FDA blockchain pilot successfully completed

By Bill Borden and Stephanie Trefcer

IBM, KPMG, Merck and Walmart’s pilot program found that blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to identify, track and trace prescription medicines and vaccines distributed within the United States and potentially improve patient safety.

This initiative demonstrates blockchain’s ability to connect disparate systems and organizations, in order to record a common view of product traceability. The pilot also shows how blockchain 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 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.” 

Since the pilot project announcement in June 2019, the four companies have worked closely with the FDA’s DSCSA pilot program to study blockchain’s effectiveness for tracing prescription drugs and vaccines. The DSCSA aims to combat diversion, tampering and counterfeiting in the pharmaceutical supply chain with new requirements being phased in until the law goes fully into effect in 2023 – which could help greatly address the issue of patient safety as drugs move through the supply chain.

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.

At IBM Think’s virtual conference on May 5, Tegan Keele, U.S. program lead for KPMG Blockchain, will join panelists from Merck and IBM to discuss how blockchain solutions can work to improve transparency and visibility, which are all key elements in blockchain’s potential to improve the safety of prescription drugs in the U.S. They will also highlight the specific key results of the pilot program report that was submitted to the FDA and discuss the potential of the findings to accelerate COVID-19 solution development.

Please click to register to join the IBM Think livestream on May 5 at 2:05-2:30 EDT.

For more information or to arrange an interview, please contact Bill Borden.

Media contact

Bill Borden

Bill Borden

Director, Healthcare & Life Sciences Comm., KPMG US

+1 201-505-6351

 

 

Arun Ghosh

Arun Ghosh

Principal, Advisory, U.S. Blockchain Leader, KPMG US

Tegan Keele

Tegan Keele

US Blockchain Program Leader, KPMG US

+1 781-708-3298

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