Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low- and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs. In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017. All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic’s storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2–8 °C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2–86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7–30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter. Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for post-marketing surveillance.

中文翻译：

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马拉维催产素和米索前列醇的质量，可用性和储存条件

产后出血（PPH）是低收入和中等收入国家（LMIC）孕产妇死亡的主要原因。催产素和米索前列醇用于预防和治疗PPH。但是，这两种药物在化学上都是不稳定的，并且对环境条件敏感。先前的研究报告说，中低收入国家的催产素和米索前列醇制剂不合格率很高。在马拉维四个地区的随机选择的卫生机构中，确定了催产素和米索前列醇的可用性，并评估了卫生工作者对催产剂的储存要求和使用的知识。使用温度记录仪记录催产素的储存温度。催产素注射液和米索前列醇片剂的样本是从医疗机构和批发商处收集的。分析催产素样品的身份，化验（=催产素的量）和根据美国药典40的pH值。米索前列醇样品根据《国际药典》 2017年进行了身份，化验，溶出度和相关物质的分析。所有走访的医院和卫生中心都提供催产素。在非冷藏的存储地点，记录的平均动力学温度超过了标签中规定的42％的催产酸存储温度。在冷藏存储地点，超过33％的地点超过了2–8°C的所需温度。在65个催产素样品中，有7个（11％）显示出与规格的中等偏差，占催产素申报量的82.2–86.8％。在30个米索前列醇样品中，有5个（17％）显示出极度偏差，仅占申报量的12.7–30.2％。向国家主管部门和世界卫生组织报告了米索前列醇含量极低的情况，导致立即在马拉维召回了各自的品牌。此后，该品牌在英国的分销商很快关闭了业务。催产素在马拉维的可用性非常好，其质量也优于其他LMIC中先前的研究报告。但是，医疗机构的储存条件常常不符合要求。发现米索前列醇片剂极不合格，对孕产妇健康构成严重风险。这表明需要继续努力，以确保药品采购和注册以及上市后监督的质量。此后，该品牌在英国的分销商很快关闭了业务。催产素在马拉维的可用性非常好，其质量也优于其他LMIC中先前的研究报告。但是，医疗机构的储存条件常常不符合要求。发现米索前列醇片剂极不合格，对孕产妇健康构成严重风险。这表明需要继续努力，以确保药品采购和注册以及上市后监督的质量。此后，该品牌在英国的分销商很快关闭了业务。催产素在马拉维的可用性非常好，其质量也优于其他LMIC中先前的研究报告。但是，医疗机构的储存条件常常不符合要求。发现米索前列醇片剂极不合格，对孕产妇健康构成严重风险。这表明需要继续努力，以确保药品采购和注册以及上市后监督的质量。对孕妇健康构成严重威胁。这表明需要继续努力，以确保药品采购和注册以及上市后监督的质量。对孕妇健康构成严重威胁。这表明需要继续努力，以确保药品采购和注册以及上市后监督的质量。