Medication Abortion

Background

A safe and effective option at early gestations, medication abortion accounted for more than one-third (39%) of all abortions in the United States in 2017. Medication abortion is as safe as surgical abortion, but is noninvasive and can be completed in a patient’s chosen setting, such as at home.

Medication abortion using a combination of mifepristone and misoprostol was first approved by the U.S. Food and Drug Administration (FDA) in 2000. In 2016, on the basis of scientific studies, the FDA updated its protocol to a regimen that is just as effective but uses less medication, has fewer side effects, has a longer time span for use (up to 70 days after a patient’s last menstrual period) and requires fewer visits to the provider. By the time the protocol was updated, this evidence-based regimen was already in widespread use. Decades of clinical evidence suggest that medication abortion can even be provided without laboratory tests or ultrasound prior to administration, opening up further possibilities for service delivery.

However, abortion restrictions continue to hamper the delivery of medication abortion. Since 2004, states have enacted several types of restrictions targeting medication abortion. Most of the laws take one of two approaches: limiting provision to the FDA protocol or requiring in-person administration. By limiting providers to the current FDA protocol, states may preclude providers from taking advantage of future evidence-based changes in the administration of medication abortion. And by requiring in-person administration, states prevent providers from using telemedicine to administer medication abortion. In doing so, they reduce access to abortion in rural areas. In addition, a few states require providers to share with patients the medically unsupported claim that medication abortion can be reversed.

State Laws and Policies

For a chart of current laws and policies in each state related to medication abortion, see Medication Abortion.

For information on state laws and policies related to other sexual and reproductive health and rights issues, see State Laws and Policies, issue-by-issue fact sheets updated monthly by the Guttmacher Institute’s policy analysts to reflect the most recent legislative, administrative and judicial actions.

Relevant Data and Analysis

Administration of Medication Abortion

The protocol for administering medication abortion is based on decades of research showing that it is safe and effective.

  • The current FDA protocol1 for administering medication abortion, updated in March 2016, is widely tested and evidence-based. This regimen is supported by the American College of Obstetricians and Gynecologists (ACOG), National Abortion Federation and Planned Parenthood Federation of America.
    • While the FDA protocol is approved for use up to 70 days after a patient’s last menstrual period, clinical guidance for early abortion allows use up to 77 days, or 11 weeks of pregnancy.2
    • Under the protocol, only one visit is required for a patient to obtain medication abortion pills, and the patient may take the second medication in the regimen (misoprostol) at home or at another chosen location. Follow-up with the provider can be done over the phone 7–14 days later.3,4
  • Evidence shows that medication abortion is safe.3,4 Serious complications requiring hospitalization for infection treatment or transfusion occur in less than 0.4% of patients under the standard protocol.5
  • Medication abortion is highly effective; it has a success rate of more than 95% using the standard protocol.6

The administration of medication abortion is more heavily regulated than necessary. The medication abortion regimen is low risk and easy to follow, and the process can be safely managed by patients and providers. Despite this, the FDA imposes restrictions on medication abortion that hinder access for potential patients and do not reflect its long record of safe use.

  • Mifepristone, the medication licensed for medication abortion in the United States, is available as both a brand-name pill (Mifeprex) and as a generic (approved in 2019).4 Both are subject to a Risk Evaluation and Mitigation Strategy (REMS) that limits dispensing to certified providers and specified settings, which do not include retail pharmacies.7
  • The FDA’s limitations on mifepristone can discourage providers from offering medication abortion because providers have to preorder and stock the medication ahead of time and, as a result of the history of violence and harassment against abortion providers, may be reluctant to be added to the manufacturer’s record of certified providers.8,9
  • The REMS dispensing requirement prevents patients from obtaining the medication from a pharmacy (whether online or in person) like most other safe and effective medications.8,9
  • A 2017 expert panel suggested that the REMS is inconsistent with mifepristone’s safety record and simplicity of use, and places an unfair burden on those seeking access to medication abortion.8
  • During the COVID-19 pandemic, a federal district court temporarily blocked the FDA from requiring that medication abortion be dispensed in person for the duration of the pandemic, noting that an unnecessary trip to a medical facility likely imposed an undue burden on access.10

Expanding Abortion Access Using Medication Abortion

Medication abortion can be safely offered in diverse settings and by a range of health care providers.

  • An expert panel convened by the National Academies of Science, Engineering and Medicine in 2018 concluded that requiring medication abortion be provided at a particular type of facility, solely by a physician or in the physical presence of certain health care providers, yields no improvement in safety or quality of care.11
  • The use of medication abortion has increased, even as overall abortion rates decline. In 2017, medication abortion accounted for 39% of all abortions—an increase of 25% since 2014.12
    • The majority of medication abortions are provided at specialized abortion clinics, where more than half of patient visits are for abortion services. However, in 2017, nearly half (47%) were provided at nonspecialized clinics offering a broader range of health care services or at physicians’ offices.12
    • The number of abortion providers offering only medication abortion increased slightly between 2014 and 2017 (from 23% to 26%). A higher proportion of nonspecialized clinics (41%) offered medication abortion as their sole abortion service, compared with specialized abortion clinics (4%).12
  • Medication abortion does not need to be administered by physicians. It can be safely provided by other trained health care providers, including physician assistants, nurse practitioners and certified nurse midwives. State laws that restrict provision only to physicians limit patient access.11
    • The World Health Organization (WHO) recommends that general practice physicians, nurses, midwives and other advanced practice clinicians be allowed to provide medication abortion.13 Training in surgical abortion is not necessary to administer medication abortion.
    • The 2016 FDA protocol update expanded provider eligibility to include advanced practice clinicians.4
  • The recent growth in the use of telemedicine in diverse health care settings has proven that it is an effective and important tool for expanding access to care, improving health outcomes and reducing health care costs.14
    • The use of telemedicine has increased substantially in the last decade. For instance, a study of private health insurance claims showed the proportion of patients using telehealth increased by 1,200% between 2012 and 2017.15
    • By reducing time and costs associated with provider visits, communications technologies help improve the accessibility of medical care while lowering the cost of provision.16
    • The American Medical Association supports the use of telemedicine to improve the quality of health care delivery to patients.17
    • In testimony before the U.S. Senate Judiciary Committee, ACOG supported policies that increase access to reproductive health services, including the use of telemedicine for medication abortion.18
  • The use of telemedicine for medication abortion can help address barriers for people who live in rural areas and others who may have difficulty traveling to a health facility.19
    • An expert panel convened by the National Academies of Science, Engineering and Medicine in 2018 concluded that there is no medical need for medication abortion to be administered in the physical presence of a health care provider.11
    • To help prevent the spread of coronavirus during the COVID-19 pandemic, experts developed a no-test protocol to reduce in-person encounters. This protocol, endorsed by the National Abortion Federation, allows most patients to get the necessary medication from a clinic, or in some states, by mail, without ultrasounds or lab tests. Patients only have to come to a clinic for preabortion tests if they have particular contraindications or risk factors.20
    • In 2017, 38% of women aged 15–44 lived in a county that had no abortion clinic.12
    • Introducing telemedicine for medication abortion has substantially increased the number of clinic sites in rural regions of Maine and may have contributed to increases in other states, such as Alaska and Washington.21,22
    • Removing barriers to clinic access for rural people or mitigating the need for travel could reduce delays in receiving care and enable individuals to obtain an abortion at the earliest stages of pregnancy, when it is safest.19,23
    • In the United States, telemedicine abortion is typically offered using a site-to-site model: The prescribing clinician is at one health center and the patient receives medication at another. However, other models of direct-to-patient services have been tested and shown to be safe. The largest U.S. study of a telemedicine abortion service by mail, published in 2019, showed that individuals who received medication abortion by mail had similar outcomes as those who received it at a physician’s office; these individuals also reported high levels of satisfaction with the service.24 Medication abortion patients rarely experience adverse outcomes. The complication rate for medication abortion is exceedingly low (less than 0.5%), whether it is provided in person or by telemedicine.25
  • Many people worldwide, including some in the United States, choose to self-manage medication abortion outside of a formal health care setting.
    • WHO suggests that self-managed abortion can be safe and effective, but individuals must have accurate information and access to a health care provider if they want or need one.13
    • In a 2017 survey of Google users in the United States who searched for terms related to self-managed abortion, more than 70% of respondents were searching because they were pregnant and either did not want to be or were unsure about wanting to be, and more than 80% of respondents were specifically seeking information on ”self-abortion” or “abortion pill.”26
  • Studies have shown that individuals are able to accurately evaluate their eligibility for medication abortion and the completion of a medication abortion, indicating that women are able to self-administer medication abortion drugs when given clear instructions and guidance.27

Counseling About Medication Abortion Reversal

Some states require that abortion counseling include the unverified claim that medication abortion can be “reversed” by giving a patient a high dose of progesterone to stop the abortion after they take mifepristone. There is no medical evidence to support this assertion, and there are no data on the safety of this unproven treatment. In 2015, Arkansas became the first state to implement mandatory abortion reversal counseling; Arizona and South Dakota subsequently adopted similar laws.

  • These laws are primarily based on a case study published in 2012 that did not conform to minimum standards for medical research. The study—coauthored by an acknowledged antiabortion activist—describes the experience of six abortion patients who were given high doses of progesterone after taking only the first of the two drugs needed to complete the approved medication abortion regimen.28 The study authors did not apply for ethical approval and did not use a control group.1,29-31 In 2018, some of the same authors published results from an observational study of more than 500 abortion patients; this study also did not follow a uniform course of treatment or have a control group.32
  • A 2019 study attempted to test the experimental treatment in a rigorous, ethically designed controlled study, but researchers halted the study because of significant safety concerns. As a result, researchers were unable to draw conclusions about progesterone’s efficacy in stopping a medication abortion.33 ACOG does not support the use of progesterone to “stop” a medication abortion because the treatment does not meet clinical standards and is not based on scientific evidence.31 In addition, the FDA has not evaluated the claim that medication abortion can be reversed.
  • A 2017 Louisiana Office of Public Health report commissioned by the state legislature concluded that “there is neither sufficient evidence nor a scientific basis to conclude that the effects of an abortion induced with drugs or chemicals can be reversed.”34
  • Medication abortion is most effective when the patient follows the evidence-based protocol and takes both drugs. In addition, up to half of women who take only mifepristone continue their pregnancies.31
  • An expert panel convened in 2018 by the National Academies of Science, Engineering and Medicine concluded that requiring providers to give patients inaccurate or misleading information about the potential harms of abortion diminishes the quality of health care by interfering with patients’ ability to make personal medical decisions based on adequate information.11

Data Center

Recent State Action On This Issue

States that have addressed this issue over the past three years are listed below.

EState enacted a relevant measure

V: State vetoed measure

A: State adopted measure in at least one chamber

 

States that require counseling on medication abortion “reversal”

Arkansas (2019)

E

Idaho (2018)

E

Kansas (2019)

V

Kentucky (2019)

E

Nebraska (2019)

E

North Dakota (2019)

E

Oklahoma (2019)

E

Tennessee (2020)

E

Wisconsin (2019)

V

References

1. U.S. Food and Drug Administration (FDA), Mifeprex (mifepristone) information, 2018, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-a….

2. National Abortion Federation, 2020 Clinical Policy Guidelines for Abortion Care, Washington, DC: National Abortion Federation, 2020, https://prochoice.org/providers/quality-standards/.

3. Jones R and Boonstra H, The public health implications of the FDA’s update to the medication abortion label, Health Affairs Blog, 2016, http://healthaffairs.org/blog/2016/06/30/the-public-health-implications….

4. FDA, Questions and answers on Mifeprex, 2019, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-a….

5. Raymond EG et al., First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review, Contraception, 2013, 87(1):26–37, https://www.contraceptionjournal.org/article/S0010-7824(12)00643-9/fulltext.

6. Chen MJ and Creinin MD, Mifepristone with buccal misoprostol for medical abortion: a systematic review, Obstetrics & Gynecology, 2015, 126(1):12–21, https://escholarship.org/uc/item/0v4749ss.

7. FDA, Risk Evaluation and Mitigation Strategy (REMS) for single shared system mifepristone 200 mg, 2019, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_0….

8. Mifeprex REMS Study Group, Sixteen years of overregulation: time to unburden Mifeprex, New England Journal of Medicine, 2017, 376(8):790–794, https://www.nejm.org/doi/full/10.1056/NEJMsb1612526.

9. Raymond EG, Chong E and Hyland P, Increasing access to abortion with telemedicine, JAMA Internal Medicine, 2016, 176(5):585–586, http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2….

10. American Civil Liberties Union (ACLU),Federal court blocks FDA restriction that unnecessarily imposes COVID-19 risks on patients seeking abortion care, news release, New York: ACLU, July 13, 2020, https://www.aclu.org/press-releases/federal-court-blocks-fda-restrictio….

11. National Academies of Sciences, Engineering and Medicine, The Safety and Quality of Abortion Care in the United States, Washington, DC: National Academies Press, 2018.

12. Jones RK, Witwer E and Jerman J, Abortion Incidence and Service Availability in the United States, 2017, New York: Guttmacher Institute, 2019, https://www.guttmacher.org/report/abortion-incidence-service-availabili….

13. World Health Organization, Expanding Health Worker Roles for Safe Abortion in the First Trimester of Pregnancy, 2016, http://apps.who.int/iris/bitstream/10665/206191/1/WHO_RHR_16.02_eng.pdf.

14. Donovan M, Improving access to abortion via telehealth, Guttmacher Policy Review, 2019, 22:23–28, https://www.guttmacher.org/gpr/2019/05/improving-access-abortion-telehe….

15. FAIR Health, FH Healthcare Indicators and FH Medical Price Index 2019: An Annual View of Place of Service Trends and Medical Pricing, New York: FAIR Health, 2019, https://www.fairhealth.org/publications/whitepapers.

16. Kvedar J, Joel Coye M and Everett W, Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth, Health Affairs, 2014, 33(2):194–199, https://www.healthaffairs.org/doi/10.1377/hlthaff.2013.0992.

17. American Medical Association, Council on Medical Service, Coverage of and payment for telemedicine, Report 7-A-14, 2014, http://www.modernhealthcare.com/assets/pdf/CH95086612.PDF.

18. Lawrence HC, Testimony of the American Congress of Obstetricians and Gynecologists (ACOG), submitted to U.S. Senate Committee on the Judiciary, S. 1696, The Women’s Health Protection Act hearing, July 15, 2014, https://www.actforwomen.org/wp-content/uploads/2015/09/ACOG-Testimony-W….

19. Jones RK and Jerman J, Time to Appointment and Delays in Accessing Care Among U.S. Abortion Patients, New York: Guttmacher Institute, 2016, https://www.guttmacher.org/report/delays-in-accessing-care-among-us-abo….

20. Raymond EG et al., Commentary: no-test medication abortion: a sample protocol for increasing access during a pandemic and beyond, Contraception, 2020, 101(6):361–366, https://www.contraceptionjournal.org/article/S0010-7824(20)30108-6/fulltext.

21. D’Almeida K, Telemedicine abortion care is coming to Maine, Rewire.News, Feb. 29, 2016, https://rewire.news/article/2016/02/29/telemedicine-abortion-care-coming-maine/.

22. Kohn JE et al., Medication abortion provided through telemedicine in four U.S. states, Obstetrics & Gynecology, 2019, 134(2):343–350, doi:10.1097/AOG.0000000000003357.

23. Boonstra HD and Nash E, A surge of state abortion restrictions puts providers—and the women they serve—in the crosshairs, Guttmacher Policy Review, 2014, 17(1):9–15, https://www.guttmacher.org/gpr/2014/03/surge-state-abortion-restrictions-puts-providers-and-women-they-serve-crosshairs.

24. Raymond E et al., TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States, Contraception, 2019, 100(3):173–177, https://www.contraceptionjournal.org/article/S0010-7824(19)30176-3/abstract.

25. Grossman D and Grindlay K, Safety of medical abortion provided through telemedicine compared with in person, Obstetrics & Gynecology, 2017, 130(4):778–782, https://journals.lww.com/greenjournal/Fulltext/2017/10000/Safety_of_Med….

26. Jerman J, Onda T and Jones RK, “What are people looking for when they Google ‘self-abortion’?”, Contraception, 2018, 97(6):510–514, https://www.contraceptionjournal.org/article/S0010-7824(18)30068-4/fulltext.

27. Kapp N et al., A research agenda for moving early medical pregnancy termination over the counter, BJOG, 2017, 124(11):1646–1652, http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.14646/full.

28. Graham R, A new front in the war over reproductive rights: “abortion-pill reversal,” New York Times Magazine, July 18, 2017, https://www.nytimes.com/2017/07/18/magazine/a-new-front-in-the-war-over….

29. Delgado G and Davenport ML, Progesterone use to reverse the effects of mifepristone, Annals of Pharmacotherapy, 2012, 46(12):1723.

30. Grossman D et al., Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: a systematic review, Contraception, 2015, 92(3):206–211.

31. ACOG, Facts are important: Medication abortion “reversal” is not supported by science, 2017, https://www.acog.org/advocacy/facts-are-important/medication-abortion-r… .

32. Delgado G et al., A case series detailing the successful reversal of the effects of mifepristone using progesterone, Issues in Law & Medicine, 2018, 33(1):3–14.

33. Creinin MD et al., Mifepristone antagonization with progesterone to prevent medical abortion: a randomized controlled trial, Obstetrics and Gynecology, 2019, 135(1):158–165, https://journals.lww.com/greenjournal/Citation/2020/01000/Mifepristone_….

34. Louisiana Department of Public Health, Legislative Report on 2016 House Concurrent Resolution 87, 2017, http://www.dhh.louisiana.gov/assets/docs/LegisReports/HCR87RS20161.pdf.


Source URL: https://www.guttmacher.org/evidence-you-can-use/medication-abortion