Finding a better way to track and trace medicines and vaccines

The FDA pilot program results are in: Blockchain technology could help protect pharmaceutical product integrity

May 4, 2020

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Merck, IBM, KPMG and Walmart successfully complete FDA pilot program to evaluate the use of blockchain to help protect pharmaceutical product integrity

  • Pilot program was successful in demonstrating the application of blockchain technology for the tracing and verification of prescription products
  • Results of pilot demonstrate how patient safety can be potentially enhanced by improving supply chain visibility and informing parties within seconds after a simulated recall

Merck, IBM, KPMG LLP, and Walmart today announced the completion of a pilot program which proved blockchain technology can be used to help meet the FDA’s Drug Supply Chain Security Act (DSCSA) requirements to identify, track and trace prescription medicines and vaccines distributed within the U.S.

The initiative met its objectives, demonstrating the ability of blockchain to connect disparate systems and organizations in order to record a common view of product traceability. It also showed how it could potentially improve patient safety by reducing the time it takes to alert the supply chain of a product recall from a few days to a few seconds.

“The pilot program showed that blockchain could help meet FDA’s DSCSA requirements and also potentially serve as a tool to increase patient safety,” says Craig Kennedy, head of supply chain for Merck. “We now need to take what we have learned and work with others across the health care system to create a standard for DSCSA interoperability based on blockchain and continue to demonstrate how it can be efficiently integrated into existing systems.”  

“Customer trust is important to us, and we want our customers to feel confident about the products we sell,” said Asma Ishak-Mahdi, Pharmaceutical Blockchain Lead for Walmart. “We are encouraged by the results of this pilot and how it can potentially contribute to the safety and security of prescription drugs and vaccines.”  

The four companies worked closely with the FDA’s DSCSA pilot program to study blockchain’s effectiveness for tracing prescription drugs and vaccines. The pilot successfully connected a blockchain-based system from IBM with Merck’s existing industry-standard system for serialization. KPMG led the functional design of the pilot, including the process workflow, user interface development, defining configuration requirements for IBM’s blockchain platform and overall integration to demonstrate compliance with the DSCSA. Pilot participants were able to incorporate blockchain to determine product quality and origins of the product.

The pilot enabled traceability of individual products and their ownership exchanges among supply chain trading partners. Today, notifying the members of a supply chain about affected products could take as long as three days. Based on the results of the simulation, the blockchain pilot participants estimated they could verify a product’s status in just a few seconds.

“Permissioned blockchain networks can help reconcile the fundamental tension between the benefits of cross-industry data with the need to keep private, proprietary information private,” said Mark Treshock, IBM’s Global Solutions Leader for Blockchain in Healthcare and Life Sciences. “Alongside our distinguished partners, we look forward to applying this technology to bring more transparency to the entire supply chain for vaccines and prescription drugs.”

“The pilot is an important milestone to demonstrate how this technology could help bring the pharmaceutical supply chain into regulatory compliance with the DSCSA,” said Arun Ghosh, KPMG’s U.S. Blockchain leader. “Blockchain’s ability to tag a drug just a few seconds after a recall can potentially improve pharmacy safety, and we anticipate far reaching health implications for tracking and tracing medicines in areas where counterfeiting or adulterated products are a problem. Blockchain represents a real opportunity to help ensure patient safety.” 

Having established this initial feasibility, the project team’s final report to FDA includes several recommendations regarding additional value that can be addressed through an expanded solution involving additional industry participants with an aim toward an industry standard for interoperable blockchain. The final report to the FDA can be found here.