Stability of oxytocin along the supply chain: A WHO observational study

Abstract

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.

Keywords: Oxytocin; Postpartum haemorrhage; Quality; Supply chain; Temperature monitoring.