Misoprostol for PPH: Overcoming Challenges
Alisha Graves, MPH
Senior Programs Manager
CORE Group Conference
Washington, DC
October 13-14, 2011
VSI’s approach
2November 30, 2010
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• Hormone-like substance• Uterotonic: Contracts the uterus, ripens
the cervix• Approved by the FDA in 1984 (Cytotec)
for the prevention of peptic ulcer during NSAID treatment
What is Misoprostol?
The case of misoprostol
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Misoprostol is capable of curbing maternal mortality due to postpartum hemorrhage & unsafe abortion
• Effective, evidence-based intervention• Heat-stable, low-cost, generic tablets • Simple to administer without skilled attendance
Ideal in low-resource settings & supported by international health organizations
Improving community-based drug provision
“Interpretation Community provision of misoprostol and antibiotics to reduce maternal deaths from post-partum haemorrhage and sepsis could be a highly effective addition to health-facility strengthening in Africa. Investigation of such interventions is urgently needed to establish the risks, benefits, and challenges of widespread implementation.”
Source: Pagel et al. Estimation of potential effects of improved community-based drug provision, to augment health-facility strengthening, on maternal mortality due to post-partum haemorrhage and sepsis in sub-Saharan Africa: an equity-effectiveness model. The Lancet, 2009.
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Challenges and solutions for large-scale implementation
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Challenge #1: Political sensitivity
Objections!– Abortion– promoting home births– inferior to oxytocin– working with TBAs
• Identify and support local experts and advocates
• scientific evidence & global policies support its use
• www.vsinnovations.org offers resources to help you prepare an advocacy toolkit
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Overcoming Political SensitivitiesGlobal Policies and Scientific Evidence
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• WHO added misoprostol to its Model Essential Medicines List for Treatment of Incomplete Abortion & PPH prevention (WHO, 2009; 2011)
• Misoprostol reduced PPH by half (RR=0.53), when compared to not using anything in community settings in India (Derman et al.Lancet, 2006)
• Community based distribution of misoprostol was found to be safe, effective and acceptable in both Afghanistan and Nepal (Sanghvi et al. IJGO, 2010; Rajbhandari et al. IJGO, 2010)
• A recent study from Bangladesh reported 81% protection against primary PPH when used in community settings (Hashima-E-Nasreen et al., Global Health Action 2011)
Challenge #2: Barriers to Access on a National Level
Institutionalization
• Registration
• Addition to national essential medicines list
• National guidelines and job aids
• Public procurement and distribution
• National curricula
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Global Misoprostol Registration by Indication
NEPAL
INDIA
TANZANIA & ZANZIBAR
NIGERIA
*Misoprostol may or may not be registered for gastric ulcers
Registered for postpartum hemorrhage (PPH) & treatment of incomplete abortion*
Registered for PPH and other ob/gyn indication*
Registered for PPH*
Registered for another ob/gyn indication, not PPH*
Registered for gastric ulcers only
BANGLADESH
ZAMBIA
UGANDA
SUDAN
GHANAKENYA
Last updated: August 2011
SOMALILAND
MOZAMBIQUE
PAKISTAN
SIERRA LEONE
MALAWI
ETHIOPIA
Challenge #3: Barriers to Access on a Local Level• Lack of trained providers
– Antenatal care distribution– Community health workers– Traditional birth attendants
• Rural environments– Public and private sectors, including pharmacists &
drug sellers– Local implementers– Social marketing– Demand generation
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Community Awareness Campaign on Birth Preparedness and PPH Prevention
Key messages:• Promote attendance at ANC
throughout pregnancy• Importance of delivering in a
health facility• Plan early for a safe delivery• PPH consequences & blood
loss measurement• Misoprostol is available at
ANC12
17 Feb 201013
17 Feb 2010
Other challenges (perceived & real!)
• Programming for prevention vs treatment
• Estimating blood loss
• Cost
• Safety, eg use for other indications
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“As men, we are the gravediggers in our communities. Since this project came, we have
not dug any graves for our women.”- Safe Motherhood Action Group member, Kapiri Mposhi, Zambia
“I had nightmares while I was pregnant because I feared bleeding. I am grateful for
misoprostol for protecting me.”- Mother with previous PPH, Hayin Ojo, Nigeria
“Thank you to those who have provided us with this drug. You
have given us pride.”- Antenatal care provider, Masaiti, Zambia
Thank You
Community mobilization involves the delivery of clear messages through
local groups
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Summary of Strategies for Community-based Distribution of Misoprostol
Treatment• TBA recognition of PPH and treatment with misoprostol
Prevention• ANC distribution
• HEWs trained in PPH management at health post and home births in collaboration with TBAs and other CHWs
• TBA distribution of misoprostol at delivery for PPH prevention
• Private sector
• Hybrid Models: ANC + TBA18
INDICATION REGIMEN
Postpartum hemorrhage prevention 600 mcg, oral
Postpartum hemorrhage treatment 1000 mcg, rectal800 mcg ,sublingual
Treatment of incomplete abortion & miscarriage
600 mcg, oral400 mcg, sublingual
Treatment of missed abortion 800 mcg, vaginal600 mcg, sublingual
Labor Induction(live fetus > 24 weeks)
25µg Vaginal (q 4 hrs, max 6 doses) , or50µg Oral (q 4 hrs, max 6 doses) , or
20µg Oral solution* (q 2 hrs, max 12 doses)
Intrauterine Fetal Death(13-17 weeks)(18-26 weeks)(27+ weeks)
200 mcg, vaginal (q 6 hours, max 4 doses)100 mcg, vaginal (q 6 hours, max 4 doses)
25-50 mcg vaginal (q 4 hours, max 6 doses)
Pregnancy termination (36-48 hours after 200 mg mifepristone) (<12 weeks)
800 mcg vaginal400 mcg oral
Pregnancy termination (alone) (<12 weeks)
800 mcg, vaginal (q 6,12 or 24 hours for 3 doses)
800 mcg, sublingual (q 3 hours for 3 doses)
Regimens for Misoprostol Indications