Falsified Medicines Directive : challenges faced by small member states

Abstract

Within the European Union (EU), Directive 2001/83/EC or the Falsified Medicine Directive (FMD), amended to Directive 2011/62/EU, was implemented to safeguard consumers and minimise entrance of counterfeit medicines on the market. Directive 2011/62/EU with Commission Delegated Regulation (EU) 2016/161 proposes an end-to end verification system with prescription-only medicines by ‘decommissioning’ dispensed medicines and raising alerts on scan duplicates, previously scanned barcodes or non-existent barcodes in the database managed by the European Medicines Verification Organisation (EMVO). The verification feature consists of a unique identifier (UI) in the form of a 2D data matrix code and human readable information that is to be scanned, and an anti-tamper device (ATD) that is evident on the outer packaging. The European verification system is handled by the EMVO which consists of the National Medicines Verification Organisation (NMVO) per member state and a National Competent Authority (NCA) as an external regulator. The aim of the study is to assess FMD implementation perspectives of Maltese community pharmacists, Maltese wholesalers, and NMVOs and NCAs of European Union member states, European Economic Areas (EEA) and European Free Trade Association (EFTA). The data required for the study was obtained by administering three questionnaires. The first questionnaire was developed and disseminated to Maltese pharmacists working in the community setting. A complete list of community pharmacies in Malta and Gozo was obtained from the Malta Medicines Authority website. From the 229 community pharmacies identified, 129 have provided their company or work email addresses. The questionnaire was placed in an online platform and was sent out to the respondents through email and social media. Forty-six responses from community pharmacies were collected. The FMD implementation in Malta is perceived to be followed by the practicing pharmacists (N=46) in the community pharmacy as mandated by the Delegated Regulation. Problems identified involve the scanning activities related to the verification system. The scanning process in the FMD system is considered cumbersome and adds workload for the participants (n=18). The system is perceived to be time consuming especially when the FMD is implemented for Pharmacy Of Your Choice (POYC) (4 out of 8 comments from pharmacists). The FMD system in the community pharmacy is not totally compatible with POYC software. Recommendations, such as improving FMD implementation for POYC, creating a separate verifying system or merging of the two systems were noted from the participating pharmacists. The second questionnaire was developed and disseminated to Maltese wholesalers. A list of wholesalers in Malta and Gozo was obtained from the Malta Medicines Authority website. The questionnaire was sent to 44 wholesalers that handle medicines under the FMD guidelines and protocols. Sixteen responses were collected and summarized. The FMD implementation of wholesalers in Malta is perceived to be followed as per the guidelines provided by the Delegated Regulation. The wholesaler participants are aware and are already implementing the verification system (n=13). Vigilance with possible falsified medicines is thoroughly practiced and compliance to the verification system is a priority. Problems met by the wholesalers stem from the point of Marketing Authorization Holders (MAH) or manufacturers. Discrepancy in uploading creates mismatch in scanning thus ensuing investigation. Medicinal packs under investigation are placed on hold and are not sent out to the market. The third questionnaire was developed and disseminated to NMVOs and NCAs of twenty-nine countries with a total of 58 respondents. Sixteen responses were received in total, nine were from NMVOs and seven were from NCAs. The questionnaire was placed in an online platform and disseminated via email. The participating NMVO countries were Austria, Croatia, Finland, Poland, Iceland, Norway, Sweden, Luxembourg and Belgium. The participating NCA countries were Poland, Slovenia, Iceland, Latvia, Croatia, Malta and Estonia. The FMD implementation is perceived to be followed according to the requirements set by the Delegated Regulation and countries are having less issues than they had at the beginning of the implementation period. The alerts received by the NMVOs are recognized to be false alerts and may be a part of the initial adjustment or stabilization period. The community pharmacists and wholesalers of Malta are in line with the implementation process as required with the delegated regulation. The NMVOs and NCAs are in good communication with each other in terms of minimizing the risk of entry of falsified medicines in the market. The results gathered would be of use in improving the implementation standards of the country, contributing in understanding the daily processes of the FMD implementation, and enhancing patient healthcare outcomes.