This site is intended for Healthcare Professionals only

Falsified Medicines Directive developments

Finance bookmark icon off

Falsified Medicines Directive developments

Gareth Jones, NPA Public Affairs Manager, explains concerns over FMD delegated acts

As many pharmacy contractors will now be aware, July 2015 saw the introduction of a new requirement for anyone selling medicines online to display a common logo. Websites selling medicinal products at a distance are now required to display the logo and direct members of the public in the UK to the MHRA. NPA members who want advice on whether or not they are required to display a logo should contact the NPA by emailing independentsvoice@npa.co.uk.

This is one of a number of different ways in which governments are seeking to tackle the problem of counterfeit medicines at a European level, through the EU Falsified Medicines Directive (2011/63/EU). Another measure for implementation from the directive is the verification of the authenticity of medicinal products through a unique identifier (2D barcode) at the point of supply to the patient.

The directive places an obligation on the European Commission to adopt delegated acts setting out the details relating to this measure and how they might be implemented. The NPA supports the principles behind the new measures to ensure patient safety and remove counterfeits from the supply chain. However, it is essential that measures are proportionate and do not negatively impact on the safe and effective running of community pharmacies.

Through the Pharmaceutical Group of the European Union (PGEU), the NPA has been monitoring the progress of these delegated acts, which were finally published at the beginning of October. The NPA has already begun to lobby the UK government on interpretation of the delegated acts from Europe. Implementation in the UK is likely to be required by February 2019. The NPA has expressed a number of concerns, over both the costs and practicalities associated with verification.

Currently, implementation would require products to be scanned upon handover to the patient, which could add time to dispensing processes. Additionally, there would be only a 10-day window for scanned products that are not collected by a patient to be returned to stock. This could increase medicines waste – a concerning consequence, particularly at a time when the Health Service is under huge financial pressure and medicines waste is already a significant problem. The NPA feels that community pharmacy should be able to benefit from the same flexibilities that have already been offered to hospitals.

Keeping pharmacy data safe also remains one of our prime concerns, and the NPA is now part of a group set up to oversee the UK database that will manage the authentication of products. We will be keeping readers up-to-date as more details emerge and will continue to press the UK government on the current FMD proposals to ensure that any measures are not unnecessarily onerous.

Copy Link copy link button

Finance

Share: