FMD deadline: “Progress” towards compliance sufficient

Ahead of the Saturday February 9 implementation deadline for the Falsified Medicines Directive (FMD) imminent, pharmacy bodies advised that the regulator will consider progress towards becoming FMD-compliant as a relevant factor in its inspections, rather than requiring all pharmacies to be fully compliant at this stage.

Meanwhile, with reports from EU member states of inaccurate error messages when verifying medicines under FMD, pharmacists have been advised that despite early glitches most medicine packs with FMD safety features may be dispensed.

SecurMedUK, the body responsible for delivering FMD, has told PM there is currently "no information" regarding how many medicine packs with FMD safety features are in the supply chain as of the deadline as "at this stage manufacturers are primarily loading data". A spokesperson said they are working to previous estimates from DHSC that "15-20% of packs would be serialised" by February 9; one pharmacist told PM he suspected the real number was "more like a tenth" of this.

4,086 community pharmacies in the UK were signed up to the medicines verification system as of February 5 according to SecurMed UK. 

GPhC: We will be pragmatic and proportionate

General Pharmaceutical Council chief executive Duncan Rudkin said: “We recognise that not all pharmacies will be meeting the legal obligations of FMD straight away. We intend to take a pragmatic and proportionate approach to the implementation of the new safety features.

“When inspecting a pharmacy, 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.”

Royal Pharmaceutical Society chief executive Paul Bennett 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.”

NPA: Expect some early glitches

Following an update on safety features from the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Pharmacy Association has told members that while some medicine packs with FMD safety features may return an error message from the FMD database when they are verified and/or decommissioned, they may still be dispensed unless there is a “clear indication” they are counterfeit [the MHRA lists signs of tampering as an example].

NPA head of corporate affairs Gareth Jones said there would be “very few medicines packs in the supply chain that have the new FMD safety features” by Saturday’s deadline and that some with the features may still return an alert.

While many pharmacies will be compliant by the deadline, “it will take time” for the entire medicines supply chain to comply, Mr Jones said, adding: “In the meantime our advice to members is they must be mindful of the relevant guidance and be making efforts to comply, but ultimately they must put their patients’ needs first.”

The NPA call centre will be open on Saturday to assist pharmacists with queries, the Association said.

The MHRA has said its decision to be “pragmatic” and “flexible” around enforcement has been taken after EU member states reported issues such as error alerts. The Agency added that it is aware of issues around packs released before the deadline, and of packs with 2D barcodes that do not relate to FMD.

“We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible,” it said.

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