Bob Celeste, senior director of healthcare, GS1 US, answers Packaging Digest's questions in discussing what’s going on in traceability and the status of DSCSA implementation.
What do you see happening related to track-and-trace developments?
Celeste: The national Drug Safety and Quality Act, and its Drug Supply Chain Security Act (DSCSA) became law in November 2013. With its passage, we now have a sound policy to ensure product identification vigilance in the pharmaceutical supply chain, and a consistent, standardized approach for combating counterfeiting, theft and diversion of pharmacologics. The law, a long time in coming, has put the entire industry on the same path toward a safer, stronger, more fail-proof automated drug supply chain.
GS1 US has created a resource site that explains the provisions and deadlines of the law, and how it impacts the various parties in the Rx supply chain. We are constantly developing materials specific to each supply chain partner, and we add these resources to the site as they become available. Watch for information about which parties can help industry participants implement standards correctly, and videos on the various ramifications, considerations and application of GS1 Standards in solutions to the law.
In addition, we have also worked with industry members to publish implementation case studies, and a guideline that supports track-and-trace requirements. Very soon, we will release an update to that guideline that addresses current and future requirements more specifically. The guideline will help companies comply with early term, mid-term and later requirements of DSCSA.
DSCSA Implementation phases are:
Lot-Level Management --Starting January 1, 2015 for Manufacturers, Wholesalers and Repackagers; and July 1, 2015 for pharmacy (hospitals and retail). Constituents need to be able to share Transaction Information, History and Statements initially at the Lot (or Batch) level of identification.
Item Serialization --Mid-Term (2017 – 2019). Mark packages of drug products using a Product identifier (GS1 Global Trade Item Number® (GTIN®) or NDC), Serial Number, Lot Number and Expiration Date.
Serialized Item-Level Traceability --Later (2023). Make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or re-packager.
What are the key drivers behind this movement?
Celeste: It comes down to patient safety, and enabling a safer, automated and serialized supply chain. The ability for pharmaceutical supply chain stakeholders to share information at the lot-level, and to identify and trace prescription drugs at the item-level is essential for providing critical transparency and accountability in healthcare.
A serialized supply chain, where a product is uniquely identified, labeled and tracked every step of the way through manufacture to patient use, allows information to be exchanged with trading partners about where a drug has been. Having this capability will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain, and facilitate more efficient recalls of drug products.
How far along are pharmaceutical products in this?
Celeste: Prior to DSCSA, there existed a patchwork of State Drug Pedigree and tracing laws. Complying with the growing number of varying State laws, members of the U.S. drug supply chain requested that Congress act and create one law that would govern the identification, management and traceability of drug products within the U.S. Pharmaceutical manufacturers and packagers have been able to leverage the work that they have done to comply with the state laws to now support the federal law, so in general, the major companies are pretty far along in their understanding of what needs to be done by when. Retail and hospital pharmacies, however, may not yet be aware as a whole how the law impacts them (deadlines come in mid-2015 for them), so more work needs to be done to reach these audiences.
On the medical device side, manufacturers are working towards adoption deadlines under FDA’s Unique Device Identification (UDI). Class III med devices need to be uniquely marked by Sept. 24, 2014.
Industry members in both of these initiatives have been working and collaborating for many years to make serialization and UDI a reality. Now it’s a matter of leveraging best practices and sharing lessons learned, and taking one step at time to create a more efficient, safer and fully automated supply chain. GS1 Healthcare US is here to help.
What healthcare market workgroups are involved in these efforts?
Celeste: GS1 Healthcare US works collaboratively with industry to create Community Workgroups, including ones focused on the Rx supply chain. We have groups working on DSCSA readiness, including the Secure Supply Chain Task Force, which consists of more than 50 members across the US pharmaceutical supply chain that work to identify industry-wide implementation needs and enable efficient product serialization and visibility using GS1 Standards. Members look at specific issues in the industry, and develop implementation guidelines, business cases, roadmaps, best practice guides and educational opportunities to enable industry-wide adoption.
For more information, visit GS1Healthcare US.