Antignac Marie, Diop Bara Ibrahima, Macquart de Terline Diane, Bernard Melisande, Do Bernard, Ikama Stéphane Méo, N'Guetta Roland, Balde Dadhi M, Tchabi Yessoufou, Sidi Aly Abdallahi, Ali Toure Ibrahim, Zabsonre Patrick, Damorou Jean Marie F, Takombe Jean Laurent, Fernandez Christine, Tafflet Muriel, Empana Jean Philippe, Plouin Pierre François, Narayanan Kumar, Marijon Eloi, Jouven Xavier
Department of Pharmacy, Saint-Antoine Hospital, HUEP, AP-HP, Paris, France.
Department of Cardiology, University Hospital of Fann, Dakar, Senegal.
Int J Cardiol. 2017 Sep 15;243:523-528. doi: 10.1016/j.ijcard.2017.04.099. Epub 2017 Jun 20.
The growing menace of poor quality and falsified drugs constitutes a major hazard, compromising healthcare and patient outcomes. Efforts to assess drug standards worldwide have almost exclusively focused on anti-microbial drugs; with no study to date on cardiovascular drugs. Our study aims to assess quality of seven routinely used cardiovascular medications (anticoagulants, antihypertensives and statins) in ten Sub-Saharan African countries.
Drugs were prospectively collected using standardized methods between 2012 and 2014 from licensed (random pharmacies) and unlicensed (street-markets) places of sale in Africa. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Three quality categories were defined based on the ratio of the measured to the expected dosage of the active ingredient: A (good quality): 95% to 105%, B (low quality): 85 to 94.99% or 105.01 to 115%, C (very low quality): <85% or >115%.
All expected medicines (n=3468 samples) were collected in Benin, Burkina-Faso, Congo-Brazzaville, the Democratic Republic of Congo, Guinea, Côte d'Ivoire, Mauritania, Niger, Togo and Senegal. Out of the 1530 samples randomly tested, poor quality (types B and C) was identified in 249 (16.3%) samples. The prevalence of poor quality was significantly increased in certain specific drugs (amlodipine 29% and captopril 26%), in generic versions (23%) and in drugs produced in Asia (35%). The proportion of poor quality reached 50% when drugs produced in Asia were sold in street-markets.
In this first study assessing the quality of cardiovascular drugs in Africa, we found a significant proportion of poor quality drugs. This requires continued monitoring strategies.
低质量和假药的威胁日益增大，构成了重大危害，损害了医疗保健和患者治疗效果。全球评估药品标准的工作几乎完全集中在抗菌药物上；迄今为止尚无关于心血管药物的研究。我们的研究旨在评估撒哈拉以南非洲10个国家中7种常用心血管药物（抗凝剂、抗高血压药和他汀类药物）的质量。
2012年至2014年期间，采用标准化方法从非洲有许可证的（随机药房）和无许可证的（街头市场）销售点前瞻性收集药品。我们开发了一种经过验证的反相液相色谱-串联质谱法，以在经认证的公共实验室中准确量化活性成分。根据活性成分实测剂量与预期剂量的比值定义了三个质量类别：A（质量好）：95%至105%，B（质量低）：85%至94.99%或105.01%至115%，C（质量极低）：<85%或>115%。
在贝宁、布基纳法索、刚果布拉柴维尔、刚果民主共和国、几内亚、科特迪瓦、毛里塔尼亚、尼日尔、多哥和塞内加尔收集了所有预期的药品（n = 3468个样本）。在随机检测的1530个样本中，249个（16.3%）样本被鉴定为质量差（B类和C类）。某些特定药物（氨氯地平29%和卡托普利26%）、仿制药（23%）和亚洲生产的药物（35%）中质量差的发生率显著增加。当亚洲生产的药物在街头市场销售时，质量差的比例达到50%。
在这项评估非洲心血管药物质量的首次研究中，我们发现了相当比例的低质量药物。这需要持续的监测策略。
