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Approaches to enhancing the quality of drug therapy : a joint statement by the CMA and the Canadian Pharmaceutical Association

https://policybase.cma.ca/en/permalink/policy187
Last Reviewed
2019-03-03
Date
1996-05-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
1996-05-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy. Goal of This Joint Statement The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider. Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy. This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements. This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices. Goal of Drug Therapy The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research. Working Together for Optimal Drug Therapy Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient-physician-pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others. For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects. Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other. Strategies for Collaborating to Optimize Drug Therapy Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following. - Respecting and supporting patients' rights to make informed decisions regarding their drug therapy. - Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all. - Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers. - Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy. - Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care. - Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients. - Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care. - Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues. - Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians. - Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education. - Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy). - Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy. - Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making. The Physician's Responsibilities Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role. - Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate. - Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate. - Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate. - Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities. - Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy. - Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public. - Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate. - Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist. - Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures. The Pharmacist's Responsibilities Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably. - Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber. - Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations). - Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate. - Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician. - Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments. - Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department. - Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities. - Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient. - Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public. - Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate. - Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures.
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Authorizing Cannabis for Medical Purposes

https://policybase.cma.ca/en/permalink/policy11514
Last Reviewed
2020-02-29
Date
2015-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2015-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
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
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Canada’s lower-risk cannabis use guidelines (LRCUG)

https://policybase.cma.ca/en/permalink/policy13726
Date
2017-05-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy endorsement
Date
2017-05-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Canada’s Lower-Risk Cannabis Use Guidelines (LRCUG) Recommendations
Cannabis use has health risks best avoided by abstaining
Delay taking up cannabis use until later in life
Identify and choose lower-risk cannabis products
Don’t use synthetic cannabinoids
Avoid smoking burnt cannabis—choose safer ways of using
If you smoke cannabis, avoid harmful smoking practices
Limit and reduce how often you use cannabis
Don’t use and drive, or operate other machinery
Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant
Avoid combining these risks Reference summary Fischer, B., Russell, C., Sabioni, P., van den Brink, W., Le Foll, B., Hall, W., Rehm, J. & Room, R. (2017). Lower-Risk Cannabis Use Guidelines (LRCUG): An evidence-based update. American Journal of Public Health, 107(8). DOI: 10.2105/AJPH.2017.303818. Endorsements summary The LRCUG have been endorsed by the following organizations: Council of Chief Medical Officers of Health (in principle) Acknowledgment The Lower-Risk Cannabis Use Guidelines (LRCUG) are an evidence-based intervention project by the Canadian Research Initiative in Substance Misuse (CRISM), funded by the Canadian Institutes of Health Research (CIHR). A longer evidence summary of the guidelines, aimed at health professionals, is available at camh.ca. Cannabis use is a personal choice, but it comes with risks to your health and well-being. Follow these recommendations to reduce your risks. Cannabis use is a personal choice, but it comes with risks to your health and well-being. Follow these recommendations to reduce your risks. Health risks of cannabis use There is strong scientific evidence that cannabis use is associated with a variety of health risks. The risks depend on your constitution, which kinds of cannabis products you use and how or how often you use them. Some of the main health risks are:
problems with thinking, memory or physical co-ordination
impaired perceptions or hallucinations
fatal and non-fatal injuries, including those from motor-vehicle accidents, due to impairment
mental health problems and cannabis dependence
chronic respiratory or lung problems
reproductive problems. Reducing health risks related to cannabis use Cannabis use has health risks best avoided by abstaining To avoid all risks, do not use cannabis. If you decide to use, you could experience immediate, as well as long-term risks to your health and well-being. Any time you choose not to use, you avoid these risks. Delay taking up cannabis use until later in life Using cannabis at a young age, particularly before age 16, increases the likelihood of developing health, educational and social problems. Avoid cannabis use during adolescence. Generally, the later in life you begin to use cannabis, the lower the risk of problems. Identify and choose lower-risk cannabis products High-potency cannabis products, with high tetrahydro­cannabinol (THC) content, are more likely to result in harms. Some products contain a higher dose of canna­bidiol (CBD), which counteracts some of THC’s adverse effects. This means that products with high CBD-to-THC ratios reduce some of the risks. Know what you’re using. Ideally, choose cannabis products with lower risk of harms. Don’t use synthetic cannabinoids Compared with natural cannabis products, synthetic cannabis products (e.g., K2 or Spice) can lead to more severe health problems, even death. If you use, give preference to natural cannabis products and abstain from synthetics. Avoid smoking burnt cannabis—choose safer ways of using Smoking burnt cannabis, especially when combined with tobacco, can harm your lungs and respiratory system. Choose other methods, such as vaporizers or edibles instead—but recognize that they also come with some risks. For example, edibles are safer for your lungs, but you may consume larger doses and experience more severe impairment because psychoactive effects are delayed. If you smoke cannabis, avoid harmful smoking practices If you smoke cannabis, avoid “deep inhalation” or “breath-holding.” These practices are meant to increase psychoactive experiences, but they increase the amount of toxic material absorbed by your lungs and into your body. Limit and reduce how often you use cannabis Frequent cannabis use (i.e., daily or almost every day) is strongly linked to a higher risk of health and social problems. Limit yourself—and ideally your friends or others you may be using with—to occasional use, such as on weekends or one day a week at most. Don’t use and drive, or operate other machinery Driving while impaired by cannabis substantially increases your risk of being involved in a motor-vehicle accident resulting in injury or death. Don’t use and drive, or use other machinery. Wait at least six hours after using cannabis—or even longer if you need. Combining cannabis and alcohol further increases impairment, so be sure to avoid this combination if you plan to drive. Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant Some individuals should not use cannabis because of specific risk profiles. If you or an immediate family mem­ber has a history of psychosis or substance use disorder, your risk of cannabis-related mental health problems increases, and you should abstain from use. Pregnant women should not use cannabis because it could harm the fetus or newborn. Avoid combining the risks identified above The more of these risky behaviours you engage in when using cannabis, the higher your risk of harms. For ex­ample, initiating cannabis use at a young age and smok­ing high-potency products every day puts you at much higher risk of both immediate and long-term problems. Avoid combining these high-risk choices. When choosing to use cannabis, you can actively take steps to reduce risks to your health. Below are 10 science-based recommendations for how to do so. These recommendations are aimed mainly at non-medical cannabis use. © 2017 CAMH 5638 / 06-2017
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Cannabis for Medical Purposes

https://policybase.cma.ca/en/permalink/policy10045
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) has always recognized the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief. However, there are a number of concerns, primarily related to the limited evidence to support many of the therapeutic claims made regarding cannabis for medical purposes, and the need to support health practitioners in their practice.1,2,3,4 While the indications for using cannabis to treat some conditions have been well studied, less information is available about many potential medical uses. Physicians who wish to authorize the use of cannabis for patients in their practices should consult relevant CMPA policy5 and guidelines developed by the provincial and territorial medical regulatory authorities to ensure appropriate medico-legal protection. The CMA’s policy Authorizing Marijuana for Medical Purposes6, as well as the CMA’s Guidelines For Physicians In Interactions With Industry7 should also be consulted. The CMA makes the following recommendations: 1. Increase support for the advancement of scientific knowledge about the medical use of cannabis. The CMA encourages the government to support rigorous scientific research into the efficacy for therapeutic claims, safety, dose-response relationships, potential interactions and the most effective routes of delivery, and in various populations. 2. Apply the same regulatory oversight and evidence standards to cannabis as to pharmaceutical products under the Food and Drug Act, designed to protect the public by the assessment for safety and efficacy. 3. Increase support for physicians on the use of cannabis for medical purposes in their practice settings. As such, CMA calls on the government to work with the CMA, The College of Family Physicians of Canada, the Royal College of Physicians and Surgeons, 2 and other relevant stakeholders, to develop unbiased, accredited education options and licensing programs for physicians who authorize the use of cannabis for their patients based on the best available evidence. Background In 2001, Health Canada enacted the Marihuana Medical Access Regulations (MMAR). These were in response to an Ontario Court of Appeal finding that banning cannabis for medicinal purposes violated the Charter of Rights and Freedoms.8 The MMAR, as enacted, was designed to establish a framework to allow legal access to cannabis, then an illegal drug, for the relief of pain, nausea and other symptoms by people suffering from serious illness where conventional treatments had failed. While recognizing the needs of those suffering from terminal illness or chronic disease, CMA raised strong objections to the proposed regulations. There were concerns about the lack of evidence on the risks and benefits associated with the use of cannabis. This made it difficult for physicians to advise their patients appropriately and manage doses or potential side effects. The CMA believes that physicians should not be put in the untenable position of gatekeepers for a proposed medical intervention that has not undergone established regulatory review processes as required for all prescription medicines. Additionally, there were concerns about medico-legal liability, and the Canadian Medical Protective Association (CMPA), encouraged those physicians that were uncomfortable with the regulations to refrain from authorizing cannabis to patients. Various revisions were made to the MMAR, and then these were substituted by the Marihuana for Medical Purposes Regulations (MMPR) in 2013/ 2014 and subsequently by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in 2016 and now as part of the Cannabis Act (Section 14)9. Healthcare practitioners that wish to authorize cannabis for their patients are required to sign a medical document, indicating the daily quantity of dried cannabis, expressed in grams. For the most part, these revisions have been in response to decisions from various court decisions across the country.10,11,12 Courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the effectiveness of cannabis. Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gate keeper for access to a medication without adequate evidence. The CMA participated in many Health Canada consultations with stakeholders as well as scientific advisory committees and continued to express the concerns of the physician community. As previously noted, the Federal government has been constrained by the decisions of Canadian courts. 3 The current state of evidence regarding harms of cannabis use is also limited but points to some serious concerns. Ongoing research has shown that regular cannabis use during brain development (up to approximately 25 years old) is linked to an increased risk of mental health disorders including depression, anxiety, and schizophrenia, especially if there is a personal or family history of mental illness. Long term use has also been associated with issues of attention, impulse control and emotional regulation. Smoking of cannabis also has pulmonary consequences such as chronic bronchitis. It is also linked to poorer pregnancy outcomes. Physicians are also concerned with dependence, which occurs in up to 10% of regular users. From a public and personal safety standpoint, cannabis can impact judgement and increases the risk of accidents (e.g. motor vehicle incidents). For many individuals, cannabis use is not without adverse consequences.3,13,14 Pharmaceutically prepared alternative options, often administered orally, are also available and regulated in Canada.15 These drugs mimic the action of delta-9-tetra-hydrocannabional (THC) and other cannabinoids and have undergone clinical trials to demonstrate safety and effectiveness and have been approved for use through the Food and Drug Act. Of note is that in this format, the toxic by-products of smoked marijuana are avoided.16 However, the need for more research is evident. Approved by the CMA Board in December 2010. Last reviewed and approved by the CMA Board in March 2019. References 1 Allan GM, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician, 2018;64(2):111-120. Available: http://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Jan 8). 2 College of Family Physicians of Canada (CFPC). Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance. Mississauga: CFPC; 2014. Available: https://www.cfpc.ca/uploadedFiles/Resources/_PDFs/Authorizing%20Dried%20Cannabis%20for%20Chronic%20Pain%20or%20Anxiety.pdf (accessed 2019 Jan 8). 3 The National Academies of Sciences, Engineering and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: National Academies Press; 2017. 4 Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015;313(24):2456-73. 5 Canadian Medical Protective Association (CMPA). Medical marijuana: considerations for Canadian doctors. Ottawa: CMPA; 2018. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2014/medical-marijuana-new-regulations-new-college-guidance-for-canadian-doctors (accessed 2019 Jan 8). 6 Canadian Medical Association (CMA). Authorizing marijuana for medical purposes. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11514 http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-04.pdf (accessed 2019 Jan 8). 7 Canadian Medical Association. (CMA) Guidelines for Physicians In Interactions With Industry. Ottawa: CMA; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22). 4 8 R. v. Parker, 2000 CanLII 5762 (ON CA). Available: http://canlii.ca/t/1fb95 (accessed 2019 Jan 8). 9 Cannabis Act. Access to Cannabis for Medical Purposes. Section 14. 2018. Available: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/page-28.html#h-81 (accessed 2019 Jan 8). 10 Hitzig v. Canada, 2003 CanLII 3451 (ON SC). Available: http://canlii.ca/t/1c9jd (accessed 2019 Jan 8). 11 Allard v. Canada, [2016] 3 FCR 303, 2016 FC 236 (CanLII), Available: http://canlii.ca/t/gngc5 (accessed 2019 Jan 8). 12 R. v. Smith, 2014 ONCJ 133 (CanLII). Available: http://canlii.ca/t/g68gk (accessed 2019 Jan 8). 13 Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227. 14 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: https://www.who.int/substance_abuse/publications/msbcannabis.pdf (accessed 2019 Jan 8). 15 Ware MA. Is there a role for marijuana in medical practice? Can Fam Physician 2006;52(12):1531-1533. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1952544/pdf/0530022a.pdf (accessed 2019 Jan 8). 16 Engels FK, de Jong FA, Mathijssen RHJ, et.al. Medicinal cannabis in oncology. Eur J Cancer. 2007;43(18):2638-2644. Available: https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804907007368.pdf?locale=en_US (accessed 2019 Jan 8).
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Complementary and alternative medicine (update 2015)

https://policybase.cma.ca/en/permalink/policy11529
Date
2015-05-30
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Date
2015-05-30
Replaces
Complementary and alternative medicine (Update 2008)
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) 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.
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Direct-to-consumer advertising (DTCA)

https://policybase.cma.ca/en/permalink/policy188
Last Reviewed
2020-02-29
Date
2002-09-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2002-09-30
Replaces
Position paper on direct to consumer prescription drug advertising (1986)
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Direct-to-Consumer Advertising (DTCA) Policy Statement Canadians have a right to information about prescription drugs and other therapeutic interventions, to enable them to make informed decisions about their own health. This information must be evidence based and provide details about side effects and health risks as well as benefits. Brand-specific direct-to-consumer advertisements, such as those permitted in the United States, do not provide optimal information on prescription drugs. We are concerned that DTCA: * is not information but marketing, and sends the message that a prescription drug is a “consumer good” rather than a health care benefit. * may not provide enough information to allow the consumer to make appropriate drug choices. For example, it generally does not provide information about other products or therapies that could be used to treat the same condition. In addition, it may stimulate demand by exaggerating the risks of a disease and generating unnecessary fear. * may strain the relationship between patients and providers, for example if a patient’s request for an advertised prescription drug is refused. * drives up the cost of health care, and undermines the efforts of physicians, pharmacists and others to promote optimal drug therapy. Patient groups, health care providers, governments and pharmaceutical manufacturers should be supported in activities to develop objective, reliable plain-language information about prescription drugs to ensure that Canadians are able to make informed health care decisions. Therefore we: * Support the provision of objective, evidence-based, reliable plain-language information for the public about prescription drugs. * Oppose direct-to-consumer prescription drug advertising in Canada.
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Drug testing in the workplace (Update 2001)

https://policybase.cma.ca/en/permalink/policy194
Last Reviewed
2018-03-03
Date
2001-05-28
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2018-03-03
Date
2001-05-28
Replaces
Drug testing in the workplace (1992)
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public. Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general. Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another. Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents. Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit). Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice. Testing: Any discussion of drug testing must take the following into account: If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed. The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing. The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work. If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen. The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons: Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society. The mass, low-cost screening tests may not be reliable or valid. The circumstances may not justify possible human rights violations. Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing. CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
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Guidelines for Physicians in Interactions with Industry

https://policybase.cma.ca/en/permalink/policy9041
Last Reviewed
2019-03-03
Date
2007-12-01
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2007-12-01
Replaces
Physicians and the pharmaceutical industry (Update 2001)
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines. The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians. Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations. General Principles 1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians. 2. Relationships between physicians and industry are guided by the CMA's Code of Ethics and by this document. 3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship. 4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices. 5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology. 6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment. Industry-Sponsored Research 7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient. 8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures. 9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care. 10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process. 11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry. 12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid. 13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity. 14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent. 15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed. 16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article. 17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible. Industry-Sponsored Surveillance Studies 18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided. 19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice. 20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study. Continuing Medical Education / Continuing Professional Development (CME/CPD) 21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training. 22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD. 23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers. 24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed. 25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities. 26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity. 27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support. 28. Generic names should be used in addition to trade names in the course of CME/CPD activities. 29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product. 30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact. 31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity. 32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members. 33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority. Electronic Continuing Professional Development (eCPD) 34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD. 35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors. 36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies. 37. There should be no direct links to an industry or product website on any web page which contains eCPD material. 38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant. 39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module. 40. If the content of eCPD modules is changed, re-accreditation is required. Advisory/Consultation Boards 41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed: A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself. B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement. C. Whenever possible, meetings should be held in the geographic locale of the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards. Clinical Evaluation Packages (Samples) 42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated. 43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal. Gifts 44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making. Other Considerations 45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers. 46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis. 47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour. 48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately. 49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity. 50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products. Medical Students and Residents 51. The principles in these guidelines apply to physicians-in training as well as to practising physicians. 52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.
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Harms associated with opioids and other psychoactive prescription drugs

https://policybase.cma.ca/en/permalink/policy11535
Date
2015-05-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Date
2015-05-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
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. Recommendations 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. References 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/
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Insite: CMA submission regarding Insite supervised injection site and program.

https://policybase.cma.ca/en/permalink/policy14129
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Court submission
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
S.C.C. File No.: 33556 IN THE SUPREME COURT OF CANADA (APPEAL FROM THE BRITISH COLUMBIA COURT OF APPEAL) BETWEEN: ATTORNEY GENERAL OF CANADA AND MINISTER OF HEALTH FOR CANADA Appellants (Appellants/Cross-Respondents) —and — PHS COMMUNITY SERVICES SOCIETY, DEAN EDWARD WILSON and SHELLY TOMIC, VANCOUVER AREA NETWORK OF DRUG USERS (VANDU) Respondents (Respondents/Cross-Appellants) —and — ATTORNEY GENERAL OF BRITISH COLUMBIA Respondent (Respondent) —and — ATTORNEY GENERAL OF QUEBEC, DR. PETER AIDS FOUNDATION, VANCOUVER COASTAL HEALTH AUTHORITY, CANADIAN CIVIL LIBERTIES ASSOCIATION, CANADIAN HIV/AIDS LEGAL NETWORK, INTERNATIONAL HARM REDUCTION ASSOCIATION AND CACTUS MONTREAL, CANADIAN NURSES ASSOCIATION, REGISTERED NURSES' ASSOCIATION OF ONTARIO AND ASSOCIATION OF REGISTERED NURSES OF BRITISH COLUMBIA, CANADIAN PUBLIC HEALTH ASSOCIATION, CANADIAN MEDICAL ASSOCIATION, BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION, BRITISH COLUMBIA NURSES'S UNION Interveners FACTUM OF THE INTERVENER, CANADIAN MEDICAL ASSOCIATION BORDEN LADNER GERVAIS LLP 100 Queen Street — Suite 1100 Ottawa, ON KIP 1J9 Guy J. Pratte/Nadia Effendi Tel: (613) 237-5160 Fax: (613) 230-8842 Counsel for the Intervener, Canadian Medical Association 2 TO: Roger Bilodeau, Q.C. REGISTRAR SUPREME COURT OF CANADA AND TO: Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.fratergustice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Attorney General of Canada Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.frater@justice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Minister of Health for Canada Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, PHS Community Services Society Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, PHS Community Services Society 3 Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, Dean Edward Wilson and Shelly Tomic John W. Conroy, Q.C. Conroy & Company 2459 Pauline St Abbotsford, British Columbia V2S 3S1 Telephone: (604) 852-5110 FAX: (604) 859-3361 E-mail: jconroy@johnconroy.com Counsel for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Craig E. Jones Attorney General of British Columbia 1001 Douglas Street, 6th floor Victoria, British Columbia V8V 1X4 Telephone: (250) 387-3129 FAX: (250) 356-9154 E-mail: craigjones@gov.bc.ca Counsel for Respondent, the Attorney General of British Columbia Hugo Jean Procureur general du Quebec 1200 Route de l'Èglise, 2e etage Ste-Foy, Quebec G1V 4M1 Telephone: (418) 643-1477 FAX: (418) 644-7030 E-mail: hjean@justice.gouv.qc.ca Counsel for Intervener, Attorney General of Quebec Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, Dean Edward Wilson and Shelly Tomic Henry S. Brown, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St P.O. Box 466, Stn "D" Ottawa, Ontario KIP 1C3 Telephone: (613) 233-1781 FAX: (613) 788-3433 E-mail: henry.brown@gowlings.com Agent for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Robert E. Houston, Q.C. Burke-Robertson 70 Gloucester Street Ottawa, Ontario K2P 0A2 Telephone: (613) 566-2058 FAX: (613) 235-4430 E-mail: rhouston@burkerobertson.com Agent for Respondent, the Attorney General of British Columbia Pierre Landry Noel & Associes 111, rue Champlain Gatineau, Quebec J8X 3R1 Telephone: (819) 771-7393 FAX: (819) 771-5397 E-mail: p.landry@noelassocies.com Agent for Intervener, Attorney General of Quebec 4 Andrew I. Nathanson Fasken Martineau DuMoulin LLP 2900 - 550 Burrard Street Vancouver, British Columbia V6C 0A3 Telephone: (604) 631-4908 FAX: (604) 631-3232 Counsel for Intervener, Dr. Peter AIDS Foundation Ryan D. W. Dalziel Bull, Housser & Tupper LLP 3000 - 1055 West Georgia Street Vancouver, British Columbia V6E 3R3 Telephone: (604) 641-4881 FAX: (604) 646-2671 E-mail: rdd@bht.com Counsel for Intervener, British Columbia Civil Liberties Association Sheila Tucker Davis LLP 2800 Park Place 666 Burrard Street Vancouver, British Columbia V6C 2Z7 Telephone: (604) 643-2980 FAX: (604) 605-3781 E-mail: stuckergdavis.ca Counsel for Intervener, Vancouver Coastal Health Authority Paul F. Monahan Fasken Martineau DuMoulin LLP 333 Bay Street, Suite 2400 Bay Adelaide Centre, Box 20 Toronto, Ontario M5H 2T6 Telephone: (416) 366-8381 FAX: (416) 364-7813 E-mail: pmonahan@fasken.com Counsel for Intervener, Canadian Civil Liberties Association Scott M. Prescott Fasken Martineau DuMoulin LLP 1300 - 55 Metcalfe Street Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: sprescott@fasken.com Agent for Intervener, Dr. Peter AIDS Foundation Brian A. Crane, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St Ottawa, Ontario K1P 1C3 Telephone: (613) 233-1781 FAX: (613) 563-9869 E-mail: brian.crane@gowlings.com Agent for Intervener, British Columbia Civil Liberties Association Marie-France Major McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: mane-france.maior@mcmillan.ca Agent for Intervener, Vancouver Coastal Health Authority Julia Kennedy Fasken Martineau DuMoulin LLP 55 Metcalfe Street Suite 1300 Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: ikennedy(&fasken.com Agent for Intervener, Canadian Civil Liberties Association Michael A. Feder McCarthy Tétrault LLP Suite 1300, 777 Dunsmuir Street Vancouver, British Columbia V7Y 1 K2 Telephone: (604) 643-5983 FAX: (604) 622-5614 E-mail: mfeder(qmccarthv.ca Counsel for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Rahool P. Agarwal Ogilvy Renault LLP 3800 - 200 Bay Street Toronto, Ontario M5J 2Z4 Telephone: (416) 216-3943 FAX: (416) 216-3930 E-mail: ragarwal(iogilvyrenaul1.com Counsel for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontario and Association of Registered Nurses of British Columbia Owen M. Rees Stockwoods LLP 77 King Street West Suite 4130, P.O. Box 140 Toronto, Ontario M5K IHI Telephone: (416) 593-7200 FAX: (416) 593-9345 E-mail: owenr~stockwoods.ca Counsel for Intervener, Canadian Public Health Association 5 Brenda C. Swick McCarthy Tétrault LLP 200 - 440 Laurier Avenue West Ottawa, Ontario KIR 7X6 Telephone: (613) 238-2000 FAX: (613) 563-9386 Agent for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Sally A. Gomery Ogilvy Renault LLP 1500 - 45, O'Connor Street Ottawa, Ontario KIP lA4 Telephone: (613) 780-8661 FAX: (613) 230-5459 E-mail: sgomery(qogilvyrenaul1.com Agent for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontaro and Association of Registered Nurses of British Columbia Dougald E. Brown Nelligan O'Brien Payne LLP 1500 - 50 O'Connor S1. Ottawa, Ontario KIP 6L2 Telephone: (613) 231-8210 FAX: (613) 788-3661 E-mail: dougald.brown(inelligan.ca Agent for Intervener, Canadian Public Health Association Marjorie Brown Victory Square Law Office 100 West Pender Street Suite 500 Vancouver, British Columbia V6B 1R8 Telephone: (604) 684-8421 FAX: (604) 684-8427 E-mail: mbrown(avslo.ca Counsel for Intervener, British Columbia Nurses' Union Michael A. Chambers Maclaren Corlett 50 O'Connor Street, Suite 1625 Ottawa, Ontario KIP 6L2 Telephone: (613) 233-1146 FAX: (613) 233-7190 E-mail: mchambers(amacorlaw.com Counsel for Intervener, Real Women Canada 6 Colleen Bauman Sack Goldblatt Mitchell LLP 500 - 30 Metcalfe St. Ottawa, Ontario KIP 5L4 Telephone: (613) 235-5327 FAX: (613) 235-3041 E-mail: cbauman~sgmlaw.com Agent for Intervener, British Columbia Nurses' Union TABLE OF CONTENTS Part I — Statement of Facts ........................................................................................................... .1 A. Overview ......................................................................................................................... 1 B. CMA's Interest in the Appeal ............................................................................................ 1 C. CMA's Position on the Facts ............................................................................................ 1 Part II — Statement of the Questions in Issue ................................................................................3 Part III — Statement of Argument .................................................................................................3 A. Charter Interpretation Must be Guided by Reality, Not Ideology ......................................... 3 B. The Impugned Provisions Infringe Section 7 of the Charter ................................................. 5 (1)Denying Access to Necessary Health care Infringes Section 7 of the Charter.................. 5 (2)The Rights to Life and Security of Patients Have Been Infringed ................................... 5 (3)Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment .................................................................................................................. 6 (4)The Rights to Liberty of the Individual Respondents Have Been Infringed ..................... 8 (5)The Principles of Fundamental Justice Have Not Been Respected ................................. 8 a) The Impugned Provisions Are Arbitrary ..................................................................... 8 b) The Impugned Provisions Are Overbroad ................................................................... 9 C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter ................................................................................................................................ 9 D. Remedy ......................................................................................................................... 10 Part IV — Submissions as to Costs .............................................................................................. 10 Part V — Order Sought ................................................................................................................10 Part VI — Table of Authorities .................................................................................................... 11 Part VII — Statutes, Regulations, Rules ...................................................................................... 13 PART I — STATEMENT OF FACTS A. Overview 1. Fair and equitable access to medically necessary, evidenced-based health care is of fundamental importance to Canadian patients and physicians, as this Court recognized in Chaoulli. 2. Where life and security of a person is at risk because of a medical condition, like drug addiction, the Court's delineation of a government or legislature's constitutional obligations should be guided by facts. Unfounded ideological assumptions about the character of patients must not trump clinical judgment based on the best medical evidence available; otherwise, the life, liberty and security of patients is put at risk arbitrarily, contrary to section 7 of the Charter. 3. The Appellants' position that those addicted to drugs have foregone any right to access medical treatment is antithetical to the raison d'être of the Canadian health care system and inconsistent with the federal government's obligations under section 7 of the Charter. 4. Neither the statutory law nor the Constitution allows the state to deny access to health care because of "lifestyle" choices or presumed waiver of legal or constitutional rights. B. CMA's Interest in the Appeal 5. The Canadian Medical Association ("CMA") is the national voice of Canadian physicians with over 74,000 members across the country. Its mission is to serve and to unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and heath care. 6. Critical to CMA's role is the upholding of harm reduction as one pillar in a comprehensive public health approach to disease prevention and health promotion. Further, the CMA possesses a distinct expertise and broad-based knowledge of many aspects of policy and law concerning harm reduction as a clinically mandated and ethical method of care and treatment. C. CMA's Position on the Facts 7. By Order dated February 17, 2011, the CMA was granted leave to intervene in this Appeal. 2 8. The CMA accepts the facts as stated by the Respondents. 9. This appeal flows from separate actions commenced by some of the Respondents seeking relief that would obviate the need for exemptions granted by the Federal Minister of Health under section 56 of the Controlled Drugs and Substances Act (the "Act"), S.C. 1996 c. 19. Thus, when within the confines of the Vancouver Safe Injection Site ("Insite"), patient drug users were not liable to prosecution for possession of a controlled substance contrary to section 4(1) of the Act, or staff for trafficking contrary to section 5(1). The initial exemptions, based on "necessity for a scientific purpose", were granted for a term of three years commencing September 12, 2003. They were thereafter extended to December 31, 2007, and then to June 30, 2008. Insite's ability to operate was dependent upon the exemptions. However, no further extensions were forthcoming. 10. In their actions, the Respondents, in addition to the division of powers argument, contended that sections 4(1) and 5(1) of the Act violated section 7 of the Charter, were unconstitutional, and should be struck down. The Respondents were successful before the Applications Judge and the Court of Appeal. 11. The Applications Judge found that sections 4(1) and 5(1) of the Act infringed section 7 of the Charter and declared them to be of no force and effect. 12. On appeal by the Attorney General of Canada and cross-appeal by the Respondents, PHS, Wilson and Tomic, the majority of the Court of Appeal found that sections 4(1) and 5(1) of the Act were inapplicable to Insite by reason of the application of the doctrine of interjurisdictional immunity. 13. In concurring reasons, Rowles J.A. also found that sections 4(1) and 5(1) engaged section 7 of the Charter and that such application did not accord with the principles of fundamental justice because of overbreadth. 14. The findings of the Applications Judge and Rowles J.A. under the Charter are, the CMA submits, premised on the correct and supported fact that harm reduction is an evidenced-based form of medical treatment for patient drug addicts suffering from the illness of addiction. It is unconstitutional for governments to prevent access to treatment on pain of criminal penalty and deprivations of life, liberty and security of the person on grounds informed by ideological 3 assumptions and not the evidence. PART II - STATEMENT OF THE QUESTIONS IN ISSUE 15. The following constitutional questions, as stated by the Chief Justice on September 2, 2010, are to be determined in this appeal: 1. Are ss. 4(1) and 5(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, constitutionally inapplicable to the activities of staff and users at Insite, a health care undertaking in the Province of British Columbia? 2. Does s. 4(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 3. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 4. Does s. 5(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 5. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 16. Questions two to five, which relate to the Charter, are of particular importance for the CMA, and are addressed in more detail below. The CMA submits that sections 4(1) and 5(1) of the Act infrnge the rights guaranteed by section 7 of the Charter and are not justified under section 1. PART III - STATEMENT OF ARGUMENT A. Charter Interpretation Must be Guided by Reality, Not Ideology 17. When determining whether or not impugned legislation infringes the Charter, courts must not play host to political debates, but instead must rise above them by ensuring that public policy passes constitutional muster. Chaoull v. Québec (Attorney General), (2005) 1 S.c.R. 791, at para. 89 (CMA Authorities, Tab 2). R. v. Morgentaler, (1988)1 S.C.R. 30 at 45-46 (CMA Authorities, Tab 13). 18. The Appellants' position is clearly premised on ideological preconceptions with regard to individuals suffering from addictions. Yet, as the history of birth control legislation in Canada shows, a legal framework informed by ideological assumptions about the morality of patients seeking to control their reproduction can violate a person's most fundamental rights. See R. v. Morgentaler, supra at 62 where the Court rejected arguments that it should assess administrative structures in the abstract: "when denial of a right as basic as security of the person is infringed by the procedure and administrative structures created by the law itself, the courts are empowered to act" (CMA Authorities, Tab 13). 4 19. In order for the courts to meet their role in determining whether a particular piece of legislation is constitutional, it must consider Parliament's enactments by relying on the available evidence. In fact, it is well established that a deprivation of the rights to life, liberty or security of the person must be proven by solid evidence. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 [CMA Authorities, Tab 20]. 20. The presentation of facts is not a mere technicality, but rather it is essential to a proper consideration of Charter issues: Charter cases will frequently be concerned with concepts and principles that are of fundamental importance to Canadian society. For example, issues pertaining to freedom of religion, freedom of expression and the right to life, liberty and the security of the individual will have to be considered by the courts. Decisions on these issues must be carefully considered as they will profoundly affect the lives of Canadians and all residents of Canada. In light of the importance and the impact that these decisions may have in the future, the courts have every right to expect and indeed to insist upon the careful preparation and presentation of a factual basis in most Charter cases. The relevant facts put forward may cover a wide spectrum dealing with scientific, social, economic and political aspects. Often expert opinion as to the future impact of the impugned legislation and the results of the possible decisions pertaining to it may be of great assistance to the courts. MacKay v. Manitoba, [1989] 2 S.C.R. 357 at 361 [CMA Authorities, Tab 5]. 21. Specifically, with respect to section 7 of the Charter, this Court has confirmed that the task of the courts is to evaluate the issue in "the light, not just of common sense or theory, but of the evidence". The Court dispenses with unsubstantiated theoretical arguments, relying instead on empirical and scientific evidence presented by the parties: In support of this contention, the government called experts in health administration and policy. Their conclusions were based on the "common sense" proposition that the improvement of health services depends on exclusivity (R.R., at p. 591). They did not profess expertise in waiting times for treatment. Nor did they present economic studies or rely on the experience of other countries. They simply assumed, as a matter of apparent logic, that insurance would make private health services more accessible and that this in turn would undermine the quality of services provided by the public health care system. The appellants, relying on other health experts, disagreed and offered their own conflicting "common sense" argument for the proposition that prohibiting private health insurance is neither necessary nor related to maintaining high quality in the public health care system. Quality public care, they argue, depends not on a monopoly, but on money and management. They testified that permitting people to buy private insurance would make alternative medical care more accessible and reduce the burden on the public system. The result, they assert, would be better care for all [...] To this point, we are confronted with competing but unproven "common sense" arguments, amounting to little more than assertions of belief. We are in the realm of theory. But as discussed above, a theoretically defensible limitation may be arbitrary if in fact the limit lacks a connection to the goal. This brings us to the evidence called by the appellants at trial on the experience of other developed countries with public health care systems which permit access to private health care. The experience of these countries suggests that there is no real connection in fact between prohibition of health insurance and the goal of a quality public health system. 5 Chaoulli, supra at paras. 136-149 (see also paras. 115, 117, 136-149, 150, 152 where the Court refers to Statistics Canada studies and evidence from other western democracies) [CMA Authorities, Tab 2]. See also Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 at 601-602 [CMA Authorities, Tab 16]. 22. Drug addicts suffer from a medical condition that can be treated. Hence, Insite is designed as a health treatment aimed at reducing the harmful consequences of drug use as well as exposing its vulnerable patients to other health care options. In this context, the federal legislation and government actions at issue amount to a denial of evidence-based medical treatment whose effect is to put the life and security of patients at great risk. 23. Charter interpretation should generally be grounded on fact rather than speculation or ideological assumptions, especially where life and security of the person (i.e., the patient) is at risk because of a medical condition (such as addiction). In such cases, the Court's delineation of the state's constitutional obligations should be guided by evidence-based medicine and independent clinical judgment. Chaoulli, supra at paras. 85, 107 [CMA Authorities, Tab 2]. See also Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 at 452-454 [CMA Authorities, Tab 7]; Auton (Guardian ad litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657, at para. 66 [CMA Authorities, Tab 1]. 24. Accordingly, CMA submits that, at the very least, in the health care field where lives are at risk, there must be sound evidentiary basis for legislative and government action that deny medical care. B. The Impugned Provisions Infringe Section 7 of the Charter (1) Denying Access to Necessary Health care Infringes Section 7 of the Charter 25. While the legislature is generally entitled to enact legislation prohibiting drug use or trafficking, this legislation (however well-intended) cannot have the effect of putting the lives of affected persons at risk. This Court has already found in Chaoulli that section 7 of the Charter was infringed when governments impeded timely patient access to care. (2) The Rights to Life and Security of Patients Have Been Infringed 26. Both the Applications Judge and the Court of Appeal found that the right to life and security was engaged in the present case. The evidence on these issues was plentiful: 1. Addiction is an illness. One aspect of the illness is the continuing need or craving to consume the substance to which the addiction relates; 6 2. Injection drug use leads to an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis A, B and C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; increased hospital and emergency service utilization; 3. The risk of morbidity and mortality associated with addiction and injection is ameliorated by injection in the presence of qualified health professionals at Insite; 4. User of Insite who are addicted to heroin, cocaine and other controlled substances are not engaged in recreation. Their addiction is an illness frequently, if not invariably, accompanied by serious infections and the real risk of overdose. Reasons for Judgment of the Applications Judge, paras. 87, 89, 135-136, Appellants' Record, Vol. I, pp. 24-25, 34. See also Reasons for Judgment of the B.C. Court of Appeal, para. 30, Appellants' Record, Vol. I, p. 65. (3) Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment 27. The Appellants did not really dispute the medical evidence to the effect that addiction to drugs was a disease. They sought instead to justify their position by claiming that drug addicts had "chosen" their lifestyle and were solely responsible for their medical condition. For the following reasons, this "rationale" does not pass constitutional muster. 28. The Appellants assert that the section 7 rights are not engaged as they stem from an alleged "choice made by the consumer", relying on the fact that 95% of the injections in the downtown east side of Vancouver do not take place at Insite. The Appellants do not explain how this assertion demonstrates why addicts are able to make a choice not to inject themselves, given that it only addresses where they inject themselves. In any event, contrary to the Appellants' choice theory, the evidence before the Applications Judge and his findings were to the contrary: the reasons for the addiction and resulting need are based on a complicated combination of personal, governmental and legal factors, some of which lend themselves to choice and others that do not.' Further, the Applications Judge found that it is the illness of addiction, and the failure to manage it, that has led to further illness and death. Reasons for Judgment of the Applications Judge, paras. 65, 89, 142, Appellants' Record, Vol. I, pp. 21, 24-25, 35. See also Reasons for Judgment of the B.C. Court of Appeal, para. 39, Appellants' Record, Vol. I, p. 67. Contra the facts in R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 [Malmo-Levine] [CMA Authorities, Tab 12]. 29. The Appellants' position amounts to a claim that the users of Insite have effectively waived their constitutional rights under section 7. Notwithstanding that the jurisprudence is In fact, the evidence is clear that in the case of the Respondent Tomic, her first experience with illegal drugs was not a personal choice [Reasons for Judgment of the Applications Judge, para. 65, Appellants' Record, Vol. I, p. 21]. 7 unclear as to whether a right under section 7 can actually be waived, it is well established that a waiver or a renunciation of any right under the Charter must be voluntary, freely expressed and accompanied with a clear understanding of the purpose the right was meant to serve and the consequences of declining its protection. There is no evidence whatsoever that the patients of Insite who suffer from addiction, knowingly and unequivocally waived their rights under the Charter, and more specifically their right to access medical treatment. See e.g. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844, at paras. 71-72; Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551, at paras. 96-102; R. v. Richard, [1996] 3 S.C.R. 525, at paras. 22-26; R. v. L.T.H., [2008] 2 S.C.R. 739, at paras. 41-42; R. v. Clarkson, [1986] 1 S.C.R. 383 at 394-396; Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 at 49; Yorkton Union Hospital v. S.U.N. (1993), 16 Admin. L.R. (2d) 272, at para. 44 (C.A.) [CMA Authorities, Tabs 3, 17, 15, 11, 8, 4, 18 respectively]. 30. Indeed, Canadians do not forego their right to health care or to protection from section 7 violations because of their "choice" of lifestyles. The Appellants' position that addicts must take responsibility for the choice they make undermines the raison d'être of the Canadian health care system, namely (as found by the Applications Judge and the Court of Appeal) the fundamental right of Canadians to access medical treatment and the ethical and clinical responsibilities of their health care providers. 31. The Appellants' position skirts the clinical question at issue for physicians and their patients: 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. In Canada, neither the ethical obligations of physicians to treat patients, nor the patients' legal right to treatment, are subject to a moral assessment of a patient's lifestyle. Behaviours that might be deemed "risky" do not deprive patients of their rights of access to clinically required medical care. 32. Section 31 of CMA's Code of Ethics (relied on by the Court in the past e) provides that all physicians must "[r]ecognize the responsibility of physicians to promote fair access to health care resources". The patients at Insite would be deprived of positive health outcomes if Insite were to close or even continue to operate under the ongoing threat of closure. 33. Adopting the Appellants' approach to Charter interpretation would set an extremely dangerous precedent. Thus, if one were to apply the rationale of "choice" to other medical 2 See e.g. R. v. Dersch, [1993] 3 S.C.R. 768 at 784-785, where the Court refers to CMA's Code of Ethics [CMA Authorities, Tab 9]. 8 contexts, such as chronic disease, patients suffering from diabetes because of contributing factors such as poor nutrition and lack of exercise would, under the same logic, be denied medical care. Indeed, many of the complex elements beyond individual choice such as socio-economic and genetic factors found by the Applications Judge in the case at bar to shape addiction as an ilness are prevalent in other diseases. This approach would be not only unethical and clinically unsound, but unconstitutionaL. (4) The Rights to Liberty of the Individual Respondents Have Been Infringed 34. The courts have recognized that the threat of criminal prosecution and possibility of imprisonment for an offence is suffcient to trigger the liberty interest and scrutiny under section 7. Malmo-Levine, supra at para. 84 ICMA Authorities, Tab 12). R. v. Parker (2000),188 D.L.R. 4th 385, at para. 101 (Ont. C.A.) ICMA Authorities, Tab 14). 35. Vulnerable patients suffering from addiction and the health care providers who provide treatment at Insite suffer violations of their constitutionally guaranteed rights (section 7 of the Charter) because of the threat of prosecution under the Act. The uncertainty associated with a ministerial exemption mechanism for Insite from certain provisions of the Act imposes a great burden on those already labouring under the weight of addiction. Moreover, health care providers are also put at risk in their ability to provide medically necessary and evidence-based health care services in a timely manner to all citizens by the capricious exemption mechanism contained in the Act. (5) The Principles of Fundamental Justice Have Not Been Respected 36. It is well established that a law that is arbitrary or overbroad will constitute a breach of the principles of fundamental justice. The CMA submits that the Applications Judge was correct when he found that the impugned provisions were arbitrary, or if not arbitrary, grossly disproportionate and overbroad. The Court of Appeal agreed that the provisions were overbroad. P. Hogg, Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1 ICMA Authorities, Tab 19). R. v. Heywood, (1994) 3 S.c.R. 761 at 792-794 ICMA Authorities, Tab 10). Chaoull, supra at para. 127 ICMA Authorities, Tab 2). Rodriguez, supra at 590-591 ICMA Authorities, Tab 16). a) The Impugned Provisions Are Arbitrary 37. A law is arbitrary when it bears no relation to, or is inconsistent with, the objective that 9 lies behind it. In order not to be arbitrary, a limit on the section 7 right requires not only a theoretical connection between the limit and the legislative goal, but a real connection on the facts. Chaoulli, supra at paras. 130-131 [CMA Authorities, Tab 2]. 38. In the present case, by prohibiting access to evidence-based, medically necessary care, the government has contributed to the very harm it claims it seeks to prevent, i.e. drug possession and addiction. The best available medical evidence suggests that clinics such as Insite not only protect life, but offer positive health outcomes and care alternatives to vulnerable patients. 39. Moreover, the justification of any denial of access to necessary medical care based on ideology rather than facts is arbitrary since, by definition, it bears no real connection to the facts. b) The Impugned Provisions Are Overbroad 40. It is a well-established principle of fundamental justice that criminal legislation must not be overbroad. If the government, in pursuing a legitimate objective, uses means which are broader than is necessary to accomplish that objective, the principles of fundamental justice will be violated. Heywood, supra at 792-793 [CMA Authorities, Tab 10]. See also Malmo-Levine, supra at paras. 130-131 [CMA Authorities, Tab 12]. 41. A fortiori, that will be true when the state itself has a particular interest in acting to protect vulnerable persons. In the present case, the evidence before the Applications Judge demonstrated that harm reduction has been a component of Canada's drug strategy for many years. In 2002, the House of Commons Special Committee on the Non-Medical Use of Drugs rejected the dichotomy between harm reduction and an abstinence-based treatment model. It also specifically considered the creation of a safe injection facility in the downtown east side of Vancouver because it recognized that that community presented a "public health disaster". 42. Hence, while the government may be justified in preventing drug possession and trafficking, it cannot cast a legislative prohibition so widely that it captures persons in need of medical care. C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter 43. Should the Court find that sections 4(1) and 5(1) of the Act infringe the rights guaranteed Guy Pratt /Nadia ffend Borden L dner Gervais L 1 0 by section 7 of the Charter, the CMA submits that the provisions cannot be justified under section 1 of the Charter as any law that offends the principles of fundamental justice cannot be justified, and more specifically, meet the minimal impairment branch of the section 1 analysis. See e.g. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46, at para. 99 [CMA Authorities, Tab 6]; Heywood, supra at 802-803 [CMA Authorities, Tab 10]. D. Remedy 44. Fundamental justice requires either permanent exemptions or a declaration that the impugned law, as it applies to users of supervised injection sites, is invalid. The CMA submits that this position is consistent with sound constitutional interpretation of section 7 of the Charter, while protecting the most vulnerable patient populations in accordance with evidence-based medicine and physicians' ethical obligations. PART IV — SUBMISSIONS AS TO COSTS 45. The CMA seeks no costs and asks that none be awarded against it. PART V — ORDER SOUGHT 46. The CMA submits that constitutional questions two and four should be answered affirmatively. Should the Court answer these questions in the affirmative, however, constitutional questions three and five should be answered negatively. 47. The CMA seeks leave of this Court, pursuant to rule 59(2) of the Rules of the Supreme Court of Canada, to present oral argument at the hearing of this appeal. Rules of the Supreme Court of Canada, SOR/83-74, as amended, Rule 59(2) [Part VII of Factum]. ALL OF WHICH IS RESPECTFULLY SUBMITTED THIS 13th DAY OF APRIL, 2011. OTTO1 \ 4423086 \ 7 11 PART VI — TABLE OF AUTHORITIES TAB SOURCES Paras. in factum where cited Cases 1. Auton (Guardian a litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657 23 2. Chaoulli v. Quebec (Attorney General), [2005] 1 S.C.R. 791 17, 21, 23, 36, 37 3. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844 29 4. Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 29 5. MacKay v. Manitoba, [1989] 2 S.C.R. 357 20 6. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46 43 7. Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 23 8. R. v. Clarkson, [1986] 1 S.C.R. 383 29 9. R. v. Dersch, [1993] 3 S.C.R. 768 32 10. R. v. Heywood, [1994] 3 S.C.R. 761 36, 40, 43 11. R. v. L.T.H., [2008] 2 S.C.R. 739 29 12. R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 28, 34, 40 13. R. v. Morgentaler, [1988] 1 S.C.R. 30 17, 18 14. R. v. Parker (2000), 188 D.L.R. 4th 385 (Ont. C.A.) 34 15. R. v. Richard, [1996] 3 S.C.R. 525 29 16. Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 21, 36 17. Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551 29 18. Yorkton Union Hospital v. S. UN. (1993), 16 Admin. L.R. (2d) 272 (Sask. C.A.) 29 12 TAB SOURCES Paras. where in factum cited Secondary Sources 19. Hogg, P., Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1. 36 20. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 19 13 PART VII — STATUTES, REGULATIONS, RULES
Canadian Charter of Rights and Freedom, sections 1 and 7
Controlled Drugs and Substances Act, S.C. 1996, c. 19, sections 4(1), 5(1), 56
Rules of Supreme Court of Canada, SOR/83-74, as amended, Rule 59 14 Canadian Charter of Rights and Freedoms PART I OF THE CONSTITUTION ACT, 1982 Charte canadienne des droits et libertes PARTIE I DE LA LOI CONSTITUTIONNELLE DE 1982 Rights and freedoms in Canada 1. The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society. Life, liberty and security of person 7. Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice. Droits et libertes au Canada 1. La Charte canadienne des droits et libertes garantit les droits et libertós qui y sont enonces. Its ne peuvent etre restreints que par une regle de droit, dans des limites qui soient raisonnables et dont la justification puisse se demontrer dans le cadre d'une society libre et democratique. Vie, liberte et securite 7. Chacun a droit a la vie, a la liberte et a la securite de sa personne; it ne peut etre porte atteinte a ce droit qu'en conformite avec les principes de justice fondamentale. 15 Controlled Drugs and Substances Act S.C. 1996, c. 19 Possession of substance 4. (1) Except as authorized under the regulations, no person shall possess a substance included in Schedule I, II or III. Trafficking in substance 5. (1) No person shall traffic in a substance included in Schedule I, II, III or IV or in any substance represented or held out by that person to be such a substance. Exemption by Minister 56. The Minister may, on such terms and conditions as the Minister deems necessary, exempt any person or class of persons or any controlled substance or precursor or any class thereof from the application of all or any of the provisions of this Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. Loi reglementant certaines drogues et autres substances L.C. 1996, ch. 19 Possession de substances 4. (1) Sauf dans les cas autorises aux termes des reglements, la possession de toute substance inscrite aux annexes I, II ou III est interdite. Trafic de substances 5. (1) Il est interdit de faire le trafic de toute substance inscrite aux annexes I, II, III ou IV ou de toute substance presentee ou tenue pour telle par le trafiquant. Exemption par le ministre 56. S'il estime que des raisons medicales, scientifiques ou d'interet public le justifient, le ministre peut, aux conditions qu'il fixe, soustraire a l'application de tout ou partie de la presente loi ou de ses reglements toute personne ou categorie de personnes, ou toute substance designee ou tout precurseur ou toute categorie de ceux-ci. 16 Rules of the Supreme Court of Canada (in force on October 13, 2006) Regles de la Cour supreme du Canada. (en vigueur le 13 octobre 2006) 59. (1) In an order granting an intervention, the judge may (a) make provisions as to additional disbursements incurred by the appellant or respondent as a result of the intervention; and (b)impose any terms and conditions and grant any rights and privileges that the judge may determine, including whether the intervener is entitled to adduce further evidence or otherwise to supplement the record. (2)In an order granting an intervention or after the time for filing and serving all of the memoranda of argument on an application for leave to appeal or the facta on an appeal or reference has expired, a judge may, in their discretion, authorize the intervener to present oral argument at the hearing of the application for leave to appeal, if any, the appeal or the reference, and determine the time to be allotted for oral argument. (3)An intervener is not permitted to raise new issues unless otherwise ordered by a judge. 59. (1) Dans l'ordonnance octroyant l'autorisation d'intervenir, le juge petit : a) prevoir comment seront supportes les &pens supplementaires de l'appelant ou de l'intime resultant de l'intervention; b) imposer des conditions et octroyer les droits et privileges qu'il determine, notamment le droit d'apporter d'autres elements de preuve ou de completer autrement le dossier. (2)Dans l'ordonnance octroyant l'autorisation d'intervenir ou aprês l'expiration du Mai de depOt et de signification des memoires de demande d'autorisation d'appel, d'appel ou de renvoi, le juge peut, a sa discretion, autoriser l'intervenant a presenter une plaidoirie orale a l'audition de la demande d'autorisation d'appel, de l'appel ou du renvoi, selon le cas, et determiner le temps alloue pour la plaidoirie orale. (3) Sauf ordonnance contraire d'un juge, l'intervenant n'est pas autorise a soulever de nouvelles questions.
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