Dataset Information

Evaluation of community pharmacists' readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis.

ABSTRACT: OBJECTIVES:To evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed. SETTING:Community/retail pharmacies. PARTICIPANTS:We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring that they were nationally representative. INTERVENTIONS:We mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval. RESULTS:102 responses (20.44% response rate) were received. Readiness to implement was poor: 4 (3.9%) said very much, while 40 (39.2%) said not at all and 29 (28.4%) said not really. Increased workload and reduced profitability were anticipated, accompanied with improved patient safety. Prevalence of 'substandard and falsified (SF) medical products' was estimated at 1%-5%, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9%) had identified SFs (p<0.001?one-sample binomial test). Of these, three (2.9%) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist's role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9%) more often than in affluent areas 1 (2%). CONCLUSIONS:Many pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness among pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of under-reporting maybe prevalent. A larger sample study using this survey would be valuable.

SUBMITTER: Barrett R

PROVIDER: S-EPMC6955531 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Evaluation of community pharmacists' readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis.

Barrett Ravina R

BMJ open 20200109 1

<h4>Objectives</h4>To evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed.<h4>Setting</h4>Community/retail pharmacies.<h4>Participants</h4>We invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring that they were nationally representative.<h4>Interventions</h4>We mailed ...[more]

PMID: 31924640

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Project description:The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.

Project description:BackgroundWe report on efforts to measure readiness to adopt opioid safety initiatives in community pharmacies within 2 large chains. Previous studies identified lack of knowledge, confidence, or enthusiasm in addressing harm reduction efforts. We implemented an intervention that provided training to improve opioid safety. The goal was to increase naloxone prescribing and nonprescription syringe sales, reduce stigma, and decrease opioid overdoses among patients and customers.ObjectivesTo assess pharmacy readiness for intervention delivery, by characterizing pharmacy culture around opioid safety; describing current practices and challenges interacting with patients and customers on naloxone, nonprescription syringe sales, and buprenorphine; and determining pharmacy defined goals for implementing the intervention.MethodsThe sample included pharmacy managers and staff pharmacists from 2 large chains who completed a brief phone interview. Interviews consisted of Likert-scale and open-ended, theoretically driven questions. Questions focused on workplace culture, patient engagement, naloxone and buprenorphine prescribing, nonprescription syringe sales, and intervention goals. Coding categories for the open-ended questions were derived using a thematic review of responses.ResultsA total of 163 respondents described both workplace culture and how they encourage patient opioid safety as including public health awareness, patient engagement, and naloxone prescribing. Sale of nonprescription syringes exhibited high variability: no sales barriers (53.9%), sales with barriers (21.5%), and no sales (20.9%). Half of pharmacists (50.3%) interacted with buprenorphine prescribers outside of medication fills. Most respondents (68.7%) endorsed being ready to promote the intervention. Pharmacists named goals in adopting the intervention of wanting more knowledge and educational materials, talking points with patients, and best practices for offering naloxone.ConclusionCommunity pharmacists, before implementation, described awareness of and receptiveness to opioid safety initiatives, with substantial barriers around nonprescription syringe sales. Assessed knowledge level, culture, and identified barriers that emerged in the readiness assessments can be used to tailor future pharmacy-specific programming.

Project description:Background: To describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P=0.003). Conclusions: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic was not a major barrier to clinical research activities in pediatric oncology. Clinical Trial Registration: NCT04614662.

Project description:BackgroundThe implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections - which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike - make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured.MethodsA working group of the Clinical Research/Quality Assurance subcommittee of the German Association of Research-Based Pharmaceutical Companies (VFA) was established to outline the regulatory requirements, the experience gathered with inspections by means of a survey and to set up guidance on how to manage an inspection.Results and conclusionsThe survey, conducted with the help of 15 pharmaceutical companies within the VFA, included a total of 224 inspections (74 inspections in Germany, 150 from other European countries). Most frequent findings in and outside Germany were related to "documentation" (40.5% vs. 21.3%), "investigational new drugs" (16.2% vs. 14.7%), "drug safety" (13.5% vs. 8%) and "application for a clinical trial authorization" (5.4% vs. 12%). From a German perspective, key findings of this working group were the necessity for a clear differentiation of responsibilities between national and federal as well as international authorities, a harmonization of inspection procedures and topics, and a clarification of whether pre-study/on-study and pre-approval/post-approval GCP inspections of the federal higher authority are included in the "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten" (ZLG) requirements. The survey illustrated, that inspections usually are conducted at the investigational site, and that most of the findings are well known and thus could be prevented by communicating and discussing audit results more intensely within study groups. Again, the survey illustrated, that a harmonization of inspections appears warranted. Finally a code of practice is provided that considers these findings and delivers a basis for a successful inspection whether at the sponsor or the GCP site.

Project description:Policy Points: Policymakers in the United States should consider expanding pharmacy practice laws to allow pharmacists to vaccinate adolescents as a way to improve geographic access to adolescent vaccines, particularly for human papillomavirus (HPV) vaccine, which has low uptake. Our state-level analysis showed that pharmacists are more geographically dispersed than primary care physicians in the US state of Texas. Including pharmacists among available adolescent vaccine providers would improve the geographic distribution of vaccine providers, especially in areas with an inadequate number of primary care physicians. CONTEXT:The largest disparities in human papillomavirus (HPV) vaccination in the United States are due to geography. One potential way of addressing these disparities is by improving geographic access to HPV vaccination. Two federal panels have recommended including community pharmacists as HPV vaccine providers as a strategy to improve opportunities for HPV vaccination for adolescents. We sought to evaluate whether community pharmacists can improve the number of vaccine providers in areas with primary care physician shortages in the US state of Texas. METHODS:We gathered publicly available physician and pharmacist 2016 workforce data from the Texas Medical Board and Board of Pharmacy. We conducted geospatial analysis of census tracts to analyze the distribution of physicians and pharmacists and how pharmacists change vaccine provider coverage across the state. FINDINGS:Census tracts with high numbers of physicians per capita tended to be located near one another, in 5 of 5 analyses of Moran's I (median = .04). In contrast, pharmacist rates were not spatially dependent on census tract in any of our analyses. If pharmacists were added to primary care physicians as vaccine providers, 35% of urban census tracts that previously had inadequate coverage would be adequately covered, while 18% of inadequately covered rural census tracts would become adequately covered. Overall, when pharmacists were included with primary care physicians as vaccine providers, vaccine providers per capita increased in 2,413 of the 4,508 urban census tracts (54%), while the rate increased in 223 of 746 rural census tracts (30%). CONCLUSIONS:Pharmacists are more geographically dispersed across census tracts than primary care physicians. As a result, adding pharmacists to the workforce would increase the availability of vaccine providers in areas with inadequate primary care provider coverage.

Dataset Information

Evaluation of community pharmacists' readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis.

Publications

Evaluation of community pharmacists' readiness to implement the Falsified Medicines Directive (Directive 2011/62/EC): an English cross-sectional survey with geospatial analysis.

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