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African Journal of Reproductive Health
Women's Health and Action Research Centre
ISSN: 1118-4841
Vol. 9, Num. 1, 2005, pp. 7-9
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Untitled Document
African Journal of Reproductive Health, Vol. 9, No. 1, April, 2005 pp.
7-9
Editorial
Misoprostol and Women's Health in Africa
Friday Okonofua1
1 Editor, African Journal of Reproductive Health
and Provost, College of Medical Sciences, University of Benin, Benin City,
Nigeria.
Code Number: rh05001
In March 2005, the World Health Organization (WHO) announced that it has included
misoprostol in its essential drug list as part of a regimen for the termination
of pregnancy in the first trimester of pregnancy. This welcome development
has important implications for the promotion of women's health worldwide and
for women in sub-Saharan Africa in particular. Available evidence indicates
that countries in sub-Saharan Africa have some of the highest rates of maternal
mortality in the world. Of the estimated 550,000 maternal deaths in the world
annually, 270,000 deaths (nearly 50%) are known to occur in African countries.
The WHO estimates that for every 100,000 live births in Africa, there are 1000
maternal deaths, compared with 276 for Asia, 190 for Latin America and 10 for
Europe.1 Indeed, one in 16 women is estimated to die in her reproductive
years from a pregnancy-related cause in many parts of Africa. These alarming
rates of maternal morbidity and mortality, which have shown no signs of abating,
call for concerted and realistic action to save mothers and newborns in the
region.
The results of several studies have shown that the leading causes of maternal
mortality in Africa are primary postpartum haemorrhage, unsafe abortion, prolonged
obstructed labour, puerperal sepsis and
eclampsia.2-4 For those who are familiar with obstetric practice in
these countries, it is clear that one of the most important
medical interventions that would significantly reduce the case
fatalities associated with these conditions is increased access to a safe and
effective uterotonic that is able to contract the uterus and evacuate its contents
in a rapid and efficient manner.
For years, the only available uterotonics for use in African
countries have been oxytocin and ergometrine. However, the use of these drugs
in Africa is limited by a number of factors. In the first place, they rapidly
deteriorate and lose their potency under the high temperatures in African countries,
unless they are stored in refrigerators which are not always available in these
countries. More than 50% of drug potency can be lost by improper storage of
these drugs in African countries. Secondly, both ergometrine and oxytocin need
to be given intravenously or intramuscularly, a condition that is difficult
to fulfil within the low-resource settings of many African countries. Thirdly,
and most importantly, these drugs are not always effective because of their
site of action. While they are good at stimulating uterine contractions, they
have little or no action on the cervix. This means that in conditions that
require cervical dilatation such as in second trimester induction of labour,
they will achieve uterine contractions without significant cervical dilatation,
with limited effectiveness and usefulness. By comparison, prostaglandins are
effective in inducing uterine contractions as well as dilating the cervix.
Many cases of unwarranted maternal deaths in Africa occur
because of lack of an effective drug to dilate the cervix during induced or
spontaneous labour or in cases of missed abortion requiring uterine evacuation.
When synthetic prostaglandins first became available, it was thought that these
would provide a solution, but they also rapidly went out of favour because
of their high cost which put them out of reach of many African countries. The
appearance
of misoprostol, a prostaglandin E1 analogue in the late 1980s as a
potent and cheap uterotonic was, therefore, received with great expectations
by women's health advocates in Africa.
Misoprostol has several advantages over other prostaglandins
on the market. These include the following: (1) being an E1 analogue,
it has no effect on the bronchi or blood vessels; (2) it is heat-stable and
can be stored for several years without the need for refrigeration; (3) it
is active orally, vaginally, sublingually and rectally; (4) it is cheap and
affordable; and (5) it has limited side effects. These characteristics have
made misoprostol ideally suitable for use in African countries, and strongly
positioned to contribute to reducing the high rate of maternal morbidity and
mortality in the region. Unfortunately, no clear efforts have yet been made
to promote the use of the drug in Africa.
The use of misoprostol in reproductive health has been extensively
studied in various parts of the world, and there is clear consensus of its
greater effectiveness compared to other uterotonics.5,6 Elsewhere,
there is now firm and incontrovertible evidence that misoprostol is highly
effective in labour induction at all trimesters of pregnancy and in the prevention
and treatment of post-partum haemorrhage. By contrast, only few clinical trials
of the use of misoprostol in sub-Saharan African countries are available, and
there has been little attempt to integrate its use into reproductive health
care in Africa.
The poor use of misoprostol in Africa compared to other parts
of the world is attributable to several reasons, the most important
of which is the lack of knowledge of the
drug by service providers, and health
policymakers. Many reproductive health service providers
in Africa have limited knowledge of the beneficial effects of the drug. The
situation is compounded by the fact that the drug has not been licensed
in many African countries for use in reproductive health. The drug was first
discovered and licensed for the treatment of gastroduodenal ulcers, and had
only been used off label
for reproductive health indications in many countries.
Consequently, drug inserts directing its use in reproductive health are often
not available, which limits the ability of clinicians in
developing countries to use the drug for this purpose.
To date, the manufacturer of misoprostol, Searle (now incorporated into Pfizer),
has failed to apply for licensing for any reproductive health indications despite
the well known benefits.
Furthermore, prior to March 2005, miso-prostol had not been
included in the essential drug list of the WHO. This meant that many African
countries, which rely heavily on the essential drug list of the WHO, did not
include misoprostol in their drug procurement and licensing policies. To date,
misoprostol is approved for use in reproductive health care in only four countries
in Africa, Tunisia, South Africa, Ghana and Uganda, with poor understanding
of the drug in the remaining countries in the region. The recent inclusion
of the drug in the WHO essential drug list means that the attention of policymakers
and drug regulators will now be drawn to the potential health benefits of the
drug, improving the understanding and use of the drug, particularly
in the countries in the region where it has yet to be licensed. This will allow
greater integration of the drug into health care delivery in these countries
and increase the awareness of women, service providers and other end users.
Apart from the likelihood of increased licensing of the drug in countries across
the world, the recent decision by the WHO will heighten the possibility
that countries will take steps to cover the
costs of the drug in their national public health
systems. This will increase the affordability, availability
and accessibility of the drug to women.
In sum, there can be no doubt that misoprostol is one of the
most important discoveries in reproductive health care in the last decade that
has considerable implications for reducing maternal mortality in low-income
countries. In view of the potentially beneficial effects of misoprostol in
reducing the high rates of maternal mortality in Africa, it is no longer morally
and ethically acceptable that women are denied the benefits of this drug.
Since the drug exclusively benefits women, the continued poor
availability and use of the drug disadvantages African women, and is a form
of social injustice. Women's equal access to the benefits of scientific progress
is a right protected by international human rights treaties, including the
African Charter on Human and Peoples' Rights.7 The denial
of information and service delivery options on misoprostol to African women
is a form of discrimination against women and violates their right to security,
which governments are obliged to remedy.
We conclude that there is a need for African countries to
take steps to license misoprostol and promote its increased use for reproductive
health care in their countries. Research must also be intensified to document
the use and benefits of misoprostol in improving women's health across African
countries and to determine how best to ensure women's fair access to its use.
The reduction of maternal mortality is a public health challenge
in Africa and one of the key indicators of the Millennium Development Goals
(MDGs), the achievement of which many African countries are currently devoting
considerable energy and resources. We believe
that increasing access to use of misoprostol
is one of the most important interventions that
can contribute to a decline in maternal mortality
and lead to the rapid achievement of one of the MDGs in sub-Saharan Africa.
The time to act
is now!
Acknowledgements
I am grateful to Professor Rebecca Cooke of the University
of Toronto, Canada for her useful comments and suggestions for improving the
initial draft of this manuscript.
References
- Hill K, AbouZhar C and Wardlaw T. Estimates of maternal
mortality for 1995. Bull WHO 2001; 79: 182-193.
- Daley I. Maternal mortality associated with hypertensive
disorders of pregnancy in Africa, Asia, Latin American and the Caribbean. Br
J Obstet Gynaecol 1992; 99: 547-553.
- Hickey MU and Kasonde JM. Maternal mortality at a University
Teaching Hospital. Med J Zambia 1977; 11: 74-78.
- Prevention of Maternal Mortality (PMM) Network. Barriers
to treatment of obstetric emergencies in rural communities of West Africa. Stud
Fam Plann 1992; 23(5): 279-290.
- Blanchard K, Clark S, Winikoff B, Kabani G and Shannon
C. Misoprostol for women's health: a review. Obstet Gynecol 2002;
99: 316-332.
- Weeks AD, Fiala C and Safan P. Misoprostol and the debate
over off-label use. Br J Obstet Gynaecol 2005; 112: 269-272.
- Cook RJ, Bernard M, Dickens BM and Fathalla MF. Human rights
principles. In: Reproductive Health and Human Rights - Integrating Medicine,
Ethics and Law. Oxford: Clarendon Press, 2003, pp 149-216.
© Women's Health and Action Research Centre 2005
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