Medicines regulation and law
Pharmacy multiples to ensure FMD compliance 'as soon as practicably possible'
The Falsified Medicines Directive will come into force across the EU on 9 February 2019 but the UK’s biggest pharmacy multiples are unable to implement the necessary software and hardware in time.
Pharmacy multiples in the UK have admitted they are unlikely to be ready for full implementation of the Falsified Medicines Directive (FMD) before it comes into force across the EU on 9 February 2019.
The directive, which will see pharmacists verifying the authenticity of all prescription medicines, has come at a “challenging time”, according to the head of the representative body for large pharmacy operators, but he added that pharmacy chains would “go live” with their FMD processes as soon as “practicably possible”.
In early February 2019, The Pharmaceutical Journal revealed that it was likely that less than half of pharmacies in the UK would be fully ready by the FMD implementation date, but the Medicines and Healthcare products Regulatory Agency (MHRA) has said it will take a “pragmatic approach”, working with stakeholders to help them achieve compliance.
The General Pharmaceutical Council (GPhC) has said it does not see 9 February 2019 as a “cliff edge” date and that if, during an inspection, a pharmacy was found not to be fully compliant, it would look to understand the reasons why and seek evidence that there was a clear plan in place.
Malcolm Harrison, chief executive of the Company Chemists’ Association (CCA), said: “Our members are working towards full preparedness for FMD. Like all contractors, they are doing so at a challenging time for community pharmacy with well-documented funding pressures and specific uncertainties around FMD caused by the UK’s exit from the EU.
“We also recognise other practical challenges around the implementation of FMD, such as the availability of medicines that have the correct safety features on their packaging, and that have been uploaded on to the UK Medicines Verification System. We are confident that all contractors and marketing authorisation holders will continue to work with SecurMed and systems suppliers to deliver full implementation of FMD as soon as is practicably possible.”
A spokesperson for LloydsPharmacy told The Pharmaceutical Journal that the multiple has been distributing hardware to its stores in readiness for FMD and has “a robust rollout plan” in place, but has advised the GPhC that not all stores will be compliant by 9 February 2019.
They said: “We want 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 rollout, but we want to make absolutely sure that our teams are comfortable before the system goes live.”
Likewise, a spokesperson for Rowlands Pharmacy said that while the chain was doing its best to “implement FMD by 9 February  … there are considerable logistical and staff issues to be considered”.
All Rowlands pharmacies had, the spokesperson said, registered with SecurMed and by 9 February 2019 all will have the necessary hardware. “The rate at which branches ‘go-live’ will depend on the outcome of our 17 pilot sites, which will inform our deployment strategy,” the spokesperson added, noting that “the efforts we have made are in line with GPhC and MHRA expectations, given the scale and complexity involved”.
Well Pharmacy is “working towards all [of its] stores being FMD compliant”, according to Matthew Gabbitas, change operations manager at the multiple. “We are taking the change in legislation seriously and we’re working hard to test, learn and review the processes to ensure we get it right.”
In September 2018, some suppliers of FMD hardware solutions warned that pharmacies who leave it until the last minute to purchase solutions may face price hikes.
Cegedim Rx, which supplies software and hardware within the UK, said that FMD hardware prices “have not changed since the solution was first launched”, and that it had “been working closely with [its hardware supplier] to forecast demand to mitigate any risk of [shortage-related price rises] occurring”.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206114
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