The United States Food and Drug Administration (USFDA) announced today that IBM, KPMG, Merck and Walmart will be included in a pilot project in support of the U.S. Drug Supply Chain Security Act (DSCSA). Together, these companies will address the requirements of the DSCSA to identify, track and trace prescription medicines and vaccines distributed within the United States.
Enacted by U.S. Congress on November 27, 2013, the DSCSA outlines a framework to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. This will improve the FDA’s ability to help protect consumers from counterfeit, stolen, contaminated, or harmful drugs.
The DSCSA pilot is intended to assist drug supply chain stakeholders, including the FDA, in developing the technology that will identify and trace certain prescription drugs. The project is also meant to evaluate the most efficient processes to comply with supply chain security requirements.
We are focused on ensuring that the U.S. market has cutting edge technology to satisfy the requirements of the DSCSA. A permissioned blockchain will provide an increased level of authority for patients and consumers, guaranteeing the drugs and vaccines they are receiving are not counterfeit, stolen, contaminated or harmful. Consumers will be able to see the provenance of a product from the manufacturer all the way to the point of use. Reliable and verifiable supply helps improve confidence among all the stakeholders we serve—especially patients—while also strengthening the foundation of our business,” Craig Kennedy, senior vice president of supply chain at Merck told me.
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While the DSCSA pilot will trace various vaccines and prescription medicines from Merck, each company involved brings unique expertise to the project, as well as prior experience in implementing blockchain solutions to enhance the safety and traceability of products. Merck, for example, already taps into the Bitcoin blockchain, Exonum, in collaboration with Nebula Genomics to access patient data to determine the causes of certain diseases.
And Walmart, which is a member of IBM’s Food Trust network, will now use blockchain to track and trace its prescription drugs as part of the pilot project.
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 U.S. Drug Supply Chain Security Act requirements will help us do just that.”
The pilot, which will operate on IBM’s permissioned blockchain, aims to create an interoperable, shared network that will allow for real-time monitoring of products. This will benefit consumers requesting more detailed information about products, as well as regulators who want to protect users from harmful drugs.
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.”
Ghosh also notes that one of the main items in the pilot is a mobile app, which is designed to scan a QR code at the time of prescription pick up. Individuals with the app will be able to scan a product’s QR code to see the provenance, such as the manufacturing site, how long it has been on shelves at participating stores and other useful information.
Transparency Is Key
And while there are other ways to trace and track products without using blockchain technology, Mark Treshock, IBM Global Solutions Leader for Blockchain in Healthcare & Life Sciences, points out that blockchain is the ideal application for this pilot due to the high-level of transparency it provides.
Yes, there are other ways to do this without blockchain, but based on DSCSA requirements this is the ideal application. Blockchain allows participants to come together to share confidential information. We believe this is an ideal use for the technology because it not only provides an audit trail that tracks drugs within the supply chain, but 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.”
Echoing Treschock, Kennedy points out that transparency is Merck’s primary goal for this project.
“If you evaluate today’s pharmaceutical supply chain system in the U.S., it’s really a series of handoffs that are opaque to each other and owned by an individual party. There is no transparency that provides end-to-end capabilities. This hampers the ability for tracking and tracing within the supply chain.”
In particular, Kennedy notes that an important segment for Merck in the U.S. is their vaccine portfolio. While the intention for this pilot is to cover all Merck products, it’s especially crucial to demonstrate a clear transparency of vaccines as they leave the manufacture and are received at the final destination.
As part of this pilot we want to be able to show clear transparency of vaccines as they leave the manufacture all the way up to the point of dispense. We want to demonstrate that multiple participants can easily do this across a permissioned blockchain. We are confident that we will be able to show the FDA that using blockchain technology has specific value for both the patient population and U.S. regulators,” said Kennedy.
The DSCSA pilot project is scheduled for completion by the fourth quarter of 2019 and results are expected to be published in an FDA DSCSA program report. In the meantime, some participants are already making predictions as to what this could mean for the future of the pharmaceutical industry.
“If this pilot proves what we believe it will, we will continue demonstrating that blockchain can be a solution for tracking and tracing prescription drugs and vaccines. This pilot is just the first step. We envision this as being an industry utility in which applications can be built to meet compliance requirements, while ensuring patient safety worldwide,” said IBM’s Treschock.
Date: June 17, 2019