How Unsafe Drugs Can Reach Patients?

Drug Safety Project
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Case Studies: How Unsafe Drugs Can Reach Patients
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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).1 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.

Previously dispensed drugs, held under unknown conditions, were illegally resold to patients at U.S. pharmacies, costing the New York Medicaid program $500 million

In 2012, the U.S. attorney for southern New York uncovered a massive criminal ring of drug diversion and relabeling that cost the state Medicaid program more than $500 million and put unknown numbers of patients at risk from compromised medicines.2

“Collectors” purchased the drugs from patients and sold the medicines back into distribution through pharmaceutical wholesalers, allowing them to eventually reach pharmacies. The unsuspecting patients who received these recycled drugs were exposed to medicines that may have expired or been contaminated.3

The practice of diverting and reintroducing pharmaceutical products for profit is not new. Similar schemes in other states are well documented. In 2013, for example, three people were indicted in a Tennessee court for allegedly buying medicines that had been collected from patients and then reselling the drugs to pharmacies as legitimate products.4

Counterfeit cancer medicines were distributed in the United States

Twice in 2012 and once in 2013, FDA announced that counterfeit cancer medicines had been found in the United States. The fake drugs contained none of the active ingredient necessary to treat the disease.5

According to FDA, the counterfeit drugs came from foreign suppliers that were providing medicines to U.S. medical practices using illegal channels that were approved for use in other countries such as Turkey, but not the United States.6 FDA notified more than 100 doctors in 33 states that they had purchased illegal prescription drugs from foreign or unlicensed suppliers.7

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