Merck and Co. has been selected by the US Food and Drug Administration (FDA), along with Walmart, IBM, and KPMG, to participate in a pilot program in support of the US Drug Supply Chain Security Act (DSCSA) to identify, track and trace prescription medicines and vaccines through the use of blockchain technology.

The program is intended to assist drug supply-chain stakeholders, including the FDA, in the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed in the US in the implementation of the DSCSA.

DSCSA, which was signed into law in November 2013, has staged implementation over a 10-year period and is designed to create a system that will facilitate the exchange of information (i.e., transaction information, transaction history, and transaction statement) at the individual package level about where a drug has been in the supply chain.

Under the pilot program, each company will bring individual expertise to create a shared permission blockchain network that allows real-time monitoring of products. The network is intended to reduce the time needed to track and trace inventory; allow timely retrieval of reliable distribution information; increase accuracy of data shared among network members; and help determine the integrity of products in the distribution chain, including whether products are being kept at the correct temperature. IBM, KPMG, and Walmart, the largest retailer in the US, have experience in implementing blockchain solutions to help enhance the safety and traceability of products. Walmart, for example, currently has blockchain pilots in pork, mangoes and leafy green vegetables.

Blockchain is designed to establish a permanent record and may be integrated with existing supply chain and traceability systems. It not only can provide an audit trail that tracks drugs within the supply chain, it can track who has shared data with whom, without revealing the data itself, according to IBM.

The DSCSA pilot project program is intended to help identify and evaluate the most efficient processes to comply with and apply drug supply-chain security requirements. The program will aid in identifying attributes the system will need for enhanced product tracing and verification, as well as electronic means to share the information. The FDA says it will be sharing new approaches considered through this program with the broader drug supply-chain community.

The program is scheduled to be completed in the fourth quarter of 2019, with results expected to be published in an FDA DSCSA program report. After which, the projects participants will evaluate next steps.

Source: Merck and Co.