TraceLink proposes blockchain system for DSCSA pilot

TraceLink has proposed a blockchain-based system intended to help the US FDA meet its commitment to implement a traceability system for drugs.

The move comes just a couple of weeks after the US regulator officially requested candidates for a pilot programme to identify technologies that could underpin the electronic, interoperable track-and-trace system – due to come into effect in November 2023 – with specific reference to blockchain.

TraceLink says that its offering – called Trace Histories – is built on its digital supply network which is already widely used in the pharma supply chain. Adding blockchain means that it can now offer a system that is “designed specifically to help pharmaceutical manufacturers, wholesale distributors, pharmacies, and hospitals securely exchange information and satisfy the 2023 DSCSA requirement.”

The DSCSA is aimed at reducing diversion of medicines distributed domestically and keeping falsified drugs from entering the US supply chain. Medicine packs are already supposed to carry serialized codes to give them a unique identity that can be used to track them from manufacturer to dispenser, but adding blockchain could potentially provide an additional layer of trust between the players in the supply chain.

Blockchain is a continuously growing list of records, called blocks, which are linked and secured using cryptography and therefore resistant to modification of the data they contain. Proponents say that means that the data is immutable and can be shared and validated equally by all the nodes in the network.

According to TraceLink, Trace Histories integrates directly into companies’ existing global compliance and serialization infrastructures. It also employs a “gather upon request” approach with permissioned data security, allowing companies to securely share critical and confidential information with authorized partners in an open, interoperable format to meet the final 2023 DSCSA deadline requiring full unit level traceability across the supply chain.

“The 275,000+ partners on our end-to-end digital supply network are already validated, which provides companies with a unique opportunity to leverage blockchain technology, while ensuring the safe exchange of data,” said Shabbir Dahod, president and chief executive of TraceLink.

 “Trace Histories maintains the pseudonymity of blockchain participants and control of confidential information within each participant’s system by only enabling the disclosure of information necessary to respond to verified trace requests.”

Participants in TraceLink’s pilot project will include pharmaceutical manufacturers, wholesale distributors, major retail pharmacy chains, diversified healthcare organisations, and third party logistics providers (3PLs).