The EU’s anti-counterfeit legislation, the Falsified Medicines Directive (FMD) – which requires all pharmacies to be able to scan barcodes on medicines packaging at the point of dispensing – comes into force on February 9.
Speaking ahead of the deadline, the UK FMD Working Group for Community Pharmacy – which is managing the rollout across the sector – has warned that “many ‘false positive’ alerts” are expected to be generated when pharmacy teams attempt to scan and decommission medicines.
“This does not necessarily indicate a falsified medicine, and in most cases, it will be appropriate to dispense the medicine, subject to the normal checks,” it said.
The two most common error messages are “unknown product code” and “failed to find batch”, the group explained, which are most likely to be caused by manufacturers not uploading relevant data to the system.
Very few FMD-compliant medicine packs
The National Pharmacy Association (NPA) is advising pharmacies to keep dispensing medicines as normal, unless “there is a clear indication they are counterfeit”.
Despite tomorrow’s deadline, “there will be very few medicine packs in the supply chain that have the new FMD safety feature and some that do may still return an error message”, NPA head of corporate affairs Gareth Jones said.
“Many NPA members will be FMD compliant, but it will take some time for the rest of the medicines supply chain to fully comply.”
The working group warned that some generic medicine packs may have the required 2D barcode, but they do not have an anti-tampering device – medicines need both to be fully FMD compliant.
The Pharmaceutical Services Negotiating Committee (PSNC) said: “FMD is a huge project and it is important that during the initial period, medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified.”
MHRA taking “pragmatic approach”
The General Pharmaceutical Council (GPhC) confirmed last month that checking pharmacies are compliant with the FMD will be part of its pharmacy inspections.
In a statement today (February 8), chief executive Duncan Rudkin said: “We recognise that not all pharmacies will be meeting the legal obligations of the FMD straight away. Our inspectors would consider all of the relevant evidence, including whether the pharmacy had a clear plan in place to meet all of the requirements of FMD, before deciding whether or not the relevant standard had been met.”
Deciding whether to “instigate any enforcement action” will fall to the Medicines and Healthcare products Regulatory Agency (MHRA), the GPhC said.
In updated guidance published yesterday, the MHRA said it “will be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified”.
NHS England: Continue with caution
In a letter from NHS England to healthcare professionals – seen by C+D – the commissioning body warned community pharmacies to continue to prepare for the FMD, but do so with caution.
The MHRA has made it “clear that in an event of a no-deal [Brexit], we would have to remove the FMD requirements from law, as we would no longer have access to the EU system”, NHS England’s senior responsible officer Keith Farrar said in the letter.
“Whilst we remain mandated to continue preparations, these need to continue with appropriate caution given the possibility of a no-deal scenario,” he stressed.
The UK FMD Working Group has published guidance on managing the early stages of the FMD, including the 11 possible alert messages that pharmacists and staff might receive when scanning medicines packs.