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Falsified Medicines Directive

NPA advises pharmacists to dispense medicines even if they receive FMD database alerts

Guidance from the National Pharmacy Association on implementing the Falsified Medicines Directive advises pharmacists to dispense medicines even if they get an error message, unless there is a clear indication that the medicine is counterfeit.

Gareth Jones, head of corporate affairs at the National Pharmacy Association

Source: National Pharmacy Association

Gareth Jones, head of corporate affairs at the National Pharmacy Association, explained that on 9 February 2019, “very few medicines packs” would have the new FMD safety features, including a 2D barcode

The National Pharmacy Association (NPA) has told its members to dispense medicines “even if they return an alert from the Falsified Medicines Directive (FMD) database” in the early stages of its implementation.

The FMD is due to come into effect from 9 February 2019, although The Pharmaceutical Journal revealed that less than half of pharmacies are expected to be ready for FMD in time.

In a statement, Gareth Jones, head of corporate affairs at the NPA, said that on 9 February 2019, “very few medicines packs” would have the new FMD safety features, including a 2D barcode, “and some that do may still return an error message” when scanned.

“Unless there is a clear indication that the medicine is counterfeit, or there is some other significant overriding factor, then the medicine should be dispensed,” he said.

His comments were made alongside guidance published by the FMD Working Group, which includes the Pharmaceutical Services Negotiating Committee (PSNC) and the Company Chemists’ Association, on 7 February 2019. It said that packs returning errors stating an “unknown product code” or “failed to find a batch for the given data” indicate that the pack is not in the system and should be supplied “after normal checks”.

The NPA told The Pharmaceutical Journal that these two alerts are likely to be the most common in the early implementation phase of the FMD.

The PSNC explained that some generic medicine packs that have a 2D barcode “are not actually FMD-compliant” and generate an alert when scanned, adding that the number of alerts “will reduce … as more of the packs reaching pharmacy are FMD-compliant”.

Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA), which was also published on 7 February 2019, acknowledges that there may be teething problems with FMD and it says “the government’s priority is the continued supply of safe medicines to patients”.

The guidance goes on to say that several EU member states have formally advised pharmacists who receive “unknown” error messages to still dispense the product.

It adds: “Therefore, the MHRA will also 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.”

Ash Soni, president of the Royal Pharmaceutical Society (RPS), said he also accepted that there would be initial problems with FMD, but he cautioned pharmacists to be careful in what they dispense.

“If pharmacists are decommissioning any medicines they need to check they are ‘FMD ready’ packs by fulfilling the criteria for commissioned packs,” he told The Pharmaceutical Journal. “Pharmacists need to remember that any packs purchased before 9 February 2019 are exempt from decommissioning, regardless of whether they meet the criteria or not.”

He added: “If pharmacists do decommission packs going forward and they get a warning of being counterfeit, professionally they should seek assurances from suppliers and manufacturers about pack integrity rather than assuming it is a false alert before supplying medication to the patient.”

The General Pharmaceutical Council (GPhC) has reassured pharmacists that it will take a “pragmatic approach” to FMD compliance during its inspections.

As part of a joint statement issued by the GPhC and the RPS on FMD implementation, Paul Bennett, chief executive of the RPS, said: “We welcome the pragmatic approach taken by the GPhC in relation to FMD, which we hope will provide some assurance to our members in pharmacies that are still working towards meeting all of the requirements relating to FMD.” 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206133

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