The Falsified Medicines Directive (FMD for short) is a regulation passed by the EU Parliament in 2016 which is in force from the 9th of February 2019. The new regulation requires the addition of safety features on the packaging of all medicines to verify the authenticity of the medicine from the point of manufacturing until at the endpoint with the patient.
This regulation enforces two fundamental changes in how medicine is packaged: the addition of an anti-tampering device and the addition of a unique identifier for each medicine package. The unique identifier comes in the form of a 2D data matrix barcode.
These barcodes contain much more information than a standard linear barcode and cannot be scanned by a standard laser. Pharmacists who currently only own standard barcode readers need to purchase 2D data matrix barcode scanners to be FMD compliant.
Every pharmacy within the EU will need to be equipped with a data matrix barcode scanning solution by the 9th of February 2019.
Pharmacists (and everyone along the supply chain from the manufacturer to the end patient) will need to visually check the Anti-Tampering Device (ATD) and performing a verification and decommissioning scan “at the time of supplying it to the public”.
Ultimately, the purpose of the law is to prevent falsified medicine entering the conventional supply chain. Falsified medicines may have little or no active ingredients, the wrong active ingredients or may have had packaging stolen for re-use or re-sale. By securing the supply chain and decommissioning the packaging at the point of sale, unnecessary risk to patients is reduced.
What Pharmacists Need To Be FMD Compliant
Quite simply, pharmacists will need to change the status of the pack in the UK’s National Medicines Verification System* from “active” to “inactive—supplied”. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System (NMVS).
This means you need a 2D Matrix compatible barcode scanner, such as the ones we offer.
Pharmacists will have to ensure that their systems integrate with the National Medicine Verification System, which in turn will interact with the European Medicine Verification system. This is to ensure EU-wide accountability in the manufacturing and supply of medicine. For the UK, the NVMO is SecureMed.
What Pharmacists Have to Do
In addition to changing the status of the medicine package within the NVMS, pharmacists will have to visually check the Anti-tampering device for any signs of tampering. Staff will require sufficient training to properly work the scanners and IT systems. There are three primary types of interaction a pharmacist can perform when scanning a medicine package under FMD:
Verification – an ad-hoc check that the pack is still “active” and that no alerts or recalls have be raised. This is optional and can be undertaken at any time that the pack is in the contractor’s possession. It does not change the status of the pack.
Decommissioning – this has to be undertaken as part of the dispensing process – before the pack is handed to a patient or their representative. It checks the pack status and then changes it to “inactive” to prevent other (potentially falsified) packs with the same unique identifier being dispensed.
Re-Commissioning – this reverses the decommissioning scan if it occurs within a 10-day time period after the pack was made “inactive”. This will be used if a pack has been decommissioned but has not been used or given to the patient
Will Brexit affect this regulation?
This is highly unlikely. The Department of Health and Social Care (DHSC) and Medicines and Healthcare products Regulatory Agency (MHRA) have made statements that the UK will maintain “high regulatory alignment” with the EU post-Brexit and that this includes FMD. The SecureMed NVMO is already active so there is a likelihood that this would remain in place for oversight purposes.
As FMD needs to be implemented before the UK leaves the EU the UK will be considered, for the purposes of interpreting the FMD Delegated Regulation, still to be “inside the EU”, now and in the future, so medicines received in the UK from the EU will not already be decommissioned (or treated as exports under Article 22).
What about medicine that is to be delivered to patients?
The packaging should be decommissioned before handed to the driver/courier.
Do older packages need to be withdrawn?
No. Older stock that is not FMD compliant can be dispensed until its expiry date.
FMD provides a new level of oversight and accountability in the medicine dispensing process from manufacturing to end user. Pharmacies will need to acquire suitable 2D scanners and FMD specific software to remain compliant as well as integrating FMD specific actions, such as checking anti-tampering devices, into their dispensing process.
At RMS, we have a range of FMD compliant scanning solutions suited to any business that has to verify or decommission medicine. Check out the range.