ISSUE1642
- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Discuss the new requirements for prescribing and dispensing mifepristone for pregnancy termination.
The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.1
Removal of the longstanding in-person dispensing requirement under the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program, which is not being enforced because of the COVID-19 pandemic, will permanently allow mifepristone to be dispensed by mail by certified prescribers or certified pharmacies.
Prescribers of mifepristone must be able to date pregnancies accurately, diagnose ectopic pregnancies, provide any necessary surgical intervention or arrange for others to do so, and ensure that women have access to emergency care. There are no such requirements for prescribing or dispensing misoprostol.
First approved in 2000 for termination of pregnancies of 49 days or less, the indication for mifepristone was expanded to include pregnancies of up to 70 days' gestation in 2016.2,3 A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of misoprostol terminates early intrauterine pregnancies in about 95% of women.4,5
- FDA. Mifeprex (mifepristone) information. December 16, 2021. Available at: https://bit.ly/34e5MZB. Accessed January 6, 2022.
- Mifepristone (RU 486). Med Lett Drugs Ther 2000; 42:101.
- Mifepristone (Mifeprex) label changes. Med Lett Drugs Ther 2016; 58:55.
- UD Upadhyay et al. Safety and efficacy of telehealth medication abortions in the US during the COVID-19 pandemic. JAMA Netw Open 2021; 4:e2122320.
- L Schummers et al. Abortion safety and use with normally prescribed mifepristone in Canada. N Engl J Med 2022; 386:57.
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