Emergency anaphylaxis protocols: A cross-sectional analysis of general practice surgeries and pharmacies in both the urban and rural setting in Ireland.

BACKGROUND: The incidence of anaphylaxis appears to be increasing worldwide with cases in the community outnumbering those in the hospital setting. General practice (GP) surgeries and pharmacies, based in the community, are often the first point of contact for many patients suffering from anaphylaxis. OBJECTIVES: To determine if studied GP surgeries and pharmacies have an anaphylaxis protocol on site and have access to an anaphylaxis kit; to explore GP's and pharmacists' personal experiences with management of anaphylaxis. METHODS: A cross-sectional, questionnaire-based study was performed examining anaphylaxis protocols in a sample of general practices and pharmacies from some counties in Ireland. This consisted of a sample from rural and urban settings. The study commenced in October 2014. RESULTS: Nineteen of 24 GPs (79%) and 9 (29%) pharmacies had an anaphylaxis protocol (P < 0.001). Twenty-four (100%) GP practices and 12 pharmacies (39%) surveyed had an anaphylaxis kit on site. Twelve GPs (50%) had treated a patient with anaphylaxis in the surgery while 8 (33%) had treated a patient in the community. One pharmacist (3%) had witnessed anaphylaxis in practice. Two pharmacies and one GP had been contacted by local businesses to alert them to a case of anaphylaxis. CONCLUSION: In contrast to national and international guidelines only 79% of GPs and 29% of pharmacies in this study from Ireland had an anaphylaxis protocol onsite.

A checklist for clinical trials in rare disease: obstacles and anticipatory actions-lessons learned from the FOR-DMD trial.

BACKGROUND: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) for 5 years (July 2010 to June 2015), anticipating that all sites (40 across the USA, Canada, the UK, Germany and Italy) would be open to recruitment from July 2011. However, study start-up was significantly delayed and recruitment did not start until January 2013. METHOD: The FOR-DMD study is used as an example to identify systematic problems in the set-up of international, multi-centre clinical trials. The full timeline of the FOR-DMD study, from funding approval to site activation, was collated and reviewed. Systematic issues were identified and grouped into (1) study set-up, e.g. drug procurement; (2) country set-up, e.g. competent authority applications; and (3) site set-up, e.g. contracts, to identify the main causes of delay and suggest areas where anticipatory action could overcome these obstacles in future studies. RESULTS: Time from the first contact to site activation across countries ranged from 6 to 24 months. Reasons of delay were universal (sponsor agreement, drug procurement, budgetary constraints), country specific (complexity and diversity of regulatory processes, indemnity requirements) and site specific (contracting and approvals). The main identified obstacles included (1) issues related to drug supply, (2) NIH requirements regarding contracting with non-US sites, (3) differing regulatory requirements in the five participating countries, (4) lack of national harmonisation with contracting and the requirement to negotiate terms and contract individually with each site and (5) diversity of languages needed for study materials. Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. This delay impacted recruitment, challenged the clinical relevance of the study outcomes and potentially delayed the delivery of the best treatment to patients. CONCLUSION: Based on the FOR-DMD experience, and as an interim solution, we have devised a checklist of steps to not only anticipate and minimise delays in academic international trial initiation but also identify obstacles that will require a concerted effort on the part of many stakeholders to mitigate.

Performance-enhancing drugs in sport.

This discussion reviews the concept and history of ergogenic aides, the penetration of use in society, some benefit/risk information, drug sources in our society, detection and regulation of these agents, and provides a look to the future. It also examines the role of the clinician/endocrinologist for these patients and uses some cases as examples of drug use among adolescents/teens.

Social capital: implications from an investigation of illegal anabolic steroid networks.

Numerous studies have linked the constructs of social capital with behaviours that are health enhancing. The factors of social trust, social cohesion, sense of belonging, civic involvement, volunteer activity, social engagement and social reciprocity are all associated with social capital and their existence is often linked with communities or settings where health enhancement is high. Utilizing an interpretive perspective, this paper demonstrates how the existence of social capital may enhance the transition into drug use, the experience of using an illegal drug and decrease the risk of detection. It highlights how social capital may contribute to behaviours which are not health enhancing. Using a variety of data, including participant observation of 147 male anabolic steroid users and 98 semi-structured in-depth interviews with male anabolic steroid users, dealers and distributors it was found that social capital facilitated the operation of the illegal anabolic steroid distribution network. The subcultural norms and social trust that existed within the network allowed anabolic steroid dealers to sell the drug to others with reduced risk of detection. It is argued that social capital facilitates the distribution of illegal anabolic steroids and that social capital is a non-discriminatory concept, that may enhance both negative and positive health-related behaviours.

Effectiveness of a multi-component intervention on dispensing practices at private pharmacies in Vietnam and Thailand--a randomized controlled trial.

Private pharmacies are the first line of health care in many communities, commonly selling antibiotics in small doses and prescription-only drugs such as steroids without medical supervision. The aim was to study the effectiveness of a multi-faceted intervention on the dispensing practices of drug sellers in Hanoi and Bangkok. The study was a randomized, controlled trial with 68 Hanoi and 78 Bangkok pharmacies, randomly selected and assigned for intervention and control. Behaviour was assessed by five simulated client visits per pharmacy per dispensing practice, at baseline and a month or more after each intervention. Three three-month interventions were implemented sequentially with four months in between: enforcement of regulations with local inspectors visiting to emphasize the importance of prescription-only medicine legislation; education, performed face-to-face in Hanoi and by a large group in Bangkok; and peer review, voluntary in Bangkok and compulsory in Hanoi. The intervention resulted in significant improvements in Hanoi, reducing the dispensing of illegal steroids (29% vs. 62%) and low dose antibiotics (69% vs. 90%), sustained by means of the peer review (17% vs. 57% steroids and 71% vs. 95% antibiotics), and in fewer dispensers asking no questions and giving no advice (11% vs. 30% steroids and 51% vs. 81% antibiotics). The only significant improvement in Bangkok was the reduction in illegally dispensing steroids (25% vs. 44%) after the regulatory intervention. In Bangkok, fewer of those in the group who volunteered for the peer review asked no questions and gave no advice for low-dose antibiotics requests after the peer review (58% vs. 81%). A multi-component intervention can have a profound effect in changing dispensers' behaviour, but the effect is dependant on the context and the method of implementation. Possible reasons for differences are discussed.

Private pharmacies in Hanoi, Vietnam: a randomized trial of a 2-year multi-component intervention on knowledge and stated practice regarding ARI, STD and antibiotic/steroid requests.

OBJECTIVES: To assess the effectiveness of a multi-component intervention on knowledge and reported practice amongst staff working in private pharmacies in Hanoi regarding four conditions: urethral discharge [sexually transmitted diseases (STD)], acute respiratory infection (ARI), and non-prescription requests for antibiotics and steroids. METHOD: Randomized controlled trial with staff working in 22 matched pair intervention and control private pharmacies who were administered a semistructured questionnaire on the four conditions before and 4 months after the interventions. The interventions focused on the four conditions and were in sequence (i) regulations enforcement; (ii) face-to-face education and (iii) peer influence. Outcome measures were knowledge and reported change in practice for correct management of tracer conditions. RESULTS: The intervention/control-pairs (22 after drop-outs) were analysed pre- and post-intervention using the Wilcoxon signed rank test. STD: More drug sellers stated they would ask about the health of the partner (P = 0.03) and more said they would advise condom use (P = 0.01) and partner notification (P = 0.04). ARI: More drug sellers stated they would ask questions regarding fever (P = 0.01), fewer would give antibiotics (P = 0.02) and more would give traditional medicines (P = 0.03). Antibiotics request: Fewer said they would sell a few capsules of cefalexin without a prescription (P = 0.02). Steroid requests: No statistical difference was seen in the numbers who said they would sell steroids without a prescription as numbers declined in both intervention and control groups (P = 0.12). CONCLUSION: The three interventions in series over 17 months were effective in changing the knowledge and reported practice of drug sellers in Hanoi.