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

Abstract

ObjectivesTo evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed.SettingCommunity/retail pharmacies.ParticipantsWe 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.InterventionsWe 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.Results102 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%).ConclusionsMany 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.

Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey

“…This contrasts to a study done by Barrett et al prior to the directive's implementation, which found that 77.5% of English pharmacists surveyed believed the FMD might increase patient safety. 9 While one might hypothesise that this may be due to cultural differences in pharmacy practice, this is a notable contrast between pharmacists' pre-implementation perceptions and post-implementation experiences. In this study, 30.1% of pharmacists indicated that they experienced an increased/greatly increased number of near misses and dispensing errors with the FMD procedures; some pharmacists qualitatively attributed this as one of the reasons for an increased risk to patient safety.…”

“…This cross-sectional survey was constructed by the research team, fostered by a comprehensive review of the existing literature 9 , 10 , 11 , 12 , 14 , 15 , 16 , 17 and the research team's experience of working in community pharmacy. During the conduct of the study, KD and KM were pharmacists based primarily in academia, DON was a community pharmacist, and CC was a final year pharmacy student.…”

“…additional scanning increasing prescription turnaround time). 9 , 10 , 11 , 12 However, most of the literature was written before the FMD procedures were implemented and only hypothesised the impact of this legislation. With a paucity of evidence available, there is a clear need to establish community pharmacists' views on the FMD's effect on their practice to help inform the future of pharmacy operations and delivery of patient care.…”

Falsified Medicines Directive in a Secondary Care Environment—Impact on Supply Chain

“…This paper targets the hospital pharmacy supply chain and the impact of the FMD in the dispensing operations. While some of the work in this field relates to problems with FMD implementation or readiness for implementation [ 15 , 16 , 17 , 18 ], our work analyzes the actual supply chain and proposes a new supply chain under the FMD requirements. The case hospital pharmacy supply chain is based in the Austrian Tirol region.…”

Facing Counterfeit Medications in Sexual Medicine. A Systematic Scoping Review on Social Strategies and Technological Solutions

“…123 The need of specific education of the pharmacist in identifying falsified medicines has been found as a major strategy also in United Kingdom. 157 Additionally, while buyers are often enticed by the possibility of getting the desired drug at a cheaper price, this is rarely the case, due to several "hidden" costs, including shipment, customs clearance, online medical consultations, additional packaging and so forth 112 ; additionally, in the case that no products are received by the buyer, there is little, if any at all, chance to retrieve all money spent. This is, of course, on top of the potential risks associated with sharing payment information on "shady" websites, such as "phishing" and other forms of digital threats.…”