In Canada, after abortion pill mifepristone became available as a normal prescription, the abortion rate remained relatively stable, the proportion of abortions provided by medication increased rapidly, and adverse events and complications remained stable, found a University of British Columbia-led study published in the New England Journal of Medicine.
The researchers say Canada’s experience offers a roadmap for other countries.
The study used comprehensive government health data to examine 315,000 abortions in Ontario, Canada, between 2012 and 2020. An analysis showed no increase in abortion-related health complications after the removal of restrictions on mifepristone, which is considered the “gold standard” drug for medical abortion globally.
“Complications were already very rare, and we found that abortion continued to be safe and effective when mifepristone was prescribed without restrictions,” said Dr Laura Schummers, the study’s lead author and a postdoctoral fellow in UBC’s department of family practice.
“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.”
Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone.
The previous rules, which went into place when the drug was first approved in July 2015, included a requirement that physicians observe patients taking the medication. Additionally, the drug could only be dispensed to patients by specially trained physicians who registered with the manufacturer, and not by pharmacists.
Many of the restrictions that Canada removed are still mandated by countries around the world, including the US.
“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” says Professor Wendy Norman, the study's senior author and professor in UBC’s department of family practice.
“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.”
The findings revealed that the increase of medical abortion, those performed using medication, rather than surgically, was rapid, after the change in policy. Before mifepristone became available, 2.2% of abortions were provided using medication. That percentage rose to 31.4% two years after the drug became available as a normal prescription.
At the same time, the overall abortion rate continued to decline after restrictions were removed, decreasing from 11.9 to 11.3 abortions per 1,000 female residents aged 15-49 years.
“We saw that patients and their health care providers rapidly began choosing medical abortion, which can sometimes be preferred over surgical methods by offering care closer to home and earlier in pregnancy,” said study co-author Dr Sheila Dunn, scientist and family physician at Women’s College Hospital in Toronto.
“As other studies have shown, making abortion more accessible does not increase the number of people seeking abortion. We found that abortion rates continued to decrease after mifepristone's availability as a normal prescription.”
By linking and analysing government health data on a secure data platform at ICES, a not-for-profit research institute in Ontario, the researchers produced a complete picture of abortion health outcomes that they say provides the best data available on abortion safety.
“We were able to complete a robust safety profile for the entire province by linking together health records from all practitioner visits, hospital visits and outpatient prescriptions,” said co-author Dr Elizabeth Darling, assistant dean of midwifery and associate professor at McMaster University, and an ICES scientist.
“This paints the most comprehensive picture of abortion safety to date, capturing any setting where a complication would present. It demonstrates very clearly that restrictions on the abortion pill are not necessary for safety.”
Study details
Abortion Safety and Use with Normally Prescribed Mifepristone in Canada
Laura Schummers, Elizabeth K. Darling, Sheila Dunn, Kimberlyn McGrail, Anastasia Gayowsky, Michael R. Law, Tracey-Lea Laba, Janusz Kaczorowski, Wendy V. Norman.
Published in the New England Journal of Medicine on 8 December 2021
Background
In the United States, mifepristone is available for medical abortion (for use with misoprostol) only with Risk Evaluation and Mitigation Strategy (REMS) restrictions, despite an absence of evidence to support such restrictions. Mifepristone has been available in Canada with a normal prescription since November 2017.
Methods
Using population-based administrative data from Ontario, Canada, we examined abortion use, safety, and effectiveness using an interrupted time-series analysis comparing trends in incidence before mifepristone was available (January 2012 through December 2016) with trends after its availability without restrictions (November 7, 2017, through March 15, 2020).
Results
A total of 195,183 abortions were performed before mifepristone was available and 84,032 after its availability without restrictions. After the availability of mifepristone with a normal prescription, the abortion rate continued to decline, although more slowly than was expected on the basis of trends before mifepristone had been available (adjusted risk difference in time-series analysis, 1.2 per 1000 female residents between 15 and 49 years of age; 95% confidence interval [CI], 1.1 to 1.4), whereas the percentage of abortions provided as medical procedures increased from 2.2% to 31.4% (adjusted risk difference, 28.8 percentage points; 95% CI, 28.0 to 29.7). There were no material changes between the period before mifepristone was available and the nonrestricted period in 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 detected 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 continuing to delivery (adjusted risk difference, 0.08%; 95% CI, 0.04 to 0.10).
Conclusions
After mifepristone became available as a normal prescription, the abortion rate remained relatively stable, the proportion of abortions provided by medication increased rapidly, and adverse events and complications remained stable, as compared with the period when mifepristone was unavailable. (Funded by the Canadian Institutes of Health Research and the Women’s Health Research Institute.)
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