On the 9th February 2019 the EU FMD legislation came into force, with the objective of preventing falsified products entering the supply chain and reaching patients.  From that date, prescription medicines released into the supply chain had to carry two new features, a unique identifier (UI) and tamper evidence.  The principle was simple in concept, both these new features must be checked prior to the point of dispensing in a hospital or at the point of dispensing in a community pharmacy. 

In practice this was very ambitious and required the establishment of IT systems across the EU, securely holding millions of UIs so that a barcode on the medicine’s packaging could be scanned and the UI verified.  A failure to find a matching UI in the IT systems or a duplicate UI could signal a potential falsified pack.

Despite the amount of effort and investment required by all stakeholders, the February 2019 deadline was met and 18 months later  the European Medicines Verification System (EMVS) is checking around 160 million UIs per week and the systems have successfully detected actual falsified products.

As one of the members of the original EFPIA working group, tasked with looking at the prevention of falsified medicines in Europe, I have worked within  this space for around 12 years.  The success of the legislation and systems is therefore of great significance to me, on both a professional and personal level.  Therefore when EFPIA approached me to deliver this report, I was delighted to get involved.

The EU FMD has brought about the standardisation of medicinal product identification and common 2D barcodes on all prescription medicine packs.  The 2D DataMatrix barcodes now contain four important pieces of data about the product: product code, serial number, batch/lot and expiry date.  This level of standardised barcodes, along with the data they contain, has the potential to enable hospitals to leverage further benefits, which were difficult to achieve before this level of harmonisation and barcoding prevalence.

Having the chance to visit hospitals that  had implemented the EU FMD, provided valuable  first-hand insights into the challenges of EU FMD implementation, but also demonstrated how the new 2D DataMatrix was opening up opportunities for them.  Hospital staff were keen to talk about how they planned to reduce the operational impacts of the EU FMD, but more importantly how they intended to leverage the EU FMD 2D DataMatrix moving forward.

Following the flow of the product through the hospital supply chain showed that benefits existed at all points; where the EU FMD pack is handled, stored and processed including in Logistics, Manufacture & transformation and Clinical.

Secondary research also showed that the use of barcoding and product identification brings impressive financial benefits to those hospitals which leverage them.  In one hospital alone they were able to save over €4 million through the reduction of over-ordering products.  These savings can be used to offset the costs of implementing and operating the EU FMD within the hospital setting.

Applications of a standardised 2D barcode go beyond supply chain efficiencies and increasing patient safety, having impacts on clinical effectiveness and new payment models.  These barcodes even open up the opportunity to digitally web-enable products, allowing the provision of live data and services directly to the healthcare provider, something that several of the clinicians interviewed were very keen to see in future.

With the EU FMD firmly in place and helping to address the issue of falsified products, I am looking forward to seeing how healthcare providers can continue to leverage the use of the 2D DataMatrix to bring benefits beyond the EU Falsified Medicines Directive, within the hospital setting.

To learn more about the benefits of the EU FMD within the hospital setting and access the report click here.