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.
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.
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
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.
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.
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.
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.
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.
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
iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14
Frank J. Chaloupka, Rosalie Liccardo Pacula
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
The Canadian Medical Association is pleased to present this submission to the House of Commons Standing Committee on Health regarding Bill C-422, National Lyme disease strategy.
The Canadian Medical Association (CMA) is the national organization representing over 80,000 physicians in Canada; 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.
Lyme disease is a growing problem in Canada. According to the Public Health Agency of Canada (PHAC) there were 315 cases of Lyme disease reported in Canada in 2012 -two and one-half times more cases than the 128 reported in 2009, the year that it became a reportable disease. In the Ottawa area, cases have increased almost 8 fold from 6 in 2009 to 47 in 2013. The PHAC surveillance indicates that established populations of blacklegged ticks are spreading their geographic scope, and are increasing in number, in much of southern Canada. In 2013 the US Center for Disease Control and Prevention released new estimates of Lyme disease that was 10 times higher than the previous yearly reported number of 30,000 reported cases.1 This highlights the difficulty in establishing the true burden of illness from Lyme disease.
Why this matters to Canada's physicians
The Canadian Medical Association supports the implementation of a national strategy that can address the breath of public health and medical issues surrounding the spread of Lyme disease in Canada. As with any new infectious disease threat, Canada needs to ensure that we are prepared to address the impact of Lyme disease on Canadians.
CMA's policy on climate change and human health notes that changes in the range of some infectious disease vectors such as blacklegged ticks, are a possible consequence of climate change in Canada. Research has suggested that the tick vector of Lyme disease has been expanding into southeastern Canada which can lead to increased disease risk for those living in areas with tick populations.2
In this policy, CMA recommends that the federal government report diseases that emerge in relation to global climate change, and participate in field investigations, as with outbreaks of infectious diseases like Lyme disease, and develop and expand surveillance systems to include diseases caused by global climate change.
The World Medical Association Declaration of Delhi on Health and Climate Change urges colleges and universities to develop locally appropriate continuing medical and public health education on the clinical signs, diagnosis and treatment of new diseases that are introduced into communities as a result of climate change. Diagnosis of Lyme disease can be difficult, as signs and symptoms can be non-specific and found in other conditions. 3 If Lyme disease is not recognized during the early stages, patients may suffer seriously debilitating disease, which may be more difficult to treat.4 Given the increasing incidence of Lyme disease in Canada, continuing education for health care and public health professionals and a national standard of care would improve identification, treatment and management of Lyme disease. Greater awareness of where blacklegged ticks are endemic in Canada, as well as information on the disease and prevention measures, can help Canadians protect themselves from infection.
The CMA supports a national Lyme disease strategy which includes the federal, provincial and territorial governments and the medical and patient communities. This strategy must address concerns around research, surveillance, diagnosis, treatment and management of the disease and public health prevention measures will advance our current knowledge base, and improve the care and treatment of those suffering from Lyme disease.
Once again, CMA is pleased to provide this brief to the Standing Committee on Health as part of its study on this important issue. Canada's physicians recognize the importance of monitoring all emerging infectious diseases in Canada. In addition, Canada's physicians recognize the importance of developing strategies to treat, manage, and prevent Lyme disease in Canada.
1 CDC provides estimate of Americans diagnosed with Lyme disease each year, media release August 19, 2013 Accessed at http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html on Feb 21, 2014.
2 Ogden, N., L. Lindsay, and P. Leighton. 2013. Predicting the rate of invasion of the agent of Lyme disease Borrelia burgdorferi. Journal of Applied Ecology. April, 2013. 50(2):510-518.
3 Mayo Clinic, accessed at http://www.mayoclinic.org/diseases-conditions/lyme-disease/basics/tests-diagnosis/con-20019701 on Feb 21, 2014.
4 Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43: 1089-134.
The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered.
The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information.
We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below:
CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further.
CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product".
CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons:
* The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily.
It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced.
In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are.
For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information:
Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes.
CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary.
And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public.
That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity.
As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations.
However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA).
The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach.
The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works.
In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required.
CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required.
CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive.
Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened.
Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship.
Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship.
While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim.
CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent.
In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect.
To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians.
That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security.
Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.
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.
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:
The Canadian Medical Association (CMA) is pleased to provide the comments below in response to Finance Canada's consultation document Pension Innovation for Canadians: The Target Benefit Plan.
The CMA is the professional voluntary association representing over 80,000 physicians across Canada. 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.
The CMA has participated in, and made recommendations to, Finance Canada over the course of the government's multi-year consultation process on Canada's pension framework. Indeed, in light of the importance of the pension framework to our membership, the CMA has been an active participant in previous consultations regarding the pension framework. The CMA's participation in the current, multi-year initiative included responding to the 2010 consultative paper Ensuring the Ongoing Strength of Canada's Retirement Income System as well as participating in the legislative and regulatory consultation on the Pooled Registered Pension Plan (PRPP) framework.
While the CMA recognizes that this consultation is focused narrowly on the federally regulated pension plans governed by the Pension Benefits Standards Act 1985, the CMA supports additional consultation on Canada's pension framework. The CMA recommends that Finance Canada expand its consultation to explore options to address weaknesses in Canada's pension framework, including a focus on the third pillar: tax-incentivized savings vehicles.
As part of a consultation on the third pillar, the CMA recommends that Finance Canada explore three issues, as elaborated further below:
* Increasing the combined contribution limit for registered retirement savings plans (RRSPs);
* Enabling well-governed professional organizations that represent a particular membership as pension plan sponsors; and,
* Possible impacts of registered retirement income funds (RRIF) mandatory drawdown rates.
Like the Canadian population at large, physicians represent an aging demographic - 42% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles.
The Summary Report on Retirement Income Adequacy Research presented to the F/P/T Ministers of Finance in 2009, suggests that higher-earning Canadians may not be saving enough for retirement. This report highlighted that income replacement rates in retirement fall below 60 per cent of after-tax income for about 35 per cent of Canadians in the upper income quintile. This is related to the effect of maximum contribution limits on tax-incentivized retirement savings vehicles.
Tax-incentivized private saving vehicles are a critical element of Canada's pension framework. As highlighted in the 2010 interim report of the Senate Banking Trade and Commerce Canadians Savings for Their Future: A Secure Retirement, the introduction of the RRSP framework in 1957 sought to address a tax inequity due to the ineligibility of private savings for tax-incentive in comparison with registered pension plans. From 1972 to 1991 the RRSP contribution limit was set at 20 percent of earned income and in 1991, the government reduced the contribution limit to 18 percent of earned income; further, over this time period the real value of the absolute dollar limit reduced significantly. Recent increases to the absolute dollar limits have been strongly welcomed.
To ensure that contribution limits do not pose a barrier to saving for future retirement income needs, the CMA recommends that Finance Canada initiate a consultation on future increases to the RRSP contribution limit, both absolute and percent of earned income.
As part of the 2010 Finance Canada consultation and as reiterated during the legislative and regulatory consultation period on the PRPP framework, the CMA highlighted its support for exploring measures to enable organizations to sponsor plans on behalf of the self-employed. During the PRPP consultation, the CMA recommended amending the legislation such that well-governed professional organizations representing a particular membership are able to sponsor and administer PRPPs for their own members, including self-employed members. Once again, the CMA supports an extension of this recommendation to the broader pension framework.
Finally, the CMA has taken note of the concerns regarding the registered retirement income funds (RRIF) mandatory drawdown rates expressed in the C.D. Howe Institute's recent pension policy e-brief Outliving our savings: Registered retirement income funds rules need a big update. The CMA recommends that Finance Canada include RRIF mandatory drawdown rates as part of a consultation.
The CMA appreciates the opportunity to provide comment as part of Finance Canada's consultation on enabling target benefit plans within the federally regulated pension framework. The CMA supports further consultation on Canada's pension plan with an aim to ensure optimization of the third pillar, tax-incentivized savings vehicles, to ensure it enables adequate savings levels by self-employed individuals for their future retirement income needs.
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014.
The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications.
While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes.
There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients.
The CMA recommends that Health Canada further revise the proposed amendments to the
Marihuana for Medical Purposes Regulations to:
1) Enable consistent and best practice oversight
In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory
framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances.
For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners.
Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes.
It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority.
However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions.
Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners.
2) Safeguard protection of privacy
As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information.
In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information.
The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information.
The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended.
In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by
licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment.
3) Clarify and enforce consumer advertising requirements
Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards.
Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act:
3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.
9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.
(2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).
Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations:
70. No person shall
(a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof;
(b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or
(c) advertise in a pharmacy a preparation referred to in section 36.
While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations.
The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail.
Overview of recommendations
1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions.
2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners.
3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information.
4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations.
5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations.
6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards.
List of Appendices:
* Appendix A - CMA Policy Statement: Medical Marijuana
* Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information
* Appendix C - CMA Policy Statement: Principles Concerning Physician Information
"The 2014-15 budget signals the end to a tough but necessary period of fiscal consolidation. Current expectations are for a surplus of $6.4-billion in 2015-16, plus a contingency reserve of $3-billion; there is finally some room to manoeuvre in the years ahead."
Glen Hodgson, Senior VP and Chief Economist
Conference Board of Canada - February 2014
Having emerged from the global economic downturn, now is the time for the federal government to make strategic investments that will ensure Canada's long-term economic sustainability. The ageing of Canada's population is the most pressing policy imperative of our time. As highlighted in Finance Canada's 2012 report, Economic and Fiscal Implications of Canada's Ageing Population, action to prepare for an ageing population will support the sustainability of Canada's public finances and social programs.
The CMA's recommendations for the 2014-15 federal budget focus on strategic investments in three key areas:
1. Supporting Canadian families and seniors
A) Pan-Canadian Seniors Strategy
The CMA is concerned that Canada is ill-prepared for the demographic shift already underway. By 2036, it is expected that a quarter of Canada's population will be over age 65; almost double the proportion of today. Already, patients aged 65 and older account for nearly half of Canada's health care spending. Seniors also face challenges accessing health services across the continuum of care. These challenges are getting worse, despite growing efforts to provide sustainable, high-quality health care for seniors, and despite most provinces having seniors care strategies in place.
Canadians share our concern. According to an Ipsos Reid poll commissioned by the CMA, a majority of respondents (83%) said they were concerned about their health care in their retirement years. This poll found that nine out of ten Canadians (93%) believe Canada needs a national strategy for seniors health care that integrates home care, hospitals, hospices, and long-term care facilities into the continuum.
Recommendation: The CMA recommends that the federal government provide targeted funding to support the development of a pan-Canadian strategy to address the needs of the aging population.
B) Incenting savings for future continuing care needs
According to the Organization for Economic Cooperation and Development (OECD), long-term care spending in Canada averaged 1.2% of GDP over the 2006-10 period and could more than double to 2.5% by 2060. The Canadian Life and Health Insurance Association estimates there will be an unfunded long-term care liability of $590 billion over and above existing government programs as the boomer generation passes through their old age1.
Of the approaches available to address this unfunded liability, encouraging and incentivizing individuals to save for their future continuing care needs is the least demanding of public finances as compared with increased personal or business income taxes or mandatory contributions.
There has been increasing interest among Canadians with focused savings vehicles established by the federal government. There continues to be increased uptake with Registered Education Savings Plans (RESPs) to support post-secondary education. The growth in RESP assets was significant in 2011 and 2012, representing an average annual rate of 12.6%.2
There has also been increased uptake in the use of tax sheltered individual savings vehicles, such as the Tax Free Savings Account (TFSA). According to a Finance Canada report, as of 2011 there were 8.2 million individuals with a TFSA, representing 31% of tax filers, and they contributed $30.7 billion in that year. The report noted that the greatest proportionate growth in TFSA uptake was observed among those with incomes of less than $20,000, with their participation rate almost doubling from 11% in 2009 to 20% in 20113.
Recommendation: The CMA recommends that the federal government use its economic levers to encourage Canadians to save over their lifetime for future continuing and long-term care needs not covered under the Canada Health Act.
C) Promoting Healthy Ageing
The Public Health Agency of Canada (PHAC) defines healthy ageing as "the process of optimizing opportunities for physical, social and mental health to enable seniors to take an active part in society without discrimination and to enjoy independence and quality of life."
Such initiatives could focus on:
* Physical activity - 57% of seniors in 2008 reported being physically inactive4;
* Injury prevention - 40% of admissions to nursing homes, 62% of injury-related hospitalizations, and almost 90% of hip fractures are due to falls by seniors5;
* Nutrition - 28% of men and 31% of women over 65 were obese (BMI = 30); this is higher than the population average. Underweight is also a problem among seniors, 17% of whom report a BMI of 20 or less6.
The federal government has already undertaken steps to address healthy ageing among Canada's seniors, such as 'Seniors: Active. Engaged. Informed'. In funding over 13,000 projects across Canada, the New Horizons for Seniors Program has demonstrated success in enabling new programs to achieve specific goals; this program can be harnessed to deliver projects focused on promoting healthy ageing.
Recommendation: The CMA recommends that the New Horizons for Seniors program be expanded by $5 million per year to include funding for programs promoting healthy ageing activities for Canadian seniors.
2. Ensuring the availability and access to continuing care
"When we poll CARP members, they call for leadership in helping Canadians save for retirement, get home care when they need it and get access to affordable drug."
Susan Eng, VP, Advocacy for CARP - February 2014
A) Addressing the Continuing Care Infrastructure Crisis
A major issue facing health care systems across the country is the high number of alternate level of care patients (ALC) in acute care hospitals. ALC patients-many of whom are seniors-are those who have completed the acute care phase of their treatment but remain in an acute care bed or who are admitted into a hospital bed due to the lack of more appropriate assisted living settings.
The CMA supports efforts to allow Canadian seniors to remain in the community as long as possible. However, there are increasing pressures on the continuing care sector given the rise in the number of seniors with complex health and social needs. These pressures not only relate to the construction of new facilities, including assisted living units and other innovative residential models for seniors, but apply as well to the need to upgrade and retrofit existing facilities7.
Despite increasing the availability of home care, Canada will face a significant infrastructure shortage in the continuing care sector. The CMA estimates this infrastructure shortage costs the health care system about $2.3 billion a year; this cost is estimated to skyrocket as our population ages.
Recommendation: The CMA recommends the federal government deliver $2.3 billion in funding to leverage provincial/territorial strategic investment in the construction, renovation and retrofitting of assisted living units, other innovative residential models, and long-term care facilities.
B) Supporting Caregivers
The 2011 Budget introduced a new non-refundable Family Caregiver Tax Credit to provide tax relief to those who provide informal care for a dependent relative within their home. However, the credit is limited to 15% of a maximum $2,040 in expenses for 2013 or a maximum sum of $306. While this credit can be added to other tax credits, the total amount is small in relation to the burden experienced by caregivers and it remains non-refundable.
The CMA is concerned that the scarcity of financial support and programs supporting caregivers represents significant risks in relation to economic costs, lower productivity, impacts on the labour market, inefficiencies within the health care system and, most importantly, patient care.
Informal caregivers are the backbone of any health care and social care system. The work of the 1.5 to 2 million caregivers in Canada is estimated at $25-26 billion annually, while incurring $80 million dollars annually in out-of-pocket costs8. The role of informal caregivers will only increase with the move to providing more care at home.
Recommendation: The CMA recommends the federal government make the Family Caregiver Tax Credit a refundable tax credit as part of an effort to better support informal caregivers.
3. Accelerating innovation in health care through enhanced use of electronic medical records (EMRs)
"The need for innovation ..., both in terms of medical technologies and healthcare delivery systems, is one of the most pressing public policy challenges of our times."
Hon. Rona Ambrose, Health Minister - January 2014
The CMA supports prioritizing continuing the development and meaningful use of electronic medical records (EMRs).
A recent report estimates the costs of a pan-Canadian electronic health record (EHR) between $7.9 billion and $16.0 billion9 while total gross savings over a 20-year range were projected at over $82 billion. To date, approximately $2.1 billion in federal funding has been invested. Five national benefit evaluation studies have been commissioned since 2008 and these analyses estimated $7.7 billion in benefits to date as a result of this investment10.
This initial investment has resulted in digitized health care information and paper processes, and created a robust marketplace for innovation by EMR vendors. As such, the value of investments in EMRs is emerging. The 2013 National Physicians Survey11 indicated that:
* Almost 70% of medical general practitioners (GPs) and specialists now use an EMR, up from 56% in 2012 and 37% in 2009.
* 45% of GPs and 40% of specialists report increased or greatly increased efficiency due to the use of EMRs.
* 63% of GPs and 50% of specialists report the quality of patient care they provide is better or much better since they started using an EMR.
The next step in the evolution of EMRs is enhanced use. In Canada, federal investment does not extend beyond the equivalent of the first stage of the U.S. framework for Meaningful Use. There remain significant gaps in funding to achieve enhanced use of EMRs by clinicians, regional interoperability, and to structure EMR data to leverage big data analytics.
Recommendation: The CMA recommends the federal government continue to fund Canada Health Infoway (CHI) to administer remaining project funds from the $500 million allocated in 2009, and allocate an additional $500 million, to be administered by CHI, for projects to achieve enhanced use of EMRs.
1 Canadian Life and Health Insurance Association. Helping Canadians prepare for long-term care costs. CLHIA report on long-term care policy. 2014.
2 Employment and Social Development Canada. 2012 CESP Annual Statistical Review. http://www.esdc.gc.ca/eng/jobs/student/reports/statistics/cesp_2012.shtml#h2.4-h3.1
3 There is a detailed analysis of the TFSA in the 2012 Tax Expenditures and Evaluations report by Finance Canada (Pages 31-42 in http://www.fin.gc.ca/taxexp-depfisc/2012/taxexp-depfisc12-eng.pdf).
4 PHAC 2010
5 PHAC 2010
6 PHAC 2010
7 Canadian Medical Association, The Need for Health Infrastructure in Canada. Submitted to Hon. Denis Lebel, PC, MP Minister of Transport, Infrastructure and Communities. March 18, 2013.
8 Hollander, M.J, Liu, G., Chappeell, N.L. (2009). Who cares and how much? The imputed economic contribution to the Canadian health care system of middle aged and older unpaid caregivers providing care to the elderly. Healthcare Quarterly, 12(2), 42-59.
10 Remote Patient Monitoring (RPM) Evaluation; EMR Evaluation; Telehealth evaluation; Drug Information Systems (DIS) evaluation; Diagnostic Imaging (DI) systems evaluation
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada.
The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential.
The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse.
A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure."
Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing
Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA
Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription
Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the
consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E
3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper
resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably.
National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa:
Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf
prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered.
The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5
Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards.
The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected.
As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9.
Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the
Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance.
Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6
Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23.
Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol.
Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9.
The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved
progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet.
There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects.
The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management.
Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential.
The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations.
The CMA recommends that:
1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders.
2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations.
3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages.
4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects.
5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths.
6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1
Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety.
Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite.
The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3
In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.*
CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult.
Public health approach to addiction
Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components.
Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program).
Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5
Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential.
Harm reduction is part of health practice
Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms.
Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs.
The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9
Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10
Supervised Consumption Sites are evidence-based
Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment.
Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12
Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services.
Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15
Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been:
* A reduction in the overall rate of needle sharing in the area;19
* A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21
* Increased access to addiction counseling and increased enrolment in detox programs;22 23
* Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24
* Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and
* No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26
* Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28
Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence.
Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety.
Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation.
The CMA has the following concerns with Bill C-2:
1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation."
2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation.
3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances".
4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need.
It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.
* "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services.
1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4
2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do
3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3
4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23
5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967
6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf
8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf
9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf
10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf
13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm
14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services
15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics
16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf
17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404.
19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18.
20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351.
21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7.
22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919.
23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence.
24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36.
25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34.
26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76.
28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36.
29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper.
30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction.
31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374.
32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136
33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20)
34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's Notice of proposed order to amend the schedule to the Tobacco Act1, from October 14, 2014, on the restriction of the use of additives.
Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use.
Flavoured tobacco products include candy or fruit flavoured products including cigarillos, water pipe tobacco, smokeless tobacco and blunt wraps. They come in flavours that are appealing to youth such as chocolate, mint, cherry, peach, or strawberry. Flavouring makes the tobacco products more palatable to youth and young adult smokers because they have a lower tolerance for irritation and an underdeveloped taste for tobacco smoke.2 Menthol is a long standing and common flavour used in cigarettes and is used to reduce the harshness of cigarette smoke. It is the most popular flavour among youth. Almost three out of 10 Canadian youth who smoked cigarettes in the last 30 days (29 per cent) reported smoking menthol cigarettes.3
Tobacco Use and Youth
While tobacco use has declined in Canada we must remain vigilant in our efforts to reduce smoking rates. Today 16 per cent of Canadians continue to smoke on a regular basis and physicians are particularly concerned about the smoking prevalence among young adults and youth with 20 per cent of those aged 20-24, and 11 per cent of youth aged 15-19 currently smoking on a regular basis. 4
Flavoured tobacco products, with their appeal to young Canadians are a major threat to the health and well-being of our youth. A recent report, Flavoured Tobacco Use: Evidence from Canadian Youth based on the 2012/13 Youth Smoking Survey, shows that young people are using flavoured tobacco products at high levels. Results show that 50 per cent of high school students in Canada who used tobacco products in the previous 30 days used flavoured tobacco products.5
Previous Amendments Regarding Flavouring Agents
The CMA supported efforts of the federal government in 2009 to limit the addition of flavouring agents to tobacco products through the 2010 Act to Amend the Tobacco Act. But the Act did not cover all tobacco products and it excluded menthol as a flavouring agent. Manufacturers have been able to modify the weight and packaging of their products to technically comply with the Act while they continue to market flavoured products.
It is the CMA's position that the federal government has an important role in smoking cessation and prevention among youth. The CMA supports the proposed extension of the prohibitions on the use of certain flavouring additives in relation to the manufacture and sale of little cigars to cigars weighing more than 1.4 g but less than 6 g.
The CMA remains very concerned that these amendments do not ban menthol flavouring in tobacco products. To that end, the CMA recommends that Health Canada extend its prohibition on flavouring additives to include a ban on the addition of menthol in all tobacco products.
1 Health Canada. Notice of proposed order to amend the schedule to the Tobacco Act. October 14, 2014. Accessed at: http://www.hc-sc.gc.ca/hc-ps/consult/_2014/tobacco-act-loi-tabac/index-eng.php
2 Carpenter CM, Wayne GF, Pauly JL, Koh HK, Connolly GN. New cigarette brands with flavors that appeal to youth: Tobacco marketing strategies: Tobacco industry documents reveal a deliberate strategy to add flavors known to appeal to younger people. Health Affairs 2005;24(6):1601-1610.
3 Manske SR, Rynard VL, Minaker LM. 2014 (September). Flavoured Tobacco Use among Canadian Youth: Evidence from Canada's 2012/2013 Youth Smoking Survey. Waterloo: Propel Centre for Population Health Impact, 1-18. cstads.ca/reports.
4 Canadian Tobacco Use Monitoring Survey 2012 , accessed at http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/research-recherche/stat/ctums-esutc_2012-eng.php.
5 Manske SR, Rynard VL, Minaker LM. 2014 (September). Flavoured Tobacco Use among Canadian Youth: Evidence from Canada's 2012/2013 Youth Smoking Survey. Waterloo: Propel Centre for Population Health Impact, 1-18. cstads.ca/reports.
Minaker L, Manske S, Rynard VL, Reid JL & Hammond D. Tobacco Use in Canada: Patterns and Trends, 2014 Edition - Special Supplement: Flavoured Tobacco Use. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.
Canadian Medical Association 2
November 10, 2014
On behalf of its more than 82,000 members and the Canadian public, CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery.
The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 51 national medical organizations.
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for its study on e-cigarettes.
Electronic cigarettes, or e-cigarettes, which replicate the act and taste of smoking, but do not contain tobacco, are growing rapidly in popularity. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid, mainly propylene glycol. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine. Flavourings are also added with the intention of boosting their appeal to young people. Issues have been identified with labelling of e-cigarettes, where upon inspection, there have been contaminants, and nicotine has been detected in products labeled without nicotine.1 Users are generally able to modify the contents of e-cigarettes, with the addition of other substances, including marijuana.
Originally most e-cigarette manufacturers were small entrepreneurial companies; now, however, all major transnational tobacco companies are also producing e-cigarettes and competing for a share in the market.
There are little data on Canadian use. In the U.S., one in five adult smokers has tried them, according to the Centers for Disease Control and Prevention2.
Current Regulatory Status
Health Canada issued a warning in 20093 about the potential dangers and the fact that e-cigarettes had not been fully evaluated for safety, quality and efficacy. The sale of e-cigarettes containing nicotine is currently illegal in Canada under the Food and Drugs Act regulations4 though they can still be purchased in the US or over the Internet. However, those that do not make any health claim and do not contain nicotine may legally be sold in Canada under the same regulation. Health Canada is considering additional regulatory measures but none have yet been introduced. Some municipal jurisdictions are also considering regulation changes.
Internationally, regulation of e-cigarettes is just beginning, and approaches vary. A few countries - such as Brazil, Norway and Singapore - have banned them outright. France plans to regulate e-cigarettes in the same way as tobacco products, and the US Food and Drug Administration is considering a similar approach. On the other hand, Britain will regulate e-cigarettes as non-prescription drugs starting in 2016.5
Current evidence is insufficient to estimate the health effects of e-cigarettes. There are both defenders and opponents, though their arguments are based largely on opinion since e-cigarettes are only beginning to undergo rigorous clinical testing.6
Proponents, including some health officials and groups, say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease.7 Some believe they serve a useful purpose as a harm reduction tool or cessation aid, although marketing them as such is not permitted since that claim has never been approved by Health Canada.
Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the e-cigarettes may contain other toxic ingredients such as nitrosamines, a carcinogen. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to use of tobacco by people who might otherwise have remained smoke-free.8 The use of flavouring agents and attractive packaging could entice children and youth, and survey data in some countries has shown that teens are increasingly experimenting with e-cigarettes.
There has also been a dramatic increase in cases of nicotine overdose by ingestion or through dermal contact, particularly in children.9 The number of these incidents seems to be rising in countries that monitor poisonings.
The World Health Organization recently released a report on the health impacts of electronic nicotine delivery systems (ENDS) use which incorporates the 2013 deliberations and scientific recommendations by the WHO Study Group on Tobacco Product Regulation. It concludes that "ENDS use poses serious threats to adolescents and fetuses. In addition, it increases exposure of non-smokers and bystanders to nicotine and a number of toxicants." The report says that it is possibly less toxic for the smoker than conventional cigarettes but it is unknown by how much.10 This report suggests that governments should have the following regulatory objectives:
* impede the promotion and uptake of e-cigarettes with nicotine by non-smokers, pregnant women and youth;
* minimize potential health risks to e-cigarette users and non-users;
* prohibit unproven health claims from being made about e-cigarettes; and
* protect existing tobacco-control efforts from commercial and other vested interests of the tobacco industry.11
Given the absence of solid evidence of harms or benefits, CMA recommends that:
1. E-cigarettes containing nicotine should not be authorized for sale in Canada.
2. The sale of all e-cigarettes should be prohibited to Canadians younger than the minimum age for tobacco consumption in their province or territory.
3. Smoke-free policies should be expanded to include a ban on the use of e-cigarettes in areas where smoking is prohibited.
4. Research on the potential harms and benefits of electronic cigarette use should be supported.
1 Institut national de santé publique du Québec (INSPQ). (Mai 2013). La cigarette électronique: état de situation. Available : http://www.inspq.qc.ca/pdf/publications/1691_CigarElectro_EtatSituation.pdf
2 Centers for Disease Control and Prevention. About one in five U.S. adult cigarette smokers have tried an electronic cigarette. Centers for Disease Control and Prevention Press Release. February 28, 2013 Available: http://www.cdc.gov/media/releases/2013/p0228_electronic_cigarettes.html (accessed October 31, 2014)
3 Health Canada. Health Canada Advises Canadians Not to Use Electronic Cigarettes (archived). Available: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2009/13373a-eng.php (accessed October 31, 2014)
4 Health Canada. Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada. Available: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_avis_e-cig-eng.php (accessed October 31, 2014)
5 Kelland, K. & Hirschler, B. Insight - No smoke, plenty of fire fuels e-cigarettes. Reuters. June 13, 2013. http://uk.reuters.com/article/2013/06/13/uk-ecigarettes-insight-idUKBRE95C0F720130613 (accessed October 31, 2014)
6 Non-Smokers Rights Association. Product Regulation: The Buzz on E-Cigarettes. Available: http://www.nsra-adnf.ca/cms/page1385.cfm (accessed October 31, 2014)
7 Weeks, C. Could e-cigarettes save smokers' lives? Some health advocates think so. The Globe and Mail April 29, 2013. Retrieved from http://www.theglobeandmail.com/life/health-and-fitness/health/could-e-cigarettes-save-smokers-lives-some-health-advocates-think-so/article11583353/?cmpid=rss1
8 Toronto Public Health. E-cigarettes in Toronto. Staff report to the Toronto Board of Health. August 1, 2014. Available: http://www.toronto.ca/legdocs/mmis/2014/hl/bgrd/backgroundfile-72510.pdf (accessed October 31, 2014).
9 Centers for Disease Control and Prevention. Notes from the Field: Calls to Poison Centers for Exposures to Electronic Cigarettes - United States, September 2010-February 2014. Morbidity and Mortality Weekly Report, 63(13): 292-293. April 4, 2014. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm?s_cid=mm6313a4_w (accessed October 31, 2014).
10 World Health Organization. Electronic nicotine delivery systems. Conference of the Parties to the WHO Framework Convention on Tobacco Control. Sixth session Moscow, Russian Federation, 13-18 October 2014. Provisional agenda item 4.4.2. Available: http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf?ua=1
Since 2010, the Canadian Medical Association (CMA) has been calling for health care transformation in Canada to better meet the needs of Canadians. A high performing health care system must be able to respond to the changing nature of its population's health needs.
The CMA believes that seniors care is the paramount health care issue of our time. Our older population will double over the next 20 years, while the 85 and older group is set to quadruple. Currently, we spend almost half of all our health care dollars on seniors. Improving seniors' care will go a long way to fixing our health care system; this is because strategies to address the needs of this population can be leveraged to address the needs of other population groups. That is why CMA has called for the development of a Pan-Canadian Seniors Strategy as a necessary first step.
The CMA welcomes the creation of the Advisory Panel on Healthcare Innovation to better prepare health systems across the country for the above challenges and to contribute toward the sustainability of Canada's public finances and social programs. This brief identifies five important innovations that will not only benefit Canada's growing seniors population but the broader Canadian population as well.
Five Innovations to Improve our Health Care System
1. Supportive living models and palliative care
Canada suffers from a lack of integrated community/residential supports and palliative care models, contributing to poor patient outcomes, significant inappropriate use of health care resources, and higher health care costs. An obvious sign of this gap is the significant number of alternate-level-of care (ALC) patients-most of whom are seniors-languishing in hospitals across Canada. ALC patients are those inpatients that no longer require acute care and are waiting for placement in a more appropriate setting. According to a 2009 Canadian Institute for Health Information (CIHI) report, dementia accounted for almost one-quarter of ALC hospitalizations and more than one-third of ALC days.i Dementia is the leading cause of dependency and disability among older persons. The Wait Time Alliance (WTA) has stated that the most important action to improve timely access to specialty care for all Canadians is by addressing the issue of alternate-level-of-care (ALC) patients.ii
The creation of supportive and integrated living models particularly for the frail elderly and those with dementia would lead to improved health outcomes for these patients as well as savings to the health care system.
* Supportive living models can involve providing technology and human resources to support seniors to stay in their home. It has been estimated that tele-homecare could yield an annual reduction in approximately $540 million in inpatient costs and $23 million in emergency department visit costs.iii
* For others, particularly those with dementia, residential care models are required that can properly support their needs and provide the highest quality of life possible. A few such models are already in existence but more are required. Models include the Bruyère Village in Ottawa (http://www.bruyere.org/bruyere-village) and Saskatoon's Sherbrooke Community Centre (http://www.sherbrookecommunitycentre.ca/). CMA recommends that federal and provincial infrastructure programs allow for innovative residential care options to be eligible for funding.
* Despite the vast majority (96%) of Canadians supporting the use of palliative and hospice care in end-of-life care, only 16-30% of Canadians who are dying have access to or receive hospice, palliative and end-of-life servicesiv. This issue must be addressed immediately across the country. Currently, there is no standard palliative and hospice care model in Canada. However, there are some innovative programs around the country that are leading the way to higher quality palliative care (e.g., West Island Palliative Care Residence in Quebec). The CMA is currently preparing a report to inform health care decision makers including physicians on tools to integrate palliative and hospice care services in their respective communities. But assistance is required to implement innovative practice models across the country.
2. Integrated strategies for high-users of health care and at-risk populations
It is now recognized that a targeted approach is necessary to make substantive change to improve the health status of populations; including reducing health inequities and ensuring more appropriate access to health care resources by those citizens who have a range of socio-economic needs.
Approximately five percent of patients account for two-thirds (66 percent) of provincial health expenditures-many of whom are elderly. This picture is consistent across the country.v This high use is often due to systemic issues, such as poor integration or lack of access, rather than the choices of these patients. There is general agreement that multi-sectoral approaches are necessary that involve the integration of clinical and social care as well as other sectors to best address this population group that often has polymorbidities.
Programs are being implemented in a few provinces at the regional or provider level to try and accommodate the needs of the high-users population by coordinating and integrating care for the benefit of the patient and the family. Examples include Health Links in Ontario and the Regional Integrated Complex Patient Care Planning (RICP2) program at Vancouver Coastal Health Authority. However, funding models-particularly for inter-sectoral approaches-to support the wide-spread adoption of these approaches are rare.
In addition to the high-users are those populations that feature a high burden of illness. Hundreds of research papers have confirmed that people in the lowest socio-economic groups carry the greatest burden of illness.vi Those within the lowest socio-economic status are 1.4 times more likely to have a chronic disease, and 1.9 times more likely to be hospitalized for care of that disease.vii
As with the high-user group, a multi-sectoral approach is required to address the social determinants of health. While it is important for society to strive to eliminate poverty and provide adequate housing and food security, the health care sector can also contribute. Some innovative programs have been put in place such as the Well North program in the United Kingdom that is targeted at improving the health of the poorest fastest, reducing premature mortality and reducing worklessness.viii In Canada, the St. Michael's family health team has an income security specialist on their multi-disciplinary team. This individual helps patients to navigate the government's social services system, will help patients reduce expenses, complete their taxes, set up bank accounts, access free programs, budget and save for emergencies. These patients are identified through screening conducted by family physicians on the team.
There are innovative approaches being developed to address the needs of high-volume users as well as at-risk populations. As many of these innovations involve greater integration between health and the community sector and attention to issues not traditionally funded through health care payment systems, there is a need to provide access to funds to enable these innovations to continue and be spread across the country.
A targeted, integrated approach to identify communities in need is required and this must be based on reliable community data (i.e., meaningful use of patient data) which can be used to integrate resources to improve health status. The Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is Canada's first multi-disease electronic medical records (EMR) surveillance and research system that allows family physicians, epidemiologists and researchers from across the country to better understand and manage chronic care conditions for their patients. Health information is collected from EMRs in the offices of participating primary care providers (e.g. family physicians) for the purposes of improving the quality of care for Canadians suffering from chronic and mental health conditions and three neurologic conditions including Alzheimer's and related dementias. CPCSSN makes it possible to securely collect and report on vital information from Canadians' health records to improve the way these chronic diseases and neurologic conditions are managed (http://cpcssn.ca/). Despite this innovative approach to sharing information to better manage chronic care conditions, its five-year federal funding terminates in 2015. The estimated cost of continuing the project is approximately $3 million per year.
3. Optimal prescribing
Poor prescribing can lead to poor patient outcomes and unnecessary costs to the health care system (e.g., fractured hips from falls). The evidence is clear that many seniors in Canada are exposed to inappropriate drug therapy. Data from European countries such as Denmark, , show that inappropriate prescribing can be controlled with only 5.8% of elderly patients using an inappropriate medication in a four month period in 2001. In Canada, CIHI studied senior's drug claims from public programs in four provinces from 2000 to 2006 and found that the rate of inappropriate drug use in 2005-06 varied from 25.2% in Manitoba to 31.3% in New Brunswick. The rate of regular use of such medications ranged from 12.9% in Alberta to 18.8 % in New Brunswick.
E-prescribing decreases the likelihood of adverse drug events or interactions, and provides tools to monitor both patient adherence and practitioner prescribing patterns. One component of an optimal prescribing strategy would be to provide support to provincial/territorial ministries of health to complete the implementation of drug information systems and regional e-prescribing solutions, and/or to develop an agenda to accomplish the enhanced use of electronic medical records.
A second component of an optimal prescribing initiative would be the development of a collaboration of content experts and professional associations to raise awareness of inappropriate prescribing among physicians and other health professionals and then to develop online educational courses and practice tools to assist at the point of care. Initially the focus might be on prescribing for seniors, but subsequently could expand to cover other priority topics such as inappropriate antibiotic use or the use of narcotics for non-cancer pain.
4. Choosing Wisely Canada - Reducing the provision of low value care
A disconcerting proportion of health care, estimated in the United States to be as much as 30%, confers little of no benefit on patients and may, through exposure to excess radiation, drug reactions, adverse events during procedures, or the worry associated with false positive tests, actually cause harm. This represents both sub-optimal quality of care and poor stewardship of scarce health care resources.
The provision of unnecessary care is driven by many elements including physician habit, lack of up-to-date clinician knowledge, patient demand, and structural or financial incentives in the health system. To counter these diverse influences the CMA partnered with the University of Toronto to launch Choosing Wisely Canada, a campaign to facilitate evidence-informed conversations between physicians and patients about the necessity of tests and treatment about low-value tests and treatment. As of October 2014, 102 recommendations have been developed by national specialty societies about clinical activities that generally should be avoided. For example, the Canadian Geriatrics Society advises physicians and patients against the use of antipsychotics as a first choice to treat behavioural and psychological symptoms of dementia as well as against the use of benzodiazepines or other sedative-hypnotics in older adults as a first choice for insomnia, agitation or delirium.
Within its first year of operation the campaign enlisted over 30 national specialty societies, the College of Family Physicians of Canada, the Royal College of Physicians and Surgeons of Canada, all provincial and territorial medical associations, and six large citizen groups. To date the campaign has been resourced by seed funding from the Ontario government, direct contribution from the CMA, and a modest contribution agreement from Health Canada.
If the early success of Choosing Wisely Canada is to be sustained, secure long-term funding is essential. Such resources are necessary to support the development and dissemination of materials to raise physician awareness, provide educational opportunities, make available point-of-care tools, assist with implementation at the practice level, and contribute to data collection for evaluation. The medical professional has clearly stepped forward to take ownership of the low value care challenge; they deserve federal support to ensure a successful long-term outcome.
5. National Health Care Guidance Institute
Clinical practice guidelines (CPGs) have a unique ability to enhance quality of care. The peer-reviewed literature provides robust evidence that guideline use is associated with a positive impact on both processes of care and patient outcomes. Additionally, a number of studies have reported that the application of specific CPGs result in cost-effective care, including, for example, those used in the treatment of community-acquired pneumonia, stroke prevention in primary care, traumatic brain injury, and the use of lipid-lowering drugs. Conditions such as these gain particular significance in the face of an aging population: what is the out-patient antibiotic of choice in an elderly patient with pneumonia?; in an older patient with a cardiac arrhythmia what are the comparative risks of treatment with anticoagulants versus possible cerebrovascular accident?; at what age is it no longer helpful to treat hyperlipidemia? CPGs available at the point of care provide evidence-based answers to such questions.
Internationally, national governments have recognized the value of CPGs and taken a leadership role in ensuring their quality and making them available to practitioners. Three among many examples are: United States (Agency for Healthcare Research and Quality, National Guideline Clearinghouse); United Kingdom (National Institute for Health and Clinical Excellence); and Australia (National Health and Medical Research Council, National Institute of Clinical Studies).
The challenge is that CPGs are not uniformly utilized across Canada nor do we possess a national body or systematic approach to CPG development and dissemination. There are various models that can be implemented to execute this function (e.g., full function agency, collaborative virtual agency) to perform such key functions as prioritizing areas for guideline development, maintaining a national repository and driving active dissemination. The key is having a dedicated agency that can oversee the development and dissemination of CPGs at a pan-Canadian level to improve the quality of care that Canadians receive.
Federal mechanisms to support health innovation
All health systems in Canada and elsewhere are facing the challenge to better meet the needs of their seniors' population. National governments can provide necessary direction and support. The federal government must play a leadership role on seniors care and supporting health care innovation in concert with the provinces and territories and as a system manager itself for those patients falling under federal jurisdiction (e.g., armed forces). This can begin with a First Ministers' Conference as part of the development of a Pan-Canadian Seniors Strategy.
CMA recognizes there are elements of transformation already taking place in the country across the continuum of care that are being supported by technological innovation or clinical innovation (e.g., Choosing Wisely Canada). However, in many cases, there is little funding available to fund projects beyond pilot project status or bring them up to scale, and there is very little cross-country awareness of these "pockets of excellence" due to the absence of mechanisms to share best practices.
Accordingly, CMA recommends the establishment of a National Health System Innovation Fund targeted to provinces and territories to support the adoption of health system innovations including those identified in this brief. Funding criteria should be designed to not only support the development of these innovations but to incent their adoption on a scaled-up basis.
Finally, recognizing the relationship of the social determinants of health on the demands of the health care system, the federal government should implement a requirement for all cabinet decision-making to include a health-in-all policies approach whereby all polices from tax, to transportation, to trade would undergo a health lens to ensure that negative health impacts were minimized/eliminated and positive health outcomes were supported or expanded. This would help to minimize the often unintended health consequences that arise from policies outside of the health sector.
This brief identifies five opportunities for innovating Canada's health care system by improving seniors care-the paramount health care issue of our time. Our proposed innovations would not only improve the efficient delivery of health care but more importantly the quality of care provided to all Canadians. These innovation initiatives require medical leadership at the point of care level in tandem with change at the broader system level with federal support. Together, these innovations can further contribute to the transformation of Canada's health care system-one that better meets the needs of Canadians today and into the future.
i Canadian Institute for Health Information. Alternate level of care in Canada. Ottawa (ON): The Institute; 2009. Available: https://secure.cihi.ca/free_products/ALC_AIB_FINAL.pdf
ii Wait Time Alliance, Shedding light on Canadians' total wait for care. Report card on wait times in Canada. June 2012.
iii Telehealth Benefits and Adoption: Connecting People and Providers Across Canada. Praxia and Gartner. May, 30, 2011.
iv Canadian Hospice Palliative Care Association. 2014. Fact sheet: hospice palliative care in Canada. [Accessed 11 November 2014]. Available from http://www.chpca.net/media/330558/Fact_Sheet_HPC_in_Canada%20Spring%202014%20Final.pdf
v Canadian Institute for Health Information. Pan-Canadian forum on high users of health care-Summary report. The Institute: 2014.
vi Dunn, James R. (2002) The Health Determinants Partnership Making Connections Project: Are Widening Income Inequalities Making Canada Less Healthy? Available at: http://www.opha.on.ca/our_voice/collaborations/makeconnxn/HDP-proj-full.pdf
vii CIHI/CPHI (2012) Disparities in Primary Health Care Experiences Among Canadians with Ambulatory Care Sensitive Conditions. http://secure.cihi.ca/cihiweb/products/PHC_Experiences_AiB2012_E.pdf
The Canadian Medical Association (CMA) submits this response to the Canada Revenue Agency (CRA) as part of its public consultation on the Disability Tax Credit.
The CMA has long-standing and significant concerns pertaining to the Disability Tax Credit. Most notable is the recent legislative development that resulted in physicians being captured in the definition of “promoter”. In light of the significant concern with physicians being captured in the definition of “promoter”, this submission will focus exclusively on the regulatory development following the enactment of the Disability Tax Credit Promoters Restrictions Act. However, the CMA will follow up at a later date with feedback and recommendations to CRA on how the Disability Tax Credit form and process can be improved.
Prior to providing the CMA’s position for consideration as part of the regulatory consultation, relevant background respecting the CMA’s participation and recommendations during the legislative process is reviewed.
2. Background: CMA’s Recommendations during the Legislative Process
The CMA actively monitored and participated in the consultation process during the legislative development of Bill C-462, Disability Tax Credit Promoters Restrictions Act. During its consideration by the House of Commons, the CMA appeared before the House of Commons Finance Committee and formally submitted its recommendations.1 The CMA’s submission to the Finance Committee is attached as an appendix for reference. Throughout this process, the CMA consistently raised its concern that the bill proposed to include
physicians in the definition of “promoter”, to which the response was consistently that physicians would not be captured. The Member of Parliament sponsoring the bill conveyed this message at the second reading stage in the House of Commons:
1 Canada. Parliament. House of Commons. Standing Committee on Finance (2013). Evidence, May 7, 2013. 41st Parliament, 1st Session. Retrieved from www.parl.gc.ca/HousePublications/Publication.aspx?DocId=6138958&Language=E&Mode=1&Parl=41&Ses=1
“Mr. Massimo Pacetti: Mr. Speaker…[in] her bill, she says that the definition of a promoter means a person who directly or indirectly accepts or charges a fee in respect to a disability tax credit. Who is a promoter exactly? Is a doctor, or a lawyer or an accountant considered a promoter?
Mrs. Cheryl Gallant: Mr. Speaker, that is an excellent question from my colleague opposite. We are looking at third party promoters quite apart from the regular tax preparers and accountants. It is a new cottage industry that sprung up once the 10- year retroactive provision was made. It recognizes that there are volunteer organizations and even constituency offices that do this type of work. They help constituents fill out applications for tax credits. There is a provision for exemptions so people who volunteer their time at no charge or doctors do not fall into this.”2
In contradiction to this statement, during the Senate National Finance Committee’s study of Bill C-462, CRA Assistant Commissioner Brian McCauley confirmed the CMA’s concerns,
stating explicitly that physicians would be captured in the definition of “promoter” and explained “they have to be captured because, if they weren't, you leave a significant compliance loophole”.3
As will be explained further below in this submission, this statement reveals a lack of
understanding of the implications of capturing physicians in the definition of “promoter”, in that it has established duplicative regulatory oversight of physicians, specific to the Disability Tax Credit form.
3. Priority Issue: Identify Physicians as an Exempt Profession in Regulation
The CMA has been consistent in our opposition to the approach that resulted in physicians being included in the definition of “promoters”. The definition of “promoter” captures physicians who may charge a fee to complete the disability tax credit form, a typical practice
2 C. Gallant. (2013 Feb. 5) Parliament of Canada. Debates of House of Commons (Hansard). 41st Parliament, 1st Session. Retrieved at www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=5962192#Int-7872066
3 Canada. Parliament. Senate. Standing Committee on National Finance (2014). Evidence, April 2, 2014. 41st Parliament, 2nd Session. Retrieved at www.parl.gc.ca/Content/SEN/Committee/412/nffn/09ev-51313-e.htm?Language=E&Parl=41&Ses=2&comm_id=13.
for uninsured physician services.
As indicated on page 4 of the CRA’s consultation document, the Disability Tax Credit Promoters Restrictions Act includes the authority to “identify the type of promoter, if any, who is exempt from the reporting requirements under the Act.” Two questions are included on page 7 of the consultation document in relation to this regulatory authority.
It is the CMA’s recommendation in response to Question 12 (“Are there any groups or professions that should be exempt from the reporting requirements of the new Act?”) that physicians licensed to practice are identified in regulation as an exempt profession.
Specifically, the CMA recommends that CRA include an exemption in the regulations for “a health care practitioner duly licensed under the applicable regulatory authority who provides health care and treatment” from the reporting requirements of the Disability Tax Credit Promoters Restrictions Act.
As explained below, this exemption will not introduce a potential loophole that may be exploited by third party companies to circumvent the new restrictions and will mitigate the legislative development that has introduced duplicative regulatory oversight of physicians.
4. Exemption Required to Avoid Duplicative Regulatory Regime; Not a Loophole
By capturing physicians in the definition of promoters, the Disability Tax Credit Promoters Restrictions Act has introduced a duplicative regulatory body for physicians: a development which the CMA has fundamentally opposed.
As CMA understands it, the CRA’s key concern in capturing physicians in the definition of promoter is with respect to the possibility that third party companies may circumvent these limitations by employing a physician. As previously noted, this issue was raised by CRA’s Assistant Commissioner Brian McCauley in his appearance before the Senate National Finance Committee during its study of Bill C-462.
A) CMA’s Recommendation Respects Existing Regulatory Oversight Regime of Physicians
The CMA’s recommendation and regulatory proposal limits the exemption of physicians as a profession to those currently licensed under the regulatory authority of provincial/territorial medical regulatory colleges. In Canada, medical practice is the regulatory purview of provinces and territories.
Charging a fee for the completion of a form is a typical practice for uninsured services – these are services that fall outside of provincial/territorial health insurance coverage. The practice of charging a fee for an uninsured service by a licensed physician is an activity that is part of medical practice. Such fees are subject to guidelines by provincial and territorial medical associations and oversight by provincial/territorial medical regulatory colleges.
The regulatory oversight, including licensing, of physicians falls under the statutory authority of medical regulatory colleges, as legislated and regulated by provincial and territorial governments. For example, in the Province of Saskatchewan, the Medical Profession Act, 1981 establishes the regulatory authority of the College of Physicians and Surgeons of Saskatchewan. This regulatory authority is comprehensive and captures: medical licensure, governing standards of practice, professional oversight, disciplinary proceedings, and offences. In Ontario, this authority is established by the Regulated Health Professions Act, 1991; in British Columbia, by the Health Professions Act, 1996, and so on.
B) CMA’s Recommendation Does Not Introduce a Loophole
The exemption of physicians as a profession that is “duly licensed under the applicable regulatory authority who provides health care and treatment” would not constitute a loophole. Firstly, any concerns regarding the practices of a physician that is exempted based on this definition could be advanced to the applicable regulatory college for regulatory oversight and if appropriate, discipline.
The CMA’s proposed regulatory exemption would not be applicable in the case of a physician not licensed to practice; in this case, the individual would not be under the regulatory authority of a medical regulatory college and would fall under the CRA’s regulatory purview,
as established by the Disability Tax Credit Promoters Restrictions Act. With regard to the example raised by CRA’s Assistant Commissioner Brian McCauley in his remarks before the Senate Committee of a retired doctor hired by promoter, retired physicians can retain their licence. If this was the case for this particular physician, as noted above, when CRA had concerns regarding this physician’s actions, his or her regulatory college could have taken appropriate disciplinary action. If, on the other hand, this retired physician’s licence had lapsed, both the individual and the promoter who hired him or her would be potentially liable for fraud (assuming that the term “medical doctor” used in Form T2201 refers to an actively licensed physician) which would convey more serious consequences than those proposed by the Disability Tax Credit Promoters Restrictions Act.
The CMA strongly encourages the CRA to identify physicians as a profession that is exempt from the reporting requirements of the Disability Tax Credit Promoters Restrictions Act. This exemption is critical to ensure that possible unintended consequences, specifically duplicative regulatory oversight of physicians, are avoided.