Pharmacy Leaders Provide Guidance to Help Prepare for Falsified Medicines Directive
Leaders in community pharmacy have provided guidance to help the pharmacy profession prepare for the implementation of the EU's Falsified Medicines Directive.
The FMD is due to be rolled out in the UK by February 2019, but many are still unprepared for what is going to hit them.
The UK's FMD Working Group for Community Pharmacy has provided guidance to build an understanding of the options open to pharmacy contractors and to "start conversations" between pharmacies and IT system suppliers. Unfortunately, this is not a complete and final implementation plan for FMD, as many important details are still missing from the Government, so each pharmacy owner will need to decide how to implement FMD in their own business.
The FMD Working Group consists of experts from the UK's major pharmacy bodies: NPA, AIM, CCA, PSNC, CPW, CPS and CPNI. The Group has regular meetings with the Department of Health and the Medicines and Healthcare products Regulatory Agency to discuss the operation of FMD and to offer practical and pragmatic solutions for implementation.
The Way Forward for FMD in Community Pharmacy covers key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety. A really important assumption is that after Brexit the UK will still be considered to be insider the EU for FMD purposes, thus mirroring the UK Government’s desire for "high regulatory alignment" with EU medicines laws.
Raj Patel MBE, the Chair of the Working Group, and a Board member at the NPA, said: "FMD is going to happen, and it’s only a year until the kick off date for safety features including 2D barcodes and tamper-proof seals on medicine packs. Time is short, so we must make whatever preparations we can, on the basis of the facts already available, even if these are frustratingly incomplete. There remains a yawning information gap and a lack of assurances about the position post-Brexit, so we are working from reasonable assumptions about the position.
"We see it as our duty to supply pharmacies with the best steer possible, while acknowledging that meeting the February 2019 implementation date will be heroically challenging, to say the least. The pharmacy sector has major investment decisions in relation to FMD which cannot be postponed for much longer. However, we can now start having conversations with each other and our suppliers, so that we are better prepared."
Comment
In July 2017, we held a very successful seminar within PING (the Pharmaceutical Industry Network Group) in conjunction with the NPA on FMD and the implementation for people from across the pharma supply chain. The well-attended event provided an insight into what was going to happen under FMD, from leading speakers who are involved with SecurMed UK, the body responsible for the database of medicines under the new legislation and which comprises all the main pharma supply chain bodies representing manufacturers, wholesalers and pharmacies. The event was reported in The Pharmaceutical Journal.
What is concerning is that over six months on since that informative event - when we heard that time was really critical to meet the implementation deadline - we still do not have all the answers about how the system will work. However, the new paper should at least help, and it is welcome to see the NPA and other pharmacy bodies take a lead to provide invaluable guidance to pharmacists.