FMD-Day: Are You Ready?
Already, questions have been asked about the implications of the incoming EU legislation on low-margin products - as manufacturers are asked to soak up the costs of new barcoded packaging. With mooted IT costs of almost £4,000 per pharmacy payable every five years to remain compliant with the law pharmacists are rightly concerned about the lack of clarity on the funding model and the spectre that compliance with EU scanning law could become part of their pharmacy inspection.
What’s it’s all about?
In the FMD, from February 9, 2019 market authorisation holders will be required to place two safety features on all new packs of prescription medicines placed on the market in Europe:
- a unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity
- an anti-tamper device (ATD).
In order to comply with the requirements of FMD, pharmacy contractors will be required as part of the dispensing process to:
- check the anti-tampering device (ATD) to ensure it is intact prior to dispensing
- change the status of the pack in the UK’s National Medicines Verification System from “active” to “inactive—supplied”. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System (NMVS).
Where are we now?
FMD guidance for community pharmacies: “Way Forward document for Community Pharmacies” (available online at: https://communitypharmacyhumber.org/resources-a-z/d-h/fmd-falsified-medicinesdirective/) was published at the start of 2018 and in this community pharmacies were advised that they would need to make significant changes to their practice in order to comply with the FMD: namely, that they would have to update IT systems and associated hardware, as well as connect to the verification system (“registration/on-boarding”), revise workflows and standard operating procedures, train staff, and ensure patients are up to speed with the changes. However, around eight months on, what progress has pharmacy been able to make?
To date, pharmacy contractors have received only positive indications that the FMD will be implemented as planned. Policy work on FMD has been going on for around a decade, leading up to the initial adoption of the EU Directive in 2011. This has led to an agreed scope of the FMD that includes almost all prescription medicines. Only non-prescription medicines (except for two omeprazole products), unlicensed products, including specials and clinical trial supplies, and a few specialist products will be excluded from the authentication process.
It is also worth remembering that the UK is one of 32 countries implementing the FMD – the others including the 28 (current) member states of the EU, plus the four members of the European Free Trade Area (Iceland, Norway, Liechtenstein and Switzerland).
Belgium and Italy, to name but two participants, have already indicated strong support for the new authenticated dispensing environment. FMD in practice is already being piloted in Ireland.
In the UK, an MHRA consultation on delivering the safety aspects of the FMD has got underway, running until September 23. Pharmacists have also been told that a national system provider has been found – to develop the portal through which UK dispensing will be authenticated against the European database. The successful partner is Arvato, part of the Bertelsmann group, an award winning IT solutions provider with a background in delivering large healthcare IT solutions, including anti-fraud and product serialisation. From September, community pharmacists are able to start making connections to the system.
However, pharmacists have been warned that before they sign up to the FMD they must ensure that any IT contracts are ‘Brexit-proof’. In a statement made in August FMD community pharmacy working group chairman 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.”
He explains: “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.”
But, the key question for pharmacy – who will pay for the system – remains unanswered. The EU is clear that community pharmacies (and wholesalers) will be required to pay for the kit as well as any software upgrades that they need. Each of the four national community pharmacy negotiators (PSNC, CPS, CPW and CPNI) is working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements.
Given that recently there has been very little dialogue between pharmacy and its paymasters in general – never mind specifically on the FMD - it is easy to see why FMD-sceptics abound. The question whether the white FMD elephant turns into a red-letter day for medicines’ safety - that is something that only the next six months can answer.
WANT TO HEAR MORE?
FMD and Brexit panel
Sunday 7th October
13:55 - 14:40
Claymore Richardson, Senior Policy Manager,Department of Health and Social Care
Leyla Hannbeck, Director of Pharmacy, National Pharmacy Association
Martin Sawer, Executive Director, Healthcare Distribution Association
Raj Patel, Chair of Community Pharmacy FMD Working Group
Dr Rick Greville, ABPI Director - Wales and the Distribution & Supply Chain
Leon Finnerty, Programme Head (ai), Medicines and Pharmacies / Falsified Medicines Directive, NHS Digital