Overview
“Medication abortion plays a crucial role in providing access to safe, effective and acceptable abortion care.” World Health Organization. Medical Management of Abortion, Geneva, 2018, p. 54 (World Health Organization) https://www.who.int/reproductivehealth/publications/medical-management-abortion/en/.
Medication abortion also referred to as medical abortion is the use of medicines to induce an abortion. Often referred to as the “abortion pill”, the U.S. Food and Drug Administration (FDA) has approved a regimen of two medicines, mifeprex (generic version is mifepristone ) and misoprostol for medical abortion up to 70 days gestation. The first pill, mifeprex is taken orally, and then 24 to 48 hours later, misoprostol is applied buccally. If mifeprex is unavailable then misoprostol alone is dispensed. Mifeprex (mifepristone) is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) which imposes a series of requirements for administering the medicine to individuals seeking a medication abortion. For example, mifeprex must be “…ordered, prescribed and dispensed by or under the supervision of a healthcare provider….” U.S. Food and Drug Administration (FDA). Mifreprex (mifepristone) Information. U.S. Food and Drug Administration, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
On December 16, 2021, the FDA announced it will no longer require in-person dispensing of mifeprex (mifepristone) in clinics, medical offices, and hospitals. This modification to REMS allows for dispensing of medication abortion by mail under the supervision of a certified healthcare provider. This revision improves patient access to medication abortion and provides for the use of telehealth. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. But see; 19 states prohibit access to medication abortion by mail. Guttmacher Institute. Medication Abortion, State Laws and Policies. 1 June 2023, https://www.guttmacher.org/state-policy/explore/medication-abortion
As of 2023, the FDA has permanently removed the in-person dispensing requirement for mifepristone and added a pharmacy certification process that will permit retail pharmacies to dispense mifepristone directly to patients who have a prescription from a certified provider.
Updated Mifepristone REMS Requirements
https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/01/updated-mifepristone-rems-requirements
Additionally, the FDA’s modification on the REMS now allows certified pharmacies to dispense medication abortion. U.S Food and Drug Administration. “Questions and Answers on Mifeprex.” https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex