The effectiveness and safety of medication abortions obtained via telehealth are on par with those delivered in person, with no differences in outcomes between synchronous and asynchronous communications like secure text messaging, according to a study published Thursday in Nature Medicine.
The findings were drawn from more than 6,000 telehealth medication abortions dispensed by three virtual clinics to patients in 20 states and Washington, D.C., between April 2021 and January 2022.
Of note, the University of California, San Francisco (UCSF) researchers’ conclusion speaks to a key point of focus in an upcoming Supreme Court case on the regulatory approval of the abortion pill mifepristone, which was used in the study.
An appeals court had preserved the product’s initial Food and Drug Administration (FDA) approval but struck down the subsequent moves in 2016 and 2021 to permit, respectively, mail-order prescriptions and remote consultation and prescription over concerns that the regulator had overlooked safety risks.
“This research confirms that the FDA followed science in allowing patients to get medication abortion through telehealth and the mail,” Ushma Upadhyay, Ph.D., the study’s first author, a professor at UCSF and a public health scientist with its Advancing New Standards in Reproductive Health program, said in a release from the institution. “Our findings make it abundantly clear that the case at the Supreme Court is simply an attempt to restrict access to abortion care, even in those states where it’s legal.”
Overall, Upadhyay and colleagues’ review of telehealth abortion patients’ electronic records found that 97.7% were completed without evidence of a subsequent intervention or ongoing pregnancy. In-person effectiveness rate as found on mifepristone’s FDA label is 97.4%, with the researchers also citing comparison rates of 95% to 98% from other large U.S. studies of in-person prescribing.
Telehealth abortion safety, or the portion of abortions not followed by a serious adverse event, was 99.75%, with ectopic pregnancies occurring at a rate of 0.14% and follow-up emergency department visits at 1.3%. These were also similar to prior data on in-person prescribing, the researchers wrote, with mifepristone’s FDA label showing an in-person safety rate of 99.7%.
The observed effectiveness and safety rates were similar when breaking the sample apart into synchronous and asynchronous care, the latter of which comprised 72.3% of the sample. The overall rates were also “consistent with, although slightly lower than” similar studies from other countries and were on par with studies of self-managed medication abortion models in the U.S. and abroad.
The researchers noted that remote consultations increase the medication abortion’s reach to patients who may face travel, cost and stigma-related barriers. Additionally, the similar effectiveness and safety of asynchronous telehealth approaches like secure texting are meaningful from a health equity standpoint due to their simpler tech requirements and scheduling flexibility, they wrote.
Both approaches offer a way for clinicians in states with legal abortion and “shield laws” to provide medication abortion to patients living in states where it is banned, they added.
“This study demonstrates that policies that restrict telehealth abortion owing to concerns or claims about effectiveness or safety need to be revisited and revised to ensure equitable access to this essential healthcare service,” they wrote.
Mifepristone is used in more than half of all abortions across the U.S., with prescriptions for it and the other primary abortion-inducing drug, misoprostol, rising following the Supreme Court’s decision to overturn Roe v. Wade in 2022.
The top court is scheduled to hear arguments in the case over mifepristone’s regulatory approvals on March 26. UCSF noted in its release that Upadhyay and colleagues’ study was cited in an amicus brief submitted to the Supreme Court by more than 300 reproductive health researchers. Conversely, a study that outlined concerns over mifepristone’s safety that was cited by Judge Matthew Kacsmaryk, the district court judge whose initial ruling to pull the drug triggered the higher courts’ reviews, was retracted last week by its publisher.
Federal agencies as well as the healthcare and pharmaceutical industries have pushed for the Supreme Court to support the FDA’s initial and subsequent regulatory approvals. In written briefs filed ahead of the case, they argued that the product has been demonstrated as safe and does not harm those who brought the case. Overturning the approvals, however, would have disastrous effects on the FDA’s authority and “threatens profound harms to the government, healthcare system, patients and the public,” the administration’s legal team wrote.