Prescribing abortion pill without restrictions safe and effective, NEJM study finds

The study has been published in the New England Journal of Medicine.

The study used comprehensive government health data to examine 315,000 abortions in Ontario between 2012 and 2020. An analysis showed no increase in abortion-related health complications following 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 (she/her), 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 U.S.

"Our study is a signal to other countries that restrictions are not necessary to ensure patient safety," says Professor Wendy Norman (she/her), 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 uptake of medical abortion -- those performed using medication, rather than surgically -- was rapid following the change in policy. Before mifepristone became available, 2.2 per cent of abortions were provided using medication. That percentage rose to 31.4 per cent 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 (she/her), 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 analyzing 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 (she/her), 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."

This study was funded by the Canadian Institutes of Health Research and the Women's Health Research Institute with the support of ICES.