The Falsified Medicines Directive (FMD) – created to prevent counterfeit medicines from entering the supply chain – will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019.
Software supplier FMD IT said an “alarmingly high” number of pharmacies – as much as a third of the sector – “don’t believe” the FMD is going to happen and “don’t understand” it, managing director Gareth Dunsmore told C+D last month (August 21).
As a result, “I suspect there will be a bottleneck as there's a last-minute rush towards compliance”, Mr Dunsmore said.
Some larger companies that have ordered “a couple of hundred scanners” through the company are waiting six weeks for them to be delivered, Mr Dunsmore added.
Another sector supplier, PharmData, estimated that “about 40% of pharmacies don’t have an idea as to what [FMD] solution they’ll put in place yet”, co-founder Oliver Staunton told C+D yesterday (September 12), and only “a very small proportion [are prepared]”, he continued.
Mr Staunton agreed there could be a bottleneck as the deadline approaches, with some pharmacies waiting until January to look for a solution.
Independents less prepared
The unprepared pharmacies are mostly independents with one branch, FMD IT’s Mr Dunsmore claimed.
Only 1% of the community pharmacies that the company has worked with are independents, with the “vast majority” of enquiries coming from groups with at least 10 branches, he said.
PharmData’s Mr Staunton warned “independents probably will be more lost” in preparing for the FMD. “A lot of independents” won’t understand it until the “last minute”. There is a “lot of confusion for pharmacies about what to do or when to do it”, he added.
“Lack of awareness and guidance”
A third supplier, EMIS Health, said there still remains a “lack of awareness and guidance” around the EU legislation.
“There needs to be a significant drive by government to raise awareness of the FMD, and support pharmacies with the implementation and change of standard operating procedures associated with the directive,” general manager Shanel Raichura said.
“One area that requires urgent review is the onboarding process that community pharmacy needs to undertake ahead of February 9, 2019.”
Another supplier, Cegedim Rx, told C+D “there are still concerns from customers about costs, funding and operational impact”.
NPA: Pharmacies must comply with FMD
The National Pharmacy Association (NPA)’s head of corporate affairs Gareth Jones stressed that “community pharmacies must comply with the FMD” by the deadline, despite the “uncertainty over Brexit”.
“Our advice is: Get ready, but avoid signing any long-term contracts,” Mr Jones said.
“Meanwhile, we’re hopeful the Pharmaceutical Services Negotiating Committee…will negotiate reimbursement. The costs of regulatory burdens should be a matter for governments.”