Radio-tagged product codes that are gaining popularity for inventory control might also one day help keep fake medicine out of the drug supply.
Drug makers and sellers are urging the Food and Drug Administration to consider the new technology as it seeks safeguards against the growing threat of counterfeit medicine, said FDA pharmacy chief Tom McGinnis, who heads the agency’s new anti-counterfeiting task force.
The radio-frequency transmitters already are used at highway toll booths to read speed passes, and Wal-Mart is spurring the technology in other industries by telling its top 100 suppliers to embed the chips in shipping crates for better inventory control by 2005.
It’s a still-evolving technology, so widespread use on prescription drugs is probably a few years away, McGinnis said, although he expects some companies with drugs particularly vulnerable to counterfeiters will try it sooner.
Also drawing FDA attention is a program by Serono Inc. that tracks every box of a treatment for AIDS wasting, called Serostim, from factory to a network of pharmacies specially authorized to sell it. Additionally, pharmacies must report that bar-coded tracking number to get reimbursement from certain third-party payers, like New York’s Medicaid office.
Serono started the program last fall, after a rash of Serostim counterfeits. No fakes have been detected since, Serono Vice President James Sapirstein said.
The FDA task force next week will outline possible options to fight counterfeiters, with final recommendations due in January.
Until some sort of protective technology arrives, drugstores and even patients need to know that counterfeit drugs, while still rare in this country, are a growing problem, McGinnis said.
“We need to raise the level of concern,” he said.
Patients should immediately report anything suspicious about a drug to their pharmacist, who in turn must promptly alert the drug’s maker and the FDA, he said. Suspicious signs could be a drug that looks, smells or tastes different than it usually does.
Fake drugs are proving an increasing challenge to the FDA, which has investigated more than 20 counterfeiting cases a year since 2000, up from roughly five a year in the 1990s. In the biggest case, still unsolved, more than 150,000 bottles of the top-selling cholesterol medicine Lipitor were recalled last spring because of counterfeit pills.
Fueling the problem is the increasing popularity of buying drugs via Internet sites, some that ship from overseas with no controls to guarantee the medicine is what’s advertised. More worrisome, some counterfeits are slipping into the mainstream drug supply and being sold through traditional drugstores.