Counterfeiting

The FDA appointed a task force in 2003 to identify steps that the FDA, other government agencies, and the private sector could take to minimize the risks to the public from counterfeit medications. Counterfeiting, on the surface, does not appear related to biosurveillance, but it is when we consider that counterfeiters may introduce harmful substances into the drug distribution systems for consumption. The monitoring techniques being developed to address the problem of counterfeiting can potentially improve biosurveillance.

The FDA task force held discussions with the pharmaceutical industry, law enforcement officials, technology developers, and security experts and produced a report in February 2004 (FDA, 2004b). The report recommended that each drug have an electronic pedigree, which is a "secure record documenting the drug was manufactured and distributed under safe and secure conditions.'' A pedigree is a documented history or genealogy. In this context, a pedigree would provide the government with assurance that the product arriving in a drugstore or hospital stockroom is the genuine article—the same drug that emerged from the factory.

The FDA illustrated this method to show how the serialization and pedigree tracking process is expected to work for a drug manufactured in Virginia, which is sold to a pharmacy in Texas through a chain of wholesalers.

• A manufacturer in Virginia puts the serial number on the drug package and starts the pedigree to ship the drug to a wholesaler in South Carolina.

• The wholesaler adds to the pedigree.

• The drug is sold to a second wholesaler in Mississippi, who verifies that the pedigree has not been forged or altered. This custodian adds his certification to the pedigree.

• When a pharmacy in Texas purchases the drug, the product arrives, accompanied by its pedigree, showing its complete, authenticated history in the supply chain.

By 2006, the FDA expects the drugs vulnerable to counterfeiting to be serialized and tracked with electronic pedigrees. The National Association of Boards of Pharmacy (NABP) has published a list of the most vulnerable drugs for counterfeiting. NABP is a professional association representing the state boards of pharmacy in all 50 states in the United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, New Zealand, eight Canadian Provinces, and three Australian states. Table 10.1 shows the S1 drugs deemed susceptible to counterfeiting.

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