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.
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
Canada’s Lower-Risk Cannabis Use Guidelines (LRCUG)
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
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.
The LRCUG have been endorsed by the following organizations:
Council of Chief Medical Officers of Health
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
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,
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.
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.
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.
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).
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,  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).
To Whom It May Concern:
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to Health Canada’s Patented Medicines Regulations Consultations. The CMA is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations.
As the second-largest share of total health expenditures in Canada, forecast to be 16% in 2016, the cost of drugs is of significant concern to physicians.1 In 2014, 42.6% of prescribed drug spending ($12.5 billion) came from the public sector.2 Pharmaceuticals play an important role in overcoming disease and maintaining health but access to these drugs can be problematic outside of hospital care due to their cost. This is why the CMA has called for a pan-Canadian system of catastrophic coverage for prescription drugs.3 We viewed this as a step toward the development of comprehensive, universal coverage for prescription medicines in Canada.4
1 CIHI. National Health Expenditure Trends 1975-2016, December 15, 2016
3 Canadian Medical Association (CMA). A New Vision for Health Care in Canada: Addressing the Needs of an Aging Population. 2016 Pre-budget Submission to the Minister of Finance. Ottawa: The Association; 2016 Feb 12
In its brief to the Commission of Inquiry on the Pharmaceutical Industry in August, 1984, the CMA stated that we “fully support the objective of providing prescription drugs to patients at the lowest possible cost that is consistent with wise health care delivery.”5 This remains our objective. This submission will address the proposed improvements to the regulations raised in the consultation document from a broad perspective.
5 Canadian Medical Association (CMA). Brief to the Commission of Inquiry on the Pharmaceutical Industry August 15, 1984
6 Gray C. Patented drugs: Is the price right? CMAJ 1998 158:1645
7 Silversides A. Monitoring the price of new drugs CMAJ 2006 174(11):1548-1549
8 The Commission of Inquiry on the Pharmaceutical Industry. The Report of the Commission of Inquiry on the Pharmaceutical Industry H.C. Eastman, Commissioner. Ottawa Minister of Supply and Services 1985 p. 347
9 Industry Canada. Pharmaceutical industry profile. https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (Accessed 2017 June 20)
10 Morgan SG, Leopold C, Wagner AK. Drivers of expenditures on primary care prescription drugs in 10 high-income countries with universal health coverage. CMAJ 2017;189:E794-9
The ability of the PMPRB to monitor drug prices has long been the subject of review and concern.6,7 The CMA is pleased that the Government of Canada is undertaking this review to provide the Patented Medicines Prices review Board (PMPRB) with a new regulatory framework to protect Canadians from excessive prices and improving the regulatory process. The board needs to use every economic measure and tool at its disposal to ensure Canadians pay fair and equitable prescription drug prices.
As the Eastman Commission pointed out in its 1985 report, “Canadian consumption is a small proportion of world consumption so that Canadian patent policy has little effect on the world-wide profitability of the pharmaceutical industry.”8 Indeed, Canadian pharmaceutical sales represent 2% of the global market which makes us the tenth largest world market.9 Yet our small size with respect to the global market has not shielded us from high prices. For example, a recent study found that although the volume of therapies purchased in Canada across six classes of “primary care medicines” was similar, we paid an estimated $2.3 billion more for them in 2015 than if these treatments had the “same average cost per day in Canada as in the nine comparator countries combined.”10
Prescription medication spending is an issue for many Canadians, especially when it has an impact on compliance with prescription regimes, an unintended consequence of the manner in which the board’s regulatory framework has been applied. On the
Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.11 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.12
11 Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15.
12 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23.
13 Vebeeten D, Astiles P, Prada, G. Understanding Health and Social Services for seniors in Canada. Ottawa: The Conference Board of Canada, 2015.
16 Morgan SG, Lee A. Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7: e014287. doi:10.1136/bmjopen-2016-014287 (access 2017 Jun 16)
17 Zhang R., Martin D., Naylor CD., Regulator or regulatory shield? The case for reforming Canada’s Patented Medicines Prices review Board. CMAJ 2017 April 10;189:E515-6. doi: 10.1503/cmaj.161355
The CMA is especially worried about the impact high drug costs have on seniors in the absence of universal drug coverage. They have access to some level of drug coverage in all provinces and territories but it is not even.13 Eight provinces have an income-test that determines the deductibles they will pay while in two they pay a small portion of the cost with the province or a third-party insurer covering the rest.14 All three territories have plans for those who qualify but the provisions may be limited.15 A recent study found that older Canadian adults (55 and older) had the second-highest prevalence (8.3%) of cost-related non-adherence (CRNA) for prescribed medications.16 CRNA was higher among those with lower incomes and lower among those over 65.
Finally, the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures the government undertakes to strengthen and improve the PMPRB do not exacerbate drug shortages.
The PMPRB’s current benchmark “that Canadian prices for patented drugs should be less than the median of prices in selected comparison countries” places us at a distinct disadvantage.17 As the authors note, “it puts Canada well above the OECD average by
aligning Canada with countries that spend more from the outset.”18 The PMBRB should expand its range of comparator countries beyond those identified originally (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States) to include those OECD countries with middle to low patent drug pricing.19
Furthermore, to ensure that the process is clear and transparent for Canadians, the PMPRB should “set prices closer to what comparator countries actually pay for their drugs as opposed to the “sticker” prices that most commonly represent the starting point for confidential negotiations.”20 Canadians deserve that much after years of paying such high prices for their patented medicines.
The CMA is very concerned about the cost of medications. In the absence of universal drug coverage and, at a minimum, a pan-Canadian system of catastrophic coverage of prescription drug costs, a strengthened and robust regulatory framework for the pricing of patented medicines in Canada is crucial. The CMA calls on the federal government to revise the PMPRB regulations such that it provides Canadians with transparency and clarity around the setting of patented medicines prices while achieving the lowest costs possible and ensuring we continue to have access to a wide array of pharmaceutical products.
Granger R. Avery, MB BS, FRRMS
The Canadian Medical Association (CMA) is pleased to provide its response to Health Canada's public consultation on the Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall), in reference to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which came into force on November 6, 2014.
The CMA supports a robust legislative framework toward an unbiased, evidence-based system for the oversight of pharmaceutical products, which spans both the pre- and post-approval of these products, with the ultimate goal of patient safety. Prescription medication plays a critical role as part of a high-quality, patient-centred and cost-effective health care system. It is a priority to physicians that all Canadians have access to affordable, safe and effective prescription medications.
Stemming from this perspective, the CMA strongly welcomed the new ministerial authorities established by Vanessa's Law as an important contribution to patient safety and the effectiveness of Health Canada's oversight of prescription pharmaceuticals. With these new authorities now in effect, it is critical that implementation is comprehensive, effective and transparent. As such, CMA's response to this public consultation on the new Guide will focus on the need for:
* increased clarity on the thresholds that underpin the use of these new authorities,
* guidance on the notification of public, physicians and other health care practitioners, and
* a commitment to ongoing oversight and revision process of this guidance.
ISSUE 1: PROVIDE INCREASED CLARITY ON THE THRESHOLDS
In CMA's brief1 to the House of Commons Standing Committee on Health as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, key recommendations included clarification of both ministerial authority and responsibility in support of patient safety. The CMA supported the intent of the expansion of these powers, but expressed concern with the lack of clarity on the threshold required to be met to enable the use of these new authorities.
In order to ensure the consistent and effective implementation of these new ministerial authorities, the CMA considers it essential that the Guide provide more clarity on the threshold that enables the use of the new authorities, including the determination of serious risk.
To determine this threshold, Health Canada relies on experts to analyze scientific information and make a recommendation to the Minister.
The CMA recommends that guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
As the definition of "serious risk of injury to human health" is not provided in Vanessa's Law, it is critical that it be addressed in the Guide. Annex A of the Guide states that "the determination of whether a therapeutic product presents a serious risk is complex and is conducted on a case-by-case basis when new information becomes available", and puts forward a "non-exhaustive" list of elements to be considered. It also states that different weights would be attributed to different elements and suggests further contextual elements. The CMA is concerned that without a clear process for the determination of what constitutes a serious risk that subjectivity may have an undue role in this determination and there is the potential for a lack of consistency from case to case. Further, a detailed process is required to ensure that this threshold does not constrain ministerial authority when action is needed.
The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
ISSUE 2: INCLUDE GUIDANCE NOTIFICATION TO PUBLIC, PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
The CMA is supportive of the guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker, i.e., that power is exercised in a process that is free from bias, based on evidence and in a transparent manner.
In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies2 and by Health Canada, when these new authorities are exercised.
Access to accurate, unbiased information is essential for people to make decisions about their own health.. A clear elaboration and articulation of the process and timelines for how and when public notification is issued in relation to the exercise of the new ministerial authorities is critical to ensure their comprehensive, effective and transparent implementation.
Also, when new information is discovered about a prescription medication, it is important that health professionals be informed as quickly and efficiently as possible.
As part of Health Canada's commitment to transparency, the CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
The U.S. Food and Drug Administration (U.S. FDA), for example, provides guidance and instructions on their public notification expectations in a situation where a product may pose a significant health hazard.3 In addition, there are different mechanisms of public notification, including 'mobile web' and alerts.
Finally, also consistent with the guidance of the U.S. FDA, the CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
ISSUE 3: SPECIFY THE OVERSIGHT AND REVISION OF THE GUIDANCE
As part of its public consultation outreach with stakeholders on this new guidance, Health Canada officials have described the Guide as an evergreen document that will be continually updated. The CMA is supportive of Health Canada's efforts to engage stakeholders and the public in the development and revision of this guidance.
To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
The CMA welcomed this opportunity to submit recommendations on how Health Canada may improve the Guide to New Authorities, which is critical to the comprehensive, effective and transparent implementation of the new authorities established by Vanessa's Law. The CMA looks forward to continued and ongoing collaboration with Health Canada on its implementation of these important new powers.
Overview of Recommendations
1. The CMA recommends that the guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
2. The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
3. In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies and by Health Canada when these new authorities are exercised.
4. The CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
5. The CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
6. To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
1 Canadian Medical Association (2014) Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2014-09.pdf
2 Note: Throughout this submission, "companies" refers to whom the new ministerial powers apply outside of the regulator - as explained in the consultation document, in the case of s. 21.1 it is a "person" (can include an individual, a research institution, a corporation or an authorization holder), in the case of 21.2 it is the therapeutic product authorization holder, and in the case of s.21.3 it is a "person".
3 U.S. Food and Drug Administration (2015) Guidance for Industry: Product Recalls, Including Removals and Corrections. Retrieved from: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
CAM in Canada
CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories:
* Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
* Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
* Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
* Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
* Resist any influence or interference that could undermine their professional integrity;9
* Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
* Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
* Instructions for use;
* Indications that the product or therapy has been convincingly proven to treat;
* Contraindications, side effects and interactions with other medications;
* Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
Dear Mr. Rodrigue:
The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2
1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018
2 Ibid pg.1
3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide.
The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling.
The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol
must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important.
Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message.
As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion.
Foods to be exempted from front-of-package nutrition labelling
There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium.
Nutrient thresholds for sodium, sugar & saturated fat
CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern.
4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca.
While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in”
sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education.
Nutrient content claims, in relation to Front-of-Packaging Labelling symbol
Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion.
High-intensity sweetener labelling
Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display.
Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine.
For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
The Canadian Medical Association (CMA) is pleased to provide comment on the proposal by Health Canada1 to revise the listing for naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of naloxone, "when indicated for emergency use for opioid overdose outside hospital settings".
The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care.
The harms associated with opioids, which include prescription medicines such as oxycodone, hydromorphone and fentanyl, as well as illegal drugs such as heroin, is a significant public health and patient safety issue. Harms include addiction, diversion, overdose and death.
According to 2013 estimates2, Canada has one of the highest per capita consumptions of prescription opioids in the world. 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.3
Data on the harms caused by opioids are not collected systematically in Canada; however, practitioners have seen the significant impact of these drugs on their patients and to whole communities, including indigenous peoples. Opioid addiction rates from 43% to 85% have been reported in some indigenous communities.4 5 In Ontario, according to the Office of the Chief Coroner, opioid-related deaths nearly tripled from 2002 to 2010.6
Canada's physicians believe that Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs, whether illegal or prescription-based.7 One component of this strategy is the prevention of overdose deaths and complications with appropriate medication and prompt emergency response.
For over four decades, naloxone (or Narcan(r)) has been used as a prescription drug for the complete or partial reversal of opioid overdoses. Naloxone counteracts the life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. The World Health Organization placed naloxone on its list of essential medications in 1983.
Physicians have been encouraged to identify patients who could benefit from the co-prescription of naloxone, along with opioids, when these are necessary. Increased risk for opioid overdose includes previous episodes of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use.8 9
More recently, with the increase in opioid overdoses, different provinces have created programs to increase access to naloxone outside of health care settings, such as "take-home naloxone programs". The experience in Canada and in other countries has been shown to have various benefits, including reducing overdose deaths.10 11 In Canada, naloxone has been administered through intramuscular or subcutaneous injection in these community-based programs, but in other countries it has also been available in a nasal spray form or in a pre-filled auto-injector format. Those that receive the naloxone kit are trained in the recognition of signs and symptoms of opioid overdose, in the administration of naloxone and first aid and in the need to call for medical follow-up.
In its 2015 policy on Harms associated with Opioids and other Psychoactive Prescription Drugs, the CMA supports the improvement of access to naloxone, particularly by individuals who are at a high risk of overdose as well as third parties who can assist a person experiencing an opiate-related overdose. The CMA also encourages the creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. This would include training for health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.12 Also in 2015, the CMA approved a resolution supporting "the development and implementation of a national strategy on the use of naloxone".13
A report issued by the United Nations Office on Drugs and Crime and the World Health Organization supports making naloxone available to first responders as well as to people dependent on opioids, their peers and family members who are likely to be present when an overdose occurs.14 Many other organizations, such as the Canadian Pharmacists Association, the American Medical Association and the American Public Health Association, are also supportive of enhanced access to naloxone in the community.15 16 17
The prescription status has been one of the barriers to increased access to naloxone. It is more likely that a family member, partner or friend would need to administer the naloxone in an overdose than the person who is prescribed the drug. Community-based programs have had to work with standing orders from prescribers. First responders, such as police officers and firefighters, should be able to carry and administer the drug, given they are often the first professionals to arrive at a scene where someone has overdosed.
According to Health Canada, the provinces and territories have collectively asked that the prescription status be re-evaluated. Health Canada has undertaken a Benefit-Harm-Uncertainty assessment of naloxone, and come to the following conclusions:
This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training.
The main risks associated with the unsupervised use of the drug are:
* the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation;
* the administrator may not seek professional care for follow-up of the patient after injection;
* chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose;
* that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome).
These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.18
Various jurisdictions have delisted or are studying special conditions for the status of naloxone as a prescription drug, including Italy and some U.S. States.19
The CMA appreciates the opportunity to provide feedback on this important matter to physicians, and congratulates Health Canada in taking the initiative to make naloxone more accessible in the community; thereby helping to address the concerning levels of opioid overdoses in Canada.
That Health Canada proceed with the revisions to the listing for naloxone on the Prescription Drug List, to allow the non-prescription use of naloxone when indicated for emergency use for opioid overdose outside hospital settings. As outlined in Health Canada's assessment, the potential risks can be mitigated by well-designed community-based programs.
That Health Canada assess the option of licensing naloxone products that don't require training for intramuscular or subcutaneous injection, such as nasal sprays or automated handheld injectors (similar to epinephrine auto-injectors for use in serious allergic reactions), in order to further increase accessibility.
1 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17).
2 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. Available: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2012/NDR_2012_Annex_2_EFS.pdf (accessed 2016 March 17).
3 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.
4 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 (accessed 2016 March 17).
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On behalf of the Canadian Medical Association (CMA), I am responding to your request for consultation on renewal of the Federal Tobacco Control Strategy (FTCS) and on the consultation document: “Seizing the Opportunity: The Future of Tobacco Control in Canada.” We are pleased that Health Canada is renewing the FTCS.
The most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014. The decrease is welcome news but much more needs to be done to ensure the decline continues.
We support the Endgame Summit’s goal of less than 5% tobacco use by 2035. It must be recognized that specific sub-populations, such as Indigenous populations, will require different targets along with prevalence reduction goals that recognize their unique circumstances and needs. Tobacco has ceremonial significance among Indigenous peoples; the harm associated with tobacco arises not from its ceremonial use but from its daily, repeated abuse.
As the Summit suggests a renewed strategy must go beyond the traditional approaches of incremental stricter measures by focussing on the activities of the tobacco industry while offering more assistance to those affected by tobacco products. The whole-of-government approach recommended by the Summit and the framework it proposes are essential for the success of the strategy in the long-term.
The CMA believes that despite the reduction in smoking rates, tobacco control remains a priority and should continue to be supported by a sustained, well-funded federal strategy and strong leadership and support from Health Canada, including a coordinated, comprehensive
national cessation strategy. We recommend that the next version of the FTCS make the following initiatives a priority:
. Pricing There is abundant evidence that high prices are crucial to discouraging tobacco use, especially among young people who are particularly sensitive to price increases. The Summit’s recommendation of a joint pricing strategy developed by Health Canada and Finance Canada that combines substantial excise tax increases and other measures will be key in that regard. As in reducing prevalence, pricing strategies that recognize the unique circumstances and needs of specific sub-populations will need to be developed.
. Plain and Standardized Tobacco Packaging The CMA recommends only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA also supports a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.”
. Retailing The CMA recommends tightening the licensing system to limit the number of outlets where tobacco products can be purchased. The more restricted is tobacco availability, the easier it is to regulate.
. Age of sale The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco, preventing them from starting to use tobacco and encouraging them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. The CMA supports raising the minimum age of sale to 21 years.
. Promotion Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to young people. The CMA supports educational and public relations initiatives aimed at countering these messages. For example, movie classification systems should restrict access by children and youth to films that portray tobacco use and tobacco product placement. The CMA also supports a total ban on promotion, including tobacco-branded tobacco accessories and non-tobacco products.
. Industry interference The CMA supports the Endgame Summit’s recommendations with respect to preventing the tobacco industry’s interference with health policy (i.e., Article 5.3 Guidelines to the Framework Convention on Tobacco Control).
It is the CMA’s position that the federal government has a vital role to play in smoking cessation. A fully funded and resourced tobacco control strategy that meets the challenges of the 21st century will help accomplish that goal.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism