Imagine two women, each facing an unintended pregnancy and living where legal restrictions make it impossible for her to get an abortion under the care of a trained medical provider. A woman going through this experience in many countries in Latin America, Asia, and Africa is likely to know, or learn from a friend, that she can take medications on her own to have an abortion safely.
1
Misoprostol and mifepristone are registered in 90 and 50 countries, respectively (
Winikoff and Sheldon, 2012
).1Misoprostol and mifepristone are registered in 90 and 50 countries, respectively (
She can get the pills at a pharmacy and take them in her own home.Winikoff and Sheldon, 2012
).A woman going through the same experience in the United States probably will not know about that possibility. But even if she does, she will have a hard time finding out which medication to take, at what dose, and in what way, and an even harder time getting access to it from a reliable source where she can be sure the pills are what the seller claims. If she manages to clear those hurdles, she will take the pills under a shadow of uncertainty and fear, not knowing where to turn for trustworthy information about what to expect and afraid that if anyone learns what she is doing she will be criminally prosecuted for having an illegal abortion or even charged with feticide (
Bazelon, 2014
, Bazelon, E. (2014, September 22). A mother in jail for helping her daughter have an abortion. New York Times. Available: http://www.nytimes.com/2014/09/22/magazine/a-mother-in-jail-for-helping-her-daughter-have-an-abortion.html?_r=0. Accessed September 9, 2015.
Paltrow and Flavin, 2013
, Pieklo, 2015b
, Pieklo, J. (2015b, May 29). Ninth Circuit Court strikes another 20-week abortion ban. RH Reality Check. Available: http://rhrealitycheck.org/article/2015/05/29/ninth-circuit-court-strikes-another-20-week-abortion-ban/. Accessed September 10, 2015.
Robinson, 2012
).Yet, in many parts of the United States there are women for whom legal abortion is effectively not available because the cumulative burden of legal restrictions imposed by state and federal legislators has put safe, legal care out of reach (
Jones and Kooistra, 2011
). Drawing on the successful experience of women in other countries where abortion is highly restricted and where women have decreased maternal morbidity and mortality through use of misoprostol for medication abortion, we propose an action agenda that will similarly give U.S. women the tools to take safe and effective medication abortion into their own hands.Medication Abortion in the United States
More than a million abortions take place every year in the United States, 90% of which are in the first 12 weeks of pregnancy (
Guttmacher Institute, 2014
). The potential of medication abortion (abortion using pills) to meet women's needs and provide a more women-centered option for pregnancy termination is great. In 2000, when mifepristone was first approved in the United States, many hoped the introduction of medication abortion would help to alleviate the challenges caused by a shortage of abortion providers and make it easier for women to receive abortion care in a wider range of settings (Guttmacher Institute. (2014). Facts on induced abortion. Available: www.guttmacher.org/pubs/fb_induced_abortion.html. Accessed September 9, 2015.
Coeytaux et al., 2003
). But today's reality has fallen far short of those hopes, in large part because of the persistent campaigns, waged by opponents of abortion, to restrict access to abortion pills. These opponents are targeting medication abortion precisely because they are fully cognizant of how empowering it would be for women if they could safely end an unwanted pregnancy without having to access an abortion clinic or a clinician with prescribing authority. Reproductive rights supporters need to seriously challenge the new restrictions that are being put in place, especially given that they are not supported by scientific evidence.The U.S. Food and Drug Administration (FDA) approved Mifeprex (the trade name for mifepristone) with a drug label that sets out a complicated and highly medicalized regimen for providing the pills, rather than allowing distribution directly to consumers through pharmacies, like other prescription drugs. Mifeprex is only available to physicians who request it and who provide proof that they are “able to assess the duration of pregnancy accurately, diagnose ectopic pregnancies and provide surgical intervention and emergency care as needed (or refer women elsewhere for such care)” (
Mifeprex Prescriber's Agreement, 2005
). Additionally, providers who prescribe mifepristone in the United States are required to enroll in a national registry, a significant barrier for clinicians who might be willing to offer this form of abortion care if they were able to do it without being publicly identified as abortion providers. The FDA's label also states that a woman should make three visits to a physician, first to receive the mifepristone, then 2 days later for a dose of a second drug, misoprostol, and once again, on day 14, for follow-up (Mifeprex Prescriber's Agreement. (2005). Available: http://earlyoptionpill.com/wp-content/uploads/2014/04/Mifeprex_Labeling_Prescribers_Agreement.pdf. Accessed September 9, 2015.
Boonstra, 2013
).It is highly unusual for the FDA to include such a restrictive regimen on a drug label. No other drug with a comparable safety profile carries a remotely similar label. Numerous drugs sold over the counter in the United States—such as acetaminophen, anti-histamines, and nonsteroidal anti-inflammatories—result in considerably more adverse events, including death, than mifepristone. Moreover, this highly medicalized model of care promotes the false impression that abortion pills can be safe only if provided under the care of a clinician. Evidence from women's use of medication abortion around the world belies that assumption (
Lafaurie et al., 2005
, Lara et al., 2006
, Ngo et al., 2011
).Over the past 15 years, since the FDA approval of Mifeprex, the way medication abortion is provided in clinical practice has been simplified: whereas the label requires three visits, the number of required visits has been reduced to two; the dose of mifepristone has been lowered from 600 mg of mifepristone to 200 mg; and the women are now given the misoprostol to take at home. However, despite evidence that the simplified regimen is safer than, and as effective as, the FDA-approved regimen (
American College of Obstetricians and Gynecologists, 2014
), the drug label remains unchanged. As a result, U.S. women are denied the highest standard of evidence-based care and anti-choice advocates have a justification for restrictive laws. These include requirements that providers follow the outdated FDA label regimen, prohibitions on the use of proven telemedicine practice techniques to provide medication abortion, and mandates that a provider must be physically present when the medication is dispensed. In failing to move medication abortion into a wider variety of settings and to create less medicalized pathways for access, advocates have missed a critical opportunity to increase abortion access, agency, and autonomy for the millions of women living in the United States.One way to try to improve abortion access in the U.S. communities where services have been shut down would be to eliminate the FDA's medically unsupported restrictions on access to mifepristone. Without those regulatory hurdles, a wider range of providers would be able to offer medication abortion, potentially increasing access for women who are currently denied the care they need. Another way would be for U.S. women to explore the potential of using misoprostol alone, given that its distribution is less restricted than mifepristone's.
The Potential of Misoprostol
The combination of mifepristone and misoprostol is currently the standard of care for medication abortion in the United States, in large part because it is the most effective regimen (
American College of Obstetricians and Gynecologists, 2014
); the combination approaches 98% efficacy, whereas misoprostol used alone is 85% effective (Kulier et al., 2011
). But medical experts, including the World Health Organization (WHO, 2012
), recognize that mifepristone is not always available and, where it is not available, recommend the use of misoprostol alone.It was women in Brazil, living under very restrictive laws outlawing abortion, who discovered that misoprostol (sometimes known by its brand name Cytotec), a readily available drug marketed for the prevention of gastric ulcers, could safely end unwanted pregnancies. In a country where the health system was failing them, these women came up with a creative strategy to meet their needs and shared their discovery with others, through word of mouth, woman to woman. This experience, which began in the early 1980s, has been repeated elsewhere, and, today, in many parts of the world, a woman can go to the pharmacy to obtain pills, take them in her own home, without necessarily interfacing with a health care provider, and successfully end an unwanted pregnancy (
Lara et al., 2006
, Ngo et al., 2011
, Shah and Weinburger, 2012
, Sherris et al., 2005
). These women have become active agents in securing their own reproductive autonomy and in the process have reduced significantly the morbidity associated with unsafe abortion in their countries.Globally, the medical establishment has taken notice. Much research has been done to demonstrate the safety and efficacy of misoprostol for abortion (
Consensus statement, 2003
, Moreno-Ruiz et al., 2007
, von Hertzen et al., 2007
). The WHO's safe abortion guidelines state that misoprostol can be used alone to cause an abortion through 12 weeks after the first day of a woman's last menstrual period. The WHO also recognizes that the risk of unsafe abortion lies on a spectrum, making medication abortion taken outside the medical system by women who are using correct doses and regimens safer than other methods women might use when access to care is severely restricted (- von Hertzen H.
- Piaggio G.
- Huong N.T.M.
- Arustamyan K.
- Cabezas E.
- Gomez M.
- et al.
WHO Research Group on Postovulatory Methods of Fertility Regulation.
Efficacy of two intervals and two routes of administration of misoprostol for termination of pregnancy: A randomised controlled equivalence trial.
Efficacy of two intervals and two routes of administration of misoprostol for termination of pregnancy: A randomised controlled equivalence trial.
The Lancet. 2007; 369: 1938-1946
Ganatra et al., 2014
).U.S. women are not able to follow the example of women in the global south because in the United States it is necessary to have a prescription to obtain misoprostol. Approved by the FDA for the prevention of gastric ulcers, misoprostol is routinely prescribed (off-label) to prevent and stop hemorrhage and to induce labor or prepare the cervix for procedures such as hysteroscopy and endometrial biopsy (
MedLine Plus, 2013
). It is also prescribed as part of the regimen most commonly used for medication abortions in U.S. clinics; mifepristone is followed 24 hours later with a dose of misoprostol. But obtaining the drug for self-use is difficult because, although it is commonly stocked in pharmacies, it requires a prescription. Nonetheless, there is growing evidence of home use of misoprostol by women in the United States, primarily among immigrants from countries where such use is common practice (MedLine Plus. (2013). Misoprostol [website]. Available: www.nlm.nih.gov/medlineplus/druginfo/meds/a689009.html. Accessed September 9, 2015.
Debrez, 2013
, Eckholm, 2013
, Eckholm, E. (2013, July 13). A pill available in Mexico is a Texas option for abortion. New York Times. Available: http://www.nytimes.com/2013/07/14/us/in-mexican-pill-a-texas-option-for-an-abortion.html. Accessed September 9, 2015.
Grossman et al., 2010
, Grossman et al., 2012
, Hellerstein, 2014
, Hellerstein, E. (2014, June 27). The rise of the DIY abortion in Texas. The Atlantic. Available: http://www.theatlantic.com/health/archive/2014/06/the-rise-of-the-diy-abortion-in-texas/373240/. Accessed September 9, 2015.
Jones, 2010
, Rosing and Archibald, 2000
).Why Are We Not Telling Women about This Safe and Effective Method?
Evidence shows that misoprostol used alone will safely and effectively end most pregnancies under 16 weeks of gestation (
Ngoc et al., 2011
). Yet, even as access to abortion services continues to be severely curtailed in the United States, we are keeping this information from women. Why?Some argue that encouraging the use of misoprostol alone lowers the standard of care because misoprostol is not as effective when used alone as when it is used as part of the FDA-approved regimen that combines it with mifepristone. However, that comparison fails to recognize the current reality for U.S. women who face insurmountable barriers to access. For a woman in those circumstances, information about and access to misoprostol provides a path to safe abortion care where none currently exists.
Others mention health risks. However, the risk of a woman being harmed by using misoprostol for abortion is very low and easily mitigated. Indeed, the greatest risk is that the misoprostol is not effective and the pregnancy continues. In the limited cases when the drugs do not fully end a pregnancy, the follow-up treatment is the same as that used for miscarriage management—care that is commonly available at medical facilities throughout the United States, including in places where abortion care is not.
The legal risks are harder to evaluate and quantify, and vary from state to state (
Yanow, 2009
, Yanow, 2012
). Using misoprostol for a purpose other than the one approved by the FDA—known as off-label use—is both legal and common in the United States; antidepressants, to give but one example, are frequently prescribed to treat nerve pain or menopausal hot flashes. Off-label use is accepted, and even encouraged, where there is a body of evidence supporting safe and effective use of a drug for a purpose for which the manufacturer has not sought FDA approval. However, the FDA restricts companies from advertising and promoting their products for unapproved uses. Clinicians without a commercial incentive have more leeway; however, advocates are wary of drawing attention to the off-label use of misoprostol for abortion (Greenhouse, 2013
).Greenhouse, L. (2013, September 4). The next abortion case is here. New York Times. Available: http://opinionator.blogs.nytimes.com/2013/09/04/the-next-abortion-case-is-here/. Accessed September 9, 2015.
The greater legal risk is prosecution for performing an illegal abortion, and both women and providers may be vulnerable in states where abortion laws are restrictively drawn. In recent months, women in several states (Arkansas, Idaho, Pennsylvania, Indiana, and Georgia) have been prosecuted for using medication on their own to end a pregnancy. Similarly, a nurse in Arkansas was recently charged with performing an unlicensed abortion after she allegedly provided a woman with a drug to induce abortion (that case is still pending). In most states, there is no legal authority to charge a woman for terminating her own pregnancy. As a result, the Idaho and Georgia cases have already been dropped (
Pieklo, 2015a
, Pieklo, J. M. (2015a, February 4). Purvi Patel convicted of feticide and neglect of dependent. RH Reality Check. Available: http://rhrealitycheck.org/article/2015/02/04/purvi-patel-convicted-feticide-neglect-dependent/. Accessed September 10, 2015.
Jarvie, 2015
). Nonetheless, these cases prove that, throughout the United States, women who choose to terminate their pregnancy by using pills and providers (or friends and family members) who try to help them face potential legal risks.Jarvie, J. (2015, June 10). Murder charge dropped against Georgia woman who took pills for abortion. LA Times. Available: http://www.latimes.com/nation/la-na-abortion-murder-20150611-story.html. Accessed September 9, 2015.
The Emergency Contraception Example
Twenty years ago, emergency contraception (EC, also referred to as the morning after pill and “Plan B”) was the best kept contraceptive secret. A woman only had access to this option to prevent pregnancy after unprotected intercourse if she could find a provider willing to tell her about it, cut up a pack of birth control pills, and give instructions on how to use the drug correctly (
Hoffman, 1993
, Hoffman, J. (1993, January 10). The morning-after pill: A well-kept secret. New York Times. Available: http://www.nytimes.com/1993/01/10/magazine/the-morning-after-pill-a-well-kept-secret.html. Accessed September 9, 2015.
Pillsbury et al., 1999
). Similar to the status of misoprostol today, this was an off-label use of an existing product that was readily available but accessible to only a few. Courageous advocates and clinicians fought to make emergency contraception more widely accessible. In the first stage, they set up a hotline that provided reliable information about how to use oral contraceptive pills for this purpose and referred women to providers who would prescribe the pills. Later, two pioneering reproductive health companies took on the challenge that no major pharmaceutical company was willing to take and brought dedicated EC products to market (Coeytaux and Pillsbury, 2001
, Foster and Wynn, 2012
). Today, after 20 years of advocacy, EC is finally available on store shelves without medically unnecessary restrictions.It is time to take similarly bold action to better meet U.S. women's abortion needs. We can do for abortion what advocates did for emergency contraception—share the knowledge that rigorous research has produced, teach woman how to use the medication safely, and give women access to the pills.
An Agenda for Action
- •Make accurate information available about safe and effective use of misoprostol to end an unintended pregnancy.
- ○Engage advocacy organizations in the effort to provide women with accurate information from trusted sources about how to use misoprostol safely for pregnancy termination.
- ○Raise awareness of the research on misoprostol among health care providers serving women.
- ○Disseminate information about misoprostol, including explicit and user-friendly directions on how to use it to end a pregnancy, through women's health resources, hotlines, videos, and websites; The Women on Waves website and the Guide for Women, written by theInternational Women's Health Coalition, Gynuity Health Projects, 2010, are two excellent examples.
International Women's Health Coalition, Gynuity Health Projects. (2010). Abortion with self-administered misoprostol: A guide for women. Available: http://iwhc.org/resource/abortion-self-administered-misoprostol-guide-women/. Accessed September 9, 2015.
- ○
- •Help women gain access to reliable sources of misoprostol.
- ○Identify providers who are willing to prescribe the drug.
- ○Recommend online sites that sell the pills with quality controls to ensure they are what they claim to be.
- ○Develop pathways for women to obtain pills from Canada, Mexico, or other countries where misoprostol is readily available.
- ○Explore advance prescription possibilities.
- ○
- •Increase public awareness of women's ability to use misoprostol to end a pregnancy safely.
- ○Pitch stories on evidence of the safety of misoprostol self-administration to health reporters and others with related beats.
- ○Share women's stories and information through social media and publish opinion pieces advocating for these proposals in online and print media.
- ○Develop apps that can assist women in their decision making.
- ○Launch a public information and education campaign.
- ○
- •Make medication abortion in general more widely available.
- ○Eliminate unnecessary regulatory barriers so that medication abortion can be provided in the ways that are safest, most effective, and most responsive to women's needs.
- ○Build on successful efforts to increase the range of providers, including family practice doctors and midlevel providers, offering medication abortion.
- ○Work with health care systems that are using innovative telemedicine practices to ensure inclusion of medication abortion services.
- ○
We realize just how audacious our proposal is. However, women are paying the price for our current timidity. We believe it is time to use this potentially game-changing technology to facilitate women's agency and autonomy, reduce barriers to care, and improve health outcomes. And maybe, just maybe, by putting these pills in women's hands, we can help to reframe the way people think about abortion—toward a process managed by and controlled by a woman.
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Biography
Francine Coeytaux, MPH, Public Health Institute, has more than 40 years of experience working in Africa, Latin America, and the United States, advocating for reproductive rights and promoting the development of new reproductive technologies, including emergency contraception, medication abortion, and microbicides.
Biography
Leila Hessini, MPH, MA, is Director of Community Mobilization and Women's Organizing at Ipas. Her global experience is informed by extensive residency in Egypt, Morocco, France, and the United States and engagement with women's human rights advocates in more than 40 countries.
Biography
Amy Allina, BA, is a senior leader in reproductive health, rights and justice. She served previously as Deputy Director of the National Women's Health Network and is a co-founder of Raising Women's Voices for the Health Care We Need.
Article info
Publication history
Published online: September 22, 2015
Accepted:
August 11,
2015
Received in revised form:
August 7,
2015
Received:
May 28,
2015
Identification
Copyright
© 2015 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.
