Authorizing Cannabis for Medical Purposes
The legalization of cannabis for recreational purposes came into effect with the Cannabis Act in October 2018, and patients continue to have access to cannabis for therapeutic purposes. The Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations. Patients can obtain cannabis for medical purposes when a physician or nurse practitioner provides a “medical document” , authorizing its use, and determining the daily dried cannabis dose in grams.
With the authorization, patients have the choice whether to (a) buy directly from a federally licensed producer; (b) register with Health Canada to produce a limited amount for personal consumption; (c) designate someone to produce it for them; or (d) buy cannabis at provincial or territorial authorized retail outlets or online sales platforms, if above the legal age limit.
While acknowledging the unique requirements of patients suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief, physicians remain concerned about the serious lack of clinical research, guidance and regulatory oversight for cannabis as a medical treatment. There is insufficient clinical information on safety and efficacy for most therapeutic claims. There is little information around therapeutic and toxic dosages and knowledge on interactions with medications. Besides the need for appropriate research, health practitioners would benefit from unbiased, accredited educational modules and decision support tools based on the best available evidence.
The Canadian Medical Association has consistently expressed concern with the role of gatekeeper that physicians have been asked to take as a result of court decisions. Physicians should not feel obligated to authorize cannabis for medical purposes.
Physicians who choose to authorize cannabis for their patients must comply with their provincial or territorial regulatory College's relevant guideline or policy. They should also be familiar with regulations and guidance, particularly:
Health Canada’s Information for Health Care Practitioners – Medical Use of Cannabis (monograph, summary and daily dose fact sheet),
the Canadian Medical Protective Association’s guidance;
the College of Family Physicians of Canada’s preliminary guidance Authorizing Dried Cannabis for Chronic Pain or Anxiety; and
the Simplified guideline for prescribing medical cannabinoids in primary care, published in the Canadian Family Physician.
The CMA recommends that physicians should:
Ensure that there is no conflict of interest, such as direct or indirect economic interest in a licensed cannabis producer or be involved in dispensing cannabis;
Treat the authorization as an insured service, similar to a prescription, and not charge patients or the licensed producer for this service;
Until such time as there is compelling evidence of its efficacy and safety for specific indications, consider authorizing cannabis only after conventional therapies are proven ineffective in treating patients’ conditions;
Have the necessary clinical knowledge to authorize cannabis for medical purposes;
Only authorize in the context of an established patient-physician relationship;
Assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests;
Engage in a consent discussion with patients which includes information about the known benefits and adverse health effects of cannabis in its various forms (e.g., edibles), including the risk of impairment to activities such as driving and work;
Advise the patient regarding harm reduction strategies and the prevention of accidental exposure for children and other people;
Document all consent discussions in patients' medical records;
Reassess the patient on a regular basis for its effectiveness to address the medical condition for which cannabis was authorized, as well as for addiction and diversion, to support maintenance, adjustment or discontinuation of treatment; and
Record the authorization of cannabis for medical purposes similar to when prescribing a controlled medication.
The Cannabis Regulations provide some consistency with many established provincial and territorial prescription monitoring programs for controlled substances. Licensed producers of cannabis for medical purposes are required to provide information to provincial and territorial medical licensing bodies upon request, including healthcare practitioner information, daily quantity of dried cannabis supported, period of use, date of document and basic patient information. The Minister of Health can also report physicians to their College should there be reasonable grounds that there has been a contravention of the Narcotic Control Regulations or the Cannabis Regulations.
Approved by CMA Board February 2015
Latest update approved by CMA Board in February 2020
Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)
Canadian Medical Association Submission to the Senate Standing Committee on Legal and Constitutional Affairs
On behalf of its more than 82,000 members and the Canadian public, CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery.
The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 51 national medical organizations.
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Standing Committee on Legal and Constitutional Affairs study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1
Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite.
The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3
In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.*
CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult.
Public health approach to addiction
Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components.
Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program).
Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5
Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential.
Harm reduction is part of health practice
Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms.
Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs.
The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9
Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10
Supervised Consumption Sites are evidence-based
Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment.
Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12
Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services.
Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15
Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been:
* A reduction in the overall rate of needle sharing in the area;19
* A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21
* Increased access to addiction counseling and increased enrolment in detox programs;22 23
* Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24
* Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and
* No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26
* Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28
Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence.
Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety.
Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation.
The CMA has the following concerns with Bill C-2:
1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation."
2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation.
3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances".
4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need.
It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.
* "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services.
1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4
2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do
3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3
4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23
5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967
6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf
8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf
9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf
10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf
13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm
14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services
15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics
16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf
17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404.
19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18.
20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351.
21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7.
22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919.
23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence.
24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36.
25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34.
26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76.
28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36.
29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper.
30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction.
31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374.
32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136
33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20)
34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
CAM in Canada
CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories:
* Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
* Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
* Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
* Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
* Resist any influence or interference that could undermine their professional integrity;9
* Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
* Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
* Instructions for use;
* Indications that the product or therapy has been convincingly proven to treat;
* Contraindications, side effects and interactions with other medications;
* Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
The harms associated with psychoactive prescription medicinesi including sedatives and tranquilizers1, stimulants2, and analgesics, particularly opioids3, such as oxycodone, hydromorphone and fentanyl, are a significant public health and patient safety issue.
Canada has one of the highest per capita consumption of prescription opioids in the world.4 Dispensing of medications has substantially increased in Canada, although patterns vary considerably between provinces.5 In 2011, while opioid consumption for medical purposes in morphine equivalence (ME)ii was 62mg per person globally, Canada's ME was 812mg per person.6 When comparing to other developed countries, Australia's ME was 427 and Denmark's 483. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.7
Psychoactive medications pose significant health and safety risks. The harms include overdoses, suicides, motor vehicle accidents, relationship and employment problems, workplace accidents and exposure to blood borne pathogens and other infections when used by injection, besides addiction.
Data are not collected systematically in Canada, making it difficult to assess the harms and track the trends and impact of the introduction of policy changes. However, practitioners have seen the significant impact of these prescription drugs on their patients and to public health. Studies in Ontario show that the number of people enrolled in methadone maintenance treatment rose from about 7,800 in 2001 to over 35,000 in 2011, where opioids have surpassed heroin as the drug used.8 Opioid-related deaths nearly tripled from 2002 to 2010, according to the Office of the Chief Coroner of Ontario.9 Another study showed that other non-opioid depressants (sedatives), such as benzodiazepines, were involved in 92% of the opioid-related deaths.10
The impact is felt particularly among vulnerable populations, such as youth, seniors, First Nations and those living in poverty. In 2013, opioids were reported as the third most common drug used by students in Ontario (after alcohol and marijuana).11 Opioid addiction rates anywhere from 43% to 85% have been reported in some Indigenous communities.12 13 While accurate data on the harms of prescription medication among seniors is lacking, it is well known that the prevalence of pain is higher among older adults and that they account for a significant proportion of prescriptions.
The "high" they produce also leads to these medications being sought after for recreational purposes and, as they are legal products, they are often more easily accessible than street drugs. Surveys with youth have shown that as much as 70% of opioids have been obtained from legitimate prescriptions to family and friends (55% were shared at no cost).14 As well, because opioids have high abuse liability and addiction potential, people have resorted to illegal behaviour to obtain them, such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Of great concern, opioid dispensing levels are strongly correlated with increased mortality, morbidity and treatment admissions for substance use.15 16 Studies in Ontario and British Columbia have replicated similar findings in the US. Many patients were prescribed these medications and developed dependence.17
Psychoactive medications are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. Medications, such as opioids, have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.
Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.18 19 However, there is evidence for significant pain relief in the short term but a need for more evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.20 21 22
Important contributing factors for the increase in prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with the patient. In addition, there are new highly potent opioid drugs available.23 24
Canada's physicians are deeply concerned about the harms of opioids and other psychoactive prescription medications. As prescribers, they have a fundamental role in helping to ensure safe and effective use of these drugs, and the deterrence of abuse. 25 26 27 Physicians assess patients and consider whether a prescription is clinically indicated according to best practices, as well as consider whether the benefits outweigh the risks, while screening for risk factors for substance dependence and diversion. This area can be a source of tension with patients who might seek to obtain drugs through fraudulent means.28 It is also an area which causes concern to many physicians, and this could be affecting access to adequate pain management where it is needed.29
The challenge for physicians and public policymakers is how to mitigate the harms of psychoactive prescription drug use, while ensuring that patients have access to the appropriate treatment for their clinical conditions.
Comprehensive National Strategy
Canada's physicians believe that this challenge requires a complex and multifaceted solution; and to further such a solution, the CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant.
The federal government has created the National Advisory Council on Prescription Drug Misuse, co-chaired by the Canadian Centre on Substance Abuse, the Coalition on Prescription Drug Misuse (Alberta) and the Nova Scotia Department of Health and Wellness, in partnership with Health Canada's First Nations and Inuit Health Branch's Prescription Drug Abuse Coordinating Committee. In its 2013 report First Do No Harm: Responding to Canada's Prescription Drug Crisis30, there are nearly 60 recommendations toward the development of a strategy to combat the harms associated with psychoactive prescription medications. However, there is much still to be done.
The CMA supports collaborative efforts by the federal and provincial/territorial governments, and by health professionals and other stakeholders, to develop and implement a comprehensive national strategy. Such a strategy should include the following:
1. Improvement of Drug Safety
Health Canada, as the agency that approves prescription drugs for use and monitors their safety once on the market, has several levers by which it can control Canadians' access to drugs. One of these is the Controlled Drugs and Substances Act (CDSA) and its regulations, which govern access to illegal products and recently has included psychoactive prescription drugs.
Because of their health and safety risks, it is important that Health Canada ensures that the CDSA subjects psychoactive substances to high levels of regulatory scrutiny during both the approval process and post-approval surveillance. The Act should require manufacturers to:
* Meet stringent pre-approval requirements. For example, Health Canada could require intensive review of pre-approval clinical trial results and of product monographs by an expert impartial review committee (including addiction, pain and public health expertise); or require that the manufacturer fulfill special conditions, such as formal post-market studies, as a condition of the drugs' approval; or even require larger sample sizes or longer study periods to assess harms;
* Adhere to restrictions on the marketing of controlled medications to health professionals and the general public. The adequacy of regulations needs to be assessed in this regard.
* Develop and cover tamper-resistant formulations of psychoactive drugs of concern. Although not a standalone solution, tamper-resistant formulations can reduce the potential for manipulation to be able to use through snorting, chewing or intravenously.
2. Enhancement of Optimal Prescribing through Evidence-Based Guidance, Education and Support for Prescribers
CMA recommends that appropriate prescribing of psychoactive medications should be addressed through evidence-based guidance and education. A strategy to support optimal therapy might include:
* Support for models of care that allow a physician to spend time with complex patients.
* Ongoing development and dissemination of clinical guidance. The Canadian Guideline for Use of Opioids to Treat Chronic Non-Cancer Pain was published in the CMAJ in 2010. CMA has co-sponsored an online CME module based on this guideline. There is interest in similar guidelines for sedatives and stimulants.
* Evaluative research to support the critical review of guidelines periodically. It is essential to review data on chronic conditions for which risks might outweigh benefits.
* Relevant, unbiased and easily accessible information for prescribers, which can readily be incorporated into everyday practice. This should include clinical decision-support tools for use at the point of care, inclusive of dosing guidelines and guidance on when to seek consultation with experts. Physicians also require tools, including those that facilitate: monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; tapering of problematic or ineffective doses; among others.
* Educational programs in optimal prescribing, pain management and in the management of addictions, as part of the curriculum in medical school, and residency training as well as in continuing education. Particular support is needed for those in primary care.
* Guidance for prescribers about how to deal with conflict in their practice. This would include guidance for patient-centred educational discussions on safe opiate prescribing and use and management of addictions.
* Access to expert advice if required through such means as:
o Policies or standards of practice developed by provincial regulatory colleges of physicians, which can include limitations on prescription volume, treatment period and indications.
o Communities of practice, knowledge hubs and clinical support networks that link practitioners with experts in the field, facilitating triage and supporting front line generalists. Experts can not only provide clinical information, but can provide mentorship and personal advice about best practices.
o Feedback to practitioners about their prescribing practices, particularly if potentially concerning patterns are identified. This initiative should be facilitated by collaborative work between health care professionals and their respective provincial regulatory colleges.
o Academic detailing programs, which use personalized, one-on-one techniques to deliver impartial prescribing information to practitioners.
3. Enhancement of Optimal Prescribing through Physician Regulation and Prescription Monitoring Programs
Medicine is a regulated profession, and the provincial colleges of physicians have ultimate authority and responsibility for the oversight of physician practice. The colleges have taken a leading role in educating their members about appropriate prescribing, in monitoring prescribing practices to ensure their appropriateness and taking disciplinary action when required, and through collaborating with law enforcement agencies to detect and halt criminal diversion.
The CMA recommends that federal and provincial regulations regarding controlled substances recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and the purpose for which the data are collected. Standardization of monitoring systems across Canada according to best practices can contribute to addressing the harms associated with psychoactive prescription medication by:
* Allowing health care practitioners to identify previous or concomitant prescriptions of controlled medications with more than one practitioner at the time the prescription is requested or filled;
* Deterring interprovincial or jurisdictional fraud, by allowing health care practitioners to identify other prescriptions at the time the prescription is requested or filled; and
* Improving professional regulatory bodies' capacity for oversight and intervention by establishing a mechanism for real-time monitoring.
The CMA recommends that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring.
PMPs should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary.
CMA also recommends that Health Canada ensure that its legislative framework be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can help individual physicians or pharmacists identify potential diversion and double prescriptions, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, and could minimize the potential administrative burden.
PMPs should conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. The CMA strongly recommends that Health Canada undertake a privacy impact assessment of the regulatory framework for controlled prescription drugs, and share the results with stakeholders.
4. Increase in Access to Treatment for Pain
Chronic pain affects many aspects of a person's life including their ability to work, their emotional, mental and physical health, and their quality of life. Pain costs Canada an estimated $60 Billion dollars per year; more than the cost of heart disease, cancer and diabetes.31 CMA has endorsed a national strategy for pain, developed and proposed by the Canadian Pain Coalition and Canadian Pain Society,32 which addresses four target areas: awareness and education; access; research; and ongoing monitoring.
Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include:
* Care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals;
* Recommendation of non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies;
* Appropriate pharmaceutical prescription options, covered by provincial formularies; and
* A focus on patient participation and empowerment.
However, specialized pain treatment programs are in short supply. Wait times are greater than one year at more than one third of publicly funded inter-professional treatment programs.33 In many parts of Canada, particularly rural and remote areas, such programs are not available. In addition, while physician visits are covered by the public health care system, services provided by other health professionals are more likely to be either covered by private health benefits or paid out of pocket, and are therefore beyond the means of many Canadians. These factors may result in heavier reliance on prescription medication as treatment for chronic pain.
The CMA recommends that all partners work to improve and promote access to specialized treatment programs for pain management, and that investments be made in research about options for treatment.
5. Increase in Access to Treatment for Addiction
Access to addiction treatment is very limited and, when available, is primarily comprised of detox or the substitution treatments with methadone or Suboxone(r) (buprenorphine and naloxone). As addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry by definition, which manifests along biological, psychological, social and spiritual dimensions, treatment must address all those areas rather than just one or another.34
The CMA supports the enhancement of access to options for addiction treatment that address different needs. Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that addiction programs be culturally relevant for Indigenous communities.
Treatment programs must also be integrated within the health care system and be adequately funded to meet evidence based, best-practice guidelines.
CMA also supports the development and dissemination of practice tools and guidelines to help physicians assess the addiction potential of a patient receiving psychoactive medications, and to assist in managing patients who have addiction and related problems and complications.
6. Increase in Information through Epidemiological Surveillance
One of the challenges in dealing with prescription drug abuse, which can reflect hazardous (episodic) use, harmful (regular) use or addiction, is the incompleteness of our knowledge of the extent of the problem. Countries, such as the US and France, are able to monitor psychoactive drug use, while in Canada we still rely on unsystematically collected or locally limited data. The creation of a national surveillance system that supports the collection of systematic, standardized information would:
* Permit the thorough assessment of the problem, with the development and monitoring of indicators;
* Support the early detection of diversion or inappropriate prescribing behaviour;
* Support the establishment of best practices to address crucial issues;
* Identify research priorities; and
* Evaluate the impact of the implementation of strategies.
Sources of information should include PMPs, coroner's investigations, emergency room admissions, and poison control data, among others.
7. Prevention of Deaths due to Overdose
Overdose deaths have increased dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. Opioid death and complications overdoses can be prevented with appropriate medication and prompt emergency response. The CMA recommends the:
* Creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. Training should be made available to health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.35
* Improvement of access to naloxone to reverse opioid overdoses. This should include the prescription of naloxone to high risk individuals and third parties who can assist a victim experiencing an opiate-related overdose.
* Enactment of Good Samaritan laws by all levels of government in order to protect callers from criminal charges if they call emergency services to report an overdose. 36 37
8. Provision of Information for Patients and the Public
Awareness programs that provide accurate information to patients and the general public are important, and could include:
* Information on the benefits and harms of psychoactive prescription medication use, and signs of dependence and overdose. This should include the risk of dependence and addiction associated with the use of opiates for the treatment of acute and chronic pain.
* Messages aimed at the prevention of problematic drug use among young people and other populations at risk.
* Information regarding safe medication storage and disposal, and reducing access to medications from family and friends. CMA supports national prescription drug "drop off" days, and recommends that patients be educated about the importance of routinely returning unused prescription drugs to the pharmacy.
The CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based. This strategy should include:
* That Health Canada require that manufacturers meet stringent pre-approval requirements, adhere to restrictions on the marketing of controlled medications to health professionals and the general public, and develop formulations of psychoactive drugs of concern that are tamper-resistant.
* Support for optimal prescribing through evidence-based guidance, education and supports, such as clinical guidance, clinical decision-support tools, educational programs, expert advice, and supportive models of care.
* The enhancement of optimal prescribing through physician regulation and the development of a pan-Canadian system of real-time prescription monitoring programs, compatible with electronic medical and pharmacy record systems, based on national standards.
* Increased access to specialized pain management and treatment, according to best practices, with investments in research.
* The enhancement of access to options for addiction treatment that address different needs, and the support for the development and dissemination of practice tools and guidelines.
* The creation of a national surveillance system that supports the collection of systematic, standardized information to better inform and track policy changes.
* The creation and scaling up of community-based programs that
* Offer access to opioid overdose prevention tools and services, including the improvement of access to medication to reverse opioid overdoses (naloxone) and the enactment of Good Samaritan laws by all levels of government.
* The provision of accurate information to patients and the general public, including safe medication storage and disposal.
i Psychoactive drugs are substances that, when taken, have the ability to change an individual's consciousness, mood or thinking processes (WHO, 2004). Psychoactive prescription drugs include sedatives (such as benzodiazepines and barbiturates), stimulants (such as amphetamines), and opioids (such as oxycodone, hydromorphone, morphine and fentanyl). [World Health Organization (2004) Neuroscience of psychoactive substance use and dependence. Available at: http://www.who.int/substance_abuse/publications/en/Neuroscience.pdf]
ii Comprises six main opioids: fentanyl, hydromorphone, methadone, morphine, oxycodone and pethidine.
1 Canadian Centre on Substance Abuse. Prescription sedatives and tranquilizers. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Sedatives-and-Tranquilizers-2013-en.pdf
2 Canadian Centre on Substance Abuse. Prescription stimulants. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Stimulants-2013-en.pdf
3 Canadian Centre on Substance Abuse. Prescription opioids. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Canadian-Drug-Summary-Prescription-Opioids-2013-en.pdf
4 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013.
5 Fischer B, Jones W, Murray K, et al. Differences and over-time changes in levels of prescription opioid analgesic dispensing from retail pharmacies in Canada, 2005-2010. Pharmacoepidemiol Drug Saf. 2011;20:1269-77.
6 United Nations Office on Drugs and Crime. World drug report 2014. New York: The Office; 2014. Available: www.unodc.org/documents/wdr2014/World_Drug_Report_2014_web.pdf
7 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
8 Fischer B, Argento E. Prescription opioid related misuse, harms, diversion and interventions in Canada: a review. Pain Physician. 2012;15:ES191-ES203.
9 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013.
10 Dhalla IA, Mamdani MM, Sivilotti MLA, et al. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone CMAJ. 2009;181(12): 891-6.
11 Centre for Addiction and Mental Health. Drug use among Ontario students, 1977-2013: results of the Ontario Student Drug Use and Health Survey. Toronto: The Centre; 2013. Available: www.camh.ca/en/research/news_and_publications/ontario-student-drug-use-and-health-survey/Documents/2013%20OSDUHS%20Docs/2013OSDUHS_Highlights_DrugUseReport.pdf
12 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf
13 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf
14 US Department of Health and Human Services Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. Rockville (MD): The Department; 2011. p. 25. Available: www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf
15 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q. 2011;14(1):22-4.
16 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf. 2013;22(4):438-42.
17 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend. 2004;73(2):199-207.
18 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142 DOI: 10.1136/bmj.d5142.
19 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician. 2014;17(1):E1-10.
20 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology. 2014;83:1277-84. Available: www.neurology.org/content/83/14/1277.full.pdf+html
21 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10:147-59.
22 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;(1):CD006605.
23 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health. 2008;99(3): 182-4.
24 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
25 Silversides A. Opioid prescribing challenges doctors. CMAJ. 2009;181(8):E143-E144.
26 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142.
27 Kirschner N, Ginsburg J, Sulmasy LS. Prescription drug abuse: a policy position paper from the American College of Physicians. Ann Intern Med. 2014;160:198-213.
28 Saveland C, Hawker L, Miedema B, et al. Abuse of family physicians by patients seeking controlled substances. Can Fam Physician. 2014;60:e131-6.
29 Wenghofer EF, Wilson L, Kahan M, et al. Survey of Ontario primary care physicians' experiences with opioid prescribing. Can Fam Physician. 2011;57(3):324-32.
30 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse-report-en.pdf
31 Canadian Pain Strategy Initiative. Rise up against pain: the Canadian Pain Strategy. Available: http://canadianpainstrategy.ca/en/home.aspx
32 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
33 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
34 American Society of Addiction Medicine. Public policy statement: definition of addiction. 2011. Available: www.asam.org/for-the-public/definition-of-addiction
35 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
36 Follett KM, Piscitelli A, Parkinson M, et al. Barriers to calling 9-1-1 during overdose emergencies in a Canadian context. Crit Social Work. 2014;15(1):18-28. Available: http://www1.uwindsor.ca/criticalsocialwork/system/files/Follett_Piscitelli_Parkinson_Munger_2014.pdf
37 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
The Canadian Medical Association (CMA) is pleased to provide its response to Health Canada's public consultation on the Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall), in reference to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which came into force on November 6, 2014.
The CMA supports a robust legislative framework toward an unbiased, evidence-based system for the oversight of pharmaceutical products, which spans both the pre- and post-approval of these products, with the ultimate goal of patient safety. Prescription medication plays a critical role as part of a high-quality, patient-centred and cost-effective health care system. It is a priority to physicians that all Canadians have access to affordable, safe and effective prescription medications.
Stemming from this perspective, the CMA strongly welcomed the new ministerial authorities established by Vanessa's Law as an important contribution to patient safety and the effectiveness of Health Canada's oversight of prescription pharmaceuticals. With these new authorities now in effect, it is critical that implementation is comprehensive, effective and transparent. As such, CMA's response to this public consultation on the new Guide will focus on the need for:
* increased clarity on the thresholds that underpin the use of these new authorities,
* guidance on the notification of public, physicians and other health care practitioners, and
* a commitment to ongoing oversight and revision process of this guidance.
ISSUE 1: PROVIDE INCREASED CLARITY ON THE THRESHOLDS
In CMA's brief1 to the House of Commons Standing Committee on Health as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, key recommendations included clarification of both ministerial authority and responsibility in support of patient safety. The CMA supported the intent of the expansion of these powers, but expressed concern with the lack of clarity on the threshold required to be met to enable the use of these new authorities.
In order to ensure the consistent and effective implementation of these new ministerial authorities, the CMA considers it essential that the Guide provide more clarity on the threshold that enables the use of the new authorities, including the determination of serious risk.
To determine this threshold, Health Canada relies on experts to analyze scientific information and make a recommendation to the Minister.
The CMA recommends that guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
As the definition of "serious risk of injury to human health" is not provided in Vanessa's Law, it is critical that it be addressed in the Guide. Annex A of the Guide states that "the determination of whether a therapeutic product presents a serious risk is complex and is conducted on a case-by-case basis when new information becomes available", and puts forward a "non-exhaustive" list of elements to be considered. It also states that different weights would be attributed to different elements and suggests further contextual elements. The CMA is concerned that without a clear process for the determination of what constitutes a serious risk that subjectivity may have an undue role in this determination and there is the potential for a lack of consistency from case to case. Further, a detailed process is required to ensure that this threshold does not constrain ministerial authority when action is needed.
The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
ISSUE 2: INCLUDE GUIDANCE NOTIFICATION TO PUBLIC, PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
The CMA is supportive of the guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker, i.e., that power is exercised in a process that is free from bias, based on evidence and in a transparent manner.
In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies2 and by Health Canada, when these new authorities are exercised.
Access to accurate, unbiased information is essential for people to make decisions about their own health.. A clear elaboration and articulation of the process and timelines for how and when public notification is issued in relation to the exercise of the new ministerial authorities is critical to ensure their comprehensive, effective and transparent implementation.
Also, when new information is discovered about a prescription medication, it is important that health professionals be informed as quickly and efficiently as possible.
As part of Health Canada's commitment to transparency, the CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
The U.S. Food and Drug Administration (U.S. FDA), for example, provides guidance and instructions on their public notification expectations in a situation where a product may pose a significant health hazard.3 In addition, there are different mechanisms of public notification, including 'mobile web' and alerts.
Finally, also consistent with the guidance of the U.S. FDA, the CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
ISSUE 3: SPECIFY THE OVERSIGHT AND REVISION OF THE GUIDANCE
As part of its public consultation outreach with stakeholders on this new guidance, Health Canada officials have described the Guide as an evergreen document that will be continually updated. The CMA is supportive of Health Canada's efforts to engage stakeholders and the public in the development and revision of this guidance.
To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
The CMA welcomed this opportunity to submit recommendations on how Health Canada may improve the Guide to New Authorities, which is critical to the comprehensive, effective and transparent implementation of the new authorities established by Vanessa's Law. The CMA looks forward to continued and ongoing collaboration with Health Canada on its implementation of these important new powers.
Overview of Recommendations
1. The CMA recommends that the guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
2. The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
3. In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies and by Health Canada when these new authorities are exercised.
4. The CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
5. The CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
6. To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
1 Canadian Medical Association (2014) Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2014-09.pdf
2 Note: Throughout this submission, "companies" refers to whom the new ministerial powers apply outside of the regulator - as explained in the consultation document, in the case of s. 21.1 it is a "person" (can include an individual, a research institution, a corporation or an authorization holder), in the case of 21.2 it is the therapeutic product authorization holder, and in the case of s.21.3 it is a "person".
3 U.S. Food and Drug Administration (2015) Guidance for Industry: Product Recalls, Including Removals and Corrections. Retrieved from: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
The Canadian Medical Association urges the pan-Canadian Pharmaceutical Alliance to invite the federal government and private health insurance industry to participate in its price negotiations for prescription drugs.
The Canadian Medical Association urges the pan-Canadian Pharmaceutical Alliance to invite the federal government and private health insurance industry to participate in its price negotiations for prescription drugs.
The Canadian Medical Association urges the pan-Canadian Pharmaceutical Alliance to invite the federal government and private health insurance industry to participate in its price negotiations for prescription drugs.
The Canadian Medical Association, Canadian Paediatric Society, Canadian Psychiatric Association, Canadian Society of Addiction Medicine and College of Family Physicians of Canada are pleased to provide a joint supplementary submission to the Senate Standing Committee on Social Affairs, Science and Technology study on mental health, mental illness and addiction in Canada.
This submission provides advice on the areas that we believe require the most immediate attention from the federal government over the short term, and that will have the most direct benefit for those affected by mental illness, poor mental health and addiction.
The four areas are:
1. Federal Leadership &Capacity
2. Access Benchmarks and Surveillance Information
3. Best practices in mental illness, mental health and addiction
4. Human resource planning
This submission also provides recommendations for specific “priority tasks” under each of these four general areas.
1. Federal Leadership & Capacity
Federal leadership and capacity must be rapidly and significantly enhanced in order to address the existing deficiencies in the mental health system. This will signal and institutionalize a renewed commitment by the federal government and will ultimately provide support for Canadians impacted by mental illness, poor mental health and addictions.
Federal capacity can be enhanced through one of 3 models: a unit in an existing federal department, a federal arm’s length agency, or a pan-Canadian arm’s length agency.
Model 1: Unit within an existing federal department
Under this option, a new Branch led by an assistant deputy minister (ADM) would be created within Health Canada to provide policy leadership and deliver federal programs and services in the area of mental health, mental illness and addiction. The ADM would have general authority for its management and direction, be answerable to the deputy minister, and work with all other federal departments and agencies to develop and coordinate policies, programs and services in this area.
Model 2: Creation of a federal arm’s length Centre for Mental Illness, Mental Health and Addiction
This option would entail the creation of a more independent organization within the purview of the federal government. The ‘Centre for Mental Illness, Mental Health and Addiction’ would be structured as a federal agency in which decision-making powers are vested in a Board of Directors with a CEO responsible for the daily operations. This Board would be representative of all relevant stakeholders including health providers, health researchers, governments and affected populations. The Centre would remain under the health portfolio, with accountability through the Minister of Health. The Centre’s main function would be to deliver federal programs and services, working closely with Health Canada, the Public Health Agency of Canada, Department of Justice and other organizations such as the Canadian Centre for Substance Abuse. While the Centre would provide advice, the responsibility for federal policy development with respect to mental illness and mental health would continue to reside within Health Canada.
Model 3: Pan-Canadian arm’s length institute
This option consists of incorporating an Institute as a not-for-profit entity with the federal and provincial governments as shareholders. This model has been used in other areas where federal-provincial collaboration is essential, such as the Canadian Institute for Health Information. As in the previous model, the Institute for Mental Illness, Mental Health and Addiction would have a board, and a CEO. However, instead of direct accountability to the Minister of Health, the institute would be accountable to the Conference of F-P-T Ministers of Health. It would be responsible for delivering pan-Canadian programs and services that are complementary to provincial and territorial mental health/illness programs and services. Policy development responsibilities for mental health, mental illness and addiction would continue to reside with federal and provincial/territorial governments.
Each of the models outlined above has strengths and weakness. It is also possible that we could move from one model to another over time once the system is stabilized. However, for the short term, we contend that Model 1, a dedicated unit within Health Canada, would be the best fit with our objective of enhancing federal leadership and capacity to address mental illness, mental health and addiction issues.
The strength of Model 1 is that by elevating responsibility for mental health /illness issues to the branch level it raises the profile and importance of these issues. This would reinstate and indeed increase the capacity that had existed within Health Canada but was lost through numerous reorganizations and resource reallocations. In addition intra-departmental and inter-departmental synergies can be maximized with this model.
Should this model be chosen, it is important that the federal government demonstrate the kind of collaborative leadership that it has shown in the area of primary care through initiatives funded via the Primary Health Care Transition Fund. 1
The same leadership principles apply to reform of the mental health system in that while there are common problems and solutions across Canada there are also the needs of specific communities which must be addressed individually.
Of immediate priority for this unit are initiatives to reduce stigma and to address the mental health needs of First Nations and Inuit Peoples.
A stigma reduction strategy is an on-going function that must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours, thus a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level.
The strategy should include aspects of:
* Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention;
* Enhanced provider/student education and support;
* Policy analysis and modification of discriminatory legislation;
* Support for a strong voluntary sector to voice the concerns of patients and their families;
* Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories;
* Researching stigma.
The stigma associated with mental illness in children can hinder early identification and intervention and places them on a damaging path of suffering and pain. The effective treatment and community reintegration of people with mental illness and/or addiction will not only improve the lives of those directly affected but will also work to reduce stigma in the long term.
First Nations and Inuit Peoples
All people with mental illness and/or addiction have a right to programs and services that facilitate recovery and/or improve their quality of life. It is clear that the First Nations and Inuit peoples of Canada experience mental illness, addiction and poor mental health at rates exceeding that of other Canadians. Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities, and identify the structures and interventions to reduce the burden of mental illness and addiction is critical to the health and wellness and future of First Nations and Inuit peoples. Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community mental health strategies. The establishment of a First Nations and Inuit Mental Health Working Group that is comprised of First Nations and Inuit mental health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate mental health strategies and programming in these communities.
We believe that as a population, the First Nations and Inuit peoples should be the priority for the federal government in the provision of much need treatment and support.
A. Establish a Mental Health, Mental Illness and Addiction Branch at Health Canada.
B. Implement a Stigma Reduction Strategy
C. Improve the capacity of First Nations and Inuit peoples to address the mental health needs of their communities in a culturally appropriate manner.
2. Access Benchmarks and Surveillance Information
Access to services, both public and private, currently acts as a barrier to treatment and recovery from mental illness, poor mental health and addiction. Promotion of collaborative care models along with better coordination of services would greatly improve the quality of care received. Governments must facilitate integration and access to these services.
Recently, the Supreme Court decision in the case of Chaoulli and Zeliotis vs Quebec struck down two provisions in Quebec’s health insurance legislation that prohibit Quebec residents from purchasing private insurance for insured health services. This decision suggests that if Canadians wish to keep their “single-tier” system of universal, first dollar public coverage for health care, then governments must ensure that needed services are available to all Canadians at the time and to the extent of need, including mental health services. Governments must provide timely access to essential services within the public system in order to maximize potential for recovery and quality of life.
With the support of the federal government, and on behalf of the medical community, we (CMA, CPA, CPS, CSAM, CFPC) can coordinate and implement a process to develop medically acceptable wait time benchmarks for access to mental illness and addiction care for children and adults. The outcome of this process would be to provide all governments with performance goals to strive for in providing timely access to mental illness and addiction services.
With the establishment of benchmarks we will be able to measure how the system is performing. A basic mental illness surveillance system exists and the primary dissemination product is “A Report on Mental Illness in Canada”. However, there is agreement that the current information is limited for several reasons:
* There is limited data in the system regarding mental health, addiction and many mental illnesses;
* The quality of the data in the system has not been validated for many mental illnesses and addictions;
* Not all data sources have been accessed for the surveillance system;
* Since many supports and services for mental illness and addictions lie outside the formal health system, the collection of these data has not been possible with current constraints;
* There is a need for a broader dissemination system.
An expanded mental illness surveillance system should work closely with other chronic disease surveillance initiatives to ensure that indicators of common interest are obtained collaboratively and in an efficient manner.
A. Federal government financially support the coordination and implementation of a process to develop wait time benchmarks for accessing mental illness and addiction services developed by the CMA, CPA, CPS, CSAM, CFPC.
B. Creation of an enhanced mental illness surveillance system to produce:
* Information about the prevalence and incidence of mental illnesses, addiction and risk factors at the national, provincial/territorial and regional level.
* Progress on improving the availability and accessibility to services.
* The availability and accessibility of community resources to support people with mental illness and addiction.
* Progress on improving the availability and accessibility to community resources.
* Information about the cost of mental illness, poor mental health and addiction to people with the conditions, their families and the health system.
* Wait list information for mental health services.
3. Best practices in mental illness, mental health and addiction
There are numerous interventions that are effective for various mental illnesses and addiction but ensuring optimal use of effective interventions in the real world has been a challenge. Several factors including lack of use by physicians, failure to prescribe or implement in the recommended manner, costs associated with treatment, and undesirable side effects limit the effectiveness of proven therapies for individual patients. A key element in our capacity to prevent and offer treatment for mental illness and addiction rests with the application of evidence or the promotion of best practices. Therefore we are proposing a pan-Canadian program that can facilitate knowledge exchange across disciplines to optimize outcomes for this population.
We are aware that there is currently an initiative led by the Public Health Agency of Canada to establish a Consortium of Best Practices for Chronic Disease prevention. The goal of the Consortium is to create a Pan-Canadian forum for knowledge exchange between governments, researchers, non-governmental organizations and consumers. This initiative is a positive step and should be closely aligned with our proposed program for mental illness, mental health and addiction. The program we are proposing would go further than just prevention, to include treatment and policy alternatives, both within and outside the health domain.
The program would serve to enhance best practice approaches through activities such as:
* Development of a clearing house to hold evidence-based information for mental illness, mental health and addiction by searching, reviewing and summarizing the current literature and web resources;
* Identification of gaps in knowledge, and gaps between evidence and practice;
* Development of tools to promote best practices relating to mental illness, mental health and addiction, such as the Canadian Collaborative Mental Health Initiative Tool Kit.
A. Establish a program to specifically promote inter-disciplinary best practices in prevention, treatment, community interventions and social supports across the continuum of research, policy, to support practice for evidence-based decision making in the area of mental health, mental illness and addiction.
4. Human resource planning
Improving access to specialized and primary mental health diagnostic and treatment services with psychosocial community services that support early intervention, prevention of further disability, rehabilitation, improvement of quality of life and recovery should be considered a fundamental underlying goal of a pan-Canadian action plan.
Several initiatives are currently under way in various parts of the country to enhance collaborative approaches to care among health care providers and to better integrate primary and secondary health care services. However, these efforts are taking place in a context of relative shortage of addiction specialists, psychiatrists, paediatricians, family physicians and other mental health care professionals.
Family doctor and specialist shortages and changing practice patterns have created serious gaps in the availability of mental health services for many Canadians. Health human resource planning needs to consider and address functionally sub-specialized areas of practice as growing numbers of family doctors are moving into these areas, for example general practice psychotherapy and addiction medicine. Health human resource planning must also continue to ensure sustainability of current initiatives and continued access to care.
Early interventions in general and with children specifically are critical to preventing long term disability and minimizing the devastating impact of mental illness. There are far too few mental health professionals to help children, insufficient resources allocated to support their mental health needs, and inadequate research being conducted to fill the gaps in knowledge which exist in this area. We believe that improving the mental health of Canada’s children, including strategies that increase the amount of health providers with expertise in this area must be a priority for the federal government.
* Establish a pan-Canadian mental health human resource infrastructure responsible for collecting data, monitoring, conducting research, reporting, and making recommendations related to Canada’s ongoing mental health human resources needs, with a priority focus on children’s services, in order to ensure a sustainable supply of health human resources;
* Introduce toolkits to assist health practitioners and consumers to implement best practices in collaborative care and develop new models of care in the area of mental health;
* Support the evaluation of new models of care in achieving patient centred objectives and improving outcomes;
* Increasing research capacity and resources in the area of children’s mental health.
Again, our organizations, representing the medical community, appreciate the opportunity to submit to the Committee further elaboration on key initiatives to ensure federal leadership is taken. We want to thank the committee not only for seeking our advice but also for bringing national attention to issues related to mental illness, mental health and addiction.
1 The Primary Health Care Transition fund supported provinces and territories in their efforts to reform the primary health care system in addition to supporting various pan-Canadian initiatives to address common barriers. Although the Primary Health Care Transition Fund itself was time-limited, the changes which it supported were intended to have a lasting and sustainable impact on the health care system.
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs.
The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat.
In summary, our response to the Minister’s three proposals is as follows:
* Supply monitoring network: We support supply monitoring as a necessary activity.
* Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed.
* Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate.
Our detailed comments on the proposals are below.
1) Drug supply monitoring system
The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow:
* 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence.
* 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme.
* 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members.
The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada.
* 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages.
2) Export Restriction
CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow:
* 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction.
* 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation.
3) Requiring a Patient-Practitioner Relationship
The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons:
* The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress.
* Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported.
* The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality.
In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them.
* Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention.
In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour.
We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation.
Briane Scharfstein, MD, CCFP, MBA
Associate Secretary General, Professional Affairs
cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate,
CMA Provincial/Territorial Divisional CEO’s