The research conducted by the business consortium stems from a U.S. Food and Drug Administration (FDA)( pilot program, which was established to assess the capabilities of blockchain. The pilot demonstrated the ability of blockchain to connect disparate systems to record a common view of product traceability, and improve patient safety by reducing the time it takes to recall medicines from several days to just a few seconds.
A blockchain refers to a growing list of records, called blocks, that are linked using cryptography. The digital solution is currently tamper proof (this is something that could be later challenged by quantum computing) and ensures, at least in theory, the complete traceability of the supply of goods.
The pilot presented n important technological milestone with the focus of bringing the pharmaceutical supply chain into regulatory compliance with the U.S. Drug Supply Chain Security Act (DSCSA). This piece of legislation defines the critical steps needed to build a system whereby all members of the pharmaceutical supply chain are required to verify, track and trace prescription drugs as they are distributed in the U.S.
The two project fundamentals were:
To demonstrate that blockchain can provide a common record of product movement by connecting disparate systems and organizations to meet DSCSA 2023 interoperability requirements in a secure way.
To improve patient safety by triggering product alerts and increasing visibility to relevant supply chain partners in the event of a product investigation or recall.
The data was presented during a livestream session, titled “Evolving the Pharmaceutical Industry and Improving Patient Safety with Blockchain,” during IBM’s THINK Conference which was presented on May 5, 2020. In the session, Merck, IBM and KPMG’s Blockchain Program Leader Tegan Keele discussed how blockchain not only aids the healthcare supply chain, but also how it is aiding the distribution of medicines during the time of COVID-19 and how the approach of digital ledgers is assisting pharmaceutical firms in reducing the influx of counterfeit medicines into the market.
The results of the pilot program have been submitted to the FDA, and a response is due from the U.S. government later in 2020 to determine the next steps.