TVO | Published on Aug 12, 2016 by Terri Coles
Ontario doctors may be able to prescribe and distribute a Health Canada-approved abortion drug by as early as this fall, but some activists and researchers say federal conditions on its use will do little to make pregnancy termination available to the many women who live far from clinics or hospitals that provide abortions.
Mifepristone, also known as RU-486, is a drug that induces a medical abortion by blocking progesterone, a hormone needed to maintain pregnancy. In Canada, where it is sold under the brand name Mifegymiso, federal regulations allow the drug to be taken up to 49 days past a woman’s last menstrual period. UnlikePlan B, which prevents the implantation of a fertilized egg and is meant to be taken within a couple days of having unprotected sex, mifepristone terminates a pregnancy. The drug can widen access to abortion care by providing a non-surgical option that doesn’t have to be administered in a hospital or clinic.
“The nature of the existing restrictions on mifepristone suggest that the motivations to regulate it go beyond considerations for the women’s health,” says Rachael Johnstone, an assistant professor of politics and gender studies at Queen’s University who specializes in Canadian abortion access. “The amount of oversight that’s required is somewhat condescending, and it’s not clear that it’s [medically] required.”
Once the drug is stocked across the country, federal rules that require it to be dispensed by physicians instead of pharmacists are likely to considerably restrict access, experts say. Unlike pharmacists, physicians are not generally equipped to store and dispense prescribed medications from their offices and usually only do so in emergency situations. A doctor would have to meet pharmacy standards for dispensing medication, including dispensing only to his or her own patients, storing drugs securely and appropriately, and having an audit procedure in place, according to the College of Physicians and Surgeons of Ontario. Even opioids such as oxycodone, fentanyl and methadone are nearly always dispensed by pharmacists in Ontario.
“In the context of the Canadian system, this decision doesn’t make sense,” says Dr. Wendy Norman, a professor with the University of British Columbia’s medical faculty. “It’s almost unheard of for a physician to have to dispense a drug.”
For some, the conditions placed on the dispensation and administration of Mifegymiso in Canada represent a lost opportunity to make abortion more accessible to Canadian women.
“I think the word is disappointed,” says Sandeep Prasad, executive director of Action Canada for Sexual Health and Rights. “I’m not sure that we had any particular expectation. We were so focused on wanting to see the approval happen.”
First approved in France in 1998, Mifegymiso has since been approved in about 60 countries, including the United States and several jurisdictions in Europe. The abortifacient drug was approved by Health Canada in July 2015, but due to manufacturer issues has still not been shipped or made available for prescription and sale.
In addition to the requirement that physicians dispense the drug instead of pharmacists, federal rules for Mifegymiso also require that doctors who want to prescribe it complete about six hours of training. The guidelines also recommend, though do not require, that women take the first pill of the two-pill dose in the presence of the prescribing physician. It’s not yet clear if provincial health plans will cover Mifegymiso’s cost, the way surgical abortion is, or through private or provincial prescription plans.
“Our big fear is that the only doctors who are going to be willing to deal with all these restrictions are going to be existing surgical abortion providers,” Prasad says. “That is not at all helpful to realizing the promise of mifepristone in Canada, and that promise is one of ensuring wider access.”
Increasing access in Ontario is a concern, especially considering that many women live hours away from a clinic or hospital providing surgical abortion. The province has 12 non-hospital clinics providing surgical abortion, according to Abortion Rights Coalition Canada. Half are in Toronto, another five are located throughout the GTA or southern Ontario, and all are in urban centres. The furthest north is in Ottawa. About 17 per cent of Ontario hospitals provide surgical abortion, according to Abortion Rights Coalition Canada.
The urban and southern concentration of abortion clinics and the lack of hospitals providing surgical abortion, highlights the need for a drug like Mifegymiso, Norman says. “It has huge potential to address a significant problem throughout Canada, particularly in Ontario. But it’s not going to make any difference if the current restrictions do not change.”
Those conditions run counter to a briefing note about Mifegymiso Norman prepared last May based on family planning research conducted at the University of British Columbia and shared with Health Canada officials.
Norman wrote that allowing Mifegymiso to be prescribed by physicians, but dispensed by pharmacists, would widen access to abortion care in Canada without compromising patient safety.
“Women are travelling vast distances. They’re leaving behind their families, their children, their work in order to be able to access reasonable care, and in so doing they’re incurring enormous expenses,” Norman says. The expected $270 to $300 cost for a Mifegymiso dose, if not covered by insurance or OHIP, becomes much higher if women have to travel to get a prescription.
But conditions for the prescription and administration of Mifegymiso aren’t significantly different in Canada than in other jurisdictions, and weren’t set by Health Canada specifically, says Maryse Durette, a spokesperson for the federal health agency.
“We basically approved it how the company suggested we should do things,” Durette says. Celopharma Inc., the Canadian distributor for Mifegymiso, and sponsor Linepharma International Limited outlined their recommendations in the monograph submitted to Health Canada and the agency approved those recommendations, she says.
“Everywhere in the world where this drug is approved, the same directives for administration of the drug applies,” Durette says.
In its initial submission for the approval of Mifegymiso, Linepharma made several suggestions to Health Care Canada, including restrictions on distribution and administration of the drug, education for drug prescribers, a Canadian clinical study done on the drug’s safety after approval, and the implementation of a bilingual phone support line for Mifegymiso patients. Health Canada agreed to these suggestions in its approval of the drug.
However, China, India, Nepal, and Bangladesh do allow the sale of mifepristone at pharmacies, according to Women on Waves. And Australia also allows for some pharmacist dispensation, Durette says. The United States, which approved the drug in 2000, also does not allow the drug to be dispensed through retail pharmacies but some states do approve health-care professionals other than physicians to dispense the drug.
However, federal restrictions on Mifegymiso could soon be changed. Celopharma released a statement last week in collaboration with Linepharma, announcing its preparation of a supplemental document submission later this year. Drug manufacturers can file such supplemental submissions for already approve drugs, and can cover changes including labelling, indications, manufacturing methods and methods of administration.
“To ensure that women take the medication under the supervision of their health-care professional, Mifegymiso will not be available in retail pharmacies for direct distribution to women,” the Celopharma statement read. “However, certified pharmacies can stock and ship the medication to prescribers’ offices.”
“Abortion access is something that the government is still supportive of,” says Andrew MacKendrick, press secretary for the office of Federal Health Minister Jane Philpott. Shortly after being named health minister Philpott indicated her support for increasing access to abortion services for Canadian women, including those in rural areas. Since then restrictions have loosened in both Prince Edward Island and New Brunswick, MacKendrick says, which the minister supports.
Making Mifegymiso more widely and easily available, in Ontario and across the country, is a key part of further expanding that access, Norman says.
“Our government has says that they want to be responsive to the needs of Canadians and that they want to base their delivery of governance in Canada on evidence,” Norman says. “There’s extensive evidence showing that Mifegymiso is a very safe way to offer and administer abortion.”
Terri Coles is a freelance reporter living in St. John’s, N.L., who covers general news, politics and health.