Mlugu Eulambius M, Mhagama Jacob, Matiko Damas, Agustine Siya, Nandonde Moses, Masunga Emmanuel, Kunambi Peter P, Sangeda Raphael Zozimus, Mwalwisi Yonah H, Fimbo Adam
Department of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Tanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Am J Trop Med Hyg. 2024 Oct 1;111(6):1215-1222. doi: 10.4269/ajtmh.24-0145. Print 2024 Dec 4.
Sustainable access to high-quality antimalarial medicines is pivotal to achieving universal and effective malaria control. Poor-quality antimalarial medicines are prevalent in sub-Saharan Africa, impeding malaria control initiatives and claiming the lives of many children. Regular monitoring of the quality of antimalarial medicines is crucial to ensure the quality of service to the community. A cross-sectional study using a postmarket surveillance (PMS) approach was conducted from 2019 to 2023. Samples were collected from the port of entry, local manufacturers, and various distribution outlets in 15 regions of mainland Tanzania. The samples were subjected to tier 1 evaluation, comprising a product information review (PIR) and identification using the Global Pharma Health Fund-Minilab® techniques. Samples that failed the identification tests and 10% of the samples from distribution outlets that passed the tests were subjected to confirmatory testing (tier 2), which included assays, related substances, dissolution, and sterility per the pharmacopeial monographs. During five annual PMSs, 2,032 antimalarial samples were collected and subjected to quality tests. All samples complied with the standard specifications for identity, dissolution, related substances, sterility, physical evaluation, disintegration, and assay. A total of 292 (55.5%) tested samples failed the PIR evaluation, with incomplete package information in leaflets contributing to 64.7% of all deviations. Antimalarial medicines circulating in the mainland Tanzanian market meet expected quality standards. Continuous monitoring of the quality of antimalarial medicines is recommended.
可持续获取高质量抗疟药物对于实现全面有效的疟疾控制至关重要。劣质抗疟药物在撒哈拉以南非洲地区普遍存在，阻碍了疟疾控制举措，并夺走了许多儿童的生命。定期监测抗疟药物的质量对于确保为社区提供的服务质量至关重要。2019年至2023年采用上市后监测（PMS）方法进行了一项横断面研究。从坦桑尼亚大陆15个地区的入境口岸、当地制造商和各个分销网点采集了样本。这些样本进行了一级评估，包括产品信息审查（PIR）和使用全球制药健康基金 - 迷你实验室®技术进行鉴定。鉴定测试不合格的样本以及通过测试的分销网点样本的10%进行了确证测试（二级），包括根据药典专论进行的含量测定、有关物质、溶出度和无菌检查。在五次年度PMS期间，共采集了2032份抗疟样本并进行了质量测试。所有样本在鉴别、溶出度、有关物质、无菌、物理评估、崩解和含量测定方面均符合标准规格。共有292份（55.5%）测试样本未通过PIR评估，说明书中包装信息不完整占所有偏差的64.7%。坦桑尼亚大陆市场上流通的抗疟药物符合预期质量标准。建议持续监测抗疟药物的质量。
