The Falsified Medicines Directive (FMD) – which came into force on February 9 – requires all pharmacies to scan barcodes on medicines packaging at the point of dispensing.
However, the FMD is “currently in the ramp-up and stabilisation phase” and pharmacies should continue to expect error messages until all stakeholders – pharmacies, wholesalers, manufacturers, parallel distributors and software suppliers – adjust to the directive, Jerome Bertin, general manager at SecurMed, the non-profit organisation that manages the UK’s medicines verification systems, told C+D.
The Medicines and Healthcare products Regulatory Agency (MHRA) explained that one common error message occurs when pharmacies “try to scan 2D barcodes that do not relate to FMD safety features”.
SecurMed added: “A significant amount of non-FMD compliant packs still exist in the UK supply chain and will be dispensed before FMD-compliant medicines fully replace these.”
The UK FMD Working Group for Community Pharmacy – which is managing the rollout – warned the day before the FMD came into force that “many ‘false positive’ alerts” were expected to be generated when pharmacy teams attempt to scan and decommission medicines.
The two most common error messages are “unknown product code” and “failed to find batch”, the group explained at the time. These are most likely to be caused by manufacturers not uploading relevant data to the system and do not necessarily indicate a falsified medicine.
When asked by C+D how false alerts can be differentiated from genuine alerts, Mr Bertin said SecurMed has a team that “continually reviews alerts” to determine which are false positives, before submitting them to the MHRA for investigation.
“The system does allow manufacturers to issue a recall [and] pharmacies scanning medicines that have been recalled would be automatically notified of this by the system,” he explained.
The MHRA said data and system suppliers are currently working to resolve “a small number of Europe-wide issues causing the problem” of false alerts, while it is working with stakeholder groups to create guidance for community pharmacies on managing the messages.
More than 10,000 pharmacies compliant
A total of 10,172 community pharmacies across the UK were FMD compliant as of July 5, according to SecurMed.
Raj Patel, chair of the UK FMD Working Group, said this shows community pharmacies’ “commitment to patient safety, even in light of Brexit and funding uncertainties”.