US: Experts worried about exceptions process handling under DSCSA

Pharmaceutical manufacturers and other trading partners need to have a process in place for managing exceptions for products that cannot be accepted by trading partners under the Drug Supply Chain Security Act (DSCSA) because of incorrect or missing data, according to experts who spoke at a 17 August webinar sponsored by the Healthcare Distribution Alliance (HDA).

DSCSA mandates that after 27 November 2023, serialized data will need to be affixed onto all prescription drug packages before sending on to trading partners. If any of the data elements are wrong or missing, products will be returned to the sender.

At the meeting, two experts from solution companies stressed the importance of sending the right data along to trading partners by the November deadline.

Riya Cao, the CEO of LSPedia, said there is a 10% error rate in the data her company is receiving from customers. “That is high, that 10% error rate means your shipment” will be affected, and that the trading partner will not be able to receive the product, she said, adding that “resolving these errors is absolutely necessary.”

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.

Aggregation means that the unique identifiers attached to each product must be uniquely serialized to higher packaging levels. Inference systems allow trading partners to infer the contents of a large container of individual units without having to open it.

Cao said that companies should have standard operating procedures in place for managing exceptions and errors. “We really want to make sure that you pay greater attention to the details,” she said.

Avoid 2% redistribution

Dwight De Vera, vice president of product strategy for Inmar Intelligence, said it is imperative that trading partners resolve exceptions within 72 hours. After this window, products will be considered suspect or illegitimate and sent back to the distributors.

“If we don’t fix it in 48 hours, the possibilities of us fixing it” diminishes, he said. “What the dispenser does not want to talk about is starting a suspect product investigation.”

One “unfortunate statistic” cited by De Vera is that 2% of products received by pharmacies wind up in reverse distribution and are sent back to the distributor because products are unusable or outdated.  Under DCSSA, this reverse distribution rate is expected to be even higher because of the expectations that all products have serialized data.

Despite these concerns, experts said that much progress has been made by trading partners in implementing DSCSA and having these track and trace systems in place.

De Vera said, “One of the things that is really great, we have been working on this for more than half a decade. Before half a decade ago, this was a theory, and the exciting news is that today the exchange of serialized data is a reality….. The encouraging news is that the baseline is established, and the work is established, and it is decentralized…. We have kind of created a technical barrier to bad actors, you have to really try hard to onboard into the network.”

Cao concurred and said that the industry has made great strides on improving the data they are sending. One improvement is that her company is seeing a decrease in the number of days it takes to resolve data exceptions. “We are encouraged by these trends…I encourage you to keep doing the work that you’re doing,” she said.

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