Pharmacists must work towards full compliance with the Falsified Medicines Directive (FMD) deadline despite implementation delays in the supply chain, pharmacy bodies have said.
The UK FMD working group for community pharmacy said there will be a ‘significant quantities’ of medicines without the FMD safety features – including a 2D barcode and anti-tamper device – in circulation after the February 9 deadline, but pharmacists should still make sure they have everything in place for the change.
Packs without the safety features can still be wholesaled and dispensed, and pharmacists should have clear standard operating procedures in place to empower staff to make judgement calls they can later justify, ‘rather than disrupt supply to patients’, the working group said.
From February 9, pharmacists must check the device and scan the barcode to mark each pack as decommissioned, or dispensed, in the FMD database as part of a series of measures to prevent the spread of counterfeit medicines across Europe.
Chair of the working group, Raj Patel, said: ‘Pharmacists must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features.
‘They must also carefully consider the terms of any contract for FMD solutions and make sure they are future-proof in any post-Brexit scenario.’
He added that all pharmacies will need to update their standard operating procedures and other adjustments might be needed, such as modifying dispensing workflows.
LloydsPharmacy and Boots face FMD delays
LloydsPharmacy and Boots have both confirmed that not all of their branches will be compliant with FMD for the 9 February deadline.
A Boots spokesperson told The Pharmacist that due to ‘early delays of clarity in requirements and uncertainty due to Brexit’, it is still ‘continuing our journey with our FMD solution’.
‘This will begin with the introduction of a standalone solution into some stores in February, with the majority of stores rolling out at the same time as our new pharmacy management and record (PMR) system, in which we have developed an integrated FMD solution. This will bring additional patient safety checks as well as FMD compliance,’ the spokesperson added.
LloydsPharmacy said it it has’a robust roll out plan but have advised the General Pharmaceutical Council (GPhC) that not all our stores will be compliant by 9th February’.
It has been ‘distributing the hardware to our stores in readiness for FMD’ but wants to ‘make sure that our colleagues are familiar with the process before we introduce additional steps in their already busy day’.
‘Pilot stores will provide feedback that informs the roll out but we want to make absolutely sure that our teams are comfortable before the system goes live,’ it added.
Deadline day ‘not a cliff edge’
The GPhC told The Pharmacist that pharmacies found not to be meeting FMD requirements during premises inspections may face regulatory action, including improvement action plans.
GPhC director of insight, intelligence and inspections, Claire Bryce Smith, said: ‘In our discussions with pharmacy owners and pharmacy teams we have said that we do not see the implementation date of 9 February as being a “cliff edge”.’
‘If during an inspection in the following months we identified a pharmacy that was not meeting all of the requirements relating to FMD, we would be looking to understand the reasons why and seeking evidence that there was a clear plan in place.’