No surge in abortion after mifepristone restrictions have been lifted in Canada

A Canada-based study found that delimitation of Mifeprix was associated with an increase in medical abortion, but overall abortion rates are stable and safety results are reassuring. bottom.

The rate of medical abortion in British Columbia jumped from 2.2 percent when mifepristone was unavailable to 31.4 percent after it became accessible on a regular prescription (adjusted risk difference 28.8 percentage points, 95). % CI 28.0-29.7), Wendy Norman, MD, MHSc reported, The University of British Columbia, Vancouver, and colleagues.

“During the study, abortion rates continued to decline in absolute terms, but compared to pre-approval trends for mifepristone, 1.2 abortions per 1,000 female residents exceeded the predicted rate. I noticed that it increased, “the researchers write. New England Journal of Medicine..

Abortion safety results were similar before and after mifepristone was available on regular prescriptions. Serious adverse events occurred at 0.03% and 0.04% rates before and after increased access to the drug, and other abortion complication rates were 0.67% and 0.74%, respectively.

Researchers have found that there was a slight increase in ongoing intrauterine pregnancy that continued to give birth (adjusted risk difference 0.08%, 95% CI 0.04-0.10).

“When mifepristone became available as a regular prescription drug in Canada, the rate of abortion remained virtually stable, but the frequency of medical abortions was in the period prior to the availability of mifepristone. It has increased significantly compared to frequency, “Norman and colleagues write. They added that uterine drainage and ongoing intrauterine pregnancy remain a rare outcome, even after the drug has become more accessible.

Carrie Kwiack, MD, of the Emory University School of Medicine in Atlanta, who was not involved in the study, said: Today’s MedPage These findings support evidence of a favorable safety profile for mifepristone. She said that the most serious potential concerns about medical abortion include ongoing pregnancy rates and undetected ectopic pregnancies.

Cwiak added that findings on the use, safety, and efficacy of mifepristone are important not only for patients seeking medical abortion, but also for patients who endure early miscarriage.

Medical abortions can end the pregnancy up to the 10th week of pregnancy and are often done using both mifepristone and misoprostol dosing regimens. Mifepristone has a good safety profile, but the drug is tightly regulated in countries around the world.

In Canada, mifepristone became available on a regular prescription in November 2017. This is a “world unprecedented practice” that allows doctors or nurses to prescribe, pharmacists to dispense, and patients to administer the drug independently. Prior to this period, mifepristone was not available in Canada until 2016 and was available under certain restrictions for approximately a year before the protocol was removed.

However, in the United States, mifepristone is still under the limits of risk assessment and mitigation strategies (REMS) and requires direct drug administration to patients in healthcare facilities. During the COVID-19 pandemic, the FDA has decided Do not enforce face-to-face dispensing requirements -However, we will continue to comply with REMS even after a public health emergency ends.

“The question is why Mifepristone has REMS limitations,” Cwiak said. “If it’s already proven safe, there’s no reason to limit its use.”

In this study, Norman’s group used to compare the use, safety, and efficacy of abortion in Ontario during periods when mifepristone was unavailable and available on regular prescriptions. Performed an interrupted time series analysis. Researchers have linked the administrative health database to create a population-based cohort of female residents aged 12 to 49 in Ontario. All of these cohorts were aborted between January 2012 and March 2020.

Researchers measured abortion rates, rates of medically-induced abortions, and rates of late-stage abortions. In addition, they tracked serious adverse events such as blood transfusions, abdominal surgery, ICU admissions, hospitalization-induced sepsis, and mild complications, and analyzed the safety outcomes of abortions that occur within 6 weeks of treatment. bottom.

During the survey, there were approximately 315,000 abortions in Ontario. The majority were surgical and only 10% were treated with medication. More than 195,000 miscarriages occurred when mifepristone was not available, 35,644 were performed in a limited short time, and 84,032 were performed when the drug was available on a regular prescription.

When mifepristone was restricted, only 8.3% of abortions were medical. After the restrictions were lifted, the rate of abortion dropped from 5.5% to 5.1%.

Subsequent uterine excretion increased from 1.0% to 2.2% when mifepristone restriction was lifted, and ongoing intrauterine pregnancy increased from 0.03% to 0.08%. Ectopic pregnancies detected after abortion increased from 0.15% to 0.22%.

Norman et al. Recognized that the prescribing data used in this study was limited. This is because not all Mifepristone prescriptions for income-based prescribing subsidies or patients under the age of 25 have been captured and may have caused an early underestimation. Ingestion of mifepristone.

Researchers also said that by linking data across multiple databases, only residents covered by state health insurance could be included. In addition, due to the delayed availability of cause of death data, Norman’s group was unable to report abortion-related deaths.