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HDA working group has draft standards, and traceability vendors have product offerings
Last week’s Pharma Traceability Seminar (Washington, DC, Oct. 15-17), organized by the Healthcare Distribution Alliance, showcased a key next step in the 10-year slog to 2023 compliance with the US Drug Supply Chain Security Act (DSCSA): a verification router service (VRS). The near-term goal of VRS is to enable pharma wholesalers—who receive some 60 million returned packages annually—to validate those returns before they can be put back into commercial distribution. This validation is one of the requirements of DSCSA, and while it falls heavily on the shoulders of wholesalers (who must be able to carry out the verfication by November 2019), it is very much in manufacturers’ interests to ensure that their products are not wasted. If all returns must be disposed of, costs would rise for distribution processes, and ultimately affect manufacturers’ net revenues.
HDA set up a working group to address verification a couple years ago, bringing together multiple wholesalers and manufacturers. Last year, a best case (among a variety of possible methods) was determined, to create interoperable nodes where a request for verification could come from a wholesaler or other permitted party, and the nodes would act as a “phone book’ to identify which node has the necessary information. (In theory, one centralized repository would simplify this process—but all manufacturers would have to agree to support that, an idea that went nowhere. Another approach, where the manufacturer sends all necessary verification data along with its shipments, is possible but has significant operational problems.) Manufacturers need to make their serialized data available and handle (and verify) queries themselves, or work with their serialization software vendors to create their information nodes.
As it has turned out, multiple serialization vendors (at least those who support Level 4, or enterprise-level, communications) have done just that:
Adents and Chronicled, and optionally rfXcel, are deploying blockchain-based systems, said to meet all the requirements of the HDA initiative. VP of operations Julien Flaury, speaking on behalf of Adents’ VRS, says that while blockchain is inherently a networking technology that multiple parties would participate in, Adents is using the technology primarily to validate the identity of the requesting or responding party. (A fullblown, blockchain-based network could be a next step—if industry decides to go in that direction.) Whether blockchain-based or not, a VRS needs to have a lookup directory (where the information on where to send a query is stored), to provide millisecond response, and to be interoperable so that one VRS node can communicate with other nodes. David Colombo, director at KPMG Advisory Services (KPMG is a contractor to HDA to coordinate the VRS development process), says that VRS vendors will be responsible for self-testing their interoperability and response times. It is likely that a vendor who cannot meet the requirements will be caught out quickly.
Providing a VRS seems to be a desirable feature of any vendor offering a Level 4 traceability system, and more could come on to the program soon. One of the leading serialization vendors, Optel Group, says that “Our software will have the necessary Application Programming Interface (API) to support a verification routing service well in advance of the Big 3 [wholesaler] timelines.”
There is some talk of the VRS standards being shifted over to an organization like GS1, the source of many serialization standards, but that has not yet been determined. It is also conceivable that the overall VRS-establishment process, which brought multiple supply chain partners together to develop a uniform industry practice, could be a model for how the overall DSCSA compliance process can be achieved—there are many hurdles to overcome before the legislated start date for a national system, in 2023.