Diluted cancer drugs. Schizophrenia or HIV medication laced with talcum powder, aspirin and salt water. Menstrual cramps pills polluted with lead-based highway paint. These are not the sick scenarios of bad made-for-TV movies. They're real-life incidents that have occurred during the last few years due to the escalation of counterfeit pharmaceuticals. Purdue Pharma L.P. and numerous other drug manufacturers are taking this issue very seriously. They're aggressively attacking the scourge by piloting new radio frequency identification (RFID) tracking systems designed to keep a constant watch over their products as they go to market.

Purdue Pharma (Stamford, CT), the maker of OxyContin and Palladone, among other prescription and non-prescription drugs, last November was one of the first to launch a pilot program to integrate RFID tags at the item-level for two of its largest customers: Wal-Mart and drug wholesaler H.D. Smith. The pilot, which places RFID tags on the labels for 100-tablet bottles of OxyContin, is just the start of Purdue Pharma's major RFID initiative and multi-layered security approach. The drug manufacturer is also pursuing other overt and covert measures to safeguard its products. The goal: To transform the way Purdue Pharma packages and ships medications in order to deter counterfeiting and diversion, and to track the authenticity and safety of its products throughout the entire pharmaceutical supply chain.

"We've seen a greater incidence of counterfeit drugs, and we ... take the threat very seriously," explains Aaron Graham, the company's vice president and chief security officer, who was hired in 2002 to take on counterfeiting and other security issues. "RFID is critical to how we can keep counterfeit drugs out of our nation's supply chain."

Counterfeit prescription drugs have become such a matter of concern that other pharmaceuticals manufacturers are placing a similar bet on RFID. Pfizer Inc. (New York) last November announced plans to use RFID tags to authenticate all Viagra sold in the United States by the end of this year, and will consider the technology for other products moving forward.

GROWING PHENOMENON

The U.S. Food and Drug Administration (FDA) is also concerned about the counterfeiting trend; it released a report last year to promote and assist companies looking to adopt RFID throughout the drug-distribution system. While the FDA maintained drug counterfeiting isn't yet a widespread problem, it acknowledged that the number of FDA investigations surrounding counterfeit cases is on the rise. The FDA now looks into more than 20 cases a year since the year 2000, up from around five annually in the 1990s.

The report, which didn't mandate any deadlines for RFID's use, said the technology showed the most promise as a means for tracking and tracing a drug's "pedigree" -- a record of the drug as it moves through the supply chain showing it was manufactured and distributed under safe and secure conditions. Typically, if a pedigree exists at all in today's world, it's achieved with a paper trail.

Using RFID tags, the FDA report contends, companies could achieve mass serialization, meaning they could assign a unique number (the electronic product code) to each pallet, case and package of drugs and then use that number to record information about all the transactions involving the product. As a result, a drug purchaser could immediately determine critical factors such as a drug's authenticity, where it was intended for sale and whether it was previously dispensed. The FDA sketched out a timeline for RFID implementations, predicting that a variety of companies would conduct feasibility studies in 2004 and 2005, with more widespread adoption and deployment of RFID throughout the pharmaceutical supply chain by 2007.

Purdue Pharma is in the small camp of companies getting an early jump on the FDA's recommendations. The manufacturer initially took an interest in RFID as a result of retail giant Wal-Mart's mandate, issued a few years ago to its major suppliers, to embrace the technology as a means to streamline operations, achieve supply chain efficiencies and lower inventory costs. Specifically, Wal-Mart requested that suppliers of Class Two prescription drugs (addictive painkillers and other prescription narcotics) perform item-level tagging on their products.

Based on that demand, Purdue Pharma got started on its RFID initiative, but it quickly realized there were other benefits beyond appeasing Wal-Mart. "We saw potential for RFID, not only as "slap and ship" or putting tags on bottles to send to Wal-Mart," explains Chuck Nardi, Purdue Pharma's information officer of commercial systems. "We plan to expand RFID on more products going to more customers as the industry grows with it. Then we can collect the data and use it as a new element within different business processes."