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Health Canada has approved updates to the prescribing and patient information of the abortion drug Mifegymiso, which addresses some concerns about “unnecessary barriers” and delays in accessing it.
Mifegymiso is a combination of two drugs, mifepristone and misoprostol, that are taken in sequence and result in the medical termination of a pregnancy.
Health Canada made the announcement on Tuesday, stating that with the approved update, an ultrasound is no longer required before the drug is prescribed by a healthcare professional.
Previously, the Canadian product monograph for Mifegymiso indicated that an ultrasound was required before prescribing it to confirm the number of weeks the woman is pregnant and to rule out an ectopic pregnancy.
Now, prescribers have the ability to use their medical judgement on how best to determine those two factors.
It also responds to concerns that some patients may have been facing unnecessary barriers or delays in accessing the drug. With the updated policy, abortion services should become more widely available.
"This is one step in the right direction to continue to address barriers that make access to medical abortion challenging in regions where services are few and far between or plagued with long wait lists," said Action Canada for Sexual Health and Rights.
According to a study conducted in Canada, 44.9% of women had to travel an hour or more to access abortion services in 2013. Women in minority groups and lower income brackets often face heightened barriers to services, and were found to have to travel even farther.
Health Canada approved Mifegymiso in 2015, and by then the drug was already available in 60 other countries. The drug only began shipping to health centres and hospitals in 2017, reports Macleans.
The B.C. government announced universal, no-cost coverage for the drug starting on Jan. 15, 2018. The out-of-pocket cost of Mifegymiso without PharmaCare was around $300.
The product monograph still recommends an ultrasound when the gestational age is uncertain or an ectopic pregnancy is suspected.
Health Canada based its decision on a review of the information submitted by the company (Linepharma International Limited, which is represented in Canada by Celopharma Inc.), the most recent scientific literature, and experience with the use of the product internationally.