In February, the European Commission announced that the Falsified Medicines Directive (FMD) will become law across Europe on 9 February 2019.
The FMD aims to prevent counterfeit medicines entering supply chain. The most common counterfeits medicines for the treatment of sexual dysfunction, heartburn and cancer. For example, fake Avastin, containing toxic chemicals entered the supply chain in 2012.
Prescription medicines will have a unique identifier in the form of a bar code that recognises the product name, pharmaceutical form and strength, pack size, batch number and expiry date. Each pack will also have an anti-tampering device. These will have to be checked in pharmacies at the time of supply. When a bar code is canned, the pharmacy scanner will be connected to a “repository” held by the Marketing Authorisation. If the product is not genuine, an alarm will be triggered and the Marketing Authorisation holder will have to notify the authorities.
It may no longer be possible in the UK to supply imported medicines that can be sold over the counter in their country of origin, because they will not have the anti-tamper device and bar code.
When the identifier is verified, the pharmacy must “decommission” the identifier, probably by selecting an on-screen option. Once decommissioned, it will not be possible to re-supply that item. There might be occasions when, after scanning and decommissioning, a patient does not receive the medication. This might happen if a patient was not at home to take delivery, or the wrong item was selected and then not supplied. Decommissioned medicines cannot be returned to stock. However, pharmacies will be able to reverse the decommissioning if no supply was made and the decommissioning is done on the same premises within 10 days.
If a split pack is used, the pharmacy must verify the pack when it is first opened, and then decommission the pack. If technical problems prevent scanning, a supply may be made. The pharmacy will be required to make a record of the identifier and verify and decommission it as soon as the technical problem has been solved.
If a pharmacy suspects that a product has been falsified or tampered with, the MHRA must be notified – and the product must not be supplied.
Whether the UK is in EU or not in just under 3 years' time, the risk of counterfeit medicines can only be dealt with on a Europe-wide basis.
Originally published in Chemist and Druggist, 19 April 2016