Pharmacists Can Now Dispense Mifepristone Under Updated REMS Program – Birth Control Pharmacist

What Does the January 2023 Update Mean for Mifepristone Dispensing?

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

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

This only affects the administration aspect of mifepristone. The requirements related to safe prescribing of this drug remain the same. This update is expected to ease the burden on patients and make medication abortion care more accessible. This change in the REMS program is a step in the right direction for access to reproductive health.

The other component of the medication abortion regimen is misoprostol. Pharmacies provide misoprostol for abortion medication as well as other indications, so they can continue to use it without any changes.

Certification Requirements

Here are some of the most important steps in the certification process that pharmacists should be aware of.

• Decide who will be the authorized representative(s). This individual(s) will oversee compliance with the REMS program.

• Choose a Pharmacy Agreement Form from either Danco Laboratories o GenProBio to complete. You should choose the form that corresponds to the product — brand or generic — that you plan to administer frequently.

• Develop a record keeping system for prescriber agreement forms. You can keep a binder with physical forms or create a digital folder on the pharmacy’s computer. You will need a Prescriber Agreement Form (for either manufacturer) from each prescriber before filling the first prescription they issue.

• Record the NDC and lot number from each drug package administered in the patient’s record.

• Mifepristone must be given to the patient within four calendar days of the date the pharmacy receives the prescription.
  • If patients are scheduled to receive medication >4 days after the pharmacy receives the prescription, confirm appropriateness of dispensing with the prescriber.
  • If the pharmacy ships mifepristone by mail, they must use a shipping service that provides tracking information.

How Should Pharmacists Counsel Patients?

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

Why is this important?

Pharmacists play an important role in abortion medicine by ensuring that patients receive the correct medications in a timely manner and providing education on the proper use of medications. By providing guidance on other aspects of the abortion process, such as follow-up care and contraceptive options, pharmacists help 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 complying with the requirements for dispensing mifepristone.

Frequently Asked Questions

Can mifepristone be covered by prescription drug insurance?

No information yet on whether this is covered as a pharmacy benefit in various health plans. Pharmacies must process claims in anticipation of coverage, and if not, this will put the need for coverage on the radar for these health plans. For now, explain to patients that this may be an out-of-pocket cost until their health plans comply with the update. If any pharmacist has a connection with health plans, this is an important issue to advocate for.

Federal Medicaid funding only paying for abortions when the pregnancy is the result of rape or incest or a threat to the life of the pregnant woman. Sixteen states have opted to use their own state funds to pay for medication abortions, for those enrolled in Medicaid.

• 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 the employer’s 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 give mifepristone or misoprostol?

Pharmacists can legally refuse to fill prescriptions because of religion or personal values ​​in most states with conscience laws. However, some state requires that pharmacists avoid neglecting or abandoning patient needs. In other words, you have to make sure that the patient can still get the drugs elsewhere in a up to date fashion if you don’t fill the prescription. Check your state policy.

Are there any special storage or handling requirements for mifepristone?

No, but it’s important to note that:

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

Where can pharmacists receive training to administer abortion pills?

Located on our website are a continuing pharmacy education course which can help educate pharmacists about everything they need to know about medication abortion and the implications of dispensing. This is a 1-hour home study activity with no cost to participate, supplements UCSF’s ANSIRH, and has received no commercial support.

How can pharmacists support patients seeking medical abortion pills, particularly in areas where access to such services may be limited?

If a pharmacy is not yet certified to dispense mifepristone, they may refer their patients to mail order pharmacies. Here are three safe online options they can use: Bee Health, American Mail Order Pharmacyand ManifestRx.

How will state bans affect pharmacy dispensing?

Although pharmacies in any state can complete the pharmacy agreement for Danco or GenBioPro, they will not be able to legally provide mifepristone for medication abortion if they are in a state that prohibits medication abortion. Check your state’s policies.