Verification Router Service – Comply with the Saleable Returns DSCSA requirements
Did you know that on average, there are about 60 million pharmaceutical saleable product returns in the US market every year? That is 7-8 billion dollars’ worth of product annually. Even though it is only 2-3% of the total sales, this is not an insignificant number by any means, especially if you consider that starting in November of 2019, wholesaler distributors will need to perform some 60 million product verifications annually to reintroduce all that returned saleable product back to the market.
This year, manufacturers, wholesale distributors and solution providers had to push hard through the various obstacles to develop communication standards and to make interoperability required for such product verifications possible.
Verification of Saleable Returns: the HDA outlined the principles of a VRS system
Through a dedicated working group – of which Adents is a member – the Healthcare Distribution Alliance (HDA) has facilitated the development of specifications, standards, and use case scenarios needed to build the Verification Routing Service (VRS) – the ecosystem of wholesale distributors (Requestors), manufacturers (Responders) and a network of solution providers enabling the routing of the Verification Requests (VR). Such non-trivial industry wide system is being developed to address the DSCSA “saleable returns” requirement, coming in effect on November 27, 2019 (the US FDA recently delayed the UPID verification requirement for saleable returns for wholesale distributors to November 2020).
VRS will allow wholesale distributors to verify products by scanning the DataMatrix or by manually entering the four product identifier elements – GTIN, serial number, lot and expiry date and passing those elements to the wholesaler’s VRS solution provider. That VRS, in turn, will consult with its internal look-up directory (LD) to identify where to route the verification request next and then send it onward to the appropriate VRS of the product manufacturer. After verifying the Product Identifier (PI) information against its own repository, the manufacturer will send the response back through the same path.
There are some intrinsic complexities that need to be addressed in such a decentralized system. The system needs to be fully interoperable, while being very secure, yet nimble for new entrants, whether they are new wholesale distributors, manufacturers or solution providers.
There is also the look-up directory (LD), which is like a phonebook for GTINs with addresses, to allow the routing of the VR to the correct manufacturer. For such routing to be successful, the LD needs to be updated timely by the GTIN owner and then the update needs to be propagated to all other VRS providers, so they can update their LDs to keep things synchronized.
Look-up directory is the cornerstone of the VRS. If LD’s data integrity is compromised, the issue may get replicated across the network and verification requests can start to bounce or worse, be sent to illegitimate party.
Adents Answers the VRS Call
At Adents, having had the experience of implementing traceability in other markets, we understood the challenges and complexity of having to implement traceability in pharmaceutical industry, while honoring the existing business rules and processes of the industry. Addressing this complexity is the most recently introduced, blockchain-based Adents NovaTrack. Like Adents Prodigi, NovaTrack was developed in close collaboration with Microsoft. This, in turn, has led to the introduction of a seamless Adents Verification Router Service Solution with blockchain-based look-up directory.
Adents’ new VRS Solution, developed in accordance with all HDA VRS requirements and specification, is fully interoperable, agile and agnostic, making it compatible with any existing Level 4 enterprise level serialization solution. At the same time Adents VRS benefits from blockchain technology and strong Microsoft Azure architecture, because its LD is based on NovaTrack platform.
VRS: What Does this Mean?
This means that an organization can implement Adents’ VRS Solution without regard to its particular Level 4 solution. The company may choose to host their Product Identifier (PI) data in their existing EPCIS repository or can host it in Adents Prodigi L4-L5 solution. There is also flexibility to develop own Requestor/Responder capability or utilize Adents developed components for generation of a compliant Request/Response message.
Further, by using Adents VRS Solution, our customers will be benefiting from the use of blockchain technology, for immutability and integrity of LD data, while positioning themselves for smooth transition to the future, where enforcement of the governance and business rules is standardized and implemented by smart contracts, and power of distributed ledger is utilized to the fullest.
At Adents, we consider blockchain to be the best long-term technology to meet the US DSCSA’s short-term requirement. Use of blockchain technology in our VRS solution is the step towards more ambitious and visionary approach, such as a highly relevant establishment of a US interoperable Unit Level Traceability System by 2023 and beyond.