Alex Jennings
GP practices in Berkshire, Buckinghamshire and Oxfordshire have been advised by their local medical committee (LMC) not to buy expensive hardware to comply with the Falsified Medicines Directive (FMD).
In an email to its practices, Richard Wood, chief executive of the LMC, said it was still waiting for “definitive guidance” from the Department of Health and Social Care on how the FMD will be implemented when it comes into force on 9 February 2019.
Meanwhile, pharmacies have been told by the General Pharmaceutical Council that compliance with the FMD, which is an EU directive, will form part of its pharmacy inspections processes, with non-compliant pharmacies facing regulatory action.
However, Wood’s email said: “On day one there will be very few products bearing the new codes, and it is likely that it will be several months for old medicine stocks to be used up.
“We therefore expect that there will be a gradual impact from these requirements. We are waiting for definitive guidance from the government on how the FMD will be implemented.”
He continued: “Do not buy expensive kit which might be redundant until we have clear national guidance. It is not the responsibility of practices to provide if it is for the delivery of the contract.”
Plans to implement the FMD in the UK could be hamstrung by a no-deal Brexit, as the UK would no longer have access to the EU central data hub.
However, the MHRA has said that in the event of a no-deal Brexit, it would consider options for a UK-only falsified medicines framework.
When asked by The Pharmaceutical Journal, Wood was unable to suggest what GP pharmacists should do when dispensing in a practice with no FMD hardware.
Under FMD requirements, dispensers will have to decommission medicines using a 2D barcode printed on compliant packs. They will also need software to connect them to the UK Medicines Verification System. An EU assessment from 2015 estimated that this could cost pharmacies around €530 per year.
The British Medical Association (BMA) said in guidance on its website that it expects the FMD IT hardware and software “that will be required in every pharmacy … to be provided by the NHS”.
It added: “The General Practitioners Committee of the BMA has concerns the authentication system will result in burdensome bureaucracy for pharmacists, practices and dispensing doctors and that it will not fit in with current pharmacy/dispensary IT systems.
“This is likely to result in an increase in the time taken to dispense, thereby representing an increase in workload.”
The BMA said that it will be issuing further official guidance once it receives more information from NHS England.
