The supply chain of medicinal controlled substances: addressing the Achilles heel of drug diversion

Abstract

The escalation of prescription drug abuse in the U.S. has attracted the attention of public health and safety officials as well as others puzzled by how such a tightly regulated enterprise could so easily be breached by those seeking controlled substances for nonmedical use. Prescribers and patients who use, misuse, or, in some cases, redistribute or divert these drugs have figured prominently in government strategies aimed at addressing this issue. This review departs from this paradigm and focuses on wholesale drug distributors, a highly efficient and largely behinds-the-scene link in the supply chain of controlled substances. By law, distributors are required to identify and report to the Drug Enforcement Administration (DEA) orders for controlled substances that are suspicious and may indicate drug diversion. Ten cases are examined in which distributors were each charged with failing to prevent the diversion of millions of doses of controlled substances. Special attention is given to a payment system employed by the industry that may encourage this unlawful commerce. Court records, agency and industry reports, and other published sources are used to document referenced cases and their disposition, and recommendations are offered for improving distributors' compliance with the law.