By: Ashley Dao, PharmD Candidate c/o 2024

Medical abortion is approved by the Food and Drug Administration (FDA) to end intrauterine pregnancy through ten weeks gestation (i.e., within 70 days of the start of a patient’s last menstrual period). Mifepristone plays a major role in the termination of early pregnancies within the United States (U.S.). When taken in conjunction with misoprostol, its mechanism of action allows it to work as a highly effective form of medical abortion. Mifepristone is a progestin antagonist that competes with progesterone at progesterone receptor sites. By blocking the effects of progesterone, mifepristone disrupts pregnancy by causing decidual necrosis, myometrial contraction, and cervical softening. The most common side effects of mifepristone use (reported by >15% of patients in U.S. clinical studies) are diarrhea, nausea, vomiting, dizziness, headache, and fever.¹

In 2020, the Guttmacher Institute conducted a census of all known abortion providers in the US. The data revealed an upward trend in the use of the “abortion pill”; medical abortion accounted for 53% of U.S. abortions that year while in 2017, it accounted for only 39%.² Medication abortion is a safe, effective, and accessible form of abortion. It has an estimated complication rate of 0.22% and a mortality rate of 0.001%, with sepsis being the leading cause of drug-induced death.³ As of June 30, 2022, the FDA states that since its initial approval in 2000, mifepristone has been used by approximately 5.6 million U.S. patients; out of this population, there have been only 28 reports of deaths associated with its use.⁴ Despite over 20 years of scientific reviews and research supporting medication abortion as a safe and effective regimen, access to mifepristone is still restricted due to the nature of the drug. Mifepristone is subject to an FDA-imposed Risk Evaluation and Mitigation Strategies (REMS) Program that limits who can prescribe and dispense it. 

On January 3, 2023, the FDA modified the mifepristone REMS Program to allow mifepristone to be dispensed by certified pharmacies. The new REMS Program states that mifepristone must be dispensed by or under the supervision of a certified prescriber or certified pharmacies for prescriptions issued by a certified prescriber. Prior to this change, mifepristone could only be dispensed in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.⁵ The FDA determined that modifications to the REMS Program would reduce burden on the healthcare system and ensure the benefits of mifepristone outweigh the risk. Healthcare providers must complete a Prescriber Agreement Form to become certified and pharmacies must complete a Pharmacy Agreement Form to dispense mifepristone. Before dispensing mifepristone, patients also must review and sign a Patient Agreement Form with a certified prescriber. Healthcare providers are responsible for explaining the risk of the mifepristone treatment regimen to patients before prescribing. Pharmacists are responsible for ensuring that mifepristone is dispensed to patients in a timely manner, and if mifepristone is shipped, they must use a shipping service that offers tracking.⁶

This is not the first time that the federal government has broadened access to mifepristone. The FDA has incrementally expanded access to medical abortion since approving mifepristone. Prior modifications to the mifepristone REMS Program occurred in 2020 during the height of the coronavirus disease 2019 (COVID-19) pandemic. The pandemic brought to light the benefits of telehealth. On April 12, 2021, the FDA announced its “intent to exercise discretion with respect to in-person dispensing requirement during the COVID-19 public health emergency.”⁷ This would allow mifepristone to be mailed to patients during the pandemic. In December 2021, the FDA issued a permanent decision to allow the mailing of abortion pills and it would modify the REMS Program to add a requirement that pharmacies that dispense the drug be certified. On January 3, 2023, these modifications were reviewed and approved. The new FDA REMS program for mifepristone increases accessibility to abortion medication, but many patients throughout the country still face barriers.⁸

The FDA’s decision of expanding the mifepristone REMS Program to include certified pharmacies demonstrates the agency’s confidence that medical abortion is safe, effective, and time sensitive. Patients now have the ability to choose whether they want to go to their local pharmacy, receive the product by mail order, or visit a certified healthcare provider. There are still barriers in many states to safe abortion care, but this new regulation will benefit many patients in states without abortion bans or restrictions. 

References

1. Mifeprex (mifepristone) [package insert]. New York, NY; Danco Laboratories, LLC; Revised 01/2023.
2. Jones. R, et al. Medication abortion now accounts for more than half of all US abortions. Guttmacher Institute. Published February 24, 2022. Last Updated December 1, 2022. Accessed January 24, 2023. https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions
3. Allen R, O’Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009;2(3):159-168. Accessed May 16, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2760893/.
4. Mifepristone U.S. Post-Marketing Adverse Events Summary through 06/30/2022. FDA. Accessed March 12, 2023. https://www.fda.gov/media/164331/download
5. Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for Mifepristone 200mg. FDA. Accessed March 17, 2023. https://www.fda.gov/media/164650/download
6. Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. FDA. Last Updated March 23, 2023. Accessed May 19, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
7. Woodcock J. FDA response to ACOG April 2021 [letter]. ACLU. Accessed May 19, 2023. https://www.aclu.org/letter/fda-response-acog-april-2021
8. The Availability and Use of Medication Abortion. KFF. Last Updated May 19, 2023. Accessed May 19, 2023. https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/

Published by Rho Chi Post