Experts continue to sound the alarm on DSCSA compliance progress in the pharmaceutical manufacturing industry, with implementing GS1 Electronic Product Code Information Services (EPCIS), as well as trading partner plans for exchanging data. The upcoming November 27, 2023 DSCSA compliance date requires transaction data with product identifiers to be provided with physical product.
As Jeff Falardeau, manager, pharmaceutical information technology at Cardinal Health, said at the Healthcare Distribution Alliance (HDA) 2021 Traceability Webinar Series, “…we're just really concerned about the runway left and the number of manufacturers that still need to jump in the pool here and start testing with us before 2023.”
|Watch this video on exchanging data EPCIS files.|
HDA’s Research Foundation released its inaugural report, EPCIS Implementation Benchmarking Survey, enlightening industry trading partners on the status of successful data connections, defined as “[connections that are] fully integrated and working in a production environment,” and perceived obstacles to implementation.
Available as a complimentary download, the 16-page report’s data reflects responses from 70 companies across the pharmaceutical supply chain, including manufacturers, distributors, and 3PLs.
The results offered some startling statistics, including the following:
- 59% of manufacturers report they are not currently sending data to distributors—HDA says manufacturers cite “delays due to either past or potential future enforcement discretion” as the top obstacle to implementing EPCIS at 43%.
- More than half (57%) of manufacturers have no successful connections in a production environment today.
- Most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with distributors’ dispenser customers.
- 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 barriers to implementation.
The number of connections that manufacturers or distributors plan to make is concerning. As Allison Sheldon, senior manager, Pfizer Digital Serialization, Pfizer Inc. explained in April, it takes around six weeks to onboard a trading partner in a best-case scenario. The survey reports, “Once fully implemented, one-quarter of distributors anticipate having fewer than 10 connections. Half of distributors expect to have somewhere between 70 and 250 connections, and a quarter plan to have between 350 and 650 connections.” Resources will be strained in order to onboard numerous stakeholders by the 2023 deadline.
|Read this story on four DSCSA guidances released this summer.|
Said Justine Freisleben, vice president, industry relations, 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.”
“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.”
Download the full complimentary report: EPCIS Implementation Benchmarking Survey