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Ongoing study Over-the-Counter Medication Abortion

Para ver este contenido en español, clic aquí.

Please note: This webpage does not provide access to abortion pills or abortion care services. If you need information about how to obtain abortion care, including with pills, please visit INeedAnA or Abortion Finder.

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.

Study Design

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 are investigating whether individuals can:

ANSIRH researchers are currently in the planning phase to conduct an Actual Use Study. In this study, people seeking medication abortion will assess their eligibility for a prototype over-the-counter medication abortion product, using the previously developed Drug Facts Label and survey tools.

Implications

Medication abortion is safe and effective. Medication abortion now accounts for more than 60% of abortions in the US and has the potential to further expand access to care. In the current context, patients are usually evaluated by a clinician either in-person or via telehealth or online models of care and then prescribed medication abortion to take at home. While not approved by the FDA, an over-the-counter (OTC) model where people can pick up the medications at a local pharmacy without a prescription could improve access to abortion for many. The OTC model has the potential to reduce travel burden, does not require internet access or a mailing address, and can help to ensure access to abortion care earlier in pregnancy. We sought to understand if abortion patients and the general public are interested in OTC medication abortion as a potential option, and found high levels of interest in being able to access OTC medication abortion, and identified many benefits to the model. View this video for a summary of these findings.

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.

Additional Resources