The following case studies illustrate breaches in the pharmaceutical supply chain—the route a drug travels from its raw-material origins to the delivery of a finished medicine. These examples, many of which are summarized in the Pew report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways that contaminated, fake, or otherwise unsafe medicine can reach patients. They also underscore the need for reform.
Eighty percent of the active and bulk chemical ingredients in U.S. drugs originate overseas, according to estimates by the Food and Drug Administration (FDA). The increasingly global and outsourced production of drugs creates vulnerabilities in the pharmaceutical supply system, which, without sufficient oversight by industry and regulators, can put patients' lives at risk.
Once a finished drug enters distribution, it can pass through many hands before reaching a pharmacy, thereby creating opportunities for criminals to insert illegitimate products into the supply chain. Stolen and counterfeit medicines have made it onto pharmacy shelves or reached patients numerous times over the past decade.
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