An ultrasound will no longer be required before women are prescribed the two-step abortion drug Mifegymiso, Health Canada said on Tuesday.
The drug, which can be used to end a pregnancy in the first trimester as an alternative to surgical termination, was approved for use in Canada in 2015.
Previously, the product’s monograph required that an ultrasound be performed to determine how far along the pregnancy was and to rule out an ectopic pregnancy – one outside the uterus.
Prescribing the drug to women who are more than nine weeks pregnant or who may have an ectopic pregnancy could not only make Mifegymiso ineffective, but also harm both the mother and the fetus.
The federal agency said it made the change because of concerns that women were facing needless barriers to accessing the drug. Some pro-choice groups had raised concerns that the ultrasound requirement could lead to serious delays, particularly in regions where ultrasound services are limited or had long waiting lists.
Health Canada added that the change was made after reviewing information submitted by the drug’s manufacturer, scientific literature and other information about how the drug is used internationally.
“With the changes to the product monograph, prescribers now have the flexibility to use their medical judgement on how best to determine the gestational age and to rule out an ectopic pregnancy,” Health Canada said in a news release on Tuesday. The monograph still recommends an ultrasound be performed if there is any uncertainty over both questions.
Some of Canada’s provinces and territories offer universal coverage for Mifegymiso, a combination of two oral drugs – mifepristone and misoprostol – that are taken individually, separated by 24 to 48 hours.
In November 2017, Health Canada expanded its rules around who could dispense the drug directly to patients to also include pharmacists and nurse practitioners in some jurisdictions.
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