EDITORIAL: Don't Lose or Get Lost in the Data


Judging from the latest industry polls, drug packagers worry about whether RFID will work for them, and when. Many are currently grappling with RFID reliability, affordability, and compatibility. But the real question isn’t whether RFID will work, because we are assured that it will. Rather, what if RFID works too well?

Because of its ability to carry nearly unlimited data, RFID may enable drug manufacturers, distributors, and others to gather reams of supply chain data. One tag could conceivably hold electronic product numbers (EPC), serial numbers, lot codes, expiration dates, date stamps, and location and user codes for every stop along the supply chain. This electronic data will be quite useful for those creating and maintaining electronic drug pedigrees. The big question is, how will industry manage all this data?

“The biggest gap is data management,” says a vice president of packaging technology at one of the largest drug distributors in the country. “Millions of pieces of data are going to come from millions of packages. What do you do with that data?” To answer that question, this distributor is currently participating in the Drug Security Network (DSN) Lab, which we’ve covered in this month’s Track & Trace column, starting on page 28.

This distributor says that new state pedigree laws will require his firm to capture data from the drugs they get from manufacturers. He will then need to couple that data with those that they generate from their own repackaging operations and to convey it all to the next recipient. “Our pedigrees will have to show how we handle all drugs.”

While the emerging state pedigree laws do not require electronic pedigrees, this distributor is testing RFID use for them. The new RFID tags his firm will put on the repackaged products will need to carry data from the tags on the previous bulk packages, and more.

On top of tracking data from all these new packages, companies “will also have to track the data from packages already used,” this distributor adds. “You will need to retire the EPCs and archive them.”

All this data needs to be saved somewhere, too, generating more questions. “Who will manage that database of data?” he asks. “A third party like EPC Global? Will it be set up regionally?”

Working in the DSN Lab has helped this distributor and his trading partners answer some questions, such as those involving drug pedigrees and serialization. But many remain, especially those that require all of industry—from manufacturers to distributors to pharmacies—to come to a consensus on data sharing and archiving. “All of this will affect drug packaging,” he says.

All these questions need answers, and soon. But the first step in building electronic pedigrees is to understand the true potential of RFID, and to use it wisely. While the RFID tags can carry everything including the kitchen sink, the data and their structure must be standardized for efficient and reliable drug tracking and tracing. Drug manufacturers need to agree together what data elements are important and convince their trading partners to cooperate in data gathering and sharing. Otherwise, drug custodians may waste time and money tracking useless data and may let precious data slip through the cracks.

 

Daphne Allen
Editor

 

 

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