Pharmacists in the community setting may have an opportunity to facilitate access to abortion medication in the United States. In the coming months, mifepristone (Mifeprex) is expected to have an updated Risk Evaluation and Mitigation Strategy (REMS) Program that allows dispensing through local brick-and-mortar and mail-order locations. pharmacy. This change will involve pharmacists in abortion care and bring them to the forefront of the national discussion about reproductive rights. Staying current on new regulations and their legal implications is paramount to successfully navigating the new role pharmacists can play in reproductive health and providing the best patient care.
Background
Mifepristone (Mifeprex) and misoprostol (Cytotec) are used together for medical abortion, or termination of drug-induced interuterine pregnancy. Since 2000, this drug combination has provided pregnant patients with a safe, non-invasive way to end an unwanted but otherwise uncomplicated pregnancy. Patients take mifepristone first, followed by misoprostol for 24 to 48 hours. While misoprostol is dispensed in the prescriber’s office or at a local pharmacy, there have historically been strict dispensing regulations on mifepristone.
To access medication abortion, patients must first make an appointment with a reproductive healthcare provider to ensure there are no contraindications to this method of pregnancy termination. Before the coronavirus-19 pandemic, the mifepristone prescriber was the only individual allowed to administer this medication. Patients must be physically present with the prescriber to obtain mifepristone. Appointments to receive this medication often occur after initial pregnancy tests, and barriers to abortion such as intimidation by protesters and geographical proximity to clinics severely limit patient access to this service.
During the coronavirus pandemic, enforcement of the in-person dispensing requirement has been relaxed provided that compliance with all other requirements is included in Patient Agreement Form maintain, which allows for the use of mail to dispense mifepristone, can be sent to the patient from the clinic or a mail order pharmacy partner. This temporary change not only allowed more access to abortion medication, but led to more calls for permanent changes to the REMS Program related to mifepristone.
More information on abortion medication can be found here here.
Forthcoming FDA Update on the Mifepristone REMS Program
The success of the pandemic-spurred dispense by mail model has emboldened advocacy for adjustments to mifepristone-related provisions. Although no formal announcement was made, the FDA’s questions and answers on the 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 drug.
Although this change brings about a groundbreaking change in safe abortion access in the United States, there are limitations to its timely implementation in pharmacy practice. In accordance with FDA policies for updating REMS requirements, REMS change notification letters were sent to the manufacturers of Mifeprex and generic mifepristone. The manufacturers, Danco Laboratories and GenBioPro, will develop an updated REMS Program and submit it to the FDA for approval. Once approved, changes to the REMS Program will take effect. Pharmacies must be certified to dispense mifepristone.
This change will only affect the dispensing aspect of mifepristone. The requirements related to safe prescribing of this drug will likely remain the same.
How to Prepare for Changes in Pharmacy Practice
Although the details of the updated REMS Program are not yet public, there are steps pharmacists can take to prepare for this change.
- Familiarize yourself 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 fairly straightforward. The certification process for pharmacies is likely to be similar.
- Complete a pharmacy continuing education program about medication abortion to become familiar with adverse events, contraindications, advisory points, and follow up requirements associated with mifepristone and misoprostol.
- Develop pharmacy policies regarding dispensing this medication. If a staff pharmacist is not willing to verify and issue a mifepristone prescription, reasonable alternatives must be available to ensure patient access to this medication.
- Get to know the local resource for patients. In states where abortion restrictions in place, it is critical to stay current on the options 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 change to mifepristone’s REMS Program, pharmacists can play a greater role in patients’ reproductive health. A commitment to lifelong learning is an essential part of effective pharmacy practice. Regardless of personal beliefs, we as health care providers have a responsibility to practice in an educated manner that respects our patients’ autonomy and right to care within the law.
Jacqueline Muscat is a Class of 2023 pharmacy student at the University of Michigan College of Pharmacy.
