The abortion pill mifepristone, considered the global “gold standard” for medical abortions, will become available to Canadians later this year. But UBC professors say Health Canada’s regulations for the drug will limit access to abortions and compromise patient safety.
Only registered doctors who complete an online training program will be allowed to prescribe and dispense the drug, which is to be taken in a $300 two-step regimen in combination with another pill, misoprostol.
Wendy Norman, an associate professor in the department of family practice, and Judith Soon, assistant professor in the faculty of pharmaceutical sciences, say pharmacists’ expertise and services have been removed from the equation, and patients are being put at risk.
Why should pharmacists be dispensing mifepristone?
WN: This Health Canada requirement will mean less access for women. Pharmacists know dispensing best; they have the infrastructure in place and already meet all the regulatory requirements. Doctors will need to meet provincial regulations and rules to allow them to dispense – a process that could take months. Only those in special abortion clinics or similar high-volume settings are likely to offer the new treatment, as the total set of added barriers to prescribing this drug, listed as an “essential medicine” by the World Health Organization (WHO), will be overwhelming for most doctors.
JS: The Health Canada restrictions are unusual and unnecessary – we’re going backwards. Pharmacists are uniquely positioned as medication experts within the Canadian health-care system. They provide clinical checks for allergic reactions and drug interactions. They can safely dispense mifepristone with the same care and attention they provide to any other prescription drugs, including those with a range of safety profiles such as high-risk cancer drugs.
How could mifepristone improve access to abortions for women in Canada?
JS: Mifepristone eliminates the need for a specialist referral when a non-surgical method is available. It also improves access to abortions in rural and remote areas with limited access, if any, to surgical abortions.
WN: If pharmacists could dispense this drug to women, more physicians would prescribe it, and more women will have access to this highly effective treatment.
What are safety regulations for this drug like in other countries?
WN: In Canada, drug regulations are proposed by industry and accepted by Health Canada. When mifepristone came on the market in 1989, little was known about its safety. Countries that have had it for a long time use the cumbersome “physician must dispense” model.
The company that made the application to have this drug approved here in Canada is from France. The approvals in France 27 years ago, and in the U.S. 16 years ago both had similar restrictions, so, perhaps without understanding current Canadian systems, the foreign industrial applicant proposed to use the same approach here.
JS: Australia approved mifepristone in 2012, allowing pharmacists to dispense it safely and effectively. This gives improved access to abortion for women. Canada can rely on the experiences of other countries and treat mifepristone like any other prescription medication. Physicians can prescribe mifepristone and pharmacists can dispense it.
Do you have other concerns about access to this drug in Canada?
JS: Rural and remote areas are already stretched with limited access to physicians, especially specialists. Adding the unnecessary dispensing role to physicians in these areas is detrimental to the women who lack access to specialists for surgical abortion.
WN: This normal reproductive medical treatment is considered an “essential medicine” by the WHO, and is available in more than 60 countries around the world. This gold standard alternative to surgical abortion should be provided cost-free (as is surgery). Health policy should support, rather than impede, access for women in all regions of Canada.
Norman and Soon published a commentary about the mifepristone regulations today in the Canadian Medical Association Journal.