Skip header and navigation
CMA PolicyBase

Policies that advocate for the medical profession and Canadians


19 records – page 1 of 2.

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.
Documents
Less detail

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
Documents
Less detail

Best practices for smartphone and smart-device clinical photo taking and sharing

https://policybase.cma.ca/en/permalink/policy13860
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
Text
Clinical photography is a valuable tool for physicians. Smartphones, as well as other devices supporting network connectivity, offer a convenient, efficient method to take and share images. However, due to the private nature of the information contained in clinical photographs there are concerns as to the appropriate storage, dissemination, and documentation of clinical images. Confidentiality of image data must be considered and the dissemination of these images onto servers must respect the privacy and rights of the patient. Importantly, patient information should be considered as any information deriving from a patient, and the concepts outlined therefore apply to any media that can be collected on, or transmitted with, a smart-device. Clinical photography can aid in documenting form and function, in tracking conditions and wound healing, in planning surgical operations, and in clinical decision-making. Additionally, clinical photographs can provide physicians with a valuable tool for patient communication and education. Due to the convenience of this type of technology it is not appropriate to expect physicians to forego their use in providing their patients with the best care available. The technology and software required for secure transfer, communication, and storage of clinical media is presently available, but many devices have non-secure storage/dissemination options enabled and lack user-control for permanently deleting digital files. In addition, data uploaded onto server systems commonly cross legal jurisdictions. Many physicians are not comfortable with the practice, citing security, privacy, and confidentiality concerns as well as uncertainty in regards to regional regulations governing this practice.1 Due to concern for patient privacy and confidentiality it is therefore incredibly important to limit the unsecure or undocumented acquisition or dissemination of clinical photographs. To assess the current state of this topic, Heyns et al. have reviewed the accessibility and completeness of provincial and territorial medical regulatory college guidelines.2 Categories identified as vital and explored in this review included: Consent; Storage; Retention; Audit; Transmission; and Breach. While each regulatory body has addressed limited aspects of the overall issue, the authors found a general lack of available information and call for a unified document outlining pertinent instructions for conducting clinical photography using a smartphone and the electronic transmission of patient information.2 The discussion of this topic will need to be ongoing and it is important that physicians are aware of applicable regulations, both at the federal and provincial levels, and how these regulations may impact the use of personal devices. The best practices supported here aim to provide physicians and healthcare providers with an understanding of the scope and gravity of the current environment, as well as the information needed to ensure patient privacy and confidentiality is assessed and protected while physicians utilize accessible clinical photography to advance patient care. Importantly, this document only focusses on medical use (clinical, academic, and educational) of clinical photography and, while discussing many core concepts of patient privacy and confidentiality of information, should not be perceived as a complete or binding framework. Additionally, it is recommended that physicians understand the core competencies of clinical photography, which are not described here. The Canadian Medical Association (CMA) suggests that the following recommendations be implemented, as thoroughly as possible, to best align with the CMA policy on the Principles for the Protection of Patient Privacy (CMA Policy PD2018-02). These key recommendations represent a non-exhaustive set of best practices - physicians should seek additional information as needed to gain a thorough understanding and to stay current in this rapidly changing field. KEY RECOMMENDATIONS 1. CONSENT * Informed consent must be obtained, preferably prior, to photography with a mobile device. This applies for each and any such encounter and the purpose made clear (i.e. clinical, research, education, publication, etc.). Patients should also be made aware that they may request a copy of a picture or for a picture to be deleted. * A patient's consent to use electronic transmission does not relieve a physician of their duty to protect the confidentiality of patient information. Also, a patient's consent cannot override other jurisdictionally mandated security requirements. * All patient consents (including verbal) should be documented. The acquisition and recording of patient consent for medical photography/dissemination may be held to a high standard of accountability due to the patient privacy and confidentiality issues inherent in the use of this technology. Written and signed consent is encouraged. * Consent should be considered as necessary for any and all photography involving a patient, whether or not that patient can be directly recognized, due to the possibility of linked information and the potential for breach of privacy. The definition of non-identifiable photos must be carefully considered. Current technologies such as face recognition and pattern matching (e.g. skin markers, physical structure, etc.), especially in combination with identifying information, have the potential to create a privacy breach. * Unsecure text and email messaging requires explicit patient consent and should not be used unless the current gold standards of security are not accessible. For a patient-initiated unsecure transmission, consent should be clarified and not assumed. 2. TRANSMISSION * Transmission of photos and patient information should be encrypted as per current-day gold standards (presently, end-to-end encryption (E2EE)) and use only secure servers that are subject to Canadian laws. Explicit, informed consent is required otherwise due to privacy concerns or standards for servers in other jurisdictions. Generally, free internet-based communication services and public internet access are unsecure technologies and often operate on servers outside of Canadian jurisdiction. * Efforts should be made to use the most secure transmission method possible. For data security purposes, identifying information should never be included in the image, any frame of a video, the file name, or linked messages. * The sender should always ensure that each recipient is intended and appropriate and, if possible, receipt of transmission should be confirmed by the recipient. 3. STORAGE * Storing images and data on a smart-device should be limited as much as possible for data protection purposes. * Clinical photos, as well as messages or other patient-related information, should be completely segregated from the device's personal storage. This can be accomplished by using an app that creates a secure, password-protected folder on the device. * All information stored (on internal memory or cloud) must be strongly encrypted and password protected. The security measures must be more substantial than the general password unlock feature on mobile devices. * Efforts should be made to dissociate identifying information from images when images are exported from a secure server. Media should not be uploaded to platforms without an option for securely deleting information without consent from the patient, and only if there are no better options. Automatic back-up of photos to unsecure cloud servers should be deactivated. Further, other back-up or syncing options that could lead to unsecure server involvement should be ascertained and the risks mitigated. 4. Cloud storage should be on a Canadian and SOCII certified server. Explicit, informed consent is required otherwise due to privacy concerns for servers in other jurisdictions. 5. AUDIT & RETENTION * It is important to create an audit trail for the purposes of transparency and medical best practice. Key information includes patient and health information, consent type and details, pertinent information regarding the photography (date, circumstance, photographer), and any other important facts such as access granted/deletion requests. * Access to the stored information must be by the authorized physician or health care provider and for the intended purpose, as per the consent given. Records should be stored such that it is possible to print/transfer as necessary. * Original photos should be retained and not overwritten. * All photos and associated messages may be considered part of the patient's clinical records and should be maintained for at least 10 years or 10 years after the age of majority, whichever is longer. When possible, patient information (including photos and message histories between health professionals) should be retained and amalgamated with a patient's medical record. Provincial regulations regarding retention of clinical records may vary and other regulations may apply to other entities - e.g. 90 years from date of birth applies to records at the federal level. * It may not be allowable to erase a picture if it is integral to a clinical decision or provincial, federal, or other applicable regulations require their retention. 6. BREACH * Any breach should be taken seriously and should be reviewed. All reasonable efforts must be made to prevent a breach before one occurs. A breach occurs when personal information, communication, or photos of patients are stolen, lost, or mistakenly disclosed. This includes loss or theft of one's mobile device, texting to the wrong number or emailing/messaging to the wrong person(s), or accidentally showing a clinical photo that exists in the phone's personal photo album. * It should be noted that non-identifying information, when combined with other available information (e.g. a text message with identifiers or another image with identifiers), can lead to highly accurate re-identification. * At present, apps downloaded to a smart-device for personal use may be capable of collecting and sharing information - the rapidly changing nature of this technology and the inherent privacy concerns requires regular attention. Use of specialized apps designed for health-information sharing that help safeguard patient information in this context is worth careful consideration. * Having remote wipe (i.e. device reformatting) capabilities is an asset and can help contain a breach. However, inappropriate access may take place before reformatting occurs. * If a smartphone is strongly encrypted and has no clinical photos stored locally then its loss may not be considered a breach. * In the event of a breach any patient potentially involved must be notified as soon as possible. The CMPA, the organization/hospital, and the Provincial licensing College should also be contacted immediately. Provincial regulations regarding notification of breach may vary. Approved by the CMA Board of Directors March 2018 References i Heyns M†, Steve A‡, Dumestre DO‡, Fraulin FO‡, Yeung JK‡ † University of Calgary, Canada ‡ Section of Plastic Surgery, Department of Surgery, University of Calgary, Canada 1 Chan N, Charette J, Dumestre DO, Fraulin FO. Should 'smart phones' be used for patient photography? Plast Surg (Oakv). 2016;24(1):32-4. 2 Unpublished - Heyns M, Steve A, Dumestre DO, Fraulin FO, Yeung J. Canadian Guidelines on Smartphone Clinical Photography.
Documents
Less detail

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).
Documents
Less detail

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.
Documents
Less detail

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.
Documents
Less detail

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.
Documents
Less detail

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.
Documents
Less detail

Guiding Principles for Physician Electronic Medical Records (EMR) Adoption in Ambulatory Clinical Practice

https://policybase.cma.ca/en/permalink/policy9117
Last Reviewed
2019-03-03
Date
2008-02-23
Topics
Health information and e-health
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2008-02-23
Topics
Health information and e-health
Text
GUIDING PRINCIPLES FOR PHYSICIAN ELECTRONIC MEDICAL RECORDS (EMR) ADOPTION IN AMBULATORY CLINICAL PRACTICE The following principles outline what is important to physicians and why as they make the decision to adopt electronic medical record systems (EMRs) in ambulatory clinical practice. Physician adoption of the EMR has the potential to transform patient care and the quality of health statistics and health research in Canada, as long as the right conditions are met and the guiding principles outlined here are adhered to. Adoption of EMRs in clinical ambulatory practices will lead to significant improvements in data comprehensiveness, clinical relevance and quality — and this, in turn, will lead to improved clinical decision support, core data sets and health statistics that meet the primary goal of enhancing health care delivery, treatment and outcomes. PRINCIPLES General Policy
Privacy. A physician’s ethical and legal responsibility as data steward of the patient’s medical information must be protected and enhanced.1
Choice. There must be appropriate independence of choice that respects physicians’ professional and business autonomy. Physicians must be free to choose the EMR product that best meets the needs of their practice model, type and size.
Voluntary. Physician adoption of EMRs must be voluntary, not mandated or coerced.
Non-discriminatory. Programs designed to offset physicians’ costs or encourage them to adopt EMRs must be non-discriminatory (i.e., not tied to a single EMR product or health care practice model). While such restrictions may be attractive to some payors and administrators, they discriminate against physicians who do not meet their criteria and risk creating two “classes” of physicians and patients.
Outcome-related incentives. Incentives for EMR adoption should be tied to clinical benefits and outcomes, not driven by cost containment. Financial incentives or bonuses that are tied to clinical outcomes may encourage EMR utilization and optimize the use of these systems in ambulatory clinical practices. 1 For more detail on the physician’s ethical responsibilities as data steward of patient information please refer to the CMA Code of Ethics and Professionalism, Guiding Principles for the Optimal Use of Data Analytics by Physicians at the Point of Care, and Guiding Principles for Physicians Recommending Mobile Health Applications to Patients. Page 2 Financial
Unrestricted. Funding for EMRs in physician offices must be equally available to all physicians, and not restricted to a single EMR product or physician practice model.
Funding. Cost analyses have determined that the majority of the benefits from EMRs accrue to the health care system (i.e., payors and patients) and not to individual physicians. It is only reasonable that those who benefit most should assume the costs.
Comprehensive. The cost of implementing an EMR system goes beyond acquisition of hardware and software. Funding for physician adoption of EMRs must be comprehensive and include costs associated with the initial purchase, as well as implementation, change management, ongoing operation, and evergreening of the system.
Save harmless. Early adoptors who need to update or replace their existing systems, as well as physicians whose EMR vendor goes out of business, must not be disadvantaged. These physicians must not be penalized or excluded from funding programs, and should be provided with the necessary transition support. Business
Vendor sustainability. Vendor stability is critical to EMR adoption by physicians. This can be achieved through vendor compliance with technical and business requirements that address fiscal sustainability as well as EMR product quality, technical standards and capabilities.
Due diligence. Because physician practices vary in type, size and needs, there is no “one-size-fits-all” EMR solution. Physicians must assess the needs of their individual practice to determine the best product.
Workflow re-engineering. Implementation of EMRs in ambulatory clinical practice may require workflow adjustment or re-engineering. Assessments of workflow and practice needs must be part of EMR change management programs.
HR impact. Adoption of EMRs in ambulatory clinical practices will have an impact on human resources. Provision should be made for physician and office staff retraining, retention and turnover.
Support and service agreements. Physician use of EMRs in ambulatory clinical practice requires appropriate support and service agreements not only to provide the necessary infrastructure and connectivity, but also to guarantee ongoing, accessible and reliable technical support. Physicians must be able to access patient records in their EMR system at all times, regardless of where the records are physically stored (e.g., off-site with an alternate service provider, or onsite in a local client server).
Risk management strategies (liability and insurance) tied to EMR adoption must address the privacy, security, business continuity and professional liability requirements of physician practice in an electronic environment. Change management and transition
Critical to success. To fully realize the benefits from EMR adoption, the move from paper to electronic records requires change management support and services geared specifically to physician EMR adoption.
Ongoing. Change management is a key success factor in driving both uptake and optimal utilization of EMRs in ambulatory clinical practice. To realize the full benefits of EMR adoption on health care outcomes, physician change management programs must be ongoing, not one-time. Page 3
Comprehensive. Comprehensive change management for physicians who adopt EMRs must include the tools and services to assist with system needs assessment, EMR selection, implementation, workflow adjustment, and training for physicians and staff, as well as suggestions to maximize use of the EMR.
Physician driven and designed. Change management must meet the real and individual needs of physicians as they move to an EMR-based practice. This requires flexibility (not one-size-fits-all), “just in time” capacity and delivery, and a mechanism for evaluating the program.
Payor funded and delivered. Delivery and costs of these programs should be borne by payors as part of any physician EMR funding programs or agreements. Usability and human factors
User interface and usability. User interface and usability of EMR systems are critical success factors for physician acceptance and optimal utilization of EMRs in clinical practice.
Workflow. EMR adoption requires changes to physician workflow, such as history-taking and charting. Done properly, workflow changes related to EMRs should result in administrative efficiencies and improved clinical outcomes.
Core principles of practice must be respected. The EMR must allow the physician to practice comprehensive care, efficiently manage patients with multiple problems and respect the doctor-patient relationship where the patient’s values, wishes, advance directives and physical and social function are integral to medical care.
Training and education. Training in the use, benefits, shortcomings and opportunities of an EMR must become part of the medical education curricula in all stages of physician practice: undergraduate, postgraduate and continuing medical education.
Standardized data. Large data sets that record every observation are unworkable in practice. The EMR must allow the physician to record and access data in a standardized way.
Data quality. Data quality is critical to patient care. Physicians require access to accurate, clinically relevant data. Inaccurately recorded and unfiltered data does not benefit patient care. Clinical patient care
Management of patient records. EMR systems allow physicians to quickly access and manage patient data in an organized fashion (e.g., search, sort and retrieve data, spot trends, or flag charts). This leads to more efficient practices and enhances care delivery.
Referrals and patient summaries. The ability to transmit referral requests and reports electronically using an EMR greatly facilitates the consultation process. Core clinical data sets generated from the EMR can be used to share or hand off patient care among providers, facilitating both continuity of care and emergency access to relevant data.
Drugs and lab reports. Physician use of an EMR permits drug and lab data to be recorded and shared more accurately and efficiently. Benefits to patient care include automated prescription renewals, quick identification of patients affected by drug alerts, and collation of lab data to show trends.
Decision support. EMR adoption in ambulatory clinical practice makes clinical decision support (i.e., access to timely, appropriate, evidence-based information) possible at the point of care. This has the potential to enhance patient safety, care delivery and health outcomes. Page 4
Patient values and autonomy. Patient values and autonomy cannot become secondary to the "data management" requirements of the EMR. An EMR must provide the same (or better) standards of patient confidentiality as traditional paper-based records.
Accessibility. Patient data must always be collected and stored in an EMR with the primary goal of improving individual patient care. Data accessibility for clinical care is more important than compiling a large common data set. Health Research
Standardized data. Primary care is driven by symptoms, not diagnoses, and both must be recorded in the EMR in a standardized way.
Clinical coding. Primary care disorders are low-prevalence and will require a high degree of precision when data are coded.
Evidence-based care models. The episode-of-care data model demonstrates how symptoms and symptom clusters evolve over time. It is possible to derive the sensitivity and specificity of symptoms and symptom clusters to improve pre-test likelihood and avoid unproductive testing.
Core and aggregate data. Standardized data means that core data sets can be combined, and their aggregation allows identification and analysis of rarer conditions.
Documents
Less detail

Guiding principles for physicians recommending mobile health applications to patients

https://policybase.cma.ca/en/permalink/policy11521
Date
2015-05-30
Topics
Health information and e-health
Physician practice/ compensation/ forms
  1 document  
Policy Type
Policy document
Date
2015-05-30
Topics
Health information and e-health
Physician practice/ compensation/ forms
Text
GUIDING PRINCIPLES FOR PHYSICIANS RECOMMENDING MOBILE HEALTH APPLICATIONS TO PATIENTS This document is designed to provide basic information for physicians about how to assess a mobile health application for recommendation to a patient in the management of that patient's health, health care, and health care information. These guiding principles build on the Canadian Medical Association's (CMA) Physician Guidelines for Online Communication with Patients.1 Background * Mobile health applications, distinct from regulated medical devices, may be defined as an application on a mobile device that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The functions of these applications may include: o The ability to store and track information about an individual or group's health or the social determinants thereof; o Periodic educational information, reminders, or motivational guidance; o GPS location information to direct or alert patients; o Standardized checklists or questionnaires.2 * Mobile health applications can enhance health outcomes while mitigating health care costs because of their potential to improve a patient's access to information and care providers.3 * Mobile health applications are most commonly used on a smart phone and/or tablet. Some may also interface with medical devices. * The use of mobile health applications reflects an emerging trend towards personalized medicine and patient involvement in the management of their health information. By 2016, 142 million health apps will have been downloaded.4 According to some industry estimates, by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users worldwide will have downloaded at least one mobile health application.5 * While mobile health application downloads are increasing, there is little information about usage and adherence by patients. It is believed that many patients cease to use a mobile health application soon after downloading it. * Distributers of mobile health applications do not currently assess content provided by mobile health applications for accuracy, comprehensiveness, reliability, timeliness, or conformity to clinical practice guidelines.6 However, mobile applications may be subjected to certain standards to ensure critical technical requirements such as accessibility, reachability, adaptability, operational reliability, and universality. * Increasingly there are independent websites providing reviews of medical apps and checklists for health care professionals. However, the quality criteria used by these sites, potential conflicts of interest, and the scope and number of mobile apps assessed are not always declared by these groups. To date, randomized controlled trials are not usually employed to assess the effectiveness of mobile health applications. Some believe that the rigorousness of this type of assessment may impede the timeliness of a mobile health application's availability.7 * Some examples of the uses of mobile health applications include tracking fitness activities to supplement a healthy lifestyle; supported self-management of health and health information; post-procedure follow up; viewing of test results; and the virtualization of interaction between patients and providers, such as remote patient monitoring for chronic disease management. Some mobile health applications may be linked to a patient profile or patient portal associated with a professional or recognized association or medical society or health care organization. * Some mobile health applications may be an extension of an electronic medical records (EMR) platform. Guiding principles * The objective of recommending a mobile health application to a patient must be to enhance the safety and/or effectiveness of patient care or otherwise for the purpose of health promotion. * A mobile health application is one approach in health service delivery. Mobile health applications should complement, rather than replace, the relationship between a physician and patient. * No one mobile health application is appropriate for every patient. Physicians may wish to understand a patient's abilities, comfort level, access to technology, and the context of the application of care before recommending a mobile health application. * Should a physician recommend a mobile health application to a patient, it is the responsibility of the physician to do so in a way that adheres to legislation and regulation (if existing) and/or professional obligations. * If the mobile health application will be used to monitor the patient's condition in an ongoing manner, the physician may wish to discuss with the patient what they should watch for and the steps they should take in response to information provided. * Physicians are encouraged to share information about applications they have found effective with colleagues. * Physicians who require additional information about the competencies associated with eHealth and the use of health information technologies may wish to consult The Royal College of Physicians and Surgeons of Canada's (RCPSC) framework of medical competencies, CanMEDS.8 * Physicians may wish to enter into and document a consent discussion with their patient, which can include the electronic management of health information or information printed out from electronic management platforms like mobile health applications. This agreement may include a one-time conveyance of information and recommendations to cover the elements common to many mobile health applications, such as the general risk to privacy associated with storing health information on a mobile device. Characteristics of a safe and effective mobile health application A mobile health application does not need to have all of the following characteristics to be safe and effective. However, the more of the following characteristics a mobile health application has, the likelier it will be appropriate for recommendation to a patient: 1. Endorsement by a professional or recognized association or medical society or health care organization As recommended by the Canadian Medical Protective Association (CMPA), it is best to select mobile health applications that have been created or endorsed by a professional or recognized association or medical society.9 Some health care organizations, such as hospitals, may also develop or endorse applications for use in their clinical environments. There may also be mobile health applications associated with an EMR platform used by an organization or practice. Finally, some mobile health applications may have been subject to a peer review process distinct from endorsement by an association or organization. 2. Usability There are a number of usability factors than can complicate the use of mobile applications, including interface and design deficiencies, technological restrictions, and device and infrastructure malfunction. Many developers will release periodic updates and software patches to enhance the stability and usability of their applications. Therefore, it would be prudent for the physician recommending the mobile health application to also recommend to the patient that they determine if the application has been updated within the last year. Physicians considering recommending a mobile health application to a patient may wish to ask about the patient's level of comfort with mobile health technologies, their degree of computer literacy, whether or not the patient owns a mobile device capable of running the application, and whether or not the patient is able to bear potential one-time or ongoing costs associated with use of the application. Physicians may consider testing the application themselves beforehand to understand whether its functionality and interface make it easy to use. 3. Reliability of information Physicians considering recommending a mobile health application may wish to understand how the patient intends to use the information, and/or review the information with the patient to understand whether it is current and appropriate. Information presented by the mobile health application should be appropriately referenced and time-stamped with the last update by the application developer. 4. Privacy and security There are inherent security risks when a patient uses mobile health applications or enters sensitive information into their mobile device. Mobile devices can be stolen, and the terms of use for mobile health applications may include provisions for the sharing of information with the application developer and other third-parties, identified or un-identified, for commercial purposes. In 2014, the Officer of the Information and Privacy Commissioner of Alberta assessed approximately 1200 mobile applications and found nearly one-third of them required access to personal information beyond what should be required relative to their functionality and purpose, and that basic privacy information was not always made available.10 Physicians entering into and documenting a consent discussion with their patients may wish to include the electronic management of health information in the scope of these discussions, and make a notation of the discussion in the patient's health record. If physicians have not entered into and documented a general consent discussion, they may wish to indicate to the patient that there are security risks associated with mobile health applications, and recommend that the patient avail themselves of existing security features on their device. Physicians may wish to recommend to the patient that they determine whether a privacy policy has been made available which discloses how data is collected by the application and used by the developer, or a privacy impact assessment, which demonstrates the risks associated with the use of the application. Some mobile health applications may feature additional levels of authentication for use, such as an additional password or encryption protocols. If all other factors between applications are equal, physicians may wish to recommend that patients use mobile health applications adhering to this higher standard of security. 5. Avoids conflict-of-interest Physicians may wish to recommend that patients learn more about the company or organization responsible for the development of the application and their mandate. There is a risk of secondary gains by mobile health application developers and providers where information about patients and/or usage is gathered and sold to third parties. A standardized conflict of interest statement may be made available through the mobile health application or on the developer's website. If so, physicians may wish to refer the patient to this resource. Physicians who develop mobile applications for commercial gain or have a stake in those who develop applications for commercial gain may risk a complaint being made to the College on the basis that the physician engaged in unprofessional conduct if they recommend mobile health applications to their patients in the course of patient care. 6. Does not contribute to fragmentation of health information Some mobile health applications may link directly to an EMR, patient portal, or government data repository. These data resources may be standardized, linked, and cross-referenced. However, health information entered into an application may also be stored on a mobile device and/or the patient's home computer, or developers of mobile health applications may store information collected by their application separately. While there may be short-term benefits to using a particular mobile health application, the range of applications and developers may contribute to the overall fragmentation of health information. If all other factors between applications are considered equal, physicians may wish to recommend mobile health applications which contribute to robust existing data repositories, especially an existing EMR. 7. Demonstrates its impact on patient health outcomes While not all mobile health applications will have an appropriate scale of use and not all developers will have the capacity to collect and analyze data, physicians may wish to recommend mobile health applications that have undergone validation testing to demonstrate impact of use on patient health outcomes. If mobile health applications are claiming a direct therapeutic impact on patient populations, physicians may wish to recommend that their patients seek out or request resources to validate this claim. References 1 Canadian Medical Association. Physician guidelines for online communication with patients. Ottawa: The Association; 2005. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD05-03.pdf?_ga=1.32127742.1313872127.1393248073 2 US Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Mobile medical applications: guidance for industry and Food and Drug Administration staff. Rockville (MD): The Administration; 2015. Available: www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 3 Canada Health Infoway. Mobile health computing between clinicians and patients. White paper. Toronto: The Infoway; 2014 Apr. Available: www.infoway-inforoute.ca/index.php/resources/video-gallery/doc_download/2081-mobile-health-computing-between-clinicians-and-patients-white-paper-full-report 4 iHealthBeat. 44M mobile health apps will be downloaded in 2012, report predicts. Available: www.ihealthbeat.org/articles/2011/12/1/44m-mobile-health-apps-will-be-downloaded-in-2012-report-predicts 5 Jahns R-G. 500m people will be using healthcare mobile applications in 2015. Research2guidance. Available: www.research2guidance.com/500m-people-will -be-using-healthcare-mobile-applications-in-2015/ 6 Lyver, M. Standards: a call to action. Future Practice. 2013 Nov. Available: www.cma.ca/Assets/assets-library/document/en/about-us/FP-November2013-e.pdf 7 Rich P. Medical apps: current status. Future Practice 2013 Nov. Available: www.cma.ca/Assets/assets-library/document/en/about-us/FP-November2013-e.pdf 8 Royal College of Physicians and Surgeons of Canada. The CanMEDS 2015 eHealth Expert Working Group report. Ottawa: The College; 2014. Available: www.royalcollege.ca/portal/page/portal/rc/common/documents/canmeds/framework/ehealth_ewg_report_e.pdf 9 Canadian Medical Protective Association. Managing information to delivery safer care. Ottawa: The Association; 2013. Available: https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/managing-information-to-deliver-safer-care 10 Office of the Information and Privacy Commissioner of Alberta. Global privacy sweep rasies concerns about mobile apps [news release]. Available: www.oipc.ab.ca/downloads/documentloader.ashx?id=3482
Documents
Less detail

19 records – page 1 of 2.