The global counterfeit drug trade: Patient safety and public health risks

  • Tim K. Mackey
    Institute of Health Law Studies, California Western School of Law, San Diego, California

    Joint Doctoral Program on Global Health, University of California, San Diego State University, San Diego, California
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  • Bryan A. Liang
    Telephone: +619‐515‐1568; Fax: +619‐515‐1599
    Institute of Health Law Studies, California Western School of Law, San Diego, California

    San Diego Center for Patient Safety, University of California, San Diego School of Medicine, San Diego, California

    Department of Anesthesiology, University of California San Diego School of Medicine, San Diego, California
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      Counterfeit drugs are a global problem with significant and well‐documented consequences for global health and patient safety, including drug resistance and patient deaths. This multibillion‐dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource‐poor nations alike. The epidemiology of counterfeits is also wide in breadth and scope, including thousands of counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegal activity. In addition, information technologies available through the Internet and sales via online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public–private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis. © 2011 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:4571–4579, 2011


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