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

3

• 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

4

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.

5

Challenges and solutions for large-scale implementation

6

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

7

Overcoming Political SensitivitiesGlobal Policies and Scientific Evidence

8

• 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

9

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

11

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

15

16

“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

17

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