Abortion complications did not increase after Canada removed mifepristone restrictions

An interrupted time-series analysis showed little change in the rate of abortion-related adverse events and complications in Ontario, Canada, before and after the country lifted prescribing restrictions on mifepristone.

The analysis also showed that the proportion of medication-provided abortions rose “rapidly,” but the abortion rate stayed “relatively stable,” researchers wrote.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions — meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when and where they choose,” Laura Schummers, ScD, a postdoctoral fellow in the department of family practice at the University of British Columbia, said in a press release.

In 2017, Canada became the first country to remove regulatory restrictions on mifepristone dispensing and administration, according to the press release. Previous rules required physicians to observe patients taking mifepristone, and the drug “could only be dispensed to patients by specially trained physicians who registered with the manufacturer, and not by pharmacists,” the release said.

In the United States, the FDA waived mifepristone’s in-person dispensing requirement during the COVID-19 public health emergency, so long as other requirements of its Risk Evaluation Mitigation Strategy program are met.

For the study, Schummers and colleagues compared abortion use, safety and effectiveness in Ontario from 2012 to 2016 and Nov. 7, 2017, to March 15, 2020. According to the researchers, the start of the latter period coincided with the availability of mifepristone without restrictions in Ontario.

The results, published in The New England Journal of Medicine, showed that 195,183 abortions occurred before mifepristone was available and 84,032 occurred after it was available without restrictions, a decline that was slower than expected “on the basis of trends before mifepristone had been available,” the researchers wrote. The adjusted risk difference in the time-series analysis was 1.2 per 1,000 women aged 15 to 49 years (95% CI, 1.1-1.4). The percentage of all abortions that were conducted as a medical procedure increased from 2.2% to 31.4%, for an adjusted risk difference of 28.8 percentage points (95% CI, 28-29.7).

The researchers wrote that there were “no material changes” between the two time periods regarding the incidence of severe adverse events (0.03% vs. 0.04%; adjusted risk difference = 0.01 percentage points; 95% CI, –0.06 to 0.03), complications (0.74% vs. 0.69%; adjusted risk difference = 0.06 percentage points; 95% CI, –0.07 to 0.18) or ectopic pregnancy identified after abortion (0.15% vs. 0.22%; adjusted risk difference = –0.03 percentage points; 95% CI, –0.19 to 0.09). There was a small increase in ongoing intrauterine pregnancy that continued until delivery (adjusted risk difference = 0.08%; 95% CI, 0.04-0.1).

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” Wendy Norman, MD, CCFP, FCFP, DTM&H, MHSc, a professor in the department of family practice at the University of British Columbia, said in the press release. “There is no scientific justification for mifepristone restrictions, which only make it harder for people to access the care they need. Canada’s experience offers a roadmap for other countries on how to safely improve access to family planning services.”

References:

Prescribing the abortion pill without restrictions is safe and effective: UBC-led study. Accessed under embargo Dec. 7, 2021. Published Dec. 8, 2021.

Schummers L, et al. N Engl J Med. 2021;doi:10.1056/NEJMsa2109779.