LEGISLATION
faLSIfIED mEDIcInES DIrEctIVE: arE YoU PrEParED?
onE of thE BIggESt conSIDEratIonS for commUnItY PharmacY IS thE ProcESSIng of morE than a BILLIon PrEScrIPtIon ItEmS EVErY YEar.
W
hilst 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 falsified medicines in circulation every year. the EU’s response to this threat to the formal supply chain is fmD, the falsified medicines Directive.
Leading pharmacy It developer Positive Solutions, working in partnership with pharmacy automation specialists BD rowa technologies, is already actively engaging in the delivery of a series of workshops to demystify the realities of fmD.
28 - PharmacY In focUS
‘the elephant in the room is fmD,’ says mark merry, head of Product Development for Positive Solutions ‘and it’s not going away.’ the medicines and health 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.
‘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 definitely happening - no cancellation, no Brexit opt out and no delay in its enactment – and
there’s a lot of clarification required between now and the introduction of this legislation.’
Just how compliant community pharmacies will need to be from the outset, is still unclear. Drug manufacturers can (and are) introducing fmD compliant packs into the market already, ahead of the february 2019 launch date.
fmD aims to provide a secure supply chain from manufacturers through wholesale to dispensing and ultimately, the patient. although patient safety is driving the need for fmD, it would be unfair to expect community pharmacies to be 100 per cent compliant from day one, when only a relatively small number of
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