HDA 2023 Traceability Seminar: Mitigating Data Errors to Keep Products Moving

HDA 2023 Traceability Seminar session, “Exceptions Handling: Mitigating Data Errors to Keep Products Moving.” August 30, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

Wrapping up the first day of this year’s annual Healthcare Distribution Alliance (HDA) Seminar, six industry leaders came together to offer various workshop recommendations, personal insights, and answer questions. Titled “Exceptions Handling: Mitigating Data Errors to Keep Products Moving,” the session featured Bruce Harold, director of EDI, KeySource, Arthi Nagaraj, head of analytics, strategic projects and serialization, Sanofi US, Tracy Nasarenko, senior director, community engagement, GS1 US, Maryann Nelson, regulatory manager, Cardinal Health, Inc., Jeff Primeau, VP, business solutions cencora, Integrated Commercialization Solutions, and Tim Stearns, senior director, industry relations, Healthcare Distribution Alliance.

This Q&A has been edited for clarity and brevity.

Tim Sterns: This question is directed at Maryann and Jeff. Who in your organizations will be involved in handling the exceptions that are being given to companies on transitioning to the FDA’s new supply chain policies by Nov. 27, 2024?

Nelson: They’re complex. They’re going to require coordination across multiple departments. For exceptions, a wholesale distributor discovers that through receiving regular distribution, we’re going to get that error message from our sterilization repository that they’re going to have to quarantine that product. They’re going to have to provide a general description of the error and perhaps supporting documentation. If it's missing for the entire shipment, maybe that’s the packing slip. That information needs to be relayed to the manufacturer.

Cardinal Health has formed a centralized exception team that’s going to coordinate these certifications. If we don’t have the right manufacturer contacts or the wrong contacts, we’re probably going to have to change our sourcing teams to get us where we need to be. Depending on the manufacturer’s response, our EPCIS support team will likely have to get involved to make sure corrected data is received. Even for mistakes, overages or shortages that are identified by our downstream trading partners, those are likely that originate in customer service. So, we have to be treating them as an example to ask for serial numbers so that the incident can be properly researched. The bottom line is you can't really operate in a silo. Many of these roles are going to require some level of technical expertise to be able to identify the cause and the appropriate corrective action.

Primeau: I think it’s the bridge with the pharmacy discussion. If you take that perspective of how many people get involved, thinking about shipping, going to a pharmacist, and they encountered an overage, now they’re going to contact customer service. We’re going to have to figure out who it came from.

Stearns: What staffing levels do you anticipate? What will be needed in facilities? Could you speak to the importance of technical knowledge and experience?

Nasarenko: When we talk more about what kind of expertise, I think you’ve heard quite a bit about how complicated exceptions can be, especially with it being at a centralized level. The concept of having to fix it within my four walls doesn’t exist anymore. You have to have it so that product can be traced through the supply chain. Therefore, there has to be that coordination between the different trading partners. It has a different added level of expertise because you definitely have that same expertise you need, but now, you’re getting into the technical aspects, understanding your systems and how you can fix it. That has to be coordinated with your quality systems and warehouse systems. That’s just the added level of expertise and coordination that’s necessary to handle exceptions.

Nagaraj: We don’t exactly know what it is yet. What we are planning toward is hiring a couple of analysts who will regularly monitor exceptions. I’ll go back to the solution maturity piece. Right now, our solutions are not there, at least not all solutions are there, you know exactly what is failing or what's going wrong. There are a lot of things that we can do, but that’s what we are planning.

In terms of technical knowledge, it’s not just final EPCIS or B2B exchanges. There are so many interfaces within the company before we send that out to our customers. To be able to resolve these exceptions, you need a deep knowledge of master data sources that is causing the exception.

What number of root causes can lead to exception-level estimates fluctuating? Can you speak to the impact of what even a single error under the disguise of EPCIS can mean?

Primeau: The simple answer is a single EPCIS problem can stop a whole file in any system. You think that the large shipments you’re doing is manufactured, especially to the Big Three. You start the whole file because of one error in the system, and as a result, there are a lot of products that needs to be corrected. Now unfortunately, if it's that type of problem, there's a better chance of seeing it up front, seeing before the product arrives there and being able to ask for records. Some other systems will be able to work around that. It may make it more complex to get a correction because if the whole file fails, quality may be affected.

What are you doing internally to handle exceptions? In contrast, what are manufacturers doing to handle exceptions compared to distributors?

Harold: A lot of different carriers have to know something about this process, and they know what to do, seeing their portion of it. We are focusing on receiving permission because the upstream process has to be controlled before we really get a good quality downstream process. With process improvements, we need to reduce the number of exceptions. To catch exceptions earlier in the process, we need to look into it. Obviously, early recognition and preventative measures are very important.