Medicine safety is a central concern in modern healthcare. Ensuring that healthcare practitioners administer the right medicine to the right patient at the right time and in the right dose requires a joined-up approach involving different systems and verifications at various stages of the process.
Closed-loop systems monitor, validate, record and communicate each verification effectively, helping to eliminate costly and dangerous mistakes.
Verification includes checks that the medicine is not falsified. A falsified medicine deliberately or fraudulently misrepresents its identity, composition or source. The
European Medicines Verification System (EMVS) plays a central role in protecting the public from falsified medicines. Since
February 2019, every pack of prescription medicine entering the European pharmaceutical supply chain must, by law, contain a unique identifier on its outer packaging. This barcode contains a product code, a unique serial number and the batch identifier and expiry date of the medicine. Any person who is authorised or entitled to supply prescription medicines to the public must, by law, use the EMVS to verify the authenticity of the unique identifier before they supply the pack. In most cases, pharmacists or dispensing doctors perform this verification at the point of dispense.
The European pharmaceutical supply chain is largely free of falsified medicines. The EMVS helps ensure this remains the case. However, the most revolutionary aspect of the
Falsified Medicines Directive is the mandatory introduction of uniform and unique identifiers for all prescription medicines. European markets, including the UK, have adopted GS1 standards to represent these identifiers. For the first time, it is possible to establish a firm basis for medicine management based on the relationship between the manufacturer’s product code and existing formularies. The implications are huge and will transform closed-loop medicine supply and administration.
GS1 establishes the
Global Trade Item Number (GTIN) as the product identifier representing the manufacturer’s provision of specific pharmaceutical forms, doses and strengths of branded and generic medicines. Each GTIN is a globally unique number that represents a unique combination of medicine characteristics for which a regulatory authority has granted marketing authorisation. Any change in these characteristics requires the generation of a new GTIN, eliminating the possibility of ambiguity.
Manufacturers have used GTINs to identify medicinal products a long time. However, the new requirements provide a uniform approach mandated by law which is closely associated with marketing authorisation and forms part of the global movement to adopt GS1 healthcare standards. These developments provide a new framework for adoption of the GTIN as the central product identifier for authorised medicines.
Of course, there are still barriers in real-world adoption of GTINs in medicine management. European legal requirements do not extend to non-prescription medicines, unless ‘blacklisted’ by the European commission. Ensuring full compliance with the law will take time and effort, and some prescription medicines still lack the unique identifier. It will take time for regulatory authorities to evolve their marketing authorisation processes to ensure correct use of the unique identifier. And, despite the emerging international adoption of GTINs, technical and legal incompatibilities still arise within the global supply chain. No system is perfect, but the Falsified Medicines Directive represents a major advance in product identification.
In the UK, the
NHS Dictionary of Medicines and Devices (DM+D) has included a companion GTIN data set for some time. European initiatives such as IDMP SPOR will capture GTINs as a matter of course. The SPOR Product Management System (PMS) is expected to integrate with the EMVS to accelerate the process of capturing GTINs for each product. The EMVS is the first of a new breed of medicine safety systems that promotes the use of the GTIN as a key identifier within healthcare. Having built the core EMVS systems, our mission at Solidsoft Reply is to provide the systems that will power a new era of medicine safety, optimisation and management that extends across the entire pharmaceutical supply chain and reaches all the way to the point of care within clinical settings.