What you need to know about exceptions in April 2023, and what you can do before the November deadline

April 13, 2023

As trading partners across the pharmaceutical industry onboard EPCIS data ahead of the FDA's November 27, 2023 deadline, they're increasingly facing the issue of exceptions -- transaction errors that prevent an order from being received into inventory. These can be caused by data problems, mismatches between the EPCIS data and the physical product as received, or even damage to packaging that prevents the label from being read.

However, apart from the intrepid group joining LSPedia for its weekly Exceptions Pilot meetings, exceptions aren't fully understood within the industry yet. Here's a quick view of what you need to know to get started.

Exceptions management is a core part of life under DSCSA.

Implementing DSCSA without planning for exceptions is like building a boat without planning for leaks.

Exceptions can have serious consequences, as missing transaction data, or any mismatches with the product they describe, must be resolved before a shipment can be received. This can result in temporary quarantine, return to the sender, or even destruction of the product. At the dispenser level, these can directly prevent medications from reaching patients, or cause staff to go to great lengths to source a needed medication on short notice.

The difficulty of resolving exceptions can vary wildly, though across the board, they're more difficult if you don't have a robust solution for exceptions management. It's not possible for any company in the pharmaceutical supply chain to say they're invulnerable to a given error, or even a category of them. Don't get caught off-guard by writing off exceptions as minor or one-off concerns; rather, they should be a core part of your supply chain planning.

The longer an exception takes to find, the bigger its impact will be.

The errors that can cause an exception can go undiscovered for quite some time. It can be as simple as a case containing 11 aggregated items when the file says it has 12; this kind of issue means the case itself may change hands multiple times before someone happens to open it.

An undiscovered exception becomes increasingly difficult to resolve the further down the supply chain it is (that is, the closer a medication is to reaching the patient), due in part to the need for the receiver and sender to re-establish the chain of events in its history before they have enough information to determine how best to fix the error. As such, having thorough DSCSA protocols and procedures are important at every step in the supply chain.

Exceptions management can be automated.

With an advanced solution like LSPedia's OneScan Investigator, exceptions management can be automated, helping companies proactively defend against exceptions; this, in turn, protects their partners, patients, and stress levels.

Investigator cuts the resolution time for an exception from days to minutes by alerting users to errors and guiding them through the resolution process. This enables a company to locate a problem before it can stop business, sending notifications with live hyperlinks that allow the point of contact to quickly view the issue and take the next step.

Exceptions don't have to be expensive -- but they will be if you ignore them.

We've already established that affordable, accessible exceptions management is available; the benefit isn't just in fixing problems quickly, but in avoiding the heavy costs they can incur.

Exceptions affects all parts of the classic resource trio of labor (personnel needed), space (storage of quarantined product), and time (hours/days needed to pursue difficult issues). As such, these can be expensive slowdowns, and major headaches for receivers and senders alike. Quarantine storage 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.

And 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.

New exceptions are inevitable.

With the industry-wide adoption of tracing at the package level, data exchanges are rising at an incredible rate. This is good news for the supply chain overall -- as it's the mechanism for complete traceability -- but it brings along an according increase in exceptions, including many complex new situations for trading partners to work through under pressure.

It's possible to predict the types of exception that will occur, but not every individual variation can be predicted perfectly. That's one reason we launched the Exceptions Pilot, a cross-industry effort to document the exceptions that are arising at this pivotal moment and create a playbook of standards and procedures around them.

In short: While exceptions will become more familiar over time, they'll never be something you can ignore. To get started, contact LSPedia today.