Expanding access to medical abortion Marge Berer Editor, Reproductive Health Matters Chair, ICMA Steering Committee *** Lisbon, March 2010

Abortion methods 1960s/70s Surgical : dilatation and curettage (D&C), dilatation and evacuation (D&E) and hysterotomy. Surgical : dilatation and curettage (D&C), dilatation and evacuation (D&E) and hysterotomy. Medical : intra-amniotic, extra-amniotic and intra-muscular (urea, saline, various older prostaglandins and ethacridine lactate). Medical : intra-amniotic, extra-amniotic and intra-muscular (urea, saline, various older prostaglandins and ethacridine lactate). A trained physician was required to carry out these abortions, and the risk of complications was much higher than today, especially as pregnancy progressed.

Current methods recommended by WHO Manual vacuum aspiration Manual vacuum aspiration Vacuum aspiration Vacuum aspiration Dilatation & evacuation Dilatation & evacuation Medical abortion (mifepristone + misoprostol) Medical abortion (mifepristone + misoprostol)

What is medical abortion? Medical abortion is the use of pills to cause a miscarriage; it has high efficacy (92–99%) and an excellent safety record. Medical abortion is the use of pills to cause a miscarriage; it has high efficacy (92–99%) and an excellent safety record. Medical abortion can be used from the time a woman first misses her period up through the 2nd trimester of pregnancy. Medical abortion can be used from the time a woman first misses her period up through the 2nd trimester of pregnancy. Yte its potential as a very early abortion method ( almost 100% effective ) remains to be recognised and developed. Yte its potential as a very early abortion method ( almost 100% effective ) remains to be recognised and developed.

Medical abortion has improved Medical abortion is safer and more effective now than 10 –15 years ago: Medical abortion is safer and more effective now than 10 –15 years ago: Misoprostol causes fewer complications than previous prostaglandins. Misoprostol causes fewer complications than previous prostaglandins. Optimum regimens, including for misoprostol alone – based on evidence. Optimum regimens, including for misoprostol alone – based on evidence. Much more experience with the method. Much more experience with the method.

Why is it so important? Offers a choice of abortion method for both women and providers. Offers a choice of abortion method for both women and providers. Can increase access to safe abortion where there are few surgical abortion providers. Can increase access to safe abortion where there are few surgical abortion providers. Fundamentally alters the way abortion services should be delivered. Fundamentally alters the way abortion services should be delivered. Can put the means of abortion into women’s hands. Can put the means of abortion into women’s hands.

This conference is about expanding access to medical abortion Why is access such a problem?

Overmedicalised provision Hospital-based clinics for 1st trimester. Hospital-based clinics for 1st trimester. 600 mg mifepristone – 3 times too much. 600 mg mifepristone – 3 times too much. No choice of using misoprostol at home. No choice of using misoprostol at home. Ultrasound to determine gestation / check abortion complete. Ultrasound to determine gestation / check abortion complete. Extra visits. Extra visits. Physician-only provision. Physician-only provision.

Restricted/poor access Legal abortion restricted or unavailable. Legal abortion restricted or unavailable. Lack of approval/registration of drugs. Lack of approval/registration of drugs. Misoprostol available in secret, from chemists, on the street and on the black market. Misoprostol available in secret, from chemists, on the street and on the black market. Cost of drugs uncontrolled. Cost of drugs uncontrolled. Treatment for complications not assured. Treatment for complications not assured. Training for providers haphazard, practice often not evidence-based. Training for providers haphazard, practice often not evidence-based.

Problematic aspects for women: restricted settings Incorrect use, doses too large or too small, self-medication beyond 9 weeks. Incorrect use, doses too large or too small, self-medication beyond 9 weeks. Uncertainty whether bleeding is normal or not. Uncertainty whether bleeding is normal or not. Uncertain whether abortion complete or not. Uncertain whether abortion complete or not. And while we want to see women in control of the method, this does not mean being left alone with the responsibility. And while we want to see women in control of the method, this does not mean being left alone with the responsibility.

Barriers to approval The registration and approval process has been made as difficult as possible: The registration and approval process has been made as difficult as possible: approval commercially driven; drug companies refuse to apply even in countries with legal abortion. approval commercially driven; drug companies refuse to apply even in countries with legal abortion. national drug regulatory agencies imposing outdated, overly stringent regulatory conditions, or not allowing the method into the public sector at all. national drug regulatory agencies imposing outdated, overly stringent regulatory conditions, or not allowing the method into the public sector at all.

Registration/approval Mifepristone is currently registered/ approved in only 44 countries since 1988 when registered in France and China. Mifepristone is currently registered/ approved in only 44 countries since 1988 when registered in France and China. Misoprostol has been approved or can be found in most countries, except a few sub-Saharan African and Asian countries. But it didn’t arrive as an abortion drug. Misoprostol has been approved or can be found in most countries, except a few sub-Saharan African and Asian countries. But it didn’t arrive as an abortion drug. Off-label use is common. Off-label use is common.

Even so… access to medical abortion is getting better… and better!

WHO Essential Medicines list Mifepristone and misoprostol added to WHO Essential Medicines list in 2005 – one aim to reduce unnecessary deaths from unsafe abortion. Mifepristone and misoprostol added to WHO Essential Medicines list in 2005 – one aim to reduce unnecessary deaths from unsafe abortion. (Hans Hogerzeil, Director of Medicines Policy and Standards, WHO, and Secretary of its Essential Medicines Committee in 2005) “Essential drugs” – drugs that every country should have available. “Essential drugs” – drugs that every country should have available.

Use/availability expanding More countries approving medical abortion. More countries approving medical abortion. More women choosing it and more providers offering it. More women choosing it and more providers offering it. National laws/regulations have begun incorporating specifics of medical abortion. National laws/regulations have begun incorporating specifics of medical abortion. Additional indications being approved – e.g. prevention and treatment of post partum haemorrhage – making drugs more accessible. Additional indications being approved – e.g. prevention and treatment of post partum haemorrhage – making drugs more accessible. Medical and surgical methods are being combined in various (creative) ways. Medical and surgical methods are being combined in various (creative) ways.

Global use of medical abortion Millions of women have used medical abortion globally, but no global data collected. China – up to 200 million abortions since 1988 (50% of all abortions) China – up to 200 million abortions since 1988 (50% of all abortions) USA – 1.5 million abortions USA – 1.5 million abortions India – 6 million mifepristone pills sold in 2009 alone India – 6 million mifepristone pills sold in 2009 alone Viet Nam – 1 million abortions Viet Nam – 1 million abortions (Personal communication, Beverly Winikoff, Feb 2010)

Moreover, women are quietly taking these drugs into their own hands.

Meanwhile, back at the hospital.. Dosage ( 200mg/600mg mife ) and regimens. Dosage ( 200mg/600mg mife ) and regimens. Delivery of misprostol (oral, vaginal, buccal, sublingual). Delivery of misprostol (oral, vaginal, buccal, sublingual). Where woman takes pills, where abortion happens. Where woman takes pills, where abortion happens. Pain relief or not. Pain relief or not. Ultrasound or not. Ultrasound or not. More or fewer visits. More or fewer visits. When to do follow-up / what kind. When to do follow-up / what kind. Surgical or medical at 9-13 weeks and in 2nd trimester? Surgical or medical at 9-13 weeks and in 2nd trimester?

Enhancing access

WHO Safe Abortion Guidance 2003 Abortion services should be provided at the lowest appropriate level of the health care system. Abortion services should be provided at the lowest appropriate level of the health care system. Vacuum aspiration can be provided at primary care level up to 12 completed weeks of pregnancy and medical abortion up to 9 completed weeks of pregnancy. Vacuum aspiration can be provided at primary care level up to 12 completed weeks of pregnancy and medical abortion up to 9 completed weeks of pregnancy. This guidance is more than 8 years old and is still often not being implemented.

Increase role of non physicians Use mid level providers who are closest to women geographically and socially: Use mid level providers who are closest to women geographically and socially: nurses nurses midwives midwives family planning workers and family planning workers and physician assistants. (ICMA 2004) physician assistants. (ICMA 2004) These providers can manage medical abortion provision on their own These providers can manage medical abortion provision on their own. Let’s allow them to do so. (Berer 2009)

Women-centred perspectives Don’t be overly protective of women needing abortions. Simplify services. Don’t be overly protective of women needing abortions. Simplify services. Give good information that all women can understand, including how to take the drugs safely. Give good information that all women can understand, including how to take the drugs safely. Allow home use of both drugs (<9 wks). Allow home use of both drugs (<9 wks). Support bona fide web provision and self medication, esp. where services are lacking/illegal. Support bona fide web provision and self medication, esp. where services are lacking/illegal.

More global stakeholders When ICMA began in 2002, few people knew about medical abortion. When ICMA began in 2002, few people knew about medical abortion. Today, many international, regional, national and local stakeholders involved in advocacy, providing information, and providing medical abortion pills through many outlets. Today, many international, regional, national and local stakeholders involved in advocacy, providing information, and providing medical abortion pills through many outlets. Many more drug companies, many new brands, and now the two drugs are being packaged together. Many more drug companies, many new brands, and now the two drugs are being packaged together.

Increased opportunity Opportunity to share goals, develop simple, women centred service delivery norms, support each others’ work and engage in joint activities. Opportunity to share goals, develop simple, women centred service delivery norms, support each others’ work and engage in joint activities. Let’s try to get consensus on some of the contentious issues on the agenda of this conference. Let’s try to get consensus on some of the contentious issues on the agenda of this conference. To expand access for women, let’s work together to promote medical abortion in the context of safe abortion. To expand access for women, let’s work together to promote medical abortion in the context of safe abortion.