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Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations

https://policybase.cma.ca/en/permalink/policy11114
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety

https://policybase.cma.ca/en/permalink/policy11125
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
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Canadian Medical Association submission to the Standing Senate Committee on Banking, Trade and Commerce: Higher rate now: Why excise tax on tobacco is long overdue for an increase

https://policybase.cma.ca/en/permalink/policy11129
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula
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The Health risks and harms associated with the use of marijuana

https://policybase.cma.ca/en/permalink/policy11138
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the health risks and harms associated with the use of marijuana. Marijuana, or cannabis, is a Schedule II drug under the Canadian Controlled Drugs and Substances Act, and growing, possessing, distributing and selling marijuana is illegal, subject to penalties. Despite that, according to the latest Canadian Alcohol and Drug Use Monitoring Survey1, about 10% of Canadians ages 15 years and over had used marijuana at least once in the past year. It is the second most used substance, following alcohol (at 78%). Even though there has been a decrease in marijuana use among youth (ages 15 to 24) in recent years, usage is still double that of the general population, at 20%. A quarter of youth that had used marijuana in the past 3 months, used it daily, however most use is infrequent and experimental. The average age of initiation is 16.1 years, and it is very concerning that continued use is most common among those who initiate use early. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.2 The 2012 Canadian Community Health Survey - Mental Health3 reported that 1.3% of people aged 15 and over met the criteria for cannabis abusea or dependenceb - double that of any other drugs. The lifetime risk of dependence is estimated at about 9%, increasing to almost 17% in those who initiate use in adolescence.4 Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. CMA has longstanding concerns about the health risks associated with smoking marijuana. While our comments have more recently been made in the context of medical marijuana, the core issue is the same: marijuana usage poses serious health risks5. Teenagers are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. It is estimated that marijuana contains more than 400 active chemicals, including over 60 cannabinoids, of which delta-9 tetra-hydrocannabinol (THC) is the most often studied due to its psychoactive properties. The concentration of the various chemicals varies for different plants, batches and growth locations, and has varied over time. There is the potential for contamination by pesticides or other substances. Rates and quantities of components absorbed will also vary depending on whether the drug is smoked, used in food, inhaled with a vaporizer or applied topically. This is challenging for research on the health effects of marijuana. When marijuana is smoked, THC and other components are inhaled and absorbed through the lungs, rapidly entering the bloodstream. Effects are perceptible within seconds and fully apparent in a few minutes. The main feature of its use is that it produces a feeling of euphoria (or 'high') and sensory alterations, but it is also sought out to reduce pain, relieve anxiety, decrease vomiting and increase appetite. Adverse reactions can occur, such as drowsiness, sedation, blurred vision, photophobia, difficulty breathing and vomiting. However, its acute toxicity is extremely low, as no deaths directly due to acute cannabis use have been reported. Toxic dose-related effects that can occur include anxiety, panic, depression, paranoia or psychosis. Acute impairment typically clears 3-4 hours after use. Marijuana slows reaction times, impairs motor coordination and concentration as well as the completion of complex tasks. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Student Alcohol and Drug Use6 report states that 14-21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Chronic use is more common among those that start using as young teens; those that are tobacco smokers and heavy alcohol consumers and have used other illegal drugs. People with a number of pre-existing diseases who are chronic smokers of marijuana are probably at increased risk of exacerbating the symptoms of their diseases. For example, adults with hypertension, ischaemic or cerebrovascular disease could be at increased risk due to the cardiovascular stimulatory effects of marijuana. There is an increased risk of psychosis, depression and anxiety, particularly among those who have a personal or family history. A persistent lack of energy in chronic users has been referred to as an "amotivational syndrome". Although cognitive impairments (loss of memory, focus and the ability to think and make decisions) are likely reversible a few weeks after discontinued use, this seems not to be true for those who began using in early teen years, while the brain is still developing. Smoke from marijuana preparations contains many of the same compounds as tobacco cigarettes including increased levels of tar. Smoking marijuana may be more harmful than tobacco, as it often involves unfiltered smoke and deeper, longer inhalation. Chronic users often have shortness of breath after exercise, coughing and chest tightness. It is probably associated with bronchitis and emphysema and may have risks for chronic lung disease and lung cancer, comparable to cigarette smoking. This is less of a problem for those that use vaporizers, as a harm reduction strategy. The use of marijuana during pregnancy has been shown to affect the development and learning skills of children, more noticeably from the age of three, with these effects lasting into the teen years. Studies have shown an increase in hyperactivity, inattention and impulsivity. These children will be more prone to addiction and mental health issues as well as decreased cognitive functioning, and could require supports when in school. Some studies point to a lower birth weight. Besides health concerns, marijuana use can lead to social and interpersonal problems, including difficulties at school, in relationships and with the law. Awareness of Canadians of the harms of marijuana is generally low. 7 Youth tend to emphasize the drug's ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There were also many myths, such as that it would counter cigarette effects, preventing cancer. Many stated that they did not consider marijuana as a drug because it was "natural" and relatively benign compared to other drugs. It is concerning that some teens said that marijuana actually made people better drivers by increasing their focus. There seems to be skepticism around prevention programs which aim exclusively at abstinence. Feedback has been that effective approaches would involve providing more fact-based information at an earlier age and using programs that aim at reducing the harms of using marijuana. It is essential that youth and users from other age groups be involved in the conceptualization and development of any such programs. CMA makes the following recommendations to the Committee: 1) Public Health Approach to Psychoactive Substance Use The CMA recommends that the federal government adopt a public health approach to increase the focus on preventing drug abuse, on treatment of addiction, on monitoring, surveillance and research and on harm reduction. Addiction should be recognized and treated as a serious, relapsing chronic disease, and substance use is a complex behaviour influenced by many factors. Therefore, a comprehensive multi-factorial strategy is necessary, and lessons can be learned from work that has been done to decrease tobacco and alcohol use and to reduce the harms related to these substances. A public health approach would place an increased focus on preventing drug abuse and dependence; on the availability of assessment, counselling and treatment services for those who wish to stop using; and on harm reduction to increase the safety for those that are using. It would seek to ensure the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. The CMA believes that resources currently devoted to combating simple marijuana possession through the criminal law could be diverted to public health strategies, particularly for youth. A public health approach also includes efforts around the monitoring, surveillance and research of marijuana use to better inform the strategy. This is essential to better understand the short and long term harms as well as policy options to address prevention, treatment, harm reduction and enforcement. 2) Comprehensive Education and Awareness Program to Address Marijuana Use The CMA recommends that the federal government develop, in collaboration with the provinces and territories and key stakeholders, a comprehensive education and awareness program to minimize marijuana use. A comprehensive program to minimize marijuana use should include, but not be limited to: - Education and awareness raising of the known and potential harms of marijuana; - Strategies to prevent early use in adolescence; - Support for programs that decrease stigma associated with mental health and addiction; and - Support for health professionals' awareness and evidence-informed practice in the prevention, management and treatment of drug use. A specific focus on youth is essential, as they are not only more likely than adults to engage in risky drug use, particularly boys, but also disproportionately experience greater harms from that use. It is also particularly important for women of child bearing age, due to the risk to the fetus during pregnancy. Information that is tailored to the needs of specific populations will help people make informed choices. Efforts to prevent, reduce or delay the use of marijuana could result in a reduction of suffering and costs to the health care system. Health professionals must be involved and supported in this area, and it is important to ensure the availability of evidence informed clinical practice guidelines, practice tools and continuing medical education resources. 3) Driving Under the Influence Prevention The CMA recommends that the federal government continue to support, in collaboration with the provinces and territories and key stakeholders, strategies for the prevention of impaired driving. The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers due to marijuana. Efforts to prevent, reduce or delay marijuana use, especially in youth, are particularly important. Education is also important as many are not aware that marijuana affects driving ability or even that there are procedures that the police can use to identify impairment due to psychoactive substances. The CMA supports a similar multidimensional approach such as has been adopted with alcohol and driving. However, the specificities of impairment due to marijuana must be understood and investments made in research. Collaboration with key stakeholders such as schools, drivers' education and licensing bodies, as well as enforcement organizations is essential. In conclusion, the Canadian Medical Association reiterates the concern of Canada's physicians around marijuana use, particularly by young people. We are committed to working with governments and stakeholders to address this issue. a Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. b Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. 1 Health Canada (2013) Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Retrieved from: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php 2 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 3 Statistics Canada (2013) Canadian Community Health Survey - Mental Health. Retrieved from: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm 4 Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf 5 Beirness, D.J., & Porath-Waller, A.J. (2009). Clearing the smoke on cannabis: Cannabis use and driving. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11789-2009.pdf. Diplock, J., & Plecas, D. (2009). Clearing the smoke on cannabis: Respiratory effects of cannabis smoking. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11797-2009.pdf. Gordon, A.J., Conley, J.W. & Gordon, J.M. (2013) Medical consequences of marijuana use: a review of the current literature. Curr Psychiatry Rep 15:419. Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf Holmes, E., Vanlaar, W. & Robertson, R. (2014) The problem of youth drugged driving and approaches to prevention: a systematic literature review: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://ccsa.ca/Resource%20Library/CCSA-Youth-Drugged-Driving-technical-report-2014-en.pdf Kalant, H., & Porath-Waller, A.J. (2012). Clearing the smoke on cannabis: Medical use of cannabis and cannabinoids. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2012%20CCSA%20Documents/CCSA-Medical-Use-of-Cannabis-2012-en.pdf. Porath-Waller, A.J. (2013). Clearing the smoke on cannabis: Highlights. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Clearing-Smoke-on-Cannabis-Highlights-2013-en.pdf. Porath-Waller, A.J. (2009a). Clearing the smoke on cannabis: Chronic use and cognitive functioning and mental health. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0115422009_e.pdf. Porath-Waller, A.J. (2009b). Clearing the smoke on cannabis: Maternal cannabis use during pregnancy. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0117832009_e.pdf. 6 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 7 Cunningham, J.A., Blomqvist, J., Koski-Jannes, A., & Raitasalo, K. (2012). Societal Images of Cannabis use: Comparing Three Countries. Harm reduction journal, 9(1), 21-7517-9-21. Retrieved from: http://www.biomedcentral.com/content/pdf/1477-7517-9-21.pdf Porath-Waller, A., Brown, J., Frigon, A., & Clark, H. (2013). What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf Racine, S., Flight, J., & Sawka, E. (Eds.). (2006). Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://publications.gc.ca/site/eng/349980/publication.html
Documents
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Prescription drug shortages

https://policybase.cma.ca/en/permalink/policy11187
Date
2014-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
BD14-05-159
The Canadian Medical Association will continue to make prescription drug shortages a priority in its lobbying efforts; review its current efforts, define further possibilities and report back to the Board at its May 2014 meeting.
Policy Type
Policy resolution
Date
2014-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
BD14-05-159
The Canadian Medical Association will continue to make prescription drug shortages a priority in its lobbying efforts; review its current efforts, define further possibilities and report back to the Board at its May 2014 meeting.
Text
The Canadian Medical Association will continue to make prescription drug shortages a priority in its lobbying efforts; review its current efforts, define further possibilities and report back to the Board at its May 2014 meeting.
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Bill C-17 An Act to amend the Food and Drugs Act

https://policybase.cma.ca/en/permalink/policy11196
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act. The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end. 1) Clarify ministerial authority and responsibility The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety. The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3): * Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening. * Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety. Recommendation 1 In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority. Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3. 2) Oversight of natural health products The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting. To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety. Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products. 3) Comprehensive post-market surveillance and response system The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings. A) Increasing accountability and public transparency Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks. Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4 Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear. The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data. Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication. Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks. B) Improving the reporting and communication system The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness. When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting. In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes: * Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care. * Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line. * Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting. * Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis. Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health. In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report. Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it. Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes: * Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records; * Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and * Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public. Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting. Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution". Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective. 1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf 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: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf 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: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf 2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada. http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30) 3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21) 4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2) 5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/oag-bvg-eng.php
Documents
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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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