As has been known for years, establishing a successful implementation of the Drug Supply Chain Security Act (DSCSA) will require close coordination among manufacturers, wholesaler-distributors, pharmacies and health systems (even, conceivably, individual doctor’s offices)—a tall order. Yet there has been no reliable mechanism for accomplishing this coordination—apart from banging on FDA’s door—to date. That is changing now with the establishment of the Partnership for DSCSA Governance, Inc. (PDG), an independent, nonprofit, “sector neutral” (as it characterizes itself) group to work out the steps toward DSCSA compliance by the law’s 2023 deadline.
At that date, DSCSA mandates that all the parties involved in the pharmaceutical supply chain will have an electronic means of exchanging information about pharmaceutical products (there are some excluded ones) from point of origin to point of dispensing. The nominal purpose of DSCSA has been to prevent counterfeit products from entering the supply chain; however, many advocates of the system point to significant savings or improvements in overall pharmaceutical distribution and use once the system is up and running.
General membership in PDG includes pharmacies, distributors, third party logistics providers (3PLs), manufacturers, industry trade associations and technology providers; PDG’s news release says that 26 companies or associations are current members, with another dozen coming onboard soon. The board positions represent Pfizer, Novartis, BMS, Walgreens, Geisinger Health System, AmerisourceBergen and HDA, among others. “While DSCSA specifies what needs to be accomplished, it does not explicitly state how. This provides pharmaceutical trading partners—of all sizes and from all sectors—a unique challenge and opportunity to have a voice and hand in figuring out how interoperable tracing will be achieved,” stated Matt Price, vice chairman of the PDG board and senior director of government & regulatory affairs at Medline Industries, Inc.
To clarify, here is what PDG is not: It is not a standards-setting body (at least in its current form); it will arrive at consensus views of how IT systems could interoperate, and what existing technical standards can be employed. And although several members who have been involved in its gestation were part of a similar group called the Pharmaceutical Distribution Security Alliance (PDSA), which came together and represented industry perspectives as DSCSA was written, it is separate from that organization. Finally, while the term “governance” regularly pops up in discussions about applying blockchain technology to the pharma supply chain, PDG is not specifically a blockchain-implementation effort (although clearly that will be a topic of discussion).
The first order of business for PDG will be to develop a report to deliver to FDA; that agency had included the governance effort as one of the pilot programs it designated in early 2019 for furthering DSCSA implementation efforts. PDG “looks forward to beginning its work to establish a technical vision for interoperable drug tracing in earnest in January and to producing a blueprint for DSCSA interoperability in 2020,” stated Eric Marshall, executive director of PDG.
There are already some knotty problems to be resolved in DSCSA compliance. Wholesalers are demanding that manufacturers “aggregate” the contents of cases of individual products (so that the cases don’t need to be opened to be accepted into the wholesalers’ inventory systems), which is not a requirement of DSCSA. Retail pharmacies are wrestling with the disparities between the serial codes that identify products, and the longstanding NDC numbering system they are accustomed to. The biggest challenge, though, will be establishing an interoperable, digital system that can securely convey product information along the supply chain.
It appears that the executive leadership of PDG was chosen expressly to bring in as many organizations as possible. “For PDG to be as effective as it can be, it’s critical that we expand membership to include the broadest base of pharmaceutical supply representatives as possible,” Max Peoples RPh, chairman of the PDG Board and owner of Uptown Pharmacy. “It is particularly important that small businesses and non-traditional businesses engage in order to make their voices heard.”
Membership in PDG is open to all trading partners and their associations. Solutions providers and technical experts are also invited to formally engage and lend their expertise. For more information about how to join PDG, contact Eric Marshall at Eric.Marshall@LeavittPartners.com.