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Pharmacies warned of false FMD alerts day before law comes into force

Pharmacies have been told to keep dispensing medicines despite expectations of “many” false alerts, ahead of the EU scanning law coming into force tomorrow.

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.

Is the sector ready for the FMD?

The C+D Salary Survey 2018 suggested that two thirds of pharmacy owners were unprepared for the FMD at the end of last year. Since then, Boots and Lloydspharmacy have admitted they will both miss the deadline, while Rowlands told C+D it is still facing “considerable logistical and staff issues” before it can start decommissioning medicines in its pharmacies.

What issues still need to be resolved? C+D asked sector leaders and representatives from the pharmaceutical industry what the big hurdles are that pharmacies will face as they start scanning.

PSNC: Not enough compliant packs in the supply chain

The Pharmaceutical Services Negotiating Committee said: “At present, there are not many FMD-compliant packs in pharmacies. We also know that some generic medicine packs that have a 2D data matrix are not actually FMD-compliant packs (they do not have an anti-tampering device). In the initial phase of implementing FMD, many ‘false positive’ alerts are expected.”

Avicenna CEO: Pharmacists will be put under pressure

Salim Jetha, CEO of independent pharmacy support group Avicenna, said: “My concern is that quality payments, the FMD, and the various end of year submissions are too close to each other, putting pharmacists under great pressure.”

NPA: The sector is on a journey to compliance

Raj Patel, chair of the UK FMD working group for community pharmacy, said: “Practical adjustments might be required, such as modifying dispensing workflows and all pharmacies will need to update their standard operating procedures.

“However, there will be very few packs of medicines in pharmacies with the FMD safety features on February 9, as they will take time to come through the medicines supply chain, so inevitably the sector is on a journey towards full implementation.”

Numark: Major change for pharmacies

A Numark spokesperson said: “Our role is that of a support function, to enable pharmacies to fully understand the requirements. We are consistently communicating the FMD deadline in our communications to reiterate the date for compliance, as well as advising this will mean major changes for pharmacies.”

ABPI: Brexit uncertainty risks patient safety

Dr Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry (ABPI) – the trade group which represents branded medicines manufactures in the UK – said: “[The FMD] means that patients across Europe will have the best protection from fake medicines in the world. It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit.”

While a spokesperson added: “There is a transition period for the directive. Those packs already on the market in the EU before the deadline will not require the safety features, so there will be a transition period where the UK market will contain compliant, partially compliant or non-compliant packs – but the packs still have full regulatory approval for being on the market.”

Is your pharmacy prepared for the FMD?

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