The implementation of the EU Falsified Medicines Directive (FMD) in the UK should be achieved “at minimum cost to pharmacy contractors,” the UK FMD Working Group for Community Pharmacy has said. The process, being introduced in 2019, should also be straightforward, easy to use, have a minimal impact on pharmacy working practices, said the group, which includes representatives from the main UK pharmacy bodies.

A new website, FMD Source, updates contractors on what the changes will involve, work done so far, and what should be expected in the coming two years.

FMD is expected to add extra steps to the dispensing process. All pharmacies will need the right software and hardware, to be able to link with the UK’s central medicines database, the UK Medicines Verification System, and to scan a 2D barcode on every medicine pack before it is dispensed to a patient.

Who will pay for what?
Community pharmacy contractors will be required to ensure that all their pharmacies are connected to a central database, including updating software and an introducing hardware (including scanners) as needed. This will be paid for by pharmacies and wholesalers, says the group.

It adds that negotiators are “working hard for a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and other suppliers”.

Standard operating procedures will need to be updated to ensure that all relevant prescription medicines are authenticated and decommissioned during the dispensing process, prior to handover to patients.

Processes will be needed to deal with any unexpected results and with reverse decommissioning if needed.

The costs of establishing national verification systems and their governing bodies will fall to manufacturers.

What’s happened so far?
Policy work has been going on for around 10 years, leading to formal adoption of the directive in 2011. The development of the European and national verification systems has been stakeholder-led, with the key five supply chain ‘constituencies’ represented: research-based manufacturers, generic manufacturers, parallel traders, wholesalers and pharmacies. These constituencies have been working alongside the European Commission and national Health Ministries and regulators. 

The European Medicines Verification Organisation (EMVO) has established the European Medicines Verification System (EMVS), which is now up and running, and has created a blueprint model for national verification systems. SecurMed UK will develop the UK’s National Medicines Verification System.

PMR involvement
PMR system suppliers will be part of this ongoing planning. The UK FMD Working Group says: “FMD data interfaces with current PMR systems will form an integral part of how this works in practice. PMR suppliers are aware of current FMD progress.”

Wholesale Dealer’s Licence? 
Contractors who have a wholesale dealer’s authorisation will need to ensure they abide by the regulations for wholesalers as well as those for pharmacies, the group warns. 

Will pharmacy reimbursement be linked? 
The UK FMD Working Group says pharmacy reimbursement will not be linked to the new system, at least not yet. “The Delegated Regulation gives Member States the flexibility to use information derived from unique identifiers for the purposes of reimbursement, pharmacovigilence and pharmacoepidemiology. At present, we do not expect that the Department of Health will be using this flexibility for the purposes of pharmacy reimbursement, particularly because the UK does not have an established system of national reimbursement numbers.”

Does Brexit change anything?
The vote to leave the European Union is not expected to affect the UK’s commitment to implementing the FMD. The DH and the MHRA have said that work is continuing on a ‘business as usual’ basis.

The UK FMD Working Group says: “Given the global nature of falsified medicines and the fact that the UK remains a major member of the pharmaceutical sector, we believe that the UK would have to adopt pack serialisation in order to maintain its reputation as a safe part of the medicines supply chain. At present, it seems likely that this would be the European FMD system.”

 

What is the FMD?

The FMD aims to address the issue of falsified medicines entering the legitimate supply chain. Under the directive, almost all new packs of prescription medicines that enter the European Market will have to bear two safety features: a unique identifier in the form a 2D barcode and an anti-tamper device (ATD).

The 2D barcode will consist of: product code; serial number; national reimbursement number batch number (this is unlikely to be used in the UK); and expiry date.

Before medicines are dispensed, they will need to be authenticated by scanning their barcode and verifying them against the NMVS. Once they are verified, they are ‘decommissioned’, meaning that their status in the NMVS changes from ‘active’ to ‘inactive – dispensed’.

Scanning and authentication will come into effect across Europe from Saturday 9 February 2019.

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