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Falsified Medicines Directive

First hospital pharmacist to decommission under FMD warns of flaw in system

Pharmacist Alex Jennings warns that if data are not properly uploaded to the national verification system, pharmacies could end up “full of unknown stock”.

Medicine being scanned into computer

Source: Courtesy of Alex Jennings

This pack of insulin is thought to be the first medicine in the UK to be processed under Falsified Medicines Directive standards

A hospital pharmacist who is thought to be the first person to decommission a medicine under the Falsified Medicines Directive (FMD) in the UK has warned that the system could be ‘undermined’ by medicine packets that carry FMD hardware, but are not registered with the national medicines verification system (NMVS).

In December 2018, the National Pharmacy Association announced that Market Pharmacy in Bolton was the first community pharmacy in the UK to become fully FMD-compliant, successfully decommissioning and recommissioning a medicine. 

However, The Pharmaceutical Journal has now learned that a pack of insulin was processed under FMD procedures on 11 November 2018, at Aintree University Hospital NHS Foundation Trust — making this, as far as can be established, the UK’s first registered decommission of a medicine. The insulin pack was decommissioned at 14:29 by Alex Jennings, assistant clinical director of pharmacy at the hospital. Jennings also developed the software that Aintree University Hospital uses to decommission medicines. 

“I spent two days searching for stock that we held [which had been uploaded to the NMVS] and eventually, after many failed scans, I came across the Lilly range of insulin,” he said.

However, Jennings highlighted an issue that he believes could “undermine FMD” for pharmacists who need to decommission medicines at the point of supply to a patient: he said that he has encountered medicine packs that carry the 2D barcode and associated safety features required by FMD, but that were not recognised by the NMVS.

He told The Pharmaceutical Journal: “Many [packs] are starting to appear with 2D barcodes. A smaller cohort have both the 2D barcode and the security seal. Theoretically, these could be on the NMVS; but so far I have only found two product ranges to be on it. Are the manufacturers going to upload all FMD-compliant data at a later date?

“The biggest problem, longer term, is scannable stock that is not in the system.”

Jennings is concerned that pharmacies could be “full of unknown stock”.

Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance and an expert on FMD, said that since the directive is not yet in force, it is not illegal for manufacturers to send out packs without having first uploaded the pack data to the NMVS. He said that anyone experiencing the issues that Jennings described should inform SecurMed or the Medicines and Healthcare products Regulatory Agency.

 

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20205959

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