• Albert I Wertheimer, Nicole M Chaney, and Thomas Santella.
• Center for Pharmaceutical Health Services Research, Temple University, Philadelphia, PA 19140, USA. albert.wertheimer@temple.edu
• J Am Pharm Assoc (2003). 2003 Nov 1; 43 (6): 710-7; quiz 717-8.

ObjectivesTo examine the problem of counterfeit drugs and its effects around the world, to consider the likely directions the problem will take, and to propose options for controlling or mitigating the problem.Data SourcesRecently published clinical literature identified through review of articles abstracted at MEDLINE. Search terms were counterfeiting, counterfeit drugs, substandard drugs, fake drugs, world counterfeiting, and counterfeit pharmaceuticals. Further information was abstracted from an array of informational sources, including magazines such as Business Week, newspapers such as the International Herald Tribune, National Public Radio news reports, pharmaceutical company press releases, and information from the World Health Organization.Study SelectionMultiple reviewers were used to retrieve relevant and current data.Data ExtractionRelevant data were extracted independently by multiple reviewers.Data SynthesisTraditionally, the problem of counterfeit pharmaceuticals has been limited to developing nations in Asia and Africa. Now, drug counterfeiting is rapidly becoming a worldwide concern, and counterfeit drugs are reaching the U.S. market. This article defines the problem of counterfeit drugs in its many forms and discusses the extent of the problem, with particular attention to the respective rates of counterfeiting across the globe and the origins of counterfeit drugs.ConclusionTechnologic advances have worsened the counterfeit drug problem. Because drug counterfeiting is a worldwide concern, worldwide action is needed to combat the problem.

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