No wave of abortions after dropping mifepristone restrictions in Canada

While the lifting of restrictions on mifepristone (Mifeprex) was associated with an increase in medical abortions, the overall rate of abortions remained stable and the safety results were reassuring, according to a Canada-based study.

The proportion of medical abortions in Ontario increased from 2.2% when mifepristone was not available to 31.4% after it became available with a normal prescription (adjusted risk difference of 28.8 percentage points , 95% CI 28.0-29.7), reported Wendy Norman, MD, MHSc, University of British Columbia in Vancouver, and colleagues.

“During the study period, the abortion rate continued to decline in absolute terms, although compared to the trend before the approval of mifepristone, we noted an increase of 1.2 abortions per 1. 000 residents … compared to the expected rate, “wrote the researchers in New England Journal of Medicine.

Abortion safety outcomes were similar before and after mifepristone became available through a normal prescription. Serious adverse events occurred at a rate of 0.03% and 0.04% before and after increased drug access, and the rates of other abortion-related complications were 0.67% and 0.74 %, respectively.

There was a slight increase in ongoing intrauterine pregnancies through childbirth (adjusted risk difference 0.08%, 95% CI 0.04 to 0.10), the researchers found.

“When mifepristone became available as a normally prescribed drug in Canada, the frequency of medical abortions increased dramatically compared to the frequency in the period before mifepristone became available, although the rate of abortions remained noticeably stable, ”Norman and colleagues wrote. They added that uterine evacuation and ongoing intrauterine pregnancy remained rare outcomes, even after the drug became more accessible.

Carrie Cwiak, MD, MPH, of Emory University School of Medicine in Atlanta, who was not involved in this study, said MedPage today that these results strengthen the evidence for the favorable safety profile of mifepristone. The most significant potential concerns regarding medical abortion include the rate of ongoing pregnancy and undetected ectopic pregnancy, she noted, relatively unchanged or rare results in this study.

Cwiak added that the findings on the use, safety and efficacy of mifepristone are not only important for patients seeking medical abortion, but also for those who experience an early miscarriage, as the drug may offer an alternative treatment to surgery.

Medical abortions can terminate a pregnancy for up to 10 weeks gestation and are often performed using a drug regimen of both mifepristone and misoprostol. Although mifepristone has a favorable safety profile, the drug has been heavily regulated in countries around the world.

In Canada, mifepristone became available on a regular prescription in November 2017, a “worldwide unprecedented practice” of allowing any physician or nurse practitioner to prescribe, any pharmacist to dispense, and any patient to administer the drug. independently, the researchers said. Prior to this period, mifepristone was not available in Canada until 2016, and available under specific restrictions for about a year before the protocols were discontinued.

In the United States, however, mifepristone is still subject to Risk Assessment and Mitigation Strategy (REMS) restrictions, which require providers to administer the drug to patients in person at a medical facility. During the COVID-19 pandemic, the FDA decided do not apply the in-person delivery requirement – however, he will continue to comply with the REMS at the end of the public health emergency.

“The question is, why do we have the REMS restrictions for mifepristone?” said Cwiak. “There is no reason why we should be banned from using it if it has already been proven to be safe.”

In this study, Norman’s group conducted interrupted time series analysis to compare the use, safety and efficacy of abortion in Ontario during the time when mifepristone was not available to when became available on normal prescription. The researchers linked administrative health databases to create a cohort based on the population of Ontario residents aged 12 to 49, all of whom had an abortion from January 2012 to March 2020.

The researchers measured the abortion rate, the rate of medically induced abortions and the percentage of abortions performed in the second trimester. Additionally, they analyzed the safety outcomes of abortions occurring within 6 weeks of a procedure, tracking serious adverse events such as blood transfusion, abdominal surgery, ICU admission, or sepsis following a procedure. hospitalization, as well as less serious complications.

Almost 315,000 abortions were performed in Ontario during the study period. The majority were surgical, with only 10% performed with medication. Over 195,000 abortions were performed when mifepristone was not available, 35,644 were performed during the short time it was restricted, and 84,032 were performed when the drug became available with a normal prescription.

Only 8.3% of abortions were medical when mifepristone was restricted. The second trimester abortion rate fell from 5.5% to 5.1% after the restrictions were lifted.

Subsequent uterine evacuation decreased from 1.0% to 2.2% when restrictions on mifepristone were lifted, and the current intrauterine pregnancy decreased from 0.03% to 0.08%. Ectopic pregnancies detected after an abortion fell from 0.15% to 0.22%.

Norman and colleagues acknowledged that the prescribing data used in this study was limited because they did not capture all prescriptions of mifepristone for patients who received income-based prescribing grants, or for those who had less. age 25, which may have caused an underestimation of the first intake of mifepristone.

The researchers also noted that linking data between multiple databases only allowed them to include residents eligible for provincial health insurance. Additionally, due to delays in the availability of cause-of-death data, Norman’s group was unable to report abortion-related deaths.