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IBM, Merck, Walmart unveil results of blockchain FDA pharmaceutical pilot

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In February last year, the U.S. Food & Drug Administration (FDA) announced a pilot program to encourage new technologies to be trialed in the pharmaceutical supply chain. A blockchain consortium of IBM, KPMG, Merck and Walmart was formed as one of the pilot groups, and today detailed results were published.

In February last year, the U.S. Food & Drug Administration (FDA) announced a pilot program to encourage new technologies to be trialed in the pharmaceutical supply chain. A blockchain consortium of IBM, KPMG, Merck and Walmart was formed as one of the pilot groups, and today detailed results were published.

The FDA’s purpose was to ensure that companies are prepared for the Drug Supply Chain Security Act (DSCSA), which is being phased in gradually through to 2023. One of the stages that became law last year was to ensure that returns made to wholesalers can be verified as legitimate. As many returns are re-sold, this helps to ensure mainstream wholesalers do not inadvertently sell counterfeit drugs.

KPMG and IBM were both solution providers on the project, with KPMG as the pharma subject matter expert and it took on the role of the functional design and process workflow, amongst other aspects.

The IBM / Merck group’s pilot was to use blockchain to test drug recalls and enable rapid alerts amongst supply chain participants. It also aimed to use blockchain as a shared record of the movement of drugs through the supply chain.

And the results showed that recalls can be done in seconds, rather than as much as three days. This is primarily the result of the traceability that blockchain enables. Given the potential impact of drug recalls on patient health, this could be a lifesaver.

The solution used the permissioned enterprise blockchain Hyperledger Fabric and leveraged the IBM Food Trust at the platform and solution layers.

Three months ago, the group announced a longer term consortium called the Pharmaceutical Utility Network (PhUN), and the pilot results highlighted potential next steps.

One of the challenges of doing this sort of thing for the entire industry is integration. However, the paper pointed out that there are a limited number of technical solutions adhering to a common standard, and hence the integration could be accelerated. Most solutions comply with GS1 standards.

It also noted that there are multiple blockchain solutions being developed, and interoperability needs to be addressed.

One of the largest blockchain FDA pilots was implemented by Mediledger and included the big three pharma wholesalers that account for 94% of U.S. sales, seven top-ten pharmaceutical manufacturers, as well as both Walmart and Walgreens.


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