The FDA is looking to form a tighter grip on security for the wider drug supply chain and shared the first results from a pilot program aimed at accomplishing that goal.
The Drug Supply Chain Security Act (DSCSA), enacted in 2013, directed the FDA to explore methods to boost the safety and security of the drug supply chain. In 2019, the FDA set up pilot programs to help the agency and other players in the supply chain understand more technical aspects of the supply chain and assist with finding areas of security improvement. Around 20 groups signed on to the pilot program, including Sanofi and AmerisourceBergen, in addition to some health tech companies and academic centers.
The pilot projects investigated various ideas, including using barcodes, product identification, data analysis and better recall communication.
“These pilot projects explored and evaluated methods to enhance the safety and security of the pharmaceutical distribution supply chain,” said the FDA’s report.
The DSCSA itself requires the electronic tracing of prescription drug products, and it aims to boost the FDA’s ability to protect consumers from drugs that may be counterfeit, stolen or contaminated. The law also requires the FDA to build an electronic, interoperable system by November that will identify and trace certain prescription drugs throughout the supply chain.
While the FDA already laid out the requirements in several guidance documents, the agency plans on using the results from the pilot projects to inform the implementation of the DSCSA requirements.
Here are a few examples from the pilot programs:
-Rymedi, a software company that focuses on healthcare information, led a consortium including Indiana University Health, WakeMed Health and Hospitals and other companies that used a blockchain-based program to track specialty medicine transfers between health systems and integrate with health records that can be tracked in real-time and be applied in clinic and patient settings.
“The program generated important insights and lessons for the coordination of clinician and patient workflows and legacy data system integrations needed to implement and ease adoption,” Rymedi’s chief strategy officer Jason Cross said in an email to Endpoints News.
Cross explained that some manufacturers are under-monitored and the integrity of products can be an issue, along with digital solutions being managed separately in the pharmaceutical sector from other data systems.
“We went in wanting to push the envelope on how to create significant value from enhanced data capture across typically siloed parts of pharma and healthcare,” Cross said. “This is important for accelerating improvements in patient-centric, value-based care.”
-In another pilot project, Bluesight and Novartis’ Sandoz worked with medical centers to identify gaps in the use of barcodes on medication packages. The program, called KitCheck, focused on using radio frequency identification (RFID) as an alternative to the 2D barcodes that are primarily used to track drugs. Ramsey Doany, a strategy manager at Bluesight, told Endpoints that RFID can reduce the costs of DSCSA compliance and improve the accuracy of tracking items through the supply chain.
“Our pilot specifically focuses on the implementation of RFID technologies with a 2D barcode for track and trace,” he said. “We are the only pilot to suggest this technology for implementation starting at the manufacturer through administration to the patient.”
-LedgerDomain, a company that works with companies on DSCSA compliance, worked with UCLA Health on a blockchain-based system in its pilot program, trying to map out the process for drug verification and tracking, inbound shipping and administration.
The report said that the program, dubbed BRUINchain, met all DSCSA requirements and was able to trace product notifications to all key stakeholders and reduce the burden of paperwork in the process.
“The biggest challenge we’re working to solve is how companies with no prior business relationships can interoperate independent of specific software vendors,” said LedgerDomain CEO Ben Taylor.