Home use of misoprostol

What is early medical abortion?

Early medical abortion (EMA) is a non-invasive, non-surgical method of termination of pregnancy up to 63 days (9 weeks) gestation, using a combination of two drugs: mifepristone and misoprostol. Mifepristone is a synthetic steroid which blocks the hormone progesterone. Without this hormone, the lining of the uterus breaks down and the pregnancy ceases to be sustainable. Misoprostol is a prostaglandin, which causes the uterus to contract and expel the pregnancy.

What happens during an early medical abortion?

The experience of undergoing a medical abortion is comparable to a natural miscarriage. At a bpas clinic, a woman is given one mifepristone tablet to swallow, after which she will go home. She then uses the second medication, misoprostol, typically 24-48 hours later. Under the current interpretation of the law, the woman is required to return to the clinic to use this medication. Misoprostol is inserted vaginally in most cases, but can be taken orally or dissolved under the tongue or between the cheek and gum.

Women can go straight home from the clinic after taking misoprostol, in order to make themselves comfortable before the uterus starts to contract. Cramping and bleeding usually begin 1.5 to 2 hours after administration, but this can start sooner. The procedure is normally complete within 4-6 hours, but this too can vary. Women can expect to experience some bleeding for several days as part of normal recovery.

How safe is medical abortion?

Very safe. No medical procedure is risk free, but the risks of early medical abortion are extremely small and considerably less than the risks of continuing a pregnancy to term. EMA can often be carried out as soon as a pregnancy is confirmed, and the earlier an abortion can be performed the lower the chance of any complications.

EMA also avoids any anaesthetic risk that surgical procedures may pose, and any risk of infection is minimised by providing all women with prophylactic antibiotics. Rare complications that can occur include continuing pregnancy and incomplete abortion, which is why all women are encouraged to attend a follow-up appointment to check that the procedure was successful.

All women leave the clinic with an appropriate supply of pain relief, antibiotics, and detailed advice as to what to expect, and what might indicate a problem. They have access to a specialist 24 hour, seven days a week helpline and we ensure that there is the facility to attend for urgent medical treatment, if needed.

How many women use early medical abortion?

The 2013 abortion statistics show a continuing trend towards abortions taking place earlier in pregnancy. Over three-quarters (79%) of abortions now take place at under 10 weeks' gestation, compared to 58% in 2003; about one third take place under six weeks' gestation. Almost two thirds (64%) of abortions at under 8 weeks' gestation are performed by organisations like bpas, in the independent sector under NHS contract.

Source: Abortion Statistics, England and Wales: 2013. Department of Health.

Highly sensitive tests, which can diagnose pregnancy just days after conception, mean that women who suspect a pregnancy can confirm this much sooner, while most areas now allow self-referral, so that a woman can access services without the delays that might be caused by waiting for a referral from her GP.

But it is the increasing availability and acceptability of Early Medical Abortion, also known as the 'abortion pill' - a method pioneered in the UK by BPAS – that has played a key role. Early medical abortion now accounts for 60% of all abortions performed nationally at gestations of under 9 weeks.

What is problematic with the way EMA is currently administered?

Currently the Department of Health defines 'treatment for the termination of pregnancy' in an approved setting as meaning that both the prescribing and administration of abortion drugs must take place in a licensed clinic. This means that women incur the cost and inconvenience of returning to a clinic for a medically unnecessary visit to administer the misoprostol on site. The insistence that women return to the clinic to take misoprostol adds clinically unnecessary demands, and costs, to NHS-funded abortion services.

Women can have understandable concerns about travelling home while waiting for the drug to take effect. Yet nor is it reasonable to demand that they stay in the clinic until they pass the pregnancy: a process that can take a few hours. A study of bpas clients in 2010 found that most women who have opted for early medical abortion (86%) would rather go home to complete an EMA than remain in a clinical setting.

Is it safe for women to go home and administer misoprostol themselves?

Home use of misoprostol is both safe and acceptable to women – as has been shown by countless studies and clinical practice in countries across the world. Many women choose to administer misoprostol themselves while in the clinic, so there would be few grounds to suppose that they would not do so equally effectively at home.

The impact of allowing women to self-administer at home has been considered in a number of international studies examining practice in countries as diverse as US, Sweden, Vietnam and Guadeloupe. These studies show there is no increased safety risk to women from home administration, as long as suitable safeguards and support mechanisms are in place. Further, the evidence shows there are considerable benefits.

In 2007, the House of Commons Science and Technology Select Committee (STC) published a thorough and wide-ranging report on scientific developments relating to the 1967 Abortion Act. The Committee noted:

When this legislation was put in place, abortion was a surgical procedure. That is why places were specified where abortions could be carried out. However, in the last 10 years, medical abortions have increased in frequency, the requirements of which, from a medical provisions point of view, are markedly different. It is common practice in other countries for the second stage of an early medical abortion to be completed at home.

The STC report, published seven years ago, noted that 'outside the UK, research has shown that self-administration of misoprostol at home is safe, effective and acceptable'. The Committee argued:

'We were impressed by the evidence that there are no particular safety concerns about early medical abortions on three grounds. First, the studies that have assessed the safety of medical abortions have been conducted so as to compare the relative safety of procedures with letting a pregnancy continue to term. The fact that medical abortions also cause unpleasant symptoms is not a reason for restricting the administration of misoprostol to a clinic; especially when the majority of women choose to go home after taking misoprostol, presumably because they want to be as comfortable as possible when these symptoms manifest. Second, the reported mortalities associated with medical abortions are “rarer than anaphylaxis after being given a shot of penicillin”. Thirdly, women already take misoprostol at home to complete natural miscarriages with no apparent safety concerns.'

The overwhelming evidence about the safety of the home use of misoprostol, and the success of this approach in other European and North American countries, led the Committee in 2007 to conclude that:

'[S]ubject to providers putting in place the appropriate follow up arrangements, there is no evidence relating to safety, effectiveness or patient acceptability that should serve to deter Parliament passing regulations which would enable women who chose to do so taking the second stage of early medical abortion at home, or that should deter Parliament from amending the act to exclude the second stage of early medical abortion from the definition of "carrying out a termination"'.

What attempts have been made to change the law with respect to home use?

In 2008, the last time there was an opportunity for Parliament to debate the 1967 Abortion Act, the government blocked the debate. Four years later, in 2011, bpas brought a legal challenge to the Department of Health, arguing that women should be given both sets of drugs for medical abortion at the same time, allowing them to complete their abortion at home.

BPAS questioned whether the legal definition of 'treatment' for abortion covers both the prescription and the administration of medication. But the High Court ruled that treatment covered the administration as well, although it said the health secretary had the power to amend the rules if advances in medicine justified it.

The Hon Mr Supperstone J ruled that Section 1(3A) of the Abortion Act as amended in 1990 enables the Secretary of State to react to 'changes in medical science' as it gives him 'the power to approve a wider range of place, including potentially the home, and the conditions on which such approval may be given relating to the particular medicine and the manner of its administration or use.'

Four years on from the High Court ruling, the Department of Health has made no moves to consider licensing women's home as a 'class of place', and there are no plans to review the abortion law. This resistance to change ignores serious anomalies both in Britain, and internationally.

In Britain, women who have a spontaneous miscarriage are often given misoprostol to take home with them, so they do not have to wait for several agonising days before the pregnancy is expelled. This indicates that the problem is not seen as a clinical one, to do with the use of misoprostol: rather it is a problem with how the law around abortion is interpreted.

What is the situation now?

Because of the Department of Health's refusal to look at how the care of women undergoing early medical abortion might be improved, BPAS remains in the peculiar position where, if a woman comes to the clinic having had an early miscarriage, she can leave with misoprostol tablets in her shoulder bag; if she has come for an abortion, she has to return on another occasion to insert the tablets into her own vagina.

A further development in medical abortion has been through the availability of 'abortion pills' online. For countries where abortion is illegal, this has become an alternative to 'backstreet abortion' methods. Online abortion services carry risks, particularly where there are unscrupulous suppliers selling drugs that do not work; but there are also some reputable, women-centred services dedicated to helping women have safe 'DIY abortions' in countries where abortion is illegal.

In Britain, where early abortion is free and easily accessible, there should be no reason for women to seek the drugs for 'DIY abortions' online. But should abortion services become more restricted, or should the law continue to make women's experience of early medical abortion unnecessarily difficult, it would not be surprising if women decide to take matters into their own hands by seeking the drugs online. This would be undesirable from a regulatory, legal, and public health perspective.