Associate blog post from Grant Courtney, Principle Consultant
It’s been 14 months since EU FMD came into force and after initial problems bedding in the new systems, false alerts remain a problem preventing the realisation of the full benefits of the directive. With many grace periods now coming to an end, where are manufacturers on the EU FMD journey and what are the real consequences of unresolved alerts moving forward? Grant Courtney, Principle Consultant at Be4ward, examines the reasons behind these alerts occurring and looks at the action stakeholders must take now to keep the supply chain flowing.
On the 9th February 2019, new legislation was introduced within the EU with the aim of increasing patient safety by preventing falsified products from entering the pharmaceutical supply chain. The EU Falsified Medicines Directive (2011/62/EU) or EU FMD as it is known, called for a significant overhaul to the existing pharma supply chain system, requiring the establishment and implementation of new organisations and systems needed to authenticate every medicine distributed across the European market.
Initially most of the stakeholder effort was focused on meeting the compliance deadline. For manufacturers this included upgrading productions lines, putting in new IT systems, establishing new processes and running regulatory pack change programmes. Products were generally ready in time across the industry and from the 9th February 2019, as per the directive, all packs which were released onto the market carried a 2D data matrix barcode with a unique identifier (serial number) encoded, along with a tamper evident feature to ensure the integrity of the pack. It would be wrong to believe that hitting the compliance deadline was the end of the journey. In many respects, February 2019 was just the starting point for the EU FMD.
Over 130 million prescribed packs are now scanned every single week. The scale of the systems is impressive, and the EU FMD has fundamentally changed the way in which prescription medicines are manufactured and how they are managed prior to dispensing. These changes present an even greater challenge than the technical ones already encountered, and the implications and impacts are only just starting to surface 12 months in.
For most of the millions of packs being dispensed each day, the pharmacists receive positive confirmation that the unique identifier is valid and, in a status, may allow the pack to be dispensed. When this occurs everything runs smoothly, however not all scans end with a positive confirmation.
The EU FMD systems are designed to identify any unique identifier on a pack which is not in the system or has a status which means it should not be dispensed. When a pack fails to authenticate, the system generates an alert which is distributed to several stakeholders including an alert to the Market Authorisation Holder (MAH).
Alerts generated by the system due to the unsuccessful authentication of a pack are vital as they flag a potential falsified product, allowing action to be taken to address the reason and any potential criminal activity. An alert raises concern over the quality and authenticity of the product, preventing it being dispensed to the patient.
Initially the level of alerts being generated were very high, running at about 6% of all scans. Many of these alerts were false due to two main causes. Firstly, some manufacturers had not managed to upload all the serial numbers into the European Medicines Verification System (EMVS) so missing data was triggering errors. Secondly, the pharmacy systems had not been configured correctly and were introducing errors into the decoded barcode data. These errors included converting upper case characters into lower case and interpreting dates incorrectly.
During the past year, most authorities have taken a lenient view on the alerts, understanding that new software and processes have to stabilise and become embedded. In recognition of this many operated a period of stabilisation, whereby packs that triggered an alert could still be dispensed at the discretion of the pharmacist.
Many of these early problems have now been resolved, consequently the level of alerts has reduced to around the 1% mark as an average across EU countries. However, this level is still considered too high with many false alerts still taking place. It will be progressively more difficult to reduce this further and we can expect this to take many months more to resolve.
In part two of the blog, we examine in more detail the process that happens when an alert is triggered, what manufacturers should be doing and what's coming next in the EU FMD journey.
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