Pharmacists play an important role in the provision of reproductive health care, including prescribing hormonal contraception and emergency contraception in some states. But pharmacists have limited involvement in abortion care, primarily due to the FDA’s dispensing restrictions on mifepristone. There is increasing interest in removing the dispensing restrictions on mifepristone in the United States, which would enable pharmacists to dispense the drug directly to patients with a prescription from their clinician. We are conducting a study, under an Investigational New Drug (IND) application to the FDA, examining the effectiveness and acceptability of pharmacist dispensing of medication abortion.
Used together with misoprostol, mifepristone is the gold standard regimen for safe and effective medication abortion. The U.S. Food & Drug Administration (FDA)’s current Risk Evaluation and Mitigation Strategy (REMS) requires that mifepristone be dispensed only from a doctor’s office, clinic or hospital by a certified health care provider and the health care provider must obtain a signed Patient Agreement Form before dispensing mifepristone. Under an Investigational New Drug Award from the FDA, a mechanism that allows researchers to bypass some restrictions on medications to study alternative uses of the medication, ANSIRH researchers are conducting a study to investigate the feasibility, acceptability, and effectiveness of pharmacist dispensing of medication abortion at participating clinics and pharmacies in California and Washington.
People participating in this study obtain medication abortion (mifepristone and misoprostol) from a pharmacy instead of the clinic after undergoing standard clinical evaluation for medication abortion in their clinician’s office or clinic. As part of the study, we are collecting data from a variety of sources for participants who receive care with this model. We are surveying patients, evaluating their clinical outcomes from electronic health records, and surveying and interviewing pharmacists about their experiences dispensing medication abortion.
Dispensing of mifepristone by trained pharmacists could improve access to medication abortion by enabling people to bypass geographic, financial, or insurance obstacles to clinic-based care and to receive abortion care earlier in pregnancy. Pharmacist dispensing could also help to increase the number of clinicians willing and able to provide medication abortion by enabling them to avoid the associated costs and logistical challenges of stocking and dispensing the medication in their facilities.
The next step: Provision by mail order
While dispensing abortion drugs at brick-and-mortar pharmacies is an important first step in improving access to abortion, we recognize that some pharmacies and pharmacists may refuse to carry and/or dispense mifepristone. We are therefore also investigating the feasibility and acceptability of mail-order pharmacy dispensing of medication abortion, in collaboration with an established online pharmacy. Mail-order dispensing of mifepristone could increase access to medication abortion particularly for individuals who live in parts of the country with few abortion providers and where few pharmacies may agree to stock the medication.
Are you a provider interested in offering medication abortion?
We are currently recruiting interested clinicians who are not providing medication abortion and who see 10-20 people who might be eligible for and interested in medication abortion per year to participate in this study. For more information about the Mail-Order Mifepristone Study, please contact us.
Are you a pharmacist interested in learning about medication abortion?
ANSIRH is also offering pharmacists the opportunity to learn more about medication abortion and receive Continuing Pharmacy Education (CPE) credit. ANSIRH developed this module for pharmacists and pharmacy technicians, in collaboration with Dr. Sally Rafie from University of California, San Diego. The one-hour, online course participants with an overview of medication abortion, and reviews current and future roles for pharmacists in its provision. Participants who complete the course will be able to:
- Describe the current climate of access to abortion services in the United States
- Review the mechanisms of action, indications, safety, and effectiveness of mifepristone-based regimens for medication abortion
- List patient counseling points for medication abortion
- Explain the effects on access to medication abortion of the FDA’s prohibition of pharmacy dispensing of mifepristone
- Discuss the potential ways in which pharmacy professionals could be involved in provision of medication abortion care
Participants in the course will receive one CPE credit upon completion. The course is being offered for free for pharmacists and pharmacy technicians through UCSF’s continuing education portal and can be accessed here.
For the course, we developed two educational videos explaining the mechanism of action for a medication abortion and the effect of the REMS on access to abortion care. The videos can be viewed below.
How does mifepristone work? How does the REMS affect access to abortion?