Blog Posts

CMAJ Commentary- Drs. Norman & Soon argue normal Pharmacist dispensing is the better option in Canada

Abortion pill regulations limit access, put Canadian women at risk: UBC profs
Oct. 17, 2016

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 US 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: LINK

Dr. Norman discusses mifepristone policy on CBC National Radio- “180”

Dr Norman discusses mifepristone policy- CBC's "180"

Dr Norman discusses mifepristone policy- CBC’s “180”

Dr. Norman meets with Dr. Kaye Wellings, Lead investigator of the UK’s NATSAL, at the London School of Hygiene and Tropical Medicine

Sarah Munro receives MSFHR Trainee Award

We would like to congratulate Sarah Munro, our new post-doctoral fellow, on receiving a trainee award from the Michael Smith Foundation for Health Research. Please see this link for more information on her achievement: http://www.msfhr.org/news/msfhr-news/msfhr-announces-2016-trainee-award-recipients . Sarah is working on the mifepristone implementation study that we highlighted in our last post.

Sarah’s doctoral study at UBC, in the Doctor of Philosophy in Interdisciplinary Studies program, focused on shared-decision making on birth after caesarean, in hopes of supporting women to make informed decisions about method of delivery. She is an advocate for patient centered care and has worked with health authorities including Fraser, Northern and Perinatal Services BC. In her words, “Producing research and implementing research are two different beasts. I am hopeful that by partnering with clinicians and health authority decision makers, our patient decision aid will be relevant for day-to-day practice and be implemented sustainably so that it has a positive impact on women’s childbirth experiences.”

Mifepristone Implementation

We are pleased to announce that we were recently offered funding  for our Mifepristone study from the Partnerships for Health System Improvement Program by Canadian Institutes of Health Research and Michael Smith Foundation for Health Research.

Although the gold standard for medical abortion care worldwide has been the use of mifepristone, the medication was only recently approved in Canada in July 2015.  The introduction of mifepristone presents an exceptional opportunity to better understand the effectiveness of health care provider training on adoption of medical abortion into practice and the impact on access to abortion, particularly for women in rural and remote areas.  Our study of mifepristone implementation seeks to understand address the facilitators and barriers to support successful initiation and ongoing provision of medical abortion service in Canada.  The study is an observational prospective mixed methods study offered to mifepristone health professional certificates, enrolling up to 1500 within the first year. We are also creating a “Community of Practice” platform to support clinical, health service, and system challenges faced by clinicians adopting mifepristone.

Health Canada’s current regulation requiring physician only dispensing   ignores current safeguards compared to the standard of pharmacist-dispensing, which is required in most Canadian provinces. CART is currently raising awareness about the implications of Health Canada’s restrictive policy. “This policy will limit access for women.” says Dr. Norman.

Our new summer students!

The CART-GRAC team is pleased to welcome four students who will be working with us this summer!

Marabeth Kramer is working with CART for 8 weeks as part of the Faculty of Medicine’s Summer Student Research Program. She will be starting her second year at the UBC Southern Medical Program in Kelowna this August. Her interest in the OBGYN specialty is aligned with her work CART involving chart review for two studies examining IUD efficacy and best practice. She is also assisting with the development of a resource page and a FAQ list for an online platform that will be accessed by providers recently trained in the provision of mifepristone.

© Photography by Mark Whitehead

Marek Blachut is a recent graduate of the International Baccalaureate (IB) programme at St. John’s school and a returning member of the CART-GRAC research team. He has returned for the summer, as a research assistant to aid in the translation, compilation, and implementation of the Mifepristone study as well as data collection for the Better Contraceptive Choices Project.

marek [pic

Hannah Rahim, recipient of the Mini Med School Summer Studentship from BC Children’s Hospital and recent IB graduate of Mulgrave School is assisting CART-GRAC to offer more effective and dynamic knowledge translation. She will be increasing the accessibility of our research to the public through developing our social media presence while raising awareness about family planning and health equity. Hannah will also be conducting chart reviews at abortion clinics for the Better Contraceptive Choices Project.

hannah

Emily Teng, recipient of the Summer Student Scholar Award of the Canadian Institutes of Health Research-Public Health Agency of Canada Chair in Applied Public Health Research, has just graduated from the IB programme at St. John’s School and will be working with the team as a volunteer. She will assist Dr. Saied Samiedaluie in Operations Research Modeling to contribute to cost-effectiveness health policy options.

emily

 

 

 

 

Annual SOGC Meeting!

CART-GRAC collaborators from coast to coast met during the annual meeting of the SOGC (Society of Obstetricians and Gynecologists of Canada) meeting to plan advances in Family Planning Health Policy Research for Canada! (Pictured, Dr. Edith Guilbert, INSPQ, Quebec; Dr. Melissa Brooks,  Dalhousie University, Nova Scotia; Dr Wendy Norman, University of British Columbia, BC)

rotated cart grac pic

The Canadian Sexual Health Survey

We would like to thank all of the women who participated in our Canadian Sexual Health Survey. The survey gathered information regarding sexual and reproductive health, contraception use, pregnancy outcomes and accessibility of reproductive health services, enabling us to analyze how women plan and space their pregnancies. Unlike many countries, Canadian epidemiological data on sexual health to this date is very limited. Collection of this data is essential to inform health policies to improve the quality of life of Canadian women and their families. We hope that the government will be inspired to continue our project through the regular collection of nation-wide data about sexual health in the future, in order to create policies that are best representative of our Canadian population.

Our project surveyed 21 communities across all 5 health authorities, reaching many communities without airports or car rentals that were more challenging to access. “But it was often in these communities where we would have the warmest welcomes, with people stopping our surveyors on the street to say ‘we support you!’ and providing connections, free printing, or booths at farmers’ markets,” says Eva McMillan, research coordinator of the Sexual Health Survey. “I feel that this speaks to power of the voices of rural BC. The people there want to express their need for contraception and to have their voices heard about their sexual health and experiences. Our project is going to give voice to these women.”

We are currently using the data obtained from our survey to create Canada’s First Cost Effectiveness Model to predict, at a provincial level, the number of pregnancies and their subsequent outcomes based on survey indicators for sexual partners and activity, contraception use and social determinants of health. Policy analyses using this model  can assist the government to evaluate the potential health and financial benefits of free contraception for women, thereby supporting  evidence-informed policies for optimal health system strategies. When women have access to effective contraceptive techniques that they may have not otherwise been able to afford, they are able to avoid unintended pregnancies and abortions.   According to a study by the Guttmacher Institute, health system costs can be reduced by 75% by investing in family planning to avoid treating complications arising from unintended pregnancies.

Eva

Photo of Eva McMillan, Research Coordinator

Issue Brief: Health Canada could Improve Abortion Safety & Access by permitting pharmacist-dispensed mifepristone

Dr. Norman suggests how Health Canada’s Mifepristone decision reduces safety- and has practical suggestions on how to improve safety and access.  Read the full briefing note for the details by clicking the link:

Briefing Note_Health Canadas mifepristone decision reduces safety_2016-05-12

“What is Health Canada thinking on the abortion pill?” – Ottawa Citizen Editorial Board

CART in the news April, 2016:

Excerpts from the National PostOttawa Citizen and Toronto Star

The Toronto Star: “It’s been available in France since 1988, Britain since 1991 and the United States since 2000. Now 28 years after it first appeared on the market, mifepristone — better known as the abortion pill RU-486 — will be available in Canada in July under the brand name Mifegymiso.

This is cause for celebration among the 100,000 women who choose an abortion each year in Canada. They will finally have an option other than a surgical abortion with a medication that is already available in 61 countries and is so safe and effective that the World Health Organization includes it in its Model List of Essential Medicines.

The pill will give Canadian women easier access to abortions. They will not have to travel long distances to hospitals or clinics to have one performed surgically and the procedure will not be delayed because of waiting lists.

Still, women’s health advocates and Canadian pharmacists say Health Canada’s restrictive policies on how the drug is to be distributed, while common to other countries where it is available, could make it more difficult than necessary for women to access the pill. That must be changed.”

The Ottawa Citizen: “Just in case you’d thought the legalization of a pill was going to make abortion accessible across Canada, Health Canada, which approved the drug last summer, is here to tell you that when it hits markets this summer, it’s going to be a pain to get ahold of.”

“The government should seriously consider expanding dispensing services and, potentially, prescribing as well. In some jurisdictions, midwives and nurse practitioners can prescribe the drug. For those concerned about what the family doctor might think, for example, this would lift a huge burden.

Caution is understandable. An excess, which has the effect of limiting access, is not.”

and

The National Post: “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.”

 

Read the full stories by following the links above or here:  National PostOttawa Citizen  and Toronto Star  .  You can also read CART’s full recommendation, and briefing note in our blog post from May 4th.