EPCIS exceptions are on the rise. Are you ready for them?

July 13, 2023

As the final enforcement deadline for the Drug Supply Chain Security Act draws near, more and more trading partners at every level of the pharmaceutical supply chain are hastily onboarding EPCIS data — and many are seeing significant amounts of errors.

These errors, known as exceptions, occur when the data that accompanies the product doesn't match the product as delivered. When an exception occurs, it doesn't necessarily mean a product is illegitimate or harmful; it just means something unexpected happened. (For example, if a split shipment arrives across two different days, the EPCIS data won't match up. Or, if a label is damaged, a case may not scan correctly.)

The rate of exceptions is indeed escalating, and will continue to do so as we approach the November 27, 2023 deadline. With the shift to item-level tracking, more trading partners are exchanging and processing serialized data than ever before, and these files are more complex than ever before. So, the only way to minimize supply chain disruptions is to to put in place strong resolution, collaboration, and prevention processes.

Whether you've already on pace for DSCSA compliance or are just getting started, it's important to have the facts on DSCSA exceptions.

Exceptions can halt product movement.

‍Exceptions are much more than simple corrections to make. Under DSCSA, missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be cleared. This means that a showstopping exception can force companies to make tough choices on how to deal with the product they've received, including whether it ought to be quarantined temporarily, returned to the sender, or even destroyed. And each of those scenarios causes additional problems, since none of them result in the medication reaching the patient in a timely fashion.

Exceptions add cost.

Without a robust system to manage EPCIS exceptions, any daily receiving effort could require additional hours or even days to resolve, rather than minutes. That's an expensive slowdown, and a headache for both the receiver and the shipper. Quarantine storage also requires valuable space, particularly for product that legally cannot be sold or moved through the supply chain (outside of a return) while its status is in question.

If exception situations lead to lost product, then it needs to be re-ordered. On the patient-facing end, dispensers may need to figure out alternatives for their patients, forcing last-minute changes that can be met with suspicion. All of this takes additional staff hours to work through, with the clock ticking for the patient.

Resolving EPCIS exceptions by hand is a daunting prospect. Trading partners who expect personnel to find errors by scrolling through long code documents (potentially amounting to hundreds of pages) should expect wasted staff hours to go up and productivity to go down.

EPCIS exceptions can be unpredictable.

There's a general framework for what to expect, but the industry's transition to serialized data ahead of the DSCSA deadline means a hundredfold increase in data exchanges. Inevitably, this will bring more errors, and many complex new situations for trading partners to work through together under pressure.

LSPedia and its partners held the 2023 Exceptions Pilot to make sure there are resources, procedures, and standards that can help companies across the pharma supply chain handle new exceptions as they emerge.

What you don't know about exceptions can hurt you — and your customers.

Generally, the further along a medication is in the supply chain — from manufacturer to distributor to dispenser to patient — the harder and more time-consuming an exception is to correct, as more inquiries will be required to understand the problem.

Given the complexity of EPCIS files, the massive increase in their exchange, and the interoperable access and point-to-point collaboration required to trace problems, trading partners are going to want to ensure that any issues can be identified and resolved early and thoroughly.

You can detect them automatically.

As we've made clear, it's nigh-impossible to tackle exceptions without a dedicated system. LSPedia's Investigator, a module of its OneScan Suite, can cut the resolution time for an exception from days to minutes by automatically alerting users to EPCIS errors and guiding them through the resolution process, enabling them to locate a problem before it can stop business. Its notifications send live hyperlinks that allow the point of contact to quickly view the issue and apply necessary fixes.

Further, outsourcing to Proactive Resource Group can move the exceptions management function offsite entirely.