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[假药:日益严重的威胁]

[Counterfeit medicines: a growing threat].

作者信息

Barbereau S

机构信息

ReMeD, Paris, France.

出版信息

Med Trop (Mars). 2006 Dec;66(6):529-32.

PMID:17286014
Abstract

The medical drug market has undergone considerable transformation in recent years. Like other products, medicines have been affected by globalization. Free trade policies have had a number of negative effects including a reduction in quality control not only for some products but also for raw materials and finished products. The global environment has also created conditions conducive to counterfeit medicines. The term counterfeit medicine is defined differently from one country to another in terms of quality, legality and fraudulent intent. This situation prompted the WHO to propose the following definition: "A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging." Weak pharmaceutical regulation often compounded by widespread corruption in developing countries has greatly facilitated the development of this illicit market with harmful and costly effects on public health. Due to the lack of pharmocovigilance accidents involving use of counterfeit drugs go unreported. For this reason it is not possible to measure the economic impact. While counterfeiting has become a major threat in developing countries, it also affects industrialized countries. Fraudulent behavior occurs all over the world.

摘要

近年来,药品市场经历了相当大的变革。与其他产品一样,药品也受到了全球化的影响。自由贸易政策产生了一系列负面影响,包括不仅对某些产品,而且对原材料和成品的质量控制都有所降低。全球环境也为假药创造了有利条件。假药的定义在不同国家因质量、合法性和欺诈意图而有所不同。这种情况促使世界卫生组织提出了以下定义:“假药是指在身份和/或来源方面被故意和欺诈性地错误标注的药品。造假行为既适用于品牌药,也适用于仿制药,假药可能包括成分正确或错误的产品、无有效成分的产品、有效成分不足的产品或包装虚假的产品。”发展中国家药品监管薄弱,往往还存在普遍的腐败现象,这极大地助长了这个非法市场的发展,对公众健康产生了有害且代价高昂的影响。由于缺乏药物警戒,涉及使用假药的事故未被报告。因此,无法衡量其经济影响。虽然造假已成为发展中国家的一个重大威胁,但它也影响到工业化国家。欺诈行为在世界各地都有发生。

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[Quality of medicines in least developed countries].[最不发达国家的药品质量]
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Bull Acad Natl Med. 2008 Oct;192(7):1423-34; discussion 1434-6.

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