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Purdue Pharma states its case for RFID

Pharmaceutical manufacturer pioneers the use of RFID to provide authentication and traceability of its products through the distribution chain.

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Purdue Pharma LP has one of the most visible RFID programs in pharmaceutical manufacturing. “In trying to get an RFID program off the ground, you’re working with an emerging technology, so you want to go in step-wise fashion, with buy-ins from many cross-functional project teams in your company,” said Mike Celentano, associate director of supply chain systems and RFID for Stamford, CT-based Purdue Pharma. “There’s also off-site testing and considerable concept work.”

Celentano credited this steering-by-committee approach for the initial success of the company’ RFID program, when he spoke in a presentation at the recent Brand-Protection Packaging Forum (www.packworld.com/bppf). Celentano and Aaron Graham, Purdue Pharma’s chief security officer, delivered a co-presentation, “The Case for RFID: Is it an Authentication Solution or a Track-And-Trace Tool?”

The company’s RFID program aims to address patient safety by combating counterfeiting. “The problem of counterfeiting has gotten so out of hand that China executed the head of its FDA,” said Graham. “From our manufacturer’s perspective, public health is the issue—patient safety and brand integrity—so we use packaging and RFID as a way to address the problem through serialization and track-and-trace technology.”

Graham, a former undercover narcotics agent for the U.S. Drug Enforcement Agency, delivered a dramatic presentation, complete with video that touched on some of the global horror stories about counterfeit drugs. “The point I want to make is when a person takes a pill in the safety of his or her home, is he or she really assured that the drug is authentic? I think the answer is no,” he told forum attendees.

Counterfeit products and packaging often look so much like authentic versions that it can be difficult for experts to tell the difference, much less consumers. Adding to the difficulty is the distribution chain, Graham explained, where the bad guys can become an authorized distributor of record (ADR), allowing them to buy and sell products legally, even though their intent is to divert them. “If you’re an ADR, you can say you bought drugs directly from the manufacturer and start a new paper pedigree. The Prescription Drug Marketing Act of 1988 has a loophole big enough to drive a truck through,” said Graham, where secondary wholesaling is concerned.

Purdue Pharma has invested years of research and considerable finances into making sure that its packaged drugs can be tracked and traced throughout the pharmaceutical distribution chain.

RFID-enabled packaging

By establishing an electronic rather than a paper pedigree, says Celentano, a packaged product becomes difficult to counterfeit. “RFID and product serialization can make a difference,” he says. He made the following points during the BPPF presentation:

• The pharmaceutical industry is being compelled by regulatory drivers at both the state and federal levels to move toward serialization at the smallest saleable package.

• We’re not really being told how to serialize, what numbering to use, or to use bar coding or RFID, as long as we’re moving toward a serialization platform. I think the pharmaceutical industry is quickly moving to a standards-based technology that will be meaningful to everyone in the supply chain. The Serialized Global Trade Identification Number [SGTIN] is a standard that comes out of the GS1 EPC Global organization, an industry standards body that’s vertical in nature, but has a pharmaceutical and life sciences branch. We’re trying to capitalize on the standards from that body so that we’re moving together toward a solution.

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