The retailer and biopharmaceutical company Merck, along with IT company IBM and professional services firm KPMG, are participating in a program for the U.S. Drug Supply Chain Security Act (DSCSA), a 2013 regulation that is being phased in over the course of a decade and seeks to build an electronic system to trace certain prescription drugs as they are distributed in the U.S.
According to an announcement, Walmart and its partners will focus on creating a shared blockchain network to monitor Merck products as they are dispensed through the retailer’s U.S. pharmacies.
“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,” said Mark Treshock, global blockchain leader for healthcare and life sciences at IBM, which is providing blockchain technology for the project. “Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”
Merck did not respond to a request for comment, so it wasn’t clear which of its drugs will be included. However, examples of Merck products include allergy medicine Clarinex, osteoporosis drug Fosamax, HPV vaccine Gardasil, cancer drug Keytruda and male pattern hair loss treatment Propecia.
In an email, Treshock said it is applicable to all prescription drugs dispensed in the U.S., but the company “intentionally kept the pilot to a small group of committed participants.”
The pilot is expected to conclude in the fourth quarter.
A spokesperson for the FDA said it will share new approaches evaluated in this program with the broader drug supply chain community thereafter.
“Our goal is to ensure that all parties can be apprised of the program’s progress and take advantage of any shared learning,” he added.
In a blog post, Arun Ghosh, U.S. blockchain leader at KPMG (which is developing the integration, analytics and user experience components), noted that pharmaceutical companies have to figure out how to comply with DSCSA by 2023 at the latest. Blockchain could be the ideal solution, as it allows multiple parties to securely access the same data.
“Drug makers have a massive challenge given the involvement of protected health information (PHI) like electronic health records, patient claims, doctors’ notes and even personal data from wearables,” he said. “Enabling interoperability—or the sharing of this data across different organizations—as proposed by DSCSA is no simple feat.”
But Ghosh said pharmaceutical tracking will also help keep counterfeit drugs off the market by removing them more quickly, improving the efficiency of recalls, more accurately sharing information and creating greater accountability.
A 2018 study on counterfeit drugs found all types of medications have been targeted for falsification, and, from 1969 to 2016, there have been at least 48 incidents around the world, resulting in 7,200 patients with conditions like unplanned pregnancies, renal failure, swelling, rashes, spasms, respiratory paralysis, hypoglycemia, comas, intraocular inflammation and seizures—and more than 3,600 deaths.
“The DSCSA was enacted to strengthen the biopharmaceutical supply chain, making it more difficult for counterfeit drugs to enter the supply chain and making it easier to isolate problems when they occur,” Treshock said.
In addition, greater transparency means participants will know more about the supply chain and be better able to prevent issues like drug shortages.
“For example, if a bad ingredient or improper handling leads to a recall, there will be a precise record on the blockchain, enabling network members to quickly identify the source of the problem, trace which drugs need to be recalled and track if they have been removed from the market,” Ghosh said.