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Leading supplier of software for DSCSA compliance builds a master data repository
Capitalizing on the 500+ clients of its Product Track software, TraceLink has unveiled a Network Product Master Data Service, to collect and organize data necessary for compliance with the Drug Supply Chain Security Act (DSCSA). By itself, this is not a new thing—TraceLink has been storing client DSCSA information all along for its clients, who can then make the information available to their downstream trading partners for their own compliance purposes. But now the service will be supplemented with National Drug Code (NDC) data obtained from FDA, and with enabling users of the database to obtain so-called GTIN-14 information, which is fundamental product-master data and would help identify any products regardless of originator. That will enable downstream dispensers, such as retail pharmacies and hospital pharmacies, to better meet compliance goals. The service also enables a paper-to-digital conversion (DSCSA information can be conveyed by paper until the early 2020s, when it must be all-digital; many manufacturers or wholesalers still send paper documentation at this time.)
DSCSA mandates the current delivery of “T3” information—transaction information, transaction history and a transaction statement—for every change in ownership of a drug, from manufacturer through the rest of the supply chain. T3, in turn, contains Global Trade Identification Number (GTIN) data, which is valuable now for data-management efficiency, and even more valuable in the future when products will be individually serialized and tracked. However, besides sometimes delivering this information today on paper, trading partners have not standardized data fields and definitions in their documentation.
(When in 14-digit form, GTIN conveys NDC information plus container count and other describers; currently, many pharma distributors depend on an EDI standard, the Advanced Shipping Notice. There is a translation step to put the EDI data into the GTIN format, and then into partial fulfillment of T3.)
TraceLink offers to digitize and normalize all these data. “The system is improving the ability for companies to distinguish which products to which T3 applies, so that accurate compliance reconciliation, verification and recordkeeping can be performed,” explains Lucy Deus, TraceLink product manager. Further, a looming problem is distinguishing between which products require DSCSA documentation and which (such as OTC products) do not. The Product Master will “help both the end users and the systems weed out the DSCSA Exempt product from compliance management,” she says.
A network effect is expected to evolve with the TraceLink repository (the Life Sciences Cloud), to which some 250,000 dispensers, contract manufacturers and others now have accounts. As more TraceLink clients put more T3 data into the system, a more complete description of products in commercial distribution will be created. "Our work with hundreds of hospitals and pharmacies that manage compliance for over 4,200 dispensing locations in the US has revealed that critical data gaps make it very difficult to efficiently create documentation needed to achieve DSCSA compliance," said Shabbir Dahod, president and CEO, TraceLink, in a statement. “Dispensers simply submit missing NDC and product master data to us, we manage that data for them, and everyone on the TraceLink network benefits as that data becomes part of the growing repository that we check whenever customers need to append shipments with information that is required."
This network effect is also the goal of the just-announced Healthcare Distribution Alliance (HDA) Origin repository, which is intended to collect GTIN-14 data from manufacturers and wholesalers, and then enable a quick look-up to identify products that show up at distribution center loading docks. The two data repositories have overlapping but not identical goals and capabilities. Origin is restricted to GTIN-14 information; TraceLink collects T3 data, which includes transactions, as well as GTIN data; but clients can restrict access to that transaction data to only authorized viewers. The issue of product returns is of particular importance to wholesalers, who handle nearly 60 million return deliveries annually in the US.
Both services have undisclosed fee structures. Origin will charge a varying scale based on data volume and repository usage; TraceLink, which makes most of its money from clients installing the Product Track software, will charge clients fees based on how much additional data harmonization (such as converting paper to digital T3s) is undertaken. HDA wants near-universal manufacturer usage (since HDA-member wholesalers handle nearly all manufacturers’ products); TraceLink wants to ensure that its clients, and their trading partners, have as complete data resources as possible. To an outsider, it appears that the Origin service is “basic accommodations,” leaving issues around DSCSA compliance up to the users to resolve, while TraceLink is the “premium” service, providing (for those who pay for it) an all-encompassing solution. All of this will take an exponential leap in complexity when the full, item-level serial-data tracking begins.