The regulatory colleges that oversee doctors and pharmacists in British Columbia are planning to tell their members that pharmacists can distribute the abortion pill directly to women, despite Health Canada guidance that says only physicians should hand out medication that ends a pregnancy.
The College of Physicians and Surgeons of B.C. and the College of Pharmacists of B.C. have been working behind the scenes for months to find a way to circumvent the federal drug regulator's plan for physician-only dispensing of Mifegymiso, a two-step abortion regimen that could be available in Canada as early as November.
Abortion advocates say that because most doctors' offices are not equipped to act as miniature pharmacies, the dispensing requirement is likely to discourage physicians from offering their patients Mifegymiso.
Health Canada has countered that it would be safer for women if doctors, not pharmacists, handed out the pills, as is the practice in nearly every other country that has approved the drug, originally known as RU-486.
But B.C. now appears to have found what one women's health researcher calls an "elegant" workaround of the doctor-dispensing rule that other provinces could adopt, too: encouraging physicians to prescribe the abortion pill "off-label" with the advance blessing of regulators. Off-label usually refers to doctors prescribing a drug for a condition that the medication wasn't originally intended to treat. But in this case, the B.C. regulators are proposing a method of dispensing the drug that isn't what Health Canada intended.
In a letter e-mailed to Health Canada on Aug. 22 and obtained by The Globe and Mail, the heads of the B.C. self-regulatory bodies told Health Canada they intended to "provide a joint message" to their members reminding them of the two options for dispensing Mifegymiso: "[T]raditional pharmacist route as well as physician dispensing."
Health Canada's chief medical officer replied two days later with a letter that essentially confirmed the two colleges are free to proceed with their plan, even if the federal drug regulator does not agree with it.
"With respect to the proposed options for dispensing [Mifegymiso,] the physician dispensing is in line with the current [safety guidelines], whereas the direct-to-patient dispensing by a pharmacist is not," Supriya Sharma wrote in a letter dated Aug. 24, also obtained by The Globe. "As you know, it is within the purview of a practitioner and pharmacist to prescribe and dispense a drug in a manner that falls outside the recommended uses and conditions of use set out in a product's label that is approved by Health Canada.Medical and pharmacy practice decisions to prescribe and dispense a drug 'off label' are governed by the B.C. Colleges of Physicians and Pharmacists, and other provincial licensing bodies that regulate medical and pharmacy practice."
The letter went on to warn that doctors and pharmacists who prescribe drugs off-label would be "accountable for these decisions as a matter of professional responsibility and in civil liability for making reasonable practice decisions in the interest of patients."
Wendy Norman, a leading researcher in women's reproductive health at The University of British Columbia, first brought concerns about physician-only dispensing of Mifegymiso to the colleges in her home province.
After conducting surveys and focus groups with doctors across the country, Dr. Norman and her research partners heard "resounding and unanimous" feedback that physician-only dispensing would be a barrier to access, especially in rural areas that do not already offer surgical abortions.
"A physician is not going to take on this practice [dispensing Mifegymiso] if they also have to learn to become a dispenser and undertake all the jobs of a dispenser: Buying, stocking, selling, turning over stock," she said.
B.C. makes it especially difficult for doctors to dispense pharmaceuticals directly to their patients. Physicians who want to do so have to apply for a special authorization; fewer than 20 physicians in the province have done so, according to the College of Physicians and Surgeons of B.C.
"It's quite an investment for a physician to be a dispensing practitioner," said Heidi Oetter, the registrar of the College of Physicians and Surgeons of B.C. "We wanted to make sure that the traditional practice of the physician writing the [prescription] and the patient taking it to the pharmacist of their choice was still an acceptable route for dispensing [Mifegymiso] so that it could actually be used."
Mifegymiso is made up of two medications, sold together in a combination pack. The first, mifepristone, blocks the hormone progesterone, causing the lining of the uterus to break down. The second drug, misoprostol, is taken 24 to 48 hours later, and induces contractions similar to a natural miscarriage.
Mifepristone has been approved in more than 60 countries, including the United States, where it has been available since 2000. Canada did not approve the drug until July, 2015, and manufacturing issues have since delayed its sale.
Nearly every country that has approved mifepristone has done so with some version of the doctor-dispensing rule, Dr. Sharma said in an interview Sunday.
France, where the drug has been available since the late 1980s, requires five doctor visits, she said.
Canada only requires two doctor visits – one to obtain the pills, and a second to ensure the abortion is complete.
"The reality of the product is there are risks associated with it and some of those risks have resulted in deaths," Dr. Sharma said. "It [the doctor-dispensing] rule is really about establishing the physician-patient relationship and being able to have that discussion around risks and benefits."
In the rare instances where pregnancy has continued after the pills are ingested, there is a risk of birth defects in the baby. There have been rare cases of blood poisoning after use of mifepristone, but the risk is similar to that of surgical abortions, spontaneous miscarriages and births.
A review of 45,000 medical abortions published in 2013 in the journal Contraception found serious complications in 0.4 per cent of cases.
Dr. Norman said allowing pharmacists to dispense Mifegymiso would not preclude doctors from seeing medical-abortion patients twice or more if need be.
"This is an antiquated approach that was just taken wholesale from the way things were first done," she said, adding that today pharmacists are the experts in distributing pharmaceuticals.
Bob Nakagawa, the registrar of the College of Pharmacists of B.C., agreed.
Mr. Nakagawa is also the chair of a council that represents pharmacy registrars in every province. Although he does not know of any other provinces yet planning to follow B.C.'s lead, he knows his counterparts across the country support selling Mifegymiso in pharmacies – he wrote Health Canada a letter to that effect on their behalf in August.
"Our view is that [Mifegymiso] should follow the same process that every other prescription drug follows," Mr. Nakagawa said in an interview."At the end of the day, our concern is that access to these services shouldn't be compromised by a distribution system that isn't consistent with normal practice."