The Falsified Medicines Directive (FMD) will be rolled out across the UK and Europe from 9 February 2019.
FMD aims to ensure patient safety by addressing the threat of fake medicine entering the medicines supply chain. “Falsified” refers to fake medicines, and also false information about a medicine’s source.
FMD introduces two safety features on all new packs of prescription medicines, and an electronic scanning authentication process carried out when dispensing.
The safety features applied to packaging will be a unique identifier (UI) and an anti-tampering device (ATD).
The UI is a two-dimensional barcode that has four key parts: a product code, serial number, expiry date and batch number. The UI code is uploaded to the European Hub by manufacturers. The physical form of the ATD will depend upon the manufacturer, but if the device is broken the medicine cannot be supplied.
In community pharmacies, pharmacy staff will check that the package’s ATD is intact. The UI code is then scanned to verify and authenticate the medicines’ status as either “active”, or “inactive” against the National Medicines Verification Systems (NMVS) database.
An “active” status means the medicine can be distributed or dispensed, and “inactive” means it cannot. Only once verified can the medicine be decommissioned, changing its status in the NMVS from “active” to “inactive – decommissioned/supplied”.
Hospital pharmacies will have the same process, but medicine can be decommissioned at any time after verification.
The FMD process prevents the same UI being verified more than once.
If you’d like more information on FMD, guidance is available on the Royal Pharmaceutical Society website and the FMD Source website.
