Reproductive Health
Sonya Collins
In December 2021, FDA permanently lifted a major restriction on medication abortions that had been temporarily lifted earlier in the COVID-19 pandemic. Prior to the pandemic, patients were required to pick up mifepristone in person from a certified prescriber. In 2020, FDA temporarily lifted this in-person requirement. The new change from FDA will permanently allow any certified mail-order or brick-and-mortar pharmacy to dispense the drug with a prescription.
“We know that previous restrictions on dispensing have limited providers in their ability to provide this service because they didn’t have the capacity to also have an in-house pharmacy,” said Sally Rafie, PharmD, BCPS, APh, NCMP, FCCP, a pharmacist specialist at UC San Diego Health and founder of the Birth Control Pharmacist project.
“Allowing pharmacies to do what they do best—stock, dispense, and counsel on medications—will expand patient access to medication abortions, allow more providers to provide this service, and allow pharmacists to get involved in a service that they’ve largely been excluded from historically.”
What pharmacists can expect
By some estimations, it may be up to a year before the change goes into effect. This comes at a time when Roe v. Wade hangs in the balance.
As FDA is moving to expand access to this type of abortion, conservative states with tight restrictions around abortion are expected to move to limit access to medication abortion, as well.
“In a lot of states, the restrictions they have in place would apply to this, too,” Rafie said. “Any state can be more restrictive than FDA or evidence-based practice, which is the case when it comes to abortion.”
Once the law goes into effect in the states that allow it, pharmacies will need to become certified to dispense the drug.
While the requirements for certification are not yet available, the expectation is that they will be similar to the requirements that prescribers had to meet under the previous law; for example, that they understand what the drug is for, how it works, and how to counsel patients on its use.
Counseling patients
Patients should receive thorough counseling on mifepristone from their prescriber, but pharmacists must be prepared to review the instructions for proper use.
“Just as with any medication, you’ll want to make sure the patient knows what the medication is for, how it works, how to take it, and what to expect,” said Rafie.
“Using the teach-back method, make sure the patient understands when to take it, in what sequence and what to expect.”
Important information about mifepristone
- Indicated for use through 70 days of gestation
- Mifepristone works by inhibiting progesterone activity
- Mifepristone is given along with misoprostol—misoprostol is taken 24 to 48 hours after mifepristone
- Cramping and bleeding are normal, but severe cramping or bleeding require immediate medical attention
- Mifepristone carries a black box warning as well as several contraindications, see full prescribing information for additional details
“Patients should call their doctor if their fever goes above 101 [degrees Fahrenheit] or stays above 100 for more than 4 hours,” Rafie said.
“If they have so much pain that the pain medicine isn’t effective, that’s another reason to call. Finally, they should call if they bleed so much that they soak two full-size pads per hour for two hours in a row.”
While patients likely get most of their general questions about medication abortion answered by their prescriber, pharmacists should prepare to answer those questions as well about, for example, future fertility or the possibility that the medication does not work.
“It’s a lot of information, so it always helps to solidify and reinforce it if they hear it a few times,” Rafie said. “Patients may have new questions arise, too, so pharmacists should be prepared to provide any information the patient needs.”
Information on medication abortion–related counseling and continuing education as well as a guide to clinic and pharmacy collaboration on medication abortion can be found at birthcontrolpharmacist.com/resources. ■