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Pharmacies must be FMD-compliant regardless of Brexit

The chair of an influential working group has warned community pharmacists they must be compliant with the falsified medicines directive (FMD) by the rollout deadline regardless of whether the UK has secured a Brexit deal or not.

Raj Patel (pictured), who chairs the UK Falsified Medicines Directive Working Group (UKFMD), said pharmacists must meet the requirements of FMD by the February 9 deadline and ensure any contract they enter into for it is “future-proof in any post-Brexit scenario.”

Pharmacists will be required to scan the barcodes of all medicines at the point of dispensing and check the anti-tampering device from next month.

“All parties recognise the challenges around FMD and we are confident that the regulators will take a pragmatic and even-handed approach to enforcement. Nevertheless, pharmacies must make efforts to be compliant with the new FMD safety features, by the deadline,” Patel said.

“Pharmacies must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features.

“They must carefully consider the terms of any contract for FMD solutions and make sure they are future-proof in any post-Brexit scenario.

“Other practical adjustments might be required, such as modifying dispensing workflows and all pharmacies will need to update their standard operating procedures.”

Patel said pharmacy was at the start of “a journey towards full implementation” of FMD since very few packs of medicines in pharmacies will have the safety features from February 9 because “they will take time to come through the medicines supply system."

UKFMD said: “It is understood there will be significant quantities of medicines in the supply chain that do not carry the new safety features, after February 9, but they can still be wholesaled and dispensed.

“Pharmacies are expected to have clear standard operating procedures in place to empower individuals to make judgement calls they could later justify, rather than disrupt supply to patients.

“General Pharmaceutical Council inspectors will not focus unduly on any single issue and will assess the pharmacy in the round considering the health, safety and wellbeing of patients and the public.”

The National Pharmacy Association (NPA) did not reveal what proportion of its independent members are ready for the rollout of FMD and how many had yet to acquire scanning equipment.

However, the NPA’s head of corporate affairs Gareth Jones told ICP: “Our members are working very hard in a difficult situation. Many NPA members are asking questions about implementation and are still looking at the options available to them in terms of FMD systems.

“We continue to advise them not to get tied into long-term contracts due to Brexit uncertainty but they need to demonstrate they are working towards compliance by February 9.”

Numark said it did not track and monitor its members’ progress with FMD.

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