Coalition of drug supply chain members welcomes pharmacist feedback on track-and-trace proposal

The November 2023 deadline for full implementation of the Drug Supply Chain Security Act (DSCSA) looms large, but many of the specifics are far from determined. DSCSA, also known as “track and trace,” mandates that all members of the U.S. supply chain—including pharmacies—use an interoperable electronic system that tracks a drug at the package level until it reaches the pharmacy. The policy is aimed at protecting consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs, including through improved recall processes.

 

 

It’s a big job, and as supply chain members are developing processes and systems to accept and electronically track products bearing a more robust barcode with more information, the need to effectively communicate has become more apparent given electronic interoperability requirement of the law. As a result, industry trading partners—including pharmacies, wholesalers, manufacturers, and associations—have proposed to the broader DSCSA community that an independent, balanced, sector-neutral governance body is needed to guide or advance the coordination demanded by the law.

 

That’s the impetus behind A Proposal: Governance for DSCSA Phase II Interoperability, a white paper from the Pharmaceutical Distribution Security Alliance (PDSA), a coalition of more than 25 pharmacies, distributors, logistics operators, manufacturers, and associations dedicated to DSCSA issues. Once formed, the governance body will also engage with FDA in piloting of governance activities as part of the Agency’s DSCSA Pilot Project Program.

 

PDSA doesn’t intend to push into business operations, nor will it attempt to issue regulations like FDA is expected to do, “but there is a space in between where there's going to need to be some alignment,” said Eric Marshall, senior director at Leavitt Partners who is serving as an advisor to PDSA.

 

The group focused specifically on the structure of a governance body—"how to put that organization in place, the bylaws of how that organization would operate, who gets seats, who gets to be members, who gets to vote on what topics, who pays for what, how board members are elected, et cetera,” Marshall said. “We are currently focused on the structure of the body, but the decision as to what technical vision should be pursued for interoperability should be made by that governance body.”

 

One of PDSA’s challenges has been balancing the needs and concerns of smaller supply chain players, like independent pharmacies and small hospitals, with larger entities that have the bandwidth and resources to devote to the track-and-trace conversation. To that end, they are keeping associations like APhA  apprised of their activity and are encouraging pharmacists to participate in PDSA’s efforts.  “I think everybody recognizes it's an important perspective,” Marshall said.

 

Marshall advises pharmacists to get involved. “What PDSA has put out is a starting point for discussion—it is by no means set in stone. PDSA very much wants to see many stakeholders who have not yet been involved in the process to come be part of the process and the conversation going forward.”

 

To take action, pharmacists can work through their associations or provide written comments, feedback, and alternate proposals by e-mailing PDSA@LeavittPartners.com. Marshall also invites pharmacists to participate in a May 1, 2019, workshop for industry stakeholders to discuss the broader governance structure and concept. The workshop is open to all interested stakeholders free of charge, with an option to listen in by video. Register by April 29 here.

 

“We would really love to see some more pharmacy participation in that workshop to have the give-and-take conversation about what works, what doesn’t work, and what needs to change in order for people to get behind [the proposal] and move it forward into formation,” Marshall said. “Although 2023 seems a long way away, the time to start thinking about it is now.”