In November 2019, the DSCSA Saleable Returns Verification requirement phases in, introducing an enormous challenge for wholesale distributors, pharmaceutical manufacturers, and the industry at large. Once the requirement takes effect, wholesalers will not be able to be re-shelve the nearly 60 million product units that come back to them from retailers each year for resale until they have verified product data provided by the manufacturer.
To satisfy the mandate, wholesalers and manufacturers need a streamlined way to rapidly route verification requests and responses amongst hundreds to thousands of trade partners, and between different system architectures. The concept of a Verification Router Service (VRS) has been introduced to provide this functionality.
A fundamental tenet of DSCSA is that disparate solutions, with multiple technical approaches, can be employed to meet the law’s requirements. In order for the collective effort to be successful, though, all the solutions must be interoperable, and based on open standards. Proprietary solutions put companies—and the industry at large—at risk of missing the deadline and jeopardizing the safety of the patients DSCSA was designed to protect.
As your company plans for the 2019 requirement, it's critical to understand the VRS challenge; the importance of an open standards approach; the TraceLink offering; and the consequences of proprietary solutions.
Understanding the Verification Router Service Challenge
Verification Router Services will enable a wholesale distributor to query the manufacturers of a saleable returned product in order to vet the product identifier. A wholesaler may publish this verification request using one VRS, but the responding manufacturer may use another. The process relies on a lookup directory, which operates as a phone book of GTINs and links to the responding system where that GTIN can be verified, that is synchronized across VRSs.
In order for these VRS solutions to interoperate—and for wholesale distributors and manufacturers to successfully communicate despite using different solutions—the VRSs need to employ commonly agreed-upon standards to manage the request, response, and routing tasks of verification.
Driving Open, Interoperable Standards through Industry Collaboration
In January 2017, the HDA Verification Routing Service (VRS) Task Force was created to address the challenge of saleable returns verification through open interoperable standards, employing a similar approach to the work the industry did in 2014-15 for DSCSA lot-level traceability. Supported by HDA, it includes stakeholders from across the industry: pharma companies; wholesale distributors, including representatives of the Big Three; pharmacy dispensers; industry consultants; TraceLink, and eleven other solution providers.
The task force has established a foundational set of user, system architecture, and technical interoperability guidelines as well as governance rules to enable solution providers to build their own versions of Verification Router Services (VRS). The group is on schedule to support the launch of commercial interoperable solutions into the marketplace by November 2018, allowing for a year of piloting and testing before the 2019 deadline. In keeping with the goal of open, interoperable systems, the VRS Task Force has also turned over essential information to the newly formed GS1 Verification for Saleable Returns workgroup.
TraceLink Product Information Manager: Standards-Based, High Performance, Lowest Cost
Product Information Manager is a standards-based network application that leverages the interoperable standards defined in partnership with the HDA task force, ensuring it meets the interoperability requirements for saleable returns. Designed to leverage serialized product information, it delivers capabilities for master data sharing and verification routing and verification responses to help companies meet the 2019 saleable returns verification requirement.
More than 195 TraceLink customers from 93 companies, from pharma manufacturers to healthcare organizations, have participated in a solution innovation group to provide input into the application development process and ensure that critical business challenges associated with saleable returns verification and master data sharing are being addressed.
Product Information Manager supports requirements for pharma companies and wholesale distributors. For pharma companies, it provides a verification responder service that receives verification requests, verifies the GTIN, serial number, lot number and expiry date and delivers a response back to the requester. For wholesalers, Product Information Manager facilitates the routing of the request to the appropriate responder and receives the response back.
Built on TraceLink’s end-to-end information-sharing platform, Product Information Manager was developed using the same highly scalable, native cloud architecture as the Life Sciences Cloud, ensuring that verification responses are provided in near real-time to minimize operational disruption. It seamlessly integrates with TraceLink's existing master data and serialization solutions or can integrate to third party master data, Level 4 serialization repositories or other business systems such as WMS or ERPs. To meet the full end-to-end DSCSA requirements for wholesalers, Product Information Manager also integrates with TraceLink's serialization and IoT-based edge solution for capturing, routing and recording verifications during the returns process.
Creating Risk with Proprietary Solutions—Blockchain or Otherwise
If solutions based on closed, proprietary technologies enter the market, they put the whole industry at risk. Without interoperability, companies will end up on an island: no other solution provider will be able to publish information into, or extract information out of, their lookup directory in order to service their customers and keep product moving smoothly through the supply chain.
Blockchain technology is a frequent conversation topic in the life sciences industry today, and it is a factor in the VRS discussion. As promising as blockchain may be in the future, proprietary blockchain technology for a VRS solution poses just as many problems as any other proprietary approach.
Proven Scale and Performance are Paramount
Blockchain is a highly evolving, as yet unproven technology. Fundamental questions of scalability; interoperability where multiple different blockchains are simultaneously in existence across the supply chain; and governance of who gets to participate and under what conditions are yet to be answered.
Cost needs to be minimal and predictable
Commercial models for private blockchains are in their infancy, and the underlying costs associated with building a private blockchain are dependent on the highly variable financial basis or currency of the blockchain technology provider. Every interaction on the blockchain—including publication of GTIN/lookup directory information, sharing of lookup directory information, initiation of verification inquiries, and responses to those verification inquiries by pharmaceutical companies—is likely to incur an expense. Yet due to the evolving nature of the underlying blockchain technology and its fee structures, it is impossible to predict the costs that a pharmaceutical company, a wholesale distributor, or a solution provider will incur on an annual basis.
Come November 2019, the continued flow of product through the U.S. supply chain will depend on having proven solutions that are based on open, interoperable standards in place. The industry cannot tolerate the risk introduced by proprietary solutions, and it does not have time to wait for technology that is still in the early stages of development or may have challenges that are yet to be discovered at commercial scale.
Contact TraceLink to discuss your saleable returns verification needs today.