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Tracing the Drug Trail

E-pedigrees promise to help industry fight counterfeit drugs

On April 21, 1980, Rosie Ruiz was the first runner to cross the finish line in the Boston Marathon’s women’s race—or so it seemed. Actually, riding the subway for most of the race and emerging from the crowd during the final half-mile helped Ruiz claim her first-place medal. (She was determined a fraud a week later.)

Interestingly, Ruiz’s bad judgment and fraudulent act set the stage for more sophisticated data tracking during races, including on-course video cameras, and most notably, runner chips. (The computer chips, which runners attach to their sneakers, interact with sensor mats placed at checkpoints between the start and finish lines. This enables officials to track and record each registered participant’s progress in real time.)

Currently, the danger of counterfeit drugs is pushing a similar data-tracking movement.

The public often associates counterfeit medicines with drugs available illegally online. However, many fake drugs unknowingly are being sold and distributed through retail pharmacies.

Until recently, counterfeiting was difficult to detect. In 2006, however, the U.S. Food and Drug Administration stepped in and began adding information-tracking guidelines to control the situation and help the retail industry fight back.

The agency tied its efforts to the use of e-pedigrees, or electronic documents that track the change of custody as items pass through the supply chain. They are a perfect fit for the pharmaceutical supply chain. Interest is growing, albeit slowly.

As of July 2006, a Florida law requires wholesale distributors based in the state to provide electronic pedigrees that can track drugs through the point of creation up through retail distribution. California will enact a similar law effective Jan. 1, 2009.

Based on its robust foundation, RFID promises to be a strong catalyst for e-pedigrees. Its powerful data-collection principles enable users to uniquely identify labeled objects, and it also provides granular insight into tagged items’ movement.

Interestingly, some fault RFID for e-pedigrees’ slow adoption. Some say RFID systems are too expensive. Others say RFID doesn’t “fit” all drugs. (For example, tags are ineffective on metal-based containers and liquid prescriptions.) Still others blame a lack of operating standards.

While these points are true, RFID is not the only e-pedigree game in town. In fact, lower-cost, tried-and-true barcodes are an option. While standard barcodes do not have the historical perspective of RFID, 2-D barcodes can help companies serialize pharmaceuticals at a lot- and bottle-level.

E-pedigrees can only be effective, however, as supply partners integrate existing systems so they can share data. By leveraging the new EPCIS (Electronic Product Code Information Services) standard, for example, trading partners have a seamless framework that secures the exchange of data at every point of the shipment of goods throughout the supply chain.

Regardless of the method they choose, all trading partners affiliated with the manufacture or sale of pharmaceuticals should be exploring how they can benefit from e-pedigrees and supply chain integration.

Without this chain-of-custody insight, I am certain the industry (and unsuspecting consumers) will remain pawns in the very dangerous drug-counterfeiting game.

© 2014