LogiPharma USA 2024: The National Association of Boards of Pharmacy's PULSE Program
In an interview with Pharma Commerce Editor Nicholas Saraceno, Mark Karhoff, supply chain & DSCSA consultant, National Association of Boards of Pharmacy, discusses the NABP's PULSE program and how it will support supply chains.
PC: Can you discuss the NABP’s PULSE platform?
Karhoff: They've been working on it for a few years now. Three or four years ago, there was a pilot that I helped run at NABP where we work with entities across the whole supply chain Even the FDA was an observer. We were focused mainly on traceability. Whenever I need to do a product trace, how is that going to happen? We learned that there is a long way to go, but the industry is probably going to be starting out with more manual means. Such as Excel spreadsheets and other general standards.
Most importantly, there was a lack of directory. So, when you think about state regulators, they have almost a similar role to the FDA in terms of what they have to do. The FDA has a few other things that are baked into the law, but they have to basically enforce it and regulate it. How do they get ahold of somebody? Nobody has a directory that includes all of the manufacturers. The FDA doesn’t have a directory that includes downstream. They’re responsible and they do a lot of registration for the manufacturer sector, drug approvals, and things like that. They have a database that’s required for wholesalers and 3PLs to self-register. Once you go beyond that, they don't have ways to get a hold beyond trying to gather information through their portal.
So really, that all brought forward the need for NABP to create this pulse platform to become a connective tissue between state regulators, small pharmacies and then all the trading partners in the supply chain. Additionally, also found that a lot of the small pharmacies lacked the resources to be able to comply with DSCSA, so they're providing tracing and eventually product tracking capabilities in the platform for dispensers as well. It’s meant to try to help fill the gap where they know there's a lot of big players that are involved. As we go down the supply chain, how do we get them engaged? That’s actually where a lot of the counterfeit events have been happening.
