The US Food and Drug Administration (FDA) has chosen IBM, Merck, KPMG and Walmart to support its latest Drug Supply Chain Security Act (DSCSA) pilot programme, which focuses on blockchain interoperability.
The companies will collaborate and pool their expertise to create an electronic, blockchain-enabled network to help identify, track and trace prescription medicines and vaccines in real-time across the whole country.
Walmart vice-president of health and wellness strategic planning and implementation Karim Bennis said: “With successful Blockchain pilots in pork, mangoes and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain.
“Our customers also need to know they can trust us to help ensure products are safe. This pilot and U.S. Drug Supply Chain Security Act requirements will help us do just that.”
It is hoped that this blockchain system will reduce the time needed to track inventory, allow quicker retrieval of reliable distribution information, improve the accuracy of data sharing among members of the network, and determine the integrity of products in the supply chain.
IBM global solutions leader for blockchain in healthcare and life sciences Mark Treshock said: “Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain.
“We believe this is an ideal use for the technology because it can not only provide an audit trail that tracks drugs within the supply chain; it can track who has shared data and with whom, without revealing the data itself.”
KPMB blockchain leader Arun Ghosh said: “Blockchain’s innate ability within a private, permissioned network to provide an ‘immutable record’ makes it a logical tool to deploy to help address DSCSA compliance requirements.
“The ability to leverage existing cloud infrastructure is making enterprise blockchain increasingly affordable and adaptable, helping drug manufacturers, distributors and dispensers meet their patient safety and supply chain integrity goals.”
Although the DCSCA was made into law in 2013, the FDA announced pilot project programmes as part of the act’s implementation in February 2019, focusing on the pharmaceutical supply chain. The aim is for the pilots to inform the FDA’s enhanced system, which is planned to be introduced in 2023.
Examples of other DCSCA pilot programmes currently underway are MediLedger’s pilot, Providence Health Technologies’ small dispenser study and Rfxcel’s verification and notification readiness and extensibility pilot.