Earlier this year, Healthcare Packaging covered an issue voiced by the supply chain traceability community that it’s difficult and time-consuming to find the right contact info to reach out to at a trading partner for serialization efforts.
At HDA’s Distribution Management Conference, attendees noted the problem spans the supply chain, with distributors and dispensers unsure of whom to reach out to at the pharma manufacturer for initiating onboarding or for verification requests. Manufacturers also expressed concern over finding the right contact at their downstream trading partners.
One company has developed technology to overcome this communication challenge—individual websites that act as a “source of truth” for contact information for a given NDC, GLN, or license number. The new service from supply chain data exchange company Trust.med is a form of centralized online registry, currently being piloted.
As an example, a website is spun up based on a product NDC for a brand owner. The brand owner populates the site with DSCSA-specific information such as contact info or verification activities. Then downstream partners who have been validated can access that information from their desktop or mobile.
As chief marketing officer Daniel Kraciun explains, “I think the industry as a whole has a perception that centralization does not attach to interoperability. But you can have a centralized registry and it doesn’t necessarily have to cost anything. You can have a place where you update once, and the rest of the industry can then get your new information versus having to continually go point-to-point to get your updated info, whether it's a credential or it's an email address.”
Kraciun explains that Trust.med creates individual domain names from their “[dot]med” top-level domain, which is kept exclusive to the pharmaceutical industry. “If you're a manufacturer, distributor, or a dispenser in the pharma supply chain, then we will provision you a domain name. But there are lots of restrictions—we obviously have to validate that you are who you say are as the first step. Then second is that, depending on the way that you want to be identified, we can spin up websites and we have default ways to do that,” he says.
- For manufacturers, the default is a site with the NDC of the product, and the related GTINs of the product.
- For distributors, the default is a global location number (GLN).
- For dispensers, the default is a global location number or license number.
“That's how you get there, just like you would go to ESPN.com. As long as I have that identifier, which is what everybody on the supply chain has, then I have the ability to visit this website,” he adds.
Updating site content
Trust.med sought to make the system interoperable. A manufacturer, distributor, or dispenser who has been provisioned one of these sites can go in and update the contact information that they want to communicate with the rest of the supply chain. They can also populate where they store their EPCIS, what their credential number is (if they have a verifiable credential), and where they want to receive their product verification requests.
The application service addresses “problem number one” of knowing whom to reach out to at a given trading partner. At the outset, Trust.med is taking the approximately 90,000 drug products currently in the VRS and creating .med websites. Then they plan to open them up for registration and activation for supply chain trading partners. Trust.med also built a GS1 Resolver, a technology already used in supply chains, that allows the owner to put links on a website. Users can also send messages via the sites.
The company has been rolling this cost-free service out slowly. “We're doing pilots right now with Sandoz and a couple other manufacturers. We plan on doing a full release of this particular service in summer where it will be up and available for solution providers to come and activate their domains to get their contact information up,” Kraciun says. For those interested, Trust.med is still accepting manufacturers to participate in the pilot as of press time.
Then they will extend the functionality to accommodate product verifications in fall, just ahead of the Nov. 2023 deadline for compliance.
Restrictions and access
You may be asking if this information is essentially publicly available if you have the NDC.
Kraciun says it's twofold: “In the future, we definitely see a world where a consumer could pick up a pill bottle, see the NDC printed on the label, and they could go to ‘that NDC.med,’ and obtain some patient-level information. But the immediate focus are the supply chain trading partners.”
While the webpage is open and available on the internet, they’ve built control mechanisms in—there are authorization permissions behind submitting a product verification. “Say it's a manufacturer, they will be able to say, ‘I only want to share my email with someone who submits their license number so that I can do my own customer check. Then I'll allow them to see the email. There are many different layers of security that are built in and totally customizable, because not every manufacturer thinks the same way,” he adds.
Trust.med wanted the sites to be clean, simple, and easy to understand. A sample website shows DSCSA actions a viewer could take on the left side including product verifications, with product tracing to follow in the coming months. Contact information appears on the right side.
Early manufacturers using Trust.med sites are communicating to their downstream partners how to access these websites in order to be able to field requests. The information can be added to a P.O. for example, letting them know to access "the NDC".med.
Much industry collaboration has taken place in the past several years and anything interoperable should work within the ecosystem that’s already been built. In terms of interfacing with the verification router service (VRS), Kraciun says they are planning a built-in VRS application to route requests for those enabled through the VRS.
Trust.med’s chief technology officer Thomas Cooper is involved with PDG, HDA, and other industry groups, including the HDA’s VRS efforts where he’s contributed to the standards. “We do currently operate as a lookup directory within that service, so we are synced with partners,” Kraciun adds.
The system is customizable. One Italian drug manufacturer is using Trust.med for data exchange, though they do not participate in the verification router service. They chose to field their product verification requests manually, and then extract the information from their ERP system and respond.
Routing requests and displaying contact info will reportedly be no-fee services. Will there be a charge for product tracing in the future? Potentially, because it requires more backend work.
“From a data exchange perspective, we will actually facilitate the movement of the information, and we earn business from manufacturers that are frustrated with the controls that their solution providers give them today,” he explains.
Trust.med is seeking to simplify a concept that’s been unusually difficult. “You have to be able to know where to go to get the information. That's a barrier that everyone faces,” Kraciun says. “We perceive that if we're going to have that issue, and everybody has to solve it, then why don't we anchor it where they can go to these IDs that are persistent throughout the industry?”
In the future, he says there is potential beyond VRS activities, such as facilitating the exchange of master data. He adds, “Nothing will ever have a 100% adoption rate, so it has to be more than [VRS]. I believe that it ties a lot of DSCSA requirements between manufacturers and dispensers together. We're excited for it to roll out.”