Oxford University Hospitals pilots FMD compliance system

Oxford University Hospitals will pilot a new medicine verification system in readiness to comply with the impending EU Falsified Medicines Directive, after studies revealed low compliance rates among hospital pharmacists.

The NHS Foundation Trust has signed a deal with Canadian-based medical track and trace service provider Optel, which will see the group of hospitals pilot Optel’s Certa system to aid verification of pharmaceuticals in hospital pharmacies.

The system, which performs 2D datamatrix barcode verification and decommissioning of prescription medication, can connect with the National Medicines Verification System across countries within the European Union, and will enable Oxford University Hospitals to comply with the Falsified Medicines Directive (FMD), which comes into force on 9 February 2019.

The FMD requires pharmaceutical manufacturers to apply safety features to medicines packs including a 2D barcode and tamper-proof security seal to ensure authenticity and supply chain traceability. Under the legislation, pharmacies are 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.

“Legislations like these represent a turning point in the healthcare industry, and this project can help evaluate user adoption and determine best practices for compliance in real-world scenarios,” Korina Fischer, vice president of healthcare at Optel said in a statement. “We are extremely pleased and honoured that Oxford University Hospitals, one of the best research hospitals in the world, chose to collaborate with Optel, and we look forward to working with them on this.”

The pilot builds upon UK studies led by Bernard Naughton, a clinical pharmacist and researcher of falsified and counterfeit drugs from Keele University, which were published last year in the BMJ OPEN journal.

An initial study found hospital pharmacies had low compliance rates of verifying product codes on medicine packs, with one in five packs not being scanned and, in some cases, packs marked as expired, recalled or counterfeit were not quarantined. The authors noted the finding “poses significant quality and safety issues with this detection approach”.

As a follow-up, the researchers explored the reasons for the lack of compliance with the requirements, concluding that small changes to the alerting system can have profound impacts on dispenser behaviour.

The results found that the authentication platform – set up by Aegate and the only system in place in the UK at the time of the research – was rapid and user friendly, but participants noted concern about the similarity of warning messaging.

The authors suggested sounding an audible signal if a counterfeit medicine is encountered, which would be harder to ignore than a pop-up warning. They also suggested making it mandatory to complete an “action taken” documentation process.

The authors also recommended that authentication technology providers test their technology in a closed loop and real-life environment prior to national implementation to ensure that operators respond appropriately to the messaging being displayed.

While full details of the Oxford University Hospitals’ pilot project design and outcome measures have not been made public, it is expected the project will act as a significant case study to help identify, implement and validate the most effective way to decommission the high volume of medications that go in and out of hospital pharmacies.

In addition, it will help define how hospital management teams can use the FMD requirement to improve patient safety, Bhulesh Vadher, clinical director of pharmacy and medicines management at Oxford University Hospitals, said.

“This is a massive opportunity to streamline processes and attain our ultimate goal of closed-loop medication management,” he said. “It’s a key step in ensuring that we meet the World Health Organisation’s Third Global Patient Safety Challenge: Medication Without Harm and that patients are given the safest possible care.”

Study author Bernard Naughton added: “There are a number of different actions that need to be aligned to meet the February 2019 FMD deadline; however, the solutions and processes implemented for FMD compliance will also present great benefits both in terms of workflow operations and patient safety.”

However, in August last year, pharmacies warned they were unprepared to meet the FMD requirements by the February 2019 deadline, a Chemist and Druggist report claimed. According to the publication, Lloydspharmacy, Boots and Well said there was a lack of information and clarity around the FMD requirement to implement barcode scanners in every pharmacy by the deadline, which they described as “not realistic”.

And at the end of last year, a survey by the Pharmaceutical Journal found that 27 per cent of UK pharmacists were unaware of the date the FMD comes into force, while almost three-quarters of those who did have the date in their diaries said they did not fully understand how the EU supply chain security legislation would affect their work.