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.

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.

New Webinar Prepares Pharmacists to Provide Reproductive Health Services and Referrals

Pharmacists play a key role in providing health care to patients. Their scope is currently expanding into women’s health, specifically in prescribing birth control. As more states pass legislation to allow pharmacists to prescribe birth control, we are preparing pharmacy staff members with the appropriate knowledge and tools to best assist their patients.

We hosted an exciting webinar, “Meeting Reproductive Health Needs at the Pharmacy” with Provide. Provide is a nonprofit organization with a goal to provide healthcare and social services to patients without bias or judgement. They understand the lack of care for patients experiencing an unintended pregnancy and seek to provide a comfortable environment for people to explore their options. This webinar shed light and helped to educate pharmacists, student pharmacists, and pharmacy technicians about family planning services including birth control access, emergency contraception, and abortion. The program included myths and facts about reproductive health, best practices to combat stigma, and how to connect patients with local resources.

Anna Pfaff and Dr. Sally Rafie led the discussion. Each touching on different subject material and bringing some diverse perspectives to the topic, Dr. Rafie as a pharmacist who also runs Birth Control Pharmacist and Anna as a patient educator who coordinates Provide’s Referrals Program. There are many barriers for different populations, further magnified during the COVID-19 pandemic and Title X restrictions, to obtain family planning services.

One very important objective of the program was preparing pharmacists and pharmacy teams to combat stigma surrounding these services. Pharmacy best practices were provided to address individual, environmental, and structural stigmas. The presenters raised awareness around these issues and shared new practical pharmacy communication guides that pharmacists and pharmacy team members can use in their everyday practices. As an example, Dr. Rafie and Monica Sliwa (a UCSD pharmacy student intern with Birth Control Pharmacist) performed a role play activity to show different approaches to assisting a patient find an emergency contraception method in the pharmacy. They also demonstrated the steps to refer patients for other services using online directories.

Fortunately, if you missed the webinar, the video recording and materials are available for on-demand home study online at https://birthcontrolpharmacist.com/referrals/. The course material is available to all, with pharmacists and pharmacy technicians having an opportunity to obtain Continuing Pharmacy Education credit. This material provides education to pharmacy staff members in reducing stigma in access to reproductive health services.

Participants provided feedback at the conclusion. Keep reading to see their positive reviews and gain a better idea of what to expect from the Newonline course:

“Though not having a place of practice due to being in my 4th year of pharmacy school, I appreciated having these materials that can be utilized in whatever area of practice I’m in. I am interested in a career in women’s health and know that these resources will be valuable to me when transitioning into my career.”

“I love the handout provided, and I learned more about abortion clinics. I feel so much more comfortable about discussing options with patients now.”

“I plan on promoting this initiative and educating my colleagues on reproductive health competencies so that patients in my practicing state will have more options for accessibility.”

Meeting Reproductive Health Needs at the Pharmacy On-Demand Webinar


About the Author

Samantha ThompsonSamantha Thompson, PharmD Candidate is a pharmacy student in the Class of 2023 at University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. Samantha completed a summer internship with Birth Control Pharmacist.