Handling Pharma Supply Chain Disruptions

In a video interview with Pharma Commerce, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, describes how the HDA Distribution Management Conference (DMC) covers a broad spectrum of topics within the pharmaceutical supply chain, with a special focus on current regulatory and operational challenges. One of the major topics at this year’s conference was the Drug Supply Chain Security Act (DSCSA), which prompted several discussions and roundtable sessions.

The DSCSA has significant implications for the pharmaceutical supply chain, especially in terms of enhancing traceability, safety, and efficiency in drug distribution. At the DMC, various presentations and dedicated roundtable sessions were held to address its impact, compliance requirements, and the ongoing industry adaptations necessary to meet its mandates. These discussions provided insight into the challenges and solutions that stakeholders in the pharmaceutical supply chain are encountering as they work to ensure compliance with DSCSA regulations.

Overall, the DMC served as an important platform for exploring the evolving landscape of drug supply chain security, with the DSCSA at the forefront of many conversations. Given its complexity and importance, the conference highlighted the need for continued collaboration and knowledge sharing among industry professionals to navigate the regulatory landscape effectively.

Rowe also comments on where he believes industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.

A transcript of his conversation with PC can be found below.

PC: Could you detail some of the supply chain disruptions that stakeholders are reporting?

Rowe: There's a couple different things, DSCSA-related or not. I think, generally, master data management seems to be the Achilles’ heel of the industry. If you have improper master data management, it can cause the system to fail. I think we've seen a lot of challenges with GLNs—the global location numbers—where I think GS1 and the industry has tried to do the best they could to go through what’s called an enumeration project to create GLNs for people, but now what's happening is you've got different dispensers or pharmacies with three or four different GLNs. Their GPO made one for them, their wholesaler made one for them. GS1 made one for them. Now it's like, “hey, we're trying to connect. I don't even know what's the right GLN,” and now, that's causing challenges.”

I think master data management is huge. I think just the flexibility of the serialization systems in general. When you think about exception handling, in many cases, that requires either re-triggering a file or maybe sending what's called a supplemental file. The serialization systems have been generally somewhat inflexible, and there's been a lack of standards, as to how exceptions would be fixed.

Just right before the conference, GS1 actually published an exception handling standards guide that's like 400 pages. It's kind of coming in here right at the tail end of implementation. I think there's going to be some bumps in the road as the serialization vendors look to adopt and standardize some of those exception handling tools. The other big disruption that was a hot topic during the conference as well was that the change in the national drug code (NDC). The NDC 12—it's coming. This is all non-official, but the rumors that are circulating is that the agency might finalize that proposed rule sometime this year, where the NDC-10 will move to an NDC-12 over the next five to seven years, and that will have a major impact across the entire pharmaceutical supply chain, from manufacturing, distribution, dispensing, reimbursement, government price reporting.

It will impact dispensing, payment, distribution processes across the entire industry, and it breaks some of the logic that we've built on the DSCSA side on embedding a lot of information to the 2D barcode. This is going to be a major disruption to the industry, kind of like what we dealt with serialization, with new barcodes, new labeling. The same thing's going to happen with the new NDC-12, but it's now not just impacting the packaging and the distribution—it's going to impact how people get paid and the dispensing of product.