The Falsified Medicines Directive (FMD), which requires all EU pharmacies to be able to scan 2D data matrix barcodes, use integrated software to verify and decommission medicines from those barcodes and check medicine packaging for tampering is in effect from the 9th of February 2019.
The new standard of packaging, alongside the new audit trail, has been created by the EU with the intention of reducing the number of counterfeit medicines on the market and decreasing the associated health risks.
The General Pharmaceutical Council (GPhC) confirmed last month that checking pharmacies for FMD compliance will be part of its pharmacy inspections and it will “use its regulatory powers, including improvement action plans, to ensure pharmacies take action” if they are not FMD compliant.
There is some reprieve for pharmacies rushing to become compliant as the GPhC has stated that it “does not see the implementation date of February 9 as being a ‘cliff edge’”.
However, legal compliance is compulsory for all pharmacy owners.
Here are our tips to becoming FMD compliant:
1. Act Now
The General Pharmaceutical Council does not warn pharmacies when they are going to be inspected, only that it will happen in the next 4 to 6 weeks. Pharmacies that are ranked as “poor” will have two days to present an action plan to the GPhC. The best way to avoid noncompliance tomorrow is to be compliant today.
We’ve prepared a resource with FMD-ready scanners to help your pharmacy become compliant.
2. Purchase 2D Barcode Scanners
2D data matrix barcodes are at the core of new, FMD ready, medicine packaging. It is this advanced type of barcode that allows for the verification, decommissioning and recommissioning scans that are essential to FMD compliance and effectively monitoring medicine distribution.
3. Get access to the National Medicine Verification System
Every EU country has a National Medicine Verification System (NMVS) that will then report back to the EU-wide European Medicine Verification System.
Firstly, your pharmacy will have to register as an End User with Securmed, the UK NVMS. These credentials will allow you access to the UK NVMS.
Secondly, with your credentials, you’ll have to acquire software that integrates with your scanners and the NVMS. The UK NVMS provides a list of FMD software providers on their website.
Some of this software starts at £20 per month, which should not be prohibitive for most pharmacies.
4. Train your staff
Your staff will now need to check medicine packaging for signs of tampering and be able to work the software solution you choose for integration with the UK NVMS. Having the hardware and software in place for FMD is essential but having the staff processes in place to make sure every transaction is FMD compliant is just as important too.
At RMS, we’re specialists in retail hardware.
Our FMD page shows the excellent Honeywell 2D scanners we offer to pharmacies at RRP beating prices. If you want more information on which type of 2D scanner would best suit your pharmacy businesses needs then do not hesitate to get in touch.