As we've reported in the past, Healthcare Distribution Alliance (HDA) has been bringing together various stakeholders to discuss critical business requirements as service provider companies develop a verification router service (VRS) network as an option for compliance with the 2019 DSCSA saleable returns requirement (click here for previous coverage).
A VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses in order to support DSCSA verification requirements and other business requirements as defined between trading partners.
At the 2018 HDA Traceability Seminar in Washington, D.C., this October, presenters gave an update on development and addressed attendees’ readiness, concerns and more.
Several months ago, HDA reported that development had taken three paths: establishing governance processes; creating testing scenarios; and launching the testing phase.
At the Traceability Seminar, speakers explained that the group used the first part of the year to develop requirements and specifications for features such as request/response messaging and look-up directories (LDs).
LDs are electronic listings of the connectivity information for each GTIN that has been set-up for responding to verification requests. Typically populated by the entity who owns the FDA labeler code, they are important because they identify the location of the electronic repository used by the manufacturer (responder) for storing/staging Product Identifier data. For scenarios where another party will be responsible for responding to verification requests, HDA reports that the FDA labeler code owner can electronically delegate responsibility to that party.
The team has also developed a SharePoint site and performed testing for subset of GTINs and solution providers (SPs). Testing is ongoing for additional GTINs and SPs, as well as for more complex practical situations, including requests and responses for systems with multiple SPs, requestors and responders. The team plans to publish a report in early 2019 with findings.
Here are a few of the key findings from an informal live poll of the audience:
Manufacturers/repackagers: How is your company planning to systematically respond to a Verification Request?
Utilize a solution provider participating in VRS network (64.2%)
Build your own solution (responding capabilities) (8.3%)
Send aggregated data with product shipment (20.2%)
Email/phone call (6.4%)
Other method (0.9%)
For any GTINs marketed and/or distributed with a co-license partner (CLP), approximately 57% there is a clear understanding of who is responsible for responding to verification requests. Approximately 43% answered that there was not a clear understanding.
Attendees’ biggest concern about implementing solutions for saleable returns verification is that solutions are still being developed and tested, and they question whether they will be interoperable. Other major concerns are the complexities of use cases such as product divestitures or mergers, as well as the time remaining for their organization to formally test, implement and train personnel.
But there was good news as well. Over half responded that they are most optimistic about industry and solution providers actively participating and collaborating on a solution, while the fact that standards have been developed for exchanging requests/responses and for synchronizing the Lookup Directory also garnered several votes.
Next steps for manufacturers
In a blog post from June, HDA advised that companies should take steps early to prepare if they are connecting to a VRS, and included suggested steps: companies should understand what is needed to connect to the VRS, talk with solution providers and communicate with their trading partners about the saleable returns requirement.