Substandard drugs among five common antihypertensive generic medications: an analysis from 10 African countries
Substandard drugs among five common antihypertensive generic medications: an analysis from 10 African countries
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DOI：
10.1097/hjh.0000000000001560
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发表时间：
2018-02-01
影响因子：
4.9
通讯作者：
Antignac, Marie
中科院分区：
文献类型：
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作者：
de Terline, Diane Macquart;Diop, Bara I.;Antignac, Marie
目标：高血压导致的死亡人数比任何其他危险因素都要多，并且在过去几十年中撒哈拉以南非洲地区的死亡人数呈上升趋势。仿制药有助于提高发展中国家抗高血压治疗的可及性和可负担性。然而，评估这些产品的质量标准很重要。我们对 10 个撒哈拉以南非洲国家的 5 种常用抗高血压仿制药进行了质量评估，并研究了价格对质量的影响。方法：在 2012 年至 2014 年期间使用标准化方法前瞻性收集药物样品。我们开发了一种经过验证的反相液相色谱和串联质谱方法，可在经过认证的公共实验室准确定量活性成分。质量是根据活性成分的测量剂量与预期剂量的百分比来定义的。结果：总共评估了 1185 个样品，其中 70.0% 为通用样品 (n = 830)。仿制药中，劣质药品比例为24.3%（n=202/830）。活性成分的实测剂量与预期剂量的百分比范围为49.2%至111.3%；大部分（81.7%）劣质样品的活性成分含量不足。此外，质量差与药物的购买价格无关。结论：在这项针对 10 个撒哈拉以南非洲国家的研究中，发现近四分之一的仿制抗高血压药物质量差。提高抗高血压药物质量的协调一致措施可能会大大改善高血压的控制，从而减少低收入和中等收入国家的有害后果。
Objective: Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality.Methods: Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient.Results: A total of 1185 samples were assessed, of which 70.0% were generic (n = 830). Among the generic drugs, the percentage of poor-quality drugs was 24.3% (n = 202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2 to 111.3%; the majority (81.7%) of the poor-quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug.Conclusion: In this study from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.