IBM, KPMG, Merck, and Walmart Conclude FDA Blockchain Pilot; DLT Is Key In Supply Chain Tracing


  • The joint partnership that participated in the FDA concluded DSCSA trial has announced it was successful and even surpassed the FDA’s expectations.
  • The objective of the trial was to investigate alternative ways of improving the traceability of prescription medicines in the US.

In collaboration with the US Food and Drug Administration (FDA), IBM alongside, KPMG, Walmart US biggest retailer, and Merck concluded a pilot program for the US prescription medicine supply chain. The joint partnership has since released its findings outlining their success.

The DSCSA act

The Blockchain solution was in part to reinforce the U.S. Drug Supply Chain Security Act (DSCSA) act passed in 2013 by US congress. The act calls for a more efficient and standard electronic method that could be an aid in tracking how certain prescription meds have been distributed in the US. The DSCSA has also set a 2024 deadline for the FDA to come up with a viable solution to be implemented by all the actors in the industry.

IBMFDAStudy

The trial was built on Hyperledger Fabric and began in June 2019. It was to ensure the Blockchain solution from IBM seamlessly integrated with legacy serialization systems from Merck Pharma. KPMG then took lead on the systems functional model confirming it conforms to the FDA’s user requirements.

Blockchain trimming Information flow time

The trial further proved it could offer safety and assurance to the patients. This was illustrated by Blockchain’s ability to trim off the time it would take to alert the whole of the supply chain in event of a product recall from days to mere seconds.

“Currently, due to the lack of interoperability and visibility to lot-level information, it can take up to 3 days to identify impacted products and alert downstream partners with this information.

It was demonstrated in the Pilot that using blockchain technology, the process would be exponentially expedited.

Using blockchain technology, partners may be alerted in as little as ten seconds.*”

After completion of the trial, the partnership seems to share the sentiment that indeed Blockchain is the most efficient way the industry could ensure conformity with the DSCSA act. Not only could the system verify drug movements across the supply chain but also in a way that would exclude participants’ confidential details.

Their findings mostly call for the incorporation of more participants to help come up with an industry-standard solution. This while reiterating the need for a commercial open-source system to foster information exchange across the participants in the Network.

Tegan Keele, Blockchain Lead at KPMG was positive that Blockchain is the solution to untangle pharma’s composite supply chain systems. Bridging the differences visible in the diverse sphere including logistic companies, the manufacturers and retailers, or pharmacies who have all implemented different systems.

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