Making sense of the Falsified Medicines Directive – new information hub for pharmacies

09 Feb 2017

A new resource hub FMD Source has been launched to provide community pharmacists in the UK with detailed information to help them prepare for the start of the EU Falsified Medicines Directive (FMD).

FMD Source is being provided by the UK FMD Working Group for Community Pharmacy which brings together all the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK.

Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy, says: “Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.”

“We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”

“That’s why we’ve launched FMD Source, a rapidly developing website, to provide an authoritative and reliable source of information on FMD – one that is based on the way UK pharmacies operate and not some theoretical ‘European’ model. We want to give pharmacists all the support they will need to get ready for FMD.”

FMD Source is designed to help UK pharmacies prepare for whatever new authentication systems are developed and introduced. It is also expected to be useful to pharmacy students intending on a career in the community.

Under the EU Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).

The UK’s database will be developed by a new organisation, SecurMed UK, which comprises of all the main supply chain bodies representing manufacturers, wholesalers and pharmacies. Pharmacy is represented jointly by the NPA and CCA and Raj Patel of the NPA is currently the “dispensing entities” Director of SecurMed UK. 

Who will be paying for FMD?

The costs of establishing each database is to be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees. Pharmacies and wholesalers will be responsible for making their connections to the database, as well as for software upgrades.

The pharmacy negotiating bodies are represented on the UK FMD Working Group and are working hard for a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and their suppliers.

What about Brexit?

Although the result of the referendum in 2016 has started the UK on a path towards leaving the European Union, it is unlikely that this will have taken place before FMD scanning and authentication comes in to effect from 9th February 2019. Other EEA countries and Switzerland are also participating in FMD. The full implementation of FMD may depend on the UK’s future relationship with the EU.

Pack serialisation is now a global approach to tackling falsification and similar systems are being developed in many markets, including India and China. As a result, serialised packs are already appearing in UK pharmacies.