October 28, 2015 — Summary of "Bold Action To Meet Women's Needs: Putting Abortion Pills in U.S. Women's Hands," Coeytaux et al., Women's Health Issues, Sept. 22, 2015.
A woman living in areas of the U.S. "where legal restrictions make it impossible for her to get an abortion under the care of a trained medical provider" likely does not know how to access and administer "medications on her own to have an abortion safely," Francine Coetaux of the Oakland, Calif.-based Public Health Institute and colleagues state. But even a woman who is aware of the possibility likely will face substantial barriers to access and will not know what to expect or whether she is criminally liable for her actions.
In this commentary, the authors "[d]ra[w] 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" to "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 U.S.
The authors note that when the medication abortion drug mifepristone "was first approved in the United States" in 2000, "many hoped" it "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." However, "today's reality has fallen far short of those hopes," largely because of abortion-rights opponents who "are targeting medication abortion precisely because they are fully cognizant of how empowering it would be for women," the authors write. The authors call for reproductive-rights supporters "to seriously challenge" these restrictions, "especially given that they are not supported by scientific evidence."
The authors give an overview of access barriers to mifepristone, noting that FDA "approved [mifepristone] with a drug label that sets out a complicated and highly medicalized regimen for providing the pills" that restricts who can administer the medication and requires providers to register in a nationwide database. FDA's label for the drug also calls for a woman to make three provider visits: one for the mifepristone, another for a second drug called misoprostol and then a follow-up visit. According to the authors, "No other drug with a comparable safety profile carries a remotely similar label" and the "highly medicalized model of care promotes the false impression that abortion pills can be safe only if provided under the care of a clinician."
Moreover, "the way medication abortion is provided in clinical practice has been simplified" since Mifeprex's approval in 2000, the authors explain, noting that now two visits instead of three are required, the dose of mifepristone has been reduced and "women are now given the misoprostol to take at home." Nonetheless, FDA has not changed the drug label, "despite evidence that the simplified regimen is safer than, and as effective as" the outdated regimen, the authors write. According to the authors, "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."
The authors list several ways "to improve abortion access in the U.S. communities where services have been shut down" including "eliminat[ing] FDA's medically unsupported restrictions on access to mifepristone" and "explor[ing] the potential of using misoprostol alone" because distribution of misoprostol is "less restricted than" that of mifepristone.
The authors explain that 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," with an efficacy rate of 98%. However, the World Health Organization and several other medical experts recommend the use of misoprostol alone -- which is 85% effective -- where mifepristone "is not available." According to the authors, "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 [unintended] pregnancy."
"Globally, the medical establishment has taken notice," the authors continue, noting that "much research has been done to demonstrate the safety and efficacy of misoprostol for abortion."
However, women in the U.S. face additional barriers because "in the United States it is necessary to have a prescription to obtain misoprostol," the authors write. They continue, "Nonetheless, there is growing evidence of home use of misoprostol by women in the United States."
Barriers to Misoprostol Access
The authors question why information about misoprostol has been kept from U.S. women, given that "[e]vidence shows that misoprostol used alone will safely and effectively end most pregnancies under 16 weeks of gestation" and "access to abortion services continues to be severely curtailed in the United States."
The authors reject arguments about how "encouraging the use of misoprostol alone lowers the standard of care" compared with the combination regimen because "that comparison fails to recognize the current reality for U.S. women who face insurmountable barriers to access." They write that "misoprostol provides a path to safe abortion care where none currently exists."
Further, the authors counter claims about "health risks," noting that "the risk of a woman being harmed by using misoprostol for abortion is very low and easily mitigated." According to the authors, "the greatest risk is that the misoprostol is not effective and the pregnancy continues."
Meanwhile, "[t]he legal risks are harder to evaluate and quantify" and differ among states, the authors write. They note that "[o]ff-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," although FDA bans "promoting their products for unapproved uses." According to the authors, "[t]he 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." The authors cite recent cases in Arkansas, Georgia, Idaho, Indiana and Pennsylvania.
Emergency Contraception Comparison
The authors suggest that advocates could expand access to medication abortion by following the examples of emergency contraception advocates. The authors write, "Twenty years ago, [EC] ... was the best kept contraceptive secret," explaining that women "only had access to this option ... if she could find a provider willing to tell her about it" and help her use it. The authors note, "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." To make EC "more widely accessible," clinicians and advocates "[i]n the first stage ... set up a hotline that provided reliable information about" EC and referred women to health care providers who were willing to prescribe it, the authors write, adding, "Later, two pioneering reproductive health companies ... brought dedicated EC products to market."
The authors argue, "We can do for abortion what advocates did for [EC] -- share the knowledge that rigorous research has produced, teach [women] how to use the medication safely, and give women access to the pills."
The authors outline "an agenda for action" that would:
~ "Make accurate information available about safe and effective use of misoprostol to end an unintended pregnancy";
~ "Help women gain access to reliable sources of misoprostol";
~ "Increase public awareness of women's ability to use misoprostol to end a pregnancy safely"; and
~ "Make medication abortion in general more widely available."
The authors "realize just how audacious [their] proposal is," but they argue that "women are paying the price for our current timidity." Further, they write, "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."