After one of the lengthiest drug approval processes on record, an abortion pill that allows women to terminate an early pregnancy at home is expected to become available in July.
But its release is already garnering criticism, with women’s health advocates saying Health Canada’s tight controls over its use are unnecessarily restrictive, “demeaning” to women and a lost opportunity to expand access to early abortions.
The two-step drug regimen, to be sold in Canada under the unwieldy name Mifegymiso, pairs one drug, mifepristone with a second, misoprostol. When used within 49 days of pregnancy, the combination induces an abortion similar to a natural miscarriage.
However, under a restricted drug access program, only registered doctors who complete a certified, online training program will be allowed to prescribe and dispense Mifegymiso. It won’t be possible for women to get the drug from a pharmacist. As per Health Canada’s requirements, “the patient will not have the prescription in (her) hands,” the drug’s distributor, Celopharma Inc., said in an email.
In addition, in a situation some have likened to a heroin addict on methadone maintenance, a doctor may insist on witnessing the woman taking the first dose — a practise normally reserved in cases of suspected drug diversion or misuse.
“There is no evidence in any jurisdiction that women would seek and obtain a mifepristone prescription, yet not use it,” said Dr. Wendy Norman, a leading researcher in sexual and reproductive health at the University of British Columbia. “This requirement is medically unnecessary and demeaning to Canadian women.”
Nor is there any safety or medical basis, she said, for limiting dispensing to doctors. “The single most important reason physicians from across the country are citing for not planning to offer mifepristone is the need for physician dispensing,” she said, which will include ordering, stocking and taking payment for the pills, which are expected to cost $270 per package.
“The physicians we have polled — particularly rural physicians — have no infrastructure for this,” Norman said.
The requirements combined will severely limit the availability of Mifegymiso “and its potential to transform abortion access in Canada,” added Sandeep Prasad, executive director of Action Canada for Sexual Health and Rights.
“The women who call us are looking for a safe way to terminate their pregnancy that doesn’t require a lot of travel to an abortion provider, and doesn’t require a surgical procedure to be performed on them.”
A newly published study by Norman and her colleagues shows that, outside B.C. and Quebec, abortion facilities are located only in the largest urban centres for most jurisdictions.
In all, the researchers identified 94 facilities providing abortions in Canada in 2012; nearly half (49 per cent) were in Quebec. Administrators reported performing a total of 75,650 abortions in 2012. Less than four per cent were medical (non-surgical) abortions.
Already in use in more than 50 countries, mifepristone is considered the “gold standard” for medical abortions. Women in France and China have had access to the drug for more than a quarter century. It was approved in the United States in 2000.
We’re really trying to balance the use of the product with the potential risks.
The drug blocks the hormone progesterone, which normally helps prepare the lining of the uterus for a pregnancy. The lining breaks down and sheds, similar to what happens during a woman’s menstrual period. Misoprostol causes the uterus to contract, expelling the pregnancy.
Under the colour-coded dosing regimen, the woman takes mifepristone by mouth on day one, and then, 24 to 48 hours later, four tablets of misoprostol.
Health Canada said the restrictions over the drug’s use are in keeping with those in other jurisdictions and are necessary to minimize health risks. The FDA has received reports of one case of ectopic pregnancy resulting in death in a woman taking mifepristone and misoprostol, several cases of sepsis (blood infections), including some that were fatal, and a single case of non-fatal heart attack. However, it’s not known whether there is any cause-and-effect relationship.
“We’re really trying to balance the use of the product with the potential risks and any of the adverse events that could come from it,” said Dr. Supriya Sharma, Health Canada’s senior medical adviser.
Sharma said there is no requirement for the medication to be taken in front of a doctor. Rather, the “under-the-supervision-of” requirement is intended to give doctors “the option to either observe directly, delegate to another staff or direct the patient as appropriate,” she said.
The regulator’s concern is two-fold, she said. “You want to make sure the person prescribed the medication is (the one) taking the medication. You don’t want that medication to go to somebody else.” Before any woman takes the drug, an ultrasound is needed to determine age of gestation and rule out an ectopic pregnancy, or pregnancy outside the uterus.
In addition, there’s a limit to how far along in the pregnancy the drug should be taken. “You don’t want someone to take it at a later time where the risks can be greater,” Sharma said.
She said it will be up to the doctor’s discretion whether “he or she is comfortable with the person going home and taking it.”
Toronto family doctor Sheila Dunn said the abortion pill “isn’t really any more difficult or challenging to use than most any of the drugs that we’re already prescribing.”
A new drug submission for the abortion pill was filed with Health Canada in December 2011. After numerous delays, including for insufficient or missing safety data, the drug was approved in July 2015.