IBM, Merck, KPMG, and Walmart finished the Drug Supply Chain Security Act (DSCSA) Interoperability Pilot in December 2019 and are now starting the Pharmaceutical Utility Network (PhUN).

It could be recollected that the U.S. Food and Drug Administration (FDA) had elected these companies in June 2019 for the DSCSA Interoperability Pilot, which was part of its DSCSA Pilot Project Program. The companies were tasked with producing a blockchain-based network that would enable real-time monitoring of products.

The DSCSA, slated to go into impact in 2024, is a U.S. law that needs supply chain stakeholders to digitally trace and track certain prescription drugs and their distribution in the U.S.

The pilot application utilizes blockchain technology to digitally save pharmaceutical product profiles and enable end-to-end tracking and tracing of the products at the serialized unit level. It also allows users to quickly and effectively recognize, investigate, and talk about a relevant suspect or illegal drug product.

“The visibility offered by blockchain makes it easier for pharmaceutical supply chain actors to comply with the DSCSA…, prevent the distribution of counterfeit drugs, facilitate the drug recall process, and more,” IBM stated in an online post. “The pilot’s findings demonstrate that leveraging blockchain technology can significantly reduce the time needed to trace a prescription drug — from up to 16 weeks to two seconds.”

The Pharmaceutical Utility Network (PhUN)

Following the successful achievement of the pilot, the partnering companies aim to formally launch and scale the blockchain-enabled solution to streamline and expedite DSCSA compliance for several stakeholders in the pharmaceutical supply chain.

IBM stated that the FDA DSCSA Interoperability Pilot marks the initial application to be released on the PhUN platform.

“PhUN takes an open-source platform-first approach — a similar concept to the Apple App Store — to empower stakeholders to comply with regulations and to use them as the basis for innovation. At scale, PhUN will integrate regulatory requirements such as the DSCSA into the platform, allowing solution developers — pharmaceutical manufacturers, distributors, dispensers, software vendors, and others — to comply with ease,” it added.

According to the online post, PhUN is now operating with first participants to examine five pharmaceutical industry problem areas, including regulatory compliance, drug shortages, cold chain efficiency, drug recalls, and clinical trials.

Meantime, Walmart last year joined MediLedger, a blockchain-based pharmaceutical industry network. Other members include Pfizer, AmerisourceBergen Corporation, McKesson Corporation, and Premier.

SAP also launched a blockchain-based solution in 2019 that supports to track and validate pharmaceutical packaging returned from hospitals and pharmacies to wholesalers ere products are resold. The solution, it stated, will help assure docility with the DSCSA.