Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, P.O Box.1176, Addis Ababa, Ethiopia.
College of Health Sciences, Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), Addis Ababa University, P.O. Box. 9086, Addis Ababa, Ethiopia.
Malar J. 2024 Sep 13;23(1):278. doi: 10.1186/s12936-024-05091-x.
Over the past years, there has been a growing concern that a considerable amount of anti-malarial supply in the underdeveloped world particularly in the private sector, is of poor quality. The World Health Organization (WHO) has received about 1500 reports that mentions instances of substandard and falsified products since 2013. The majority of the reports concerned antibiotics and anti-malarials. The majority of reports (42%) originate from the WHO African region.
This study intends to assess the quality of the most widely used anti-malarial medications [artemether-lumefantrine tablets, chloroquine phosphate tablets, primaquine phosphate tablets, artesunate, and artemether injections] in Gambella, South-West, Ethiopia.
A total of 52 samples were collected on June 2022 from Gambella National Regional State, Ethiopia. Half of the districts (six) located in the four zones of the region were chosen using simple random sampling technique. All drug retail outlets available in the selected districts (locally known as woredas) were included. The samples were subjected to visual inspection with a tool adopted from the joint WHO/FIP/ USP checklist. The pharmacopeial tests for identification, uniformity of dosage forms, assay, thickness, diameter, hardness, friability, disintegration test, dissolution, and sterility tests were carried out according to the USP 44-NF 39 and International Pharmacopoeia 11th edition, 2022 monographs.
Only 25% of the samples were registered on the Ethiopian Food and Drug Authority (EFDA's) electronic regulatory/ registration system (ERIS). Besides, 88.8% of artemether injection products were presented in clear glass ampoules. This might expose the products to photochemical degradation that leads to in loss of anti-plasmodial activity. In addition, 50% of the artemether products assessed were not bioequivalent with the comparator product in the in vitro dissolution comparison tests. Overall, the study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. The stated percent of the samples had failed in one or more of the quality test parameters assessed in this study.
The study findings reveal a high prevalence (58.3%) of substandard anti-malarial drugs in the region. Only a quarter were registered and 38% of the unregistered products failed the quality tests. Hence, the national, regional medicine regulatory bodies and other stake holders should perform the required roles to circumvent presence of Substandard and Falsified (SF) anti-malarial drugs in the study sites.
在过去的几年中，人们越来越担心欠发达国家，尤其是私营部门的大量抗疟药物供应质量较差。世界卫生组织（WHO）自 2013 年以来已收到约 1500 份提及劣质和伪造产品的报告。大多数报告涉及抗生素和抗疟药物。大多数报告（42%）来自世卫组织非洲区域。
本研究旨在评估在埃塞俄比亚西南部的甘贝拉使用最广泛的抗疟药物[青蒿琥酯-咯萘啶片、磷酸氯喹片、磷酸伯氨喹片、青蒿琥酯和青蒿琥酯注射液]的质量。
2022 年 6 月，从甘贝拉国家地区州共采集了 52 个样本。采用简单随机抽样技术，从该地区的四个区中选择一半的区（六个）。在所选择的区（当地称为 woreda）中包含的所有药物零售点都被纳入研究。使用从世界卫生组织/FIP/USP 联合清单中采用的工具对样品进行了目视检查。根据 USP 44-NF 39 和 2022 年版国际药典，对鉴别、剂型均匀度、含量测定、厚度、直径、硬度、脆碎度、崩解试验、溶出度和无菌试验进行了药检试验。
只有 25%的样品在埃塞俄比亚食品和药物管理局（EFDA）的电子监管/注册系统（ERIS）上注册。此外，88.8%的青蒿琥酯注射液产品装在透明玻璃安瓿中。这可能会使产品暴露在光化学降解下，导致抗疟活性丧失。此外，评估的青蒿琥酯产品中有 50%在体外溶出比较试验中与参比产品不一致。总体而言，研究结果显示该地区劣质抗疟药物的流行率很高（58.3%）。在本研究评估的质量测试参数中，有规定比例的样品在一个或多个参数上不合格。
研究结果显示该地区劣质抗疟药物的流行率很高（58.3%）。只有四分之一的药物注册，而 38%的未注册产品未通过质量测试。因此，国家、地区药品监管机构和其他利益攸关方应发挥必要作用，以避免在研究地点出现劣质和伪造（SF）抗疟药物。
