Oxytocin

PRODUCT PROFILE

Potential Lives Saved/Year: If uterotonic medicines, including oxytocin, were available to all women giving birth over a ten year period, it is projected that 41 million postpartum hemorrhage cases could be prevented and 1.4 million lives saved¹

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Problem and Proposed Intervention

Children at Amari Yewbesh Kebele in Oromia State of Ethiopia, in July 2013.

Globally, more than eight million of the 136 million women giving birth each year suffer from excessive bleeding after childbirth. 2 This condition—medically referred to as postpartum hemorrhage (PPH)—causes one out of every four maternal deaths and accounts for more maternal deaths than any other individual cause.[1] Where a woman gives birth should not decide her fate, and yet deaths due to PPH disproportionately affect women in low-resource settings (often referred to as developing countries).3 Uterotonics, including oxytocin, are the most effective medicines to prevent postpartum hemorrhage.1 These medicines are needed at every level of the health care system where deliveries occur, from urban hospitals to rural clinics.4 If uterotonic medicines, including oxytocin, were available to all women giving birth over a ten year period (2006-2016), it is projected that 41 million postpartum hemorrhage cases could be prevented and 1.4 million lives saved (where oxytocin is the first-line intervention for facility-based deliveries).1 Excessive bleeding after childbirth can be prevented and significantly reduced with expanded availability of maternal health medicines. Supportive policies and appropriate practices are required to take this important medicine to scale to help reach the Millennium Development Goal (MDG) 5 target: reducing maternal mortality by 75% by 2015.

[1] Postpartum hemorrhage (PPH) is defined as excessive vaginal bleeding (blood loss greater than 500 ml) within 24 hours of delivery.

Oxytocin product characteristics:

*Drug:*	Oxytocin
*Selected Indication:*	Prevention or treatment of postpartum hemorrhage (PPH)
*Formulation:*	Available in 1ml glass vials containing either 5 or 10 IU (international units) or in Uniject, a non-reusable, prefilled injection system. Both are administered by injection into a woman’s vein or muscle5
*Dose:*	10 IU for prevention of PPH and up to 40 IU for treatment
*Avg. Cost*:	roughly US$0.18 for 10 IU (supplier median price) 6,7

Initial Findings from Product Case Study Working Paper

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product. The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

	*Strengths*	*Challenges*
*Policy and Regulation*
*Global*	* Oxytocin is recommended by WHO as the first line treatment for active management of the third stage of labor (AMTSL) and to manage PPH, and is the most commonly used drug for this purpose.* It is included in WHO EML[1] for prevention and treatment of PPH.8	* Globally, more than half of women give birth at home, often without a skilled birth attendant. In most countries, skilled and unskilled birth attendants at the peripheral or community level have limited access to or are not authorized or trained to administer oxytocin.
*National, Regional*	* Oxytocin is registered in most of 31 countries studied.9 Additionally, oxytocin was included in national protocols for maternal health service provision as well as the Essential Medicines List and standard treatment guidelines in a majority of countries.	* While national policies to support the use of oxytocin may exist, these policies are often not universally or fully implemented for routine service delivery.* National standard treatment guidelines specify the level of health provider authorized to administer oxytocin and may restrict the most widely used birth attendants from providing the drug. Task-shifting outside of national guidelines occurs, nonetheless.
*Product specification & characteristics*	* Oxytocin is available in a pre-loaded and auto-disabled injection device, Uniject, which facilitates administration, appropriate dosing, and task-shifting.* Uniject packaging features a time-temperature indicator to indicate whether oxytocin is still active.* Oxytocin takes effect sooner than most other uterotonic drugs, including misoprostol.5	* Oxytocin is temperature sensitive and loses effectiveness after three months of being stored at temperatures higher than 30 degrees Celsius (86 degrees Fahrenheit). 5 The ambient temperature in tropical countries is often higher for extended periods of time. As such, cold chain storage is recommended, though national supply chains do not often ensure adequate cold storage where needed.* Oxytocin in the vial requires availability of injection supplies. The need for additional devices or supplies makes the treatment costs more expensive than the product cost alone.* The pre-loaded injectable device is not readily available in most countries.* Disposable devices require special consideration for appropriate waste management.
*Financing, Procurement & Supply*	* It is produced by more than 100 manufacturers globally.6,7* It is eligible for the WHO Prequalification of Medicines Program. To date, no manufacturers have qualified under this program for oxytocin, however.* In some countries, oxytocin is available for purchase in the private market at pharmacies and medicine shops.10* Secondary research suggests that there is current, ongoing donor support for the procurement of oxytocin11	* Oxytocin is often stored inappropriately outside of cold storage conditions.12* Countries often face challenges with accurately quantifying their need for oxytocin.* Unregistered and unapproved medicines are often widely accessible, and weak national regulatory authorities are unable to restrict their availability.* Broader recurring supply chain issues result from lack of policy enforcement; weak regulatory capacity; lack of adequate monitoring and supervision; poor quantification of needs; poorly designed or implemented logistics management information systems; weak infrastructure with low staffing at the district and facility level; and a limited pool of skilled human resources.* The source of funding available for oxytocin in many countries is unclear or unknown – an area that would benefit from greater study.
*Service Provision (Rational Use)*	* The pre-loaded and auto-disabled injection device, Uniject, provides greater ease of use for providers.	* Even in countries where appropriate guidelines are in place and oxytocin is found to be regularly available, timely and correct use continues to be a challenge. Knowledge of correct provision of oxytocin, inadequate staffing, poor quality and infrequent supervision, and inadequate training may contribute to inconsistent availability and use in some countries.9* Several countries report provider preference for less effective drugs.* Oxytocin in Uniject is not yet widely available.

Seligman, Barbara and Xingzhu Liu. Economic Assessment of Interventions for Reducing Postpartum Hemorrhage in Developing countries. Abt Associates Inc.; 2006. http://www.abtassociates.com/reports/EconReducPPHDevCo.pdf
Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Practice & Research Clinical Obstetrics and Gynaecology. 2008;22:999–1012.
World Health Organization (WHO). Maternal Mortality in 2005. Geneva: WHO; 2007.
USAID, JHPIEGO. Rapid Landscape Analysis of technologies for postpartum hemorrhage. Conducted by JHPIEGO/Accelovate for USAID at the Technologies for Health Consultative Meeting – MNCH Pathways. Unpublished. 2012.
PATH. Uterotonic Drugs for the Prevention and Treatment of Postpartum Hemorrhage [factsheet]. Available at: http://www.path.org/publications/files/MCHN_popphi_pph_fs_uterotonic.pdf. Seattle: PATH; 2008. Accessed February 7, 2012.
Management Sciences for Health (MSH), WHO. International Drug Price Indicator Guide. 2010 ed.; 2011.
DELIVER, Oxytocin Landscape.
WHO. WHO Model List of Essential Medicines (March 2011), 17th edition. Available at: http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf. Accessed March 26,2011
Fujioka A, Smith J. Prevention and Management of Postpartum Hemorrhage and Pre-Eclampsia/Eclampsia: National Programs in Selected USAID Program-Supported Countries. Maternal and Child Health Integrated Program (MCHIP); 2011. Available at: http://www.k4health.org/system/files/PPH_PEE%20Program%20Status%20Report.pdf. Accessed February 2012.
Koski A, Cofi, P. Perceptions, use and quality of uterotonic substances in Ghana. 2011; PATH Oxytocin Initiative.
USAID | DELIVER PROJECT, USAID Procurement Strategy: Oxytocin Market Assessment, unpublished data, 2011.
United Nations Population Fund (UNFPA), WHO. Joint UNFPA/WHO Mission in Collaboration with the Ministry of Health to Review the Current Status of Access to a Core Set of Critical, Life-saving Maternal/Reproductive Health Medicines in Mongolia. 2009. Available at: http://digicollection.org/hss/documents/s16325e/s16325e.pdf. Accessed February 2012.