Ethiopian Food and Drug Authority (EFDA), Federal Ministry of Health (FMoH), Addis Ababa, Ethiopia.
Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia.
Sci Rep. 2024 Oct 16;14(1):24243. doi: 10.1038/s41598-024-73609-z.
Oxytocin is the principal drug and the primary choice for labor induction and postpartum hemorrhage prevention and treatment. The problems associated with oxytocin are not usually from its effectiveness, but they are from its compromised quality which may occur at the point of manufacturing, transportation, and storage. The main objective of this study was to assess the status of oxytocin injection quality and associated factors in the health facilities located in Addis Ababa city, Ethiopia. A laboratory based instrumental quality testing alongside a cross sectional study design was used to evaluate oxytocin injection quality in Addis Ababa city administration from January to June, 2022 according to United States Pharmacopeia (USP 20), and the World Health Organization guideline of post-market medicine quality assessment. Binary logistic regression and cross tabulation analysis were conducted using SPSS 26. Significance was considered at p ≤ 0.05. Out of 107 tested oxytocin injection samples, 92.5% met the limit for oxytocin content, 81.3% for sterility test, and 91.6% for pH value. Overall, quality failure rate was 23.4%, while sterility test failure rate was 18.7%. Lack of reliable refrigerated storage condition [(AOR = 5.62, 95% CI: (1.87, 16.88)], lack of effective cold chain system during distribution [(AOR = 5.5, 95% CI: (1.53, 19.74)], and weak national medicine regulatory system [(AOR = 3.23, 95% CI: (1.13, 9.23)] were among the significantly associated factors for the failure of some of the brands. The study demonstrated that oxytocin injection quality failure rate, failing to meet at least one quality test requirement, is demonstrated in the health facilities of Addis Ababa. The determinant factors for the reported failures are related to storage, distribution, and regulatory system. Hence, these should be addressed by strictly adhering in to the national regulation and providing a comprehensive health promotion on rational use of oxytocin injection should be implemented to assure its quality and safety.
催产素是引产和产后出血预防与治疗的主要药物和首选药物。与催产素相关的问题通常不是其有效性的问题，而是其质量受到影响的问题，而这种情况可能发生在制造、运输和储存过程中。本研究的主要目的是评估埃塞俄比亚亚的斯亚贝巴市卫生机构中催产素注射质量的状况及其相关因素。根据美国药典（USP 20）和世界卫生组织上市后药品质量评估指南，我们采用基于实验室的仪器质量检测和横断面研究设计，于 2022 年 1 月至 6 月对亚的斯亚贝巴市行政区域的催产素注射质量进行评估。采用 SPSS 26 进行二项逻辑回归和交叉表分析。p 值≤0.05 为有统计学意义。在 107 个测试的催产素注射样本中，92.5%符合催产素含量的限值，81.3%符合无菌测试，91.6%符合 pH 值。总的来说，质量不合格率为 23.4%，而无菌测试不合格率为 18.7%。缺乏可靠的冷藏储存条件[比值比（AOR）=5.62，95%置信区间（CI）：（1.87，16.88）]、缺乏有效的分发冷链系统[比值比（AOR）=5.5，95%置信区间（CI）：（1.53，19.74）]和薄弱的国家药品监管系统[比值比（AOR）=3.23，95%置信区间（CI）：（1.13，9.23）]是一些品牌失败的显著相关因素。该研究表明，亚的斯亚贝巴市卫生机构中存在催产素注射质量不合格率，即至少有一项质量检测要求不合格的情况。报告失败的决定因素与储存、分发和监管系统有关。因此，应严格遵守国家法规，并开展全面的合理使用催产素注射的健康教育，以确保其质量和安全性。
