examination during the assessment of symptoms, which are potentially indicative of gynaecological cancer? (RQ1) • What is the quality of pelvic examination performed in primary care, in terms of technical competence and interpretation of findings? (RQ2) • Is pelvic examination associated with the referral of patients with gynaecological cancer, and if so, in what way? (RQ3) Methods: PRISMA guidelines were followed. MEDLINE, EMBASE and Cochrane databases were searched using a combination of four terms, their MeSH terms and synonyms: pelvic examination; primary care; competency and gynaecological cancer. Inclusion and exclusion criteria were defined. Citation lists of all identified papers were searched. Two authors (PW and PM or CMB or CB) independently screened titles, abstracts and the full texts of publications. Data extraction was performed by PW and duplicated in all papers by a second reviewer (PM, CMB or CB). Paper quality was assessed using CASP methodology. RESULTS: Nine hundred fifty four references were identified: 21 met the inclusion criteria: 5 RQ1; 6 RQ2; 10 RQ3. Examination rates prior to referral were generally low: one paper identified pre-referral PE in 52% of the patients; remaining papers demonstrated examination in less than half of the patients with suspicious symptoms. No papers explored GPs' competence at performing PE directly; but one paper identified 39% of 'clinically suspicious' cervices referred for colposcopy as having no abnormality. Pre-referral PE was associated with reduced diagnostic delay and early stage diagnosis. CONCLUSIONS: Pre-referral pelvic examination in symptomatic women appears to be under-performed, despite urgent suspected cancer referral guideline recommendation to do so (Healthcare Improvement Scotland 2014 ; National Institute for Health and Care Excellence 2015 ). While no evidence was found to confirm GPs' competence for performing PE, there was an association with shorter diagnostic delay and better outcomes in those women where it was performed.

A new technique for probing chirality via photoelectron circular dichroism.

We present a proof-of-principle approach for discriminating chiral enantiomers based on the phenomenon of multiphoton photoelectron circular dichroism. A novel stereo detection setup was used to measure the number of photoelectrons emitted from chiral molecules in directions parallel or anti-parallel to the propagation of the ionising femtosecond laser pulses. In this study, we show how these asymmetries in the ketones camphor and fenchone depend upon the ellipticity of the laser pulses and the enantiomeric excess of the sample. By using a high repetition rate femtosecond laser, enantiomer excesses with uncertainties at the few-percent level could be measured in close to real-time. As the instrument is compact, and commercial turnkey femtosecond lasers are readily available, the development of a stand-alone chiral analysis instrument for a range of applications is now possible.

Costs and effects of new professional roles: Evidence from a literature review.

One way in which governments are seeking to improve the efficiency of the health care sector is by redesigning health services to contain labour costs. The aim of this study was to investigate the impact of new professional roles on a wide range of health service outcomes and costs. A systematic literature review was performed by searching in different databases for evaluation papers of new professional roles (published 1985-2013). The PRISMA checklist was used to conduct and report the systematic literature review and the EPHPP-Quality Assessment Tool to assess the quality of the studies. Forty-one studies of specialist nurses (SNs) and advanced nurse practitioners (ANPs) were selected for data extraction and analysis. The 25 SN studies evaluated most often quality of life (10 studies), clinical outcomes (8), and costs (8). Significant advantages were seen most frequently regarding health care utilization (in 3 of 3 studies), patient information (5 of 6), and patient satisfaction (4 of 6). The 16 ANP studies evaluated most often patient satisfaction (8), clinical outcomes (5), and costs (5). Significant advantages were seen most frequently regarding clinical outcomes (5 of 5), patient information (3 of 4), and patient satisfaction (5 of 8). Promoting new professional roles may help improve health care delivery and possibly contain costs. Exploring the optimal skill-mix deserves further attention from health care professionals, researchers and policy makers.

A cohort study of influences, health outcomes and costs of patients' health-seeking behaviour for minor ailments from primary and emergency care settings.

OBJECTIVES: To compare health-related and cost-related outcomes of consultations for symptoms suggestive of minor ailments in emergency departments (EDs), general practices and community pharmacies. DESIGN: Observational study; prospective cohort design. SETTING: EDs (n=2), general practices (n=6) and community pharmacies (n=10) in a mix of rural/urban and deprived/affluent areas across North East Scotland and East Anglia. Participants Adults (≥18 years) presenting between 09:00 and 18:00 (Monday-Friday) in general practices and 09:00-18:00 (Monday-Saturday) in pharmacies and EDs with ≥1 of the following: musculoskeletal pain; eye discomfort; gastrointestinal disturbance; or upper respiratory tract-related symptoms. INTERVENTIONS: Participants completed three questionnaires: baseline (prior to index consultation); satisfaction with index consultation and follow-up (2 weeks after index consultation). MAIN OUTCOME MEASURES: Symptom resolution, quality of life, costs, satisfaction and influences on care-seeking behaviour. RESULTS: 377 patients participated, recruited from EDs (81), general practices (162) and community pharmacies (134). The 2-week response rate was 70% (264/377). Symptom resolution was similar across all three settings: ED (37.3%), general practice (35.7%) and pharmacy (44.3%). Mean overall costs per consultation were significantly lower for pharmacy (£29.30 (95% CI £21.60 to £37.00)) compared with general practice (£82.34 (95% CI £63.10 to £101.58)) and ED (£147.09 (95% CI £125.32 to £168.85)). Satisfaction varied across settings and by measure used. Compared with pharmacy and general practice use, ED use was significantly (p<0.001) associated with first episode and short duration of symptom(s), as well as higher levels of perceived seriousness and urgency for seeking care. Convenience of location was the most common reason for choice of consultation setting. CONCLUSIONS: These results suggest similar health-related outcomes and substantially lower costs with pharmacy consultations for minor ailments. Effective strategies are now needed to shift demand for minor ailment management away from EDs and general practices to the community pharmacy setting.

Public opinion of drug treatment policy: exploring the public's attitudes, knowledge, experience and willingness to pay for drug treatment strategies.

BACKGROUND: Research evidence is strong for opiate replacement treatment (ORT). However, public opinion (attitudes) can be at odds with evidence. This study explored the relationships between, attitudes, knowledge of drugs and a range of socio-demographic variables that potentially influence attitude. This is relevant in the current policy arena in which a major shift from harm reduction to, rehabilitation is underway. METHODS: A cross sectional postal questionnaire survey in Scotland was conducted where the drug, treatment strategy has changed from harm-reduction to recovery-based. A random sample (N=3000), of the general public, >18 years, and on the electoral register was used. The questionnaire was largely structured with tick box format but included two open questions for qualitative responses. Valuation was measured using the economic willingness-to-pay (WTP) method. RESULTS: The response rate was 38.1% (1067/2803). Less than 10% had personal experience of drug, misuse but 16.7% had experience of drug misuse via a friend/acquaintance. Regression modelling revealed more positive attitudes towards drug users in those with personal experience of drug misuse, (p<0.001), better knowledge of drugs (p=0.001) and higher income (those earning >£50,000 per, annum compared to <£15K; p=0.01). Over half of respondents were not willing to pay anything for drug treatment indicating they did not value these treatments at all. Respondents were willing-to-pay most for community rehabilitation and least for methadone maintenance treatment. Qualitative analysis of open responses indicated many strong negative attitudes, doubts over the efficacy of methadone and consideration of addiction as self-inflicted. There was ambivalence with respondents weighing up negative feelings towards treatment against societal benefit. CONCLUSIONS: There is a gap between public attitudes and evidence regarding drug treatment. Findings suggest a way forward might be to develop and evaluate treatment that integrates ORT with a community rehabilitative approach. Evaluation of public engagement/education to improve knowledge of drug treatment effectiveness is recommended.

Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys.

BACKGROUND: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and health-care professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs. OBJECTIVES: To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs. DESIGN: (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS. PARTICIPANTS: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028). SETTING: The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS. RESULTS: Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009. CONCLUSIONS: Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Using human error theory to explore the supply of non-prescription medicines from community pharmacies.

BACKGROUND: The importance of theory in underpinning interventions to promote effective professional practice is gaining recognition. The Medical Research Council framework for complex interventions has assisted in promoting awareness and adoption of theory into study design. Human error theory has previously been used by high risk industries but its relevance to healthcare settings and patient safety requires further investigation. This study used this theory as a framework to explore non-prescription medicine supply from community pharmacies. The relevance to other healthcare settings and behaviours is discussed. METHOD: A 25% random sample was made of 364 observed consultations for non-prescription medicines. Each of the 91 consultations was assessed by two groups: a consensus group (stage 1) to identify common problems with the consultation process, and an expert group (stages 2 and 3) to apply human error theory to these consultations. Paired assessors (most of whom were pharmacists) categorised the perceived problems occurring in each consultation (stage 1). During stage 2 paired assessors from an expert group (comprising patient safety experts, community pharmacists and psychologists) considered whether each consultation was compliant with professional guidelines for the supply of pharmacy medicines. Each non-compliant consultation identified during stage 2 was then categorised as a slip/lapse, mistake, or violation using human error theory (stage 3). RESULTS: During stage 1 most consultations (n = 75, 83%) were deemed deficient in information exchange. At stage 2, paired assessors varied in attributing non-compliance to specific error types. Where agreement was achieved, the error type most often selected was "violation" (n = 27, 51.9%, stage 3). Consultations involving product requests were less likely to be guideline compliant than symptom presentations (OR 0.30, 95% CI 0.10 to 0.95, p = 0.05). CONCLUSIONS: The large proportion of consultations classified as violations suggests that either pharmacy staff are unaware of professional guidelines and thus do not follow them (therefore these acts would not be violations), or that they knowingly violate the guidelines due to reasons that need further research. The methods presented here could be used in other healthcare settings to explore healthcare professional behaviour and to develop strategies to promote patient safety and effective professional practice.

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 > or = 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.

Specialist drug misuse nurse's motivation, clinical decision-making and professional communication: an exploratory study.

UK guidelines advocate a multidisciplinary shared care approach to manage drug-related problems. While general practitioners (GPs), consultants and pharmacists have been researched, there has been little research into the role of nurses in this field. This study examined nurses specialized in the field of substance misuse. It specifically explored their motivation for entering this area, interaction with other health professionals and their role in clinical decision-making. Seventeen face-to-face interviews were undertaken with nurses from the study population of the 21 nursing staff currently employed in one service. Responses were tape-recorded, transcribed and analysed using qualitative methods. The majority of nurses entered this field because of a specific interest in its patients and their problems. Various professionals interacted with nurses: specialist medical staff, who served as an expert resource and pharmacists through the dispensing of substitute drugs. GP participation in services was inconsistent forcing some nurses to take undue responsibility for clinical decision-making. It is essential that nurses entering this field have an interest in this field and positive attitudes towards drug users, and greater emphasis should be placed on this attribute when selecting new employees. If a shared care model is to be successful, it is important that all GPs accept their responsibilities and relieve pressure currently placed on specialist services. Alternatively, it may be necessary to adopt a new model of care.

Community pharmacy personnel interventions for smoking cessation.

BACKGROUND: Smoking cessation is a potentially appropriate role for community pharmacists because they are encouraged to advise on the correct use of nicotine replacement therapy (NRT) products and to provide behavioural support to aid smoking cessation. OBJECTIVES: This review assessed the effectiveness of interventions by community pharmacy personnel to assist clients to stop smoking. SEARCH STRATEGY: A search was made of the Cochrane Tobacco Addiction Group database for smoking cessation studies conducted in the community pharmacy setting, using the search terms pharmacist* or pharmacy or pharmacies. Date of the most recent search: March 2003. SELECTION CRITERIA: Randomized trials which compared interventions by community pharmacy personnel to promote smoking cessation amongst their clients who were smokers compared to usual pharmacy support or any less intensive programme. The main outcome measure was smoking cessation rates at six months or more after the start of the intervention. DATA COLLECTION AND ANALYSIS: Data were extracted by one author and checked by the second, noting: the country of the trial, details of participant community pharmacies, method of subject recruitment, smoking behaviour and characteristics of participants on recruitment, method of randomization, description of the intervention and of any pharmacy personnel training, and the outcome measures. Methodological quality was assessed according to the extent to which the allocation to intervention or control was concealed. Because of the potentially important cluster effects, we also rated trials according to whether they checked for or adjusted for these but, in the absence of consensus on how to pool cluster level data, we adopted a narrative approach to synthesizing the data, rather than a formal meta-analysis. MAIN RESULTS: We identified two trials which met our selection criteria. They included a total of 976 smokers. Both trials were set in the UK and involved a training intervention which included the Stages of Change Model; they then compared a support programme involving counselling and record keeping against a control receiving usual pharmacy support. In both studies a high proportion of intervention and control participants began using NRT. Both studies reported smoking cessation outcomes at three time points. However, the follow-up points were not identical (three, six and 12 months in one, and one, four and nine months in the other), and the trend in abstinence over time was not linear in either study, so the data could not be combined. One study showed a significant difference in self-reported cessation rates at 12 months: 14.3% versus 2.7% (p < 0.001); the other study showed a positive trend at each follow-up with 12.0% versus 7.4% (p = 0.09) at nine months. REVIEWER'S CONCLUSIONS: The limited number of studies to date suggests that trained community pharmacists, providing a counselling and record keeping support programme for their customers, may have a positive effect on smoking cessation rates. The strength of evidence is limited because only one of the trials showed a statistically significant effect.

Women's knowledge of and attitudes towards hormone replacement therapy.

BACKGROUND: Hormone replacement therapy (HRT) could benefit women who have reached the natural menopause, have had a hysterectomy or have a family history of osteoporosis. OBJECTIVE: Our aim was to monitor changes in women's knowledge of, and attitudes towards, HRT since 1991. METHODS: The study was a repeat of a postal survey conducted in 1991 in the Grampian region in the North East of Scotland. Six hundred women, aged 20-69 years, were selected randomly from the eight Local Health Care Co-operatives in Grampian, Scotland. The main outcome measures were women's knowledge of HRT, their attitudes towards it and the percentage of users, past users and never users within the sample. RESULTS: A 79% response rate was achieved. Overall, 17% of post-menopausal women were current takers (increased from 9% in 1991), 22% were previous takers (increased from 7%) and 61% were never takers (decreased from 84%). This increase in ever use of HRT was more pronounced in the less educated women (increase of 24% since 1991) compared with the more educated (increase of 13%). Almost half (48%) of post-menopausal women had considered taking HRT (25% increase). However, of never users, the majority (86%) had never considered HRT and had not discussed it with a doctor. Attitudes towards the menopause remained positive, although knowledge of the effects of HRT and of risk factors for osteoporosis had decreased. Forty-two per cent of never users would be persuaded to take HRT if they knew it would not cause any problems, and 52% would be persuaded to take HRT on the recommendation of a doctor. CONCLUSIONS: Since 1991, HRT use increased overall; this increase was greater in the less educated women. However, the majority of post-menopausal women remain never users, and many were unaware of HRT. Conflicting research evidence since 1991 on the risks and benefits of HRT may account for the decrease in the women's knowledge of the effects of HRT.

General practice management of illicit drug users in Scotland: a national survey.

AIMS: To describe the level of involvement of general practitioners (GPs) in the management of illicit drug dependency; nature of current practice in the management of illicit drug dependency; influence of guidelines on practice; GP training experience and needs; and to consider the policy implications of the findings. DESIGN: A cross-sectional postal questionnaire survey. SETTING: General practice in Scotland. PARTICIPANTS: A 1 : 4 randomized sample (n = 926) of general practice principals, stratified according to age, gender and number of practice partners. MEASUREMENTS: A structured postal questionnaire. FINDINGS: A 63% response rate was achieved after two reminders (n = 583). Sixty per cent of respondents treated drug users, 51.5% provided methadone maintenance but only 58% used doses in the recommended range. Maintenance prescribing of dihydrocodeine and benzodiazepines was provided by 24% and 44.8% of respondents, respectively. While 79.3% had received the national clinical guidelines only 22.5% believed this had influenced their practice. Only a third of respondents had received drug dependency training. Beliefs about whether prescribing for drug misusers is part of a GPs professional remit was split. CONCLUSIONS: There was relatively high involvement with drug users, with methadone maintenance being the most common treatment provided. Maintenance prescribing of dihydrocodeine and benzodiazepines were common despite a lack of clinical evidence supporting the effectiveness of these treatments. This may reflect the nature of the presenting drug problems and highlights the difficulties some GPs may face in managing multiple drug dependencies within current guidelines. Further local training to implement guidelines along with trials of alternative treatments currently outwith guidelines should be considered.

Community pharmacy services for drug misusers in Scotland: what difference does 5 years make?

AIMS: To assess current levels of participation of community pharmacists in needle exchange provision, assess participation in dispensing any drugs for drug misuse, explore methadone dispensing practice, assess involvement in health promotion for drug misusers, assess levels of training in drug misuse and compare all of the above with data from 5 years previously. DESIGN: A cross-sectional postal questionnaire. SETTING: All community pharmacies in Scotland (n = 1162). PARTICIPANTS: A total of 969 pharmacists managing community pharmacies on a day-to-day basis (response rate 83.4%). MEASUREMENTS: Descriptive data were collected on demography, drug misuse services provided and training. Data were combined with a dataset from an identical survey conducted 5 years previously for statistical comparison. RESULTS: Levels of needle exchange provision has not changed significantly (9.7% in 2000 compared to 8.6% in 1995). Of all respondents, 71.5% now dispense drug for the management of drug misuse, 68.9% dispense methadone and 56.7% provide a supervised methadone consumption service. The number of methadone clients receiving methadone through pharmacies has increased from 3387 in 1995 to 8792 in 2000 and the mean number of clients dispensed methadone per pharmacy has increased from 7.3 in 1995 to 13.2 in 2000; 65.1% of all methadone clients now consume their methadone under pharmacist supervision. The proportion of pharmacists dispensing methadone who provide a supervised consumption service has increased significantly from 37% to 82.8%. Considerable changes in pharmacy practice are evident with significant increases in the number of pharmacists who always lay down ground rules, ask for identification on first visits, make up prescriptions in advance and provide verbal advice and leaflets on the management of drug misuse. Training in drug misuse doubled from 31.8% to 66.8%. CONCLUSIONS: Community pharmacy involvement with drug misusers has increased dramatically in the last 5 years. However, this increase is largely in methadone dispensing and supervision. Pharmacists appear to be more proactive in providing advice and information, perhaps as a result of greater training.

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK.

PURPOSE: The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies. METHOD: Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization. RESULTS: A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p = 0.0006 and 8.8 vs. 5.8%, p = 0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms. CONCLUSION: Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-up rates.

Educational strategies to promote evidence-based community pharmacy practice: a cluster randomized controlled trial (RCT).

BACKGROUND: Community pharmacists have increasing involvement in the self-management of minor illness as a result of the availability of a wider range of over-the-counter (OTC) medicines. We undertook a randomized controlled trial (RCT) to assess the effectiveness and efficiency of educational strategies to implement evidence-based guidelines for the sale of OTC anti-fungals in the community pharmacy setting. OBJECTIVE: The aim of the study was to compare the effectiveness and efficiency of two guideline dissemination strategies in community pharmacy settings. METHODS: A 2 x 2 factorial, cluster RCT was conducted with 60 community pharmacies in the Grampian region of Scotland. The interventions included dissemination of an evidence-based guideline for OTC management of vulvovaginal candidiasis (thrush) by postal dissemination (control), educational outreach visit or attendance at a continuing professional education session. Pre- and post-intervention simulated patient visits were made to participating pharmacies. The simulated patients completed assessment forms following each visit. The primary outcome was the appropriateness (based upon the guidelines) of sale or no sale of OTC anti-fungals. RESULTS: There were no significant differences in the proportion of appropriate outcomes following educational outreach [odds ratio (OR) = 1.1; 95% confidence interval (CI) 0.52 to 2.45] or continuing professional education (OR = 0.88; 95% CI 0.41 to 1.91). CONCLUSIONS: Neither strategy was effective in improving the appropriateness of OTC management of vulvovaginal candidiasis by community pharmacy staff. Further research is needed to identify barriers to guideline implementation and evidence-based practice in this setting.

The effect of folic acid supplementation on plasma homocysteine in an elderly population.

BACKGROUND: Increased plasma homocysteine is associated with coronary artery disease, peripheral vascular disease and venous thrombosis. Folic acid is the most effective therapy for reducing homocysteine levels. The lowest effective supplement of folic acid is not known, particularly for the elderly who have the highest prevalence of these conditions. AIM: To explore the effects of daily supplements of 0, 50, 100, 200, 400 and 600 microg folic acid on plasma homocysteine in an elderly population. DESIGN: Randomized double-blind placebo-controlled trial. METHODS: Participants (n=368) aged 65-75 years were randomly allocated to receive one of the treatments for 6 weeks. Plasma homocysteine was recorded after 3 weeks and 6 weeks of supplementation. RESULTS: Only the 400 microg and 600 microg groups had significantly lower homocysteine levels compared to placebo (p=0.038 and p<0.001, respectively). Using multiple linear regression and each individual's total folic acid intake (diet plus supplement), a total daily folic acid intake of 926 microg per day would be required to ensure that 95% of the elderly population would be without cardiovascular risk from folate deficiency. DISCUSSION: A daily folic acid intake of 926 microg is unlikely to be achieved by diet alone. Individual supplementation or fortification of food with folic acid will be required to reach this target.

Long term follow-up studies of users of nonprescription medicines purchased from community pharmacies: some methodological issues.

BACKGROUND: Despite the wider availability of medicines to the general public, little is known about their safety when supplied without prescription. Pilot work has already tested 4 methods of recruiting users of ibuprofen purchased from community pharmacies. This paper describes the piloting of a fifth method (a shortened questionnaire), long term follow-up rates of all methods, consistency of reporting of ibuprofen use, and issues relating to possible comparison groups in pharmacovigilance studies. METHODS: A shortened version of a previously tested recruitment questionnaire was used. Eligible study participants were all users, aged over 17 years, purchasing ibuprofen from a research network of community pharmacies (n = 61) in Grampian, Scotland. Postal questionnaires were sent at I week and 2, 6 and 12 months irrespective of the method of recruitment. The follow-up questionnaires collected information about ibuprofen and other drug usage, symptoms and associated health service utilisation. RESULTS: The shortened form recruited 67% of people issued with a questionnaire. The overall 12-month follow-up rate was 67%, although there were important differences in the rates by method of recruitment. There was reasonable consistency in the reporting of use or non-use of ibuprofen at different follow-up times. In the 12 months after the index purchase, 17% of participants never used any ibuprofen (non-users) and 28% used it for more than 8 weeks in total (long term users). At 12 months, long term users were significantly more likely than short term users (< or =8 weeks total use) or non-users to have experienced dizziness, skin rash, itchy skin and wheeziness in the previous week. CONCLUSIONS: Our pilot work has confirmed the feasibility of recruiting, and following-up over prolonged periods, users of nonprescription medicines. Evidence of long term use of ibuprofen confirms the need for pharmacovigilance studies of this drug, although further work is required to identify a suitable comparison group in order to inform the interpretation of such investigations.