HDA Origin – A First Building Block of an Emerging Central System?
The US Drug Supply Chain Security Act (DSCSA) requires complete track & trace of prescription drugs along the pharmaceutical supply chain by 2023. To correctly implement DSCSA unit level traceability requirements, the US pharmaceutical supply chain players will be required to share transaction data (the famous 3Ts), for which maintaining correct product master data is essential.
How to facilitate data exchange along the supply chain
The US Food and Drug Administration (FDA) has not mandated the setup of a centralized data base, like the European Medicines Verification System (EMVS) in Europe for example, in the Drug Quality and Security Act (DQSA). Nor, so far, recommended this in subsequent guidance documents that help supply chain partners better understand DSCSA requirements. A centralized data hub, however would undoubtedly have its advantages, as everyone would know where to connect, what data in which format to provide and how to get relevant information to comply with DSCSA mandates. In lack of such data hub, the industry is coping with this situation by setting up systems like HDA Origin.
HDA Origin to help streamline data exchange between trading partners
The US organization Healthcare Distribution Alliance (HDA), which counts all major healthcare and pharma distributors among its members, has come up with the idea of creating a central product master data repository. As 96% of all U.S. pharmaceutical sales go through distributors, the (HDA), is well aware of the constraints the DSCSA puts on the pharma supply chain. At each transfer of ownership, information on previous transactions (3Ts) needs to be exchanged. As we have learned at the recent Serialization Innovation Summit in Paris, the relatively short timeline for DSCSA implementation is asking for a simple master data solution. Which is where Origin, as the database is called, comes in. Origin is designed to provide a uniform method for manufacturers to share product master data with direct and indirect downstream trading partners simultaneously as everybody needs to have consistent product master data in order to exchange transactional data. 13 data fields are required, incl. GTIN, NDC, NDC11, product name, dosage, packaging level etc. Unlike the European Hub, Origin does not handle serialization information however.
Connectivity and Master Data exchange
There are different ways to connect to the HDA Origin database. For small data sets, manufacturers have the possibility to manually insert their data via a web portal. However, manually typing data into a database is always risky (typing errors duplicates…) and becomes rather tedious for large amounts of data. Therefore, HDA offers the option to upload via API, or, even more practical, via a solution provider. Indeed, if you have to serialize anyway, it is a lot more efficient to directly upload your master data through your serialization solution. Furthermore, a solution like Adents Prodigi ensures that only clean data sets in the correct format are transferred. Adents was the first solution provider to first one to enter the certification process.
If you would like a product demo to see for yourself how Adents Prodigi can ensure timely serialization and reporting compliance for all your markets, click here