FMD update for contractors
FMD update for contractors
August 1, 2018
Following its latest meeting, the UK Community Pharmacy Falsified Medicines Directive (FMD) Working Group is advising that uncertainties related to Brexit mean that all pharmacies need to carefully consider which systems they choose to verify the authenticity of the medicines they supply. Authentication of medicines under FMD will start from 9th 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.
Commenting after the meeting, Chairman of the working group and NPA Board member Raj Patel, 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 working group has published a list of FMD IT system suppliers for any contractors who have not yet started to prepare for FMD, to help them consider their options.
Funding for FMD
The costs of establishing the UK’s National Medicines Verification System are to be borne by manufacturers of branded and generic medicines and parallel distributors. Under the Delegated Regulation, each sector, including pharmacy, is responsible for its own costs for connecting to the UK FMD system. Each of the four national community pharmacy negotiators, including PSNC, is working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements. Some of the costs involved include initial set-up, IT, both software and hardware, plus ongoing operational costs.