Fill the form to schedule a free consultation
According to a new survey from the Healthcare Distribution Alliance, exceptions and a lack of trained employees can both present difficult obstacles to achieving EPCIS onboarding throughout the pharma supply chain.
According to a new survey from the Healthcare Distribution Alliance, exceptions and a lack of trained employees can both present difficult obstacles to achieving EPCIS onboarding throughout the pharma supply chain, even as time grows short for trading partners to meet the final DSCSA deadline.
In May, HDA published its EPCIS Implementation Benchmarking Survey - Q4 2022, the final entry in the series of surveys that strove to document the industry's progress toward achieving full interoperable data exchange capability, as required by the Drug Supply Chain Security Act. The effort supplies key insights on present challenges to achieving interoperability on pace with the FDA's November 27, 2023 final enforcement deadline. The survey's snapshot of Q4 2022 includes potentially alarming findings, indicating that, at best, trading partners have significant work to do in creating the vital connections for exchanging EPCIS transaction data under the new law.
HDA's benchmark surveys have been tracking successful EPCIS 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.”
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.”
This is the issue of exceptions: the errors that can occur within the EPCIS data that must be exchanged ahead of a transaction, with the product as delivered, or when there's any mismatch between the two. Their causes can range from mundane (split shipments arriving on different days) to obscure (non-tracked product changes that can only be found after a case is opened), but experts agree that when these issues occur, they only get harder to fix the longer they go uncaught. At best, they require additional labor; at worst, they're showstopping, halting receiving operations until the issue is cleared.
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. This points to another major problem: November 27, 2023 is only six months away, and on that date, 100% of trading partners need to have these connections done. Respondents said the top issues preventing them from implementing EPCIS during the quarter were the “length of time to on-board trading partner[s],” “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 results might be alarming; it's not easy to hire for these skills, and getting trained personnel up to speed on your operations — not to mention aligned with your trading partners — can seem a Herculean task in the handful of months remaining.
However, there's a way to be certain you'll meet these marks months ahead of the deadline. Proactive Resource Group can handle DSCSA compliance for your organization as a 100% outsourced service, taking the tasks fully off the shoulders of your personnel.
The time savings of working with PRG are accompanied by robust cost savings, as you'll avoid extra hires, skip additional labor costs (which can grow significantly if you don't have strong exceptions management!), and will not be subject to penalties from trading partners or regulators. You can focus on growing your business amid an already challenging environment, while PRG guarantees stress-free compliance for November 2023 and beyond.
Find out more about Proactive Resource Group's services today, or get right to the point and get in touch.