Just months from the FDA’s final enforcement deadline for the Drug Supply Chain Security Act, new data from the Healthcare Distribution Alliance indicates that trading partners have significant work to do in creating the vital connections for exchanging EPCIS transaction data under the new law.
The HDA has been steadily releasing benchmark updates on EPCIS adoption in the pharmaceutical supply chain, tracking trading successful rollouts as well as companies’ plans to send data to their trading partners. The organization says the effort is meant to “inform industry trading partners on the status of successful connections — defined as a connection that is fully integrated and working in a production environment — and the key obstacles that manufacturers, distributors, repackagers and 3PLs face in establishing those connections.”
HDA says its latest benchmarking survey, covering the fourth quarter of 2022, will be its “final report of the industry’s progress on EPCIS implementation.”
Though the results show promising progress on EPCIS adoption among manufacturers, with about 90 percent having already adopted EPCIS 1.2, the authors warn that “data quality issues with EPCIS event files threaten to stall the progress toward full DSCSA compliance.” Manufacturers continued to launch connections with their downstream partners, with 56 percent of these being either “in progress” or “completed” as of the time of the survey.
The results showed that 30 percent of participants are seeing the benefits of adopting EPCIS, while 48 percent said it was too early. Among the respondents in that 30 percent, the top benefits cited were “the use of GS1 standards and that the US EPCIS 1.2 Implementation Guideline satisfies DSCSA compliance, standardization and interoperability, and efficient data capture and transfer.”
However, this comes with the caveat that this “only indicates one step of an extensive onboarding process,” and from that perspective, shows a very real problem: November 27, 2023 is only six months away, and on that date, 100% of trading partners need to have these connections done. Thus, HDA views this area as one where not enough progress was made.
Manufacturer respondents named the top issues preventing them from implementing EPCIS during the quarter, pointing to “Length of time to on-board trading partner,” “employee knowledge,” and “IT.” The previous leading issue, “trading partner understanding and/or commitment,” fell to fourth, a change that HDA attributes to the industry’s overall tighter focus on compliance.
Regarding distributors, HDA writes that, during the quarter, more planned connections were becoming completed ones. The authors note the results “moved from 2,930 to 3,077 total planned connections with small, middle-sized suppliers,” while for large suppliers, “distributors have moved from 1,140 planned connections to no new connections.” There was an increase in “in process” or “completed” connections from Q1 and Q2, rising from 22 percent to 33 percent for small, mid-sized suppliers, but no new connections were reported for large suppliers.
HDA concludes that the “momentum of implementation dwindled" during the last quarter of 2022, revealing challenges to the industry despite continued progress on data exchange preparation. The authors call on industry stakeholders to collaborate on the longtime obstacles the survey identified over its multiple iterations, naming “a perceived lack of trading partner understanding, commitment and engagement in the process of exchanging transaction data” as well as “the issue of manpower and intellectual capital as the gaps in the IT workforce and employee resources remain problematic.”
These are major challenges, and there’s a lot left to do in just a few months. LSPedia’s here to help – not only do our solutions speed up collaboration and onboarding with trading partners, we also provide comprehensive DSCSA training to ensure that your team will be ready for the DSCSA deadline far in advance.
Further, if you need to make quick progress on DSCSA and aren’t sure you’ll have the resources in time, it’s a good idea to check out Proactive Resource Group, which handles DSCSA compliance as a 100% outsourced service, with no stress on you or your personnel.
Many thanks to Healthcare Distribution Alliance for their consistent leadership and reporting on the industry’s progress!
Find us at HDA’s 2023 Business and Leadership Conference, June 11-14.
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