Why Medical Abortion Is Important for Women

Women often give birth at home.

Women often miscarry at home.

Women often induce abortion at home too.

(Toni Belfield, Medical abortion meeting, London, 27 September 2004)

Medical abortion is the use of pills to cause a miscarriage. It represents a particularly important advance in abortion technology because it is bringing women's access to safe abortion closer to home. In every country in the world, women with unwanted pregnancies seek induced abortions, safe or otherwise. Unsafe methods of abortion, particularly invasive methods, can kill and injure women, and some 13% of all maternal deaths are the result of abortions with unsafe methods provided in suboptimal conditions by unskilled providers. Medical abortion, with or without the involvement of a health care provider, is helping to reduce deaths and morbidity from complications such as sepsis and uterine perforation leading to hysterectomy, arising from unsafe invasive procedures, in places where most abortions are still illegal.

“The inclusion of these drugs to the essential drug list is a real addition to the therapeutic alternatives for women who have to undergo abortion, especially in developing countries where surgical facilities are less easily available. We are aware that many women in developing countries die from unsafe abortion, and we are very confident that these medicines will help prevent such unnecessary and tragic death.” (Hans Hogerzeil, Director of Medicines Policy and Standards, WHO and Secretary of its Essential Medicines Committee)¹

In many developing countries, where drugs can be purchased from pharmacies without a prescription, women have been buying a wide range of drugs to bring on their periods for many decades. Now, there is a combination of two drugs, mifepristone and misoprostol, that is both safe and effective for this purpose. Surely everyone with a public health perspective must welcome this development.

Miscarriage in early pregnancy is something women often go through safely at home, and medical abortion up to nine weeks of pregnancy can take place safely at home too, if women prefer it and as long as they have access to a health care provider if something goes wrong. There are some side effects, but they are well tolerated. Medical abortion has been shown to be safe and effective in clinical research for over 15 years now, and as word of its existence has spread, women all over the world have been using it, including in remote parts of developing countries.

Medical abortion in the context of safe abortion worldwide

This journal issue follows from an international conference entitled “Medical Abortion: An International Forum on Policies, Programmes and Services” that took place in Johannesburg in October 2004, organised by the International Consortium for Medical Abortion (ICMA), whose aim is to promote medical abortion in the context of safe abortion worldwide.^* ICMA's work is taking place as part of a long-standing effort worldwide since the mid-1980s to develop medical abortion methods, carry out clinical research to improve its safety, efficacy and acceptability and introduce medical abortion into health systems at primary care level. The conference consensus statement opens this journal issue.

The ICMA conference showed that the details of medical abortion were not widely known or understood, so it was agreed that ICMA would produce an information package for women, women's groups and NGOs, and providers and policymakers. As readers of this journal issue are also likely to need this information, a fact sheet has been included with some basic information about medical abortion, its effects and side effects, the drugs and optimal dosages and regimens at different stages of pregnancy, and much more. This will serve as useful background for reading the papers and for anyone wishing to advocate for medical abortion and inform others about it.

The most important paper in this journal issue, by Sharad Iyengar, is a discussion of the importance of introducing medical abortion within the primary health care system. This, he argues, should be done through simplification of service delivery protocols, using mid-level providers such as midwives and MCH/family planning nurses, robust referral links to hospitals, increasing user control and self-medication, and by simplifying arrangements for financing. Another paper describes aspects of choice and acceptability for both women and providers, based on comparisons with these aspects of surgical abortion. Several papers from both Latin America and South Asia are based on interviews with women who have used medical abortion or women who might consider it, physicians who have either provided it or who might consider providing it, and chemists who may or may not have been selling medical abortion drugs. One paper reports on a clinical study whose aim was to show, based on both safety and efficacy data as well as qualitative information, that the method should be introduced in the country.

The papers insist again and again on the need for access to medical abortion drugs at reasonable prices, and the importance of ensuring that women, providers and chemists all obtain accurate information. In addition, they contain background information on some of the legal, policy and health systems issues that affect or are likely to affect the availability of medical abortion after it has been introduced. Several of the papers come from India, where medical abortion was approved in 2002. One is a multicentre study from Mexico, Colombia, Ecuador and Peru. Others come from Nepal, an unnamed Latin American country, the northeast Caribbean, Moldova, South Africa and Turkey. These are settings where medical abortion has only recently been introduced or will be introduced soon. In others, it is only available through private practitioners, and in still others, self-medication following over-the-counter purchase is common because abortion is legally restricted.

Not surprisingly, in legally restricted settings, it is not entirely unproblematic to provide or use medical abortion. This does not reduce women's need for abortion or abortion services in these settings, however. Legal restrictions on abortion will have to be overcome to allow for improvements in the quality of service delivery. Meanwhile, until health systems in these settings are able to provide abortion services for women in an optimal way, including medical abortion, the purchase of drugs over the counter will continue and must be tolerated.

Medical abortion: service delivery and programmatic issues

Very early abortion, starting from when a woman first misses her period and up to nine weeks of pregnancy, is feasible with medical abortion, and at that stage it works almost all the time. Medical abortion can also be used for pregnancy termination after nine weeks, up to 24 weeks of pregnancy, and can be administered by a mid-level provider using appropriate regimens and with physician back-up if required. Regimens have greatly improved for second trimester medical abortion in recent years, but many providers are not aware of this and still rely on older methods which carry greater risks.

With medical abortion, even the language we use has to change. Doctors and mid-level providers do not carry out a medical abortion, for example, as they do a surgical one. Women take the mifepristone tablet by mouth, and the misoprostol tablets are inserted vaginally or taken by mouth. Vaginal insertion can be done by the provider, the woman or her partner. The abortion, as women say, then happens naturally. With early medical abortion, women do not need a hospital bed, in fact they don't need a bed at all, but can sit in a waiting room or carry on their daily activities until the abortion takes place.

Provision and use of medical abortion in well-organised health services and clinics is very straightforward, as the United States and most western European countries have shown for more than a decade. Some of the countries in Europe that pioneered the use of medical abortion over-medicalised its provision, however, out of caution in the face of a new method and due to not wanting anything to go wrong. Relaxing those regulations is taking quite some time, in spite of the evidence that it is safe to do so. Tunisia is a country that seems to have got the balance right, based on the experience of others. More recently, countries such as India and South Africa have introduced medical abortion into existing national protocols and norms on abortion that were originally written to regulate only surgical abortion.

In some countries, the drugs and regimens and even certain contraindications included in either the official registration, the drug package insert or in national guidance on medical abortion are already out of date. This speaks for greater flexibility to allow space for improvements over time as research is moving faster than bureaucracy can keep up with.

Many people seem to believe that it is not possible to provide medical abortion unless a full surgical abortion service is up and running. This is not true. Early medical abortion can be provided at primary care level by GPs, nurse-midwives, nurse-practitioners or family planning providers who have been trained, as well as by obstetrician-gynaecologists. Back-up is needed for the small minority of women with ongoing pregnancies or prolonged bleeding from incomplete abortion, as well as for emergency blood transfusion in rare cases. This means having a functioning and timely referral system, not necessarily a full surgical abortion service, though of course being able to offer both options to women is always preferable.

Up to nine weeks of pregnancy, women can be given the tablets in the clinic or to take at home, with instructions on how and when to use them and information on what to expect and what is and is not normal. In Vietnam, a large study found that 87% of women preferred aborting at home.² Those women who prefer to use the misoprostol tablets at the clinic and to remain for 4-5 hours after taking them or inserting them vaginally, should have the option to do so. They will need a comfortable place to sit, and access to sanitary pads and a toilet. For all women, a phone number they can call with 24-hour access in case of questions or concerns is very reassuring, even though experience shows that most women do not feel the need to call. Women over nine weeks of pregnancy need to stay at the clinic to use the misoprostol, as more than one dosage is usually required, and will be kept under observation for several hours after the products of pregnancy have been expelled. Follow-up at two weeks to check that abortion is complete is always recommended.

Ideally, as with contraceptive methods, women should be given a choice of either medical or surgical abortion, as few women will have contraindications to either. Providers should ideally have training in offering both methods, and their clinics should be set up to offer both kinds of care. Cost may enter into the equation for a range of reasons, and large differences in cost should be avoided if possible, with the needs of the poorest women taken into account.

The US FDA labelling for mifepristone does not require ultrasound to date the pregnancy. Instead, it requires that health care providers be able to date a pregnancy accurately and exclude ectopic pregnancy. A variety of methods are available to confirm and date pregnancy, including patient history, physical examination and pregnancy tests. Ultrasound is not necessary as a routine matter. Rather it is indicated when other assessments are discordant. This is the standard of care in obstetrics both inside and outside the abortion context, not only in the United States but also in other countries where mifepristone has been approved and used safely.³ Nor do providers have to determine the exact number of days of pregnancy to provide medical abortion, but rather the number of weeks, as the optimal dosages and regimens differ at only three or four points - between four and seven or four and nine weeks, between nine and 13 weeks, and between 13 and 24 weeks.

Access to information about medical abortion

There are a number of websites devoted to medical abortion and hundreds of articles in medical journals over the past 15 years, mostly describing clinical research and introductory studies. Patients and the lay public depend on physicians to be experts in their area of specialisation, but many of the physicians and chemists interviewed for the papers in this journal issue knew relatively little about medical abortion, and knew they needed to know more. In most cases, this was either because the drugs were only recently approved or introduced, or because abortion is legally restricted in their countries, which serves to restrict access to information as well.

In fact, research on medical abortion is moving at a faster pace than information dissemination can keep up with in all countries. In some cases, 600mg of mifepristone is still being prescribed when 200mg is equally effective at a third of the cost. In other cases, less than optimum doses and regimens of misoprostol following mifepristone are being prescribed. In still others, unnecessary surgical interventions are being carried out and there is over-dependence on ultrasound for dating pregnancies and checking whether abortion is complete. In legally restricted settings, many women are getting information only by word of mouth. Far more needs to be done about this.

Legally restricted settings: don't jump on the “ban” wagon

In legally restricted settings, health care providers, chemists and other pharmacy staff may be approached regularly for both mifepristone and misoprostol, or for misoprostol alone where mifepristone is not available. Knowing what to advise women is crucial to help women to self-medicate safely, as self-medication may be their only option. Public health professionals may cringe when they read this, but this is the ongoing reality of legal restrictions on abortion, which were not invented with medical abortion. The alternative is to force women back to using unsafe invasive methods and unskilled providers, with the consequence that the rates of mortality and morbidity will rise once more. Banning over-the-counter sales of misoprostol, as happened in Brazil a decade ago, may have silenced the anti-abortion movement temporarily, but it forced the drug onto the black market, with obvious consequences for cost and access.

The fact is that the choice is not between medical abortion drugs over the counter or a totally safe, legal situation with the best methods from a trained provider at a cost women can afford. It is therefore short-sighted to make policy or act as if it were. Doctors as well as women and chemists are experimenting with dosages of misoprostol alone because clinical researchers have been slow to study and recommend one or more effective regimens. Doctors themselves are even using combinations of medical and surgical methods, most commonly misoprostol followed by D&C, as several papers in this issue show, that are not based on evidence at all. Furthermore, many women, e.g. in India and Nepal, as shown here, are still resorting to dozens of drugs whose safety and efficacy are unknown and others that are known to be unsafe or ineffective - because they are so cheap. These are the drugs from chemists and markets whose availability should be restricted.

Moreover, the extent of high-risk practices for second trimester abortion, and not only in legally restricted settings, which are probably responsible for much abortion-related mortality today, is barely being studied, let alone the focus of efforts to replace their use with safe methods.

Building advocacy for medical abortion

Ten years ago, in countries such as the Netherlands, those who were providing surgical abortion services at first saw no need for medical abortion because they believed their services were good enough without it. Today, in contrast, in some places in Norway women are only being offered medical abortion and they must specifically ask for a surgical procedure if they prefer it. Medical and surgical methods are very different from each other, however, and it is worth repeating that women should be given a choice of method wherever possible. In poorer countries, if both medical abortion and vacuum aspiration were provided by mid-level providers, the lack of obstetrician-gynaecologists need not be a barrier, and access to safe abortions could be greatly increased at a lower cost per woman.

Efforts are needed around the world to encourage low-cost, high-quality manufacture of generic mifepristone and misoprostol, their approval for combined use for inducing abortion and for a range of other obstetric and gynaecological uses at affordable prices. This is a challenging agenda. Many more advocates, policymakers and service providers need to become involved. We hope this journal issue will help to convince those who support safe, legal abortion that they must include access to medical abortion in their efforts to make this goal a reality in their countries.

Other features in this issue

This journal issue includes three other papers on aspects of abortion care. One paper reviews international law and claims of fetal rights and shows that in every relevant international document and major court decision, starting from the Universal Declaration of Human Rights, it has been affirmed that human rights begin at birth. A paper about Cameroon describes the ways in which unsafe, clandestine abortion creates dilemmas for women that may be life-threatening on one hand and socially disastrous on the other. A third, from Brazil, is about abortion for fetal abnormality incompatible with life, where the only alternative is to deliver a stillborn baby or one that will die soon after birth. Lastly, on a very different note, one paper looks at the continuing problem of menstrual hygiene among adolescent schoolgirls in a rural area of Egypt, because sanitary towels may not be affordable or available. In addition, there are letters on policy matters related to donor support for abortion internationally in Norway, quality of post-abortion care in Brazil and participation of a partner or family member at delivery in Latin America. The journal closes with excerpts from two books on abortion, one from Poland where women needing abortions are going through hell to get them, the other a study of why women have abortions late, carried out in the UK.

Trinidad

Notes

* Information about ICMA, the ICMA conference and copies of all the presentations can be found at: <www.medicalabortionconsortium.org>.