Download Medical abortion - Implications for Africa

Medical Abortion Implications for Africa
Ipas
Ipas is an international nongovernmental organization that has worked for three decades to reduce
abortion-related deaths and injuries; increase women's ability to exercise their sexual and reproductive rights;
and improve access to reproductive-health services, including safe abortion care. Ipas's global and country
programs include training, research, advocacy, distribution of reproductive health technologies and
information dissemination.
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Ipas. 2003. Medical abortion - Implications for Africa.
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Medical Abortion – Implications for Africa
INTRODUCTION
Medical abortion is a new technology that can help eliminate the gaps in the continuum of safe and
available abortion services in Africa. Women in almost every culture have historically experimented
with drinking or swallowing various medicinal agents (teas of roots and herbs) to “bring down their
period” or to abort an unwanted pregnancy. In Africa, a modern (and very harmful) version of this
has been the ingestion of high doses of chloroquine or the drinking of bleach and other caustic
products to try to terminate an unwanted pregnancy.
Over the last two decades, scientists and providers have identified and refined the use of several
drugs that, when used correctly, can effectively and safely cause abortions. The use of these “medical
methods” to induce abortion is becoming more popular around the world, even in places where
abortion is legally restricted. The introduction of medical methods of abortion can:
• Increase access to safe abortion services by providing care in a wider range of health-care
settings
• Decrease the morbidity and mortality associated with unsafely performed abortions
• Enhance women’s options and give them more control over the procedure, and
• Improve service providers’ ability to meet individual women’s needs and preferences.
Medical abortion holds particular promise for Africa where access to reproductive health services is
very poor and where abortion-related morbidity and mortality are high. 1 Despite a lower level of
unintended pregnancies, women in Africa suffer the highest risk of abortion-related deaths in the
world.2 This is a direct consequence of the poor conditions of reproductive health services in the
region. Given this situation, African women stand to greatly benefit from medical abortion, a new
technology that, by significantly increasing their access to safe abortion services, could save their lives
and improve their health.
1
Global Health Council. 2002. Promises to Keep: The Toll of Unintended Pregnancies on Women’s Lives in the Developing World.
GHC, Washington.
2
Women in Africa have a 4 times greater risk than women in Asia of an abortion-related death and a 650 times greater risk than
women in North America. Ibid.
1
WHAT IS MEDICAL ABORTION?
Medical abortion (sometimes referred to as the abortion pill) terminates a pregnancy through the use
of medicines. An alternative method to surgical abortion and vacuum aspiration, it does not require
the insertion of any instruments into the uterus, thus reducing the risk of infection and other
complications such as the tearing of the uterus. Several drugs can be used for medical abortion; the
most commonly used and most effective regimen is the combination of mifepristone and
misoprostol.
Mifepristone (RU-486)
Mifepristone was the first drug to be developed for the termination of pregnancy. Introduced in
France in 1988 by Roussel Uclaf (thus the RU in RU-486) it is now the most commonly used
abortion method in France. For many years, one small French company, Exelgyn, held exclusive
rights to mifepristone for manufacturing and distribution anywhere in the world (with the exception
of the US where the Population Council holds the rights). Exelgyn’s worldwide patent for the drug is
now expired; their current patent covers the sale and distribution in France only. China manufactures
mifepristone and is making it available to surrounding Asian countries. Mifepristone is also being
marketed by three pharmaceutical companies in India. As of January 2003, mifepristone is registered
in Azerbaijan, the European Union (with the exception of Italy, Ireland, and Portugal), Georgia,
Norway, Switzerland, India, Israel, New Zealand, Russia, South Africa, Taiwan, Tunisia, the Ukraine,
the United States, Uzbekistan and Vietnam. Mifepristone was approved for use in the Republic of
South Africa and Tunisia in 2001 and is now being used in both countries for abortions.
Mifepristone is used in combination with a second drug – misoprostol. Mifepristone inhibits the
effect of progesterone, a hormone required to sustain a pregnancy. Without the progesterone, the
pregnancy detaches from the lining of the uterus. The second drug, misoprostol, taken two days after
the mifepristone, causes dilation of the cervix and contractions of the uterus, expelling the pregnancy
tissue.
Studies are still ongoing to determine the most effective, most acceptable and most convenient
regimen for mifepristone use in early pregnancy. Regimens differ in several ways:
• how late in the pregnancy they can be used (ranging between 7 weeks and 9 w eeks following the
last monthly period);
• the doses of the drugs;
• the mode of administration of the misoprostol (taken by mouth or inserted in the vagina);
• where the women takes the second drug (at home or in a provider’s office).
The registered regimens in most countries are based on the first one approved in France. However,
alternative regimens are being studied (and several have been approved by various governments) to
decrease side effects, make it more convenient for women, simplify the administration, and reduce
costs. Today, among the most commonly used regimen is to have the woman swallow 200 mg of
mifepristone during the first visit to the provider followed 2 days later by 400 mcg orally of
misoprostol. Allowing the home use of the second medicine, misoprostol, significantly increases the
ease of use and reduces the costs associated with medical abortion. This is particularly true for rural
and under-served areas, characteristic of Africa. The approved regimen in the Republic of South
Africa allows for home use of misoprostol and the government of Tunisia is exploring the use of
misoprostol at home. In a recent study, over 80% of the Tunisian women given a choice, opted to
take the misoprostol at home.
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Misoprostol
In many countries where mifepristone is not available, misoprostol is being used alone to induce
abortion. Marketed as “Cytotec” for the treatment of ulcers, it is an inexpensive drug available in
more than 80 countries. Widespread recognition of misoprostol's abortive properties began in Brazil,
where, in the late 1980s, women began using the medicine to self induce abortions. Women would
swallow the pills and seek treatment if the bleeding did not stop on its own. This practice became so
prevalent that health providers were able to document the impact on both the health of women and
the use of medical services.
The self-medicating use of misorprostol by Brazilian women resulted in a significant decrease in
complications of unsafe abortion. This was because the ingestion of the misoprostol replaced more
dangerous methods that involved inserting instruments in the uterus under non-sterile conditions.
While the number of women going to hospitals with bleeding due to incomplete abortions increased
significantly, they were much less likely to have an infection than the women who had used other
means of inducing their abortion. 3
Because the use of misoprostol alone has largely been covert, by women who are self-medicating or
providers operating in countries where abortion is illegal, there is a lack of clear guidelines for correct
usage. The doses used vary enormously, often exceeding the appropriate dose significantly and thus
exposing women to unnecessary levels of the drug. Studies are now underway to determine the best
regimen for using misoprostol alone to induce abortion. Ongoing clinical studies are investigating
800 micrograms taken vaginally, repeated in 24 hours for a total of 1600 micrograms4
Research is also underway to study the many other gynecological and obstetric uses of the drug.5 In
the Republic of South Africa, it is now routinely used from 2-3 hours prior to surgical abortion in a
dose of 400 mcg to help soften the cervix. It also looks particularly promising for the treatment of
post-partum hemorrhage.
Note: A third drug, methotrexate, has also been used to induce abortions. It has, however, been
found to cause birth defects in continuing pregnancies and so has not been endorsed by the World
Health Organization for use for voluntary pregnancy termination. 6 Its use was limited to the United
States during the early 1990s but once mifepristone became available most providers stopped using
methotrexate because of its side effects. Commonly used to treat cancers, methotrexate is also used
to treat ectopic pregnancies (pregnancies in which the egg implants in the fallopian tubes as opposed
to the uterus).
Vacuum Aspiration
In approximately 5 out of 100 abortions performed using the mifepristone and misoprostol
combination (and more when using misoprostol alone), the medicines will not successfully terminate
the pregnancy. In these cases, a vacuum aspiration must be performed to complete the abortion.
Because of the possibility that the drugs used in medical abortion could cause birth defects, it is
important that all medical abortions that are not successful be completed with vacuum aspiration.
3
Amy E. Pollack & Rachael Pine, Opening a Door to Safe Abortion: International Perspective on Medical Abortifacient Use, in
JAMWA Vol. 55, No.3, Supplement 2000.
4
Unpublished data, Population Council, 2003.
5
Blanchard et al., Misoprostol for Women’s Health, in Obstetrics and Gynecology Vol. 99, No.2, February 2002.
6
UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research T raining in Human Reproduction.
1997. Methotrexate for the termination of early pregnancy: a toxicology review. Reproductive Health Matters 9:162-166.
3
Heavy bleeding can also occur after medical abortion and the management of the bleeding is one of
the most common issues for clinicians and staff. 7 Vacuum aspiration, manual (MVA) or electric, is
the most appropriate method for the treatment of incomplete medical abortion. MVA is a simple
method that can be used by trained clinicians in a variety of settings. It can also be the initial method
for early abortion as well as the treatment for incomplete spontaneous abortion (miscarriage).8
COMMONLY ASKED QUESTIONS
When in pregnancy is medical abortion possible?
Medical abortion is recommended only in early pregnancy. It can be done as soon as the pregnancy
is confirmed, up to 7-8 weeks gestation (49-56 days after the last menstrual period). If the
misoprostol is used vaginally, the regimen is effective up to 63 days after the last menstrual period.
The earlier in the pregnancy the drugs are taken, the more effective the medicines. Thus, a woman
must confirm a pregnancy as soon as possible if she wants to consider medical abortion. In most
countries, including France and the United States, medical abortion is approved for use only up to 7
weeks (49 days) of gestation. But in several countries providers are making mifepristone available
through the 8th week (Tunisia) and 9th weeks (United States). In the Republic of South Africa
mifepristone was approved for up to 8 weeks (56 days).
How effective is medical abortion?
The most effective method is the combination of mifepristone and misoprostol. When used
together correctly this method is about 95-97% effective. This means that 95-97 out of 100 women
who take the medications will have a complete abortion with no further medical treatment. In the 3
out of 100 cases in which the abortion is not complete, a vacuum aspiration is required to complete
the process.
The efficacy of misoprostol alone has yet to be fully documented because the use of this drug for
abortion purposes has largely been covert by women in countries where abortion is legally restricted
(and because the combined regimen is better). To date there have been few clinical trials to test
dosages or efficacy of misoprostol used alone. But recent data from a growing number of providers
in several Latin American countries indicate that misoprostol alone could prove to be up to 85%90% effective. 9
How long does the process take?
Medical abortion involves several steps. When using mifepristone and misoprostol, the first step
takes place in a doctor’s office where the pregnancy is confirmed and the options are discussed. The
woman swallows the first medication (mifepristone) and goes home. One to three days later,
depending on the protocol, the woman either takes the second medicine (misoprostol) at home or
returns to the clinic to take it. The abortion (the passing of the contents of the uterus) usually takes
place within 4 hours after taking the second medication. It can, however, take 24 hours or longer
(women can bleed for several weeks). Women are usually asked to return for a follow -up visit, one
to two weeks after the first visit (depending on the protocol) to be examined in order to make sure
that the pregnancy was successfully terminated. Because of the risk of birth defects (although low) it
is important to make sure the pregnancy was actually terminated and to follow -up with vacuum
7
Stewart FH, Wells ES, Flinn SK, Weitz TA. Early Medical Abortion: Issues for Practice. UCSF Center for Reproductive Health
Research & Policy: SF, Calif (2001).
8
Blumenthal PD, Remsburg RE. A time and cost analysis of the management of incomplete abortion with manual vacuum aspiration.
International Journal of Gynecology and Obstetrics 45(3):261-67 (1994).
9
S. Clark et al., Misoprostol use in obstetrics and gynecology in Brazil, Jamaica, and the United States, in International Journal of
Gynecology & Obstetrics 76 (2002) 65-74.
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aspiration if not. It is also possible there could be an undiagnosed ectopic pregnancy which would
require appropriate treatment.
How long the process takes when misoprostol is used alone is still under study. Because much of the
use of misoprostol has been covert and often self-administered, little data exists on appropriate
doses, efficacy or duration of the process. 10
What is the bleeding like and how long will it last?
The amount and length of bleeding after a medical abortion differs for each woman. The further
along the pregnancy is, the more bleeding. When taking mifepristone and misoprostol, there is
usually more bleeding and cramping than during a heavy period. Women typically report some
amount of bleeding for up to 13 days after taking the drugs. 11 The bleeding may be heavier and the
cramping more severe when misoprostol is used alone.
What are the side effects of medical abortion?
Vaginal bleeding and cramping are expected effects of medical abortion and show that the drugs are
working. Common side effects are nausea, vomiting, and diarrhea. Some women also experience
headaches, dizziness, and fever or chills. Using pain relievers and/or anti-nausea medications can also
help reduce some of these effects.
There are no clear instructions about how to use misoprostol alone, therefore women who selfadminister the drug run the risk of either taking too much misoprostol and thus experiencing severe
side-effects, or too little, resulting in incomplete abortion or on-going pregnancies. Clear guidelines
would help ensure safe use of this widely available drug.
How safe is it?
Medical abortion is extremely safe. The drugs used in medical abortion have been widely studied and
are approved for use in many countries including most of Europe, the United States and China.
Millions of women from many parts of the world have used medical abortion safely for more than 10
years. Complications are rare. Prolonged or heavy bleeding is the most common complication,
occurring in about 1 in 100 women who have used the combination of mifepristone and misoprostol.
A vacuum aspiration will stop the bleeding. Bleeding heavy enough to require blood transfusion is
extremely rare but can happen, especially if there is a delay in seeking care. Infection is possible but
is less common with medical abortion than with abortion procedures that require inserting
instruments into the uterus.
The biggest safety concern is the possibility that the drugs used in medical abortion could cause birth
defects should a pregnancy continue after a woman has taken the drugs. For this reason, once a
medical abortion has been started, it must be completed.
What is the difference between medical abortion and emergency contraception?
Emergency contraception is a safe, effective birth control method that can prevent pregnancy after
unprotected sex or contraceptive failure. The most common form is emergency contraception pills
(ECPs). (In Africa the most widely available product is Postinor). Emergency contraceptive pills act
to prevent pregnancy in the same ways that oral contraceptive pills do: by delaying or blocking
ovulation, or inhibiting fertilization. To be effective, the pills should be taken within 72 hours of
intercourse. ECPs cannot be taken to terminate a pregnancy as they have no effect if a woman is
already pregnant.
10
Ibid.
Stewart FH, Wells ES, Flinn SK, Weitz TA. Early Medical Abortion: Issues for Practice. UCSF Center for Reproductive Health
Research & Policy: SF, Calif (2001).
11
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STATUS OF MEDICAL ABORTION IN AFRICA
It is likely that use of medical abortion in Africa will increase over the next decade. Tunisia and the
Republic of South Africa (RSA), countries where abortion is legal, approved the use of mifepristone
and misoprostol for medical abortion in 2001, providing the opportunity for broader use in other
African countries. More and more women in these countries are choosing medical abortion over
surgical abortion and both countries are pioneering the home use of misoprostol after mifepristone.
In fact, South Africa was the first country in the world to adopt home use of misoprostol in its label.
The approval of this regimen and the successful implementation of home use by the two countries
could motivate other countries, especially those with poor health-care infrastructure, to follow suit.
The use of medical abortion in other countries where abortion is legally restricted and/or where the
drugs are not available is more complicated. Experience in other regions of the world shows that
when the drugs are available and affordable in the marketplace (as is misoprostol in many countries)
informal use can spread quickly. The experience in Brazil of women self-administering misoprostol
has shown that widespread use of medical abortion can be safer than other methods they might use
to induce an abortion. In addition, where women have become familiar with medical abortion and
know of its availability, they begin to seek care at an earlier gestational age. 12 However, confusion
reigns regarding how much of the drug to take and how often. Because of the lack of clear guidelines,
the doses the women use vary enormously, often exceeding the appropriate dose significantly and
thus exposing women to unnecessary levels of the drug.
Advocates wishing to introduce medical abortion in Africa face two major challenges: access to the
drugs and the fact that most countries legally restrict abortion. The availability of the drugs in the
region is very unreliable. Mifepristone and misoprostol are currently registered for use in only two
countries – South Africa and Tunisia (misoprostol is also registered in Ghana.) However, anecdotal
information tells us that misoprostol has now reached many more providers and women. For
example, in Uganda, it is being imported for use at Mulago Hospital, and in Mozambique,
misoprostol is widely used to induce abortions. Moreover, Africa is a very lucrative market for the
Indian pharmaceutical companies. Given that there are now at least three Indian companies
producing a generic mifepristone, the drug is likely to be widely available in much of Africa soon.
A perhaps bigger challenge is the fact that abortion is legally restricted in all but three countries in the
region: South Africa, Tunisia and Zambia. While abortion is legal in Zambia, the restrictions in the
law – the fact that three physicians must approve the procedure – pose severe constraints on access
to abortion services. Legal restrictions on abortion make advocacy, information dissemination, and
public education regarding medical abortion difficult. In addition, in those countries where the drugs
have not been officially registered, it is not easy to develop guidelines for the use of the drugs or to
train providers in their proper use. Given these challenges, a concerted and coordinated advocacy
effort will be required to make these new reproductive technologies a reality for women in Africa.
STRATEGIES FOR ACTION
Historically, the introduction of medical abortion has been fraught with political challenges. In
France, only one year after it was introduced, the company that pioneered RU 486 (mifepristone),
withdrew the drug from the market for fear of anti-abortion politics. Health providers and women’s
rights advocates from all over the world responded with a an international petition which prompted
the French Minister of Health to order Roussel to retract its decision to withdraw the product, calling
it “the moral property of women, not just the property of the drug company.” In the United States,
12
Grimes DA, Medical abortion in early pregnancy: a review of the evidence. Obstetrics & Gynecology, 1997, 89(5)790-796.
6
advocacy groups had to lobby, fight, and wait almost a decade before having mifepristone available
for public introduction. China moved ahead by producing their own version of both the mifepristone
and the misoprostol. And women’s advocacy groups in Brazil continue to fight to secure access to
misoprostol while providers and researchers carry out clinical trials to try to answer questions about
dosage, how to reduce side-effects, and to determine the efficacy of using misoprostol alone to
induce abortions.
Experience with medical abortion in the other regions of the world provides several lessons for
Africa: 1) medical abortion will not come without a fight, 2) women’s health advocates have a critical
role to play, and 3) it will take time. African health-care providers, women’s health advocates and
policymakers will need to work together to bring this greatly needed technology to women in their
countries. Strategies for action include:
If you are a women’s advocacy group you can:
• Serve as a source of information about medical abortion
• Advocate for access to safe abortion, including medical abortion
• Facilitate information sharing and networking among groups working to expand access to safe
abortion
• Join the newly formed International Consortium for Medical Abortion
If you are a provider, you can:
• Demand access to the various drugs
• Participate in clinical trials of the drugs
• Adapt and work to institutionalize guidelines, protocols and training curricula
• Support women’s choice of abortion method
• Facilitate the research and information sharing
If you are a policymaker, you can:
• Advocate incorporation of medical abortion into health systems
• Support the registration of the drugs in your country
• Address the need for improved reproductive-health services, including medical abortion
Working together, women’s groups, health-care providers and policymakers can make progress
towards ensuring that African women have access to medical abortion and the optimum care they
deserve.
ADDITIONAL RESOURCES
Websites that provide information about medical abortion:
www.earlyoptionpill.com
www.ipas.org
http://reprohealth.ucsf.edu
www.crlp.org
www.naral.org
7
www.ppnyc.org
www.plannedparenthood.org
www.popcouncil.org
www.rhtp.org
www.misoprostol.org
ACKNOWLEDGMENTS - This document was prepared by Francine Coeytaux, MPH, with input
from Leila Hessini, MPH, Philip Mwalali, MD, Sarah Onyango, MD. Our thanks to the following
external reviewers: Kelly Blanchard, MSc, Jennifer Blum, MPH, and Eric Schaff, MD.
8