Current regulations restrict access to medication abortion and contribute to the perception that people cannot safely take medication abortion pills (mifepristone and misoprostol) on their own without clinician supervision. Yet, mifepristone and misoprostol meet many of the FDA’s criteria for being available over the counter. They are safe, have no risk of overdose, are not addictive, and people are already using them safely on their own in many parts of the world. The possibility of an over-the-counter medication abortion model would involve the medications being available without a prescription in a drug store or grocery, similar to emergency contraception or condoms and pregnancy tests. The pills would come with detailed instructions as well as information about access to a number of different resources, such as a 24-hour telephone number to call with questions about the medication.
There are several areas, such as whether people can accurately assess how far along they are in pregnancy, that require further research. ANSIRH researchers are conducting a series of preliminary studies to address these gaps and to demonstrate whether medication abortion is appropriate for over-the-counter use. In this study, we will investigate whether individuals can:
- Understand a Drug Facts Label
- Assess gestational age and rule out other contraindications for medication abortion
- Self-administer the medications according to instructions
- Identify complications and know when to seek medical care, including for ongoing pregnancy
In Accuracy of self-assessment of gestational duration among people seeking abortion, researchers asked people seeking abortion a series of questions about how far along they thought they were in pregnancy. Researchers then compared their responses to their gestational duration on ultrasound. They found that broadening the screening questions used to assess gestational duration beyond the last menstrual period start date (LMP) resulted in improved accuracy and sensitivity of self-assessment at the 70-day (or 10 week) threshold to qualify for medication abortion.
For a summary of this paper, read our web feature or view this three-minute video. Based on this study’s findings, the researchers developed an interactive tool for providers or patients to calculate the accuracy of their gestational duration self-assessment using different combinations of questions, available here.
In the short term, these efforts will help support a wide variety of efforts aimed at improving access to clinic-based and self-managed medication abortion. In the long term, FDA approval of an OTC mifepristone-misoprostol product could dramatically increase access to medication abortion.