As mentioned in our February 16 blog post, HDA and industry participants continue to make progress working with solution providers as Verification Router Service (VRS) solutions are developed for the 2019 DSCSA saleable returns requirement. This work has taken three paths: establishing governance processes; creating testing scenarios; and launching the testing phase.
Since our last update, the VRS Work Group has tracked closely with its work plan; to date, the group has completed:
- The VRS Request and Response Messaging Standard;
- Forty-two test cases and scripts (prioritizing 20 scenarios);
- The Look-up Directory (LD) specification; and,
- A governance charter, which contains recommendations of this group to the future governance body, as well as onboarding and registration criteria for solution providers.
However, there are critical details that need to be determined. Many of those items were discussed at a June 18–19 meeting with testing participants (10 manufacturers, five distributors and nine solution providers). During this meeting, the work group covered testing strategy and phases, identified roles and responsibilities, reviewed solution provider functionality, discussed the essential LD synchronization piece of the LD specification, and how to move forward among service providers to create the interoperable network that will make the ecosystem possible. Synchronization of LDs is required so that each VRS provider has a complete and accurate list of connectivity information for message requests and responses to be routed correctly. This requires the creation of a standardized gateway specification and requirements so that the network is interoperable.
The VRS Request and Response Messaging Standard was passed to GS1, which has formally launched its Global Standards Management Process (GSMP), and anticipates completing the standard by January 2019. If your company is a current GS1 member, you can participate in their work group effort. Meanwhile, a task force of solution providers is working on the LD synchronization portion of the LD specification, with an anticipated completion date of July 31.
As noted earlier, from the 42 test cases and scripts put together, the Work Group prioritized 20 for testing. Testing is anticipated to begin the week of July 16 and proceed in a step-wise manner, building in complexity through the summer and culminating in end-to-end testing in the fall. As a reminder, testing results will be presented at the HDA 2018 Traceability Seminar (October 17–19 in Washington, D.C.; registration for the seminar is now available through the HDA website).
In advance of these results, companies should be taking steps now to prepare if connecting to a VRS is a viable option for your company. Potential items to consider include:
- Understanding what is needed for your organization to connect with the VRS;
- Engaging in discussions with solution providers to understand the services they plan to offer, as well as the approach they plan to take to help comply with the 2019 saleable returns verification requirement; and,
- Communicating with trading partners about this requirement.
Stay tuned to the HDA blog for additional VRS updates. For more information on this effort, email email@example.com.
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.