The Race for Track & Trace: Are 3PLs ready for serialization?

Aggregation relationships

Serialization will mean that each pallet, case and item will have its own unique 2D barcode, enabling precise track-and-trace capabilities down to the individual product as it moves through the supply chain. In theory, the enhanced capabilities of the 2D barcode is an advance for pharma security. In practice, however, upgrading the software and hardware required to interpret and store the data is far more complex.

Carl Ambroise, IT director for 3PL pharma provider WDSrx, said of serialization upgrades, “hardware and software must accommodate the huge increase in data transfer and storage required by the regulations, as well as be flexible to securely communicate effectively with other systems within and outside our facilities.”

In isolation, the hardware and software required to serialize and trace individual products are not complicated; express delivery companies for example, have been doing it for years. Aggregation – essentially the ability to know pallet/case/item-level relationships with a single scan – is where everything gets fuzzy, both on a practical and legal basis. While it remains unclear whether DSCSA will require shippers to exchange aggregation relationships with 3PLS, on a practical level it often becomes useful when pallets are broken down for further product distribution. With serialization, you are “no longer dealing with gross quantities and at the shipment level anymore,” Daleiden said. “You’re really now starting to think about individual units moving through the supply chain.”

For reverse logistics, this matter becomes increasingly complex. Say a 3PL delivers a case of serialized Heparin to a pharmacy. Prior to the drug’s expiration, the pharmacy decides it needs to relocate across town, and wishes to use the same provider’s reverse-logistics services to process a few units of Heparin. To verify the product’s authenticity, the 3PL needs to be able to link the individual serial numbers from the original shipment and requires either aggregate relationship data, or a way to make a verification query with the manufacturer.

The next phase

With a little more than a year to go before Phase II is mandatory, there is still time to work out kinks in the system with pilot programs, but time is running out.

“During pilots, pharmaceutical companies learned what impact serialization has on the warehouse, learned how much time it takes to scan, accept full-case as it is, minimize the additional edgeware and make sure stop-gaps are in place so that pallets aren’t shipped without serial data” said Matthew Deep, vice president of technology at DMlogic.

Moving forward, Deep and Daleiden agree that a comprehensive, integrated software solution for warehouse management and compliance with DSCSA will be the next phase of track-and-trace technology. For now, flexibility and customized solutions will have to do.

In the end, experts realize that DSCSA is about so much more than compliance. It’s giving drug dispensers a way to detect counterfeit medications without a verifiable history, with the simple scan of a serialized barcode. Deep added, “I’m passionate about this because the end-result of the countless hours spent developing these solutions is patient safety.”

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