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
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the health risks and harms associated with the use of marijuana.
Marijuana, or cannabis, is a Schedule II drug under the Canadian Controlled Drugs and Substances Act, and growing, possessing, distributing and selling marijuana is illegal, subject to penalties.
Despite that, according to the latest Canadian Alcohol and Drug Use Monitoring Survey1, about 10% of Canadians ages 15 years and over had used marijuana at least once in the past year. It is the second most used substance, following alcohol (at 78%). Even though there has been a decrease in marijuana use among youth (ages 15 to 24) in recent years, usage is still double that of the general population, at 20%. A quarter of youth that had used marijuana in the past 3 months, used it daily, however most use is infrequent and experimental. The average age of initiation is 16.1 years, and it is very concerning that continued use is most common among those who initiate use early. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.2
The 2012 Canadian Community Health Survey - Mental Health3 reported that 1.3% of people aged 15 and over met the criteria for cannabis abusea or dependenceb - double that of any other drugs. The lifetime risk of dependence is estimated at about 9%, increasing to almost 17% in those who initiate use in adolescence.4 Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine.
CMA has longstanding concerns about the health risks associated with smoking marijuana. While our comments have more recently been made in the context of medical marijuana, the core issue is the same: marijuana usage poses serious health risks5. Teenagers are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development.
It is estimated that marijuana contains more than 400 active chemicals, including over 60 cannabinoids, of which delta-9 tetra-hydrocannabinol (THC) is the most often studied due to its psychoactive properties. The concentration of the various chemicals varies for different plants, batches and growth locations, and has varied over time. There is the potential for contamination by pesticides or other substances. Rates and quantities of components absorbed will also vary depending on whether the drug is smoked, used in food, inhaled with a vaporizer or applied topically. This is challenging for research on the health effects of marijuana.
When marijuana is smoked, THC and other components are inhaled and absorbed through the lungs, rapidly entering the bloodstream. Effects are perceptible within seconds and fully apparent in a few minutes. The main feature of its use is that it produces a feeling of euphoria (or 'high') and sensory alterations, but it is also sought out to reduce pain, relieve anxiety, decrease vomiting and increase appetite.
Adverse reactions can occur, such as drowsiness, sedation, blurred vision, photophobia, difficulty breathing and vomiting. However, its acute toxicity is extremely low, as no deaths directly due to acute cannabis use have been reported. Toxic dose-related effects that can occur include anxiety, panic, depression, paranoia or psychosis. Acute impairment typically clears 3-4 hours after use.
Marijuana slows reaction times, impairs motor coordination and concentration as well as the completion of complex tasks. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Student Alcohol and Drug Use6 report states that 14-21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug.
Chronic use is more common among those that start using as young teens; those that are tobacco smokers and heavy alcohol consumers and have used other illegal drugs. People with a number of pre-existing diseases who are chronic smokers of marijuana are probably at increased risk of exacerbating the symptoms of their diseases. For example, adults with hypertension, ischaemic or cerebrovascular disease could be at increased risk due to the cardiovascular stimulatory effects of marijuana.
There is an increased risk of psychosis, depression and anxiety, particularly among those who have a personal or family history. A persistent lack of energy in chronic users has been referred to as an "amotivational syndrome". Although cognitive impairments (loss of memory, focus and the ability to think and make decisions) are likely reversible a few weeks after discontinued use, this seems not to be true for those who began using in early teen years, while the brain is still developing.
Smoke from marijuana preparations contains many of the same compounds as tobacco cigarettes including increased levels of tar. Smoking marijuana may be more harmful than tobacco, as it often involves unfiltered smoke and deeper, longer inhalation. Chronic users often have shortness of breath after exercise, coughing and chest tightness. It is probably associated with bronchitis and emphysema and may have risks for chronic lung disease and lung cancer, comparable to cigarette smoking. This is less of a problem for those that use vaporizers, as a harm reduction strategy.
The use of marijuana during pregnancy has been shown to affect the development and learning skills of children, more noticeably from the age of three, with these effects lasting into the teen years. Studies have shown an increase in hyperactivity, inattention and impulsivity. These children will be more prone to addiction and mental health issues as well as decreased cognitive functioning, and could require supports when in school. Some studies point to a lower birth weight.
Besides health concerns, marijuana use can lead to social and interpersonal problems, including difficulties at school, in relationships and with the law.
Awareness of Canadians of the harms of marijuana is generally low. 7 Youth tend to emphasize the drug's ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There were also many myths, such as that it would counter cigarette effects, preventing cancer. Many stated that they did not consider marijuana as a drug because it was "natural" and relatively benign compared to other drugs. It is concerning that some teens said that marijuana actually made people better drivers by increasing their focus.
There seems to be skepticism around prevention programs which aim exclusively at abstinence. Feedback has been that effective approaches would involve providing more fact-based information at an earlier age and using programs that aim at reducing the harms of using marijuana. It is essential that youth and users from other age groups be involved in the conceptualization and development of any such programs.
CMA makes the following recommendations to the Committee:
1) Public Health Approach to Psychoactive Substance Use
The CMA recommends that the federal government adopt a public health approach to increase the focus on preventing drug abuse, on treatment of addiction, on monitoring, surveillance and research and on harm reduction.
Addiction should be recognized and treated as a serious, relapsing chronic disease, and substance use is a complex behaviour influenced by many factors. Therefore, a comprehensive multi-factorial strategy is necessary, and lessons can be learned from work that has been done to decrease tobacco and alcohol use and to reduce the harms related to these substances.
A public health approach would place an increased focus on preventing drug abuse and dependence; on the availability of assessment, counselling and treatment services for those who wish to stop using; and on harm reduction to increase the safety for those that are using. It would seek to ensure the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation.
The CMA believes that resources currently devoted to combating simple marijuana possession through the criminal law could be diverted to public health strategies, particularly for youth.
A public health approach also includes efforts around the monitoring, surveillance and research of marijuana use to better inform the strategy. This is essential to better understand the short and long term harms as well as policy options to address prevention, treatment, harm reduction and enforcement.
2) Comprehensive Education and Awareness Program to Address Marijuana Use
The CMA recommends that the federal government develop, in collaboration with the provinces and territories and key stakeholders, a comprehensive education and awareness program to minimize marijuana use.
A comprehensive program to minimize marijuana use should include, but not be limited to:
- Education and awareness raising of the known and potential harms of marijuana;
- Strategies to prevent early use in adolescence;
- Support for programs that decrease stigma associated with mental health and addiction; and
- Support for health professionals' awareness and evidence-informed practice in the prevention, management and treatment of drug use.
A specific focus on youth is essential, as they are not only more likely than adults to engage in risky drug use, particularly boys, but also disproportionately experience greater harms from that use. It is also particularly important for women of child bearing age, due to the risk to the fetus during pregnancy.
Information that is tailored to the needs of specific populations will help people make informed choices. Efforts to prevent, reduce or delay the use of marijuana could result in a reduction of suffering and costs to the health care system.
Health professionals must be involved and supported in this area, and it is important to ensure the availability of evidence informed clinical practice guidelines, practice tools and continuing medical education resources.
3) Driving Under the Influence Prevention
The CMA recommends that the federal government continue to support, in collaboration with the provinces and territories and key stakeholders, strategies for the prevention of impaired driving.
The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers due to marijuana.
Efforts to prevent, reduce or delay marijuana use, especially in youth, are particularly important. Education is also important as many are not aware that marijuana affects driving ability or even that there are procedures that the police can use to identify impairment due to psychoactive substances.
The CMA supports a similar multidimensional approach such as has been adopted with alcohol and driving. However, the specificities of impairment due to marijuana must be understood and investments made in research. Collaboration with key stakeholders such as schools, drivers' education and licensing bodies, as well as enforcement organizations is essential.
In conclusion, the Canadian Medical Association reiterates the concern of Canada's physicians around marijuana use, particularly by young people. We are committed to working with governments and stakeholders to address this issue.
a Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs.
b Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs.
1 Health Canada (2013) Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Retrieved from: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php
2 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf
3 Statistics Canada (2013) Canadian Community Health Survey - Mental Health. Retrieved from: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm
4 Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf
5 Beirness, D.J., & Porath-Waller, A.J. (2009). Clearing the smoke on cannabis: Cannabis use and driving. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11789-2009.pdf.
Diplock, J., & Plecas, D. (2009). Clearing the smoke on cannabis: Respiratory effects of cannabis smoking. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11797-2009.pdf.
Gordon, A.J., Conley, J.W. & Gordon, J.M. (2013) Medical consequences of marijuana use: a review of the current literature. Curr Psychiatry Rep 15:419.
Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf
Holmes, E., Vanlaar, W. & Robertson, R. (2014) The problem of youth drugged driving and approaches to prevention: a systematic literature review: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://ccsa.ca/Resource%20Library/CCSA-Youth-Drugged-Driving-technical-report-2014-en.pdf
Kalant, H., & Porath-Waller, A.J. (2012). Clearing the smoke on cannabis: Medical use of cannabis and cannabinoids. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2012%20CCSA%20Documents/CCSA-Medical-Use-of-Cannabis-2012-en.pdf.
Porath-Waller, A.J. (2013). Clearing the smoke on cannabis: Highlights. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Clearing-Smoke-on-Cannabis-Highlights-2013-en.pdf.
Porath-Waller, A.J. (2009a). Clearing the smoke on cannabis: Chronic use and cognitive functioning and mental health. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0115422009_e.pdf.
Porath-Waller, A.J. (2009b). Clearing the smoke on cannabis: Maternal cannabis use during pregnancy. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0117832009_e.pdf.
6 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf
7 Cunningham, J.A., Blomqvist, J., Koski-Jannes, A., & Raitasalo, K. (2012). Societal Images of Cannabis use: Comparing Three Countries. Harm reduction journal, 9(1), 21-7517-9-21. Retrieved from: http://www.biomedcentral.com/content/pdf/1477-7517-9-21.pdf
Porath-Waller, A., Brown, J., Frigon, A., & Clark, H. (2013). What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf
Racine, S., Flight, J., & Sawka, E. (Eds.). (2006). Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://publications.gc.ca/site/eng/349980/publication.html
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements."
The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety.
The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds.
Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety
As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy.
In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy.
A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach.
It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration.
In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach.
A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse
The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States.
The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination.
Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested.
The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways:
i) Improving the approval, labelling and safety monitoring of controlled substances
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require:
* More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies);
* Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals.
* Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse.
* Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions.
ii) Establishing consistent requirements for prescription monitoring
In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse.
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 in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by:
* Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled.
* Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled.
* Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring.
* Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues.
Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should:
* Enable inter-jurisdictional accessibility and operability;
* Ensure that practitioners have real-time access to the monitoring system;
* Enable electronically-based prescription monitoring; and;
* Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2).
B) Supporting harm reduction as a component of a drug strategy
The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition.
Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive.
In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites.
C) Developing clinical knowledge base about the medical use of marijuana
The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
Part 2: Ensuring protection of patient privacy
In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework.
As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information.
The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
Part 3: Enabling e-prescribing
As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers.
For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D).
Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section.
Part 4: Establishing a mechanism for changes to scope of practice
The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us.
Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety.
To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change:
* Demonstration that it will improve public health and patient safety;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
Part 5: Recognizing the authority of physician regulatory colleges
As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes.
Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action.
In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety.
In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail.
List of Appendices:
* Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada
* Appendix B: CMA Policy Statement - Medical Marijuana
* Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information
* Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
* Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012)
Overview of recommendations
The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule.
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring.
To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body".
The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework.
The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations.
The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change:
* Demonstration of public health and patient safety improvement;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.