The pharmaceutical industry's adoption of serialized data under DSCSA is still in early days. Though this transition isn't complete, trading partners across the prescription drug supply chain 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.
The rate of exceptions will only escalate this year as we approach the November 27, 2023 deadline, and more trading partners begin exchanging and processing serialized data. 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 begun your DSCSA compliance journey or are just getting started, it's important to be armed with information about DSCSA exceptions. Here's five things you need to know.
Yes, 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 tough choices on how to deal with product, 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 impact the all-important resource trio: labor, space, and time.
Imagine that any daily receiving effort requires hours or 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.
Generally, the closer a medication is to reaching the patient, the tougher and more time-consuming an exception is to correct. 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.
Yes, there's a framework for what to expect. However, the industry's transition to serialized data ahead of the DSCSA deadline -- enabling tracing at the package level -- 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 are holding the 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.
Though they can be difficult to understand and resolve on your own, it's possible to proactively protect your business from exceptions -- which, in turn, protects your partners, your patients, and your stress levels.
Investigator 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.
Questions? Contact us or write to DSCSA@lspedia.com.