With just three months left before full regulatory enforcement goes into effect, it’s vital to plan for exceptions. These are the transaction errors that can occur when the EPCIS files that must accompany each physical shipment have errors, or don’t match the products as delivered (including when either data or product are missing outright). When an exception is detected, the receiving business must investigate the matter and resolve it with the seller within three days.
Last week, our CEO, Riya Cao, joined a webinar hosted by the Healthcare Distribution Alliance to bring the matter into focus. Though Cao had some good news to share about the speed at which exceptions are being resolved, her message for the pharmaceutical industry remained urgent: trading partners who don’t plan for exceptions run a significant risk of slowdowns and other impacts when full enforcement begins on November 27, 2023.
As noted in Regulatory Focus, Cao told viewers that pharmaceutical trading partners have made important progress in improving their use of EPCIS data, as shown by a decrease in the average time needed to resolve data exceptions. “I encourage you to keep doing the work that you’re doing,” she said.
However, even as these times improve, the error rate seen in customer data remains high, at 10 percent, and is increasing as more customers exchange EPCIS files; in the last six months, the volume of inbound EPCIS files has doubled, amid the industry’s broad shift to DSCSA data ahead of the final deadline. Cao emphasized that, at the current rate, every trading partner can expect to be affected by exceptions, and urged viewers to put standard operating procedures in place for managing them.
Cao attributed many of these errors to the use of incorrect Electronic Product Code Information Services (EPCIS) data. These can include syntax errors, data errors, or errors in the master data.
Other problems include using older versions such as EPCIS 1.0 or EPCIS 1.1 instead of versions EPCIS Version 1.2 or 1.3, or missing data such as the GS1 Global Trade Item Number (GTIN) – the unique identifier for each drug at each packaging level – or GS-1 Global Location Number (GLN). “We see a lot missing GLNs or missing GTINs,” she said.
Other issues include a lack of aggregation, which allows trading partners to be able to infer the data at the smaller unit levels. “If you’re sending a large shipment don’t expect that your receivers will be able to scan everything, they need aggregation and they need inference,” she noted.
- Regulatory Focus
Cao called attention to the importance of collaboration with trading partners and solution providers, asserting that these are necessary to avoid supply chain interruptions, delays, undelivered shipments, returns, and waste, all of which can amount to serious business risks: higher workloads, inventory shortages, lost business, and lower revenue.
She asserted that the exceptions resolution process relies on smooth, standardized, and timely communication, including strong preparation and testing. Businesses who are unsure how to engage their partners on DSCSA should start this conversation with their solution provider, she said, adding that providers should have a testing environment that can be opened to partners, allowing both parties to find problems that can create exception situations.
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