Pharmacists Can Now Dispense Mifepristone Under Updated REMS Program

Mifepristone REMS Update for Pharmacies

What Does the January 2023 Update Mean for Mifepristone Dispensing?

Mifepristone is a medication that is used to end an early pregnancy. It has been available in the United States since 2000 and is widely used as a safe and effective option for ending a pregnancy during the first 10 weeks.

As of January 2023, the US Food and Drug Administration (FDA) announced an update to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. One of the most notable changes is the ability for pharmacists to dispense the drug to patients in the community retail setting. Pharmacies must become certified before they can order and dispense mifepristone. Pharmacies can become certified by choosing a designated representative to fill out the Pharmacy Agreement Form and oversee the implementation of the REMS program.

This only affects the dispensing aspect of mifepristone use. The requirements associated with the safe prescribing of this medication remain the same. This update is expected to alleviate the burden on patients and make medication abortion care more accessible. This revision to the REMS program is a step in the right direction for reproductive health access. 

The other component of the medication abortion regimen is misoprostol. Pharmacies have been dispensing misoprostol for medication abortion as well as other indications, so they can continue to do so without any changes.

 

Certification Requirements

Here are some of the most important steps to the certification process that pharmacists should know about.

  • Decide who will become the authorized representative(s). This individual(s) will oversee compliance with the REMS program.
  • Choose one Pharmacy Agreement Form from either Danco Laboratories or GenProBio to complete. You should pick the form that corresponds to the product — brand or generic — you plan to dispense most often.
  • Develop a record-keeping system for prescriber agreement forms. You can keep a binder with the physical forms or create a digital folder on the pharmacy computer. You will need a Prescriber Agreement Form (for either manufacturer) from each prescriber prior to filling the first prescription issued by them.
  • Record the NDC and lot number from each medication package dispensed in the patient’s record.
  • Mifepristone must be dispensed to the patient within four calendar days of the date the pharmacy receives the prescription.
    • If patients are set to receive the drug >4 days after the pharmacy received the prescription, confirm the appropriateness of dispensing with the prescriber.
    • If the pharmacy is mailing mifepristone, they must use a shipping service that provides tracking information.

 

How Should Pharmacists Counsel Patients?

  • Learn about the side effects, contraindications, counseling strategies, and follow-up needs related to mifepristone and misoprostol.

 

Why Is This Important?

Pharmacists play an integral role in medication abortion by ensuring that patients receive the correct medications in a timely manner and providing education on the proper use of the drugs. By providing guidance on other aspects of the abortion process, such as follow-up care and contraception options, pharmacists help to ensure that patients have a safe and successful abortion experience. It is important for pharmacists to be aware of these changes to ensure that they are providing their patients with the best care possible and following the requirements for dispensing mifepristone. 

 

Frequently Asked Questions

Can mifepristone be processed through prescription drug insurance?

There is no information yet on whether it is covered as a pharmacy benefit with the various health plans. Pharmacies should process the claims in hopes of coverage, and if not it will put the need for coverage on the radar for these health plans. For now, explain to patients it may be an out-of-pocket expense until their health plans align with the update. If any pharmacists have connections with health plans, this is an important issue to advocate for.

Federal Medicaid funding only pays for abortions when the pregnancy is a result of rape or incest or a threat to the pregnant person’s life. Sixteen states have opted to use their own state funds to pay for medication abortions, for Medicaid enrollees.

  • Alaska, California, Connecticut, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, Montana, New Jersey, New Mexico, New York, Oregon, Vermont, and Washington

Private insurance coverage of abortion services is variable and depends on the type of insurance plan, the policyholder’s state of residence, and employer coverage decisions. Pharmacists should encourage patients to contact their insurance provider if they have questions about whether a particular insurance provider will cover the cost of the drug. 

 

Can a pharmacist refuse to dispense mifepristone or misoprostol?

Pharmacists can legally refuse to fill prescriptions due to religious or personal values in most states that have conscience laws. However, some states require that pharmacists avoid neglecting or abandoning the patient’s needs. In other words, you have to ensure the patient is still able to get the medications elsewhere in a timely fashion if you are not going to fill the prescription. Check your state policy.

 

Are there any special storage or handling requirements for mifepristone?

No, but it is important to note that:

  • MIFEPREX is supplied as light yellow, cylindrical, and bi-convex tablets imprinted on one side with “MF.” One tablet is individually blistered on one blister card that is packaged in an individual package.
  • The generic mifepristone is light yellow, circular, and is also packaged individually.
  • Both should be stored at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).

 

Where can pharmacists receive training to dispense medication abortion tablets?

Located on our website is a continuing pharmacy education course that can help teach pharmacists about everything they need to know about medication abortion and the dispensing implications. It is a 1-hour home-study activity with no charge to participate, complements of UCSF’s ANSIRH, and it has received no commercial support.

 

How can a pharmacist support patients seeking medication abortion tablets, particularly in areas where access to such services may be limited?

If a pharmacy is not yet certified to dispense mifepristone, they can refer their patients to mail-order pharmacies. Here are three safe online options they can utilize: Honeybee Health, American Mail Order Pharmacy, and ManifestRx.

 

How will state bans affect pharmacy dispensing?

While pharmacies in any state may complete the pharmacy agreement for Danco or GenBioPro, they would not be able to legally dispense mifepristone for medication abortion if they are in a state that has banned medication abortion. Check your state policies.

 

How to know if a pharmacy is certified to dispense?

Pharmacies can inform their local providers when they’re enrolled to let them know about their certification. Pharmacies can consider proudly displaying signage in stores and on their social media to raise awareness about the availability of medication abortion care. We have some social media graphics that you are welcome to use. Patients are encouraged to call ahead to ask about a pharmacy’s status.

Some chains, like CVS and Walgreens, have stated they are in the works of becoming certified, but this doesn’t ensure every location will implement the program at the same rate.

 



Amanda IdusuyiAbout the Author

Amanda Idusuyi, Pharm.D Candidate, is a 4th-year student pharmacist in the Class of 2023 at the University of Connecticut School of Pharmacy. Amanda completed an elective APPE rotation with Birth Control Pharmacist.

How Pharmacy Students Can Advocate for Pharmacist Prescribing of Hormonal Contraception

Can pharmacy students advocate for pharmacists prescribing hormonal contraceptives? YES, that is exactly what Wilson Pace, a graduate of the University of Utah College of Pharmacy did. When Wilson heard about the barriers and costs that women experience when accessing contraceptives. His perseverance and dedication to advocacy as a pharmacy student allowed him to take action in his leadership class. Wilson drafted a “dream bill” which became Bill 184 in Utah. Bill 184  was passed in 2019 and allowed women in Utah to receive birth control prescriptions from their pharmacist.  

Fast forward to 2022; we now have 26 states + D.C that have either statewide protocols or collaboration practice agreements that allow pharmacists to prescribe birth control. But as pharmacy students we can do more! As of early 2022, the map below shows where pharmacists can prescribe hormonal contraceptives.

As future pharmacists we know that pharmacists are the most accessible healthcare providers (9 out of 10 Americans living within five miles of a pharmacy). The benefits pharmacists can offer women who are seeking hormonal contraceptives include accessibility, limiting barriers as well as reduced costs. 

Here are three easy ways pharmacy students can advocate for pharmacists to prescribe hormonal contraceptives if their state has not passed legislation yet:

  1. Research to see if any bills have been introduced in your state. If a bill has not been introduced you can help advocate for one to be started or start your own!
  2. Contact policymakers and advocate for them to support bills that allow. You can also look up your policy makers here: 
  3. Speak up and educate others by using your voice on social media such as LinkedIn, Facebook and Instagram. Share why it is important to you that pharmacists are able to provide access to contraceptives. To help spread your message to a larger audience use hashtags such as #advocacy #pharmacystudents #birthcontrol #birthcontrolpharmacies

What if you currently live in a state that allows pharmacists to prescribe contraceptives, can you still make an impact? The answer is YES! Even if your state has allowed pharmacists to prescribe contraceptives you can still advocate here are 3 ways you can help:

  1. Check the Birth Control Pharmacies map to see if your pharmacy is listed. If your state allows pharmacists to prescribe hormonal contraceptives, encourage your pharmacist to fill out this form. This will help women be able to find a pharmacy near them. 

https://www.birthcontrolpharmacies.com/addpharmacy

  • Educate yourself by taking Birth Control Pharmacist’s free home study course to learn how to provide contraceptive care during the COVID-19 public health emergency. It is important to stay up to date on the ways you facilitate access to over-the-counter and prescription contraceptives.
  • Promote brainstorm ways that your pharmacy can promote contraceptive services. Maybe this is by creating a private area for counseling or developing ideas on how you can promote birth control services at your pharmacy.

I was interested in learning more about pharmacists prescribing hormonal contraceptives so I reached out to Dr. Rafie who allowed me to complete a rotation with her at Birth Control Pharmacist. I learned so much about legislation and advocacy during my 4 weeks on rotation. I was even able to discuss upcoming legislation that impacts pharmacists in South Carolina with my school’s Dean. Taking action as a student is a great way to impact the future of pharmacy. 

There are numerous ways pharmacy students can advocate for increased access to contraceptive services. As pharmacy students we have the power to advocate for legislation just like Wilson Pace and make an impact. Whether it is helping change an entire state’s contraceptive laws or helping a woman find a local pharmacy that provides contraceptive services it is important that we support everyone’s reproductive health and choices!

“If you want to make a difference in health care, you have to be involved…you have to advocate for your profession.” — Wilson Pace



Amy AckershoekAbout the Author

Amy Ackershoek is a pharmacy student in the Class of 2022 at the Medical University of South Carolina College of Pharmacy.

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.