Sally Rafie, PharmD
Sally Rafie, PharmD, BCPS, APh, NCMP is a pharmacist specialist at the University of California San Diego (UCSD) Health and an assistant clinical professor at the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences. She started the Birth Control Pharmacist project (www.birthcontrolpharmacist.com) to help educate pharmacists and other health care professionals about family planning topics such as hormonal contraception, emergency contraception, and youth-friendly pharmacy services. Her advocacy efforts support widespread access to reproductive health services and products, particularly in pharmacies.
The FDA approved mifepristone for this use in 2000, but it is also used off-label for other related indications.
When did the label change?
On March 29, 2016, the FDA approved new and updated labeling for mifepristone that included revisions to the drug’s prescribing information, as well as its Risk Evaluation and Mitigation Strategy (REMS) requirements.
Although the patient medication guide is no longer required as part of mifepristone’s REMS program, it has still been updated. The patient and prescriber agreements remain part of the REMS and reflect the updates.
What are the changes?
The updates reflect the most current clinical practices and safety and efficacy data after more than 15 years of use. They will allow for expanded access to this safe and highly effective medication.
|New Label||Old Label|
|Indication||Use through 70 days gestation||Use through 49 days gestation|
|Mifepristone Dose||Day 1: mifepristone 200 mg (1 tablet)||Day 1: mifepristone 600 mg (3 tablets)|
|Misoprostol Dose and Timing||24-48 hours after Mifeprex(r): Misoprostol 800 mcg (4 tablets) buccally||Day 3: Misoprostol 400 mcg (2 tablets) orally at health care provider facility|
|Misoprostol Repeat Dose||Optional||Not optional|
|Post-Treatment||Assessment 7-14 days after mifepristone administration||Examination 14 days after mifepristone administration (patients return to provider)|
|Prescribers||By or under the supervision of a health care provider who prescribes.||By or under the supervision of a physician.|
|Patient Med Guide||Not required||Required|
Why are these labeling updates so important when the drug can be used off-label?
Unlike other medications, mifepristone is subject to additional restrictions imposed by some state laws. While some states are attempting to restrict the use of mifepristone to its FDA-approved indication, the updated label may improve access for women in those states.
Of note, the labeling updates are supported by the American Congress of Obstetricians and Gynecologists, the Association of Reproductive Health Professionals, and several other related organizations.
What do pharmacists need to know?
Pharmacists should be aware of the mechanism of action of mifepristone and misoprostol for terminating a pregnancy, among other indications.
The most important labeling change approved by the FDA is the indication for medical abortion through 70 days (or 10 weeks) gestation. Additionally, the label now contains the evidence-based regimen of mifepristone 200 mg orally, followed by misoprostol 800 mcg buccally in 24 to 48 hours. The packaging will be updated to reflect this regimen, and each mifepristone tablet will be packaged individually in a blister card.
What role do pharmacists play in medical abortion?
While mifepristone has limited distribution that doesn’t include all pharmacies, pharmacists can facilitate access to this medication in health systems by partnering with family planning providers to develop evidence-based protocols for use.
The REMS requirements are now evidence-based, which should make hospital pharmacy and therapeutic committees more comfortable with mifepristone use. There are still evidence-based indications that are not FDA-approved, but pharmacists can help develop procedures for their safe use.
In the community setting, pharmacists can ensure their inventory meets patients’ needs for misoprostol, along with analgesics or antibiotics that may be co-prescribed. Many patients will also rely on their pharmacists to provide accurate counseling about buccal administration of misoprostol.
Pharmacists can meet patients’ needs by ensuring privacy and providing medically accurate information. Pharmacies can connect with tlocal family planning providers to share best practices and assure them that their patients will be treated with respect when filling their prescriptions and purchasing OTC items.
Further, pharmacists have an opportunity to discuss contraception with patients undergoing a medical abortion. However, this must be done with sensitivity. It would be best to discuss a patient’s need for contraceptive counseling with his or her family planning provider first.