LEGISLATION
FALSIFIED MEDICINES DIRECTIVE: ARE YOU PREPARED? W
hile the pharmaceutical industry is one of the most regulated industries in the
world, an estimated one per cent of this billion items annually dispensed in the UK may be counterfeit, meaning 20 million packs of falsifi ed medicines are in circulation every year. The European Union’s response to this threat to the formal supply chain is FMD, the Falsifi ed Medicines Directive.
Leading pharmacy IT developer Positive Solutions, working in partnership with pharmacy automation specialists BD Rowa Technologies, is already actively
10 - SCOTTISH PHARMACIST
engaging in the delivery of a series of workshops to demystify the realities of FMD.
‘The elephant in the room is FMD,’ says Mark Merry, Head of Product Development for Positive Solution, ‘and it’s not going away.’
The Medicines and Healthcare products Regulatory Agency (MHRA) has been given ministerial guidance that the UK will apply all EU safety of medicine regulations in the UK during the next two years, prior to our planned departure from Europe.
It may seem to those outside
pharmacy that the introduction of FMD legislation is purely policymakers wanting to be risk averse. Many within the profession argue that the proposals create yet another burden increasing the workload of an already heavily regulated sector of healthcare. On the other hand, this legislation could be a catalyst for the implementation of more integrated pharmacy IT systems. In addition, this would deliver the capability to generate considerable amounts of consumer data and the introduction of greater digital safety measures for patients when taking medication.
Just how compliant community pharmacies will need to be from the outset is still unclear. Drug manufacturers can (and are)
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‘We have been actively engaging with a wide range of stakeholders in order to interpret the likely regulations due to come into effect in February 2019,’ continued Mark. ‘From our discussions with the UK FMD Working Group, we know FMD is defi nitely happening - no cancellation, no Brexit opt out and no delay in its enactment – and there’s a lot of clarifi cation required between now and the introduction of this legislation.’
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