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How the FDA is piloting blockchain for the pharmaceutical supply chain

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In light of the current state of our world, things like supply chain management, prescription drug traceability and pharmaceutical integrity are of utmost importance. Last year, we announced our work with KPMG, Merck and Walmart as key participants in the United States Food and Drug Administration’s (FDA) pilot program in support of the U.S. Drug Supply Chain Security Act (DSCSA) to address requirements to identify, track and trace prescription medicines and vaccines distributed within the United States.

The intent of the pilot program was to demonstrate 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. Today, we are sharing the results of the pilot program which was deemed successful in demonstrating the application of blockchain technology.

Read the full report

Connecting the dots to reach full traceability with blockchain

Blockchain is inherently designed to establish a permanent record and can seamlessly be integrated with existing supply chain and traceability systems. Enabled by blockchain technology, the results demonstrate how patient safety can potentially be enhanced by improving supply chain visibility and informing parties within seconds after a simulated recall.

With the initiative achieving its objectives, this further demonstrates the power and strength of blockchain technology and shows how it could potentially improve patient safety by reducing the time it takes to alert the supply chain of a product recall.

How the FDA blockchain pilot worked

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. IBM provided two user interfaces and completed integration with Merck systems. Pilot participants were able to incorporate blockchain to determine product quality and origins of the product.

Today, notifying the members of a supply chain about affected product 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. Blockchain’s ability to tag a drug just a few seconds after a recall can potentially improve pharmacy safety, and is anticipated to have far reaching health implications for tracking and tracing medicines in areas where counterfeiting or adulterated products are a problem.

A new age for pharmaceutical tracing with blockchain

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. It also has the power to illuminate supply chain risks.

Having established this initial feasibility, the project team’s final report to FDA includes several other 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.

Alongside our distinguished partners, we look forward to applying this technology to bring even more transparency to the entire supply chain for vaccines and prescription drugs. We are calling on additional industry and supply chain players to work with us and solve this problem together.

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