Falsified Medicines Directive Q&A: What does it mean for FDB Multilex customers?

The deadline for EU FMD compliance is fast approaching. What does this mean for FDB Multilex customers and end-users?

Q. When is the deadline for the EU Falsified Medicines Directive (FMD)?
The EU FMD is scheduled to go live across Europe (including the UK) on 9th February 2019.


Q. What is the EU Falsified Medicines Directive (FMD)?
The FMD aims to prevent counterfeit (i.e. ‘falsified’) medicines from entering the legal supply chain. The FMD states that from February 2019 onwards, prescription drugs may only be put into circulation if their packaging carries an individual serial number. Using this serial number, the identity and authenticity of a drug can be checked. The FMD also requires prescription drugs from this date to include an anti-tampering device to allow verification of whether the packaging has been tampered with.


Q. Are falsified medications a problem in the UK?
Falsified medications are a serious threat to patient safety and have a significant economic impact. The 2016 EU Intellectual Property Office Observatory (EUIPO) report on ‘The economic cost of IPR infringement in the pharmaceutical sector’ found the UK lost €605 million a year to falsified medicines.


Q. What does the Falsified Medicines Directive mean for Clinical Software suppliers?
Clinical software systems will be expected to support the scanning, verification and decommissioning process.  This functionality is being integrated into pharmacy and e-prescribing software solutions and is also supported via stand-alone systems.


Q. What does the Falsified Medicines Directive mean for Pharmacists and Dispensing Clinicians?
Pharmacists and Dispensing Clinicians will be required to check the anti-tamper device on the outer packaging of prescription medication to ensure it’s intact before dispensing.  Prescription items will also need to be scanned before they are dispensed so that the medication’s unique identifier (UI) code can be checked against a central data hub, then verified and/or decommissioned.  Any items that show up as Falsified within the verification process need to be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and not dispensed.


Q. What is the Central Data Hub?
The European Medicines Verification Organization (EMVO) has created a central hub for medicines verification across Europe. Arvato Systems has been officially named as National Blueprint Service Provider by the European Medicines Verification Organization (EMVO).    The EMVO hub connects to individual national hubs for each EU country.  In the UK the National Medicines Verification Organisation (NMVO) is run by SecurMed UK (a non-profit organisation).  SecurMed UK are working with stakeholders across the medicines supply chain to enable the EU Falsified Medicines Directive to be implemented.


Q. Does FDB Multilex integrate with the UK Medicines Verification Hub?
No, FDB have limited input or use of the UK Medicines Verification Hub, as this services a different use case to the information held on the FDB Multilex database.  Clinical software systems that support dispensing in the UK will need to work directly with the UK Medicines Verification Hub to connect their systems and enable the verification and decommissioning process.


Q. How does the Falsified Medicines Directive (FMD) fit with GS1?
In 2014, the Department of Health mandated that all NHS Trusts, as well as suppliers of products and services to the NHS, must adopt GS1 barcode standards by 2019/20. The FMD project incorporates the main standards of GS1 and complements existing UK policy.


Q. Who is responsible for maintaining and updating product/pack barcodes?
Pharmaceutical manufacturers are responsible for maintaining and updating product and pack barcodes and can upload the Unique Identifiers via the European Hub.


Q. Will FDB Multilex be making any changes to support the Falsified Medicines Directive (FMD)?
Yes, FDB Multilex currently provides the medication data structure and barcode information to support ‘Product’ identification and the FMD and supporting UK compliance standards have provided clear guidance on requirements for this barcode information. To meet these requirements, FDB Multilex is currently working to extend the field length of barcodes to allow for a larger number of characters. FDB Multilex is also looking to develop the ability to hold more than one single barcode. Note: FDB Multilex has no plans to add ‘Pack’ level codes and does not support the FMD requirement for medication verification.


Q. Was FDB Multilex involved in the development of the UK Medicines Verification Hub?
No, FDB Multilex was not involved in the design, development and implementation of the UK Medicines Verification Hub. FDB Multilex is currently liaising with NHS digital to identify whether it will be possible to extend our product level code coverage from an extended use of the UKMVO.  These discussions are at an early stage.  Further information on this will be communicated, once we have an update.


Q. Where can I find more detailed information on the Falsified Medicines Directive (FMD)?
The NHS Specialist Pharmacy Service published an updated ‘Frequently Asked Questions about FMD’ document in July 2018: https://www.sps.nhs.uk/articles/frequently-asked-questions-secondary-care-services-and-the-falsified-medicines-directive-fmd/