The European Falsified Medicines Directive (commonly known as the FMD) aims to solve a serious problem – false or tampered-with medicines entering the European supply chain. At best, these products undermine confidence in genuine pharmaceuticals – at worst, they can be fatal.
So far, so good. But what does the FMD actually mean for your pharmacy? What should you expect? What do you need to do? We’ve written this blog as a top-line guide to help you understand the FMD better – and your role within it.
What does the FMD involve?
The core of the FMD states that, as of February 2019, all new packs of medicines must include two safety features. First, an anti-tamper device (ATD), which most of us will already be familiar with, and second, a unique identifier (UI), which will be in barcode form.
The UI is the bit we’re most interested in here. As part of the Directive, medicine manufacturers will upload all their valid UI codes to a centralised database in their specific country, which at this stage is being called a National Medicines Verification System (NMVS). Any time a product is known to have been tampered with, stolen, recalled or withdrawn, the central system will be updated. There will also be a single centralised European Medicines Verification System (EMVS), which will link the national systems together and allow parallel trading of medicines.
But what about Brexit?
Sure, Britain is leaving the EU – but the FMD has been in development for around a decade, and we have committed to following it. Because the FMD aims to reduce falsified medicines throughout the continent, it would be very difficult for Britain to avoid complying while still remaining part of the European supply chain.
What does it mean for my pharmacy?
The FMD will become part of the standardised dispensing process. As of February 2019, every time you dispense a new medicine, you will be required to scan the barcode UI on its packaging. This will automatically check the status of that medicine against the centralised system, and you will be alerted as to whether it can be safely dispensed or not. You will also need to check the integrity of the ATD.
From a technology point of view, this means that in less than two years’ time you will need to have barcode scanning capability installed as part of your existing patient medical record (PMR) system.
What should I be doing now?
The good news is – very little! At this stage, this FMD is a Directive rather than a confirmed law – which means that it has a stated aim and plan but no finalised explanation of how it will definitely work in practice. All the relevant legislative bodies are currently working with technology providers – like Positive Solutions – to develop the best system and framework for implementing the FMD.
It will ultimately be the responsibility of your PMR supplier to ensure that your system is updated in time to enable you to comply with the FMD. Positive Solutions is currently working with all of the major legislative bodies and manufacturers to ensure that we are absolutely up-to-speed on the FMD, and you can rest assured that our Analyst PMR system will be ready for the implementation of the Directive.
For now, the best thing you can do is keep yourself informed about ongoing developments and ensure you are always using the latest version of our software. And don’t forget, our account managers are always on hand if you have any further questions.