Pharmacies in the dark over FMD implementation

Pharmacies in the UK are warning they are unprepared to meet Falsified Medicines Directive requirements by the February 2019 deadline, it has been revealed.

According to the publication Chemist and Druggist, the three largest chain pharmacies – Lloydspharmacy, Boots and Well – have claimed there is a lack of information and clarity around the FMD's requirement to implement barcode scanners in every pharmacy by the deadline.

They also described the FMD deadline as "not realistic" and there was concern over the requirement's impact on pharmacy business.

Under the FMD, which aims to prevent counterfeit medicines entering the European supply chain, pharmaceutical manufacturers must apply safety features to medicines packs to ensure authenticity and supply chain traceability. This includes a 2D barcode and a tamper-proof security seal.

From February 2019, pharmacies will be required to scan the barcodes of all medicines packs at the point of dispense, where the information will be sent to a European database for authentication. Pharmacies will also be required to check the integrity of tamper-proof devices on the packaging.

The shift in practice requires new systems and ways of working for pharmacies, including the introduction of scanning machines and compatible IT systems.

According to the pharmacies Chemist and Druggist spoke to, the industry has been left in the dark regarding the new requirements' implementation.

David Hamilton, commercial director at Well, said the pharmacy "urgently needs greater clarity on the detailed requirements of FMD".

He said the pharmacy was in discussions about the implementation of scanners and was "evaluating" how the FMD could impact internal systems and processes, noting that the work required to meet the new regulations was "huge".

"We are urging key stakeholders to consider the most effective implementation strategy for the UK, and acknowledge that the February 2019 deadline is not realistic," he said.

Danny McNally, head of prescription assembly solutions at Celesio UK, parent company of LLoydspharmacy, said the firm does "not have the necessary level of detail to make important business decisions, especially around how the directive is interpreted and adopted in the UK for community pharmacies".

"We are in the process of building the required IT system architecture. However, there are still some fundamental decisions to be taken by the competent authorities in the UK, which impact on the sector's ability to meet the timetable for full implementation."

He said the pharmacy was still waiting for further guidance.

Boots also told Chemist and Druggist is was seeking to understand what was required for FMD implementation.

In an interview with the Pharmaceutical Journal last year, Aileen Bryson, practice and policy lead at the Royal Pharmaceutical Society in Scotland, said there were still a lot of questions around how the FMD requirements would work for pharmacies and how they would be financed.

"A lot of thought is going to have to be given to the practicalities of implementation to make sure that access to medicines is not hampered in any way for patients. If there are any gaps in the system that's where the counterfeiting will take place."

Meanwhile, a study earlier this year, showed the FMD's barcode scanning requirements posed an implementation problem for hospital pharmacies where scanning rates were below expectations. According to the pilot study at an NHS teaching hospital, one in five serialised, coded packs were not scanned at the point of dispense, while alerts generated by rogue drug packs were not acted on and quarantined.

Many in the pharmacy industry have expressed concern that the FMD regulations are incompatible with British pharmacy and healthcare systems, while the uncertainty around Brexit has muddied how the FMD will be implemented in the UK even though it is now part of UK legislation.

Last month, SecurMed – the UK medicines verification organisation tasked with implementing and managing the FMD in the UK – announced Arvato Systems would be the IT service provider implementing the verification system for the February 2019 deadline.