– IBM, Walmart, KPMG, and Merck will collaborate as part of FDA’s pilot project to identify, track, and trace prescription medicines using blockchain technology.
The program is intended to assist drug supply chain stakeholders in developing an electronic, interoperable system to identify and trace the distribution of prescription drugs within the US.
The pilot will also support the requirements in the US Drug Supply Chain Security Act (DSCSA). Enacted by Congress in 2013, DSCSA is designed to help identify and evaluate the most efficient processes to comply with and apply drug supply chain security requirements.
The companies will create a shared permission blockchain network that allows real-time monitoring of products. The blockchain network will aim to reduce the duration of inventory tracking and enable timely retrieval of reliable distribution information.
By using blockchain, the program will also increase the accuracy of data shared among network members and help determine the integrity of products in the distribution chain. Each company will bring its own unique expertise to the project.
“Our supply chain strategy, planning and logistics are built around the customers and patients we serve,” said Craig Kennedy, senior vice president, Supply Chain, at Merck. “Reliable and verifiable supply helps improve confidence among all the stakeholders we serve—especially patients—while also strengthening the foundation of our business.”
Blockchain could be integrated with existing supply chain and traceability systems, improving the exchange of pharmaceutical data.
“Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain,” said Mark Treshock, IBM Global Solutions Leader for Blockchain in Healthcare & Life Sciences.
“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. Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”
IBM has previously partnered with FDA to apply blockchain technology to healthcare challenges. In 2017, the organizations announced a partnership that aimed to explore blockchain’s potential for sharing owner-mediated data sources, including EHR data and Internet of Things devices.
Walmart and KPMG have also implemented blockchain to increase the safety and traceability of their products.
“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,” said Karim Bennis, Walmart’s Vice President of Strategic Planning and Implementation, Health and Wellness.
“We believe we have to go further than offering great products that help our customers live better at everyday low prices. Our customers also need to know they can trust us to help ensure products are safe. This pilot and US Drug Supply Chain Security Act requirements will help us do just that.”
With the launch of this pilot program, stakeholders will be able to evaluate blockchain’s ability to protect sensitive information in healthcare.
“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,” said Arun Ghosh, KPMG Blockchain Leader.
“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.”
The pilot will conclude during the closing quarter of 2019, and the federal agency expects to publish the results in an FDA DSCSA program report. Program participants will then evaluate next steps.