FMD

The Falsified Medicines Directive (FMD) is set to come into force across the EU next week (February 9th), hoping to curb and eliminate fake and potentially dangerous falsified medications from entering legal supply chains

Digitising Patient Care

Currently speaking, more than 1.6m people visit a pharmacy every day and the NHS spends around £17bn a year on medications, more than half of which occurs in primary care. Seeing how integral pharmacy is to the wider health system, you may not be aware that community pharmacies today still remains somewhat fragmented with 1000s of independent units having little interaction with hospitals or health centres.

As of 9th February market authorisation holders must place two safety features on all prescription products delivered in Europe – that being a unique identifier in the form of a 2D data matrix, which contains the batch number, expiry date, product identifier and unique serial number. Additionally an anti-tampering device is required. The whole policing aspect of bad medications is to be conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) who will refrain from entering each pharmacy but instead continue working with relevant regulatory bodies to put FMD into already on-going investigations.

The Brexit Effect

In October last year, the MHRA stated that “regulations coming into force as part of the Falsified Medicines Directive will not apply to the UK if it leaves the EU without a deal”.

Continued Uncertainty

As of this week, PharmaSciMed has documented nearly a dozen pharmacies which are not ready for the new directive, however the The General Pharmaceutical Council (GPhC) has stated that it does not see the 9th February 2019 as a “cliff edge date” and that following routine inspection, if a pharmacy was not compliant it would work with them to understand why and ensure that there is clear and concise plan put into place bringing it up to code.