Pharmacists should not necessarily believe ‘rumours’ that the UK’s implementation of a pan-European anti-counterfeiting barcode scanning system will be delayed, the National Pharmacy Association (NPA) has said.
NPA board member Raj Patel stressed that the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) have both been ‘clear’ that the UK must be compliant with the Falsified Medicines Directive (FMD) by February 2019.
The ‘deeply frustrating silence’ from the Government on the details of the FMD makes it ‘quite impossible’ for pharmacists to invest in preparing for the directive, Mr Patel – who is also chair of the UK’s FMD Working Group – told The Pharmacist.
He said: ‘But [this] doesn’t necessarily follow the Government will shift the deadline. There is an argument for delay – but this is a complex EU-wide project and it is unlikely that there will be a change in the legal timetable.’
The MHRA said it has been working with the Department of Health and Social Care (DHSC) and the FMD working group to implement the initiative and provide guidance on it.
It said: ‘We recognise the challenges and complexity and have been working with a wide variety of stakeholders including community pharmacy to deliver implementation.’
‘Still working to the deadline’
Wholesaler Sigma Pharmaceuticals Plc director Bharat Shah told The Pharmacist last week (11 April) that he expected FMD implementation to be delayed by at least one or two years in the UK because pharmacists are not ready to roll it out.
The MHRA told The Pharmacist at the time that it is ‘certainly not looking to delay the roll-out of the delegated regulation for FMD in the UK’ and is ‘still working to the deadline’.
Mr Patel told The Pharmacist:‘We need to be careful of falling into the psychological trap of believing something to be true, just because we may wish it to be the case
‘FMD is coming to your pharmacy soon, and the clock is ticking.’
Under the FMD, 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.
Mr Shah also predicted that investing in the barcode scanners and training in how to use them will cost pharmacists thousands.
The general manager of SecurMed, which will supply the UK’s verification system, Jerome Bertin could not confirm whether or not this estimate was ‘realistic’.
Mr Patel encouraged pharmacists to read the FMD Working Group’s Way Forward for FMD in Community Pharmacy document, which covers key considerations about the directive.