This document is an initiative of IHE Pharmacy to describe how interoperability can support the effort against falsified medicines, as laid out in the Falsified Medicines Directive - EU Regulation 2016/161.
IHE provides a standard interoperability architecture for the supply of healthcare products. This effort covers traceability, barcode scanning, message exchange, etc. All of these matters help monitor the supply chain and thus support the enforcement of the Falsified Medicines Directive.
This paper explains that the requirements of the Falsified Medicines Directive constitute in identifying the medicinal products along the supply chain, and reporting that to a central data hub. Using publicly available message structures helps software solution providers benefit of IHE’s testing opportunities and support a truly interoperable tracking mechanism.
Scanning the products poses an operational challenge for users: even for easy barcode scanning, for normal volumes it becomes burdensome. In a medium hospital, the effort of identifying all the received primary packages upon reception would exceed one dedicated professional. For this, it is essential to use standardized AIDC (Automatic Identification and Data Capture) technologies: standard media (e.g. Datamatrix barcodes) and standardized content.
Standardized interoperability mechanisms also play a role in this: By providing a standard electronic shipment list, the supplier can inform about the content and unique identification numbers included in each shipped carton so that the users may scan the outside package, and the contents of the package are automatically filled into the necessary systems.
This document explains how these mechanisms - reporting and shipment content - can enable proper tracing of medicinal products, and when standardized they enable the different actors to do so with reduced effort.