1 Bad meds travel fast?
The EU Falsified Medicines Directive (FMD) has been introduced to reduce the risk of counterfeit medicines in the supply chain. The World Health Organization estimates that up to 15 per cent of all medicines are counterfeit, varying from 30 per cent in some areas of Africa and the Far East to about one per cent in the EU.
2 What does FMD mean for pharmacies?
In order to comply with the requirements of the FMD, as part of the dispensing process pharmacy contractors will be required to:
1. Check the anti-tampering device to ensure it is intact before dispensing.
2. Change the status of the pack on the UK’s National Medicines Verification System (NMVS) from “active” to “inactive – supplied”. This involves scanning the 2D barcode on each pack and communicating with the NMVS.
3 Work still to be done
The UK Community Pharmacy FMD Working Group (FMDWG) comprises representatives from PSNC, NPA, AIM, CCA, CPW, CPS and CPNI, and is working with the DHSS and the MHRA to ease FMD implementation in the UK. The group says there is still work to do to ensure community pharmacy is ready, including updating IT systems and associated hardware, connecting pharmacies to the NMVS, training staff and providing patient information. Guidance includes The Way Forward For FMD In Community Pharmacy.
4 FMD pros and cons
The FMDWG says pharmacy workflow and SOPs will need to be updated, to ensure all relevant prescription medicines are authenticated and decommissioned during the dispensing process, before handover to patients. Processes will also be needed to deal with any unexpected results and with reverse decommissioning. On the plus side, manufacturers will have better control of their products through the supply chain, protecting their brand integrity and increasing patient safety.
5 Hello to 2D barcodes
Under FMD, all prescription medicines will have a unique code placed on the packaging in the form of a 2D barcode (data matrix), which will be held on a national database. Over time all older linear barcodes will disappear from prescription medicines.
6 Special dispensation
Specials and other one-off products are outside the scope of the FMD. However, any licensed products used in their production will need to be authenticated before they are used.
7 Funding FMD
The costs of establishing the UK’s NMVS will be borne by manufacturers of branded and generic medicines and parallel distributors, which have been urged to register promptly with SecurMed UK, the UK medicines verification organisation. UK-based marketing authorisation or parallel import licence holders must register and pay set-up fees of £35,000.
8 Cost to contractors
Pharmacy is responsible for its own costs for connecting to the NMVS, which will include initial IT software and hardware set-up, plus ongoing operational costs that could total thousands of pounds. However, it is hoped that contractors’ FMD-related costs may be recognised in future NHS funding settlements.
9 Patient safety implications
Although patient safety is the main driver behind the FMD, the Community Pharmacy Patient Safety Group has warned that changes to established operating procedures can “increase risks to patients and will place a significant burden on pharmacy teams, at least in the short term”, and any risk will need to be managed.
10 Pharmacy data
The FMDWG says there are two forms of FMD data that pharmacy owners can make use of. The hard data printed on each pack and encoded in the unique identifier (UI) 2D data matrix can prove useful for stock control, re-ordering, accuracy checking and expiry-date checking. There is also data on the UI held within the verification system that will give updates when products are scanned if they are subject to a withdrawal or recall, but this requires a live link.
The launch of FMD in February will be closely followed by the UK’s departure from the European Union on 29 March.
The Brexit Health Alliance has warned of possible disruption to medicines supplies when the UK leaves the EU, imploring negotiators to put patients first. And at the European Industrial Pharmacists Group General Assembly in May, EIPG president Claude Farrugia (pictured) said that since the Falsified Medicines Directive deadline coincides with Brexit, this “exacerbates the potential risk to the availability of medicines”. Indeed, Brexit has raised questions around the necessity of implementing FMD in the UK.
The NPA has stressed that because FMD comes into force before the UK leaves the EU, there will be a requirement to implement the directive in full by February 2019. However, it adds: “Whether the same obligations remain after the UK leaves the EU depends on the outcome of the Brexit negotiations, [although] it is unlikely that the UK government would completely withdraw from a measure that is intended to improve patient safety.”
The DHSC and MHRA have both stated that the UK will maintain “high regulatory alignment” with the EU and that this includes the FMD, and the UK FMD Working Group says it is “assuming for the time being that the UK will be considered, for the purposes of interpreting the FMD Delegated Regulation, still to be inside the EU, now and in the future”.