The Supply Chain Matters blog highlights a rather significant announcement this week concerning the U.S. Food and Drug Administration’s Drug Supply Chain Security Act, and the application of modern technology to address drug safety needs.
The Drug Quality and Security Act (DQSA), was enacted by the U.S. Congress in November 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The legislation was enacted to enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.
Additionally, to further enhance the security of the drug supply chain, manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA and other trading partners within 24 hours after determining a product is illegitimate. The system will also designed to improve detection and removal of potentially dangerous drugs from the drug supply chain to protect patients consumers.
This B2B supply chain industry analyst has published a number of research commentaries reflecting on the ongoing challenges of life sciences focused supply and patient demand networks. The overall business model has been challenged with conflicting stakeholder business, cost and service objectives. The one common objective is insuring patient safety. That has been the urgency in combating counterfeit or suspect drugs across the globe, and the ultimate passing of the DQSA legislation.
Up to this point, the industry and regulators have struggled with the timetable of DSCA implementation. Challenges stemmed from perceptions related to available technology, overall cost and industry-wide participation.
However, this week, there is some optimistic news to share with our Supply Chain Matters readership.
TraceLink Inc., a global digital supply network technology provider, today announced the acceptance of its participation in the U.S. Food and Drug Administration (FDA) Pilot Project Program under DSCSA.
This pilot project focuses on two workstreams; an interoperable blockchain network and digital recalls across a pharmaceutical and drug supply network. Both are intended to bring together participants of all sizes from across the pharmaceutical supply networks to enhance patient safety and address challenging business processes through network connectivity and innovative software solutions.
Unique to TraceLink’s pilot project is the inclusion of what can be described as a diverse set of end-to-end industry stakeholders including large pharmaceutical manufacturers, biopharmaceutical companies, contract manufacturers, repackagers, wholesale distributors, major retail pharmacy chains, diversified healthcare systems, third-party logistics providers and returns processors.
Two workstreams are being designed to explore new approaches for interoperable information sharing and the use of verification and notification for enhancing patient safety, while maintaining data privacy and ownership.
2023 Traceability Workstream
This workstream is planned to leverage TraceLink’s blockchain technology application, Trace Histories as one of the tools to develop a blueprint for the industry for an open, interoperable network to fulfill the requirements for full unit level traceability across the supply chain. Trace Histories is a distributed ledger network that enables secure information exchange between authorized partners with a “gather upon request” model. Unlike other industry initiatives that require use of a single blockchain system throughout the industry, Trace Histories was purpose-built for standardization to support interoperability across blockchain and non-blockchain networks.
Product Recalls Workstream
TraceLink’s digital recalls workstream is intended to evaluate and enhance current recall verification and notification processes within the pharmaceutical supply chain by leveraging both lot level and serialization data on a digital supply chain network. Current recall processes within the industry are largely manual and time-consuming, creating inefficiencies and putting patient safety at risk. While individual companies have standing recalls processes in place, the existing recalls process is costly and ineffective when viewed across the supply network. In working toward the objectives of this workstream, pilot participants plan to evaluate different methods of effectively exchanging information on a network and coordinating with supply chain partners to prevent recalled product from reaching patients.
Both workstreams will gather ongoing industry network participant feedback and are expected to be complete in the fall of 2019.
Supply Chain Matters Perspectives
This analyst had the opportunity to touch base with TraceLink representatives prior to today’s announcement. Founded in 2009, the Cloud based technology provider has been successful in connecting a broad portion of pharmaceutical and drug supply and patient demand network participants. As noted above, in the specific area of FDA track and trace compliance, pharmaceutical manufacturers commission, or assign, a unique serial number to each saleable unit. The technology provider recently reported that to-date, it has surpassed 2.3 billion drug serial numbers commissioned across its global-based supply network, and the momentum is increasing.
This, it makes sense for the FDA to encourage TraceLink’s participation as a technology provider with established patient demand and industry supply network influence. This technology platform provider’s “2023 Pilot Project Workgroup” has objectives designed to create learnings and explore alternative approaches to prepare for DSCSA’s 2023 requirements while laying the foundation for ongoing enhancements to industry-wide network business processes related to drug safety.
We extend our best wishes for the successful completion and positive outcomes of both workgroups. This effort holds the promise of finally coming-up with practical and responsive practices and supporting technology that can benefit the entire life sciences industry in successful patient-to-business outcomes.
Congratulations to TraceLink for taking the lead in this important initiative.
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