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Drug Diversion and Counterfeiting: Emerging Role of RFID.

Article Excerpt
Article by Matthew Boyd Van Hook and George Y. Wheeler III (Washington, D.C.)

Originally published 3rd Quarter 2004

oThe realities of the wholesale marketplace have combined to create a system in which a large amount of attractively priced pharmaceuticals are constantly available, some of which are not safe or effective. The physical movement, conditions of storage, and, in some cases, even the origins of much of this merchandise is unknown to the first, second, or third level buyer, who in effect plays a form of Russian roulette. This situation cannot be allowed to continue.o

So wrote House Energy and Commerce Committee Chairman, John Dingell, in a 1986 subcommittee report1 that led to passage of the Prescription Drug Marketing Act. Remarkably, mechanisms established by Congress to address the problem are now being undermined - in some instances they were never fully implemented - and the situation recently has grown worse. In October 2003, the Washington Post ran a week-long series (oPharmaceutical Roulette - A Vast, Unregulated Shadow Marketo), with headlines alleging that the U.S. prescription drug system is oUnder Attack.o2

The gravity of the situation is particularly striking in that grassroots law enforcement authorities are increasingly concerned. Last year, for example, a statewide Florida Grand Jury examined the safety of prescription drugs in that state and reported oshocking and disturbingo evidence of counterfeiting and diversion, concluding that the opotential profits available to corrupt wholesalers rival those found in narcotics trafficking.o3 That Grand Jury also found:

Drug diversion: An alarming percentage of drugs in the wholesale market have been illegally acquired, ostolen from shipments, pharmacies, clinics, and hospitals; purchased on the black market from recipients and healthcare professionals who are defrauding insurance companies or Medicaid with bogus prescriptions; or illegally imported from overseas.o4

Relabeling scams: Counterfeiters relabel drugs oto hide the fact that they have expired, been previously dispensed, or illegally imported; to falsely overstate their strength (sometimes by as much as 2,000%); or to pass off some other substance as a genuine pharmaceutical.o5

Fake-drug horror stories: oOne case concerned a father in Michigan who repeatedly injected his son with what he thought was a growth hormone [but was later learned to be insulin]. He did not buy that medication out of a car trunk or a back alley. Those drugs were traced to a legitimate pharmacy in Orlando, Florida, but it is obvious that this mislabeled, adulterated product was brought into the stream of commerce by some counterfeiter. Had the wholesaler bothered to check the pedigree by verifying the transactions, it would have discovered that the drugs could not be traced to the manufacturer.o6

As if these domestic counterfeit and diversion...

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