LSPediA proposes guidance plan for DSCSA Phase II

The Pharmaceutical Distribution Security Alliance hosted a workshop in Washington, D.C., last week attended by 80 key stake holders from the pharmaceutical industry. The workshop was to support the PDSA’s white paper published on March 25, 2019 – A Proposal: Governance for DSCSA Phase II Interoperability.  The workshop expanded the dialogue in the white paper with the intention to move toward establishing an independent governance body.

Michael Ventura, vice president of LSPediA, and Riya Cao, CEO of LSPediA, attended the workshop with peers from all sectors of the pharmaceutical supply chain, including manufacturers, distributors, dispensers, healthcare providers, and solution providers. Leaders of related trade associations, solution providers, and representatives from the FDA also were on hand.

History

Members of the PDSA started the conversation in December 2017, discussing the need for an independent governing body so that trading partners in the supply chain can exchange data in an orderly fashion while meeting the DSCSA interoperability requirement. The real objective is a technical vision – well defined rules for authorized trading partner, authorized data access, and methods/standards of accessing data. After 17 months of sorting out the inter-dependence of a governance body and the technical vision, PDSA published the whitepaper calling out the need for a governing body in order to execute the technical vision.

Agree Or Disagree

Two-thirds of the attendees agreed that a governance body  – specifically an independent, balanced, sector-neutral, and nonprofit legal entity – is necessary for a path to DSCSA 2023. All attended agreed that the implementation of interoperability in 2023 will need new technologies and new connectivity beyond the what is in place today. To that end, collaboration and communication must occur and  rules and boundaries established. Without them, the path to interoperability would fall into traps of big and small quarrels from different interest groups.

Pharmaceutical Industry Action Group

LSPediA supports the idea of the governance body, a forum focused on addressing 2023 interoperability requirements. In the spirit of PDSA’s open dialog, LSPediA offers the following thoughts. For the convenience of articulating these thoughts, LSPediA will call this governance body the Pharmaceutical Industry Action Group (PIAG).

LSPediA supports the establishment of PIAG and a technical committee that would be  tasked to define the standards for interoperability. LSPediA envisions that PIAG creating a roadmap with clear milestones to widen the industry adoption of these standards.

LSPediA’s PIAG Roadmap

LSPediA’s PIAG Roadmap

Beyond 2023, LSPediA envisions that PIAG holds greater value in collaboration and communication by serving the industry with future standard development and educational offerings. Member companies would donate the time of volunteers to work at PIAG in a non-competitive, open forum intended to develop recommendations, guidelines and best practices for the overall good of the industry.

Moving Forward

LSPediA’s 2023 roadmap is unfolding as we speak. Participants in the FDA DSCSA Pilot Project Program are meeting with the FDA in Washington, D.C., this week as a step toward adopting advanced technologies for the implementation of interoperability in 2023. We, the industry, must innovate and create to overcome the challenges and meet the requirement. LSPediA is on the mission to do just that.

To learn more about LSPediA’s mission, follow us on LinkedIn, subscribe to our newsletter, or register for one of our a webinars.

About LSPediA – Life Sciences Solutions

LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPediA’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting.

To learn more, please call (248) 973-2008, email info@lspedia.com or visit www.lspedia.com.