The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector
The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector
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DOI：
10.1111/j.1365-2710.2005.00685.x
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发表时间：
2005-12-01
影响因子：
2
通讯作者：
Kokwaro, GO
中科院分区：
文献类型：
--
作者：
Amin, AA;Snow, RW;Kokwaro, GO
背景与目的：疟疾是肯尼亚一种重要的公共卫生疾病，每年造成26000名5岁以下儿童死亡。本文旨在评估磺胺嘧啶乙胺嘧啶（SP）和阿莫地喹（AQ）产品的质量，可在柜台上的社区在肯尼亚，大多数疟疾发烧是自我药疗使用的药物从非正规的零售sector.Methods：零售审计880零售点进行了在2002年在肯尼亚的四个地区，其中抗疟药物库存和他们的主要批发来源。此外，在形式表上记录了稽查产品的有效期和基本储存条件。最常见的库存SP和AQ产品，然后从每个地区的前10名批发商和样品进行标准的美国药典（USP）测试的内容和dissolution.Results和讨论：SP和AQ是最常见的库存抗疟药物，约占75%的所有库存的抗疟药物在四个地区。在分析的116份SP和AQ样品中，47份（40.5%）不符合含量和/或溶出度的USP质量标准。总体而言，发现约45.3%的SP和33.0%的AQ样品不合格。在不合格的SP产品中，55.2%为悬浮剂，而不合格的AQ产品中，61.1%为片剂。大多数SP失败是因为乙胺嘧啶component.Conclusion：有必要加强上市后的监测系统，以保护患者不被治疗的不合格和假冒抗疟药物在肯尼亚。
Background and objective: Malaria is a disease of major public health importance in Kenya killing 26 000 children under 5 years of age annually. This paper seeks to assess the quality of sulphadoxine-pyrimethamine (SP) and amodiaquine (AQ) products available over-the-counter to communities in Kenya as most malaria fevers are self-medicated using drugs from the informal retail sector.Methods: A retail audit of 880 retail outlets was carried in 2002 in four districts in Kenya, in which antimalarial drug stocks and their primary wholesale sources were noted. In addition, the expiry dates on audited products and the basic storage conditions were recorded on a proforma. The most commonly stocked SP and AQ products were then sampled from the top 10 wholesalers in each district and samples subjected to standard United States Pharmacopoeia (USP) tests of content and dissolution.Results and discussion: SP and AQ were the most frequently stocked antimalarial drugs, accounting for approximately 75% of all the antimalarial drugs stocked in the four districts. Of 116 SP and AQ samples analysed, 47 (40.5%) did not meet the USP specifications for content and/or dissolution. Overall, approximately 45.3% of SP and 33.0% of AQ samples were found to be sub-standard. Of the sub-standard SP products, 55.2% were suspensions while 61.1% of the substandard AQ products were tablets. Most SP failures were because of the pyrimethamine component.Conclusion: There is a need to strengthen post-marketing surveillance systems to protect patients from being treated with sub-standard and counterfeit antimalarial drugs in Kenya.