Improving the Availability of Quality Oxytocin

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.

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

GHSC-PSM Supports Countries to Implement WHO/UNFPA/UNICEF’s Recommended Three Urgent Actions

Building upon the work of the United Nations Commission on Life-Saving Commodities for Women and Children, WHO, UNICEF and UNFPA agreed to issue this statement, including a request for three specific actions to ensure effective management of and access to good quality oxytocin.
 

1. Supply chain managers should ensure that oxytocin is maintained at 2-8 ℃ (36-46 ℉)
2. Procurers and distributors of oxytocin should ensure that specifications clearly reference appropriate quality standards and requirements, including appropriate labelling for storage at 2-8 ℃ (36-46 ℉)
3. Medicine regulators should support and enforce labelling and marketing to reflect appropriate cold chain maintenance at 2-8 ℃ (36-46 ℉)

The Approach

The Global Health Supply Chain Program-Procurement and Supply Management (GHSC-PSM) project leads efforts to improve oxytocin quality in LMIC settings. At GHSC-PSM, we synthesize the most up-to-date evidence on oxytocin quality and develop new approaches to ensure its quality throughout the supply chain. We collaborate with global partners—such as WHO, UNICEF and UNFPA—to develop guidance on appropriate storage and management of oxytocin and support their implementation in GHSC-PSM-supported countries.

Using a holistic approach, we support national governments in their efforts to strengthen procurement and supply management systems 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

Advocacy
  • 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 
 
Procurement
  • Manual for Procurement and Supply of Quality-Assured Maternal, Newborn and Child Health Commodities (English, French, Spanish)
  • Uses of Medicines for Prevention and Treatment of Post-partum Hemorrhage and Other Obstetric Purposes (English, French, Portuguese, Spanish)
 

 

Quality of Oxytocin in LMICS - Results from Postmarketing Surveillance Studies

Location

Title

Author, Year

Selected Results

Democratic Republic of the Congo

Quality of oxytocin ampoules available in health care facilities in the Democratic Republic of Congo: an exploratory study in five provinces

Lambert et al., 2018 

80% out specification

Nigeria

Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits

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

Quality of oxytocin available in low- and middle-income countries: a systematic review of the literature

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 

Survey of the Quality of Medicines Identified by the United Nations Commission on Life-saving Commodities for Women and Children

World Health Organization, 2015

64% out of specification

India

Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in 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

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in 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