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Principles for the protection of patient privacy

https://policybase.cma.ca/en/permalink/policy13833

Date
2017-12-09
Topics
Health information and e-health
Ethics and medical professionalism
  2 documents  
Policy Type
Policy document
Date
2017-12-09
Replaces
PD11-03 Principles for the Protection of Patients' Personal Health Information
Topics
Health information and e-health
Ethics and medical professionalism
Text
Patients have a right to privacy and physicians have a duty of confidentiality arising from the patient-physician relationship to protect patient privacy. The right to privacy flows from the principle of respect for patient autonomy, based on the individual's right to conduct and control their lives as they choose.1 When approaching any ethical question around privacy, the principle of respect for patient autonomy must be balanced against other competing principles (e.g. beneficence, non-maleficence). The protection of privacy and the concomitant duty of confidentiality are essential to foster trust in the patient-physician-relationship, the delivery of good patient care and a positive patient care experience. Privacy protection is an important issue for Canadians,2 and research suggests that patients may withhold critical health information from their health care providers because of privacy concerns.3 Patients will be more willing to share complete and accurate information if they have a relationship of trust with their physician and are confident that their information will be protected.4 In today's ever-evolving technological environment and due to the shift away from the traditional (paternalistic) physician-patient relationship, patients, physicians and other public and private stakeholders are using and sharing personal health information in new and innovative ways. This raises new challenges for clinical practice and, crucially, how to navigate expanded uses of data via the use of new technologies and the requirements of patient privacy. Institutions, clinics, and physician-group practices may share responsibility with the physician for the protection of patient information. There is thus a tension between physician and institutional responsibilities to protect patient information, challenged by the rapidly changing use and adoption of new technologies. While this will continue to redefine expectations of privacy and confidentiality, there are several foundational principles that remain unchanged. SCOPE OF POLICY The Canadian Medical Association (CMA) Principles for the Protection of Patients' Personal Health Information aim to provide guidance on key ethical considerations pertinent to the protection of patient information in a way that takes into account a physician's (including medical learner) ethical, professional, and legal obligations. The Principles are not designed to serve as a tool for legislative compliance in a particular jurisdiction or to provide a standard of care. Physicians should be aware of privacy legislation in the jurisdiction in which they practice, the standards and expectations specified by their respective regulatory authorities (including Privacy Commissioners), publications and risk management education provided by the CMPA as well as policies and procedures of any given setting (e.g., a regional health authority or a hospital). SUBSTANTIVE PRINCIPLES THAT GUIDE THE OBLIGATIONS OF THE PHYSICIAN TO PROTECT PATIENT PRIVACY 1. Trust * Trust is the cornerstone of the patient-physician relationship and plays a central role in providing the highest standard of care. * Physicians and their patients build relationships of trust that enable open and honest dialogue and foster patients' willingness to share deeply personal information (often) in conditions of vulnerability. * Physicians can cultivate and maintain patient trust by, unless the consent of the patient has been obtained to do otherwise, collecting health information only to benefit the patient, by sharing information only for that purpose, and by keeping patient information confidential; patient trust has been found to be the most powerful determinant of the level of control patients want over their medical records.5 * To maintain trust, physicians must consider the duty to care and the duty not to harm the patient in evaluating privacy requirements. * The extent to which a patient expects (and may tolerate a loss of) privacy and confidentiality is culturally and individually relative.6 2. Confidentiality * Physicians owe a duty of confidentiality to their patients; there is both an ethical (respect for autonomy) and a legal basis imposed by privacy legislation) for this duty. * The duty to maintain patient confidentiality, like trust, is fundamental to the therapeutic nature of the patient-physician relationship; it creates conditions that allow patients to openly and confidently share complete health information, resulting in a stronger physician-patient relationship and better delivery of care.7 * The duty to maintain patient confidentiality means that physicians do not share the health information with anyone outside of the patient's circle of care, unless authorized to do so by the patient.1,8 There are varying interpretations of what constitutes the patient's circle of care; this depends on the facts of the situation and the jurisdiction.9 * Privacy requirements raise complex issues in learning environments and quality improvement initiatives. It is desirable that any of the patient's physicians who will have ongoing care interactions with the patient can remain included in information-sharing about the patient. * Shared electronic health records present challenges to confidentiality. For example, patients may wish to limit some aspects of their record to only some providers within their circle of care.10 * In practice, respecting privacy and the duty of confidentiality govern the physician's role as data steward, responsible for controlling the extent to which information about the person is protected, used or disclosed.11 A central rule to balancing a patient's right to privacy and the duty of confidentiality is the "minimum necessary" use and disclosure of personal health information, whereby a data steward should use or disclose only the minimum amount of information necessary to fulfil the intended purpose. In some circumstances, de-identifying or aggregating personal health information before use or disclosure can minimize the amount of information disclosed.12 * The duty to maintain patient confidentiality is not absolute and is subject to exceptions in limited circumstances,13 i.e., when required or permitted by law to disclose information (see below in Data Stewardship: Collection, use and disclosure of personal health information). 3. Consent * Patient consent is an important mechanism for respecting patient autonomy; obtaining voluntary and informed consent to share patient information is fundamental to the protection of privacy and the duty of confidentiality. * Physicians are generally required to obtain informed consent from the patient before they can disclose the patient's personal health information. Consent is only informed if there is disclosure of matters that a reasonable person in the same circumstances would want to know, including 1) to whom the patient information will be disclosed, 2) whether it could be disclosed to other third parties, and 3) the purpose for which it could be used or disclosed. * While informed consent is required as a general rule, physicians may infer that they have the patient's implied consent to collect, use, disclose and access personal health information 1) for the purpose of providing or assisting in providing care (i.e., share only the necessary information with those involved within the patient's circle of care); and 2) to store personal health information in a medical record (i.e., paper, electronic, or hospital-based). Physicians will want to consider if it is appropriate in the circumstances to advise the patient when a disclosure has been made. * When the patient is a minor, the physician must consider whether it is the parent or the child who determines the use and disclosure of the minor's personal health information. A young person who is deemed to understand fully the implications of a decision regarding proposed collection, use or disclosure of personal health information is generally deemed to have control over their personal health information with respect to the decision. * Where the patient is not capable to provide the required consent (e.g. is deemed to be incompetent), physicians must seek consent from the patient's substitute decision-maker. 4. Physician as data steward * As data stewards, physicians have the responsibility to understand their role in protecting patient privacy and appropriate access to patient information. * The information contained in the medical record belongs to the patient who has a general right of access to their personal health information, and the right to control the use and further disclosure and to the continued confidentiality of that information. * A data steward (e.g., physician, institution or clinic) holds the physical medical record in trust for the care and benefit of the patient.14 * Physicians should provide their patients access to their medical record, if requested.15 (See below in Data Stewardship: Access to personal information). * Physicians ought to have appropriate access to personal health information and have the ability to provide their patients with access to their medical record. Appropriate access should be interpreted to include access for patient follow up (as part of the duty to care) and review for the purpose of improving patient care. * Physicians should consider consulting available resources to assist them in fulfilling their duties as data stewards. PROCEDURAL PRINCIPLES THAT GUIDE THE APPLICATION OF PHYSICIAN OBLIGATIONS Physicians must manage personal health information in compliance with relevant legislation that establishes rules governing the access, collection, use, disclosure, and retention of personal health information, provincial privacy laws, and professional expectations and regulations specified by their respective regulatory authorities. 1. Data Stewardship: Access to personal information * Patients have a right of reasonable access to the personal health information in their medical record (i.e., paper, electronic, or hospital-based) under the control or in the custody of a physician, institution, or clinic. * In exceptional situations, physicians can refuse to release the information in the patient's medical record. 2. Data Stewardship: Collection, use and disclosure of personal health information * There are circumstances where there are required (e.g., monitoring of claims for payment, subpoenas) and permitted disclosures of personal health information without patient consent (e.g., where the maintenance of confidentiality would result in a significant risk of substantial harm to the patient or to others). * Security safeguards must be in place to protect personal health information in order to ensure that only authorized collection, use, disclosure or access occurs. * Physicians play an important role in educating patients about possible consensual and non-consensual uses and disclosures that may be made with their personal health information, including secondary uses of data for, e.g., epidemiological studies, research, education, and quality assurance, that may or may not be used with explicit consent. 3. Data Stewardship: Retention of personal health information * Personal health information should be retained for the period required by any applicable legislation and as specified by their respective regulatory authorities. It may be necessary to maintain personal health information beyond the applicable period where there is a pending or anticipated legal proceeding related to the care provided to the patient. * Likewise, physicians should transfer and dispose of personal health information in compliance with any applicable legislation and professional expectations outlined by their respective regulatory authorities. * Physicians are encouraged to seek technical assistance and advice on the secure transfer, disposal, and/or selling of electronic records.15 4. Data Stewardship: Use of technology * Physicians should obtain patient consent to use electronic means and/or devices for patient care (e.g., sending digital photographs) and for communicating patient information (e.g., the use of email). To obtain informed consent, physicians should explain to patients that there are necessary benefits and risks in using technologies in clinical contexts. The CMPA has provided a written consent form to that effect that can be included in the patient's medical record. * As a general practice, physicians are encouraged to make use of technological innovations and must evaluate whether the technology is appropriate for patient care and has reasonable safeguards to protect patient privacy. Approved by the CMA Board of Directors December 2017 See also Background to CMA Policy Principles for the Protection of Patient Privacy REFERENCES 1 Martin JF. Privacy and confidentiality. In: ten Have H, Gordijn B (Eds). Handbook of global bioethics. New York: Springer, Dordrecht; 2014. p.119-37. 2 Office of the Privacy Commissioner of Canada. Canadians and privacy final report. Gatineau: Office of the Privacy Commissioner of Canada; 2009. Available: https://www.priv.gc.ca/information/por-rop/2009/ekos_2009_01_e.asp (accessed 2017 Nov 17). 3 Canadian Medical Protective Association (CMPA). Privacy and a wired world - Protecting patient health information. Ottawa: CMPA; 2011 Dec. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2011/privacy-and-a-wired-world-protecting-patient-health-information (accessed 2017 Nov 17). 4 Royal College of Physicians and Surgeons of Canada (RCPSC). Duty of confidentiality. Ottawa: RCPSC; 2017. Available: http://www.royalcollege.ca/rcsite/bioethics/cases/section-3/duty-confidentiality-e (accessed 2017 Dec 15). 5 Damschroder LJ, Pritts JL, Neblo MA, Kalarickal RJ, Creswell JW, Hayward RA. Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Soc Sci Med 2007;64:223-35. 6 Campbell JI, Eyal N, Musiimenta A, Haberer JE. Ethical questions in medical electronic adherence monitoring. J Gen Intern Med 2016;31:338-42. Available: https://link.springer.com/content/pdf/10.1007%2Fs11606-015-3502-4.pdf (accessed 2017 Nov 17). 7 Crook MA. The risks of absolute medical confidentiality. Sci Eng Ethics 2013;19:107-22. 8 Cohen I, Hoffman A, Sage W (Eds). The Oxford Handbook of U.S. Health Law. New York: Oxford University Press; 2015. 9 Canadian Medical Protective Association (CMPA). The voice of professionalism within the system of care. Ottawa: CMPA; 2012 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2012/the-voice-of-professionalism-within-the-system-of-care (accessed 2017 Nov 17). 10 Canadian Medical Protective Association (CMPA). Did you know? Patients can restrict access to their health information. Ottawa: CMPA; 2017 Nov. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2017/did-you-know-patients-can-restrict-access-to-their-health-information (accessed 2017 Nov 17). 11 Francis JG, Francis LP. Privacy, confidentiality, and justice. J Soc Philos 2014;45:408-31. 12 Burkle CM, Cascino GD. Medicine and the media: balancing the public's right to know with the privacy of the patient. Mayo Clin Proc 2011;86:1192-6. 13 Canadian Medical Protective Association (CMPA). When to disclose confidential information. Ottawa: CMPA; 2015 Mar. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2015/when-to-disclose-confidential-information (accessed 2017 Nov 17). 14 Canadian Medical Protective Association (CMPA). Releasing a patient's personal health information: What are the obligations of the physician? Ottawa: CMPA; 2012 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2012/releasing-a-patient-s-personal-health-information-what-are-the-obligations-of-the-physician (accessed 2017 Nov 17). 15 Canadian Medical Protective Association (CMPA). Protecting patient health information in electronic records. Ottawa: CMPA; 2013 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2013/protecting-patient-health-information-in-electronic-records (accessed 2017 Nov 17). (c) 2017 Canadian Medical Association. You may, for your non-commercial use, reproduce, in whole or in part and in any form or manner, unlimited copies of CMA Policy Statements provided that credit is given to Canadian Medical Association. BACKGROUND TO CMA POLICY PRINCIPLES FOR THE PROTECTION OF PATIENT PRIVACY See also CMA Policy on Principles for the Protection of Patient Privacy Context The advent of Electronic Medical Records, the rapid spread of mobile health apps, and the increasing use of social media within the health care community, have each created new challenges to maintaining a duty of confidentiality within the physician-patient relationship. These technologies present both opportunities and challenges with respect to medical professionalism.1 The permeation of these types of interactions into everyday life now places physicians in new situations that some find difficult to navigate.2 These challenges will only increase in the coming years, as the use of online technologies in health care is continuously growing.3 Canada is only in the early stages of managing the emerging issues of technology-induced errors that compromise privacy in the health care setting.4 Therefore, this paper will briefly discuss the importance of protecting privacy, followed by an overview of the main challenges to maintaining privacy as the physician-patient relationship evolves at the backdrop of emerging technologies. Privacy and Confidentiality The overlapping, but not identical, principles of the protection of privacy and the duty of confidentiality are essential to the physician-patient relationship. These principles not only foster trust, but also the delivery of effective and lasting care. Rooted in the Hippocratic Oath, the modern-day right to privacy flows from the principle of autonomy, which attributes to individuals the right to conduct and control their lives as they choose.5 Privacy protection is an important issue to Canadians,6 with research suggesting that patients may even withhold critical health information because of privacy concerns.7 Health care professionals are bound by legal and ethical standards to maintain privacy and confidentiality of patient information.8 Physicians must therefore be aware of the implications of privacy legislation specific to their jurisdiction.7 The duty to protect patient privacy is important to uphold, as health information can potentially be identifiable and sensitive; the confidentiality of this information must therefore be protected to ensure that patient privacy is not breached. 9 While the traditional, and largely obsolete, models of the physician-patient relationship involve a unidirectional flow of information, the ease at which patients can now access medical information through the Internet, and the use of social media within the health care community, have reinterpreted how information is communicated from physician to patient, and vice versa.10 We must therefore re-define expectations of privacy and confidentiality, first by distinguishing one from the other. The terms "privacy" and "confidentiality" are often used interchangeably by both researchers and clinicians. Several bioethics discussions on the distinction between these terms places confidentiality under the umbrella of privacy.11 While confidentiality involves the information itself, which is disclosed or not, privacy is about the impact of that disclosure on the person.9 Privacy seems to be more intimately linked to the individual, focusing on the circumstances under which the information is used.12-13 Confidentiality, on the other hand, is a duty that health professionals have towards their patients to not share the information exchanged during their encounter, unless authorized by the patient.5,12 In practice, the duty of confidentiality governs the physician's role as data stewards, responsible for controlling the extent to which information about the person is protected, used or disclosed.14 As one paper describes, "privacy is invaded, confidentiality is breached."13 From a patient perspective, it is important to respect and protect privacy because it allows individuals time and space to share their concerns without feeling judged or misunderstood,11 resulting in a stronger physician-patient relationship and better delivery of care. However, from a research perspective, a fine balance must be struck between using accurate information while still upholding the privacy rights of individuals.11 As such, the argument for absolute confidentiality puts a near impossible burden on research clinicians.11 Moreover, from a public safety perspective, a physician may be morally and legally required to break confidentiality in order to protect both the patient and others who may be involved. The challenge is to balance the traditional goal of confidentiality - to protect patient privacy and interest - with that of third parties and public health.5 Therefore, a central rule to balancing confidentiality with a patients' right to privacy is the "minimum necessary" use and disclosure of personal health information, whereby a data steward should use or disclose only the minimum amount of information necessary to fulfil the intended purpose.8 It is equally important to recognize that the extent to which a patient may tolerate a loss of privacy is culturally and individually relative.15 Health care providers have a legal and ethical obligation to keep patient health information private, sharing it only with the authorization of the patient.16 Informed consent, therefore, appears to be a fundamental requirement to upholding confidentiality and patient privacy rights. Issues While emerging privacy issues touch many areas of practice, this section will emphasize three of the most prominent issues in recent literature: access and use of information, electronic medical and health records and, online communication and social media. 1. Technological change and institutional data stewardship In today's ever-evolving technological environment, including the emergence of shared electronic health records, online communication, social media, mobile applications, and big data, physicians, patients and other public and private stakeholders are using and sharing personal health information in new and innovative ways. The traditional (paternalistic) model of the physician-patient relationship involved a bidirectional flow of information. However, the ease at which patients can now access medical information from alternative sources via the Internet, and the use of social media within the health care community, has redefined how information is communicated from physician to patient, and vice versa.10 This raises new challenges for clinical practice, specifically how to navigate expanded access of data via the use of new technologies and the requirements of patient privacy by effectively managing security concerns. In many situations, the physician may not be the sole or primary custodian of (i.e., control access to) the patient's records once the health information is collected. Institutions, clinics, and physician-group practices may also have responsibility for patient information and therefore play an important role in ensuring it is protected. There is thus a grey area between physician and institutional responsibilities to protect patient information, challenged by the rapidly changing use and adoption of new technologies, such as electronic health and medical records. While this will continue to redefine expectations of privacy and confidentiality, there are several foundational principles that remain unchanged. 2. Electronic medical and health records Medical records are compiled primarily to assist physicians and other health care providers in treating patients.16 Yet, they are particularly vulnerable to privacy breaches when this information is exposed to secondary uses, including epidemiological studies, research, education and quality assurance. As contemporary information management and stewardship have had to evolve in response to emerging technology, the parameters of the "medical record" have grown increasingly ambiguous.17 With the proliferation of a wide variety of new health information technology (including electronic health and medical records), concerns about quality and safety have been raised.4 There is evidence that if such technology is not designed, implemented and maintained effectively, it may result in unintended consequences, including technology-induced errors and breaches of patient privacy.4 Reports involving Canada Health Infoway have even pointed to health information technology as a tool that may sometimes reduce rather than enhance patient safety, most often due to human factors. 4 As a result, recommendations have been made to develop a reporting system that would allow health professionals to anonymously report human errors resulting from the use of health information technology - a challenge in itself, as the distinction between human and technological error is often blurred.4 In Canada, a number of efforts have been undertaken by several organizations, including Health Canada and Canada's Health Informatics Organization.4 Yet, services aimed at improving health information technology safety, from a national level, remain poor.4 As a result, organizations like Canada Health Infoway have promoted the need for collaborative efforts to improve health information technology safety standards in Canada, 4 so to ensure that the current and future uses of "medical record" data are accurate and respectful of patient privacy. 3. Access and use of personal health information for research The courts have long established that health information belongs to the patient.18 As a result, privacy ownership refers to the belief that patients own their private information as well as the right to control access to this information.19 As in other jurisdictions, the overarching challenge in Canada is to strike a balance between enabling access to health and health-related data for research while still respecting Canadians' right to privacy and control over the confidentiality of their information.20 The integrity of healthcare information is fundamental, given that it is the basis on which treatment decisions are made both in research and in clinic. 9 There are three principles upon which information security is based: 9 1) only authorized people have access to confidential information; 2) information must be accurate and consistent, may only be modified by authorized people in ways that are appropriate; 3) information must be accessible by authorized users when needed. Canadian research ethics have demonstrated that beneficial work can be done while maintaining confidentiality to sensitive personal health information.21 Yet, the challenge remains to create a uniform system for accessing data and performing data-based research due to 1) the lack of consistency and clarity in Canada's ethical and legal framework and, 2) varied interpretations of key terms and issues across the country.21 For example, the term "non-identifiable data" remains ambiguous across provinces and is subject to interpretation by data custodians, who may consider their legal duty to protect privacy as precluding access to data.21 This lack of legal clarity has contributed to varied cautious and conservative interpretations of data access legislation.21 National uniform guidelines on the appropriate access, disclosure and use of personal health data would allow data stewards to advance their research while respecting their patients' right to privacy. 4. Online communication with patients and social media Social media and online communication is pervasive in Canadian society; from Facebook to Twitter, social media has changed the way people interact and disseminate information.21 There is currently widespread discussion among health care professionals and academics regarding the role that social media and online communication should play in the physician-patient relationship.22 A growing number of physicians have embraced the opportunities of interconnectivity that social media affords, implementing their own privacy procedures to reflect this new type of data collection, use and storage.7 While evidence has been lacking on whether the use of social media does improve patient outcomes,22 there is no denying that patients are seeking health care information from online platforms, including social media.22 This type of communication poses a unique set of opportunities and challenges for physicians: while the use of social media could increase physician reach and patient engagement, it can also blur boundaries between one's personal and professional life.22 Although patient-physician online communication is currently limited, physicians still feel that they are encountering an ethical dilemma, especially when they find themselves in boundary crossing situations, like a friend request from a patient.2 Physicians are particularly concerned that, through online communication, they may be exposed to medico-legal and disciplinary issues, especially with respect to patient privacy.2 Given different studies have suggested that unprofessional uses of social media are not uncommon,23 physicians who choose to communicate with patients online or through social media must remember that they are still governed by the same ethical and professional standards that remain paramount.22 As technology continues to evolve, so too will the traditional parameters of the patient-physician relationship. The physician's ethical and professional obligation to protect patient privacy, however, must remain paramount at the backdrop of technology use. Simply banning social media and online communication would neither eliminate risk, nor benefit patient care outcomes. 24 Instead, institutions should establish stringent policies that outline how to prevent or minimize the effects of privacy breaches associated with social media and online communication.25 This should also include a tracking mechanism to help balance the obligation to privacy with evolving technology.25 December 2017 See also CMA Policy on Principles for the Protection of Patient Privacy REFERENCES 1 Farnan JM, Snyder Sulmasy L, Worster BK, Chaudhry HJ, Rhyne JA, Arora VM. Online medical professionalism: patient and public relationships: policy statement from the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med 2013;158(8):620-627. 2 Brown J, Ryan C. How doctors view and use social media: a national survey. J Med Internet Res 2014;16:e267. Available: https://doi.org/10.2196/jmir.3589 (accessed 2017 Nov 17). 3 Lambert KM, Barry P, Stokes G. Risk management and legal issues with the use of social media in the healthcare setting. J Healthc Risk Manag 2012;31(4):41-47. 4 Kushniruk AW, Bates DW, Bainbridge M, Househ MS, Borycki EM. National efforts to improve health information system safety in Canada, the United States of America and England. Int J Med Inform 2013;82(5):e149-160. 5 Martin JF. Privacy and confidentiality. In: ten Have H, Gordijn B (Eds). Handbook of global bioethics. New York: Springer, Dordrecht; 2014. p.120-1. 6 Office of the Privacy Commissioner of Canada. Canadians and privacy final report. Gatineau: Office of the Privacy Commissioner of Canada; 2009. Available: https://www.priv.gc.ca/information/por-rop/2009/ekos_2009_01_e.asp (accessed 2017 Nov 17). 7 Canadian Medical Protective Association (CMPA). Privacy and a wired world - Protecting patient health information. Ottawa: CMPA; 2011 Dec. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2011/privacy-and-a-wired-world-protecting-patient-health-information (accessed 2017 Nov 17). 8 Burkle CM, Cascino GD. Medicine and the media: balancing the public's right to know with the privacy of the patient. Mayo Clin Proc 2011;86:1192-6. 9 Williams PA. Information security governance: a risk assessment approach to health information systems protection. Stud Health Techol Inform 2013;193:186-206. 10 Borza LR, Gavrilovici C, Stockman R. Ethical models of physician-patient relationship revisited with regard to patient autonomy, values and patient education. Rev Med Chir Soc Med Nat Iasi 2015;119(2):496-501. 11 Crook MA. The risks of absolute medical confidentiality. Sci Eng Ethics 2013;19(1):107-122. 12 Cohen I, Hoffman A, Sage W (Eds). The Oxford handbook of U.S. health law. New York: Oxford University Press; 2015. 13 Francis L. Privacy and confidentiality: the importance of context. The Monist; 91(1);2008:52-67. 14 Francis JG, Francis LP. Privacy, confidentiality, and justice. J Soc Philos 2014;45:408-31. 15 Campbell JI, Eyal N, Musiimenta A, Haberer JE. Ethical questions in medical electronic adherence monitoring. J Gen Intern Med 2016;31:338-42. Available: https://link.springer.com/content/pdf/10.1007%2Fs11606-015-3502-4.pdf (accessed 2017 Nov 17). 16 Canadian Medical Association (CMA). Medical record confidentiality, access and disclosure. Ottawa: CMA; 2000. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_The_medical_record_confidentiality_access_and_disclosure_Update_2000_PD00-06-e.pdf (accessed 2017 Oct 30). 17 Fenton SH, Manion F, Hsieh K, Harris M. Informed Consent: Does anyone really understand what is contained in the medical record? Appl Clin Inform 2015;6(3):466-477. 18 Canada. Supreme Court. McInerney v MacDonald. Dom Law Rep. 1992 Jun 11;93:415-31. 19 Petronio S, Dicorcia MJ, Duggan A. Navigating ethics of physician-patient confidentiality: a communication privacy management analysis. Perm J 2012;16(4):41-45. 20 Council of Canadian Academies (CCA). Accessing health and health-related data in Canada. Ottawa: The Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation, Council of Canadian Academies; 2015. Available: http://www.scienceadvice.ca/uploads/eng/assessments%20and%20publications%20and%20news%20releases/Health-data/HealthDataFullReportEn.pdf (accessed 2017 Nov 17). 21 Canadian Medical Association (CMA). Social media and Canadian physician: Issues and rules of engagement. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Policy_Social_Media_Canadian_Physicians_Rules_Engagement_PD12-03-e.pdf (accessed 2017 Oct 30). 22 Eysenbach G. Medicine 2.0: Social networking, collaboration, participation, apomediation, and openness J Med Internet Res 2008;10(3):e22. 23 Mayer MA, Leis A, Mayer A, Rodriguez-Gonzalez A. How medical doctors and students should use social media: A review of the main guidelines for proposing practical recommendations. Stud Health Technol Info 2012;180:853-857. 24 Moses RE, McNeese LG, Feld LD, Feld AD. Social media in the health-care setting: Benefits but also a minefield of compliance and other legal issues. Am J Gastroenterol 2014;109(8):1128-1132. 25 Yang YT, Silverman RD. Mobile health applications: The patchwork of legal and liability issues suggests strategies to improve oversight. Health Aff (Millwood) 2014;33(2):222-227.

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Excise duty framework for cannabis products

https://policybase.cma.ca/en/permalink/policy13799

Date
2017-12-07
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-12-07
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to the Government of Canada's consultation on the Proposed Excise Duty Framework for Cannabis Products published November 10.1 In the move towards the legalization and regulation of cannabis, there are many economic interests at play; private corporations and different levels of government stand to benefit greatly with sales and considerable tax revenue.2 It is essential that the federal and provincial/territorial governments be held accountable to the public health and safety objectives set out for the new regime for legal access to cannabis, particularly that of protecting children and youth.3 It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls. Final pricing must be such as to discourage the illegal production and trafficking of cannabis. However, a balance must be found with the use of taxation and pricing levers to discourage use. Revenues need to be clearly earmarked to cover the health and social costs of legalization. In some U.S. jurisdictions, for example, some of the revenue is directed to recovering the costs of regulatory programs as well as in substance use treatment programs, and for social programs. Most of the future tax revenues should be redistributed to the provinces and territories. This is because they have jurisdiction over services that will likely feel the impact with legalization, such as health care, education, social and other services, as well as enforcement of legislation and regulations. A public health approach to legalization will emphasize prevention, education and treatment initiatives which require adequate and reliable funding. It will also require strong surveillance and monitoring activities to adjust measures should unintended harms be detected. Resources need to be promptly available to address potential negative impacts. CMA recommends that the revenue resulting from the taxation of cannabis production and sales be earmarked to address health and social harms of cannabis use and its commercialization, in line with a public health approach to the legalization of cannabis. The proposal states that "Any cannabis products sold under the proposed Cannabis Act for medical purposes will be subject to the duty rates and conditions of the excise duty framework, which will become applicable as per the transitional rules (...) Cannabis products that are produced by an individual (or a designated person) for the individual's own medical purposes in accordance with the proposed Cannabis Act will not be subject to the excise duty. Seeds and seedlings used in this production will be subject to duty."1 The CMA is supportive of similar taxation treatment of cannabis products, regardless of whether they are used for medical or non-medical purposes. The CMA has long called for more research to better understand potential therapeutic indications of cannabis, as well as its risks.4 5 Physicians recognize that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with cannabis used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency, interactions with medications and adverse effects. Health Canada does not approve of cannabis as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. It is important that there be support for cannabis research in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol(r)), nabilone (Cesamet(r)) and THC/CBD (Sativex(r)). The experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the different standards.6 A lower tax rate on cannabis for medical use could potentially provide an incentive for people to seek a medical authorization, and that was observed initially in Colorado.7 The CMA recommends that the same tax rates be applied to the production and sales of both the medical and the non-medical use of cannabis products. The move towards the legalization and regulation of cannabis will require a balanced approach to discourage the illegal production and trafficking of cannabis while also using taxation and pricing levers to discourage use. Much of the revenues raised should be redistributed to the provinces and territories to enable them to cover the health and social costs of legalization. A public health approach to legalization will emphasize prevention, education, treatment and surveillance initiatives which requires adequate and reliable funding. 1 Department of Finance Canada. Proposed excise duty framework for cannabis products. Ottawa: Department of Finance Canada; 2017. Available: http://www.fin.gc.ca/n17/data/17-114_1-eng.asp (accessed 2017 Dec 05). 2 Sen A, Wyonch R. Don't (over) tax that joint, my friend. Intelligence MEMOS. Ottawa: CD Howe Institute; 2017 Jul 19. Available: https://www.cdhowe.org/sites/default/files/blog_Anindya%20and%20Rosalie_0719.pdf (accessed 2017 Dec 06). 3 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed 2017 Dec 05). 4 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/cannabis.pdf (accessed 2017 Dec 05). 5 Canadian Medical Association (CMA). Medical Marijuana. CMA Policy. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD11-02-e.pdf (accessed 2017 Dec 05). 6 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2017 Dec 05). 7 Office of the Parliamentary Budget Officer. Legalized cannabis: Fiscal considerations. Ottawa: Office of the Parliamentary Budget Officer; 2016. Available: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2016/Legalized%20Cannabis/Legalized%20Canabis%20Fiscal%20Considerations_EN.pdf (accessed 2017 Dec 05).

Documents

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Opioid overdose prevention supplies available in publicly accessible locations

https://policybase.cma.ca/en/permalink/policy13703

Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Text
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
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Management of chronic pain in older adults

https://policybase.cma.ca/en/permalink/policy13705

Date
2017-08-23
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-07
The Canadian Medical Association supports increased approval and funding of pharmacologic options for the management of chronic pain in older adults.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-07
The Canadian Medical Association supports increased approval and funding of pharmacologic options for the management of chronic pain in older adults.
Text
The Canadian Medical Association supports increased approval and funding of pharmacologic options for the management of chronic pain in older adults.
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Antimicrobial stewardship and antimicrobial resistance surveillance

https://policybase.cma.ca/en/permalink/policy13710

Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-11
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-11
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
Text
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
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Physical activity history

https://policybase.cma.ca/en/permalink/policy13719

Date
2017-08-23
Topics
Health information and e-health
Population health/ health equity/ public health
Resolution
GC17-25
The Canadian Medical Association supports the inclusion of physical activity history within the vital sign section of electronic medical record systems.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health information and e-health
Population health/ health equity/ public health
Resolution
GC17-25
The Canadian Medical Association supports the inclusion of physical activity history within the vital sign section of electronic medical record systems.
Text
The Canadian Medical Association supports the inclusion of physical activity history within the vital sign section of electronic medical record systems.
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Innovative health system pilot projects in Canada

https://policybase.cma.ca/en/permalink/policy13721

Date
2017-08-23
Topics
Health systems, system funding and performance
Health information and e-health
Resolution
GC17-23
The Canadian Medical Association will support new projects and mechanisms to facilitate the expansion and increase the scale of innovative health system pilot projects in Canada.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health systems, system funding and performance
Health information and e-health
Resolution
GC17-23
The Canadian Medical Association will support new projects and mechanisms to facilitate the expansion and increase the scale of innovative health system pilot projects in Canada.
Text
The Canadian Medical Association will support new projects and mechanisms to facilitate the expansion and increase the scale of innovative health system pilot projects in Canada.
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Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13723

Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the House of Commons Standing Committee on Health on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. i The term cannabis is used, as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O’Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1–e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1–8. The CMA’s approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like “deep inhalation” to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation (“the Task Force”).7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%–30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis’ increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force’s recommendations,12 the bill addresses several aspects of a legal-regulatory framework “to provide legal access to cannabis and to control and regulate its production, distribution and sale.”13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657–64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1–4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303–310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496–506. 19 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): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383–91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O’Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975–2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785–7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada’s Federal Tobacco Control Strategy 2012–2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9. Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug’s physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a “ticketable” offence rather than a criminal one. iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians’ perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence — double the rate for any other drug — because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis’ general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. The Lower-Risk Cannabis Use Guidelines were developed as a “science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks.”6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada’s usual pharmaceutical regulatory approval process. The Task Force’s discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review — specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach’s short- and long-term impact on the reduction of harms.5 vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis’ production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years.

Documents

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CMA response to patented medicines regulations consultations

https://policybase.cma.ca/en/permalink/policy13690

Date
2017-06-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-06-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
To Whom It May Concern: The Canadian Medical Association (CMA) is pleased to provide its comments with respect to Health Canada’s Patented Medicines Regulations Consultations. The CMA is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. As the second-largest share of total health expenditures in Canada, forecast to be 16% in 2016, the cost of drugs is of significant concern to physicians.1 In 2014, 42.6% of prescribed drug spending ($12.5 billion) came from the public sector.2 Pharmaceuticals play an important role in overcoming disease and maintaining health but access to these drugs can be problematic outside of hospital care due to their cost. This is why the CMA has called for a pan-Canadian system of catastrophic coverage for prescription drugs.3 We viewed this as a step toward the development of comprehensive, universal coverage for prescription medicines in Canada.4 1 CIHI. National Health Expenditure Trends 1975-2016, December 15, 2016 2 Ibid 3 Canadian Medical Association (CMA). A New Vision for Health Care in Canada: Addressing the Needs of an Aging Population. 2016 Pre-budget Submission to the Minister of Finance. Ottawa: The Association; 2016 Feb 12 4 Ibid In its brief to the Commission of Inquiry on the Pharmaceutical Industry in August, 1984, the CMA stated that we “fully support the objective of providing prescription drugs to patients at the lowest possible cost that is consistent with wise health care delivery.”5 This remains our objective. This submission will address the proposed improvements to the regulations raised in the consultation document from a broad perspective. 5 Canadian Medical Association (CMA). Brief to the Commission of Inquiry on the Pharmaceutical Industry August 15, 1984 6 Gray C. Patented drugs: Is the price right? CMAJ 1998 158:1645 7 Silversides A. Monitoring the price of new drugs CMAJ 2006 174(11):1548-1549 8 The Commission of Inquiry on the Pharmaceutical Industry. The Report of the Commission of Inquiry on the Pharmaceutical Industry H.C. Eastman, Commissioner. Ottawa Minister of Supply and Services 1985 p. 347 9 Industry Canada. Pharmaceutical industry profile. https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (Accessed 2017 June 20) 10 Morgan SG, Leopold C, Wagner AK. Drivers of expenditures on primary care prescription drugs in 10 high-income countries with universal health coverage. CMAJ 2017;189:E794-9 Economic Considerations The ability of the PMPRB to monitor drug prices has long been the subject of review and concern.6,7 The CMA is pleased that the Government of Canada is undertaking this review to provide the Patented Medicines Prices review Board (PMPRB) with a new regulatory framework to protect Canadians from excessive prices and improving the regulatory process. The board needs to use every economic measure and tool at its disposal to ensure Canadians pay fair and equitable prescription drug prices. As the Eastman Commission pointed out in its 1985 report, “Canadian consumption is a small proportion of world consumption so that Canadian patent policy has little effect on the world-wide profitability of the pharmaceutical industry.”8 Indeed, Canadian pharmaceutical sales represent 2% of the global market which makes us the tenth largest world market.9 Yet our small size with respect to the global market has not shielded us from high prices. For example, a recent study found that although the volume of therapies purchased in Canada across six classes of “primary care medicines” was similar, we paid an estimated $2.3 billion more for them in 2015 than if these treatments had the “same average cost per day in Canada as in the nine comparator countries combined.”10 Prescription medication spending is an issue for many Canadians, especially when it has an impact on compliance with prescription regimes, an unintended consequence of the manner in which the board’s regulatory framework has been applied. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.11 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.12 11 Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15. 12 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23. 13 Vebeeten D, Astiles P, Prada, G. Understanding Health and Social Services for seniors in Canada. Ottawa: The Conference Board of Canada, 2015. 14 Ibid 15 Ibid 16 Morgan SG, Lee A. Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7: e014287. doi:10.1136/bmjopen-2016-014287 (access 2017 Jun 16) 17 Zhang R., Martin D., Naylor CD., Regulator or regulatory shield? The case for reforming Canada’s Patented Medicines Prices review Board. CMAJ 2017 April 10;189:E515-6. doi: 10.1503/cmaj.161355 The CMA is especially worried about the impact high drug costs have on seniors in the absence of universal drug coverage. They have access to some level of drug coverage in all provinces and territories but it is not even.13 Eight provinces have an income-test that determines the deductibles they will pay while in two they pay a small portion of the cost with the province or a third-party insurer covering the rest.14 All three territories have plans for those who qualify but the provisions may be limited.15 A recent study found that older Canadian adults (55 and older) had the second-highest prevalence (8.3%) of cost-related non-adherence (CRNA) for prescribed medications.16 CRNA was higher among those with lower incomes and lower among those over 65. Finally, the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures the government undertakes to strengthen and improve the PMPRB do not exacerbate drug shortages. International Comparisons The PMPRB’s current benchmark “that Canadian prices for patented drugs should be less than the median of prices in selected comparison countries” places us at a distinct disadvantage.17 As the authors note, “it puts Canada well above the OECD average by aligning Canada with countries that spend more from the outset.”18 The PMBRB should expand its range of comparator countries beyond those identified originally (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States) to include those OECD countries with middle to low patent drug pricing.19 18 Ibid 19 Ibid 20 Ibid Furthermore, to ensure that the process is clear and transparent for Canadians, the PMPRB should “set prices closer to what comparator countries actually pay for their drugs as opposed to the “sticker” prices that most commonly represent the starting point for confidential negotiations.”20 Canadians deserve that much after years of paying such high prices for their patented medicines. The CMA is very concerned about the cost of medications. In the absence of universal drug coverage and, at a minimum, a pan-Canadian system of catastrophic coverage of prescription drug costs, a strengthened and robust regulatory framework for the pricing of patented medicines in Canada is crucial. The CMA calls on the federal government to revise the PMPRB regulations such that it provides Canadians with transparency and clarity around the setting of patented medicines prices while achieving the lowest costs possible and ensuring we continue to have access to a wide array of pharmaceutical products. Sincerely, Granger R. Avery, MB BS, FRRMS President

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Canada’s lower-risk cannabis use guidelines (LRCUG)

https://policybase.cma.ca/en/permalink/policy13726

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

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CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy13641

Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
CMA Submission: CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Submission to the Senate Standing Committee on Social Affairs, Science and Technology On behalf of its more than 85,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. April 7, 2017 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. Introduction The Canadian Medical Association (CMA) is pleased to provide this submission to the Senate Social Affairs, Science and Technology Committee for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. 1 Statistics Canada. Smoking, 2015 Health Fact Sheets Canadian Community Health Survey, 2015 82-625-X March 22, 2017 While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). 2 Czoli CD., Hammond D., White CM., Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health 2014;105(2):e97-e102 3 Filippos FT., Laverty AA., Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control 2017;26:98-104 4 Malas M., van der Tempel J., Schwartz R., et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine & Tobacco Research 2016, 1-12 doi:10.1093/ntr/ntw119 5 Ibid 6 Ibid 7 Ibid Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”5 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”6 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”7 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.8 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”9 8 O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addiction Research for BC 9 Ibid 10 El Dib R. Suzumura EA., Akl EA, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco or reduction: A systematic review and meta-analysis. BMJ Open 2017;7: e012680. Doi10:1136/bmjopen-2016-012680 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”10 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”11 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e-cigarettes.”12 11 Shahab L, Goniewicz M., Blount B., et al. Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users. Annals of Internal Medicine doi:10.7326/M16-1107 7 February 2017 12 Collier R. E-cigs have lower levels of harmful toxins. CMAJ 2017 February 27;189:E331. doi: 10.1503/cmaj.1095396 13 Sleiman M., Logue J., Montesinos VN. et al. Emmissions from electronic cigarettes : Key parameters affecting the release of harmful chemicals. Environmental Science and Technology July 2016 doi:10.1021/acs.est.6b01741 14 Ibid 15 England LJ., Bunnell RE., et al. Nicotine and the developing human. Am J. Prev Med 2015 16 Editorial. Use of Electronic Cigarettes by Adolescents. Journal of Adolescent Health 57 (2015) 569-570 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”13 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.14 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”15 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.16 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.17 17 Khoury M., Manlhiot C., et al Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ 2016 DOI:10.1503/cmaj.151169 18 U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.”18 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”19 They base this on the decline in youth smoking while rates of the use of vaping devices rise.20 Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”21 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e-cigarettes to adolescents and young adults.”22 19 Op cit. O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. 20 Ibid 21 Miech R., Patrick ME., O’Malley PM., et al E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob. Control 2017;0:1-6. doi:10.1136/tobaccocontrol-2016-053291 22 Primack BA., Soneji S., Stoolmiller M., et al Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015;169(11): 1018-1023.doi:10.1001/jamapediatrics.2015.1742 23 Hoek J., Thrul J. Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open 2017;7:e014990.doi:10 24 Ibid However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”23 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”24 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 1) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 2) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 3) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words “this product is injurious to your health” printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e-cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de-normalize smoking.”25 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”26 Further research is needed to explore these findings. 25 Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med 370:4 January 23, 2014 26 K. Choi et al. Electronic nicotine delivery systems and acceptability of adult smoking among Florida youth: Renormalization of Smoking? Journal of Adolescent Health (2016) 1-7 Recommendations: 1) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 2) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 3The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.

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CMA submission to the study of Bill C-37

https://policybase.cma.ca/en/permalink/policy13617

Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Committee on Legal and Constitutional Affairs’ study of Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts.1 1 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 The CMA is deeply concerned with the opioid crisis in Canada, with unprecedented levels of harms, including overdose deaths. The crisis is taking a toll on individuals, families and communities, as well as first responders and health professionals at the front lines. The most recent BC Coroner’s Report indicates there were about 3.6 illicit drug overdose deaths per day in February 2017, an increase of 72.9% over the number of deaths in February of last year.2 Other provinces are also facing critical situations. The CMA welcomes the introduction of Bill C-37, proposed by the Minister of Health to address various portions of the Controlled Drugs and Substances Act (CDSA), among other changes. * We are particularly appreciative, given that this is part of a new federal strategy that promises to “replace the existing National Anti-Drug Strategy with a more balanced approach (…) and restores harm reduction as a core pillar of Canada’s drug policy, alongside prevention, treatment and enforcement and supports all pillars with a strong evidence base.3 This is necessary to ensure a public health approach to drug use and addiction. * For further discussion of CMA’s position on addiction, harm reduction and supervised consumption sites, as well as terminology, such as supervised consumption sites or supervised injection sites, see CMA’s submission to the Senate Standing Committee on Legal and Constitutional Affairs. Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf This proposed legislation includes various objectives, including “to prohibit the unregistered import of pill presses, and remove the exception currently placed on border officers to only open mail weighing more than 30 grams,” (…) to “make it a crime to possess or transport anything intended to be used to produce controlled substances, allow for temporary scheduling of new psychoactive substances, and support faster and safer disposal of seized chemicals and other dangerous substances.”4 CMA is supportive of actions by the federal government that advance the work at national, provincial and local levels to address the opioid crisis. Application for a Supervised Consumption Site The objective of Bill C-37 that CMA would like to provide recommendations for is the one that seeks to “simplify the process of applying for an exemption that would allow certain activities to take place at a supervised consumption site, as well as the process of applying for subsequent exemptions.5 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 The Bill proposes to repeal the 26 requirements to apply for an exemption to the CDSA, in Section 56.1, established by the Respect for Communities Act (former Bill C-26). The CMA supports the repeal, as we have repeatedly called for the withdrawal of the amendments made by former Bill C-2, and their replacement with “legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.”7 Bill C-37 proposes to replace those 26 requirements with the five elements cited in the 2011 Supreme Court of Canada unanimous ruling on Insite8, Vancouver’s supervised injection site. These elements are, “evidence, if any, on: . the impact of such a facility on crime rates, . the local conditions indicating a need for such a supervised injection site, . the regulatory structure in place to support the facility, . the resources available to support its maintenance and . expressions of community support or opposition.”9 These elements are proposed to reduce the unnecessary obstacles and burdens on local health departments and community organizations that would deter the creation of new supervised consumption sites, even when the health and safety benefits have been clearly established. Because of this cumbersome process, the BC Ministry of Health recently authorized the creation of “overdose prevention sites” in various locations where there are concerning numbers of overdose deaths, while the ministry “wait(s) for Health Canada approval of supervised consumption services”.10 This was after the creation of unsanctioned popup sites by community groups in the downtown eastside.11 Only Insite and the Dr Peter Centre operate with approved exemptions to date, with Montreal having recently received approval for three sites.12 Many other applications have been submitted for sites in Vancouver, Victoria, Toronto and Ottawa, and others are in preparation. Although a welcome reduction to only five elements, the CMA believes that these elements require more clarity, as they can be subject to interpretation, and undue influence, and could still demand unnecessary and significant time and resources on the part of provincial and local agencies. As well, the present crisis would require an expedited process that would not delay local responses to the crisis. Hence, our first recommendation is that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. Further, CMA recommends that the elements required for an application for opening a supervised consumption site proposed in Bill C-37 be more clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. The central element to be considered is that of “the local conditions indicating a need for such a supervised injection site”. Local health authorities and community organizations struggle with the issues related to drug use, including rising rates of infections, overdoses and deaths, and this is the fundamental reason to open a supervised consumption site. The regulatory structure and the resources available to support a supervised consumption site’s maintenance are issues that local health authorities deal with regularly for any health service, given the need to provide care with reduced risk of liability. The impact of a facility on crime rates is difficult to quantify before such a site is created. Further, the government must consider the experience of the many sites both in Canada and internationally, where law and order have improved in the areas surrounding those sites. The Supreme Court stated that there has been “no discernible negative impact on the public safety and health objectives of Canada during its [Insite’s] eight years of operation.”13 As well, the crime rate is not only influenced by the existence or not of a site, but by many other factors, such as unemployment and enforcement resources. A site would necessarily be located where there are high rates of drug use, for the very purpose of offering people who use drugs much needed harm reduction and support services. The last element, expressions of community support or opposition, should not represent a burden to applicants. As stated in our brief on Bill C-2, “although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites and in European countries.”14 Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication.15 Bill C-2 is an example of how this element could be interpreted. There was an extensive list of letters of opinion required, including from representatives of local police and local and provincial governments (ministers of health and public safety), chief public health officer, professional licensing authorities for physicians and for nurses, as well as reports from community consultations.16 Such a requirement represented a cumbersome and unnecessary burden. The CMA looks forward to continued collaboration with the federal government and other organizations in the development of further action as part of the much needed comprehensive approach to address the opioid crisis. Recommendations 1. The CMA recommends that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. 2. The CMA recommends that the elements required for an exemption application to the CDSA to open a supervised consumption site, proposed in Bill C-37, be clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 7 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1

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Consultation on the renewal of Federal Tobacco Control Strategy

https://policybase.cma.ca/en/permalink/policy13804

Date
2017-04-05
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-04-05
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA), I am responding to your request for consultation on renewal of the Federal Tobacco Control Strategy (FTCS) and on the consultation document: “Seizing the Opportunity: The Future of Tobacco Control in Canada.” We are pleased that Health Canada is renewing the FTCS. The most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014. The decrease is welcome news but much more needs to be done to ensure the decline continues. We support the Endgame Summit’s goal of less than 5% tobacco use by 2035. It must be recognized that specific sub-populations, such as Indigenous populations, will require different targets along with prevalence reduction goals that recognize their unique circumstances and needs. Tobacco has ceremonial significance among Indigenous peoples; the harm associated with tobacco arises not from its ceremonial use but from its daily, repeated abuse. As the Summit suggests a renewed strategy must go beyond the traditional approaches of incremental stricter measures by focussing on the activities of the tobacco industry while offering more assistance to those affected by tobacco products. The whole-of-government approach recommended by the Summit and the framework it proposes are essential for the success of the strategy in the long-term. The CMA believes that despite the reduction in smoking rates, tobacco control remains a priority and should continue to be supported by a sustained, well-funded federal strategy and strong leadership and support from Health Canada, including a coordinated, comprehensive national cessation strategy. We recommend that the next version of the FTCS make the following initiatives a priority: . Pricing There is abundant evidence that high prices are crucial to discouraging tobacco use, especially among young people who are particularly sensitive to price increases. The Summit’s recommendation of a joint pricing strategy developed by Health Canada and Finance Canada that combines substantial excise tax increases and other measures will be key in that regard. As in reducing prevalence, pricing strategies that recognize the unique circumstances and needs of specific sub-populations will need to be developed. . Plain and Standardized Tobacco Packaging The CMA recommends only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA also supports a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” . Retailing The CMA recommends tightening the licensing system to limit the number of outlets where tobacco products can be purchased. The more restricted is tobacco availability, the easier it is to regulate. . Age of sale The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco, preventing them from starting to use tobacco and encouraging them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. The CMA supports raising the minimum age of sale to 21 years. . Promotion Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to young people. The CMA supports educational and public relations initiatives aimed at countering these messages. For example, movie classification systems should restrict access by children and youth to films that portray tobacco use and tobacco product placement. The CMA also supports a total ban on promotion, including tobacco-branded tobacco accessories and non-tobacco products. . Industry interference The CMA supports the Endgame Summit’s recommendations with respect to preventing the tobacco industry’s interference with health policy (i.e., Article 5.3 Guidelines to the Framework Convention on Tobacco Control). It is the CMA’s position that the federal government has a vital role to play in smoking cessation. A fully funded and resourced tobacco control strategy that meets the challenges of the 21st century will help accomplish that goal. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism

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Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)

https://policybase.cma.ca/en/permalink/policy11297

Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1 Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety. Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite. The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3 In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.* CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult. Public health approach to addiction Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components. Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program). Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5 Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Harm reduction is part of health practice Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms. Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs. The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9 Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10 Supervised Consumption Sites are evidence-based Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment. Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12 Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services. Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15 Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been: * A reduction in the overall rate of needle sharing in the area;19 * A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21 * Increased access to addiction counseling and increased enrolment in detox programs;22 23 * Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24 * Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and * No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26 * Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28 Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence. Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety. Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation. The CMA has the following concerns with Bill C-2: 1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation." 2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation. 3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances". 4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need. It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services. * "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services. 1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4 2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23 5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967 6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf 8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf 9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf 10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm 14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services 15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics 16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf 17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404. 19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18. 20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351. 21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7. 22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919. 23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence. 24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36. 25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34. 26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76. 28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36. 29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. 30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction. 31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374. 32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136 33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) 34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).

Documents

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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295

Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.

Documents

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Secure modes of electronic communication between patients and health care providers

https://policybase.cma.ca/en/permalink/policy11230

Date
2014-08-20
Topics
Health information and e-health
Ethics and medical professionalism
Resolution
GC14-41
The Canadian Medical Association supports the creation and use of secure modes of electronic communication between patients and health care providers.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health information and e-health
Ethics and medical professionalism
Resolution
GC14-41
The Canadian Medical Association supports the creation and use of secure modes of electronic communication between patients and health care providers.
Text
The Canadian Medical Association supports the creation and use of secure modes of electronic communication between patients and health care providers.
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National and provincial/territorial legislation to address drug-impaired driving

https://policybase.cma.ca/en/permalink/policy11247

Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Text
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
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Opioid overdose prevention tools and services

https://policybase.cma.ca/en/permalink/policy11248

Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Text
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
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Importing medications

https://policybase.cma.ca/en/permalink/policy11255

Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-56
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-56
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
Text
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
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Comprehensive regulatory standard authorizing the use of marijuana for medical purposes

https://policybase.cma.ca/en/permalink/policy11256

Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-57
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-57
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
Text
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
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