In the first two sessions of a webinar series sponsored by LSPediA, the Healthcare Distribution Alliance (HDA) covered critical information on traceability under the Drug Supply Chain Security Act (DSCSA). The “2022 Traceability Webinar Series: Just-in-Time Review for 2023” outlined DSCSA compliance for dispensers, detailed how wholesale distributors and service providers can help prepare for DSCSA, and provided key information on Verification Router Systems (VRS).
The events featured:
- Jaidalyn Rand (moderator), Director of Industry Affairs at the Healthcare Distribution Alliance
- Brad Pine, Vice President of Brand Pharma & Regulatory at Smith Drug Company
- Julie Malone, Regulatory Affairs Manager at Value Drug Company Brad Pine, Vice President of Brand Pharma & Regulatory at Smith Drug Company
- Matt Sample, SVP of Manufacturer Operations, AmerisourceBergen
- Scott Mooney, Vice President of Distribution Operations, McKesson Corporation
- Bob Celeste, Founder of the Center for Supply Chain Studies
- Dwight de Vera, Vice President of Healthcare Intelligence at Inmar Intelligence
- Ilir Ivezah, Customer Support Engineer at LSPediA
- Elizabeth Waldorf, Director of Global Traceability and Standards at TraceLink
- Herb Wong, VP of Strategy and Innovation at Antares Vision Group
DSCSA, Dispensers, and Distributors
In an August 11 webinar, panelists discussed the support that dispensers can expect from distributors regarding DSCSA data. While distributors can help in several ways – including holding transaction information and transaction statement data, providing training on the systems they use to handle product data, and collaborating on investigations into suspect products – dispensers will be responsible for putting their own data processes and policies in place. As well, they’ll be responsible for ensuring that they only do business with Authorized Trading Partners (ATPs), maintaining their Global Location Number (GLN), and responding in detail to requests from the FDA or ATPs.
The Service Provider Ecosystem & All About VRS
The second webinar, on August 25, included de Vera’s comment that, after a decade’s worth of industry innovation, “now is not the time to try something new.” Rather, with 2023 around the corner, it’s time for trading partners to make use of the solutions and strategies service providers have developed for managing EPCIS, data, serialization, drug recalls, decommissioning, and other tasks. Waldorf and Wong clarified how solution providers can help with compliance support on data, partner onboarding, verification and tracing tools; as outlined by Ivezah and de Vera, several responsibilities will remain with the dispenser, including obtaining GS1 identifiers, legal support, accountability for conducting product investigations, and acquiring ATP credentials.
Celeste and Wong led a discussion of Verification Router Service (VRS), focusing on how, in addition to processing saleable returns, VRS systems allow a pair of trading partners to quickly exchange vital information even if it’s their first time doing business. Waldorf looked ahead to the next VRS 1.3 release, which includes capabilities for helping determine whether a responder is an ATP, alongside additional tools for exceptions management and product status information.
The series will continue on September 15th with “Myths versus Realities” and “Legal and Business Requirements Across the Supply Chain,” and conclude on September 29th with “DSCSA 101 and Timeline” & “EPCIS Onboarding Checklist.”
As well, HDA plans to hold its 2022 Traceability Seminar in Washington D.C. on October 12-14. This in-person event will bring together healthcare supply chain leaders to address critical DSCSA implementation milestones, share strategies, and review lessons learned.
To find new DSCSA events and webinars from LSPediA, including a new round of intensive training sessions in October, visit our Upcoming Events page.