Published Online: Friday, September 1, 2006

A congressional crackdown on pharmaceutical counterfeiters should start with a switch to a "national electronic pedigree" for prescription drugs, an official of the American Pharmacists Association (APhA) told a House Government Reform subcommittee.

The APhA has long supported the use of a "pedigree" or documentation of the movement of medication through the distribution chain to the pharmacy counter. The association official warned Congress, however, that a paper-based pedigree system for tracking pharmaceuticals "could negatively impact the security of our drug-distribution system by creating a false sense of security."

Warning that drug counterfeiters could forge paper Rx pedigrees to create "a trail as fake as the product it accompanies," APhA Vice President Susan Winckler said that "an entity sophisticated enough to counterfeit a [drug] product?would be equally capable of counterfeiting a paper pedigree" for that drug.

Winckler urged Congress to lead a coordinated effort involving pharmacists, drug manufacturers, and others to replace paper documentation with a nationwide e-pedigree system for pharmaceuticals. Significantly, however, she cautioned against allowing states to set their own pedigree requirements for drugs, even if those rules are more rigorous than the federal rules. A series of inconsistent state requirements for pharmaceuticals would "create loopholes that unscrupulous operators will exploit," Winckler warned the subcommittee.

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