Abstract：
OBJECTIVE: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC).
METHODS: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone.
RESULTS: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found.
CONCLUSIONS: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues.
METHODS: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone.
RESULTS: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found.
CONCLUSIONS: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues.
摘要：
目的：以前的研究已经证明米索前列醇的质量问题。米非司酮,然而,尚未对质量进行广泛评估。在2020年至2021年之间，概念基金会和国际计划生育联合会进行了一项研究，以确定低收入和中等收入国家（LMIC）的这些药物流产药物的质量。
方法：米索前列醇和米非司酮的批次样品的收集是在选定的LMIC中通过训练过的采样剂进行的。对单个药物包装和组合包装进行取样。世界卫生组织的实验室进行了测试方法验证和随后的样品分析。测试包括识别，分析,相关物质,米索前列醇的含量均匀性，和识别，分析,相关物质,和溶解米非司酮。
结果：样品是从布基纳法索收集的，柬埔寨,刚果民主共和国,印度,吉尔吉斯斯坦,摩尔多瓦,尼泊尔,尼日利亚,巴基斯坦,乌干达和越南。对64个汇集的批次样本进行了测试，由31个组合包装组成，26只米索前列醇和7只米非司酮产品。总的来说,54.7%的样品不符合一个或多个规格，占combipack产品的51.6%，分析了57.1％的米索前列醇片和23.7％的米非司酮片。发现了一种伪造的仅米索前列醇产品。
结论：本研究证实，LMIC中药物流产药物的质量仍然存在重大问题。对于米索前列醇，我们的研究结果表明，有关初级包装的历史问题可能已基本解决，但成品和活性药物成分的制造工艺需要改进。本研究还提供了米非司酮质量问题的证据。
方法：米索前列醇和米非司酮的批次样品的收集是在选定的LMIC中通过训练过的采样剂进行的。对单个药物包装和组合包装进行取样。世界卫生组织的实验室进行了测试方法验证和随后的样品分析。测试包括识别，分析,相关物质,米索前列醇的含量均匀性，和识别，分析,相关物质,和溶解米非司酮。
结果：样品是从布基纳法索收集的，柬埔寨,刚果民主共和国,印度,吉尔吉斯斯坦,摩尔多瓦,尼泊尔,尼日利亚,巴基斯坦,乌干达和越南。对64个汇集的批次样本进行了测试，由31个组合包装组成，26只米索前列醇和7只米非司酮产品。总的来说,54.7%的样品不符合一个或多个规格，占combipack产品的51.6%，分析了57.1％的米索前列醇片和23.7％的米非司酮片。发现了一种伪造的仅米索前列醇产品。
结论：本研究证实，LMIC中药物流产药物的质量仍然存在重大问题。对于米索前列醇，我们的研究结果表明，有关初级包装的历史问题可能已基本解决，但成品和活性药物成分的制造工艺需要改进。本研究还提供了米非司酮质量问题的证据。
