It's been confirmed: Every trading partner in the pharmaceutical industry -- from manufacturers to wholesalers to dispensers -- is expected to have DSCSA-compliant systems in place by November 27, 2023, and then spend the next year testing and stabilizing them with their partners; slowing down or stopping progress on DSCSA brings the risk of audits and penalties. There are numerous upsides to becoming fully compliant with the new law, many are seeing significant amounts of errors in the EPCIS data they receive with each physical transaction.
However, many businesses don't correctly account for the time needed to deal with exceptions, the data errors that occur when the product as delivered doesn't match the transaction data that must accompany it. In any scenario, the receiver must investigate that transaction with the shipper and resolve the matter (often with re-submission of a clean file) before the product can be taken into inventory; deepening the issue is the fact that an exception doesn't necessarily mean a product is illegitimate or harmful, or even missing. It just means something unexpected happened. And that means that exceptions are becoming very common occurrences.
The rate of exceptions will continue to rise as more and more companies onboard EPCIS in the coming months. More trading partners are exchanging and processing serialized data than ever before, and EPCIS files, while a terrific fit for the task of providing an item's complete history, are notoriously complex, designed to be read electronically (ideally with purpose-built software).
Let's take a somewhat common example: If a split shipment arrives across two different days, it will not match the EPCIS data, thus causing an exception. For another, if a label is damaged, the receiver won't be able to be certain it matches the data they have. In yet another case, the EPCIS data might not have arrived by the time the product has.
Under DSCSA, missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be received into inventory. So, an exception that lacks an immediate fix can force the receiving company to make tough choices on how to deal with the product they've received, including whether it ought to be returned to the sender or even destroyed. And each of those scenarios causes additional cascading problems, since none of them result in the medication reaching inventory (or the patient) in a timely fashion.
To reiterate: Product movement must stop if the exception cannot be resolved. Further, under DSCSA's Enhanced Security provisions, exceptions must be resolved within 72 hours. Is that a lot of time? At present, no; it's still shockingly common for difficult exceptions to take days or weeks, meaning that sometimes they're "resolved" by the receiver simply canceling the transaction and re-ordering, which is a major drain on time and cost. However, with a robust exceptions management solution like LSPedia's OneScan Investigator, resolution times can be negligible, thanks to automated error detection and guided resolution.
Electronic Product Code Information Services, or EPCIS, is a standard developed by the organization GS1 to capture and share events in an item's history, and make them readable in a common, interoperable way. This provides visibility into a product from its creation to final end-user sale, helping trading partners share exact information between organizations, supporting accurate track-and-trace operations.
For pharmaceutical products, EPCIS records:
The increased functionality of EPCIS contributes to its complexity; trying to process a file "by hand" (that is, reading it without specialized software) essentially means attempting to read dozens or hundreds of pages of lines of code. It's a time-consuming and frustrating endeavor at best; this is one reason it's so important to have a DSCSA solution in place to handle them for you.
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.
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.
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. There's now a framework for what to expect, but the industry's transition to serialized data 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'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.
Contact us today to learn how to secure your business with industry-leading exceptions management.