FDA expands access to mifepristone to mail-order and community pharmacies

By 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.”

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.

For the full article, please visit www.pharmacytoday.org for the March 2022 issue of Pharmacy Today.