Preface: In this blog I’m going to assert that “the data associated with the drug and its supply chain transactions is just as important as the drug itself.” Disclaimer: The drug is certainly the most important part in the patient healthcare equation—data has nothing to do with that. BUT… there is a comprehensive data collection and integration reality that is required to get these drugs through the supply chain and eventually to the patients who need them. Ultimately, regulations like the DSCSA are about patient safety, and at the core of the regulation is this data backbone focused on not letting bad actors get their fake drugs into the market.
If the data infrastructure for compliance is not in place, then the whole system breaks down. And this includes aggregation of serialized product information into marked cases and onto identified pallets, Wholesalers will not be able to receive product and subsequently deliver it to where it would be dispensed. So yes, the data associated with the drug and its supply chain transactions is just as important as the drug itself as it moves from manufacturer to dispenser.
If you’re not sure exactly what aggregation is, it is the process of assigning ‘children’ to a ‘parent’ in packaging. The aggregation rules are defined by the packaging hierarchy which specifies what package types can be packed into other package types (i.e. unit into case, case into pallet). It allows one pallet barcode ID to represent all the unique products in all the cases on it.
I recently attended an industry event where there was a ton of discussion on DSCSA compliance, and upcoming November 2023 deadline activities. So many milestones have been worked through already in establishing serialization of pharmaceuticals nationally. The industry is facing a final push in creating an “interoperable supply chain” as part of DSCSA compliance.
Baby steps in this direction were initiated with saleable returns verification required by wholesalers in 2020. Enforcement is not happening until 2023, which gave the industry time to get the infrastructure and connections in place to actually fulfill compliance and verify individual serial numbers when required. This is a critical step in delivering on the interoperability promise.
The data realities of the volumes of medicines moving through the supply chain make it impossible to manually scan each item at major transaction events, however. When a pallet of medications is received by a wholesaler from a manufacturer, that wholesaler needs the ability to identify the pallet and with a single scan ‘move’ all the cases and ‘eaches’ (units) in an integrated Level 4 traceability system.
Without aggregation, this cannot be done. So, wholesalers will likely reject shipments where the data is not integrated because that pallet scan can’t move all the items to their new location or give them Transaction Information/Transaction Statement (TI/TS) electronic records as required. This reality was made very clear at the industry event I attended.
We’ve talked about this before—why pharma brands shouldn’t wait to aggregate. It’s important for manufacturers who still need to add aggregation capabilities on some, or all, of their packaging lines to do this soon. The 2023 deadline will arrive shortly!
Implementing a turnkey solution like Systech’s—which has hundreds of preconfigured integration modules—can make the integration into packaging environments straightforward. Working with a trusted vendor who understands the data integrations required between all the supply chain participants is also essential.
As you can see, when I say “data is now just as important as the drugs” it is not hyperbole. Having an interoperable supply chain for compliance really boils down to mass data capture and integration. Making it work in the real world requires aggregation as a critical component.