The implementation of European anti-counterfeiting measures could cost pharmacists thousands of pounds, a major wholesaler has predicted.
Under the Falsified Medicines Directive (FMD) – which the UK must bring into force on 9 February 2019 – all packs of prescription drugs will have to bear a two-dimensional barcode with a unique serial number and anti-tamper device as a means to tackle counterfeit medicines and enhance patient safety. Pharmacists will have to scan each pack of medication before it is dispensed.
Sigma Pharmaceuticals Plc director Bharat Shah told The Pharmacist that he predicts community pharmacists could pay up to £3,000 just for the barcode scanners, which will be necessary to read products under the FMD
The verification software in the UK is being supplied by not-for-profit legal entity SecurMed. Its general manager, Jerome Bertin, told The Pharmacist that he couldn’t tell whether the costs suggested by Mr Shah were ‘realistic’.
Mr Shah also predicted that the implementation of FMD would be delayed by one to two years.
‘Between £2,500 and £3,000’
But pharmacists will likely have to pay more money on top of the initial software costs, according to Mr Shah.
He continued: ‘In my opinion, if a pharmacy has three or four scanners, hardware and software, [costs] could be in the region of anywhere between £2,500 and £3,000, as a one-off payment.
‘Training is going to be a cost too. Probably in the region of £500-£1,000 and maybe a few hundred pounds every year for ongoing training.’
Pharmacies will be required to pay for any physical scanning equipment and software to read the unique identifiers and decommission the products – a process that will prevent products from being authenticated by any other dispensing entity – as current scanners used for one-dimensional barcodes won’t read the new barcodes.
Mr Shah also argued that FMD will increase pharmacists’ workload ‘without fail’, as it will be an extra process ‘they are not doing now’.
He added: ‘This is an extra thing they [pharmacists] would be obliged to do. But in which way, we don’t know yet.’
The MHRA recently told The Pharmacist that a public consultation, which includes an impact assessment looking at the various costs associated with the implementation of FMD in the UK, will be published ‘in the coming weeks’.
Want to hear more about about FMD? Join us at Pharmacy Forward on 10 June where Raj Patel MBE, chair of the UK working group for FMD, will be speaking on what this critical subject means for you