The US Food and Drug Administration (FDA) has selected IBM, KPMG, Merck and Walmart for inclusion in a program which will support the U.S. Drug Supply Chain Security Act (DSCSA). The latter addresses requirements to identify, track and trace prescription medicines and vaccines distributed within the United States.
“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, which is known as MSD outside the US and Canada.
“Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business.”
The FDA program
The program intends to assist drug supply chain stakeholders, which includes the FDA, to develop an electronic, interoperable system which will identify and trace certain prescription drugs as distribution occurs within the 50 states in the US with each of IBM, KPMG, Merck and Walmart bringing specific expertise. One consequence will be the creation of a shared, permissioned blockchain network which enables real-time monitoring of product status.
The proposed network hopes to:
- reduce the time needed to track and trace inventory
- allow timely retrieval of reliable distribution information
- increase the accuracy of data shared among network members
- help determine the integrity of products in the distribution chain (including whether products are kept at the correct temperature).
Congress enacted the DSCSA in 2013. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This DSCSA pilot project program will identify and evaluate efficient processes which comply with and apply drug supply chain security requirements. The FDA will share, via the FDA’s website, its new approaches with the broader drug supply chain community on the agency’s website.
“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.”
The rationale for blockchain
One of the attractions of Blockchain technology is that its can establish a permanent, unalterable record. Once in place, it is possible to integrate this with existing supply chain and traceability systems. IBM, KPMG, and Walmart (the largest retailer in the US) all have experience in implementing blockchain solutions which enhance the safety and traceability of products. The pilot project:
- has a schedule with an intended completion hoped for in Q4, 2019
- results are expected to be published in an FDA DSCSA program report
- the project’s participants will evaluate possible next steps.
In addition, customers are, increasingly, requesting additional information about products. The most overt apply to food provenance. Arguably the significance of applying blockchain to drug provenance has greater life and death significance.
“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.”
Enterprise Times: what does this mean
IBM’s blockchain experience extends across its Food Trust initiative as well as supply chains. Similarly, Merck has worked with SAP on blockchain in the supply chain arena. As Bennis says, Walmart has used blockchain for pork, with customers being able in certain circumstances to see where a piece of meat originates.
There are other similar blockchain initiatives for drugs. Given this, perhaps the most significant aspect is the FDA’s stated goal – which is the dissemination of results and conclusions and the commitment that all parties can learn from the program’s progress and so take advantage of relevant conclusion.