Upcoming Changes to the Mifepristone REMS Program: Implications for Pharmacy Practice

Mifepristone REMS Change

Pharmacists in the community setting may soon have the opportunity to ease access to medication abortion in the United States. In the coming months, mifepristone (Mifeprex) is anticipated to have an updated Risk Evaluation and Mitigation Strategy (REMS) Program that allows dispensing through local brick-and-mortar and mail-order pharmacies. This change will integrate pharmacists into abortion care and bring them to the forefront of the national discussion about reproductive rights. Staying up to date on new regulations and their legal implications is paramount for successfully navigating this new role pharmacists can play in reproductive health and providing the best patient care.

Background

Mifepristone (Mifeprex) and misoprostol (Cytotec) are used together for medication abortion, or drug-induced interuterine pregnancy termination. Since 2000, this medication combination has provided pregnant patients with a safe, noninvasive means to end an unwanted but otherwise uncomplicated pregnancy. Patients first take mifepristone, followed by misoprostol in 24 to 48 hours. While misoprostol is dispensed at the prescriber’s office or a local pharmacy, there have historically been strict dispensing regulations on mifepristone.

In order to access medication abortion, patients must first make an appointment with a reproductive healthcare provider to ensure that there are no contraindications to this method of pregnancy termination. Prior to the coronavirus-19 pandemic, the prescriber of mifepristone was the only individual allowed to dispense this medication. Patients were required to be physically present with the prescriber to obtain mifepristone. Appointments to receive this medication often occur after the initial pregnancy screenings, and barriers to abortion such as intimidation by protestors and geographical proximity to clinics severely limited patient access to this service. 

During the coronavirus pandemic, enforcement of the in-person dispensing requirement has been relaxed with the condition that adherence to all other requirements included in the Patient Agreement Form be maintained, allowing for the utilization of mail to dispense mifepristone, either mailed to the patient from the clinic or a partner mail-order pharmacy. This temporary change has not only allowed greater access to medication abortion, but has led to increased calls for the permanent modification of the REMS Program associated with mifepristone.

More information on medication abortion can be found here.

Forthcoming FDA Update to the Mifepristone REMS Program

The success of the pandemic-spurred dispense by mail model emboldened advocacy for adjusting the provisions associated with mifepristone. Though no formal announcement was made, the FDA’s question and answer webpage on mifepristone was updated on December 16, 2021 to include upcoming changes. After a comprehensive review of the safety data collected through mifepristone’s REMS Program, the FDA indicated that an updated REMS is appropriate and should include pharmacy dispensing of this medication. 

While this change brings a groundbreaking transformation to safe abortion access in the United States, there are limitations on its timely implementation into pharmacy practice. Customary with the FDA’s policies for updating REMS requirements, REMS modification notification letters have been sent to the manufacturers of Mifeprex and generic mifepristone. The manufacturers, Danco Laboratories and GenBioPro, will draft an updated REMS Program and submit it to the FDA for approval. Once approved, the modifications to the REMS Program will be in effect. Pharmacies will need to be certified to dispense mifepristone.

This change will only affect the dispensing aspect of mifepristone use. The requirements associated with the safe prescribing of this medication will likely remain the same.

How to Prepare for Changes to Pharmacy Practice 

Though the details of the updated REMS Program are not yet public, there are steps that pharmacists can take in order to prepare for this change.

  • Become familiar with the websites for Mifeprex and mifepristone from Danco Laboratories and GenBioPro. The current process for prescribers to certify to prescribe and dispense this product, the Prescriber Agreement Form, is relatively straightforward. It is likely that the certification process for pharmacies will be similar.

  • Complete a continuing pharmacy education program on medication abortion to get acquainted with the adverse events, contraindications, counseling points, and follow up requirements associated with mifepristone and misoprostol.

  • Develop pharmacy policies regarding the dispensing of this medication. If a pharmacist on staff is not willing to verify and dispense a mifepristone prescription, there should be reasonable alternatives in place to ensure patient access to this medication.

  • Identify local resources for patients. In states where abortion restrictions are in place, it is incredibly important to stay up to date on the options that patients have for safe and effective reproductive care. 

Conclusions

Pharmacists have been and continue to be the most accessible healthcare providers to patients. With the upcoming modification to mifepristone’s REMS Program, pharmacists can play a larger role in patients’ reproductive health. Commitment to lifelong learning is an essential component of effective pharmacy practice. Regardless of personal beliefs, we as healthcare providers have a responsibility to practice in an educated way that is respectful of our patients’ autonomy and right to care within the law.

 



MuscatAbout the Author

 

Jacqueline Muscat is a pharmacy student in the Class of 2023 at University of Michigan College of Pharmacy.

Present and Future Pharmacist Roles in Medication Abortion Care

Medication Abortion Pharmacist

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited.

Twenty years ago, the FDA approved mifepristone. Since then, medication has transformed the accessibility of abortion. In 2017, about 39% of abortions in the United States were medication abortions, reflecting many people’s preference for this option.1 As reproductive health services are transforming, it is important that pharmacy services become adaptive to them.

What is medication abortion?

A medication abortion is the use of medications to end a pregnancy. There are a couple of medication abortion regimens, but the only regimen approved by the FDA is a combination of mifepristone and misoprostol to end a pregnancy up to 70 days gestation.2

First, a patient takes 200 mg of mifepristone orally followed by 800 mcg of misoprostol buccally, 24-48 hours after the mifepristone dose. After 7-14 days, the patient must follow-up with a health care provider.2

Mifepristone works by binding competitively to the intracellular progesterone receptor, thus blocking the effects of progesterone that support the pregnancy.3 Misoprostol works by inducing contractions in the myometrium as well as relaxation of the cervix.4

According to a systematic review performed by the American College of Obstetrics and Gynecology (ACOG), medication abortion was 97% effective up to 70 days after gestation.5

Present pharmacist roles with medication abortion

Right now, the pharmacist role with medication abortion is minimal as patients receive their dose of mifepristone in the clinic to take either at that time or at home. A prescription for misoprostol may be filled at a pharmacy to be picked up by the patient. Pharmacists will counsel patients on how to take the misoprostol and what to expect with this medication.

Mifepristone is only able to be dispensed at a clinic as a result of restrictions in place as part of the Risk Evaluation and Mitigation Strategies, or REMS, with an exception allowing mail order during the pandemic. The purpose of REMS is to assure that a medication’s benefits outweigh its risks. Recently, there have been studies on the safety of mifepristone to determine whether the REMS requirements are necessary or not.

Future pharmacist roles with medication abortion

According to articles published in the New England Journal of Medicine and Journal of the American Pharmacists Association, the REMS restrictions on mifepristone use have been deemed medically unnecessary as the rates of adverse events and mortality are extremely low. Since its approval, only 19 deaths have been reported to the FDA out of over 3 million patients who had taken mifepristone giving it a mortality rate of 0.00063%.6 Additionally, analysis of data from studies of over 423,000 women, which demonstrated that nonfatal serious adverse events from mifepristone use ranged from 0.01-0.7% and were almost always able to be treated.6

There are research studies underway to evaluate no-test medication abortion protocols, medication abortion telehealth services, and pharmacy dispensing of mifepristone. As new information emerges, there will be more opportunities for pharmacists to have a role in medication abortion care.

Educational programming for pharmacy students and practicing pharmacists on medication abortion is limited. The University of California San Francisco’s Advancing New Standards in Reproductive Health (ANSIRH) recently released a home study continuing pharmacy education program titled “Pharmacists’ Role in Medication Abortionthat is free and open to all. Birth Control Pharmacist has an open access introductory curriculum that can be integrated into pharmacy curricula.

Conclusion

In summary, medication abortion is a critical and common component of women’s health and reproductive health services. Although there are currently restrictions on the ways that patients can obtain a medication abortion, this many soon change and pharmacists will be an important part of access.

This article was originally published in Pharmacy Times.

REFERENCES

  1. Jones RK, Witwer E and Jerman J, Abortion Incidence and Service Availability in the United States, 2017, New York: Guttmacher Institute, 2019, Accessed September 8, 2020. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017
  2. U.S. Food and Drug Administration (FDA), Mifeprex (mifepristone) information, 2018. Accessed September 20, 2020. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
  3. Mifeprex (mifepristone) [prescribing information]. New York, NY: Danco Laboratories, LLC; April 2019.
  4. Cytotec (misoprostol) [prescribing information]. New York, NY: Pfizer; February 2018.
  5. Chen, MJ, Creinin, MD. Mifepristone with buccal misoprostol for medical abortion: A systematic review. Obstetrics and gynecology, 2015;126(1), 12-21. Retrieved from https://escholarship.org/uc/item/0v4749ss.
  6. Mifeprex REMS Study Group, Sixteen years of overregulation: time to unburden Mifeprex, N Eng J Med, 2017;376(8):790-794,https://www.nejm.org/doi/full/10.1056/NEJMsb1612526.
  7. Raifman S, Orlando M, Rafie S, Grossman D. Medication abortion: potential for improved patient access through pharmacies. 2018;58(4):377-81.


About the AuthorBreanna Headshot

Breanna Failla is a pharmacy student in the Class of 2022 at Midwestern University in Illinois. Breanna completed a summer internship with Birth Control Pharmacist.