Transcript Misoprostol Instructions for Use

Misoprostol:
A Life-Saving Technology
Jennifer Blum, MPH
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
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
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
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
Barriers to Use

No misoprostol product registered for either PPH or
PAC

Limited marketing of misoprostol by Phizer in subSaharan 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
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
Thank you!
Any questions?
Session 3 Brainstorm and voting
1. Speakers plot their technology on
2.
3.
4.
5.
6.
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.