Getting started with FMD - A pharmacy perspective.

With the start of medicines pack authentification under the Falsified Medicines Directive (FMD) now in force, writing on behalf of the UK FMD Working Group for Community Pharmacy, the author, describes what's been happening and what pharmacists need to do.

Authentication of medicines under the Falsified Medicines Directive (FMD) [Directive 2011/62/EU and Delegated Regulation 2016/161] started across 32 Member States of The European Union (EU) and European Economic Area (EEA) on 9th February 2019. This followed a hectic three-year implementation period during which an entire system of interconnected European and national databases was developed, pharmacies and wholesalers upgraded their internal systems and processes, and manufacturers began serialising billions of individual prescription medicine packs. 

FMD is not a "track and trace" system. Instead, it was developed on the "bookends" principle. Unique identification codes are produced and uploaded by manufacturers at one end. These codes are verified and decommissioned when the packs leave the supply chain at the other end. The decommission is normally undertaken by the community or hospital pharmacies as part of the dispensing process, but can also be undertaken by dispensing medical practices, pharmaceutical wholesalers (in some circumstances) and a range of other healthcare institutions that supply medicines to patients. 

The aim of FMD is to make it more difficult to introduce falsified products into the European medicines supply chain. Serialised packs and a process of verification and decommissioning should help identify any potentially falsified products before they reach patients. The introduction of machine-readable barcodes on all packs should also help with stock ordering, stock rotation, accuracy checking, product recalls and reimbursement.

This is an extract from an article by Jonathan Buisson from the Industrial Pharmacy Journal Issue 61, to read more subscribe now.