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

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

https://policybase.cma.ca/en/permalink/policy11514
Last Reviewed
2020-02-29
Date
2015-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2015-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Authorizing Cannabis for Medical Purposes The legalization of cannabis for recreational purposes came into effect with the Cannabis Act in October 2018, and patients continue to have access to cannabis for therapeutic purposes. The Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations. Patients can obtain cannabis for medical purposes when a physician or nurse practitioner provides a “medical document” , authorizing its use, and determining the daily dried cannabis dose in grams. With the authorization, patients have the choice whether to (a) buy directly from a federally licensed producer; (b) register with Health Canada to produce a limited amount for personal consumption; (c) designate someone to produce it for them; or (d) buy cannabis at provincial or territorial authorized retail outlets or online sales platforms, if above the legal age limit. While acknowledging the unique requirements of patients suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief, physicians remain concerned about the serious lack of clinical research, guidance and regulatory oversight for cannabis as a medical treatment. There is insufficient clinical information on safety and efficacy for most therapeutic claims. There is little information around therapeutic and toxic dosages and knowledge on interactions with medications. Besides the need for appropriate research, health practitioners would benefit from unbiased, accredited educational modules and decision support tools based on the best available evidence. The Canadian Medical Association has consistently expressed concern with the role of gatekeeper that physicians have been asked to take as a result of court decisions. Physicians should not feel obligated to authorize cannabis for medical purposes. Physicians who choose to authorize cannabis for their patients must comply with their provincial or territorial regulatory College's relevant guideline or policy. They should also be familiar with regulations and guidance, particularly:
Health Canada’s Information for Health Care Practitioners – Medical Use of Cannabis (monograph, summary and daily dose fact sheet),
the Canadian Medical Protective Association’s guidance;
the College of Family Physicians of Canada’s preliminary guidance Authorizing Dried Cannabis for Chronic Pain or Anxiety; and
the Simplified guideline for prescribing medical cannabinoids in primary care, published in the Canadian Family Physician. The CMA recommends that physicians should:
Ensure that there is no conflict of interest, such as direct or indirect economic interest in a licensed cannabis producer or be involved in dispensing cannabis;
Treat the authorization as an insured service, similar to a prescription, and not charge patients or the licensed producer for this service;
Until such time as there is compelling evidence of its efficacy and safety for specific indications, consider authorizing cannabis only after conventional therapies are proven ineffective in treating patients’ conditions;
Have the necessary clinical knowledge to authorize cannabis for medical purposes;
Only authorize in the context of an established patient-physician relationship;
Assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests;
Engage in a consent discussion with patients which includes information about the known benefits and adverse health effects of cannabis in its various forms (e.g., edibles), including the risk of impairment to activities such as driving and work;
Advise the patient regarding harm reduction strategies and the prevention of accidental exposure for children and other people;
Document all consent discussions in patients' medical records;
Reassess the patient on a regular basis for its effectiveness to address the medical condition for which cannabis was authorized, as well as for addiction and diversion, to support maintenance, adjustment or discontinuation of treatment; and
Record the authorization of cannabis for medical purposes similar to when prescribing a controlled medication. The Cannabis Regulations provide some consistency with many established provincial and territorial prescription monitoring programs for controlled substances. Licensed producers of cannabis for medical purposes are required to provide information to provincial and territorial medical licensing bodies upon request, including healthcare practitioner information, daily quantity of dried cannabis supported, period of use, date of document and basic patient information. The Minister of Health can also report physicians to their College should there be reasonable grounds that there has been a contravention of the Narcotic Control Regulations or the Cannabis Regulations. Approved by CMA Board February 2015 Latest update approved by CMA Board in February 2020
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Cannabis for Medical Purposes

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

https://policybase.cma.ca/en/permalink/policy11529
Date
2015-05-30
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Date
2015-05-30
Replaces
Complementary and alternative medicine (Update 2008)
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. CAM in Canada CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories: * Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. * Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. * Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. * Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: * Resist any influence or interference that could undermine their professional integrity;9 * Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 * Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: * Instructions for use; * Indications that the product or therapy has been convincingly proven to treat; * Contraindications, side effects and interactions with other medications; * Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients. i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
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Direct-to-consumer advertising (DTCA)

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

https://policybase.cma.ca/en/permalink/policy194
Last Reviewed
2018-03-03
Date
2001-05-28
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2018-03-03
Date
2001-05-28
Replaces
Drug testing in the workplace (1992)
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public. Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general. Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another. Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents. Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit). Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice. Testing: Any discussion of drug testing must take the following into account: If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed. The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing. The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work. If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen. The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons: Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society. The mass, low-cost screening tests may not be reliable or valid. The circumstances may not justify possible human rights violations. Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing. CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
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Flexibility in Medical Training (Update 2009)

https://policybase.cma.ca/en/permalink/policy9485
Last Reviewed
2020-02-29
Date
2009-05-31
Topics
Health human resources
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2009-05-31
Replaces
Flexibility in Medical Training
Topics
Health human resources
Text
Flexibility in Medical Training (Update 2009) The Canadian Medical Association (CMA) believes that the medical training system must be sufficiently flexible to enable medical students to make informed career choices, accommodate resident program changes, and allow practising physicians the opportunity to re-enter training to enhance their skills and knowledge, or to enter a new sphere of practice. The system must also be able to accommodate international medical graduates (IMGs) to provide them with a reasonable opportunity to attain their postgraduate credentials and become licensed to practise in Canada. For physicians-in-training, effective career guidance and positive influences on career options (e.g., role modelling, early clinical exposure, etc.) may foster confidence with career path selection and minimize program changes during residency. A flexible and well-designed re-entry postgraduate system would be characterized by: long-term stability, sufficient and appropriate capacity, accessibility, flexibility in the workforce and accountability. The CMA believes that, ultimately, society benefits from a flexible medical training system. These benefits may include enhanced patient care, improved access to physician services, as well as physician retention, particularly in rural and remote communities. A flexible system may also improve morale and satisfaction among students, residents and physicians, and facilitate better career choices. This policy outlines specific recommendations to help create and maintain a well-designed system for flexibility in physician training in Canada. Commitment and action by all stakeholders, including governments, medical schools, regulatory authorities and others, is required. The CMA believes that this policy must be considered in the context of other relevant CMA policies, including but not limited to the CMA's policies on physician resource planning, physician health and well-being, physician workforce issues and others. Definitions - Postgraduate trainee - Also known as a "resident," an individual who has received his/her MD degree and is currently enrolled in an accredited program in a Canadian school of medicine that would lead to certification by either the College of Family Physicians of Canada or the Royal College of Physicians and Surgeons of Canada. - Medical student - An individual enrolled in an undergraduate program in a Canadian school of medicine that would lead to an MD degree. - International medical graduate - An individual who received his/her MD degree from a training program other than from one of Canada's undergraduate schools of medicine. - Designated positions - Postgraduate positions within the determined complement of residency positions that are identified to meet a need other than that of accommodating the annual number of new graduates of Canadian medical schools to complete the usual training for certification and licensure. Designated positions may be identified for a variety of purposes. The need for informed career decision-making and positive influences Choice of practice discipline as lifelong career can be one of the most difficult aspects of physician training. Exacerbating this challenge are the vast array of available specialties, timing of choices, as well as practice considerations in terms of lifestyle and physician resource needs. The rapidly changing face of medical practice as well as the limited amount of information and time available to consider options, are also contributing factors. A number of other forces, both positive and negative, may affect students' choices of practice specialty. These can include financial considerations in light of student debt incurred by high tuition fees and insufficient financial support. 12 The biases of faculty, family and others may also impact decisions. In addition, limited training opportunities in general, as well as a lack of flexibility to switch training programs, may also restrict choice of practice specialty. While a myriad of personal factors are acknowledged to also play contributing roles in influencing program selection, these issues are too complex to discuss here. Ultimately, students need to have access to financial support so as to reduce stress and the influence of debt on specialty choice. They also need objective information and guidance and broad clinical experiences early in their medical training as this has been identified as a critical factor in making decisions about their future careers.3 The rotating internship, abolished in the early 1990s, used to permit residency selection at a later stage in medical training. The residency program match now takes place during the final year of undergraduate studies. As a consequence of this earlier timing, some students feel pressured to make their specialty choice too early in their medical education and often before their clerkship has even begun. This can include focusing research and program electives4 in one specific area, rather than sampling a broad range of disciplines, to demonstrate conviction of choice to residency program directors at the time of the match. Fifty-nine percent of respondents to the Canadian Resident Matching Service's (CaRMS) 2006 post-match survey indicated they completed more than half of their electives in their first-choice discipline.5 This, combined with the early timing of the residency match, can lead to an uninformed choice of residency program and the realization, at a later date, that a different training program would be more suitable. Eighty percent of medical leader respondents to the 2008 Core Competency Project survey indicated that timing of career choice was the biggest challenge for career decision-making.6 Those residents who wish to change to new training programs may not believe they have the opportunity to do so. Thirty-seven percent of resident respondents to the Core Competency Project survey considered switching disciplines during their residency training7 and 39% had spoken to a faculty member about switching programs.8 Others who do change programs are ultimately delayed entry into the workforce as a result of their prolonged training. This problem is exacerbated by an insufficient number of re-entry postgraduate training positions and large debt that confine trainees to a single career path. Lack of student confidence and preparedness in choosing a postgraduate training program, or lack of success in achieving a first choice in the postgraduate match, may predict subsequent program changes. A broad range of strategies must be available to help medical students make informed career choices. These include a wider choice of electives at an earlier stage of training, positive and unbiased mentoring experiences, improved access to career information from residents, as well as career seminars and other resources. In light of the above, the CMA recommends that: 1. the undergraduate medical school curriculum be re-designed to facilitate informed career choice and, in particular, to ensure that students enjoy a broad range of clinical experiences before they have to choose a specific discipline (i.e., via CaRMS match); 2. national career counselling curricula for both medical students and residents be developed and include the following components: national standardization; stakeholder input (students, residents and others); positive and fair role modelling by both residents and practising physicians/faculty, with appropriate professional respect among medical disciplines; and formal and informal mentorship programs; 3. a wide-range of elective opportunities be developed and communicated at a national level; 4. electives reflect a broad spectrum of experiences, including community-based opportunities; 5. clinical experiences be introduced at the earliest possible stage of undergraduate learning; 6. a national policy be implemented to ensure mandatory diversification of student elective experiences; and 7. medical schools be permitted and encouraged to model alternate systems of postgraduate learning. The need for broad-based medical education In order to provide medical students with the greatest options for flexibility in medical training, they should be actively encouraged to pursue a broad-based medical education. Previously, CMA advocated for a common postgraduate year (PGY1). In the 2008 Core Competency Project survey, 77% of physician respondents, 70% of medical student respondents and 67% of program director respondents expressed support for first year residents to do a broad-based common PGY1-like rotating internship.9 The rationale for and importance of ensuring flexibility has been outlined in the previous sections. Capacity of the postgraduate training system An essential component in ensuring flexibility within the medical training system is to establish and maintain sufficient capacity at the postgraduate training level. This is necessary for the following reasons: * Sufficient capacity may prevent highly-skilled and well-trained Canadian physicians from being forced to seek postgraduate training in the U.S. and remain there to practise medicine. * It is necessary to provide IMGs with a reasonable opportunity to attain their postgraduate credentials and become licensed to practise in Canada. This reflects the CMA's recognition of the important contribution that IMGs have made, and continue to make, in the provision of medical services, teaching and research in Canada. Opportunities for IMGs will also permit Canadians who study medicine abroad to pursue their medical careers in Canada. * It is essential to provide students with sufficient choice to seek the training that best matches their skills and interests as well as societal demands. * It is crucial to provide sufficient re-entry positions to allow practising physicians to seek training in other areas of medicine to meet the demands of their communities. [Please refer to the "Re-entry" section of this policy for more details.] In light of the above, the CMA recommends that: 8. mechanisms be developed to permit reasonable movement of residents within the overall residency structure and career counselling supports be made available to residents considering such a change; 9. the capacity of the postgraduate training system be sufficiently large to accommodate the needs of the graduating cohort, the re-entry cohort, and the training needs of international medical graduates; 10. there be a clearly defined pool of re-entry postgraduate positions and positions for international medical graduates; 11. government match and maintain undergraduate medical enrolment with a target of at least 120 ministry-funded postgraduate training positions per 100 Canadian medical graduates, to accommodate the training needs of the graduating cohort, the re-entry cohort and international medical graduates; and 12. options be explored for influencing governments to support a flexible postgraduate medical education system that also meets societal needs. Re-entry medical training system Note: This section addresses only one kind of designated position, specifically, those for licensed physicians wishing to re-enter training after a period in practice (also known as "re-entry positions"). The re-entry positions addressed in this paper would require no return for service. Designated positions for training in return for service in a specified discipline and location is a separate entity from general re-entry. Increased opportunity for exposure to the breadth of medical fields in undergraduate training, improved undergraduate career counselling and a postgraduate system that makes the changing of disciplines easier are some of the many aspects that should facilitate residents' satisfaction with career choice. There will, however, inevitably be individual cases where issues of societal need, personal health, lifestyle or personal choice necessitate a change in career direction after postgraduate training. This requires the availability of additional postgraduate positions allotted specifically to this sub-set. A sufficient and stable supply of re-entry positions is needed within the postgraduate training system to enable practising physicians to enhance their skills or re-enter training in another discipline. While this may apply mostly to family physicians and general practitioners wishing to train in a specialty discipline, it can also include practising specialists wanting to sub-specialize or train in another area, which could be Family Medicine. The additional or new training of primary care physicians, particularly in obstetrics, emergency medicine, anaesthesia, surgery, psychiatry and general internal medicine, will be of benefit to smaller communities lacking regular access to these specialty medical services. In addition, the availability of adequate re-entry positions may encourage new physicians to accept locum tenens, thus relieving overworked physicians in underserviced communities. Potentially, it could help to increase a community's long-term retention rate of established physicians. The CMA believes that a well-designed re-entry system for Canadian postgraduate medical education would be characterized by an accessible national registry, long-term stability, sufficient and appropriate capacity, accessibility, flexibility in the workforce and accountability. Stability Medical students need reassurance that re-entry positions will be available if they wish to re-enter training after a period in practice. This will enable them to better plan their careers, reduce anxieties about career selection and ultimately help to meet the health care needs of society. For physicians re-entering the postgraduate training system, there must also be the guarantee that sufficient program funding will be available to ensure completion of training. The CMA therefore recommends that: 13. a complement of clearly defined, permanent re-entry positions with stable funding be a basic component of the Canadian postgraduate training system and that the availability of these positions be effectively communicated to potential candidates; and 14. funding for re-entry positions be specifically allocated for the entire training period. Capacity The CMA believes that the capacity of the postgraduate training system must be sufficiently large to accommodate the needs of the re-entry cohort and that postgraduate re-entry positions should be supernumerary to the numbers required for the graduating cohort. [Please refer to the "Capacity of the Postgraduate Training System" section of this policy for specific recommendations.] Accessibility The CMA believes that re-entry physicians should not be restricted to competing for particular disciplines for which there is an identified need in their jurisdiction. Re-entry physicians should also be able to compete for any available disciplines across all training programs. Not every discipline will be available for re-entry each year but all should be accessible over the course of a three-year period. The CMA therefore recommends that: 15. there be accessibility within re-entry postgraduate training positions including: * open and fair competition at the national level among all re-entry candidates for the clearly defined pool of re-entry positions, * that the mix of positions available reflect the overall mix of positions in the postgraduate training system, and * recognizing the limited size of the re-entry pool, access to all specialties be available over a three-year period rather than on an annual basis; and 16. access to entry should be possible through both national and regional pools of re-entry positions, with a process comparable to that currently used for the postgraduate training system. Flexibility in the Workforce As previously mentioned, the re-entry positions discussed in this paper would require no return for service. Designated positions for training in return for service in a specified discipline and location is a separate entity from general re-entry. The CMA therefore recommends that: 17. physicians who have retrained through the re-entry system have the same practice opportunities as physicians entering the workforce for the first time. Accountability The CMA recognizes the importance of public accountability and sound fiscal management and therefore recommends that: 18. there be on-going evaluation of the re-entry system in Canadian postgraduate medical education. 1 Kwong JC, Dhalla IA, Streiner DL, Baddour RE, Waddell AE & IL Johnson. Effects of rising tuition fees on medical school class composition and financial outlook. CMAJ 2002; 166 (8): 1023-8. 2 2007 National Physician Survey Data. 3 Directions for Residency Education, 2009 - A final report of the Core Competency Project. February 2009. Royal College of Physicians and Surgeons of Canada and College of Family Physicians of Canada. 4 Ibid, page 23. 5 Ibid. 6 Ibid, page 59. 7 Ibid, page 27. 8 Ibid, page 60. 9 Ibid.
Documents
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Guidelines for Physicians in Interactions with Industry

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

https://policybase.cma.ca/en/permalink/policy11535
Date
2015-05-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Date
2015-05-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The harms associated with psychoactive prescription medicinesi including sedatives and tranquilizers1, stimulants2, and analgesics, particularly opioids3, such as oxycodone, hydromorphone and fentanyl, are a significant public health and patient safety issue. Canada has one of the highest per capita consumption of prescription opioids in the world.4 Dispensing of medications has substantially increased in Canada, although patterns vary considerably between provinces.5 In 2011, while opioid consumption for medical purposes in morphine equivalence (ME)ii was 62mg per person globally, Canada's ME was 812mg per person.6 When comparing to other developed countries, Australia's ME was 427 and Denmark's 483. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.7 Psychoactive medications pose significant health and safety risks. The harms include overdoses, suicides, motor vehicle accidents, relationship and employment problems, workplace accidents and exposure to blood borne pathogens and other infections when used by injection, besides addiction. Data are not collected systematically in Canada, making it difficult to assess the harms and track the trends and impact of the introduction of policy changes. However, practitioners have seen the significant impact of these prescription drugs on their patients and to public health. Studies in Ontario show that the number of people enrolled in methadone maintenance treatment rose from about 7,800 in 2001 to over 35,000 in 2011, where opioids have surpassed heroin as the drug used.8 Opioid-related deaths nearly tripled from 2002 to 2010, according to the Office of the Chief Coroner of Ontario.9 Another study showed that other non-opioid depressants (sedatives), such as benzodiazepines, were involved in 92% of the opioid-related deaths.10 The impact is felt particularly among vulnerable populations, such as youth, seniors, First Nations and those living in poverty. In 2013, opioids were reported as the third most common drug used by students in Ontario (after alcohol and marijuana).11 Opioid addiction rates anywhere from 43% to 85% have been reported in some Indigenous communities.12 13 While accurate data on the harms of prescription medication among seniors is lacking, it is well known that the prevalence of pain is higher among older adults and that they account for a significant proportion of prescriptions. The "high" they produce also leads to these medications being sought after for recreational purposes and, as they are legal products, they are often more easily accessible than street drugs. Surveys with youth have shown that as much as 70% of opioids have been obtained from legitimate prescriptions to family and friends (55% were shared at no cost).14 As well, because opioids have high abuse liability and addiction potential, people have resorted to illegal behaviour to obtain them, such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Of great concern, opioid dispensing levels are strongly correlated with increased mortality, morbidity and treatment admissions for substance use.15 16 Studies in Ontario and British Columbia have replicated similar findings in the US. Many patients were prescribed these medications and developed dependence.17 Psychoactive medications are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. Medications, such as opioids, have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering. Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.18 19 However, there is evidence for significant pain relief in the short term but a need for more evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.20 21 22 Important contributing factors for the increase in prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with the patient. In addition, there are new highly potent opioid drugs available.23 24 Canada's physicians are deeply concerned about the harms of opioids and other psychoactive prescription medications. As prescribers, they have a fundamental role in helping to ensure safe and effective use of these drugs, and the deterrence of abuse. 25 26 27 Physicians assess patients and consider whether a prescription is clinically indicated according to best practices, as well as consider whether the benefits outweigh the risks, while screening for risk factors for substance dependence and diversion. This area can be a source of tension with patients who might seek to obtain drugs through fraudulent means.28 It is also an area which causes concern to many physicians, and this could be affecting access to adequate pain management where it is needed.29 The challenge for physicians and public policymakers is how to mitigate the harms of psychoactive prescription drug use, while ensuring that patients have access to the appropriate treatment for their clinical conditions. Comprehensive National Strategy Canada's physicians believe that this challenge requires a complex and multifaceted solution; and to further such a solution, the CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant. The federal government has created the National Advisory Council on Prescription Drug Misuse, co-chaired by the Canadian Centre on Substance Abuse, the Coalition on Prescription Drug Misuse (Alberta) and the Nova Scotia Department of Health and Wellness, in partnership with Health Canada's First Nations and Inuit Health Branch's Prescription Drug Abuse Coordinating Committee. In its 2013 report First Do No Harm: Responding to Canada's Prescription Drug Crisis30, there are nearly 60 recommendations toward the development of a strategy to combat the harms associated with psychoactive prescription medications. However, there is much still to be done. The CMA supports collaborative efforts by the federal and provincial/territorial governments, and by health professionals and other stakeholders, to develop and implement a comprehensive national strategy. Such a strategy should include the following: 1. Improvement of Drug Safety Health Canada, as the agency that approves prescription drugs for use and monitors their safety once on the market, has several levers by which it can control Canadians' access to drugs. One of these is the Controlled Drugs and Substances Act (CDSA) and its regulations, which govern access to illegal products and recently has included psychoactive prescription drugs. Because of their health and safety risks, it is important that Health Canada ensures that the CDSA subjects psychoactive substances to high levels of regulatory scrutiny during both the approval process and post-approval surveillance. The Act should require manufacturers to: * Meet stringent pre-approval requirements. For example, Health Canada could require intensive review of pre-approval clinical trial results and of product monographs by an expert impartial review committee (including addiction, pain and public health expertise); or require that the manufacturer fulfill special conditions, such as formal post-market studies, as a condition of the drugs' approval; or even require larger sample sizes or longer study periods to assess harms; * Adhere to restrictions on the marketing of controlled medications to health professionals and the general public. The adequacy of regulations needs to be assessed in this regard. * Develop and cover tamper-resistant formulations of psychoactive drugs of concern. Although not a standalone solution, tamper-resistant formulations can reduce the potential for manipulation to be able to use through snorting, chewing or intravenously. 2. Enhancement of Optimal Prescribing through Evidence-Based Guidance, Education and Support for Prescribers CMA recommends that appropriate prescribing of psychoactive medications should be addressed through evidence-based guidance and education. A strategy to support optimal therapy might include: * Support for models of care that allow a physician to spend time with complex patients. * Ongoing development and dissemination of clinical guidance. The Canadian Guideline for Use of Opioids to Treat Chronic Non-Cancer Pain was published in the CMAJ in 2010. CMA has co-sponsored an online CME module based on this guideline. There is interest in similar guidelines for sedatives and stimulants. * Evaluative research to support the critical review of guidelines periodically. It is essential to review data on chronic conditions for which risks might outweigh benefits. * Relevant, unbiased and easily accessible information for prescribers, which can readily be incorporated into everyday practice. This should include clinical decision-support tools for use at the point of care, inclusive of dosing guidelines and guidance on when to seek consultation with experts. Physicians also require tools, including those that facilitate: monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; tapering of problematic or ineffective doses; among others. * Educational programs in optimal prescribing, pain management and in the management of addictions, as part of the curriculum in medical school, and residency training as well as in continuing education. Particular support is needed for those in primary care. * Guidance for prescribers about how to deal with conflict in their practice. This would include guidance for patient-centred educational discussions on safe opiate prescribing and use and management of addictions. * Access to expert advice if required through such means as: o Policies or standards of practice developed by provincial regulatory colleges of physicians, which can include limitations on prescription volume, treatment period and indications. o Communities of practice, knowledge hubs and clinical support networks that link practitioners with experts in the field, facilitating triage and supporting front line generalists. Experts can not only provide clinical information, but can provide mentorship and personal advice about best practices. o Feedback to practitioners about their prescribing practices, particularly if potentially concerning patterns are identified. This initiative should be facilitated by collaborative work between health care professionals and their respective provincial regulatory colleges. o Academic detailing programs, which use personalized, one-on-one techniques to deliver impartial prescribing information to practitioners. 3. Enhancement of Optimal Prescribing through Physician Regulation and Prescription Monitoring Programs Medicine is a regulated profession, and the provincial colleges of physicians have ultimate authority and responsibility for the oversight of physician practice. The colleges have taken a leading role in educating their members about appropriate prescribing, in monitoring prescribing practices to ensure their appropriateness and taking disciplinary action when required, and through collaborating with law enforcement agencies to detect and halt criminal diversion. The CMA recommends that federal and provincial regulations regarding controlled substances recognize the established authority of physician regulatory colleges for the oversight of the medical profession. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and the purpose for which the data are collected. Standardization of monitoring systems across Canada according to best practices can contribute to addressing the harms associated with psychoactive prescription medication by: * Allowing health care practitioners to identify previous or concomitant prescriptions of controlled medications with more than one practitioner at the time the prescription is requested or filled; * Deterring interprovincial or jurisdictional fraud, by allowing health care practitioners to identify other prescriptions at the time the prescription is requested or filled; and * Improving professional regulatory bodies' capacity for oversight and intervention by establishing a mechanism for real-time monitoring. The CMA recommends that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring. PMPs should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary. CMA also recommends that Health Canada ensure that its legislative framework be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can help individual physicians or pharmacists identify potential diversion and double prescriptions, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, and could minimize the potential administrative burden. PMPs should conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. The CMA strongly recommends that Health Canada undertake a privacy impact assessment of the regulatory framework for controlled prescription drugs, and share the results with stakeholders. 4. Increase in Access to Treatment for Pain Chronic pain affects many aspects of a person's life including their ability to work, their emotional, mental and physical health, and their quality of life. Pain costs Canada an estimated $60 Billion dollars per year; more than the cost of heart disease, cancer and diabetes.31 CMA has endorsed a national strategy for pain, developed and proposed by the Canadian Pain Coalition and Canadian Pain Society,32 which addresses four target areas: awareness and education; access; research; and ongoing monitoring. Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include: * Care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals; * Recommendation of non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies; * Appropriate pharmaceutical prescription options, covered by provincial formularies; and * A focus on patient participation and empowerment. However, specialized pain treatment programs are in short supply. Wait times are greater than one year at more than one third of publicly funded inter-professional treatment programs.33 In many parts of Canada, particularly rural and remote areas, such programs are not available. In addition, while physician visits are covered by the public health care system, services provided by other health professionals are more likely to be either covered by private health benefits or paid out of pocket, and are therefore beyond the means of many Canadians. These factors may result in heavier reliance on prescription medication as treatment for chronic pain. The CMA recommends that all partners work to improve and promote access to specialized treatment programs for pain management, and that investments be made in research about options for treatment. 5. Increase in Access to Treatment for Addiction Access to addiction treatment is very limited and, when available, is primarily comprised of detox or the substitution treatments with methadone or Suboxone(r) (buprenorphine and naloxone). As addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry by definition, which manifests along biological, psychological, social and spiritual dimensions, treatment must address all those areas rather than just one or another.34 The CMA supports the enhancement of access to options for addiction treatment that address different needs. Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that addiction programs be culturally relevant for Indigenous communities. Treatment programs must also be integrated within the health care system and be adequately funded to meet evidence based, best-practice guidelines. CMA also supports the development and dissemination of practice tools and guidelines to help physicians assess the addiction potential of a patient receiving psychoactive medications, and to assist in managing patients who have addiction and related problems and complications. 6. Increase in Information through Epidemiological Surveillance One of the challenges in dealing with prescription drug abuse, which can reflect hazardous (episodic) use, harmful (regular) use or addiction, is the incompleteness of our knowledge of the extent of the problem. Countries, such as the US and France, are able to monitor psychoactive drug use, while in Canada we still rely on unsystematically collected or locally limited data. The creation of a national surveillance system that supports the collection of systematic, standardized information would: * Permit the thorough assessment of the problem, with the development and monitoring of indicators; * Support the early detection of diversion or inappropriate prescribing behaviour; * Support the establishment of best practices to address crucial issues; * Identify research priorities; and * Evaluate the impact of the implementation of strategies. Sources of information should include PMPs, coroner's investigations, emergency room admissions, and poison control data, among others. 7. Prevention of Deaths due to Overdose Overdose deaths have increased dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. Opioid death and complications overdoses can be prevented with appropriate medication and prompt emergency response. The CMA recommends the: * Creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. Training should be made available to health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.35 * Improvement of access to naloxone to reverse opioid overdoses. This should include the prescription of naloxone to high risk individuals and third parties who can assist a victim experiencing an opiate-related overdose. * Enactment of Good Samaritan laws by all levels of government in order to protect callers from criminal charges if they call emergency services to report an overdose. 36 37 8. Provision of Information for Patients and the Public Awareness programs that provide accurate information to patients and the general public are important, and could include: * Information on the benefits and harms of psychoactive prescription medication use, and signs of dependence and overdose. This should include the risk of dependence and addiction associated with the use of opiates for the treatment of acute and chronic pain. * Messages aimed at the prevention of problematic drug use among young people and other populations at risk. * Information regarding safe medication storage and disposal, and reducing access to medications from family and friends. CMA supports national prescription drug "drop off" days, and recommends that patients be educated about the importance of routinely returning unused prescription drugs to the pharmacy. Recommendations The CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based. This strategy should include: * That Health Canada require that manufacturers meet stringent pre-approval requirements, adhere to restrictions on the marketing of controlled medications to health professionals and the general public, and develop formulations of psychoactive drugs of concern that are tamper-resistant. * Support for optimal prescribing through evidence-based guidance, education and supports, such as clinical guidance, clinical decision-support tools, educational programs, expert advice, and supportive models of care. * The enhancement of optimal prescribing through physician regulation and the development of a pan-Canadian system of real-time prescription monitoring programs, compatible with electronic medical and pharmacy record systems, based on national standards. * Increased access to specialized pain management and treatment, according to best practices, with investments in research. * The enhancement of access to options for addiction treatment that address different needs, and the support for the development and dissemination of practice tools and guidelines. * The creation of a national surveillance system that supports the collection of systematic, standardized information to better inform and track policy changes. * * The creation and scaling up of community-based programs that * Offer access to opioid overdose prevention tools and services, including the improvement of access to medication to reverse opioid overdoses (naloxone) and the enactment of Good Samaritan laws by all levels of government. * The provision of accurate information to patients and the general public, including safe medication storage and disposal. References i Psychoactive drugs are substances that, when taken, have the ability to change an individual's consciousness, mood or thinking processes (WHO, 2004). Psychoactive prescription drugs include sedatives (such as benzodiazepines and barbiturates), stimulants (such as amphetamines), and opioids (such as oxycodone, hydromorphone, morphine and fentanyl). [World Health Organization (2004) Neuroscience of psychoactive substance use and dependence. Available at: http://www.who.int/substance_abuse/publications/en/Neuroscience.pdf] ii Comprises six main opioids: fentanyl, hydromorphone, methadone, morphine, oxycodone and pethidine. 1 Canadian Centre on Substance Abuse. Prescription sedatives and tranquilizers. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Sedatives-and-Tranquilizers-2013-en.pdf 2 Canadian Centre on Substance Abuse. Prescription stimulants. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Stimulants-2013-en.pdf 3 Canadian Centre on Substance Abuse. Prescription opioids. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Canadian-Drug-Summary-Prescription-Opioids-2013-en.pdf 4 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. 5 Fischer B, Jones W, Murray K, et al. Differences and over-time changes in levels of prescription opioid analgesic dispensing from retail pharmacies in Canada, 2005-2010. Pharmacoepidemiol Drug Saf. 2011;20:1269-77. 6 United Nations Office on Drugs and Crime. World drug report 2014. New York: The Office; 2014. Available: www.unodc.org/documents/wdr2014/World_Drug_Report_2014_web.pdf 7 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81. 8 Fischer B, Argento E. Prescription opioid related misuse, harms, diversion and interventions in Canada: a review. Pain Physician. 2012;15:ES191-ES203. 9 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. 10 Dhalla IA, Mamdani MM, Sivilotti MLA, et al. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone CMAJ. 2009;181(12): 891-6. 11 Centre for Addiction and Mental Health. Drug use among Ontario students, 1977-2013: results of the Ontario Student Drug Use and Health Survey. Toronto: The Centre; 2013. Available: www.camh.ca/en/research/news_and_publications/ontario-student-drug-use-and-health-survey/Documents/2013%20OSDUHS%20Docs/2013OSDUHS_Highlights_DrugUseReport.pdf 12 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf 13 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf 14 US Department of Health and Human Services Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. Rockville (MD): The Department; 2011. p. 25. Available: www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf 15 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q. 2011;14(1):22-4. 16 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf. 2013;22(4):438-42. 17 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend. 2004;73(2):199-207. 18 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142 DOI: 10.1136/bmj.d5142. 19 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician. 2014;17(1):E1-10. 20 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology. 2014;83:1277-84. Available: www.neurology.org/content/83/14/1277.full.pdf+html 21 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10:147-59. 22 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;(1):CD006605. 23 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health. 2008;99(3): 182-4. 24 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81. 25 Silversides A. Opioid prescribing challenges doctors. CMAJ. 2009;181(8):E143-E144. 26 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142. 27 Kirschner N, Ginsburg J, Sulmasy LS. Prescription drug abuse: a policy position paper from the American College of Physicians. Ann Intern Med. 2014;160:198-213. 28 Saveland C, Hawker L, Miedema B, et al. Abuse of family physicians by patients seeking controlled substances. Can Fam Physician. 2014;60:e131-6. 29 Wenghofer EF, Wilson L, Kahan M, et al. Survey of Ontario primary care physicians' experiences with opioid prescribing. Can Fam Physician. 2011;57(3):324-32. 30 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse-report-en.pdf 31 Canadian Pain Strategy Initiative. Rise up against pain: the Canadian Pain Strategy. Available: http://canadianpainstrategy.ca/en/home.aspx 32 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf 33 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf 34 American Society of Addiction Medicine. Public policy statement: definition of addiction. 2011. Available: www.asam.org/for-the-public/definition-of-addiction 35 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/ 36 Follett KM, Piscitelli A, Parkinson M, et al. Barriers to calling 9-1-1 during overdose emergencies in a Canadian context. Crit Social Work. 2014;15(1):18-28. Available: http://www1.uwindsor.ca/criticalsocialwork/system/files/Follett_Piscitelli_Parkinson_Munger_2014.pdf 37 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
Documents
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Management of physician fatigue

https://policybase.cma.ca/en/permalink/policy11127
Last Reviewed
2019-03-03
Date
2014-05-24
Topics
Health human resources
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2014-05-24
Topics
Health human resources
Text
Health systems around the world are struggling with how to best meet the health needs of their populations. Health leaders speak with urgency about the need to improve the individual experience of care, improve the health of populations, and maximize return on investments. Physicians concur - they are continually focused on providing better care to their patients. Concurrently, concerns over patient safety have arisen over the last two decades, rooted in studies of adverse events. The incidence of adverse events (AEs) in acute care hospitals has been reported in the United States (US),1,2,3 Australia,4 United Kingdom,5 and Canada.6 Between 5% and 20% of patients admitted to hospital experience one or more AEs; between 36.9% - 51% of these AEs are preventable; and AEs contribute billions of dollars through additional hospital stays as well as other costs to the system, patients and the broader society.7 Leape et al. maintain that more than two-thirds of AEs are preventable.8 These outcomes have prompted decision makers, policy makers and healthcare providers to examine contributing factors, including the increasingly complex health system and its impact on the well-being of providers. Patient safety and physician well-being are the key drivers leading to restrictions on resident and/or physician duty hours aimed at reducing their fatigue. The European Working Time Directive (EWTD) was first established in 1993 to place limits on all workers' hours throughout Europe under the umbrella of health and safety legislation. That directive included physicians but excluded doctors in training. In 2000, a new directive passed to include the "junior doctor" constituency accompanied by a requirement that by 2009 all health systems in the European Union limit resident work to a maximum of 48 hours averaged per week. The intention was to improve the working lives of doctors in training and to increase patient safety. A systematic review on the impact of the EWTD on postgraduate medical training, patient safety, or clinical outcomes found studies to be of poor quality with conflicting results.9 In 2003, the Accreditation Council for Graduate Medical Education (ACGME) in the US adopted a set of duty hour regulations for physicians in training. The ACGME issued revised regulations that went into effect in July 2011, reflecting the recommendations of a 2008 Institute of Medicine report Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, calling for elimination of extended duty shifts (more than 16 hours) for first year residents, increasing days off, improving sleep hygiene by reducing night duty and providing more scheduled sleep breaks, and increasing oversight by more senior physicians.10 The Institute of Medicine's report bases its recommendations on the growing body of research linking clinician fatigue and error. In 2013, the National Steering Committee on Resident Duty Hours released Canada's first comprehensive, collaborative and evidence-based report on fatigue and duty hours for Canada's approximately 12,000 residents. The Committee stresses that a comprehensive approach is necessary in order to enhance safety and wellness outcomes. Fatigue risk management is a predominant theme in the recommendations. Fatigue management systems are in place in other sectors/industries that have a low threshold for adverse outcomes including aviation, transportation, and the Department of National Defence. In 2010, the Canadian Nurses Association released a position statement Taking Action on Nurse Fatigue that speaks to system, organizational and individual level responsibilities of registered nurses. There are currently no specific policies in Canada for physicians in practice with respect to fatigue management. Given the heterogeneity of medical practice (i.e. various specialties) and of the practice settings (i.e. rural and remote versus urban, clinic versus hospital, etc.), the solutions emanating from a fatigue management policy may be different - one size will not fit all. Impact of Physician Fatigue Patient Safety Sleep deprivation is the condition of not having enough sleep and can be either chronic or acute. It impairs cognitive and behavioural performance. "Sleep is required for the consolidation of learning and for the optimal performance of cognitive tasks. Studies of sleep deprivation have shown that one night without sleep negatively affects the performance of specific higher cognitive functions of the prefrontal cortex and can cause impairment in attention, memory, judgment, and problem solving."(p. 1841)11 A seminal study by Williamson and Feyer found that after 17-19 hours without sleep, performance on some cognitive and motor performance tests was equivalent or worse than that at a blood alcohol concentration (BAC) of 0.05%.12 Wakefulness for 24 hours is equivalent to a blood alcohol level of 0.10%.13 A chronic sleep-restricted state can cause fatigue, which is a subjective feeling of tiredness, lack of energy and motivation. A large body of research exists linking sleep deprivation/fatigue, performance and adverse patient outcomes, particularly for medical residents. 14,15,16,17,18,19, 20, 21,22, 23,24 However, literature on the impact on performance varies based on a number of factors. There are significant inter-individual differences in the global response to sleep loss, as well as significant intra-individual variations in the degree to which different domains of neurobehavioral function (e.g., vigilance, subjective sleepiness, and cognitive performance) are affected. Inter-individual differences are not merely a consequence of variations in sleep history. Rather, they involve trait-like differential vulnerability to impairment from sleep loss. 25 Evidence suggests an inconclusive relationship between duty hour reductions (primarily those implemented in the US) and patient safety, suggesting that restrictions on consecutive duty hours have not had the anticipated impact on this crucial outcome as anticipated.26 Several large studies have revealed only neutral or slightly improved patient mortality and other clinical parameters since implementation of the ACGME work hour limits in the US.27,28, 29,30 In complex and ever changing health systems, it is difficult to isolate the impact of restricted duty hours alone. Research on the effects of practicing physician sleep deprivation and extended work shifts on clinical outcomes is limited and inconclusive.31, 32 The issue of physician fatigue is complex, and is affected by much more than duty hours. Other contributing factors affect performance including work patterns, individual response to sleep loss, experience of the worker, the context of which sleep deprivation is necessary, hours of actual sleep, patient volume, patient turnover and patient acuity, environmental factors, personal stressors, workload, etc. Limiting work hours alone is not sufficient to address sleep deprivation among physicians. Reduced or disturbed periods of sleep, more consecutive days or nights of work, shift variability, and the volume of work all increase fatigue and thus can contribute to errors. One of the biggest concerns with a fatigue management strategy is continuity of care, linked to the number of transfers of care (handover) among providers. Transfers of care inevitably increase in an environment of work hour limitations.33, 34 Handovers are considered critical moments in the continuity of patient care and have been identified as a significant source of hospital errors, often related to poor communication. There is a growing body of literature on how to do these well and how to teach this well. This is an important skill for physicians in the context of a fatigue management strategy: "Standardization of the handover process has been linked to a reduction in the number of errors related to information transfers. In addition, effective mechanisms for the transfer of information at transition points have been recognized as patient safety enablers."35 Provider Well-being Provider well-being (physical, mental, occupational) is linked to system performance and patient outcomes. It is affected by fatigue and work patterns including night shift and extended hours. Comprehensive, systematic reviews of the health effects of on-call work in 2004 showed that nighttime work interrupted sleep patterns, aggravated underlying medical conditions, and increased the risk of cardiovascular, gastrointestinal, and reproductive dysfunction.36,37.38 Other research suggests an elevated risk of breast cancer,39,40 prostate cancer,41 colorectal cancer,42 asthma43, diabetes,44 and epilepsy45 for shift workers. Disruption of the body's circadian rhythms is thought to be one of the main pathways for adverse health effects from shift work, particularly for work schedules that involve night work. Given that 24-hour work is unavoidable in various industries, including healthcare, researchers have evaluated different shift schedules designed to reduce some of the negative health effects of working at night. Optimal shift schedules are aligned as much as possible with the circadian rhythm, promote adaptation of the circadian rhythm with shift work, reflect workers' needs and preferences, and meet organizational or productivity requirements. The following interventions appear to have the most beneficial effects on the health of shift workers:46 * Schedule changes including changing from backward (counterclockwise) to forward (clockwise) rotation, from eight hour to 12 hour shifts, and flexible working conditions, self-scheduling, and ergonomic shift scheduling principles * Controlled exposure to light and day; * Behavioural approaches such as physical activity, scheduled naps and education about sleep strategies; and * Use of pharmacotherapy (i.e. caffeine and melatonin) to promote sleep, wakefulness, or adaptation Sleep deprivation and on-call shifts consistently point to deterioration of mood resulting in depression, anger, anxiety, hostility, and decreased vigilance.47 ,48, 49 A Canadian study found that shift workers reported significantly higher burnout, emotional exhaustion, job stress and psychosomatic health problems (e.g. headaches, upset stomach, difficulty falling asleep) than workers on a regular day schedule.50 Prolonged duty hours by residents has been found to contribute to marital problems, pregnancy complications, depression, suicide and substance abuse,51 as well as serious conflicts with attending physicians, other residents, and nurses, in addition to increased alcohol use and instances of unethical behaviour.52 Surprisingly however, the abolishment of 24-hour continuous medical call duty for general surgery residents at one facility in Quebec was associated with self-reported poorer quality of life.53 In contrast to other recommendations on the health benefits of 8 hr shifts, the risk of a work safety incident increases markedly after more than eight hours on duty. The risk in the twelfth hour is almost double than in the eighth hour (and more than double the average risk over the first eight hours on duty).54 Extended work duration and nighttime work by interns is associated with an increased risk of reported percutaneous injuries (PIs).55 Fatigue was reported more often as a contributing factor for nighttime compared with daytime injuries. Fatigue was also more commonly reported as a contributing factor to PIs that occurred after extended work than those that occurred after non-extended work.56 Other research found that residents were most exposed to blood-borne pathogens through needle punctures or cuts during overnight duty periods.57 Health care facilities that have physicians working in them have a role in supporting and promoting provider well-being, including providing enablers of extending and continuing resiliency such as nutritious food, on call rooms, appropriate numbers of staff, locums, etc. They also have a role in working jointly and collaboratively with physicians to ensure that on-call schedules do not place work demands on individual physicians that prevent the physicians from providing safe patient care and service coverage. For example, research with emergency physicians suggests that a nap at 3 AM improves performance in physicians and nurses at 7:30 AM compared to a no-nap condition despite the fact that memory temporarily worsened immediately after the nap.58 Individual resilience, intergenerational differences, illness-related issues, as well as family commitments also need to be considered. Physicians should also be encouraged to take the necessary time to rest and recover on their time off. The obligation of physicians to provide after hour coverage and care is unavoidable and should be considered by an individual when they choose a career in medicine, and as a physician in managing their schedule/call. A review of 100 studies from around the world indicates the culture of medicine contributes to doctors ignoring the warning signs of fatigue and stress and in many cases suffering from undiagnosed ailments such as stress and depression, or from burnout.59 The authors suggest the culture of medicine is such that doctors feel they don't need help; they put their patients first. Of the 18% of Canadian doctors who were identified as depressed, only a quarter of them considered getting help and only two per cent actually did. The report suggests that burnout from working long hours and sleep deprivation because of understaffing seems to be the biggest problem worldwide.60 The Canadian Medical Protective Association (CMPA) states that physicians should consider their level of fatigue and if they are clinically fit to provide treatment or care.61 Fatigue is not a sign of weakness. All members of the health care team should support their colleagues in recognizing and managing sleep deprivation and fatigue. Physician fatigue has several ethical dimensions. The Canadian Medical Association Code of Ethics states that physicians have an ethical responsibility to self-manage their fatigue and well-being. 62 However, physicians must be trained and competent to know their own limits and evaluate their own fatigue level and well-being. The system must then support physicians in this recognition. The doctrine of informed consent is another dimension of physician fatigue. If physician fatigue is an added risk for any aspect of patient care, whether it is surgical or medical, elective or emergent, then some have argued that the doctrine of informed consent suggests that physicians have an obligation to inform patients of that risk.63 ,64 "The medico-legal considerations for physicians centre on the ethical duty to act in the best interests of their patients. This may mean that if a physician feels that his or her on-call schedule endangers or negatively impacts patient care, reasonable steps are taken to ensure patients do not suffer as a result and that the physician is able to continue providing an adequate level of care for patients."65 System Performance Addressing physician fatigue may have workforce implications. Physician workload is multifaceted comprised of clinical, research, education and administrative activities. If physician workload or duty hours are reduced, any one of these activities may be impacted. It has been suggested that implementing fatigue management strategies such as a workload ceiling for physicians may result in a greater need for physicians and thus increase system costs. However, new models of team based care delivery that incorporate technology, reduce redundancy, utilize a team based approach, and optimize the role of physicians offer an opportunity to better manage physician fatigue without necessarily requiring more physicians. Other strategies also need to be explored to improve the on-the-ground efficiency of physicians. Some of the strategies to address practicing physician sleep deprivation/fatigue such as scheduling changes and reduced workload may affect access to care, including wait times. Surgeons or others may have to cancel surgeries or other procedures because of fatigue and hours of work, forcing rescheduling of surgery/procedures and potentially increasing wait times. This is particularly relevant given Canada's large geography and varied distribution of physicians. Therefore, flexibility in strategies to address physician sleep deprivation/fatigue are needed to reflect the variety of practice types and settings in existence across the country, in particular solo practices; rural, remote and isolated sites; community locations; etc. The same holds true for smaller specialties, which has been the experience in the UK with the implementation of the EWTD. Fatigue management is a competency that needs to be taught, modelled, mentored, and evaluated across the medical education continuum, from medical student to practicing physician. Recommendations 1. Educate physicians about the effects of sleep deprivation and fatigue on the practice of medicine and physician health, and how to recognize and manage their effects. 2. Create a national tool-box of self-awareness tools and fatigue management strategies and techniques. 3. Advocate for the integration of fatigue management into the continuum of medical education. 4. Advocate for the creation of system enablers with the flexibility to: * Consider the full workload of physicians (clinical, teaching, administrative, research, etc.); * Optimize scheduling to coordinate on call and other patient care following call; and * Implement organizational/institutional level fatigue risk management plans. 5. Develop and advocate for implementation of standardized handover tools. 6. Enhance and reaffirm a culture within medicine that focuses on patient-centered care. 7. Reaffirm the culture shift within medicine that encompasses physician well-being. 8. Encourage physicians treating physicians to be aware of the aggravating effects of fatigue on their well-being and practice. Conclusion Physicians are interested in how to best meet the needs of the population, in continually improving the care provided to Canadians. To do so requires that they also care for themselves including managing the effects of sleep deprivation and fatigue. 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J Am Coll Surg 216:791- 799. 33 Olsen, E., Drage, L., Auger, R. (2009). Sleep Deprivation, Physician Performance, and Patient Safety. Chest 136: 1389-1396. 34 Choma, N., Vasilevskis, E., Sponsler, K., Hathaway, J., & Kripalani, S. Effect of the ACGME 16-Hour Rule on Efficiency and Quality of Care: Duty Hours 2.0. JAMA INTERN MED 173 (9): 819-821. 35 Canadian Medical Protective Association. (2013). CMPA Risk Fact Sheet: Patient Handover. Retrieved January 13, 2014 from https://oplfrpd5.cmpa-acpm.ca/documents/10179/300031190/patient_handovers-e.pdf 36 Nicol, A., Botterill, J., (2004). On-call Work and Health: A Review. Environmental Health 3: 1-11. 37 Knutsson, A. & Boggild, H. (2010). Gastrointestinal disorders among shift workers. Scand J Work Environ Health 36(2): 85-95. 38 Vyas, M., Garg, A., Iansavichus, A., Costella, J., Donner, A., Laugsand, L., et al. (2012). Shift work and vascular events: systematic review and meta-analysis. 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Can the health effects of shift work be mitigated? A summary of select interventions. Retrieved March 10, 2013 from http://www.occupationalcancer.ca/wp-content/uploads/2012/09/Summary_intervention-research_FINAL.pdf 47 Eastridge, B., Hamilton, E., O'Keefe, G., Rege, R., Valentine, R. et al. (2003). Effect of Sleep Deprivation on the Performance of Simulated Laproscopic Surgical Skill. The American Journal of Surgery 186: 169-174. 48 Krueger, K. & Halperin, E. (2010). Perspective: Paying Physicians to Be On Call: A Challenge for Academic Medicine. Academic Medicine 85(12); 1840-1844. 49 Haines, V., Marchand, A., Rousseau, V., & Demers, A. (2008).The mediating role of work-to-family conflict in the relationship between shiftwork and depression. Work & Stress 22(4):341-356. 50 Jamal, M. (2004). Burnout, stress and health of employees on non-standard work schedules: a study of Canadian workers. Stress and Health 20:113-119. 51 Woodrow, S., Segouin, C., Armbruster, J., Hamstra, S., & Hodges, B. (2006). Duty Hours Reforms in the United States, France and Canada: Is It Time to Refocus our Attention on Education? Academic Medicine 81(12): 1045-1051. 52 Baldwin, D., Daugherty, S., Tsai, R., et al. (2003). A National Survey of Residents' Self-reported Work Hours: Thinking Beyond Specialty. Academic Medicine 78:1154-1163. 53 Hamadani, F., Deckelbaum, D., Sauve, D., Khwaja, K., Razek, T., & Fata, P. (2013). Abolishment of24-HourContinuousMedical Call Duty in Quebec: A Quality of Life Survey of General Surgical Residents Following Implementation of the New Work-Hour Restrictions. J Surg 70: 296-303. 54 Folkard, S. & Tucker, P. (2003). Shift work, safety and productivity. Occupational Medicine 53: 95-101. 55 Ayas, N., Barger, L., Cade, B., et al. (2006). Extended Work Duration and the Risk of Self-reported Percutaneous Injuries in Interns. JAMA 296(9): 1055-62. 56 Ayas, N., Barger, L., Cade, B., et al. (2006). Extended Work Duration and the Risk of Self-reported Percutaneous Injuries in Interns. JAMA 296(9): 1055-62. 57 Parks, D., Yetman, R., McNeese, M., Burau, K., & Smolensky, M. (2000). Day-night pattern in accidental exposures to blood-borne pathogens among medical students and residents. Chronobiology International 17(1): 61-70. 58 Smith-Coggins, R., Howard, S., Mac D., Wang, C., Kwan, S., Rosekind, M., Sowb, Y., Balise, R., Levis, J., Gaba, D. (2006). Improving alertness and performance in emergency department physicians and nurses: the use of planned naps. Ann Emerg Med, 48(5): 596-604. 59 Wallace, J., Lemaire, J., & Ghali, W. (2009). Physician wellness: a missing quality indicator. The Lancet 374 (9702): 1714-1721. 60 Wallace, J., Lemaire, J., & Ghali, W. (2009). Physician wellness: a missing quality indicator. The Lancet 374 (9702): 1714-1721. 61 Canadian Medical Protective Association. The new realities of medical care. Originally published September 2012. Retrieved January 12, 2014 from https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/the-new-realities-of-medical-care 62 Canadian Medical Association. (2011). Canadian Medical Association Code of Ethics. Ottawa: Author. 63 Mercurio. M. & Peterec, S. (2009). Attending Physician Work Hours: Ethical Considerations and the Last Doctor Standing. Pediatrics 124:758-762. 64 Czeisler, C., Pellegrini, C., & Sade, R. (2013). Should Sleep-Deprived Surgeons Be Prohibited From Operating Without Patients' Consent? Ann Thorac Surg 95:757-766. 65 Canadian Medical Protective Association. The new realities of medical care. Originally published September 2012. Retrieved January 12, 2014 from https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/the-new-realities-of-medical-care
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