Misoprostol: A Life-Saving Technology

1. Misoprostol: A Life-Saving Technology Jennifer Blum, MPH

2. Setting the Stage • Misoprostol is an orally administered prostaglandin • It is inexpensive (< $0.35), off-patent, easy to store (cold chain not needed), easy to administer/“no touch” & widely available • Can use for a range of RH conditions • Both new and generic products: New products for abortion in France/EU & labor induction in Egypt & Brazil. Generics now in India, China, Egypt, Vietnam and Korea among others… • Can be given at all levels of health care system; by mid & low level providers • Where there high medical personnel turnover, misoprostol can be quickly learned and safely used • Added to WHO Model List of Essential Drugs for medical abortion with mifepristone and also for labor induction (at 25 mcg) • Not listed for PPH indication – no product registered for this indication so none for WHO to review

3. Recommended Regimens PPH Prevention Recommended dose/route: Single dose of 600 mcg orally to be swallowed after delivery of the baby PPH Treatment Recommended dose/route: Limited data available on specific dose and route for PPH treatment at this time • Data available June 2008 suggest 800 mcg sublingually for primary PPH • Studies ongoing of 600 mcg sublingually as adjunct PPH treatment Incomplete Abortion (PAC) Dose/Route: In women with uterine size ≥12 wks LMP at presentation for care with open cervical os, a single dose of either 600 mcg orally or 400 mcg sublingually

4. Misoprostol for PPH Prevention: WHO Recommendations • If AMTSL and skilled attendant, oxytocin (10 IU IM) is preferred over oral misoprostol (600 mcg) and ergometrine for PPH prevention • If no AMTSL, a uterotonic drug (oxytocin or misoprostol) should be offered by a health worker trained in its use for prevention of PPH

5. Possible Inclusion in Crises Settings • Misoprostol can be included in Interagency Emergency Health Kit or Interagency RH Kits for both PPH and PAC services • Misoprostol should be added to Core Package of RH Interventions recommended by IAWG • No data from web survey on evidence of misoprostol use for RH in relief settings – antidotal evidence suggests that use is ad hoc and on provider basis

6. Barriers to Use • No misoprostol product registered for either PPH or PAC • Limited marketing of misoprostol by Phizer in sub-Saharan Africa; limited formal distribution as well • Several countries have now “approved use” of misoprostol for PPH, e.g. India, Nigeria… • In many places, providers are not allowed to procure or use a drug for an “off-label” indication • No operations research studies, yet, to show potential use and create model of use of misoprostol in relief settings

7. Potential Benefits for Use in Relief Settings • Could reduce maternal morbidity and mortality associated with PPH prevention and treatment of unsafe abortion • Will empower women and providers by giving them a treatment option not previously available • Health care systems will benefit – doctors workloads and the cost of surgical care, IV infusions and referrals will be reduced

8. Thank you! Any questions?

9. Session 3 Brainstorm and voting • Speakers plot their technology on continuum. • Assemble in 3 groups by row. • Each group identify 1 technology currently in an RH kit but still underutilized. • Each group identify 1-2 technologies NOT currently in a kit but needed. • Each group presents and plots their technologies on the continuum. • Each participant has 3 votes to prioritize technologies identified on the continuum during coffee and tea break.