One in four UK pharmacies are not yet registered with the UK’s central Falsified Medicines Directive (FMD) hub six months after the implementation deadline, The Pharmacist has learned.
The directive, which came into force on 9 February, is a pan-European regulation that requires pharmacies to decommission and verify the authenticity of medicines using barcode scanning software before they are dispensed to patients.
There are 14,299 pharmacies currently registered with the General Pharmaceutical Council (GPhC) in England, Scotland and Wales and 550 registered with the Pharmaceutical Society of Northern Ireland (PSNI), according to the latest figures obtained by The Pharmacist.
A quarter (26%) of these 14,849 UK pharmacies are not yet fully registered with SecurMed, according to the latest statistics posted on its website on 23 August.
A SecurMed spokesperson said pharmacists may be using Brexit as an excuse for non-compliance.
Two large pharmacy multiples are piloting FMD before a full rollout and make up ‘a large proportion’ of the 3,856 outstanding registrations, said SecurMed general manager Jerome Bertin.
He added: ‘Of the remainder, we do not have any reasons they are not registering other than Brexit. We assume many are looking at the no-deal scenario as a way to avoid having to make the investment at all.’
In the event of a no-deal Brexit, the Government will withdraw the FMD legislation and UK stakeholders will no longer need to comply with the directive, according to SecurMed.
Prime Minister Boris Johnson has now admitted that the likelihood of achieving a Brexit deal with the EU is ‘going to be touch and go’.
‘Obligation to comply’
However, the GPhC highlighted that at the moment ‘there remains an obligation to comply’ with the FMD legislation and said it is working with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure pharmacies meet the requirements.
A spokesperson said: ‘We recognise that not all pharmacies are meeting the legal obligations of FMD straight away and so we are taking a pragmatic and proportionate approach as pharmacies work towards implementation of the new safety features.
‘Inspectors will consider all of the relevant evidence, including whether the pharmacy has a clear plan in place to meet all of the requirements of FMD, before deciding whether or not the relevant standard had been met.’
The regulator will ‘continue to engage’ with the non-compliant pharmacy chains to receive updates on their progress with implementation of FMD, the spokesperson added.