The Road to Interoperability
The FDA has accepted TraceLink's blockchain and digital recall project into its DSCSA Pilot Program
Maryam Mahdi | | Quick Read
TraceLink has been approved to join the FDA’s Pilot Project Program, which aims to support drug supply stakeholders, including the FDA, in developing interoperable electronic systems capable of tracing Rx drugs through their distribution. Projects will begin in August 2019, and the FDA plans to publish a report based on the findings to help solve challenges associated with the current pharmaceutical supply chain and protect consumers against counterfeit medications.
TraceLink entered a submission focused on two workstreams: an interoperable blockchain network solution called Trace Histories, and digital recalls. Both are intended to bring together companies from across the pharmaceutical supply chain.
“We are interested in the power of blockchain because of its ability to provide secure, immutable methods of information sharing across the industry. The Trace Histories workstream will explore the validity of using blockchain technology in a revolutionary way, which enables participants to post and share necessary compliance information on the blockchain while simultaneously safeguarding confidential business information.” explains Paul Cianciolo, Senior Vice President, Business Management at Tracelink.
The second workstream focuses on digital recalls. “Recall verification and notification is a notoriously challenging issue across the pharma and healthcare industries,“ says Cianciolo. “The lack of granularity (scale of detail in a dataset) associated with the products in a supply chain, the existence of information silos and the absence of a dedicated network to distribute recall events all contribute to the inefficiency of the recall process.”
In other words, a recall from a pharmaceutical manufacturer may currently have difficulty reaching the hospitals, pharmacies and patients in possession of affected products.
The digital recalls workstream will evaluate effective methods of data exchange and coordinate with industry stakeholders to prevent recalled products from reaching patients.
“Combining insights from these leading companies with TraceLink’s digital supply network and solutions will garner compelling information that will contribute to the innovation, security, and interoperability of the supply chain.”