May 6, 2016 — A “groundbreaking” new project will assess the implications of making medication abortion available outside of a clinical setting, The Guardian reports.
FDA allows mifepristone, a drug used in medication abortion, to be dispensed only in clinical settings. The Guardian reports that FDA’s limitation on where the drug may be administered is “unusual,” as such restrictions are typically applied only to intravenous medication.
For the project, researchers will run a pilot that allows four abortion clinics in Hawaii, New York, Oregon and Washington state to provide mifepristone by mail. Gynuity’s Erica Chong, Elizabeth Raymond and Beverly Winikoff created the program. According to The Guardian, Gynuity is a New York-based research group that aims to use technology to increase access to reproductive health care.
The pilot will allow a woman, during the first nine weeks of pregnancy, to receive medication abortion pills through the mail. A recipient must reside in the same state as the clinic prescribing the pills. To receive the medication, a woman must first have an ultrasound and a blood test to confirm pregnancy and assess risk. Afterward, a clinician will use video chat to counsel the woman. According to The Guardian, the pill regimen and counseling are the same as if the medication were dispensed in a clinical setting.
The pilot launched last month at a clinic in New York called Choices Women’s Medical Center and will soon launch in the other three states. According to The Guardian, the pilots in Hawaii, Oregon and Washington will help researchers assess how the model works for women in rural areas. As of 2011, 64 percent of Washington counties and 78 percent of Oregon counties had no abortion clinic, according to the Guttmacher Institute. There is no abortion clinic on seven of Hawaii’s nine islands, meaning about 140,000 women would have to leave the island to access abortion care.
Researchers also will use the pilot to assess whether telemedicine helps reduce costs for a woman accessing medication abortion, as well as whether insurers will reimburse equally for in-person and telemedicine visits.
Depending on how the study goes, the researchers foresee the study expanding to multiple states. However, according to The Guardian, 18 states have laws in effect that prevent the use of telemedicine for abortion care, preventing Gynuity from launching its program in those regions.
Daniel Grossman, a professor with the ob-gyn department at the University of California-San Francisco said, “We always thought this drug was going to totally revolutionize how abortion was provided.” He added, “This is moving us closer to what women’s health advocates see as the real potential of medication abortion.”
Raymond noted that Gynuity hopes that the pilot program will bolster efforts to end the requirement that medication abortion be dispensed in a clinical setting. Grossman added, “There’s no medical reason why the [medication abortion] pill has to be physically handed out by a clinician,” noting, “This is such an incredibly safe medicine.”
According to The Guardian, Grossman’s research into a telemedicine program piloted in Iowa helped establish the safety and efficacy of easing access to medication abortion. In that program, women were able to access medication abortion by speaking with a physician via telemedicine while at the clinic.
Separately, Paul Hyland, an ob-gyn in Australia who has helped women access medication abortion by mail in that country, praised the new pilot program. “Medication abortion is one of the most appropriate services that can be provided by telemedicine,” he said, adding, “Mifepristone is the most revolutionary drug in reproductive medicine since contraception. It’s amazing that this can be provided so easily and that we’ve taken such a long time to realize its true potential” (Redden, The Guardian, 3/31).