Researchers, Advocates Seek Pathways to Easing Access to Medication Abortion
A new analysis of medical literature examined the evidence needed to determine whether women can safely access nonprescription medication abortion without a prescription.1 Considering medical pregnancy termination through an over-the-counter regulatory lens clarifies critical evidence gaps, researchers noted.
Medication abortions accounted for 31% of all nonhospital abortions in 2014, and for 45% of abortions before nine weeks’ gestation.2 In the 16 years since the United States approved mifepristone for abortion, research and clinical experience have underlined the efficacy and safety of the mifepristone/misoprostol regimen for the procedure. However, many women who could benefit from mifepristone still do not have access to it because of multiple barriers, including FDA distribution and provider requirements.3
One key step in making medication abortion more accessible is removing unnecessary dispensing restrictions, says Kelly Blanchard, president of Ibis Reproductive Health, an international nonprofit research organization for reproductive health.
Mifepristone is not available in pharmacies like other prescription medicines, Blanchard explains. Its access is restricted by an FDA regulation mechanism known as Risk Evaluation and Mitigation Strategy (REMS), which normally is for medicines that are dangerous or require more complicated screening to use safely, she notes.
“Though mifepristone is safe and effective, the REMS require that it can only be dispensed to patients in clinics, medical offices, and hospitals by or under the supervision of a certified provider, and that each person taking mifepristone must be given a medication guide and sign an FDA-approved patient agreement,” Blanchard says. “Years of experience and rigorous research in the U.S. and around the globe show mifepristone is safe and effective, and there is no medical justification for the REMS.”4
Eliminating the REMS, which places medically unnecessary burdens on providers and patients, to reflect the safety and efficacy of mifepristone would help improve access for all people, regardless of income or ZIP code, Blanchard argues.
“Medication abortion has the potential to fill gaps in abortion access, since it doesn’t require the facilities that other abortion procedures require, and removing the REMS would hopefully be a first step toward easier access and fewer restrictions,” she says.
In 2016, the FDA approved updated labeling for mifepristone (Mifeprex) to reflect the most current clinical practices and safety and efficacy data. The drug’s new label reduces the size of the initial dose to 200 mg and extends the window for taking it to 70 days since the first day of a woman’s last menstrual period. The updated label also allows the second drug in the medication abortion regimen, misoprostol, to be taken “at a location appropriate for the patient.” (For previous Contraceptive Technology Update reporting on this subject, please visit: http://bit.ly/2qL2WGP.)
Researchers also are documenting the potential for even less supervision, including showing the safety and effectiveness of telemedicine and other innovative ways to access medication abortion, Blanchard says.
Access to abortion is difficult for many U.S. women. A national survey conducted in 2008 found that 31% of patients in rural areas traveled more than 100 miles for abortion services.5 Since then, states have enacted even more restrictions on abortion, including limits on the construction of facilities, the qualifications for clinicians, and affiliated medical procedures.
According to a new analysis from the Guttmacher Institute, the number of U.S. abortion-providing facilities declined from 1,720 to 1,671 between 2011 and 2014. Meanwhile, the number of clinics providing abortion services declined from 839 to 788 over the same period. In 2014, 90% of all U.S. counties lacked a clinic, and 39% of women of reproductive age lived in those counties.2
Telemedicine provisions of medication abortion has been shown to be safe and effective.3 A 2014 practice bulletin from the American College of Obstetricians and Gynecologists noted that the procedure can be provided safely and effectively via telemedicine with a high level of patient satisfaction.6 However, 19 states require that the clinician providing a medication abortion be present during the procedure, thereby prohibiting the use of telemedicine to prescribe medication for abortion remotely.
“We look forward to helping to both make the case and build the evidence base so women can access medication abortion in a way that meets their needs, including potentially over the counter, and can decide for themselves whether to have an in-clinic or home abortion, with no fear of legal repercussions,” Blanchard says.
REFERENCES
- Kapp N, Grossman D, Jackson E, et al. A research agenda for moving early medical pregnancy termination over the counter. BJOG 2017; doi.org/10.1111/1471-0528.14646. [Epub ahead of print].
- Jones RK, Jerman J. Abortion incidence and service availability in the United States, 2014. Perspect Sex Reprod Health 2017;49:17-27.
- Raymond EG, Chong E, Hyland P. Increasing access to abortion with telemedicine. JAMA Intern Med 2016;176:585-586.
- Mifeprex REMS Study Group. Sixteen years of overregulation: Time to unburden Mifeprex. N Engl J Med 2017;376:790-794.
- Jones RK, Jerman J. How far did US women travel for abortion services in 2008? J Women’s Health 2013;22:706-713.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 143: Medical management of first-trimester abortion. Obstet Gynecol 2014;123:676-692.
States That Require Clinician Presence
The following states require prescribing clinicians to be physically present during medication abortion procedures:
- Alabama
- Arizona
- Arkansas
- Indiana
- Kansas
- Louisiana
- Michigan
- Mississippi
- Missouri
- Nebraska
- North Carolina
- North Dakota
- Oklahoma
- South Carolina
- South Dakota
- Tennessee
- Texas
- West Virginia
- Wisconsin
SOURCE: Guttmacher Institute. State Laws and Policies. Medication Abortion. Available at: http://bit.ly/2qVoDUq. Accessed May 18, 2017.
Considering medical pregnancy termination through an over-the-counter regulatory lens.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.