What is home-use of misoprostol?

In late August 2018 the Secretary of Health for England, Matthew Hancock MP announced that women in England would be able to take the second of the two drugs involved in an early medical abortion, misoprostol, at home. Current rules in England require women to take both pills at a clinic. This follows earlier rules changes in both Scotland and Wales to allow women to take misoprostol at home.

BPAS had campaigned for the law to be changed given the unnecessary cost and inconveniences involved in demanding that women make two separate trips to a clinic to complete treatment. 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 early medical abortion than remain in a clinical setting.

This change means that women will no longer have to risk bleeding, cramping and even miscarriage on the way home after taking the pills in the clinic. It also means they can take the medication at the time that is best for them, when they are in the privacy and comfort of their own home with a trusted partner or friend.

What happens during an early medical abortion?

Early medical abortion 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.

Under current rules, 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 previous interpretation of the law, the woman was required to return to the clinic to use this second medication. Under the proposed changes, she will be able to return home before taking the second medication, allowing her to prepare and experience the process in a safe, familiar setting.

The experience of undergoing a medical abortion is comparable to a natural miscarriage. Misoprostol is inserted vaginally in most cases, but can be taken orally or dissolved under the tongue or between the cheek and gum. 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. Early medical abortion 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.

Early medical abortion 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' - 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.

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"'.

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 was not seen as a clinical one, to do with the use of misoprostol: rather it was a problem with how the law around abortion was interpreted. Prior to this change in policy, BPAS was in the peculiar position where, if a woman came to the clinic having had an early miscarriage, she could have left with misoprostol tablets in her shoulder bag; if she came for an abortion, she had to return on another occasion to insert the tablets into her own vagina.

What has happened to cause this change?

In 2008, the last time there was an opportunity for Parliament to debate the Abortion Act 1967, 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. The High Court ruled that treatment covered the administration of medication as well as the prescription of medicine, 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.'

Based on this ruling, BPAS continued to campaign for the change in rules that would allow women to take misoprostol at home. In the interim the availability of ‘abortion pills’ increased 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-centered services dedicated to helping women have safe ‘DIY’ abortions in countries where abortion is illegal. A significant concern was that, if the law in Britain continued to make women’s experience of abortion unnecessarily difficult, it would not be surprising if women decided to take matters into their own hands by seeking the drugs online. This would be undesirable from a regulatory, legal and public health perspective.

What is the current legal position on home use?

Scotland was the first part of the UK to introduce home use in October 2017. The Scottish decision was the subject of an unsuccessful legal challenge in SPUC Pro-Life Scotland Ltd v Scottish Ministers. The substance of the challenge was that classifying a home as a place where a termination could be carried out was not a permissible understanding of the Abortion Act 1967, and that allowing women to take misoprostol at home ran afoul of the requirement in the Abortion Act 1967 that abortion be carried out by a medical practitioner. The court held that the extension of places where terminations could be carried out to homes was a reasonable and rational one, and that while doctors are ultimately responsible for the regime of care administered to a woman seeking a termination, there was no requirement for a doctor to be physically present throughout the treatment.  The court considered that patients who self-administer medication at home, e.g. diabetics self-administering insulin, are still fairly considered to be under the treatment of their doctor.

In June 2018 the Welsh Health Secretary, Vaughan Gething announced that his department had communicated approval to Welsh health boards for the home use of misoprostol. In August 2018 the Health Secretary of England, Matt Hancock, announced that his department would be following suit and planned to implement home use of misoprostol by the end of 2018.

The change in policy announced in Scotland, Wales and England is a welcome step forward in ensuring that women can access safe abortion care in a setting that is as comfortable as possible for them.