Oxytocin for prevention and treatment of postpartum hemorrhage (PPH) helps ensure the health of women globally. PPH continues to be the leading global cause of maternal mortality, with deaths occurring overwhelmingly in low- and middle-income (LMIC) settings. Oxytocin is a heat sensitive product that is delivered intravenously or intramuscularly and is a highly effective therapy to prevent and treat PPH. However, these benefits are dependent on women having access to quality oxytocin injection products.
Several post-marketing surveillance studies in Africa and Asia demonstrate the presence of a large percentage of substandard oxytocin in health facilities, due to:
- Poor adherence to good manufacturing practices
- Exposure to high temperatures for long durations
Confusion on appropriate procurement and supply chain management practices has likely contributed to quality breaches in the health supply chain.
Key International Guidelines, Statements and Resources
- WHO/UNFPA/UNICEF Joint Statement on Appropriate Storage and Management of Oxytocin – A Key Commodity for Maternal Health (2019)
- WHO/UNICEF Joint Statement on Temperature-Sensitive Health Products in the Expanded Programme on Immunization Cold Chain
- WHO/PQT Statement on Oxytocin Injection: Clarification of Stability Data and Storage Statement Requirements
- WHO recommendations: Uterotonics for the prevention of postpartum heamorrhage (2018)
- WHO recommendations for the prevention and treatment of postpartum haemorrhage
WHO/UNFPA/UNICEF Recommend 'Three Urgent Actions'
Building upon the work of the United Nations Commission on Life-Saving Commodities for Women and Children, WHO, UNICEF and UNFPA issued a statement that recommends three actions to ensure effective management of and access to quality oxytocin.



The Approach
The USAID Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) project leads efforts to improve oxytocin quality in LMICs. GHSC-PSM synthesizes the most up-to-date evidence on oxytocin quality and develop new approaches to ensure its quality throughout the supply chain. The project collaborates with global partners—such as WHO, UNICEF and UNFPA—to develop guidance on appropriate storage and management of oxytocin and support implementation of the guidance in select countries.
Using a holistic approach, we support national governments in their efforts to strengthen procurement and supply management practices to ensure oxytocin quality in the following areas:
- Regulatory environment. Oxytocin degrades when it is exposed to high temperatures, and product labelling may confuse supply chain managers and health care providers. GHSC-PSM supports regulatory efforts to ensure that oxytocin is labelled for storage between 2-8° C.
- Policy and finance. National level policy and financing strategies often affect the availability of quality oxytocin. In our approach, GHSC-PSM considers how policy and financing strategies impact procurement and supply management of oxytocin. Understanding how oxytocin is purchased—whether through donor resources, national budgeting and allocation processes, or insurance schemes—informs strategies that improve the availability of affordable, quality oxytocin.
- Procurement and sourcing practices. Procurement agents at all levels of the health system need to source and procure quality oxytocin with appropriate storage conditions on the label. GHSC-PSM considers how different procurement mechanisms can streamline and improve oxytocin procurement practices.
- Forecasting and supply planning processes. Accurate forecasting and supply planning help ensure consistent availability of quality oxytocin. Deficiencies in this area can lead to stockouts and may prompt health care and supply chain staff to buy oxytocin from the unregulated sources. To this end, GHSC-PSM provides forecasting and supply planning technical assistance to ensure that the right quantities of quality oxytocin reach women when and where it is needed.
- Logistics and inventory management systems and infrastructure. Due to oxytocin’s heat sensitivity, WHO recommends that oxytocin be stored between 2-8° C. In many LMICs, cold chain storage infrastructure may be weak or insufficient. GHSC-PSM develops strategies — such as integrating oxytocin into the Expanded Programme on Immunization cold chain or increasing the frequency of ordering—to that oxytocin is stored appropriately.
Implementation Resources

- Buy Quality Oxytocin, Keep It Cold: An Advocacy Messaging Framework for Oxytocin, the First-Line Drug for the Prevention and Treatment of Post-Partum Hemorrhage (English, French, Spanish)
- Oxytocin – Evidence for Action: an analysis of the evidence that low and middle‑income governments need to prioritize decisive action to improve access to quality uterotonics to reduce preventable PPH (English)
- Medicines We Can Trust



Quality of Oxytocin in LMICs: Results from Postmarketing Surveillance Studies
Location |
Title |
Author, Year |
Selected Results |
Democratic Republic of the Congo |
Lambert et al., 2018 |
80% out specification |
|
Nigeria |
Anyakora et al., 2018 |
74.2% out of specification |
|
Nepal, Vietnam |
The degradation of pharmaceutical oxytocin samples in Nepal and Vietnam |
M. Lui et al., 2016 |
31% out of specification |
15 countries |
Torloni et al., 2016 |
45.6 % median prevalence of oxytocin samples did not pass quality testing as defined by authors; 36.0% out of specification |
|
Burkina Faso, Kenya, Madagascar, Nepal, Nigeria, Tajikistan, Tanzania, Vietnam, Zimbabwe |
World Health Organization, 2015 |
64% out of specification |
|
India |
Stanton et al., 2014 |
36.2% out of specification |
|
Ghana |
Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.Post-market quality surveillance project maternal healthcare products (oxytocin and ergometrine) on the Ghanaian market. Report of first round. |
Ghana Food and Drugs Authority (FDA) Laboratory Services Department, 2013 |
Assay: 55.6% out of specification (2% of these had 0% API); 10% failed assay but passed sterility
Sterility: 40% of samples failed sterility but passed assay; 45% of samples failed both assay and sterility tests 97.5% of samples failed sterility, assay, or both |
Ghana |
Stanton et al., 2012 |
73.9% out of specification; 4.3% expired |
|
Zimbabwe |
Stability of Injectable Oxytocics in Tropical Climates: Results of Field Surveys and Simulation Studies on Ergometrine, Methylergometrine and Oxytocin - EDM Research Series No. 008 |
Hogerzeil et al., 1993 |
1 of 6 samples expired; of remaining 5 samples, 80% out of specification |