Perspectives of practices related to the implementation of the FMD

Abstract

The Falsified Medicines Directive (FMD), Directive 2011/62/EU, establishes a synchronised European protocol to prevent falsification of medicine and guarantee that medicines are safe and that there is a conscientious control over trading. A study was conducted by the University of Malta to assess FMD implementation perspectives of community pharmacists, wholesalers, National Medicines Verification Organisations (NMVOs) and national competent authorities (NCAs) of countries in the European Economic Area. Three questionnaires were disseminated to Maltese pharmacists, Maltese wholesalers and to NMVOs and NCAs. In total, 46 pharmacists completed the questionnaire, of which 40 pharmacists agreed that they were aware of the FMD and related components and 44 pharmacists agreed that pharmacist intervention is important in detecting potential falsified medicines. In total 16 wholesalers completed the questionnaire; 15 wholesalers claimed to be knowledgeable on FMD-related safety features and 12 wholesalers claimed that they were vigilant in checking medicinal products prior to distribution. A total of 16 responses from NMVOs and NCAs were received. All NMVO and NCA representatives agreed that all features necessary for set-up and execution of a repository system were functional and that the country’s NMVO has demonstrated preparedness in handling of repository data. The study sheds light on FMD implementation practices and can be useful for stakeholders in different countries.