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E-Pedigree Pioneers

A groundbreaking pilot involving drug manufacturer Purdue Pharma and wholesaler H.D. Smith proves RFID tags can be used as the information-carrying platform to create secure electronic documents with chain-of-custody information.
By Mark Roberti
Apr 01, 2006—On Aug. 8, 2005, H.D. Smith, a pharmaceutical wholesaler based in Springfield, Ill., sends an order for a case (48 bottles) of OxyContin to Purdue Pharma, a Stamford, Conn.-based drug manufacturer. When the order is received, workers at Purdue's Wilson, N.C., manufacturing plant pull a case of the Schedule II painkiller from a secure vault and interrogate the RFID tags embedded in the labels on the bottles before putting the shipment on a truck. Behind the scenes, the Electronic Product Code stored on the RFID tag on each bottle is collected along with information about the manufacturing lot the bottle came from, the delivery number and other information. The information for each bottle is stored in a secure document known as an electronic pedigree. Later that day, a Purdue employee logs on to a secure Web site and adds a digital signature to the e-pedigrees, which are then forwarded automatically to H.D. Smith.

When the truck carrying the OxyContin arrives at H.D. Smith's distribution center in Springfield several days later, the shipment is unloaded and brought to a secure area of the facility. Fixed interrogators read the tags on the bottles within the case, and the EPCs are matched to the e-pedigrees the distributor received from the manufacturer, to confirm the authenticity of the drugs. An employee from H.D. Smith logs on to the secure Web site and digitally signs the e-pedigrees, confirming that custody has been transferred to H.D. Smith. (The system allows for the documents to be signed in batches, or one by one.)

If widely adopted, this system could make it harder for criminals to sneak counterfeit drugs into the legitimate supply chain.
This pilot was the first time RFID tags were combined with secure electronic documents to create electronic pedigrees across a real-world supply chain. It was part of a three-month field trial by Purdue and H.D. Smith that is helping to lay the foundation for e-pedigree standards. Many people and organizations, including the U.S. Food and Drug Administration, believe that widespread use of pedigrees could help secure the drug supply chain, reduce the counterfeiting of drugs and protect the public health.

"We said it would be nice to do a reference model for the industry," says Mike Celentano, associate director of supply chain and RFID systems for Purdue Pharma. "We said to H.D. Smith, 'We're uniquely positioned to ship it; you're uniquely positioned to receive it. Why don't we try to get the pedigree piece in the middle and see if we can create a model to help drive standards more quickly for the industry?' Both companies wanted to show leadership in this area."

Celentano is a member of EPCglobal's Health Care and Life Sciences Business Action Group (HCLS BAG), which has identified e-pedigree creation as one of the most promising applications for RFID and, more specifically, EPC technologies. The reason is the pharmaceutical industry and governments around the world believe that creating drug pedigrees is the best way to combat the counterfeiting and diversion of pharmaceutical drugs, a growing problem that costs drug manufacturers millions of dollars a year in lost sales and threatens the health of those who unknowingly purchase counterfeit or adulterated drugs.
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