Institute of Pharmaceutical Technology, Goethe University Frankfurt am Main, Frankfurt am Main, Hessen, Germany.
Institute of Pharmaceutical Technology, Goethe University Frankfurt am Main, Frankfurt am Main, Hessen, Germany.
J Pharm Sci. 2017 Oct;106(10):2921-2929. doi: 10.1016/j.xphs.2017.05.018. Epub 2017 May 23.
Counterfeit drugs can hurt patients and harm the pharmaceutical industry. In 2006, the International Medical Products Anti-Counterfeiting Taskforce expressed a need to generate more and better data to calculate a worldwide prevalence of counterfeiting. This review analyzes field test data that were published in the time frame January 2007 to December 2016, were accessible via Pubmed, and which addressed the prevalence of counterfeit drugs. Based on the 41 studies identified, it is still not possible to make a reliable statement about the prevalence of counterfeit drugs due to the heterogeneity of the results. To make further progress in this area, both the quantity and quality of documented field tests should be increased. Without a differentiated analysis considering therapeutic class, source, and country of counterfeit drugs, it will remain difficult to identify the root causes of market infiltration and useful points of attack to combat them. Studies with high sample power and randomized sampling, packaging inspection, and detailed chemical analysis will be necessary to correctly identify (especially professional) counterfeit samples. The classification system presented in this review should help to calculate not only the prevalence of counterfeit drugs but also the risks to the patient associated with different types of counterfeited medicines.
假药会伤害患者并损害制药行业。2006 年，国际医药产品打假专题组表示需要生成更多更好的数据来计算全球假药的流行率。本综述分析了 2007 年 1 月至 2016 年 12 月期间发表的、可通过 Pubmed 获取的、涉及假药流行率的现场测试数据。基于确定的 41 项研究，由于结果的异质性，仍然无法就假药的流行率做出可靠的陈述。为了在这一领域取得进一步进展，应增加记录现场测试的数量和质量。如果不考虑假药的治疗类别、来源和国家进行差异化分析，就很难确定市场渗透的根本原因以及打击这些假药的有效切入点。具有高样本量和随机抽样、包装检查和详细化学分析的研究对于正确识别（特别是专业）假冒样品是必要的。本综述中提出的分类系统不仅有助于计算假药的流行率，还有助于计算与不同类型假药相关的患者风险。
