Misoprostol for PAC

Task Force Presentations

PAC Consortium Meeting

May 26, 2009

Why do we care? Abortion and complications of incomplete

abortion are among the largest contributors to maternal morbidity and mortality in low resource countries

Misoprostol works, is less invasive than surgery and quicker than expectant management

In many places, safe surgical care and surgical equipment still not widely available

Misoprostol for PAC

Where we’ve come from :

• Little known about misoprostol; no evidence-based regimen

• Concerns about “mis” or incorrect use

Misoprostol for PAC

What we’ve accomplished so far:• Established evidence-based regimens

• Incorporation in country PNPs

• Misoprostol added as PAC Technology PAC Consortium• Consensus document published in IJGO –Dec 07• Instructions for Use - 8 languages• ACOG statement – Feb 09• Introductory Guidebook - May 09• Misoprostol listed in WHO EDL for incomplete abortion

indication!! – April 09

Gynuity’s Recent Studies

Country Groups N Efficacy^

600 mcg oral misoprostol vs. surgery

Dao et al 2007 (Burkina Faso)

misoprostol vs. MVA 460 94.5% vs 99.1%

Bique et al 2007 (Mozambique)

misoprostol vs. MVA 100 91 % vs. 100.0%

Shwekerela et al 2007Tanzania

misoprostol vs. MVA 300 99 % vs. 100.0%

Ghana misoprostol vs. MVA 220 99% vs.99.1%

India misoprostol vs. D&C 122 97% vs.100%

400 mcg sublingual vs. 600 mcg oral misoprostol

Moldova/Madagascar

sublingual misoprostoloral misoprostol

300 94.5% vs. 94.6%

400 mcg sublingual misoprostol vs. surgery (D&C or MVA)

Ecuador/Venezuela misoprostol vs. surgery 280 94% vs. 100%

Egypt misoprostol vs. surgery 700 >96% vs. 99%

Mauritania/Niger misoprostol vs. surgery 400 >96% vs. 100%

Instructions for Use: Miso for PAC

Purpose: Guidance for clinicians/medical personnel Dissemination via fact sheets, clinical

training, websites, inclusion in scientific articles, etc.

Content: Shadows a standard product label for use

of misoprostol for incomplete abortion and miscarriage

Instructions for Use: Indication and usage

Misoprostol is indicated for treatment of incomplete abortion and miscarriage for women with uterine size less than or equal to 12 weeks LMP at presentation

For incomplete abortion:– 600 mcg orally or 400 mcg sublingually

For missed abortion:– 800 mcg vaginally (efficacy: 60-93%)

Introductory Guidebook

Based on current scientific evidence, the guidebook offers detailed information on:

• Efficacy, safety and acceptability;• Eligibility criteria and precautions;• Dosing, timing and routes of administration;• Visit schedule and management of complications;• Counseling and information provision;• Integration of misoprostol into existing PAC

services.

ACOG Committee Opinion

Drafted by expert committee

• Summarizes situation of PAC as well as current literature

• Makes protocol recommendations based on many GHP studies.

WHO Essential Medicines List

What is the EML:

• The Model EML serves as a guide for the dev’t of national and institutional lists and has led to a global acceptance of the concept of essential medicines as a means to promote health equity.

• Basis for medicines selection in emergency

situations, guiding the responses of humanitarian assistance agencies to country requests for assistance in acute emergency settings.

WHO Essential Medicines List

• Application submitted to the WHO by GHP. • Approval for inclusion of misoprostol for incomplete

abortion indication - April 2009.

With respect to use of misoprostol for the treatment of incomplete abortion, the Committee decided that the evidence showed that misoprostol is as effective as surgery and in some settings may be safer as well as cheaper and therefore recommended inclusion of the 200 micrograms tablet on the complementary list with a note indicating the appropriate use; * for management of incomplete abortion and miscarriage.

Essential Medicines WHO Model List

Misoprostol for PAC

What more needs to be done:

• Efforts towards a registered labeled product for txt of incomplete abortion

• More evidence/experience needed from OR-type studies on use

• At lower levels of health care system• By non – physician providers• As first- line treatment

• Qualitative research• Other?