A safe and effective option at early gestations, medication abortion accounted for nearly one-third (31%) of all nonhospital abortions in the United States in 2014. Many women prefer medication abortion to surgical abortion, as it 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 during which it can be used (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 among providers.
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 the medication abortion process 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.
- The updated protocol for administering medication abortion that was approved by the FDA in March 2016 is widely tested and evidence-based. This regimen is supported by the American College of Obstetrics and Gynecologists (ACOG), National Abortion Federation and Planned Parenthood Federation of America.
- This protocol includes a lower dose of mifepristone than was used in the previous regimen. The lower dose has been shown to be safer and just as effective.1–4
- Lowering the dose of mifepristone can reduce costs for the patient.
- Under the updated protocol, only one visit is required for a patient to obtain medication abortion, and the patient may take the second medication in the regimen (misoprostol) at home or another chosen location. Follow-up with the provider can be done over the phone 7–14 days later.3,5
- The protocol is approved for use up to 70 days after a patient’s last menstrual period (up from 49 days in the previous protocol).1,5
- The updated protocol is in accordance with standard medical practice. It is safe and effective and has fewer side effects than the previous regimen.
- Evidence shows that medication abortion is safe. Serious complications requiring hospitalization for infection treatment or transfusion occur in fewer than 0.4% of patients under the updated protocol.4
- The overall success rate using this protocol is 95–99%, higher than the 92% success rate using the regimen approved in 2000.5,6
- The updated regimen has been shown to cause fewer gastrointestinal side effects, such as nausea, vomiting and diarrhea.5,7
The administration of medication abortion has been 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 has imposed restrictions on medication abortion that hinder access for potential patients and do not reflect its long record of safe use.
- Mifeprex, the mifepristone pill licensed for medication abortion in the United States, is subject to a Risk Evaluation and Mitigation Strategy (REMS) that limits dispensing to certified providers and specified settings, which do not include retail pharmacies.8
- The FDA’s limitations on Mifeprex distribution and prescription can discourage some providers from offering medication abortion. Providers who complete Mifeprex certification must be listed in a database of certified abortion providers, which elevates some providers’ perceived risk of harassment.9
- Because Mifeprex can only be dispensed by a certified provider and in certain health care settings, providers who wish to offer medication abortion in a timely fashion must keep a supply of the pills on hand, and patients who are served by telemedicine must still visit a provider’s office or clinic to obtain the medication.9,10
- This dispensing requirement prevents patients from obtaining the medication via mail order or from retail pharmacies.9,10
- A 2017 expert panel suggested that the REMS is inconsistent with Mifeprex’s safety record and simplicity of use, and places an unfair burden on those seeking access to medication abortion.9
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 to be provided at a particular type of facility, solely by a physician or in the physical presence of a health care provider yields no improvement in safety or quality of care.11
- The use of medication abortion has increased, even as overall abortion rates decline. Between 2011 and 2014, the number of medication abortions provided at facilities other than hospitals increased by 14%.12
- Facilities that offer a broad range of health care services beyond abortion increasingly provide medication abortion. The proportion of such nonspecialized health care facilities and physicians’ offices offering medication abortion increased between 2011 and 2014 by 26% and 20%, respectively.12
- In 2014, nonspecialized health care facilities provided 36% of all abortions and more than half of all medication abortions.12
- Medication abortion accounted for more than half of all abortions at facilities that provide fewer than 400 abortions per year.12
- Practically speaking, 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 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.14
- 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.15
- The use of telemedicine has increased substantially in the last decade. For instance, the number of telehealth claims under Medicare increased by nearly 1,000% between 2007 and 2016.16
- By reducing time and costs associated with provider visits, communications technologies help improve the accessibility of medical care while lowering the cost of provision.17
- The American Medical Association supports the use of telemedicine as a means of improving the quality of health care delivery to patients.18
- 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.19
- The use of telemedicine for medication abortion can help address barriers for women who live in rural areas and others who may have difficulty traveling to a health facility.20
- 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
- In 2014, 39% of women aged 15–44 lived in a county that had no abortion clinic.12
- Removing barriers to clinic access for rural women or mitigating the need for travel could reduce delays in receiving care and enable women to obtain an abortion at the earliest stages of pregnancy, when it is safest.20,21 Delaying care increases both the risks and costs of abortion.
- 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.22
- Evidence shows that allowing direct-to-patient dispensing at pharmacies or by mail can increase access to medication abortion, especially in conjunction with prescribing via telemedicine. In Australia, certifying pharmacists to dispense medication abortion drugs significantly increased the number of sites where women could obtain an abortion.23
- Many women worldwide, including some in the United States, choose to self-administer medication abortion outside of a formal health care setting.
- The World Health Organization suggests that self-managed abortion can be safe and effective, but women 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, over 70% of respondents were searching because they were pregnant and either did not want to be or were unsure about wanting to be, and over 80% of respondents were specifically seeking information on ”self-abortion” or “abortion pill.”24
- Studies have shown that women 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 given clear instructions and guidance for evaluation.25
Counseling About Medication Abortion Reversal
Recently, states have begun to require that abortion counseling include the unverified claim that medication abortion can be “reversed” if a woman is given a high dose of progesterone after she takes mifepristone. There is no medical evidence to support this assertion and 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.26 The study authors did not apply for ethical approval and did not use a control group.27–29 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, nor did it have a control group.30
- 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.29 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.”31
- 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.29
- 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
RECENT STATE ACTION ON THIS ISSUE
States that have addressed this issue over the past three years are listed below.
E: State enacted a relevant measure
V: State vetoed measure
A: State adopted measure in at least one chamber
States that prohibit prescription of mifepristone via telemedicine
South Carolina (2016)
West Virginia (2017)
States where providers must adhere to FDA protocol when prescribing mifepristone
States that require counseling on medication abortion “reversal”
Arizona (2015, 2016)
South Dakota (2016)
1. U.S. Food and Drug Administration (FDA), Mifeprex (mifepristone) label, 2005, https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf.
2. FDA, Mifeprex (mifepristone) label, 2016, https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf.
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-of-the-fdas-update-to-the-medication-abortion-label/.
4. 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.ncbi.nlm.nih.gov/pubmed/22898359.
5. FDA, Mifeprex (mifepristone) information, 2016, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm.
6. FDA, Mifeprex (mifepristone) information, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf.
7. Schaff EA, Mifepristone: ten years later, Contraception, 2010, 81(1):1–7.
8. FDA, Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex (mifepristone), 2016, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf.
9. Mifeprex REMS Study Group, Sixteen years of overregulation: time to unburden Mifeprex, New England Journal of Medicine, 2017, 376(8):790-794, http://www.escrh.eu/sites/escrh.eu/files/nejm_23feb.pdf.
10. 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/2504191.
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 and Jerman J, Abortion incidence and service availability in the United States, 2014, Perspectives on Sexual and Reproductive Health, 2017, 49(1):17–27, https://www.guttmacher.org/journals/psrh/2017/01/abortion-incidence-and-service-availability-united-states-2014.
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. FDA, Questions and answers on Mifeprex, 2016, https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm492705.htm.
15. Boonstra HD, Medication abortion restrictions burden women and providers—and threaten U.S. trend toward very early abortion, Guttmacher Policy Review, 2013, 16(1):18−23, https://www.guttmacher.org/gpr/2013/03/medication-abortion-restrictions-burden-women-and-providers-and-threaten-us-trend-toward.
16. Pittman D and Boschma J, Medicare spending on telehealth continues to climb, POLITICO Pro, 2017, https://www.politicopro.com/datapoint/2017/08/medicare-spending-on-telehealth-continues-to-climb-000595.
17. 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, http://content.healthaffairs.org/content/33/2/194.full.pdf.
18. 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.
19. Statement by Hal Lawrence on behalf of the American Congress of Obstetricians and Gynecologists (ACOG), U.S. Senate Committee on the Judiciary, Hearing on S. 1696, The Women’s Health Protection Act, July 15, 2014, http://www.acog.org/-/media/Departments/Government-Relations-and-Outreach/20140715S1696Testimony.pdf.
20. 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-abortion-patients.
21. 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.
22. Grossman D and Grindlay K, Safety of medical abortion provided through telemedicine compared with in person, Obstetrics & Gynecology, 2017, 130(4):778–782, https://www.ncbi.nlm.nih.gov/pubmed/28885427.
23. Grossman D and P Goldstone, Mifepristone by prescription: a dream in the United States but reality in Australia, Contraception, 2015, 92(3):186–189, http://www.contraceptionjournal.org/article/S0010-7824(15)00252-8/pdf.
24. Jerman J, Onda T and Jones RK, “What are people looking for when they Google ‘self-abortion’?”, Contraception, 2018, 97(6):510–514.
25. 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.
26. 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-reproductive-rights-abortion-pill-reversal.html.
27. Delgado G and Davenport ML, Progesterone use to reverse the effects of mifepristone, Annals of Pharmacotherapy, 2012, 46(12):e46.
28. Grossman D et al., Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: a systematic review, Contraception, 2015, 92(3):206–211.
29. ACOG, Facts are important: Medication abortion “reversal” is not supported by science, 2017, https://www.acog.org/-/media/Departments/Government-Relations-and-Outreach/FactsAreImportantMedicationAbortionReversal.pdf.
30. 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.
31. Louisiana Department of Public Health, Legislative Report on 2016 House Concurrent Resolution 87, 2017, http://www.dhh.louisiana.gov/assets/docs/LegisReports/HCR87RS20161.pdf.