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1.  The Effectiveness of Community Action in Reducing Risky Alcohol Consumption and Harm: A Cluster Randomised Controlled Trial 
PLoS Medicine  2014;11(3):e1001617.
In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.
Background
The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.
Methods and Findings
We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000–20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department–based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001–2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = −3.37 to −0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.
Conclusions
This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000123448
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People have consumed alcoholic beverages throughout history, but alcohol use is now an increasing global public health problem. According to the World Health Organization's 2010 Global Burden of Disease Study, alcohol use is the fifth leading risk factor (after high blood pressure and smoking) for disease and is responsible for 3.9% of the global disease burden. Alcohol use contributes to heart disease, liver disease, depression, some cancers, and many other health conditions. Alcohol also affects the well-being and health of people around those who drink, through alcohol-related crimes and road traffic crashes. The impact of alcohol use on disease and injury depends on the amount of alcohol consumed and the pattern of drinking. Most guidelines define long-term risky drinking as more than four drinks per day on average for men or more than two drinks per day for women (a “drink” is, roughly speaking, a can of beer or a small glass of wine), and short-term risky drinking (also called binge drinking) as seven or more drinks on a single occasion for men or five or more drinks on a single occasion for women. However, recent changes to the Australian guidelines acknowledge that a lower level of alcohol consumption is considered risky (with lifetime risky drinking defined as more than two drinks a day and binge drinking defined as more than four drinks on one occasion).
Why Was This Study Done?
In 2010, the World Health Assembly endorsed a global strategy to reduce the harmful use of alcohol. This strategy emphasizes the importance of community action–a process in which a community defines its own needs and determines the actions that are required to meet these needs. Although community action is highly acceptable to community members, few studies have looked at the effectiveness of community action in reducing risky alcohol consumption and alcohol-related harm. Here, the researchers undertake a cluster randomized controlled trial (the Alcohol Action in Rural Communities [AARC] project) to quantify the effectiveness of community action in reducing risky alcohol consumption and harms in rural communities in Australia. A cluster randomized trial compares outcomes in clusters of people (here, communities) who receive alternative interventions assigned through the play of chance.
What Did the Researchers Do and Find?
The researchers pair-matched 20 rural Australian communities according to the proportion of their population that was Aboriginal (rates of alcohol-related harm are disproportionately higher among Aboriginal individuals than among non-Aboriginal individuals in Australia; they are also higher among young people and males, but the proportions of these two groups across communities was comparable). They randomly assigned one member of each pair to the experimental group and implemented 13 interventions in these communities by negotiating with key individuals in each community to define and implement each intervention. Examples of interventions included general practitioner training in screening for alcohol use disorders and in implementing a brief intervention, and a school-based interactive session designed to reduce alcohol harm among young people. The researchers quantified the effectiveness of the interventions using routinely collected data on alcohol-related crime and road traffic crashes, and on hospital inpatient admissions for alcohol dependence or abuse (which were expected to increase in the experimental group if the intervention was effective because of more people seeking or being referred for treatment). They also examined drinking habits and experiences of alcohol-related harm, such as verbal abuse, among community members using pre- and post-intervention surveys. After implementation of the interventions, the rates of alcohol-related crime, road traffic crashes, and hospital admissions, and of risky and hazardous/harmful alcohol consumption (measured using a validated tool called the Alcohol Use Disorders Identification Test) were not statistically significantly different in the experimental and control communities (a difference in outcomes that is not statistically significantly different can occur by chance). However, the reported average weekly consumption of alcohol was 20% lower in the experimental communities after the intervention than in the control communities (equivalent to 1.9 fewer standard drinks per week per respondent) and there was less alcohol-related verbal abuse post-intervention in the experimental communities than in the control communities.
What Do These Findings Mean?
These findings provide little evidence that community action reduced risky alcohol consumption and alcohol-related harms in rural Australian communities. Although there was some evidence of significant reductions in self-reported weekly alcohol consumption and in experiences of alcohol-related verbal abuse, these findings must be interpreted cautiously because they are based on surveys with very low response rates. A larger or differently designed study might provide statistically significant evidence for the effectiveness of community action in reducing risky alcohol consumption. However, given their findings, the researchers suggest that legislative approaches that are beyond the control of individual communities, such as alcohol taxation and restrictions on alcohol availability, may be required to effectively reduce alcohol harms. In other words, community action alone may not be the most effective way to reduce alcohol-related harm.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001617.
The World Health Organization provides detailed information about alcohol; its fact sheet on alcohol includes information about the global strategy to reduce the harmful use of alcohol; the Global Information System on Alcohol and Health provides further information about alcohol, including information on control policies around the world
The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health
The US Centers for Disease Control and Prevention has a website on alcohol and public health that includes information on the health risks of excessive drinking
The UK National Health Service Choices website provides detailed information about drinking and alcohol, including information on the risks of drinking too much, tools for calculating alcohol consumption, and personal stories about alcohol use problems
MedlinePlus provides links to many other resources on alcohol
More information about the Alcohol Action in Rural Communities project is available
doi:10.1371/journal.pmed.1001617
PMCID: PMC3949675  PMID: 24618831
2.  Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial 
BMC Public Health  2013;13:152.
Background
There is strong evidence to support the effectiveness of Brief Intervention (BI) in reducing alcohol consumption in primary healthcare.
Methods and design
This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older) will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours) on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT) administered by telephone.
Discussion
The UK Department of Health’s stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design.
Trial registration
Current Controlled Trials ISRCTN95216873
doi:10.1186/1471-2458-13-152
PMCID: PMC3583737  PMID: 23419053
Alcohol; Brief intervention; Community pharmacist; Community pharmacy; Hazardous and harmful drinking
3.  The feasibility and acceptability of the provision of alcohol screening and brief advice in pharmacies for women accessing emergency contraception: an evaluation study 
BMC Public Health  2014;14:1139.
Background
It is widely accepted that excessive drinking contributes to both health and social problems. There has been considerable interest in the potential of community pharmacies as a setting for health advice, and evidence suggests that interventions by pharmacists can be effective. Research on interventions relating to alcohol consumption in primary care has focused on general practice, and although some evidence exists about the efficacy of pharmacy interventions, little research to date has taken place in the UK. The aim of this study was to evaluate the acceptability of alcohol screening and brief interventions to women accessing emergency hormonal contraception (EHC) in community pharmacies.
Methods
An initiative whereby women who accessed community pharmacies for EHC would be asked to complete an AUDIT questionnaire following their EHC consultation was introduced by a Primary Care Trust (PCT) in the North-East of England. The evaluation incorporated three strands: interviewing pharmacists (n = 14) about the implementation and acceptability of the initiative; interviewing clients (n = 22) identified as “low risk” to understand their perceptions of the initiative; conducting online follow-up surveys with clients in the “risky” group (n = 53) to evaluate the impact of the initiative on their alcohol consumption and contraceptive behaviour, as well as their perceptions of the service.
Results
Pharmacists’ attitudes towards screening were generally positive, although there were organisational obstacles to providing the service. Some felt uncertain about engaging clients in conversation about a sensitive topic. However, clients themselves did not report feeling embarrassed or upset, and most were happy to talk to the pharmacist and be given advice. Most clients felt that the pharmacist was an appropriate person to carry out alcohol screening and advice.
Conclusions
It is feasible for pharmacists to carry out screening and brief advice, and most customers find it acceptable. However, pharmacist take-up of the service and participation in the study was low. Pharmacists were enthusiastic about providing screening and other health promotion services; targeting different population groups for alcohol screening may be more successful. Delivery of the AUDIT tool by pharmacists may not obtain reliable responses from some specific client groups.
doi:10.1186/1471-2458-14-1139
PMCID: PMC4240821  PMID: 25369791
Alcohol brief intervention; Community pharmacy; Women; AUDIT questionnaire; Emergency contraception; UK
4.  A Randomized Trial Evaluating Two Approaches for Promoting Pharmacy-Based Referrals to the Tobacco Quitline: Methods and Baseline Findings 
Background
Historically, community pharmacies have not integrated tobacco cessation activities into routine practice, instead unbundling them as unique services. This approach might have limited success and viability.
Objective
The objective of this report is to describe the methods and baseline findings for a two-state, randomized trial evaluating two intervention approaches for increasing pharmacy-based referrals to their state’s tobacco quitline.
Methods
Participating community pharmacies in Connecticut (n=32) and Washington (n=32) were randomized to receive either (a) on-site education with an academic detailer, describing methods for implementing brief interventions with patients and providing referrals to the tobacco quitline, or (b) quitline materials delivered by mail. Both interventions advocated for pharmacy personnel to ask about tobacco use, advise patients who smoke to quit, and refer patients to the tobacco quitline for additional assistance with quitting. Study outcome measures include the number of quitline registrants who are referred by pharmacies (before and during the intervention period), the number of quitline materials distributed to patients, and self-reported behavior of cessation counseling and quitline referrals, assessed using written surveys completed by pharmacy personnel (pharmacists, technicians).
Results
Pharmacists (n=124) and pharmacy technicians (n=127), representing 64 participating pharmacies with equal numbers of retail chain and independently-owned pharmacies, participated in the study. Most pharmacists (67%) and half of pharmacy technicians (50%) indicated that they were “not at all” familiar with the tobacco quitline. During the baseline (pre-intervention) monitoring period, the quitline registered 120 patients (18 in CT and 102 in WA) who reported that they heard about the quitline from a pharmacy.
Conclusion
Novel tobacco intervention approaches are needed to capitalize on the community pharmacy’s frequent interface with tobacco users, and these approaches need to be evaluated to estimate their effectiveness. Widespread implementation of brief, yet feasible, pharmacy-based tobacco cessation efforts that generate referrals to a tobacco quitline could have a substantial impact on the prevalence of tobacco use.
doi:10.1016/j.sapharm.2012.03.001
PMCID: PMC3428501  PMID: 22554394
Tobacco; tobacco cessation; smoking; smoking cessation; pharmacist; community pharmacy; quitline; brief intervention
5.  Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomised controlled trial in Scotland 
Tobacco Control  1998;7(3):253-261.
OBJECTIVE—To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model.
DESIGN—A randomised controlled trial of community pharmacies and pharmacy customers.
SETTING—All 76 non-city community pharmacies registered in Grampian, Scotland, were invited to participate. Sixty-two pharmacies (82%) were recruited.
SUBJECTS—All the intervention pharmacy personnel were invited to attend the training; 40 pharmacists and 54 assistants attended. A total of 492 customers who smoked (224 intervention, 268 controls) were recruited during the 12-month recruitment period (overall recruitment rate 63%).
MAIN OUTCOME MEASURES—The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one, four, and nine months.
RESULTS—The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel, 85% (113) compared with 62% (99) of the controls (p<0.001). The former also rated their discussion more highly; 34% (45) of the intervention customers compared with 16% (25) of the controls rated it as "very useful" (p = 0.048). Assuming non-responders had lapsed, one-month point prevalence of abstinence was claimed by 30% of intervention customers and 24% of controls (p = 0.12); four months' continuous abstinence was claimed by 16% of intervention customers and 11% of controls (p = 0.094); and nine months' continuous abstinence was claimed by 12% of intervention customers and 7% of controls (p = 0.089). These trends in outcome were not affected by potential confounders (sex, age, socioeconomic status, nicotine dependence, and type of nicotine replacement product used) or adjustment for clustering.
CONCLUSIONS—The intervention was associated with increased and more highly rated counselling, and a trend toward higher smoking cessation rates, indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets.


Keywords: community pharmacy; health education; smoking cessation
PMCID: PMC1763872  PMID: 9825420
6.  ‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial 
Trials  2013;14:217.
Background
Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT).
Methods/Design
A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT.
Discussion
This work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.
Trial registration
Current Controlled Trials ISRCTN43606442
doi:10.1186/1745-6215-14-217
PMCID: PMC3721993  PMID: 23856015
Respiratory; Allergy; Community pharmacy; Self-care
7.  A community based approach to linking injection drug users with needed services through pharmacies: An evaluation of a pilot intervention in New York City 
Studies suggest that community-based approaches could help pharmacies expand their public health role, particularly pertaining to HIV prevention. Thirteen pharmacies participating in New York’s Expanded Syringe Access Program, which permits non-prescription syringe sales to reduce syringe-sharing among injection drug users (IDUs), were enrolled in an intervention to link IDU syringe customers to medical/social services. Sociodemographics, injection practices, beliefs about and experiences with pharmacy use, and medical/social service utilization were compared among 29 IDUs purchasing syringes from intervention pharmacies and 66 IDUs purchasing syringes from control pharmacies using chi-square tests. Intervention IDUs reported more positive experiences in pharmacies than controls; both groups were receptive to a greater public health pharmacist role. These data provide evidence that CBPR aided in the implementation of a pilot structural intervention to promote understanding of drug use and HIV prevention among pharmacy staff, and facilitated expansion of pharmacy services beyond syringe sales in marginalized, drug-using communities.
doi:10.1521/aeap.2010.22.3.238
PMCID: PMC2883795  PMID: 20528131
Community Based Participatory Research; Structural Intervention; Harm Reduction; Pharmacies; HIV Prevention; Injection Drug Use
8.  Pharmacy access to syringes among injecting drug users: follow-up findings from Hartford, Connecticut. 
Public Health Reports  1998;113(Suppl 1):81-89.
OBJECTIVE: To break the link between drug use and the human immunodeficiency virus (HIV), in 1992 the state of Connecticut rescinded a 14-year ban on pharmacy sales of syringes without a physician's prescription. In 1993, the Center for Disease Control and Prevention (CDC) evaluated the impact of the new legislation on access to syringes among injecting drug users (IDUs) and found an initial pattern of expanded access. However, it also found that some pharmacies, after negative experiences with IDU customers, reverted to requiring a prescription. This chapter reports findings from a four-year follow-up study of current IDU access to over-the-counter (OTC) pharmacy syringes in Hartford, Connecticut. METHODS: Through structured interviews, brief telephone interviews, and mailed surveys, data on nonprescription syringe sale practices were collected on 27 pharmacies, including 18 of the 21 pharmacies in Hartford and none from pharmacies in contiguous towns, during June and July 1997. Interview data on pharmacy syringe purchase from two sample of IDUs, a group of out-of-treatment injectors recruited through street outreach, and a sample of users of the Hartford Needle Exchange Program, also are reported. RESULTS: The study found that, while market trends as well as negative experiences have further limited pharmacy availability of nonprescription syringes, pharmacies remain an important source of sterile syringes for IDUs. However, the distribution of access in not even; in some areas of the city it is much easier to purchase nonprescription syringes than in other. All of the seven pharmacies located on the north end of Hartford reported that they had a policy of selling OTC syringes, whereas only six (54.5%) of the II pharmacies located on the south end have such a policy. Overt racial discrimination was not found to be a barrier to OTC access to syringes. CONCLUSIONS: To further decrease acquired immunodeficiency syndrome (AIDS) risk among IDUs, there is a need for public education to counter empirically unsupported stereotypes about IDUs that diminish their access to health care and AIDS prevention resources and services. In states or cities where pharmacy sale of nonprescription syringes is illegal, policy makers should examine the benefits of removing existing barriers to sterile syringe acquisition. In cases in which pharmacy sale of nonprescription syringes is legal, local health departments should implement educational programs to inform pharmacy staff and management about the critically important role low-cost (or cost-free), sterile syringe access can play in HIV prevention.
PMCID: PMC1307730  PMID: 9722813
9.  Patient and practitioner characteristics predict brief alcohol intervention in primary care. 
BACKGROUND: The effectiveness of an evidence-based health care intervention depends on it being delivered consistently to appropriate patients. Brief alcohol intervention is known to be effective at reducing excessive drinking and its concomitant health and social problems. However, a recent implementation trial reported partial delivery of brief alcohol intervention by general practitioners (GPs) which is likely to have reduced its impact. AIM: To investigate patient-practitioner characteristics influencing brief alcohol intervention in primary care. DESIGN OF STUDY: Cross-sectional analysis of 12,814 completed Alcohol Use Disorders Identification Test (AUDIT) screening questionnaires. SETTING: Eighty-four GPs who had implemented a brief alcohol intervention programme in a previous trial based in the Northeast of England. METHOD: GPs were requested to screen all adults (aged over 16 years) presenting to their surgery and follow a structured protocol to give a brief intervention (five minutes of advice plus an information booklet) to all 'risk' drinkers. Anonymized carbon copies of the screening questionnaire were collected from all practices after a three-month implementation period. RESULTS: Although AUDIT identified 4080 'risk' drinkers, only 2043 (50%) received brief intervention. Risk drinkers that were most likely to receive brief intervention were males (58%), unemployed (61%), and technically-trained patients (55%). Risk drinkers that were least likely to receive brief intervention were females (44%), students (38%), and university educated patients (46%). Logistic regression modelling showed that patients' risk status was the most influential predictor of brief intervention. Also, GPs' experience of relevant training and longer average practice consultations predicted brief intervention. However, personal characteristics relating to patients and GPs also predicted brief intervention in routine practice. CONCLUSION: Interpersonal factors relating to patients and practitioners contributed to the selective provision of brief alcohol intervention in primary care. Ways should be found to remedy this situation or the impact of this evidence-based intervention may be reduced when implemented in routine practice.
PMCID: PMC1314128  PMID: 11677706
10.  Recruitment of community pharmacies in a randomized trial to generate patient referrals to the tobacco quitline 
Background
Community pharmacies have the potential to reduce the prevalence of tobacco use, yet most pharmacies do not integrate cessation activities into routine practice. Acquiring participation of community pharmacies is difficult. Strategies detailing requirements by researchers to elicit such participation have not been established.
Objectives
The objective of this study was to describe the recruitment strategy and participant yield for a two-state, randomized trial evaluating two intervention approaches for increasing pharmacy-based referrals to tobacco quitlines.
Methods
Detailed study recruitment tracking forms were used to document all contact attempts between the study investigators and each potential study site. These data were analyzed to characterize the overall recruitment and consent process for community pharmacies and pharmacy personnel (pharmacists, technicians).
Results
Achieving the target sample size of 64 study sites required contacting a total of 150 pharmacies (84 independent and 66 chain). Excluding 22 ineligible pharmacies, participation rates were 49% (32 of 65) for independent pharmacies and 51% (32 of 63) for chain pharmacies (50% overall). Across the 64 participating pharmacies, a total of 124 pharmacists (of 171; 73%) and 127 pharmacy technicians (of 215; 59%) were enrolled in the study. Pharmacies that chose not to participate most often cited time constraints as the primary reason. Overall, combining both the recruitment and consent process, a median of 5 contacts were made with each participating pharmacy (range, 2–19; IQR, 4–7), and the median overall duration of time elapsed from initial contact to consent was 25 days (range, 3–122 days; IQR, 12–47 days).
Conclusions
Results from this study suggest that pharmacy personnel are willing to provide brief tobacco cessation interventions in a community pharmacy setting and are receptive to participation in multi-site clinical research trials. However, execution of a representative sampling and recruitment scheme for a multi-state study in this practice setting is a time and labor intensive process.
doi:10.1016/j.sapharm.2012.06.001
PMCID: PMC3554859  PMID: 22841641
Tobacco; tobacco cessation; smoking; smoking cessation; pharmacist; community pharmacy; quitline; brief intervention
11.  Community pharmacy interventions for public health priorities: protocol for a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions 
Systematic Reviews  2014;3:93.
Background
Community pharmacists can deliver health care advice at an opportunistic level, related to prescription or non-prescription medicines and as part of focused services designed to reduce specific risks to health. Obesity, smoking and excessive alcohol intake are three of the most significant modifiable risk factors for morbidity and mortality in the UK, and interventions led by community pharmacists, aimed at these three risk factors, have been identified by the government as public health priorities. In 2008, the Department of Health for England stated that ‘a sound evidence base that demonstrates how pharmacy delivers effective, high quality and value for money services is needed’; this systematic review aims to respond to this requirement.
Methods/design
We will search the databases MEDLINE, Embase, CINAHL, PsycINFO, Social Sciences Citation Index, ASSIA, IBSS, Sociological Abstracts, Scopus and NHS Economic Evaluation Database for studies that have evaluated interventions based on community pharmacies that aim to target weight management, smoking cessation and alcohol misuse. We will include all randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after studies (CBAs) and interrupted time series (ITS) and repeated measures studies. Data from included studies will be extracted by two independent reviewers and will include study details methods, results, intervention implementation/costs and methodological quality. Meta-analysis will be conducted if appropriate; if not, the synthesis will be restricted to a narrative overview of individual studies looking at the same question.
Discussion
The review aims to summarise the evidence base on the effectiveness of community pharmacy interventions on health and health behaviours in relation to weight management, smoking cessation and alcohol misuse. It will also explore if, and how, socio-economic status, gender, ethnicity and age moderate the effect of the interventions and will describe how the interventions included in the review have been organised, implemented and delivered, since context is an important factor governing the success of public health interventions. The findings from this review will have an impact on the commissioning of public health services aiming to promote healthy weight, smoking cessation and prevent excessive alcohol consumption.
Systematic review registration
The review has been registered with PROSPERO (registration no. CRD42013005943). Available at: http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42013005943.
doi:10.1186/2046-4053-3-93
PMCID: PMC4145162  PMID: 25145710
Systematic review; Public health; Interventions; Community pharmacy; Obesity; Weight management; Smoking cessation; Alcohol misuse
12.  Impact of a passive social marketing intervention in community pharmacies on oral contraceptive and condom sales: a quasi-experimental study 
BMC Public Health  2015;15:143.
Background
Almost 50% of pregnancies in the United States are unwanted or mistimed. Notably, just over one-half of unintended pregnancies occurred when birth control was being used, suggesting inappropriate or poor use or contraceptive failure. About two-thirds of all women who are of reproductive age use contraceptives, and oral hormonal contraceptives remain the most common contraceptive method. Often, contraceptive products are obtained in community pharmacies. The purpose of this study was to determine whether a pharmacy-based intervention would impact sales of contraceptive products in pharmacies.
Methods
This study was conducted in Iowa and used a quasi-experimental design including 55 community pharmacies (independent and grocery) in 12 counties as the intervention and 32 grocery pharmacies in 10 counties as a comparison group. The passive intervention was focused towards 18–30 year old women who visited community pharmacies and prompted those of childbearing age to “plan your pregnancy” and “consider using birth control”. The intervention was delivered via educational tri-fold brochures, posters and ‘shelf talkers.’ Data sources for evaluation were contraceptive sales from intervention and comparison pharmacies, and a mixed negative binomial regression was used with study group*time interactions to examine the impact of the intervention on oral contraceptive and condom sales. Data from 2009 were considered baseline sales.
Results
From 2009 to 2011, condom sales decreased over time and oral contraceptives sales showed no change. Overall, the units sold were significantly higher in grocery pharmacies than in independent pharmacies for both contraceptive types. In the negative binomial regression for condoms, there was an overall significant interaction between the study group and time variables (p = 0.003), indicating an effect of the intervention, and there was a significant slowing in the drop of sales at time 3 in comparison with time 1 (p < 0.001). There was a statistically significant association between pharmacy type and study group, where the independent intervention pharmacies had a higher proportion of stores with increases in condom sales compared to grocery pharmacies in the intervention or comparison group.
Conclusions
A passive community pharmacy-based public health intervention appeared to reduce the decrease in condom sales from baseline, particularly in independent pharmacies, but it did not impact oral contraceptive sales.
doi:10.1186/s12889-015-1495-x
PMCID: PMC4340340  PMID: 25885775
Unintended pregnancy; Community pharmacy; Condoms; Oral contraceptives
13.  GP-led services for alcohol misuse: the Fresh Start Clinic 
Key messages
A dedicated alcohol service, such as the Fresh Start Clinic, within the primary care setting is more likely to produce better results than patients being treated without a pre-agreed structured treatment plan in primary care. A dedicated alcohol service, such as the Community Alcohol Team (CAT) which is a consultant-led service and based in secondary care is better placed to treat patients with more complex needs. Up to 40% of all referrals to the CAT could be managed within the Fresh Start model.The Fresh Start Clinic removes the stigma attached to alcohol misuse and offers anonymity in a primary care setting.Daily attendance and breathalysing offer containment and its current location aids concordance with treatment.Aftercare is of paramount importance. Patients are seen daily during their period of detoxification, 7 days after and at 3 months. We run a weekly support group for patients who have completed their detoxification whilst waiting to engage with local support services, such as alcohol counselling offered by the third sector.
Why this matters to me
As a GP, I have an interest in mental health and substance misuse, and working with these patients is very rewarding. I particularly enjoy developing and growing new services. I discovered a great unmet need in our practice population and feel proud to have been able to transfer skills I have learnt in secondary care to primary care. The Fresh Start treatment model has improved the quality of life of a significant number of patients beyond expectations. The Fresh Start model would be very easy to implement elsewhere, and I find it hard to believe that this model has not been tried before as it appears to work well.
As an alcohol strategy lead within a PCT our biggest objective is engaging GPs in the alcohol harm reduction agenda both as clinicians and providers. Prior to commissioning the Fresh Start Clinic we surveyed GPs as to what role they wanted to play in the identification and treatment of alcohol use disorders. The key message we received was choice for both GP and patient. As a model, Fresh Start does not preclude GPs from directly treating alcohol misuse, but it offers them a safety net for those who are resistant in engaging in treatment within their own general practice. We believe fresh start is an important extension to that choice. The model has been discussed with each of our GP lead locality commissioning groups and with their support a Fresh Start clinic will operate within each of our GP commissioning clusters.
Background A growing number of patients are presenting to health services with alcohol misuse disorders. The challenge to the NHS is to deliver the most cost-effective treatment solutions for all forms of alcohol misuse disorders.
Setting NHS Wandsworth undertook a 12-month pilot to identify the most effective model for delivering treatment for alcohol dependency within the primary care setting.
Question What are the most effective models to treat patients with alcohol dependency in primary care?
Methods Model A: This was a locally enhanced services agreement (LES) agreement for screening, brief interventions and treatment. Practices were required to attend training in the management of alcohol withdrawal and had access to specialist nurse support. Model B: A GP-led clinic supported by a full-time specialist nurse prescriber. The clinic was promoted as the Fresh Start Clinic. It offers planned alcohol withdrawal within a pre-agreed structured treatment plan, and sign posts to after care.
Results There were 76 treatment episodes in the fresh start clinic compared with 6 recorded treatment episodes under the LES.
Fresh Start Clinic Waiting time to treatment is 7 days.We achieved a 100% completion rate.Patient satisfaction questionnaires confirmed positive patient experience.Twenty percent of patients completed questionnaires.Fifty seven percent abstinence at 3–6 months follow-up.Fifty percent improvement in mental well being as measured by Beck's Depression Inventory.Improvement in markers of dependency (GGT and MCV).The cost per treatment episode in the Fresh Start Clinic was significantly less.
Conclusions The Fresh Start Clinic offers clinically safe and cost-effective treatment to patients suffering from mild to moderate alcohol dependency in a primary care setting and offers choice to both GP's and patients.
PMCID: PMC3960667  PMID: 25949642
alcohol dependency; alcohol detoxification; assisted withdrawal; community treatment programme; Fresh Start Clinic
14.  The prevalence and experience of Australian naturopaths and Western herbalists working within community pharmacies 
Background
Naturopaths and Western herbal medicine (WHM) practitioners were surveyed to identify their extent, experience and roles within the community pharmacy setting and to explore their attitudes to integration of complementary medicine (CM) practitioners within the pharmacy setting.
Method
Practising naturopaths and WHM practitioners were invited to participate in an anonymous, self-administered, on-line survey. Participants were recruited using the mailing lists and websites of CM manufacturers and professional associations.
Results
479 practitioners participated. 24% of respondents (n = 111) reported they had worked in community pharmacy, three-quarters for less than 5 years. Whilst in this role 74% conducted specialist CMs sales, 62% short customer consultations, 52% long consultations in a private room and 51% staff education. This was generally described as a positive learning experience and many appreciated the opportunity to utilise their specialist knowledge in the service of both customers and pharmacy staff. 14% (n = 15) did not enjoy the experience of working in pharmacy at all and suggested pharmacist attitude largely influenced whether the experience was positive or not. Few practitioners were satisfied with the remuneration received. 44% of the total sample provided comment on the issue of integration into pharmacy, with the main concern being the perceived incommensurate paradigms of practice between pharmacy and naturopathy. Of the total sample, 38% reported that they would consider working as a practitioner in retail pharmacy in future.
Conclusions
The level of integration of CM into pharmacy is extending beyond the mere stocking of supplements. Naturopaths and Western Herbalists are becoming utilised in pharmacies
doi:10.1186/1472-6882-11-41
PMCID: PMC3128856  PMID: 21600060
15.  Feasibility and acceptability of a bar-based sexual risk reduction intervention for bar patrons in Tshwane, South Africa 
Sahara J  2014;11(1):1-9.
Abstract
Alcohol consumption is a recognised risk factor for HIV infection. Alcohol serving establishments have been identified as appropriate venues in which to deliver HIV prevention interventions. This paper describes experiences and lessons learnt from implementing a combined HIV prevention intervention in bar settings in one city- and one township-based bar in Tshwane, South Africa. The intervention consisted of peer-led and brief intervention counselling sub-components. Thirty-nine bar patrons were recruited and trained, and delivered HIV and alcohol risk reduction activities to their peers as peer interventionists. At the same time, nine counsellors received training and visited the bars weekly to provide brief motivational interviewing counselling, advice, and referrals to the patrons of the bars. A responsible server sub-component that had also been planned was not delivered as it was not feasible to train the staff in the two participating bars. Over the eight-month period the counsellors were approached by and provided advice and counselling for alcohol and sexual risk-related problems to 111 bar patrons. The peer interventionists reported 1323 risk reduction interactions with their fellow bar patrons during the same period. The intervention was overall well received and suggests that bar patrons and servers can accept a myriad of intervention activities to reduce sexual risk behaviour within their drinking settings. However, HIV- and AIDS-related stigma hindered participation in certain intervention activities in some instances. The buy-in that we received from the relevant stakeholders (i.e. bar owners/managers and patrons, and the community at large) was an important contributor to the feasibility and acceptability of the intervention.
doi:10.1080/17290376.2014.890123
PMCID: PMC4272098  PMID: 24750106
HIV prevention; bar-based intervention; server intervention; peer intervention; brief intervention; motivational interviewing; prévention VIH; intervention dans des bars; intervention des serveurs; intervention des pairs; brève intervention; entretien de motivation
16.  Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT): Design and Implementation 
Background
While the integration of alcohol screening, treatment and referral in primary care and other medical settings in the U.S. and world-wide has been recognized as a key health care priority, it is not routinely done. In spite of the high co-occurrence and excess mortality associated with alcohol use disorders (AUDs) among individuals with tuberculosis (TB), there are no studies evaluating effectiveness of integrating alcohol care into routine treatment for this disorder.
Methods
We designed and implemented a randomized controlled trial (RCT) to determine the effectiveness of integrating pharmacotherapy and behavioral treatments for AUDs into routine medical care for TB in the Tomsk Oblast Tuberculosis Service (TOTBS) in Tomsk, Russia. Eligible patients are diagnosed with alcohol abuse or dependence, are newly diagnosed with TB and initiating treatment in the TOTBS with Directly Observed Therapy-Short Course (DOTS) for TB. Utilizing a factorial design, the Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT) study randomizes eligible patients who sign informed consent into one of four study arms: (1) Oral Naltrexone + Brief Behavioral Compliance Enhancement Therapy (BBCET) + treatment as usual (TAU), (2) Brief Counseling Intervention (BCI) + TAU, (3) Naltrexone + BBCET + BCI + TAU, or (4) TAU alone.
Results
Utilizing an iterative, collaborative approach, a multi-disciplinary U.S. and Russian team has implemented a model of alcohol management that is culturally appropriate to the patient and TB physician community in Russia. Implementation to date has achieved the integration of routine alcohol screening into TB care in Tomsk; an ethnographic assessment of knowledge, attitudes and practices of AUD management among TB physicians in Tomsk; translation and cultural adaptation of the BCI to Russia and the TB setting; and training and certification of TB physicians to deliver oral naltrexone and brief counseling interventions for alcohol abuse and dependence as part of routine TB care. The study is successfully enrolling eligible subjects in the RCT to evaluate the relationship of integrating effective pharmacotherapy and brief behavioral intervention on TB and alcohol outcomes, as well as reduction in HIV risk behaviors.
Conclusions
The IMPACT study utilizes an innovative approach to adapt two effective therapies for treatment of alcohol use disorders to the TB clinical services setting in the Tomsk Oblast, Siberia, Russia and to train TB physicians to deliver state of the art alcohol pharmacotherapy and behavioral treatments as an integrated part of routine TB care. The proposed treatment strategy could be applied elsewhere in Russia and in other settings where TB control is jeopardized by AUDs. If demonstrated to be effective, this model of integrating alcohol interventions into routine TB care has the potential for expanded applicability to other chronic co-occurring infectious and other medical conditions seen in medical care settings.
doi:10.1111/j.1530-0277.2009.01094.x
PMCID: PMC2898509  PMID: 19930235
Alcohol use disorders; treatment; tuberculosis; naltrexone; brief counseling intervention
17.  Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England 
Trials  2013;14:411.
Background
Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions.
Methods/design
Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England.
Design: parallel group patient-level pragmatic randomized controlled trial.
Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine.
Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies.
Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders.
Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice.
Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice.
Sample size: 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate.
Discussion
At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken.
Trial registration
Current controlled trials: ISRCTN23560818
Clinical Trials US (clinicaltrials.gov): NCT01635361
doi:10.1186/1745-6215-14-411
PMCID: PMC4220816  PMID: 24289059
18.  Making a success of providing NHS Health Checks in community pharmacies across the Tees Valley: a qualitative study 
Background
In England and Wales, the Department of Health introduced a primary prevention programme, NHS Health Checks, to provide screening for cardiovascular risk amongst people aged 40-74. The aim of this programme is to offer treatment and advice to those identified with an increased risk of cardiovascular diseases (CVD).
The North East of England has some of the highest rates of CVD in the UK and prevention is therefore a priority. NHS Tees funded this programme of work under the local branding of Healthy Heart Checks (HHC). These were initially implemented principally through GP practices from October 2008 but, in order to mitigate the possibility that some hard to reach communities would be reluctant to engage with some primary care settings, plans were also developed to deliver the programme through workplace settings and through community pharmacies. This paper reports specifically on the findings from the evaluation in respect of the setting up of HHCs in community pharmacies and aims to offer some lessons for other service settings where this option is seen as a way of providing low threshold services which will minimise inequalities in intervention uptake.
Methods
In assessing the community pharmacy component of HHCs, a selection of staff having direct involvement in the process was invited to take part in the evaluation. Interviews were carried out with representatives from community pharmacy, staff members from the commissioning Primary Care Trusts and with Local Pharmaceutical Committee members.
Results
Evaluation and analysis identified challenges which should be anticipated and addressed in initiating HHC in community pharmacies. These have been categorised into four main themes for discussion in this paper: (1) establishing and maintaining pharmacy Healthy Heart Checks, (2) overcoming IT barriers, (3) developing confident, competent staff and (4) ensuring volume and through flow in pharmacy.
Conclusions
Delivering NHS health checks through community pharmacies can be a complex process, requiring meticulous planning, and may incur higher than expected costs. Findings from our evaluation provide insight into possible barriers to setting up services in pharmacies which may help other commissioning bodies when considering community pharmacy as a location for primary prevention interventions in future.
doi:10.1186/1472-6963-11-222
PMCID: PMC3182894  PMID: 21929809
19.  A qualitative study of anticipated barriers and facilitators to the implementation of nurse-delivered alcohol screening, brief intervention, and referral to treatment for hospitalized patients in a Veterans Affairs medical center 
Background
Unhealthy alcohol use includes the spectrum of alcohol consumption from risky drinking to alcohol use disorders. Routine alcohol screening, brief intervention (BI) and referral to treatment (RT) are commonly endorsed for improving the identification and management of unhealthy alcohol use in outpatient settings. However, factors which might impact screening, BI, and RT implementation in inpatient settings, particularly if delivered by nurses, are unknown, and must be identified to effectively plan randomized controlled trials (RCTs) of nurse-delivered BI. The purpose of this study was to identify the potential barriers and facilitators associated with nurse-delivered alcohol screening, BI and RT for hospitalized patients.
Methods
We conducted audio-recorded focus groups with nurses from three medical-surgical units at a large urban Veterans Affairs Medical Center. Transcripts were analyzed using modified grounded theory techniques to identify key themes regarding anticipated barriers and facilitators to nurse-delivered screening, BI and RT in the inpatient setting.
Results
A total of 33 medical-surgical nurses (97% female, 83% white) participated in one of seven focus groups. Nurses consistently anticipated the following barriers to nurse-delivered screening, BI, and RT for hospitalized patients: (1) lack of alcohol-related knowledge and skills; (2) limited interdisciplinary collaboration and communication around alcohol-related care; (3) inadequate alcohol assessment protocols and poor integration with the electronic medical record; (4) concerns about negative patient reaction and limited patient motivation to address alcohol use; (5) questionable compatibility of screening, BI and RT with the acute care paradigm and nursing role; and (6) logistical issues (e.g., lack of time/privacy). Suggested facilitators of nurse-delivered screening, BI, and RT focused on provider- and system-level factors related to: (1) improved provider knowledge, skills, communication, and collaboration; (2) expanded processes of care and nursing roles; and (3) enhanced electronic medical record features.
Conclusions
RCTs of nurse-delivered alcohol BI for hospitalized patients should include consideration of the following elements: comprehensive provider education on alcohol screening, BI and RT; record-keeping systems which efficiently document and plan alcohol-related care; a hybrid model of implementation featuring active roles for interdisciplinary generalists and specialists; and ongoing partnerships to facilitate generation of additional evidence for BI efficacy in hospitalized patients.
doi:10.1186/1940-0640-7-7
PMCID: PMC3533719  PMID: 23186245
Alcohol consumption; Alcoholism; Inpatients; Nursing; Nurses; Implementation; Screening; Counseling; Qualitative research; Focus groups
20.  Effects of a Brief Intervention for Reducing Violence and Alcohol Misuse Among Adolescents: A Randomized Trial 
Context
The Emergency Department (ED) visit presents an opportunity to deliver brief interventions (BIs) to reduce violence and alcohol misuse among urban adolescents at risk for future injury.
Objectives
To determine the efficacy of BIs addressing violence and alcohol among adolescents presenting to an urban ED.
Design, Setting, and Participants
Patients (ages 14–18; 12 pm–11 pm; 7 days/week) at a Level 1 ED in Flint, MI, completed a computerized survey. Adolescents reporting past year alcohol use and aggression were enrolled in a randomized trial (SafERteens) which included: a computerized baseline assessment, randomization to a control group, or a 35-minute brief intervention delivered by a computer or therapist in the ED, and follow-up assessments at 3 and 6 months.
Intervention
Combining motivational interviewing with skills training, the BI for violence and alcohol included: review of goals, tailored feedback, decisional balance exercise, role plays, and referrals.
Main Outcome Measures
Self-report measures included peer aggression and violence, violence consequences, alcohol use, binge drinking, alcohol consequences.
Results
3338 adolescents were screened (n=446, 12% refused): 1452 (43.5%) male; 1866 (55.9%) African-American. Of those, 829 (24.8%) screened positive for both alcohol and violence; 726 were randomized. As compared to the control, participants in the therapist intervention showed self-reported reductions in the occurrence of peer aggression (−34.3% therapist, −16.4% control; RR=0.74, CI=0.61–0.90), experience of peer violence (10.4% therapist, +4.7% control; RR=0.70, CI=0.52–0.95), and violence consequences (30.4% therapist, −13.0% control; RR=0.76, CI=0.64–0.90) at three months. At 6 months, participants in the therapist intervention showed self-reported reductions in peer aggression (−37.7% therapist, −28.4% control; RR=0.85, CI=0.68–1.06) and alcohol consequences (−32.2% therapist, −17.5% control; RR=0.56, CI=0.34–0.91) as compared to controls. At 6 months, participants in the computer intervention also showed self-reported reductions in alcohol consequences (−29.1% computer, −17.5% control; RR=0.62, CI=0.39–0.98).
Conclusions
Among adolescents identified in the ED with self-reported alcohol use and aggression, a brief intervention resulted in a decrease in the prevalence of self-reported aggression and alcohol consequences.
Trial Registration
ClinicalTrials.gov Identifier NCT00251212.
doi:10.1001/jama.2010.1066
PMCID: PMC3560393  PMID: 20682932
21.  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.
doi:10.1136/qshc.2005.014720
PMCID: PMC2564005  PMID: 16456211
communication; community pharmacy services; evidence based practice; non‐prescription medicines
22.  Extended brief intervention to address alcohol misuse in people with mild to moderate intellectual disabilities living in the community (EBI-ID): study protocol for a randomised controlled trial 
Trials  2015;16:114.
Background
There is some evidence that people with intellectual disabilities who live in the community are exposed to the same risks of alcohol use as the rest of the population. Various interventions have been evaluated in the general population to tackle hazardous or harmful drinking and alcohol dependence, but the literature evaluating interventions is very limited regarding intellectual disabilities. The National Institute for Health and Clinical Excellence recommends that brief and extended brief interventions be used to help young persons and adults who have screened as positive for hazardous and harmful drinking. The objective of this trial is to investigate the feasibility of adapting and delivering an extended brief intervention (EBI) to persons with mild/moderate intellectual disability who live in the community and whose level of drinking is harmful or hazardous.
Methods/Design
The study has three stages, which include the adaptation of the Extended Brief Intervention (EBI) for people with intellectual disability, a single blind, randomised controlled trial of an individual Extended Brief Intervention to test the feasibility of the intervention, and a qualitative study that will assess the perceived acceptability and usefulness of the intervention. Fifty participants in total will be recruited from community intellectual disability services and social care or third sector organisations. The main outcome is a reduction in alcohol consumption measured by the Alcohol Use Disorders Identification Test.
Discussion
Alcohol misuse is a relatively under-researched mental health problem in people with intellectual disabilities. Therefore, the study addresses both diagnostic issues and the delivery of a simple first stage intervention, which is available to the population of average intelligence and young persons in particular. The findings from the study will guide the preparation of a large-scale study to test whether this treatment is clinically and cost-effective in this population.
Trial registration
ISRCTN58783633 (19 December 2013).
doi:10.1186/s13063-015-0629-x
PMCID: PMC4389906  PMID: 25873255
Alcohol misuse; intellectual disabilities; brief intervention; AUDIT; RCT
23.  Mapping private pharmacies and their characteristics in Ujjain district, Central India 
Background
In India, private pharmacies are ubiquitous yet critical establishments that facilitate community access to medicines. These are often the first points of treatment seeking in parts of India and other low income settings around the world. The characteristics of these pharmacies including their location, drug availability, human resources and infrastructure have not been studied before. Given the ubiquity and popularity of private pharmacies in India, such information would be useful to harness the potential of these pharmacies to deliver desirable public health outcomes, to facilitate regulation and to involve in initiatives pertaining to rational drug use. This study was a cross sectional survey that mapped private pharmacies in one district on a geographic information system and described relevant characteristics of these units.
Methods
This study of pharmacies was a part of larger cross sectional survey carried out to map all the health care providers in Ujjain district (population 1.9 million), Central India, on a geographic information system. Their location vis-à-vis formal providers of health services were studied. Other characteristics like human resources, infrastructure, clients and availability of tracer drugs were also surveyed.
Results
A total 475 private pharmacies were identified in the district. Three-quarter were in urban areas, where they were concentrated around physician practices. In rural areas, pharmacies were located along the main roads. A majority of pharmacies simultaneously retailed medicines from multiple systems of medicine. Tracer parenteral antibiotics and injectable steroids were available in 83.7% and 88.7% pharmacies respectively. The proportion of clients without prescription was 39.04%. Only 11.58% of staff had formal pharmacist qualifications. Power outages were a significant challenge.
Conclusion
This is the first mapping of pharmacies & their characteristics in India. It provides evidence of the urban dominance and close relationship between healthcare provider location and pharmacy location. The implications of this relationship are discussed. The study reports a lack of qualified staff in the presence of a high proportion of clients attending without a prescription. The study highlights the need for the better implementation of regulation. Besides facilitating regulation & partnerships, the data also provides a sampling frame for future interventional studies on these pharmacies.
doi:10.1186/1472-6963-11-351
PMCID: PMC3272060  PMID: 22204447
24.  Effect of information, education and communication intervention on awareness about rational pharmacy practice in pharmacy students 
Indian Journal of Pharmacology  2011;43(4):381-384.
Background:
There is a growing indifference among the pharmacy practitioners towards their duty as information providers to the patients. The patients do not always get enough desired information about proper use of medicines from the prescribers also. This contributes to improper use of medicines by the patients.
Objectives:
To bring about awareness about rational pharmacy practice in pharmacy students for better service to the patients.
Material and Methods:
The final year students of Bachelor of Pharmacy (B. Pharm) from four colleges of Nagpur were enrolled for the study after informed consent. Their base knowledge was assessed through a written test which comprised of 27 objective questions related to rational pharmacy practice. This was followed by a series of seven articles on rational medicine use, published in leading local English news daily. The participants were reminded to read them on the day of publication of each article. As a backup, the articles were displayed on the notice board of respective colleges. Second intervention was a half day interactive session where series of six lectures were delivered to the participants on the right and wrong approaches in pharmacy practice. Posters about the do's and dont's of rational pharmacy practice were also displayed at the venue. The session was followed by a repeat test using the same pre-test to assess the change. Pre and post intervention data was compared using Fisher's Exact test.
Results:
It was observed that the intervention did bring about a positive change in the attitude and knowledge of the final year Pharmacy students about rational pharmacy practice.
Discussion:
The role of a pharmacist in health care provision is usually overlooked in India. Hence there is strong need for reinforcement in final year B. Pharm when most of the students go in for community service. Such interventions will be helpful in bringing about a positive change towards rational practice of pharmacy.
Conclusion:
This study showed that a properly timed and meticulously implemented intervention brings about a positive change in the attitude and knowledge of pharmacy students.
doi:10.4103/0253-7613.83105
PMCID: PMC3153697  PMID: 21844989
Current Index of Medical Specialities; Food and Drug Administration; Fisher's Exact test; Indian Drug Review; information, education, communication (IEC); knowledge, attitude and practice (KAP); Monthly Index of Medical Specialities; rational use
25.  Effectiveness of a Web-Based Brief Alcohol Intervention and Added Value of Normative Feedback in Reducing Underage Drinking: A Randomized Controlled Trial 
Background
Current insights indicate that Web-based delivery may enhance the implementation of brief alcohol interventions. Previous research showed that electronically delivered brief alcohol interventions decreased alcohol use in college students and adult problem drinkers. To date, no study has investigated the effectiveness of Web-based brief alcohol interventions in reducing alcohol use in younger populations.
Objective
The present study tested 2 main hypotheses, that is, whether an online multicomponent brief alcohol intervention was effective in reducing alcohol use among 15- to 20-year-old binge drinkers and whether inclusion of normative feedback would increase the effectiveness of this intervention. In additional analyses, we examined possible moderation effects of participant’s sex, which we had not a priori hypothesized.
Method
A total of 575 online panel members (aged 15 to 20 years) who were screened as binge drinkers were randomly assigned to (1) a Web-based brief alcohol intervention without normative feedback, (2) a Web-based brief alcohol intervention with normative feedback, or (3) a control group (no intervention). Alcohol use and moderate drinking were assessed at baseline, 1 month, and 3 months after the intervention. Separate analyses were conducted for participants in the original sample (n = 575) and those who completed both posttests (n = 278). Missing values in the original sample were imputed by using the multiple imputation procedure of PASW Statistics 18.
Results
Main effects of the intervention were found only in the multiple imputed dataset for the original sample suggesting that the intervention without normative feedback reduced weekly drinking in the total group both 1 and 3 months after the intervention (n =575, at the 1-month follow-up, beta = -.24, P = .05; at the 3-month follow-up, beta = -.25, P = .04). Furthermore, the intervention with normative feedback reduced weekly drinking only at 1 month after the intervention (n=575, beta = -.24, P = .008). There was also a marginally significant trend of the intervention without normative feedback on responsible drinking at the 3-month follow-up (n =575, beta = .40, P =.07) implying a small increase in moderate drinking at the 3-month follow-up. Additional analyses on both datasets testing our post hoc hypothesis about a possible differential intervention effect for males and females revealed that this was the case for the impact of the intervention without normative feedback on weekly drinking and moderate drinking at the 1-month follow-up (weekly drinking for n = 278, beta = -.80, P = .01, and for n = 575, beta = -.69, P = .009; moderate drinking for n = 278, odds ratio [OR] = 3.76, confidence interval [CI] 1.05 - 13.49, P = .04, and for n = 575, OR = 3.00, CI = 0.89 - 10.12, P = .08) and at the 3-month follow-up (weekly drinking for n = 278, beta = -.58, P = .05, and for n = 575, beta = -.75, P = .004; moderate drinking for n = 278, OR = 4.34, CI = 1.18 - 15.95, P = .04, and for n = 575, OR = 3.65, CI = 1.44 - 9.25, P = .006). Furthermore, both datasets showed an interaction effect between the intervention with normative feedback and participant’s sex on weekly alcohol use at the 1-month follow-up (for n = 278, beta = -.74, P =.02, and for n = 575, beta = -.64, P =.01) and for moderate drinking at the 3-month follow-up (for n = 278, OR = 3.10, CI = 0.81 - 11.85, P = .07, and for n = 575, OR = 3.00, CI = 1.23 - 7.27, P = .01). Post hoc probing indicated that males who received the intervention showed less weekly drinking and were more likely to drink moderately at 1 month and at 3 months following the intervention. For females, the interventions yielded no effects: the intervention without normative feedback even showed a small unfavorable effect at the 1-month follow-up.
Conclusion
The present study demonstrated that exposure to a Web-based brief alcohol intervention generated a decrease in weekly drinking among 15- to 20-year-old binge drinkers but did not encourage moderate drinking in the total sample. Additional analyses revealed that intervention effects were most prominent in males resulting in less weekly alcohol use and higher levels of moderate drinking among 15- to 20-year-old males over a period of 1 to 3 months.
Trial Registration
ISRCTN50512934; http://www.controlled-trials.com/ISRCTN50512934/ (Archived by WebCite at http://www.webcitation.org/5usICa3Tx)
doi:10.2196/jmir.1465
PMCID: PMC3057308  PMID: 21169172
Web-based brief alcohol intervention; adolescents; normative feedback; moderate drinking; alcohol use

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