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.

• Utilizing a continuing education course can help pharmacists counsel patients effectively and answer any questions they may have.

 

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.

 

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About 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.