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Health Risks of Counterfeit Pharmaceuticals

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Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality.

It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product.

The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

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  1. In this article, the terms pharmaceutical product, medicinal product, medicine, and drug are equivalent.

  2. A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source.[{xc1|1}]


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The author declares that no funds were received to assist in the preparation of this article. The author has no conflicts of interest directly relevant to the content of this manuscript.

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Correspondence to Martijn ten Ham.

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ten Ham, M. Health Risks of Counterfeit Pharmaceuticals. Drug-Safety 26, 991–997 (2003).

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