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IBM, KPMG, Merck and Walmart successfully completed the Drug Supply Chain Security Act (DSCSA) Interoperability Pilot in December 2019 and are now launching the Pharmaceutical Utility Network (PhUN).
It could be recalled that the U.S. Food and Drug Administration (FDA) had selected these companies in June 2019 for the DSCSA Interoperability Pilot which was part of its DSCSA Pilot Project Program. The companies were tasked with developing a blockchain-based network that would allow real-time monitoring of products.
The DSCSA, slated to go into effect in 2024, is a U.S. law that requires supply chain stakeholders to digitally track and trace certain prescription drugs and their distribution within the U.S.
The pilot application uses blockchain technology to digitally store pharmaceutical product profiles and allow end-to-end tracking and tracing of the products at the serialized unit level. It also allowed users to quickly and effectively identify, investigate, and communicate about a relevant suspect or illegitimate 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 said 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 completion of the pilot, the partnering companies intend to officially launch and scale the blockchain-enabled solution to streamline and facilitate DSCSA compliance for various stakeholders in the pharmaceutical supply chain.
IBM said that the FDA DSCSA Interoperability Pilot marks the first 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 working with initial participants to explore five pharmaceutical industry problem areas, including regulatory compliance, cold chain efficiency, drug shortages, drug recalls, and clinical trials.
Meanwhile, Walmart last year joined MediLedger, a blockchain-based pharmaceutical industry network. Other members include Pfizer, McKesson Corporation, AmerisourceBergen Corporation, and Premier.
SAP also launched a blockchain-based solution in 2019 that helps to track and authenticate pharmaceutical packaging returned from hospitals and pharmacies to wholesalers before products are resold. The solution, it said, will help ensure compliance with the DSCSA.
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