Kartoglu Umit, Widmer Mariana, Gulmezoglu Metin
World Health Organization, Department of Essential Medicines and Health Products, Regulatory System Strengthening, 20 Avenue Appia, Geneva 1211, Switzerland.
World Health Organization, Department of Reproductive Health and Research, World Health Organization, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.
Biologicals. 2017 Nov;50:117-124. doi: 10.1016/j.biologicals.2017.05.004. Epub 2017 May 25.
Postpartum haemorrhage is the leading cause of maternal mortality in low-income countries and oxytocin is the drug recommended by WHO for preventing and treating it. There are concerns about the quality of oxytocin available at the service level provider. The study aimed to document how temperature variations along the supply chain affect quality of oxytocin. The study was run from March to June 2015 in four regions of Ghana. 130 ampoules of oxytocin were shipped from the manufacturer to service level following Ghanaian public sector supply chain. Along the supply chain, temperatures were recorded continuously. After one month storage at central, regional and service level, ampoules were sent to laboratory for testing. Quality of the initial oxytocin sample from the manufacturer and the 130 oxytocin samples received from study points were tested according to International Pharmacopeia monograph. Samples fully complied with specifications. Temperature profile showed that the lowest and highest temperatures experienced were -9.9 °C and +30.1 °C. The results of this study indicate that the activity of oxytocin was not affected by these temperature excursions which occurred along the supply chain. The quality of the oxytocin from the manufacturer as well as from the service level was within the required specifications.
产后出血是低收入国家孕产妇死亡的主要原因，而催产素是世界卫生组织推荐用于预防和治疗产后出血的药物。人们担心服务层面提供者所提供的催产素质量。该研究旨在记录供应链中温度变化如何影响催产素质量。该研究于2015年3月至6月在加纳的四个地区开展。按照加纳公共部门供应链，130支催产素安瓿从制造商运至服务层面。在供应链沿线，持续记录温度。在中央、地区和服务层面储存一个月后，将安瓿送至实验室进行检测。根据《国际药典》专论对来自制造商的初始催产素样品以及从研究点收到的130个催产素样品进行质量检测。样品完全符合规格。温度曲线显示，经历的最低和最高温度分别为-9.9°C和+30.1°C。该研究结果表明，催产素的活性不受供应链沿线出现的这些温度波动的影响。来自制造商以及服务层面的催产素质量均在规定规格范围内。
