Ullrich Mayeski

HDA 2025 Traceability Seminar: Closing Gaps in Pharma’s Supply Chain

, Ullrich Mayeski, community engagement director of health with GS1 US, discussed how last month’s HDA Traceability Seminar received positive feedback from attendees, who emphasized both the quality of its organization and the timeliness of its content. The event, held annually, was noted for effectively addressing the current challenges facing the pharmaceutical supply chain. One of the greatest strengths of the seminar lies in its diverse audience, which brings together manufacturers, distributors, dispensers, solution providers, and professionals from varying organizational levels. This diversity facilitates meaningful conversations, both within sessions and informally, helping stakeholders compare challenges, share strategies, and build valuable relationships across the industry.

This year’s seminar differed from previous ones in tone, shifting toward a stronger sense of confidence and readiness. Manufacturers, in particular, appear to have made significant progress in providing data and resolving technical issues. Distributors also displayed greater assurance in their preparedness for the approaching regulatory requirements. While inbound processes seem relatively stable, outbound operations continue to present challenges, particularly in ensuring compliance on the dispenser side. Attendees observed that dispensers still benefit from certain exemptions, especially regarding the receiving of electronic data, which provides them additional time and flexibility.

The broader industry discussion is now less about uncertainty and more about refining readiness for enforcement. Attendees pointed to three major themes gaining traction: exception management, governance, and compliance execution. Exception management focuses on how companies will address inevitable discrepancies or system errors. Governance relates to setting consistent policies and practices across supply chain partners to ensure compliance. Overall, the event reflected an encouraging trend: the pharmaceutical supply chain is moving closer to readiness for the upcoming traceability enforcement deadlines, with conversations now centered on fine-tuning systems rather than questioning their feasibility.

In separate conversations, Mayeski also dives into panels they participated in at the conference; industry’s preparedness for DSCSA enforcement; best practices stakeholders should adopt to ensure secure, end-to-end traceability and interoperability; and much more.

What are some of the other critical interoperability gaps that you see in today’s pharma supply chain?

 I think one of the areas where the industry has to make sure that they understand the gaps appropriately is really on the dispenser side of things. We've spent so much time with manufacturers and distributors, repackagers, and for good reason, but with dispensers, there are a lot of them, and they run the gambit in terms of size.

You have very small, independent dispensers, all the way up to large, complex hospital systems that have multiple locations. They all have to meet their requirements for compliance with the law. I think diagnosing the industry, diagnosing where there are gaps and challenges for this community, is going to be really important.

One of the things about the dispenser community is a lot of the folks that maybe do some of the DSCSA work inside of a pharmacy, for example, have other responsibilities. They may have to work on inventory, restock shelves. There are things that they have to do in addition to maybe some aspects of DSCSA compliance. These pharmacies, even though they might be small in size, can be fairly complex in their operation. The industry—understanding where there are potential gaps in interoperability at that level—I think will be important so that we can have smooth execution, all the way from the top to the bottom of the supply chain.

I think the last thing, and this was highlighted during the conference, specifically when the representatives from the various boards of pharmacy spoke, is that bad actors are going to attempt to test the system. They're going to attempt to introduce counterfeit or adulterated product into the system, and it's important for industry to be able to acknowledge that that's still going to happen, and that they remain vigilant in their efforts to combat that, to make sure that the product that's in the supply chain is authentic, meets the stated label requirements, in that the industry is working together to really prevent that from happening. I think that's something that's really important for the industry to keep their eyes on.

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Ullrich Mayeski, community engagement director of health with GS1 US, emphasizes the critical need to address interoperability challenges at the dispenser level, ranging from small independent pharmacies to large hospital systems. 

HDA 2025 Traceability Seminar: Building a Secure and Interoperable Supply Chain

 What best practices should manufacturers, distributors, and dispensers adopt to ensure secure, end-to-end traceability and interoperability, both on a domestic and global scale?

 The good news here is that generally, the industry doesn't have to invent things. There are implementation guides from GS1, from HDA, and from other organizations that have really explored a lot of the issues that trading partners or supply chain is going to face when they are enacting their DSCSA compliance program. There are things like exceptions, for example. The industry has really spent a lot of time on exceptions, which are essentially instances where there's a non-conforming transaction. Something happens in your system, we have data that shows up with no product, or we have product that shows up and it doesn't have the appropriate data. How do we diagnose that? The industry spent a lot of time collaborating on what are the best practices to address that.

Instances like that, I think the industry has done a really good job on. From a best practice perspective, it’s to go back into the resources that are already available. I think that's really, really important. I think the other thing that was highlighted and lifted up during the conference and from a best practice perspective, is to really train and enhance on your SOPs. That was talked about by the regulators, and SOP management in this business is something that's very important. It's always evolving, and so that has been highlighted over the past couple of weeks, as we're getting to this point where distributors are about done with their exemption.

I think communication strategies are something else from a best practice perspective. Don't wait to communicate with a trading partner until an issue arises. You could have 100 great transactions with a trading partner and never need to contact them, but that one time that you do, if you don't have the appropriate communication plan set up, that's going to delay getting that product into inventory and ultimately where it needs to go. That communication strategy is something that's really, really important.

I think lastly, from a best practice perspective is really being able to diagnose and understand the root cause of a problem when it arises. Talk briefly about exceptions, perfect example, to understand when something happens, why it happened, and then be able to put a corrective action in place so that we mitigate future instances from that happening. It's a lot of resources for folks in the industry to have to constantly address the same issue over and over, so that supply chain innovation in terms of how they implement corrective action to the root cause of a problem I think will be really important.

Ullrich Mayeski, community engagement director of health with GS1 US, outlines how manufacturers, distributors, and dispensers can strengthen end-to-end traceability. 

Ullrich Mayeski

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