The UK FMD Working Group for Community Pharmacy has said no sanction of any nature should be handed down to pharmacists who are guilty of “isolated non-compliance” of the Falsified Medicines Directive (FMD) such as failing to scan a product because that would “not undermine the integrity of the system.”
Responding to a consultation by the Medicines and Healthcare products Regulatory Agency (MHRA) on implementation of the safety features of FMD, the group said that, besides intentional fraud and other exceptional situations, non-compliance should be met with civil not criminal sanctions.
However, the group stressed that isolated non-compliance did not warrant sanctions at all and called on implementation of the Directive’s safety features to be based on a “proportionate and risk-based approach.”
From February 9 next year community pharmacists will be required to scan the barcodes of all medicines at the point of dispensing and check the anti-tampering device under FMD.
The directive is due to come into place just weeks before the UK leaves the European Union on March 29.
In its response the FMD working group said: “We agree with the proposal that, other than in exceptional circumstances, such as intentional fraud, civil rather than criminal sanctions are used to deal with non-compliance. We believe that any sanctions must be fair and proportionate.
“Isolated non-compliance, such as failures to scan products, do not undermine the integrity of the system, which has been designed to remove the economic incentive to insert falsified medicines into the supply chain. It would therefore be inappropriate to apply any sanctions for isolated failures to comply.
“Currently, community pharmacy contractors face a great deal of uncertainty in regard to the financial, operational and patient safety impact of FMD and the exit of the UK from the EU amplifies the uncertainty and potential risk.
“Overall, the working group believes there should be a proportionate and risk-based approach to the implementation of the safety features part of the Directive that allows patient safety and integrity of the supply-chain to be assured while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy.”
The group also called for the same authentication requirements under FMD to apply across primary care.
“We therefore suggest that dispensing doctors must face the same requirements as community pharmacies. We ask whether the requirements will also apply in instances of direct supply from the manufacturer to GP surgeries, including flu vaccinations and any other medical supplies,” the group said.
They went on to suggest the proposals could lead to “an inequity between hospital outpatient pharmacies, with some being required to authenticate at the time of supply to patients and others being able to undertake this process at an earlier point. This anomaly should be addressed.”
Despite uncertainty over FMD generated by Brexit, Raj Patel, the chairman of the UK FMD Working Group for Community Pharmacy (pictured), warned community pharmacists to begin planning for the directive now.
“The working group’s position has not changed and we urge people to engage with FMD. The community pharmacy sector needs to move quickly,” he said.
“Irrespective of any Brexit confusion and whatever our post-Brexit position might be, we need to have a viable solution by the February 9 deadline.
“FMD aims to make medicine falsification detectable and uneconomic. We recognise contractors will need to make substantial time and investment, but it is important that community pharmacy meets its obligations. I urge all community pharmacies to start planning for FMD now.”
The UK FMD Working Group for Community Pharmacy is made up of the Association of Independent Multiple Pharmacies, Company Chemists’ Association, Community Pharmacy Northern Ireland, Community Pharmacy Scotland, Community Pharmacy Wales, National Pharmacy Association and Pharmaceutical Services Negotiating Committee.