Safety features that are due to come in under the Falsified Medicines Directive (FMD) must not compromise the integrity of the supply chain or delay the passage of medicines to patients, the Company Chemists’ Association (CCA) has warned.
From February 9 next year pharmacists will be required to scan the barcodes of all medicines at the point of dispensing and check the anti-tampering device, a regulation that comes into effect just weeks before the UK leaves the European Union on March 29.
In its response to a consultation by the Medicines and Healthcare products Regulatory Agency, the CCA called for “a proportionate and risk-based approach to the implementation of the safety features aspect of the Falsified Medicines Directive.”
“This is in order that patient safety and integrity of the supply-chain can be assured, while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy,” the CCA said.
The body said it was concerned that pharmacy businesses were having to enter into legal agreements and commit to financial investments in IT, staff training and other areas to the backdrop of uncertainty over how long FMD will be in place given ongoing Brexit negotiations.
CCA chief executive Malcolm Harrison said: “Our priority for FMD is to ensure patient safety and integrity of the supply chain are maintained as the UK leaves the EU, while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy.
“Our members are all working hard to ensure they will be compliant with FMD once it takes effect in February.”
He added: “We agree with the FMD Working Group that the government must be open and transparent with the pharmacy sector. This is to ensure that community pharmacy, which is already financially challenged, is not required to invest in FMD systems if they will not be needed in the future.
“If community pharmacies remain required to comply with these new aspects of the Directive, we believe the additional cost burden should be taken into account within any new NHS funding settlement.
“In the event of the UK medicines verification system being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.”