Counterfeit pharmaceuticals: current status and future projections.

OBJECTIVES: To 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 SOURCES: Recently 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 SELECTION: Multiple reviewers were used to retrieve relevant and current data.

DATA EXTRACTION: Relevant data were extracted independently by multiple reviewers.

DATA SYNTHESIS: Traditionally, 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.

CONCLUSION: Technologic advances have worsened the counterfeit drug problem. Because drug counterfeiting is a worldwide concern, worldwide action is needed to combat the problem.