Some RX Supply Chains Are Not Prepared to Share DSCSA-Required Data

The pharmaceutical supply chain is entering a critical phase in achieving the transaction data connections required to comply with the Drug Supply Chain Security Act (DSCSA) in 2023. The inaugural EPCIS Implementation Benchmarking Survey,  from HDA Research Foundation, gauges the current state of industry adoption of GS1 Electronic Product Code Information Services (EPCIS) as well as trading partner plans for exchanging DSCSA-required data.    

The DSCSA requires transaction data with product identifiers to be provided with physical products on November 27, 2023.

Currently, EPCIS is the only widely recognized international standard that allows supply chain partners to share this data in a secure, electronic and interoperable manner, as noted in FDA guidance. The Foundation’s survey aims to inform industry trading partners on the status of successful data connections, defined as “[connections that are] fully integrated and working in a production environment,” and obstacles to implementation. “Though the deadline for sharing transaction data is two years away, many healthcare supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” said Perry Fri, Executive Vice President and COO of the HDA Research Foundation. “The Foundation’s survey shows where trading partners are in the process of adopting EPCIS — and digs into what might be leading to slow implementation rates across the supply chain.”  

Data reflect responses from across the pharmaceutical supply chain, including 52 manufacturers, 21 distributors and five third-party logistics providers (3PLs); in some cases, certain companies fulfill several supply chain responsibilities. Among the key survey findings:  

• More than half (59%) of manufacturers report they are not currently sending data to distributors; manufacturers cite “delays due to either past or potential future enforcement discretion” as the top obstacle for manufacturers to implement EPCIS (43%).   
• Sixty-two percent of manufacturers are planning to connect directly with distributors; approximately 38% are planning to use a 3PL to manage connections downstream.  
• Most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with distributors’ dispenser customers. (Many of those customers plan to use a portal managed by the distributor to access data.) Additionally, three-quarters of distributors identified a “lack of trading partner commitment” as the top obstacle to implementing EPCIS. 
• Once EPCIS is implemented and data are being sent in production, half of distributors expect to have 70–250 connections, and one-quarter plan to have between 350 and 650 connections. 
• A typical 3PL currently is working to connect an average of 67 manufacturer clients. Respondents cited “readiness of their clients” and “wholesale distributors … not articulating clear deadlines to trading partners for taking necessary steps.”  

“As the Foundation’s data suggest, EPCIS implementation is clearly a huge undertaking for healthcare supply chain stakeholders; however, time is of the essence to comply with this critical DSCSA milestone,” said Justine Freisleben, vice president, Industry Relations, Healthcare Distribution Alliance (HDA). “FDA’s expectations around reaching the 2023 milestone on time are clear. Knowing this, HDA urges trading partners to plan ahead, commit to implementing a solution as soon as possible, and work with their peers to achieve compliance — and for the continued safety and reliability of the U.S. healthcare supply chain.