FDA Approves Telemedicine Abortion; Canadian Study Demonstrates Safety
The FDA cleared the way for telehealth medication abortion after conducting a review of the Risk Evaluation and Mitigation Strategy (REMS) status of mifepristone on Dec. 16, 2021.1
The change to the abortion medication’s REMS status will allow providers to dispense the pill via telehealth visits and allow certified pharmacies to dispense it. Patients can obtain the drug without an in-person clinic visit in states that do not prohibit mail-order mifepristone.
The FDA’s change follows a trial period of mail-order distribution of mifepristone during the COVID-19 pandemic. The availability of mifepristone without the requirement of in-person visits proved successful.
Research shows that mifepristone can be treated as a normal prescription without compromising safety and risking complications. Researchers used population-based data from Ontario, Canada, to compare trends in abortion use, safety, and effectiveness before mifepristone was readily available (January 2012 to December 2016), and after the medication was available without special regulatory restrictions (Nov. 7, 2017, to March 15, 2020).2
The researchers found that the proportion of medication abortions increased rapidly (from 2.2% to 31.4%) once mifepristone was available as a normal prescription. Overall, the abortion rate remained stable. Adverse events and complications did not increase after mifepristone became available when compared to before mifepristone was available.
“The big take-home message is that abortion services remain safe,” says Laura Schummers, ScD, lead author of the study and a postdoctoral fellow at the University of British Columbia in Vancouver. “One of the advantages of our study is that we capture every single healthcare encounter that people in our study had, whether they go to a walk-in clinic, general practitioner, emergency room, or hospital. Because we have a single-payer provincial health system, we can link all of these different types of visits that let us know what happened with that pregnancy.”
Schummers and colleagues studied the safety profile of medication abortion and looked at all abortion complications.
“We cast a wide net: Someone may have infection, bleeding, and things of that nature,” Schummers says. “There was no change in incidence of those complications, comparing the period between January 2012 and December 2016, when 0.7% of abortions had complications.”
After the medication abortion restrictions were lifted, the rate of complications remained at 0.7%.
“A more severe outcome would be a combination of abortion complication along with something indicating severe illness, like sepsis, an ICU [intensive care unit] admission,” she says. “Those are very rare following any kind of abortion, and those did not change from before it was available and after all restrictions were removed.”
The results show that the Canadian regulatory change in medication abortion had no effect on abortion safety in Canada, Schummers adds.
In Canada, abortion is regulated the same as any other medical procedure or medication. “It’s up to the professional organizations to regulate how abortion is provided,” Schummers explains. “There’s nothing in the criminal code about abortion.”
When Canada’s regulatory agency lifted restrictions on mifepristone for medication abortion, investigators hypothesized that unencumbered access would result in an earlier shift in gestational age across all abortions because people would not have to travel so far to obtain an abortion. But this did not happen.
“We found no significant change in percentage of abortions provided in the second trimester after 14 weeks,” Schummers adds.
A future question to study would be whether availability or accessibility of abortion services changed. “This is more nuanced, and it’s something outside the scope of this paper,” Schummers explains. “It’s something we will look at in terms of access to primary care or populations that live outside Canada’s major cities.”
Researchers will study whether easier to access medication abortion means people obtained abortions closer to their homes and at primary care facilities rather than at abortion clinics.
“In Canada, with our geographically distributed population, it’s a real challenge to make sure we have healthcare available in general,” Schummers says.
The availability of mifepristone through pharmacies, primary care, and even telehealth would alleviate the burdens of traveling, arranging child care, and taking time off work.
The FDA’s move to allow U.S. pharmacies to dispense mifepristone and providers to prescribe it via telehealth visits also will make medication abortion available for more people.
The pandemic continues to be a factor and may shift more abortion services to telehealth services, just as it has for other types of medical visits.
“How abortion services shifted in reaction to the pandemic is separate from the question of whether this is safe,” Schummers says. “We stopped this study before the pandemic because those are separate questions.”
REFERENCES
- Food & Drug Administration. Questions and answers on Mifeprex. Updated Dec. 16, 2021.
- Schummers L, Darling EK, Dunn S, et al. Abortion safety and use with normally prescribed mifepristone in Canada. N Engl J Med 2022;386: 57-67.
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