Amin A A, Snow R W, Kokwaro G O
Centre for Geographic Medicine, Kenya Medical Research Institute/Wellcome Trust Collaborative Programme, Nairobi, Kenya.
J Clin Pharm Ther. 2005 Dec;30(6):559-65. doi: 10.1111/j.1365-2710.2005.00685.x.
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.
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.
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.
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.
疟疾是肯尼亚一个具有重大公共卫生意义的疾病，每年导致26000名5岁以下儿童死亡。本文旨在评估肯尼亚社区非处方可得的磺胺多辛-乙胺嘧啶（SP）和阿莫地喹（AQ）产品的质量，因为大多数疟疾发热是使用来自非正规零售部门的药物进行自我治疗的。
2002年在肯尼亚四个地区对880个零售点进行了零售审计，记录了抗疟药物库存及其主要批发来源。此外，在一份表格上记录了被审计产品的有效期和基本储存条件。然后从每个地区的前10大批发商处抽取最常储备的SP和AQ产品样本，并对样本进行美国药典（USP）标准的含量和溶出度测试。
SP和AQ是储备最频繁的抗疟药物，占四个地区所有储备抗疟药物的约75%。在分析的116个SP和AQ样本中，47个（40.5%）不符合USP的含量和/或溶出度规格。总体而言，约45.3%的SP样本和33.0%的AQ样本被发现为不合格。在不合格的SP产品中，55.2%是混悬剂，而在不合格的AQ产品中，61.1%是片剂。大多数SP不合格是由于乙胺嘧啶成分。
有必要加强上市后监测系统，以保护肯尼亚患者不被用不合格和假冒抗疟药物治疗。
