General Pharmaceutical Council (GPhC) chief executive Duncan Rudkin has attempted to assure pharmacists anxious about their legal requirement to fulfil the Falsified Medicines Directive (FMD) by promising the regulator will “take a pragmatic and proportionate approach” to implementation.
The medicines supply chain safeguard, which will require pharmacists to scan the barcodes of all medicines at the point of dispensing and check the anti-tamper device, comes into effect tomorrow.
There have been concerns that few packs of medicines in the supply chain will initially have the new FMD safety features and some that do may still return an alert from the FMD database.
The National Pharmacy Association advised its members that most medicines can still be dispensed even if they return an alert and said medicines should only be withheld if there is “a clear indication they are counterfeit.”
Last month the GPhC said it would use its inspections to see if pharmacies are meeting the requirements of FMD. Rudkin (pictured) tried to assuage lingering concerns that the regulator might instantly apply sanctions on pharmacists.
“We recognise that not all pharmacies will be meeting the legal obligations of FMD straight away. We intend to take a pragmatic and proportionate approach to the implementation of the new safety features,” he said.
“When inspecting a pharmacy, our inspectors would consider all of the relevant evidence, including whether the pharmacy had a clear plan in place to meet all of the requirements of FMD, before deciding whether or not the relevant standard had been met.”
Last year the UK FMD Working Group for Community Pharmacy said pharmacists guilty of “isolated non-compliance” of FMD such as failing to scan a medicines pack should not be handed any sanction.
Paul Bennett, the chief executive of the Royal Pharmaceutical Society, said: “We welcome the pragmatic approach taken by the GPhC in relation to FMD, which we hope will provide some assurance to our members in pharmacies that are still working towards meeting all of the requirements relating to FMD.
“The RPS has produced a guide to FMD to support members and we are also here to answer any queries that members have.”