The Medical Letter on Drugs and Therapeutics
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In Brief: Expanded Access to Mifepristone
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Med Lett Drugs Ther. 2023 Jan 9;65(5058):1   doi:10.58347/tml.2023.5058a
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Objective(s)

First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies of up to 10 weeks' gestation. A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of the prostaglandin analog misoprostol terminates early intrauterine pregnancies in about 95% of women.

Before the COVID-19 pandemic, mifepristone could be dispensed to a patient only in-person by a certified prescriber. In late 2021, the FDA modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to allow mifepristone to be dispensed by mail by certified prescribers or pharmacies.1 The FDA has now announced that certified retail pharmacies will be permitted to dispense the drug to patients who present a prescription from a certified prescriber.2 To become certified, prescribers and pharmacies must complete agreement forms attesting to certain requirements. The patient is also required to complete an agreement cosigned by the prescriber. Retail pharmacies will not be permitted to dispense mifepristone in states that have passed laws forbidding medical termination of pregnancy.

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