February 16, 2018
By Perry Fri, HDA and the HDA Research Foundation — As an organization, HDA has been looking for new ways to communicate the work happening around DSCSA implementation with a broader audience beyond twice a year at our Traceability Seminar and Distribution Management Conference. Beginning this month, the HDA blog is expanding to feature traceability/Drug Supply Chain Security Act (DSCSA) updates as well as HDA perspectives on a variety of related issues throughout the year.
These traceability topics kick off with the latest news on HDA’s work with industry to develop a Verification Router Service (VRS). The VRS is one of two recommended solutions (based on various scenarios) rising from our 2016 pilot study conducted with EY to understand how the supply chain can best comply with the 2019 DSCSA requirement to verify serialized saleable returns. With this deadline on the horizon — and the fact that nearly 60 million saleable pharmaceutical returns are processed annually — this project will be a major effort for the Alliance and our members in the months ahead.
In simple terms, the verification router service allows companies to verify products by scanning or entering in the four product identifier elements (GTIN, serial number, lot and expiry) into a request, which is routed to a look-up directory that directs the request based on a GTIN look up to the appropriate manufacturer repository. A response is generated from the manufacturer’s repository and routed back to the requestor to let them know if the product is verified — and whether it can be returned to saleable inventory. Querying the manufacturer’s serial number repository allows verification without aggregated data being sent to wholesale distributors.
Following the presentation of the HDA pilot study at the 2016 Traceability Seminar, the VRS did not exist beyond a proof of concept, but there was an industry need given that sending serialized data is not required by law in 2019 and some manufacturers do not plan on aggregating by then. HDA committed to exploring the feasibility of the VRS throughout 2017; through the work of KPMG and the Verification Router Service Task Force (composed of manufacturers, distributors and solution providers), business requirements, solution architecture and governance principles were established.
As 2018 unfolds, the work plan for the VRS will take three paths. First, HDA is continuing the work started in the governance work group last year. The goal of this group is to put together a charter, processes around onboarding and registration for users, as well as a structure to recommend for a full production system based on the experience gained during the pilots.
Second, a technical work group will be convened to move the project into the pilot stage and help answer any outstanding questions related to connectivity and functionality. The work group will define use cases, protocol, test scripts and key performance indicators for the pilots. In conjunction with this work, GS1 is working on a verification messaging standard, devising a uniform way to request and respond based on the VRS Task Force’s defined content.
Finally, following the work group’s preparation, our plan is to conduct pilots this summer. We expect there will be multiple rounds as the VRS system is refined and various pieces of the router service are tested. The goal is to present pilot results at our Traceability Seminar, as well as through a report. At this point, 19 companies — six service providers, five distributors and eight manufacturers — have indicated their interest in piloting.
To learn more about the VRS and other traceability issues in depth, join HDA at the upcoming Distribution Management Conference (March 4–7 in Austin, Texas). In addition to the VRS update, the agenda includes a supply chain panel, an FDA policy update, and roundtable discussions with opportunities to connect with peers on DSCSA-related operational issues.
For more information about HDA efforts surrounding traceability, click here.
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 non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.