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From: IRIN <[email protected]>
Date: Wed, Mar 16, 2011 at 1:34 PM
Subject: HEALTH: Experts seek WHO nod for postpartum haemorrhage drug
To: Jean-Francois Darcq <[email protected]>
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*HEALTH: Experts seek WHO nod for postpartum haemorrhage drug
<http://www.irinnews.org/report.aspx?reportid=92207>*
[image: lead photo]DAKAR, 16 March 2011 (IRIN) - A drug many health experts
say can drastically cut postpartum
haemorrhage<http://www.who.int/making_pregnancy_safer/documents/postpartum_haemorrhage/en/>-
the leading cause of maternal deaths in the developing world - will be
in
the spotlight this month during the World Health Organization's (WHO)
biennial review of its model list of essential
medicines<http://www.who.int/mediacentre/factsheets/fs325/en/index.html>.
Health groups are urging WHO to include misoprostol for the prevention and
management of postpartum haemorrhage (PPH), or excessive bleeding following
childbirth. WHO in 2009 denied misoprostol for prevention of PPH but
proponents hope new evidence presented for the 21-25 March WHO meeting
<http://www.who.int/selection_medicines/committees/expert/18/en/index.html>in
the Ghanaian capital Accra will bring a change.
An advantage of misoprostol for treating PPH in developing countries is that
it is stable at room temperature and can be administered in tablet form,
experts say. The primary drugs for PPH - oxytocin and ergometrine - need
refrigeration and are injected. While oxytocin is cheaper, misoprostol is
more cost-effective in many settings because of these other features, say
health experts in their application to
WHO<http://www.who.int/selection_medicines/committees/expert/18/applications/Misoprostol_prevention_application.pdf>
.
Such drugs - called oxytocics - cause the uterus to contract, speed up
delivery of the placenta and lessen blood loss.
"It is simply pragmatic - I am 100 percent in support of including
misoprostol among our means for preventing or treating PPH until we get a
better option," Lawal Oyeneyin, chief medical director at Mother and Child
Hospital, Akure, Ondo State, Nigeria, told IRIN. He is among several who
submitted letters of support.
PPH causes about a quarter of maternal deaths worldwide, according to WHO;
Oyeneyin said it is "without a doubt" the most common cause of maternal
death in Ondo State. "Why exclude misoprostol when the benefits outweigh the
risks?"
Médecins Sans Frontières also wrote in support of the drug. "Oral
misoprostol is a useful alternative for injectable oxytocics when they are
not available or ineffective," said MSF international medical coordinator
Myriam Henkens.
The essential medicines list (EML) is a guide for national and institutional
essential medicines, according to WHO. While governments are not bound to
follow it, the model list heavily influences national health ministries,
experts say.
*Side effects *
In rejecting the drug last time, WHO said some adverse effects were not well
understood; the agency says further study is needed into safety and
efficacy. It recommends
<http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/misoprostol/en/index.html>the
use of misoprostol in settings where it is not possible to use oxytocin or
another injectable uterotonic, but it was not put on the list because trials
had not proven efficacy; shivering and fever can occur, and "there is an
unresolved concern of a possible increase in the risk of maternal
mortality".
Five years ago Nigeria became the first country to include misoprostol for
PPH among its essential medicines. Some governments find it difficult to do
so because it is not on WHO's list, Oyeneyin said.
Listing misoprostol for PPH prevention "will break down this barrier",
proponents say in letters to WHO.
Anthony Smith, emeritus professor of clinical pharmacology at Calvary Mater
Hospital in New South Wales, has done several consultancies with WHO,
particularly in the Pacific Islands.
"While oxytocin and ergometrine appear to be modestly superior to
misoprostol in clinical trials, misoprostol is efficacious in its own right
and is stable under hot conditions. Until such time as dependable storage
exists for oxytocin and ergometrine, misoprostol will provide acceptable
treatment for the prevention and treatment of PPH in these remote, hot
locations," he said.
[image: '']*If we were ever to remove this drug from communities there
would be riots*[image: ''] Misoprostol is a generic product and has
several manufacturers. It was developed in the 1980s and approved in the US
for prevention of gastric ulcers but has been used since in obstetrics and
gynaecology. It is used in combination with mifepristone to terminate a
pregnancy. Some health workers warn about misuse.
*Community access *
Getting misoprostol on the EML would be a step forward but just one step,
according to proponents. They say the drug should be in the hands of
community health workers and pregnant women, not uniquely at medical
facilities. While having more women give birth in properly equipped clinics
with skilled medical staff is the ideal for mother and infant health,
experts say, this remains far from the reality for most women in rural
sub-Saharan Africa and Asia.
"Where I work [in Kaduna and Zaria states] more than 90 percent of births
take place at home; in Nigeria about two-thirds," said Clara Ejembi, from
the department of community medicine at Ahmadu Bello University, Zaria
State. In some cases home delivery is
preferred<http://www.plusnews.org/Report.aspx?ReportID=92142>- either
because of custom or the quality of health facilities.
Nigeria is now revising guidelines on misoprostol to add advice on community
use. Ghana, Senegal and Tanzania are also studying community access to
misoprostol. The US Agency for International Development (USAID), which
calls misoprostol "a highly promising technology that may be used by trained
health workers working outside facilities and even in remote areas", is
testing and introducing misoprostol in Afghanistan, Bangladesh, Nepal and
Senegal.
However, WHO has expressed concern
<http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/rhr_10_11/en/index.html>about
advanced community distribution of misoprostol. Matthews Mathai of WHO's
Making Pregnancy Safer programme told IRIN: "There is evidence that
incorrect dosing can lead to excessive and violent contractions of the
uterus leading to foetal distress, foetal death and uterine rupture."
Nigerian doctor Oyeneyin said the incorrect usage concern should not rule
out access. "Opponents are worried about the safety profile of misoprostol.
But the safety issue can be addressed through training.
"When you have a problem you should use all ammunition available to tackle
it - in this case, that's oxytocin, ergometrine and misoprostol," he said.
"It's ironic that the first two are on the model list of essential medicines
while misoprostol is not. Of the three, misoprostol is most likely to be
applicable in communities."
Godfrey Mbaruku, deputy director of Ifakara Health Institute in Dar es
Salaam, Tanzania, said misoprostol must not be seen as a panacea, as PPH is
not the only complication that can arise. "The idea is not to encourage
women to deliver at home," he told IRIN. "But this allows them to have the
drug on hand in case of PPH during a home delivery."
In northern Nigeria where home births prevail, research has shown that
distributing misoprostol in the communities is a viable approach, Ejembi
said. "Among community leaders acceptance is very high; people are ready to
use this and advocate it. WHO people should come and let me take them around
to the communities so they can hear the people's voices."
She said women in the communities where she works recognize the value of
misoprostol. "If we were ever to remove this drug from communities there
would be riots."
np/mw
Read report online <http://www.irinnews.org/report.aspx?reportid=92207>
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