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The latest findings ( http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01357.html ) of counterfeit Viagra, Lipitor, and generic Evista in pharmacies along the Mexican border are disturbing. But another set of crimes ( http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01353.html ) recently discovered deserves your attention, too. They show that diverted prescriptions in the United States are more of a threat than once believed.

More than 40 prescription drugs from more than 80 pharmacies around the United States have been discovered to be part of an illegal drug diversion operation. These diverted drugs have reached patients through community pharmacies in California, New York, New Jersey, Pennsylvania, and Georgia. Distributors in four states have been indicted.

These recent instances of counterfeiting and diversion show that your products are under constant assault, even here in the United States. In light of these crimes, FDA’s recommended timetable for implementing anticounterfeiting solutions like RFID hardly seems aggressive.

But could use of anticounterfeiting technologies have prevented either of these acts? It is a hard question to answer, given the growing sophistication of counterfeiters and diverters. Using RFID to build and maintain pedigrees electronically will certainly tighten the chain of custody for drugs, helping to track drug movement throughout the supply chain.

The challenge will be catching criminals - which could be distributors or even pharmacists—that obtain drugs legally and then distribute them illegally, either through diversion or counterfeiting. Can you counter them with packaging technologies?

Maybe so, but only if you provide layers of protection and include both professionals and patients in authentication. FDA suggests a layered approach ( http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html ) to packaging and labeling technologies. Following that lead, suppliers at recent shows such as Interphex promote using several technologies together to stay ahead of criminals, even if only by a few steps. Nosco (Gurnee, IL) and New Jersey Packaging (Fairfield, NJ) were two such exhibitors.

Some of these solutions must involve patients. In both announcements of the recent crimes, FDA calls upon patients to monitor their own prescriptions, looking for anomalies in packaging and other factors. To help patients do so effectively, add several features to your packages that allow patients to authenticate products in a number of ways. The trick will be to find solutions that are simple enough to be used by the untrained eye (the patient), yet sophisticated enough to thwart the counterfeiters. In other words, patient-friendly, criminal-resistant packaging.

Daphne Allen

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