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Misoprostol

Product Profile

Misoprostol

Potential Lives Saved/Year:

If uterotonic medicines, including misoprostol, 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


>> Read the full case study (PDF)

 

Problem and Proposed Intervention


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 misoprostol, 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 misoprostol, 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 misoprostol is primarily used for home deliveries – approximately 50% of births globally).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.

                                                                 

Misoprostol product characteristics:

Drug:

Misoprostol

Selected Indication:

In low-resource settings where oxytocin and a skilled birth attendant may not be available, misoprostol may be used to prevent and treat postpartum hemorrhage (PPH).5

Formulation:

Oral (sublingual) tablet form.  Tablets contain 25 (for induction), 100, or 200 micrograms.

Dose:

WHO recommends 600 micrograms orally for the prevention of PPH, and permits 800 micrograms sublingually as the third line treatment for PPH.

Avg. Cost:

Approximately US$0.15/tablet6: 3 tablets of 200 µ for PPH prevention and 4 tablets of 200µ for PPH treatment.




Read more below.



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

* Misoprostol is included in the WHO EML[1] for several obstetric and gynecological uses including “for prevention of postpartum hemorrhage where oxytocin is not available or cannot be safely used.”7

* Guidance is provided for the use of misoprostol in the WHO Recommendations for the Prevention of Postpartum Hemorrhage, the international model for standard national treatment protocols and guidelines.8

*   Updated WHO Recommendations for the Prevention of Postpartum Hemorrhage guidance, if approved, will allow a community health worker, trained in its use, to distribute misoprostol (new recommendations do not include self-administration).

* Treatment for PPH with misoprostol is not included in the WHO EML as an appropriate indication.

* The WHO Recommendations for the Prevention of Postpartum Hemorrhage guidance assumes the presence of a trained health worker to administer the medicine, the medicine is used after childbirth for PPH, and that 600 micrograms of misoprostol is administered. In low-resource settings, these conditions are not often met.

* In previous publications, the WHO has not supported distribution of misoprostol to women either through prenatal care (for self-administration) or by community health workers.

 

National, Regional

* Some countries are piloting misoprostol distribution to women at the community level by Community Health Workers and a few are expanding its use nationally.

* Many countries have national treatment policies that include misoprostol for PPH.  67% of the 12 countries piloting distribution of misoprostol for PPH during home births and 75% of the 6 countries scaling up misoprostol for home birth use report having a national policy in place approving it for prevention of PPH.9

 

* Misoprostol is on national EMLs in 61% of 31 countries surveyed, although approved uses do not consistently include PPH prevention or treatment.

* The promotion and use of misoprostol is often hotly debated, given concern for potential off-label use for abortion.

* While national policies to support the use of misoprostol may exist, these policies are often not implemented during routine service delivery.

* National standard treatment guidelines may specify which trained health providers are authorized to administer misoprostol and at which facilities.  Task-shifting occurs, nonetheless.

 

 

Product specification & characteristics

* It is in tablet form and does not require cold chain storage.

* Its tablet form means fewer limitations on which cadre of health provider can prescribe (as opposed to injections).

* Misoprostol is slower to take effect than oxytocin.

* Manufacturers do not systematically package

misoprostol in the recommended double aluminum package.

Financing, Procurement & Supply

* There are many suppliers.  The product is available from more than 50 manufacturers globally (with at least 35 in developing countries).

* It is eligible for the WHO Prequalification of Medicines Program.  To date no manufacturers’ medicine has qualified under this program.

* In some countries, misoprostol is available for purchase in the private market at pharmacies and medicine shops.10

* A study assessing the global availability of misoprostol showed there was an improvement in availability in some low-income regions. 6

 

* Few manufacturers produce a three-pill blister pack equaling 600 micrograms (the dosing regimen for PPH prevention), creating procurement challenges.

* Manufacturers achieve economies of scale and profits from larger production runs (100,000 to 200,000 tablets) which are often too large for national procurement requirements. Splitting batches between countries can be complicated.11

* A quality study concluded that not only were there significant problems with the content and purity of

many misoprostol products, but that the degradation of some of the medicines would not have been detected by pre-shipment quality control measures.12

* A recent survey of 31 countries found that the majority of countries did not procure misoprostol, and therefore, it is often not available in public sector health facilities.9

* The source of funding available for misoprostol in many countries is unclear or unknown.

* 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.  There will be additional supply chain issues if it is used at the community level.  The “last mile” of the supply chain is usually the most difficult to reach.

Service Provision (Rational Use)

* Misoprostol for PPH may be ideal for use in home births and in health centers where mid- and low-level providers may find administration of an oral tablet easier and more compatible to their work environment.

* A rapid assessment in four African countries identified that providers, pharmacists, and even product manufacturers are largely ignorant of misoprostol’s use and dosing to prevent PPH.13

* Even when national policies support the use of misoprostol, policies are often not implemented during routine service delivery, indicating the need for greater training on provision and strengthened referral mechanisms.





[1]  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

[2] 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.

[3]  World Health Organization (WHO). Maternal Mortality in 2005. Geneva: WHO; 2007.

[4]   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.

[5]  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.

[6] Fernandez MM, Coeytaux F, de León RG, Harrison DL. Assessing the global availability of misoprostol. The International Journal of Gynecology & Obstetrics. May 2009; 105(2):180–186.

[7] 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

[8] WHO. WHO Recommendations for the Prevention of Postpartum Haemorrhage. Geneva, WHO; 2007. Available at: http://whqlibdoc.who.int/hq/2007/WHO_MPS_07.06_eng.pdf.

[9] 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.

[10] Koski A, Cofi, P. Perceptions, use and quality of uterotonic substances in Ghana. 2011; PATH Oxytocin Initiative.  

[11] Venture Strategies Innovation (VSI). Registration Status of Misoprostol in Countries Where VSI Operates. VSI; 2012.

[12]  Hall P. What Do We Know About the Quality of Misoprostol Products? Washington, DC: Concept Foundation; 2012.

[13] Strengthening Health Outcomes Through the Private Sector (SHOPS). Rapid Assessment of Availability of Essential Medicines for Maternal Health in Private Sector Markets in Ghana, Kenya, South Africa, and Bangladesh. SHOPS Project; 2011.