As we pointed out in a previous blog post, the differences between regulatory serialization and Track&Trace requirements around the world can be tricky for wholesalers and distributors to navigate. For example, while government serialization in the European Union’s Falsified Medicines Directive (EU FMD) does not require full end-to-end tracking of medicines as they make their way through the supply chain, the United States’ Drug Supply Chain Security Act (DSCSA) does, which has led to issues surrounding which entity “owns” the data. And while the EU FMD regulations do not obligate wholesalers to systematically scan all shipments as they pass through their facilities, there are scenarios where wholesalers will have to verify the authenticity of the unique identifier (UID) of the products in their physical possession to ensure the package in question is not marked as blocked, dispensed, exported, etc.
Despite what global regulations require, there are many reasons pharmaceutical companies would want to aggregate medicinal products now. For example, in the U.S., wholesalers will have to start scanning saleable returns in November 2019 and aggregation will be required by 2023. As such, the «Big Three» drug wholesalers in the U.S.—AmerisourceBergen, McKesson and Cardinal Health—are requesting that manufacturers start sending them aggregated data in 2018.
In the EU, the pharma market is comparable in size to the U.S. and many containers of medicine will be flowing through wholesalers. Wholesalers in the EU have a staggering number of medicinal products to scan; aggregation enables them to scan a pallet or case and know exactly what’s inside it. Further, Articles 22 and 23 of the EU FMD stipulate that wholesalers are required to scan the packs they manage that extend beyond the salable returns use case (Article 20). Decommissioning, exports, and accommodation of member states’ supply chains (verification responsibilities delegated to wholesalers) are all considered “risk-based scenarios” that require the scanning of medicinal products to ensure their authenticity.
Given the large number of packs flowing through the EU healthcare supply chain that are subject to risk-based verification requirements, it’s likely that European wholesalers will eventually ask for aggregation in the EU.
Importantly, there is significant business value in leveraging aggregation. Pharmaceutical organizations may increase operational efficiencies and determine where shortfalls exist in packaging systems. Aggregation provides the opportunity to verify the units and codes of medicinal products as they are packed into shipping cases and can confirm that the appropriate bottle came from the right case, pallet or batch, which can make recalls more efficient. Aggregation can also be used to quickly remedy any problems that arise during shipping; for example, if a box breaks open, the data can indicate what should (and should not) be in that case.
To support the physical and logical flow through the EU medicines supply chain in a cost-effective manner for all stakeholders, OPTEL recommends that all stakeholders strongly consider aiming their systems and processes to be aggregation-ready from the start.
Want to learn more about how OPTEL’s L4-L5 serialization and traceability solution can aggregate your medicinal products? Click here to request a demo of our software.