UK FMD Working Group update

The Falsified Medicines Directive (FMD) and Brexit uncertainties mean that all pharmacies need to carefully consider which systems they choose to verify the authenticity of the medicines they supply, according to the UK Community Pharmacy FMD Working Group.

Authentication of medicines under FMD will start from 9 February 2019. Arvato, part of the Bertelsmann group, has recently signed a contract with SecurMed UK to provide the UK FMD system. Community pharmacies should be able to start getting connected to the system from September this year. The UK system will connect to the central EU FMD hub.

Chair of the working group, NPA Board member Raj Patel MBE, said: “Given continued Brexit uncertainties, we recommend that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository”.

Continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, and if the UK government realises its aim of a close alignment on medicines policy within the BREXIT agreement, it will continue after 2020 too.

Meanwhile, the Department of Health and Social Care and MHRA have launched a consultation on some aspects of implementing FMD in the UK, which contains a section on sanctions for non-compliance.

Mr Patel continued: “With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment. However, we are mandated to comply so we must proceed, albeit with caution.”

One of the key requirements of FMD is the ‘decommissioning’ of a medicinal product before a supply is made to a patient. IT solutions will be available which will include standalone FMD systems or FMD capability integrated into patient medication record (PMR) systems. The UK Community Pharmacy FMD Working Group (FMDWG) has published a list of FMD IT system suppliers for any pharmacists who have not yet started to prepare for FMD, to help them consider their options.

Notes to editors

The UK Community Pharmacy FMD Working Group brings together all the main pharmacy bodies representing community pharmacy to influence and inform implementation of FMD in the UK.  The group comprises expert representatives from NPA, AIM, CCA, PSNC, CPW, CPS and CPNI.  It meets regularly with DHSC, MHRA, GPhC and NHS Digital to discuss how FMD will operate in UK pharmacies and to seek practical and pragmatic solutions for its implementation.

Further information can be found in “The way forward for FMD in community pharmacy” guidance document produced by the FMDWG.

This press release has been sent on behalf of the FMD Working Group. For more information contact press@npa.co.uk.