The Falsified Medicine Directive delegated regulation has now been published in the Official Journal of Europe. The regulation will apply in all member states of the European Union from February 9, 2019.
As we have previously reported, the European and UK governments are seeking to tackle the problem of counterfeit medicines at a European level through the EU Falsified Medicines Directive (2011/63/EU). This directive allows for measures to be put in place to prevent falsified medicines entering the supply chain.
The final legislation confirms the requirement for the addition of safety features to medicinal products (2D barcodes), which can be used to verify the product in the pharmacy prior to dispensing. The barcode will be verified against a repository of legitimate barcodes. Once supplied, the barcode will be decommissioned within the repository system.
The delegated regulation states that verification should take place at the time that the medicinal product is supplied to the patient. The verification of products on supply to the patient will also inform the pharmacist in real time if the product is out-of-date, recalled or withdrawn from the supply chain, which will increase patient safety. Through its membership of the Pharmaceutical Group of the European Union (PGEU), the NPA has expressed considerable concern about the requirement for products to be scanned upon handover to the patient, which will add time to dispensing processes.
The NPA has worked with the Association of Independent Multiple Pharmacies (AIMp) and the Company Chemists’ Association (CCA) to establish a community pharmacy working group on FMD implementation. The objective of the group is to seek to limit the bureaucratic demands and enhance any opportunities for pharmacy that exist within this legislation. The group will look at how costs will be managed and seek to put in place measures to prevent inappropriate use of commercially sensitive data extracted from the verification process. The group is engaged with the Department of Health and MHRA, liaises closely with Pharmacy Voice and the PMR suppliers, and is seeking to work with PSNC, Community Pharmacy Scotland (CPS), Community Pharmacy Wales (CPW) and Community Pharmacy Northern Ireland (CPNI).
A huge amount of work will be required to ensure that community pharmacy will be in a position to meet the legal obligation to authenticate medicines from February 2019. Realistically, the sector probably only has a year to determine how this system should work in community pharmacy, to allow time for the IT development and training that will be required. NPA members who want to express their views can get in touch at email@example.com.