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Principles for providing information about prescription drugs to consumers

https://policybase.cma.ca/en/permalink/policy189
Last Reviewed
2019-03-03
Date
2003-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2003-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Principles For Providing Information About Prescription Drugs To Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada1, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 2 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. 1 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 2 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general.
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Cannabis for Medical Purposes

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

https://policybase.cma.ca/en/permalink/policy9919
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Text
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
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A Prescription for Optimal Prescribing

https://policybase.cma.ca/en/permalink/policy10016
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
This paper presents the position of the Canadian Medical Association on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It also makes recommendations for future action that physicians, governments and others might take to foster optimal prescribing practices. CMA believes that optimal prescribing is the prescription of a drug that is: - The most clinically appropriate for the patient's condition; - Safe and effective; - Part of a comprehensive treatment plan; and - The most cost-effective drug available to meet the patient's needs. Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage. The CMA proposes a "prescription for optimal prescribing" that encompasses six elements, and makes the following recommendations: A National Strategy 1) Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Physicians 2) The CMA supports the development and dissemination of prescribing information that is: - based on the best available scientific evidence; -relevant to clinical practice; - easy to incorporate into a physician's workflow. 3) The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. 4) The CMA and provincial/territorial medical associations call on governments to support and fund impartial continuing medical education programs on optimal prescribing. 5) The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity and impartiality of continuing medical education. 6) The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing clinical research on the effectiveness of interventions designed to change behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. Element 2: Electronic Prescribing 7) The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. 8) The CMA calls on governments to incorporate into electronic prescribing the following principles: - Measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information; - A link with a formulary, to provide physicians with best practice information including drug cost data; - Guidelines for data sharing among health professionals and others; - Standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers 9) The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. Element 4: Collaboration among Health Care Providers 10) The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. Element 5: Impartial, Evidence-based Information for Patients 11) The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers about prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to patients. 12) The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation 13) The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 1 Introduction In an ideal world, all patients would be prescribed the drugs that have the most beneficial effect on their condition while doing the least possible harm, at the most appropriate cost to the patient and the health care system. It is generally agreed that we have not yet achieved that ideal. But the Canadian Medical Association (CMA) and the physicians of Canada believe it is a goal worth striving to attain. The CMA has a long-standing commitment to fostering high-quality health care. One of the key elements of the long-term Health Care Transformation project, in which CMA is currently involved, is ensuring that systems are in place to foster health care that is of high quality. One such system would be the active encouragement of optimal prescribing. This paper presents the CMA's position and recommendations on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It looks at prescribing mainly from the perspective of the practicing physician who is seeking the most appropriate treatments for individual patients. However it also comments on the effects of prescribing on the broader health care system, both on Canadians' overall health status and on the costs of delivering health care. 2) Optimal Prescribing: CMA's Definition and Principles a) What is Optimal Prescribing? Prescribing is not an exact science; the choice of a particular drug to treat a particular patient depends on that patient's unique circumstances. CMA's proposed definition and principles for optimal prescribing is as follows: Optimal prescribing is the prescription of a drug that is - the most clinically appropriate drug for the patient's condition; - safe and effective; - part of a comprehensive treatment plan; and - the most cost-effective drug available to best meet the patient's needs. b) Principles for Optimal Prescribing CMA believes that in an optimal prescribing environment, the following principles should apply: Principles for Optimal Prescribing 1) The primary goal of prescribing should be to improve or maintain the health of the patient. 2) Prescribing should take place in the context of overall patient care which involves diagnosis of the condition, other forms of treatment including rehabilitation, counselling and lifestyle adjustments, ongoing monitoring and re-evaluation of the patient's condition and treatment to make sure the patient is responding appropriately, ensuring patient adherence to medication regimen, and discontinuation of drug treatment when it is no longer needed. 3) Patients should be actively involved in decisions regarding their drug treatment; for this, useful and practical patient information is required. 4) Prescribing decisions should be based on the best available scientific evidence, which is continually evaluated and updated as need arises. 5) Physicians should retain clinical autonomy in deciding which drugs to prescribe. 6) Prescribing decisions should take into account the cost to the patient, and strive to achieve cost-effectiveness as long as this does not conflict with the goal of optimal patient care. 7) Physicians should be updated on new developments in pharmacotherapy, through an ongoing process of relevant, objective continuing education. 8) Health professionals should take a leadership role in developing and evaluating strategies and tools to enhance best practices in prescribing. Though these principles may also apply to the optimal use of medical devices, prescription drugs are the primary focus of the paper. 3 Why Optimal Prescribing is Important Prescription drugs are an increasingly important part of patient care in Canada. Fifty years ago, they were used mainly for short periods of time to treat acute conditions, and their contribution to overall health care costs was small. But in 2005, Canadians received 14 prescriptions per capita; that number rose to 74 for people 80 years and over.i Many Canadians now take prescription drugs over the long term to manage chronic conditions such as diabetes, osteoporosis or high cholesterol. Increased drug utilization, and the high prices of many new drug therapies, have increased the cost of prescription drugs to Canadians and to the health care system. In 2008 Canadians spent about $25.4 billion on prescription drugs. This, in constant dollars, is roughly triple what was spent in 1985.ii Together, prescription and over-the-counter drugs consume a larger portion of overall costs than do physicians' services; in fact, only hospitals consume a larger share. In many cases prescription drugs have reduced reliance on hospitalization and surgical procedures. For example, over the past decades drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. On the other hand, patients may take certain medications or classes of medications for many years, and this long-term use may have health consequences that are currently unknown. As their role in health care increases, there is increasing public scrutiny over whether the prescription drugs Canadians use are safe and effective, whether they give good value for money, and whether they are being prescribed and taken optimally for maximum patient benefit. As mentioned before, prescribing is not an exact science; what in some cases might be considered "suboptimal" is in other cases quite appropriate. In most instances, drugs are prescribed appropriately. However, evidence suggests that in some areas there is room for improvement. Prescribers can enhance patient care and improve Canadians' health by adopting strategies such as the following: - Reducing overprescribing of certain drugs. For example, overuse of antibiotics is a worldwide concerniii since it may hasten the development of antibiotic resistance, thereby reducing the physician's therapeutic arsenal. - Reducing underprescribing of certain drugs. A study of primary care practices in Ontario found that while 14% of adult patients had dyslipidemia, 63.2 % were untreated and, of those treated, 47.2% were not adequately controlled .iv - Prescribing drugs according to generally accepted clinical practice guidelines to ensure that first-line drugs are used where indicated. Second-line therapies are frequently newer and less established than first-line ones, and are thus more likely to have unidentified safety risks. - Ensuring that drugs are prescribed and taken safely, to reduce the harm caused by adverse interactions with other drugs, natural health products, alcohol or other agents in the patient's system. Activities in support of the above strategies should be included in any program or initiative aimed at improving health care in Canada. CMA believes they will contribute to Canadians' overall health status, and may have the additional benefit of reducing health care costs if the prescribed drugs are the most cost-effective available to appropriately treat patients' conditions. 4) Many Factors Affect Prescribing Prescribing does not occur in a vacuum, but is the result of a number of factors that influence physicians. It may be questioned whether these factors provide the necessary support to physicians as they seek to prescribe optimally. Some of these influences are discussed below: a) The Challenge Of Acquiring Information Our knowledge of prescription drugs and their effects is continually being updated, and physicians are required to absorb new information throughout their careers. But are physicians receiving the information they most need, in such a way that they can easily and painlessly incorporate it into their practices? CMA's answer is: there is room for improvement. The major information sources available to physicians are discussed below: i) Physician Education Medical school and residency training - Medical schools vary in how they discuss pharmacological issues, and critics have questioned whether Canada's current medical school curriculum is training future physicians adequately in the art and science of prescribing.v In some cases, pharmacotherapy is taught in the context of each individual body system - cardiac, renal, etc. - rather than as a discrete subject. With this approach, some valuable unifying elements of pharmacology may go untaught. Continuing medical education (CME) - For physicians, CME is an important source of information on new drugs and new indications for existing drugs. But is it imparting the most necessary or appropriate information? Concerns have been raised as to its impartiality; it is estimated that pharmaceutical industry sponsorship accounts for 65% of the total revenue of CME programs in the U.S. and the figure is assumed to be much the same in Canada.vi ii) Point-of-care information With increasingly heavy patient loads, the time at physicians' disposal for research is limited. Often new information is required at the point of care; for example, in the examination room during a patient encounter, when the physician requires an answer quickly. The clinical practice guidelines and point of care reference guides in common use may not be readily accessible in a concise, user-friendly format when needed. In addition, it is of concern that some experts who develop practice guidelines have ties to pharmaceutical manufacturers, which could affect the guidelines' impartiality. To compound the problem, widely used sources of information may not be giving physicians the material they most need. Physicians often receive new safety information, such as warnings of recently discovered drug risks, in the form of advisories from Health Canada or elsewhere. These advisories may not provide physicians with prescribing advice, or information about other treatment options if the drug is considered too dangerous for use. iii) Drug promotion and marketing Much of physicians' information about drugs and prescribing comes from the pharmaceutical industry representatives who visit them in their offices. Drugs promoted in this manner tend to be newer; consequently they are often more expensive than established medications and less is known about their efficacy and possible side effects. Drug promotion might help instil in some physicians' minds the perception that when it comes to medication, "new" equals "better," when this is not always the case. Industry marketing also comes in more subtle forms, such as: - Free drug samples provided to physicians; since samples tend to be mainly for new drugs, it has been suggested that they encourage these drugs' use at the expense of possibly cheaper and safer alternatives. - Collection, by commercial data management companies, of information on physicians' prescribing patterns , which is then sold to pharmaceutical companies to help tailor sales messages to individual physicians. - Manipulation of the medical publication process, through: design of clinical trials so as to get the most positive results; selective publication of clinical trial results; or "ghostwriting" of scholarly research articles by pharmaceutical industry contractors.vii b) Patient education and participation When considering a patient's drug therapy, the physician must consider the possible effect of the patient's behaviour on treatment. A patient may require counselling on the impact of natural health products, alcohol and other substances when mixed with their prescribed medications; on the importance of adherence to the prescribed treatment; or on the need for changes in behaviour (improved diet, increased physical activity) to augment the medication's benefits. This requires open and honest dialogue between patient and physician. Patient knowledge and preferences can influence both over- and under-prescribing. Some patients may not feel that they have been "treated" unless they leave the doctor's office with a prescription. A physician may prescribe a drug if a patient requests it, despite feeling ambivalent about the choice of treatment.viii On the other hand, a physician may not prescribe a needed medication because a patient insists he or she does not want to be "on drugs." The pharmaceutical industry directs promotional activities at patients as well as physicians. Though direct-to consumer advertising (DTCA) or prescription drugs is technically illegal in Canada, loopholes in the law permit a limited amount of Canadian-based drug promotion, and drug ads are often beamed across the border from the United States, one of only two countries (the other being New Zealand) where DTCA is legal. DTCA has a strong influence on patient behaviour; according to one survey by the U.S. Government Accounting Office, 27% of people who saw prescription drug advertisements, requested and received these drugs from their physicians.ix DTCA has been widely criticized for overstating drugs' benefits, playing down their risks, and contributing to a "pill for every ill" mindset and the "medicalization" of conditions that could be more appropriately managed by lifestyle changes or other non-drug therapies. In addition, the pharmaceutical industry can exert indirect influence on patient attitudes through funding of patient advocacy groups and disease-specific web sites. A patient's social context may also motivate a physician to prescribe a drug that may not be clinically indicated. For example, an antipsychotic may be prescribed to calm a patient with dementia, not so much for the patient's benefit as for that of tired and stressed-out caregivers, despite growing evidence of the drugs' health and safety risks and lack of efficacyx. Ideally, prescribing recommendations and guidelines should take into account the broader context in which a drug is prescribed. c) Drug cost and coverage The physician's prescribing of a drug and the patient's purchase of it are separate and unconnected acts. As a result, physicians may not have access to reliable, convenient information on drug costs; or if they do, they may have little reason to use this information if the patient has insurance coverage. However, rising drug prices, and the increased use of drug therapy, may require them to take cost into consideration more often. Provincial and territorial governments, and increasingly, private insurers as well, can influence physician and patient choice of drugs by restricting what medications are covered on their formularies. In addition, many payers have programs to encourage the prescribing of certain drugs such as generics. If, as not infrequently happens, a patient's condition requires a drug not on the formulary, obtaining coverage for this drug requires time-consuming paperwork. The administrative burden this imposes can be a barrier to optimal prescribing. d) The policy context Canadian decision makers have already recognized that action on prescribing is needed. One of the original nine elements of the federal/provincial/territorial National Pharmaceuticals Strategy (NPS), announced in 2004, was "Enhance action to influence the prescribing behaviour of health care professionals so that drugs are used only when needed and the right drug is used for the right problem." However, this was not considered a priority, and the entire NPS is now dormant. In 2009, the Health Council of Canada recommended that optimal prescribing be a priority element in a revived pharmaceutical strategy, noting the need for easily accessible, evidence-based information on the proper use and risks of each medication, and for national co-ordination of efforts toward improved prescribing.xi 5. The CMA's Prescription The previous sections have described the problems that currently exist with prescribing in Canada, and factors that contribute to these problems. In this section the CMA discusses what can be done to make prescribing optimal. Even as a variety of factors influence prescribing, so a variety of elements can contribute to optimizing it. What should be done to encourage optimal prescribing in Canada? The CMA believes that optimal prescribing should be addressed through the development and implementation of a national strategy comprising the six elements discussed in the following pages: Recommendation 1 Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Prescribers As our knowledge base on prescription drugs expands, it is communicated to physicians by many different means. The CMA believes it is possible to improve these communications and make them more relevant and useful to prescribing physicians. Recommendation 2 The CMA supports the development and dissemination of prescribing information that is: o based on the best available scientific evidence o relevant to clinical practice o easy to incorporate into a physician's workflow. a) Undergraduate medical education and residency training A basic grounding in pharmacology is a vital part of undergraduate medical education. Appendix 1, which was taken from a 2009 report prepared by Britain's Royal College of Physicians, contains a specific proposal for a core undergraduate curriculum in therapeutics. Basic education in pharmacology should, among other things, help prepare future physicians for the challenge of maintaining their knowledge base in practice. The academic community has a role to play, during undergraduate training and residency, in providing impartial advice on pharmaceutical matters, and ensuring that students and residents can appraise drug research and prescribing guidance critically. Recommendation 3 The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. b) Continuing medical education (CME) Traditionally, CME meant face-to-face seminars or conferences; however, studies are demonstrating that Internet-based learning is as effective as face-to-face CME.xii Developers and practitioners are increasingly looking at delivering CME online. Of particular promise are formats that deliver information electronically in short, summary bullet points, presenting the most pertinent information on a single screen where feasible. As mentioned before, a large proportion of CME is sponsored by the pharmaceutical industry. Like pharmaceutical detailing, industry-sponsored CME might steer physicians toward newer drugs which may not be first-line therapies, and which are often less thoroughly evaluated and more expensive than established treatments. Therefore, in order that physicians can be assured of receiving objective information, there is an urgent need for objective funding sources for CME, that are as distant as possible from potential sources of bias. Recommendation 4 The CMA and provincial/territorial medical associations call on governments to support and fund objective and impartial continuing medical education programs on optimal prescribing. Recommendation 5 The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity of continuing medical education. CMA's Guidelines for Physicians in Interaction with Industry (2007) proposes ways in which physicians, medical associations and medical educational bodies can minimize bias when collaborating with industry on CME and continuing professional development programs. c) New Forms of Education Besides formal CME, there are many ways of conveying information to physicians with the intent of influencing prescribing behaviour. One promising intervention is academic detailing, in which trained physicians or pharmacists use the personalized, one-on-one techniques employed by pharmaceutical detailers to encourage adoption of a desired behaviour (e.g., prescribing of a particular drug or treatment regimen) rather than specific drugs, to counterbalance marketing by pharmaceutical representatives. Academic detailing has demonstrated some success. Because it is expensive and labour intensive, it has often been difficult to persuade governments to invest in it. However, a growing number of provinces have developed, or are considering, academic detailing programs. Another promising intervention is physician self-directed learning. In Alberta two medical schools are preparing to perform an analysis of physicians' perceived and unperceived learning needs with the intention of developing individualized learning programs to address the needs of physicians in their practices. The effectiveness of various learning programs in changing behaviour is being studied on an ongoing basisxiii, through means such as the Rx for Change database, a collaborative effort between two Cochrane Collaboration groups and the Canadian Agency for Drugs and Technologies in Health. This database summarizes current research evidence, regularly updated, about the effects of strategies to improve drug prescribing practice and drug use. Because different physicians have different needs, goals and styles of learning, multiple formats are required to address them. Though one intervention in and of itself may not produce widespread, immediate or dramatic changes in behaviour, the cumulative effect of multiple messages over time can be very strong. Recommendation 6 The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing research on the effectiveness of interventions designed to change clinical behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. d) Point-of-care information In addition to formal education programs, information on pharmaceuticals and prescribing is also available to physicians at the point of care. Physicians' preference is for brief summaries of key points, which can be absorbed quickly and be accessed at point of care through hand-held personal digital assistants (PDA's) or, increasingly, through electronic health and prescription records. Drug information compendia are available in electronic and print format. For example, cma.ca provides information about prescription drugs through a program called Lexi-Drugs Online. e-Therapeutics+, developed by the Canadian Pharmacists Association, is another online resource for prescribing and managing drug therapy at the point of care. Online programs are also available that monitor physicians' prescribing habits and compare them to those of their peers. Such programs are to be encouraged if their purpose is to educate rather than to enforce a certain behaviour. However, they will require additional investment, particularly in information technology and software development. Element 2: Electronic Prescribing Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system has the potential to: - list all the drugs a patient is taking. It could also identify duplicate prescriptions for the same drug from different providers, thus helping to reduce prescription fraud and prescription drug abuse; - provide decision-support tools; for example, a warning could appear on the screen if the physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. This decision support should ideally be updated in real time so the physician has access to the most current information. - Enable the improvement of patient adherence to drug therapy, perhaps by generating reminders to patients to refill and take prescriptions. - Transmit prescriptions to pharmacies electronically, increasing convenience for the patient and eliminating a major cause of medication errors, illegible handwriting. - Automatically link to a formulary to enable the prescriber to see whether the patient's insurer has approved the medication, or to find the lowest-cost drug in a class. Two-way electronic communication with formulary managers may also help reduce some of the administrative paperwork which is a barrier to optimal prescribing. - Automatically notify physicians of drug shortages, recalls or other urgent situations. In the U.S., e-prescribing is being actively encouraged. Since January 2009, the American Medicare system provides financial incentives for its physicians who adopt e-prescribing. In Canada adoption has been slow;xiv it is estimated that fewer than 10% of physicians e-prescribe. This may be due partly to the expense, and partly because of issues which remain to be addressed, such as: - How do we assure that the confidentiality of patients' health information, and of physicians' prescribing information, is protected? - What information should be shared with other health professionals? - What legally constitutes a "signature," or other means of authenticating a prescription? - Can we ensure that pharmacies as well as physicians' offices are equipped to receive electronic prescriptions? - Can we ensure that e-prescribing software is designed so as to be practical and user-friendly for physicians; for example, that pop-up warnings contain the most important and relevant information? - Can we ensure that e-prescribing protocols simplify a physician's workload rather than adding to it - for example, that they eliminate duplication of prescription writing? E-prescribing is in its early stages, and knowledge and policy in this area are developing rapidly. CMA will continue to study the issue in the coming years. Several provinces maintain electronic prescription databases and others are in development. For example, BC PharmNet provides drug-to-drug interaction checking and patient medication profiles to pharmacists, emergency rooms and physicians with controlled access. In most provinces and territories, medical associations are working with governments on standards to implement e-prescribing. Recommendation 7: The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. Recommendation 8: The CMA calls on governments to incorporate into electronic prescribing the following principles: - measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information - a link with a formulary, to provide physicians with best practice information including drug cost data - guidelines for data sharing among health professionals and others - standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers Government drug plans and, increasingly, private insurance companies, have instituted programs to encourage prescription of certain drugs. Such programs, which are often motivated by the desire to control rising drug costs, can include the following: a) Formularies There are 18 public drug formularies in Canada managed by federal or provincial/territorial governments. These formularies often use various means to help control drug costs. For example, if a generic drug is available to treat a given condition, a payer may reimburse patients only for the generic rather than for brand-name equivalents. Or if several related drugs exist in the same class, a formulary could reimburse only for the lowest-priced drug in that class, as British Columbia's reference-based drug pricing (RDP) program does for five drug categories that contain several drugs with equal efficacy; if patients want to purchase a higher-priced drug they must pay the difference out of pocket. Such programs are not confined to Canada; Britain's National Health Services funds specific treatments only if recommended by the National Institute for Clinical Excellence (NICE) which assesses new drugs for efficacy and cost-effectiveness. Under New Zealand's PHARMAC system the government reimburses only for one drug in each class. A formulary's cost-control objectives can sometimes conflict with the goal of physician and patient to obtain the care they believe will be most optimal. For example, formulary rules limiting the length of chronic prescriptions can make it difficult for physicians to prescribe over the long term to patients who manage their conditions well. It is important that formulary rules be based on the best available scientific evidence. The ideal formulary will be designed to improve clinical care, optimize patients' health outcomes, promote patient safety, and reduce the administrative burden on the physician. Recommendation 9 The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. b) Prescribing incentives Sometimes, payers may provide incentives such as reward payments for physicians who prescribe in a desired way (for example, who prescribe more than a certain percentage of a given drug class as generics), or impose a financial penalty for physicians who do not exhibit the desired behaviour. Financial incentives to physicians to provide preventive care services have been used effectively but their effect on prescribing practices is only beginning to be evaluated. A study of U.K. prescribing incentive schemes concluded that reward payments may have contributed to cost control, but their effect on prescribing quality remained uncertain. xv CMA's ongoing Health Care Transformation initiative will provide decision makers with blueprint for a high-performing, patient-centered health care system. Among its other activities over the next few years, this initiative will be examining in greater detail the effect of pay-for-performance schemes on the quality of care in Canada. Element 4: Collaboration Among Health Care Providers No health professional is an island. Increasingly health care providers are working in collaborative teams to manage drug therapy and other forms of patient care. In such teams, for example, pharmacists may perform a variety of functions, such as reviewing patients' medication profiles to catch medication related problems such as inappropriate dosing, duplicate or unnecessary therapies; or managing long-term drug therapy for patients with chronic conditions such as asthma or diabetes. At their most effective, such collaborative arrangements could greatly improve drug therapy, and patient care in general, by allowing the team to draw on a common pool of expertise. However, if improperly implemented, they could lead to breakdown of communication and fragmentation of care. To ensure that collaborative management of a patient's drug therapy functions smoothly, it is important that clearly articulated arrangements be in place. CMA's position statement Achieving Patient-Centered Collaborative Care (2007), includes the following principles: - Patient-centered care. Patient care (including drug therapy) must be aligned around the values and needs of the patient. - Clear communication. Effective communication is essential to ensure safe and coordinated drug therapy and to ensure that the patient is receiving timely, clear and consistent messaging. For example, if a physician and pharmacist are both managing and monitoring a patient with asthma, it is essential that they notify each other if a change is made to a prescription, such as a new drug or a new dosage. Electronic health records have the potential to greatly improve communication among providers. - Clinical leader. CMA's position statement defines a clinical leader as "the individual who, based on his or her training, competency and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient." In most cases the physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume this role. Recommendation 10: The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. The CMA, recognizing the need for and value of collaboration in the management of drug therapy, will continue to explore and encourage the most effective models for collaborative practice among health professionals. Element 5: Impartial, Evidence-based Information for Patients Canadians have the right to accurate, reliable information on prescription drugs and their uses, so that they can become knowledgeable partners in their care. A good deal of information is already available to patients, and there are ways in which it could be improved and made more accessible and relevant. One way would be to improve its clarity and readability, to address the needs of the estimated 6 in 10 Canadians who lack the health literacy necessary to properly manage their health and engage in preventive practices.xvi Another way would be to provide more information from impartial sources, to reduce the impact of direct-to-consumer advertising. The CMA believes that in general, brand specific advertising is a less than optimal way of providing drug information, and that the laws currently banning direct-to-consumer prescription drug advertising in Canada should remain in effect, and tightened to eliminate existing loopholes. Physicians and other health care providers can also play an important role in providing patients with guidance and with accurate information on the medications they take. CMA and the Canadian Pharmacists Association have collaborated with Canada's Research-based Drug Companies (Rx&D) to produce a pamphlet called "Knowledge is the Best Medicine" which provides consumers with advice on safe medication use, and guidance on how to interact effectively with their physician or pharmacist. Recommendation 11: The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers on prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to their patients. Recommendation 12: The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation Drug development is an ongoing process, and the evaluation of drugs and their prescribing should be ongoing as well. Canada already supports a certain amount of research activity in this area. For example, Health Canada funds the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), a collaborative, pan-Canadian service to identify and promote optimal drug therapy. COMPUS collects and evaluates relevant existing evidence, and provides advice, tools, and strategies to implement and support the adoption of optimal drug therapy. COMPUS has produced, or is producing, evidence-based recommendations for prescribing proton pump inhibitors and drugs for diabetes management. COMPUS has established links to university-based providers of CME, and with academic detailing groups, who help to disseminate its recommendations and materials. It also manages the Rx for Change database previously mentioned. The federal government has recently established and funded a national Drug Safety and Effectiveness Network. This network will link researchers to help coordinate and fund independent research on the risks and benefits of drugs that are on the market. We hope that this signifies a long-term commitment on the country's part to optimal drug therapy. CMA believes Canada should build on this activity by encouraging research on an ongoing basis on: - prescribing guidelines and what drugs work best for which conditions - dissemination of prescribing information - what interventions most effectively influence practice? - effect of changes in prescribing on patient health outcomes, and on utilization of health services; - the safety and effectiveness of drugs, building on what currently exists (such as Health Canada's system for reporting adverse drug reactions and communicating drug safety advisories), so that information derived from post-market surveillance quickly reaches health care providers and patients and becomes part of our body of knowledge. Since the great majority of prescriptions in Canada are written by physicians, it is essential that the medical community participate actively in evaluation of prescribing practices, and disseminating and implementing the results of research. Recommendation 13: The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 5 Conclusion It is likely that drug therapy will continue to increase in importance as a component of patient care and that it will continue to become more complex and, in many cases, more costly. As a result, we expect that health professionals and the Canadian public will continue to need readily available and up-to-date information on prescription drugs: the availability of new products; the results of safety and effectiveness studies; and advice on how to prescribe and take these medications for the best health outcome. It is also likely that electronic prescribing systems, formularies and other monitoring methods will continue to be developed, and that these will influence physicians' prescribing habits. To deliver evidence-based prescribing information effectively, and encourage its smooth incorporation into clinical practice, Canada needs a comprehensive, multi-disciplinary strategy in which physicians and other health care providers, governments, patients, industry and other stakeholders work together to encourage and support optimal prescribing, in the interest of achieving the best possible health for Canadians with the most effective use of resources. The CMA is ready to join with others in developing and implementing such a strategy, in the hope that eventually, all patients will receive the prescription drugs they need, when they need them. Appendix 1 A core undergraduate curriculum for prescribers in therapeutics Core knowledge and understanding Basic pharmacology Clinical pharmacokinetics Monitoring drug therapy Adverse drug reactions Drug interactions Medication errors Poisoned patients Prescribing for patients with special requirements (e.g., the elderly, children, women of childbearing potential, pregnant and breastfeeding women, and patients with renal or liver disease) Legal aspects of prescribing drugs Developing new drugs Medicines management Ethics of prescribing Commonly used drugs Common therapeutic problems Complementary and alternative medicine Integration of therapeutics into understanding of disease management. Core skills Taking a drug history Prescription writing Drug administration Prescribing drugs in special groups Prescribing drugs to relieve pain and distress Adverse drug reactions and interactions Drug allergy Clinical pharmacokinetics Monitoring drug therapy Analysing new evidence Obtaining accurate objective information to support safe and effective prescribing Obtaining informed consent to treatment Core attitudes A rational approach to prescribing and therapeutics Risk-benefit analysis Recognizing the responsibilities of a physician as part of the prescribing community Recognizing personal limitations in knowledge Responding to the future SOURCE: Maxwell S, Walley T. Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow's doctors. Br J Clin Pharmacol 2003;55:496-503.100. Cited in Innovating For Health: Patients, physicians, the pharmaceutical industry and the NHS. A report from the Royal College of Physicians (UK) February 2009 References i Metge C, Sketris I. "Pharmaceutical Policy." In MacKinnon NJ, ed. Safe and Effective: the Eight Essential Elements of an Optimal Medication Use System. Canadian Pharmacists Association, 2007. ii Canadian Institute for Health Information. Drug Expenditure in Canada, 1985 to 2009. Released April 2010. Accessed at https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1428&lang=en&media=0. iii Wang E, Einarson T, Kellner J, Conly. Antibiotic prescribing for Canadian preschool children: evidence of overprescribing for viral respiratory infections. Clin Infect Dis. 1999; 29(1):155-60. iv Petrella R, Merikle E, Jones J. Prevalence and treatment of dyslipidemia in Canadian primary care: a retrospective cohort analysis. Clin Ther. 2007; 29(4):742-50. v Dr. Jean Gray, speaking at the Health Council of Canada symposium, "Safe and Sound: Optimizing Prescribing Behaviours"; Montreal, June 2007 vi Steinman MA, Baron RB. Is continuing medical education a drug promotion tool? Yes. Can Fam Phys 2007: 53(10); 1650-53. vii Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008: 300 (Sept. 3); 1069-1071. viii Mintzes B, Barer ML, Kravitz RL et al. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: a two-site cross-sectional survey. BMJ 2002; 324 (2 February): 278-279. ix "Should Canada allow direct-to-consumer advertising of prescription drugs?" (Debate) Can Fam PhysicianVol. 55, No. 2, February 2009, pp.130 - 133. x Valiyeva E, Herrmann M, Rochon PA. Effect of regulatory warnings on antipsychotic prescription rates among elderly patients with dementia: a population-based time series analysis. Can Med Assoc J 2008; 179(5) doi 10.1503. xi Health Council of Canada. "A commentary on The National Pharmaceuticals Strategy: a Prescription Unfilled." (January 2009) xii Cook DA, Levinson AJ, Garside S et al. Internet-based learning in the health professions: a meta-analysis. JAMA 2008; 300 (10): 1181-1196. xiii Rx for Change database; accessed at http://www.acmts.ca/index.php/en/compus/optimal-ther-resources/interventions. xiv Canadian Medical Association. "Information technology and health care in Canada: 2008 status report." xv Ashworth M, Lee R, Gray H et al. How are primary care organizations using financial incentives to influence prescribing? J Public Health 2004: 26(1); doi: 10.1093. xvi Canadian Council on Learning. Health literacy in Canada: initial results from the International Adult Literacy and Health Skills Survey (September 2007). Accessed at http://www.ccl-cca.ca/ccl/Reports/HealthLiteracy/HealthLiteracy2007.html.
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Study on Mental Health, Mental Illness and Addiction in Canada : Supplementary Submission to the Senate Standing Committee on Social Affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy1945
Last Reviewed
2013-03-02
Date
2005-10-11
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2013-03-02
Date
2005-10-11
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association, Canadian Paediatric Society, Canadian Psychiatric Association, Canadian Society of Addiction Medicine and College of Family Physicians of Canada are pleased to provide a joint supplementary submission to the Senate Standing Committee on Social Affairs, Science and Technology study on mental health, mental illness and addiction in Canada. This submission provides advice on the areas that we believe require the most immediate attention from the federal government over the short term, and that will have the most direct benefit for those affected by mental illness, poor mental health and addiction. The four areas are: 1. Federal Leadership &Capacity 2. Access Benchmarks and Surveillance Information 3. Best practices in mental illness, mental health and addiction 4. Human resource planning This submission also provides recommendations for specific “priority tasks” under each of these four general areas. 1. Federal Leadership & Capacity Federal leadership and capacity must be rapidly and significantly enhanced in order to address the existing deficiencies in the mental health system. This will signal and institutionalize a renewed commitment by the federal government and will ultimately provide support for Canadians impacted by mental illness, poor mental health and addictions. Federal capacity can be enhanced through one of 3 models: a unit in an existing federal department, a federal arm’s length agency, or a pan-Canadian arm’s length agency. Model 1: Unit within an existing federal department Under this option, a new Branch led by an assistant deputy minister (ADM) would be created within Health Canada to provide policy leadership and deliver federal programs and services in the area of mental health, mental illness and addiction. The ADM would have general authority for its management and direction, be answerable to the deputy minister, and work with all other federal departments and agencies to develop and coordinate policies, programs and services in this area. Model 2: Creation of a federal arm’s length Centre for Mental Illness, Mental Health and Addiction This option would entail the creation of a more independent organization within the purview of the federal government. The ‘Centre for Mental Illness, Mental Health and Addiction’ would be structured as a federal agency in which decision-making powers are vested in a Board of Directors with a CEO responsible for the daily operations. This Board would be representative of all relevant stakeholders including health providers, health researchers, governments and affected populations. The Centre would remain under the health portfolio, with accountability through the Minister of Health. The Centre’s main function would be to deliver federal programs and services, working closely with Health Canada, the Public Health Agency of Canada, Department of Justice and other organizations such as the Canadian Centre for Substance Abuse. While the Centre would provide advice, the responsibility for federal policy development with respect to mental illness and mental health would continue to reside within Health Canada. Model 3: Pan-Canadian arm’s length institute This option consists of incorporating an Institute as a not-for-profit entity with the federal and provincial governments as shareholders. This model has been used in other areas where federal-provincial collaboration is essential, such as the Canadian Institute for Health Information. As in the previous model, the Institute for Mental Illness, Mental Health and Addiction would have a board, and a CEO. However, instead of direct accountability to the Minister of Health, the institute would be accountable to the Conference of F-P-T Ministers of Health. It would be responsible for delivering pan-Canadian programs and services that are complementary to provincial and territorial mental health/illness programs and services. Policy development responsibilities for mental health, mental illness and addiction would continue to reside with federal and provincial/territorial governments. Each of the models outlined above has strengths and weakness. It is also possible that we could move from one model to another over time once the system is stabilized. However, for the short term, we contend that Model 1, a dedicated unit within Health Canada, would be the best fit with our objective of enhancing federal leadership and capacity to address mental illness, mental health and addiction issues. The strength of Model 1 is that by elevating responsibility for mental health /illness issues to the branch level it raises the profile and importance of these issues. This would reinstate and indeed increase the capacity that had existed within Health Canada but was lost through numerous reorganizations and resource reallocations. In addition intra-departmental and inter-departmental synergies can be maximized with this model. Should this model be chosen, it is important that the federal government demonstrate the kind of collaborative leadership that it has shown in the area of primary care through initiatives funded via the Primary Health Care Transition Fund. 1 The same leadership principles apply to reform of the mental health system in that while there are common problems and solutions across Canada there are also the needs of specific communities which must be addressed individually. Of immediate priority for this unit are initiatives to reduce stigma and to address the mental health needs of First Nations and Inuit Peoples. Stigma Reduction A stigma reduction strategy is an on-going function that must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours, thus a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level. The strategy should include aspects of: * Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention; * Enhanced provider/student education and support; * Policy analysis and modification of discriminatory legislation; * Support for a strong voluntary sector to voice the concerns of patients and their families; * Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories; * Researching stigma. The stigma associated with mental illness in children can hinder early identification and intervention and places them on a damaging path of suffering and pain. The effective treatment and community reintegration of people with mental illness and/or addiction will not only improve the lives of those directly affected but will also work to reduce stigma in the long term. First Nations and Inuit Peoples All people with mental illness and/or addiction have a right to programs and services that facilitate recovery and/or improve their quality of life. It is clear that the First Nations and Inuit peoples of Canada experience mental illness, addiction and poor mental health at rates exceeding that of other Canadians. Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities, and identify the structures and interventions to reduce the burden of mental illness and addiction is critical to the health and wellness and future of First Nations and Inuit peoples. Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community mental health strategies. The establishment of a First Nations and Inuit Mental Health Working Group that is comprised of First Nations and Inuit mental health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate mental health strategies and programming in these communities. We believe that as a population, the First Nations and Inuit peoples should be the priority for the federal government in the provision of much need treatment and support. Priority tasks: A. Establish a Mental Health, Mental Illness and Addiction Branch at Health Canada. B. Implement a Stigma Reduction Strategy C. Improve the capacity of First Nations and Inuit peoples to address the mental health needs of their communities in a culturally appropriate manner. 2. Access Benchmarks and Surveillance Information Access to services, both public and private, currently acts as a barrier to treatment and recovery from mental illness, poor mental health and addiction. Promotion of collaborative care models along with better coordination of services would greatly improve the quality of care received. Governments must facilitate integration and access to these services. Recently, the Supreme Court decision in the case of Chaoulli and Zeliotis vs Quebec struck down two provisions in Quebec’s health insurance legislation that prohibit Quebec residents from purchasing private insurance for insured health services. This decision suggests that if Canadians wish to keep their “single-tier” system of universal, first dollar public coverage for health care, then governments must ensure that needed services are available to all Canadians at the time and to the extent of need, including mental health services. Governments must provide timely access to essential services within the public system in order to maximize potential for recovery and quality of life. With the support of the federal government, and on behalf of the medical community, we (CMA, CPA, CPS, CSAM, CFPC) can coordinate and implement a process to develop medically acceptable wait time benchmarks for access to mental illness and addiction care for children and adults. The outcome of this process would be to provide all governments with performance goals to strive for in providing timely access to mental illness and addiction services. With the establishment of benchmarks we will be able to measure how the system is performing. A basic mental illness surveillance system exists and the primary dissemination product is “A Report on Mental Illness in Canada”. However, there is agreement that the current information is limited for several reasons: * There is limited data in the system regarding mental health, addiction and many mental illnesses; * The quality of the data in the system has not been validated for many mental illnesses and addictions; * Not all data sources have been accessed for the surveillance system; * Since many supports and services for mental illness and addictions lie outside the formal health system, the collection of these data has not been possible with current constraints; * There is a need for a broader dissemination system. An expanded mental illness surveillance system should work closely with other chronic disease surveillance initiatives to ensure that indicators of common interest are obtained collaboratively and in an efficient manner. Priority Tasks: A. Federal government financially support the coordination and implementation of a process to develop wait time benchmarks for accessing mental illness and addiction services developed by the CMA, CPA, CPS, CSAM, CFPC. B. Creation of an enhanced mental illness surveillance system to produce: * Information about the prevalence and incidence of mental illnesses, addiction and risk factors at the national, provincial/territorial and regional level. * Progress on improving the availability and accessibility to services. * The availability and accessibility of community resources to support people with mental illness and addiction. * Progress on improving the availability and accessibility to community resources. * Information about the cost of mental illness, poor mental health and addiction to people with the conditions, their families and the health system. * Wait list information for mental health services. 3. Best practices in mental illness, mental health and addiction There are numerous interventions that are effective for various mental illnesses and addiction but ensuring optimal use of effective interventions in the real world has been a challenge. Several factors including lack of use by physicians, failure to prescribe or implement in the recommended manner, costs associated with treatment, and undesirable side effects limit the effectiveness of proven therapies for individual patients. A key element in our capacity to prevent and offer treatment for mental illness and addiction rests with the application of evidence or the promotion of best practices. Therefore we are proposing a pan-Canadian program that can facilitate knowledge exchange across disciplines to optimize outcomes for this population. We are aware that there is currently an initiative led by the Public Health Agency of Canada to establish a Consortium of Best Practices for Chronic Disease prevention. The goal of the Consortium is to create a Pan-Canadian forum for knowledge exchange between governments, researchers, non-governmental organizations and consumers. This initiative is a positive step and should be closely aligned with our proposed program for mental illness, mental health and addiction. The program we are proposing would go further than just prevention, to include treatment and policy alternatives, both within and outside the health domain. The program would serve to enhance best practice approaches through activities such as: * Development of a clearing house to hold evidence-based information for mental illness, mental health and addiction by searching, reviewing and summarizing the current literature and web resources; * Identification of gaps in knowledge, and gaps between evidence and practice; * Development of tools to promote best practices relating to mental illness, mental health and addiction, such as the Canadian Collaborative Mental Health Initiative Tool Kit. Priority Task: A. Establish a program to specifically promote inter-disciplinary best practices in prevention, treatment, community interventions and social supports across the continuum of research, policy, to support practice for evidence-based decision making in the area of mental health, mental illness and addiction. 4. Human resource planning Improving access to specialized and primary mental health diagnostic and treatment services with psychosocial community services that support early intervention, prevention of further disability, rehabilitation, improvement of quality of life and recovery should be considered a fundamental underlying goal of a pan-Canadian action plan. Several initiatives are currently under way in various parts of the country to enhance collaborative approaches to care among health care providers and to better integrate primary and secondary health care services. However, these efforts are taking place in a context of relative shortage of addiction specialists, psychiatrists, paediatricians, family physicians and other mental health care professionals. Family doctor and specialist shortages and changing practice patterns have created serious gaps in the availability of mental health services for many Canadians. Health human resource planning needs to consider and address functionally sub-specialized areas of practice as growing numbers of family doctors are moving into these areas, for example general practice psychotherapy and addiction medicine. Health human resource planning must also continue to ensure sustainability of current initiatives and continued access to care. Early interventions in general and with children specifically are critical to preventing long term disability and minimizing the devastating impact of mental illness. There are far too few mental health professionals to help children, insufficient resources allocated to support their mental health needs, and inadequate research being conducted to fill the gaps in knowledge which exist in this area. We believe that improving the mental health of Canada’s children, including strategies that increase the amount of health providers with expertise in this area must be a priority for the federal government. Priority Tasks: * Establish a pan-Canadian mental health human resource infrastructure responsible for collecting data, monitoring, conducting research, reporting, and making recommendations related to Canada’s ongoing mental health human resources needs, with a priority focus on children’s services, in order to ensure a sustainable supply of health human resources; * Introduce toolkits to assist health practitioners and consumers to implement best practices in collaborative care and develop new models of care in the area of mental health; * Support the evaluation of new models of care in achieving patient centred objectives and improving outcomes; * Increasing research capacity and resources in the area of children’s mental health. Conclusion: Again, our organizations, representing the medical community, appreciate the opportunity to submit to the Committee further elaboration on key initiatives to ensure federal leadership is taken. We want to thank the committee not only for seeking our advice but also for bringing national attention to issues related to mental illness, mental health and addiction. End Notes 1 The Primary Health Care Transition fund supported provinces and territories in their efforts to reform the primary health care system in addition to supporting various pan-Canadian initiatives to address common barriers. Although the Primary Health Care Transition Fund itself was time-limited, the changes which it supported were intended to have a lasting and sustainable impact on the health care system.
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Letter on cross-border pharmacy control

https://policybase.cma.ca/en/permalink/policy1947
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs. The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat. In summary, our response to the Minister’s three proposals is as follows: * Supply monitoring network: We support supply monitoring as a necessary activity. * Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed. * Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate. Our detailed comments on the proposals are below. 1) Drug supply monitoring system The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow: * 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence. * 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme. * 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members. The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada. * 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages. 2) Export Restriction CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow: * 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction. * 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation. 3) Requiring a Patient-Practitioner Relationship The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons: * The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress. * Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported. * The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality. In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them. * Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention. In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour. We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation. Yours truly, Briane Scharfstein, MD, CCFP, MBA Associate Secretary General, Professional Affairs cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate, Health Canada CMA Provincial/Territorial Divisional CEO’s
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Mental Health, Mental Illness & Addiction : CMA Submission to the Standing Committee on Social affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy1950
Last Reviewed
2012-03-03
Date
2005-04-20
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2012-03-03
Date
2005-04-20
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Social Affairs, Science and Technology’s study of mental health, mental illness and addiction in Canada. The Committee is to be commended for their commitment to the examination of the state of mental health services and addiction treatment in Canada. The Interim Report Mental Health, Mental Illness and Addiction: Overview of Policies and Programs in Canada is a most comprehensive and thorough study. It highlights and reinforces the myriad of players, programs and services as well as the scope and breadth of concerns related to mental health/mental illness care. The Issues and Options paper cogently outlines all the major issues facing mental health, mental illness and addiction care today and provides a platform to stimulate an important public debate on the direction that should be taken to address mental health reform in Canada. The CMA was pleased to appear before the Committee during its deliberations in March of 2004 to speak to the issues facing mental health and mental illness care and put forward recommendations for action by the federal government. The CMA recommended: * developing legislative or regulatory amendments to ensure that psychiatric hospitals are subject to the five program criteria and the conditions of the Canada Health Act, * adjusting the Canada Health Transfer to provide net new federal cash for these additional insured services, * re-establishing an adequately resourced federal unit focussed on mental health, mental illness and addiction, * reviewing federal policies and programs to ensure that mental illness is on par, in terms of benefits, with other chronic diseases and disabilities, * mounting a national public awareness strategy to address the stigma associated with mental illness and addiction. The physicians of Canada continue to support these recommendations. While the Committee has asked for input on a number of important issues in its Issues and Options paper, CMA will focus on the role of the federal government in three areas: * national leadership and intergovernmental collaboration, * accessibility, * accountability. We understand that the Canadian Psychiatric Association, the College of Family Physicians of Canada and the Canadian Paediatric Society will, in their submissions to the Standing Committee, address specific issues of concern to the medical profession in the areas of primary care, child and adolescent mental health and mental illness services, and psychiatric care. The CMA supports the positions of these national specialty organizations. THE ROLE OF THE FEDERAL GOVERNMENT The economic burden of mental health problems is estimated, at a minimum, at $14.4 billion annually. 1 Mental illness and addiction affects one in five Canadians during their lifetime. According to a 2003 Canadian Community Health Survey, 2.6 million Canadians over the age of 15 reported symptoms consistent with mental illness during the past year. Mental illness impacts people in the prime of their life. Estimates from 1998 indicates that 24% of all deaths among those aged 15-24 and 16% of all deaths among those aged 25- 44 are from suicide 2. In contrast, the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS) that tragically, resulted in 483 cases and 44 deaths with an estimated economic impact in the Greater Toronto Area of 2 billion dollars served as the ‘wake-up call’ that galvanized the federal government into paying attention to public health in Canada. In the aftermath of SARS, the federal government appointed a Minister of State for Public Health, established the Public Health Agency of Canada and selected a Chief Public Health Officer for Canada. Nine hundred and sixty five million dollars has been invested by the federal government in public health in the two federal budgets following SARS and a new spirit of federal-provincial-territorial cooperation on public health issues has been spawned. The evidence of the enormous burden that mental illness and addiction places on Canadian society has been a clarion call to many concerned stakeholder organizations across the country to mobilize and search for solutions. It is astounding that the federal government has not heard the call. And it is hard to imagine just what more could constitute a ‘wake-up call’ for mental health care. In fact the federal government falls woefully short of fulfilling its responsibilities to the people of Canada. The Interim report of the Committee correctly outlines the state of fragmentation and gaps in services to those specific populations under direct federal jurisdiction. It also notes the ‘apparent ambivalence’ over the years by the federal government about the place of mental health services within publicly funded health care. This ambivalent approach also spills over to the broad national policies and programs of the federal government that can impact those suffering from mental illness, addiction or poor mental health. The federal government has systematically excluded mental health services since the earliest days of Medicare. Mental illness has been treated like a second class disease with little dedicated federal funding, and with programs and services not subject to national criteria or conditions as are set out in the Canada Health Act. In fact, the federal government could be seen as moving in reverse with the downgrading of mental health resources within Health Canada through the 1980s and 1990s. Leadership The CMA firmly believes that strong federal leadership is required to address the sometimes invisible epidemic of mental health problems and addiction in Canada.The government must lead by example and begin by ‘cleaning up its own backyard’ in terms of its direct role as service provider to those Canadians under its jurisdiction. It should take a ‘whole of government’ approach that recognizes the interplay of health services, education, housing, income, community and the justice system on mental health and mental illness care. Further, the federal government has a responsibility to ensure that there is equitable access to necessary services and supports across the county. This will require a strong degree of cooperation and collaboration among provinces and territories and the federal government. The federal, provincial and territorial governments must come together to develop a national action plan on mental health, mental illness and addiction modeled on the framework developed by the Canadian Alliance on Mental Illness and Mental Health in 2000. The CMA has noted the options put forward to elevate mental health, mental illness and addiction in government priorities: A Canada Mental Health Act or a Minister of State for mental health, mental illness and addiction. We continue to believe that an adequately resourced, dedicated federal centre focussed on mental health, mental illness and addiction must be established within Health Canada. This will ensure that mental health, mental illness and addiction are not seen as separate from the health care system but an integral component of acute care, chronic care and public health services. A centre with dedicated funding and leadership at the Associate Deputy Minister level is required to signal the intent of the government to seriously address mental health, mental illness and addiction in terms of both its direct and indirect roles. This centre must also have the authority to coordinate across all federal departments and lead F/P/T collaborations on mental health, mental illness and addiction. The responsibility of the provinces and territories for the delivery of services for mental illness and addiction within their jurisdictions is unquestioned. But, as CMA has noted in relation to the acute care and public health systems, we have a concern with the disparity of these services across the country. We believe that the federal government must take a lead role, working with the provinces and territories, in establishing mental health goals, standards for service delivery, disseminating best practices, coordinating surveillance and research, undertaking human resource planning and reducing stigma. It is unfortunate that the Council of Deputy Ministers of Health withdrew its support of the F/P/T Advisory Network on Mental Health in 1990. The lack of a credible and resourced F/P/T forum for information sharing, planning and policy formation has impeded inter-provincial cooperation and collaboration for over a decade. F/P/T collaboration is essential to ensure adequacy of services in all parts of the country and end the piecemeal approach to mental illness and addiction. It would also encourage pan Canadian research and knowledge transfer. The CMA therefore recommends: 1. That the federal government create and adequately resource a Centre for Mental Health within Health Canada led by an Associate Deputy Minister with a mandate to initiate and coordinate activity across all federal departments to address the federal government’s responsibilities to specific populations under its direct jurisdiction, to oversee national policies and programs that impact on mental health, mental illness and addiction and to support intergovernmental collaboration. 2. That the federal government re-establish and adequately resource the F/P/T Advisory Network on Mental Health with a broader mandate to encompass mental health, mental illness and addiction. 3. That the federal government work with the provinces, territories and the Canadian Alliance on Mental Illness and Mental Health to establish a Pan Canadian Mental Health, Mental Illness and Addiction Network to develop a national mental health strategy, mental health goals and action plan; and serve as a forum for inter-provincial cooperation and collaboration on mental health, mental illness and addiction. Accessibility Accessibility leads the way as the number one concern regarding the health care system for patients and their families. This concern is in no way lessened when we look at access to mental health and addiction services and programs. The CMA has long identified accessibility as an essential issue that must be addressed to improve the health care system. In recent years, public concern over timely access has been growing. Recent polling for the CMA has shown that a significant majority of Canadians have suffered increased pain and anxiety while waiting for health care services. 3 The same polling clearly demonstrated that the vast majority of Canadians attributed long waits for health care services to a lack of available health providers and infrastructure. More recently, another opinion poll found that Canadians gave the health care system an overall grade of “C” in terms of their confidence that the system will provide the same level and quality of service to future generations. 4 The 2003 Hospital Waiting Lists in Canada report released by the Fraser Institute included a psychiatry waiting list survey which revealed that wait times from referral by a GP ranges from a Canadian average of 8.5 weeks to 20 weeks in New Brunswick. Patients then face a further delay as they wait for appropriate treatment after they have been seen by the specialist. This wait can be anywhere from 4 weeks to 19 weeks depending on the treatment or program. 5 The 2004 National Physician Survey, a collaboration between the CMA, the Royal College of Physicians and Surgeons of Canada, and the College of Family Physicians of Canada, found that 65.6% of physicians rated accessibility to psychiatrists as fair or poor. 6 These statistics do not reflect those patients that do not make it on to lengthy waiting lists where access is effectively denied. In September 2004 the CMA released a national plan of action to address issues of accessibility, availability and sustainability across the health system 7 . Better Access Better Health lays out a number of recommendations designed to ensure that access exists at times of need, and to improve system capacity and the sustainability of the system. While Better Access Better Health speaks to the health care system writ large, the provision of mental health services and addiction treatment clearly falls under this umbrella. Specific recommendations detailed in the plan of action for pan-Canadian wait-time benchmarks, a health human resource reinvestment fund, expanding the continuum of care and an increase in federal “core’ funding commitments would all have a positive impact on the accessibility of mental health and addiction services. The review of mental health policies and programs in select countries (Report 2 of the Interim Report) is striking for the similarity of problems facing mental health care. In each of the four countries studied there is concern for the adequacy of resources as well as recognition of the need to coordinate and integrate service delivery. The CMA agrees with the Committee’s commentary that: “The means for achieving these objectives that stands out from our survey of four countries is to set actionable targets that engage the entire mental health community, and to establish measurable criteria for the ongoing monitoring of reform efforts. Comprehensive human resource planning in the mental health field, as well as adequate funding for research and its dissemination are also suggested as key elements of a national strategy to foster mental health and treat mental illness.” CMA strongly supports setting national standards and targets with regard to mental health services and addiction treatment, but it must be understood that standards and targets can not be established until we have a clear and accurate picture of the current situation in Canada. Pan-Canadian research is needed to determine the availability of services across the country. Surveillance of mental illness risk factors, outcomes and services is essential to guide appropriate development and delivery of programs. Research is also needed to determine ways of integrating the delivery of mental health services between institutional and community settings. The Health Transition Fund supported 24 projects between 1997 and 2001 that made a substantial contribution toward a practical knowledge base in mental health policy and practice. The 2000 Primary Health Care Transition Fund is also supporting projects in the mental health field. For those projects that are due to be completed in 2006, they should be encouraged to put in place a prospective evaluation framework to determine the feasibility and scalability of collaborative care initiatives. As noted in Better Access Better Health availability is first and foremost about the people who provide quality care and about the tools and infrastructure they need to provide it. The shortage of family practitioners, specialists, nurses, psychologists and other health care providers within the publicly funded health care system is certainly an impediment to timely access to care. A health human resources strategy for mental health, mental illness and addiction is a first step in finding a solution to the chronic shortage of health professionals. The CMA therefore recommends: 4. That the federal government, through the Institute of Neurosciences, Mental Health and Addiction, undertake a program of surveillance and research to determine actual availability of services for mental health, mental illness and addiction across the country. 5. That the federal government in consultation with provincial and territorial governments, health care providers and patients/clients establish national standards and targets for access to services. 6. That the Institute of Neurosciences, Mental Health and Addiction and the Institute of Health Services and Policy Research within Canadian Institutes of Health Research establish a joint competition for research on ways of integrating the delivery of mental health services between institutions and community settings. 7. That the federal government undertake an evaluation of those Health Transition Fund and Primary Health Care Transition Fund projects in the mental health, mental illness and addiction field to determine the feasibility and scalability of collaborative care initiatives. 8. That the federal government work with the provinces and territories to develop a health human resource strategy for the field of mental health, mental illness and addiction. Accountability In its presentation to the Committee in March of 2004, CMA recommended that the federal government make the legislative and/or regulatory amendments necessary to ensure that psychiatric hospital services are subject to the criteria and conditions of the Canada Health Act. This would accomplish two objectives. It would signal the federal government’s serious intent to address the historical imbalance in the treatment of mental health and illness care while at the same time increase the accountability of these institutions and services to the values espoused in the Canada Health Act. This would be a very positive step, but we must also develop accountability mechanisms that can measure the quality and effectiveness of the mental health services provided. Since 2000, First Ministers and their governments have committed to reporting on numerous comparable indicators on health status, health outcomes and quality of services. In September 2002, all 14 jurisdictions including the federal government, released reports covering some 67 comparable indicators. In November 2004, these governments released their second report covering 18 indicators with a focus on health system performance including primary health care and homecare. Unfortunately, mental illness--despite its magnitude--has received little attention in these reports. Of the now 70 indicators that have been developed, only 2 directly address mental illness (potential years of life lost due to suicide and prevalence of depression). Furthermore, no performance indicators related to mental health outcomes or wait times for mental health services have been included in these reports. This is one more example of the oversight of mental illness related issues and the vicious circle that exists since few indicators makes it difficult to present the case for greater attention. The lack of information on availability of services, wait times and health outcomes for mental health services compromises governments’ ability to establish a funding framework to allocate funding equitably. Research that will reveal gaps in service delivery, and the establishment of targets should allow governments to better calculate sustainable funding levels needed to build capacity in the mental health, mental illness and addiction fields. As important as it is to ensure that mental health and addiction services within the health system are available, accessible and adequately resourced we must not lose sight of the fact that to effectively address mental health, mental illness and addiction issues services from a broad range of government sectors are required. Therefore the proposed Associate Deputy Minister for Mental Health must be accountable to ensure collaboration across sectors within the federal government. As in public health in general, a clarification of the roles and responsibilities of the various levels and sectors of government and health providers involved in the provision of mental health, mental illness and addiction services would allow for greater accountability. The CMA therefore recommends: 9. That performance indicators for mental health services and support, based on the work of the F/P/T Advisory Network on Mental Health, are incorporated in the federal, provincial and territorial reporting of comparable indicators on health status, health outcomes and quality of services called for in the 2003 First Ministers’ Accord on Health Care Renewal. 10. The federal, provincial and territorial governments establish resource targets based on national standards for access to services and minimum wait times to determine and commit to sustainable funding levels. 11. That the Health Council of Canada report on the performance of the mental health, mental illness and addiction system. CONCLUSION The CMA welcomes the spotlight that the Committee has shone on the mental health, mental illness and addiction system in Canada and has been pleased to provide input on behalf of the physicians of Canada. The neglect of those impacted by mental illness and addiction must not be allowed to continue. It is unconscionable that millions of Canadians do not have access to the programs, treatments or supports that would ease their suffering. The federal government must recognize its responsibility towards these Canadians, embrace its leadership role and ensure that the mental health, mental illness and addiction system is placed on an equal footing within the health care system in Canada. Physicians are an integral part of the mental health, mental illness and addiction field. We are eager to work with governments and other concerned stakeholders to bring to fruition a national mental health strategy with mental health goals and an associated action plan that can effectively address the concerns of today and prepare the mental health, mental illness and addiction system for the future. CMA recommendations on Mental Health, Mental Illness and Addiction 1. That the federal government create and adequately resource a Centre for Mental Health within Health Canada led by an Associate Deputy Minister with a mandate to initiate and coordinate activity across all federal departments to address the federal government’s responsibilities to specific populations under its direct jurisdiction, to oversee national policies and programs that impact on mental health, mental illness and addiction, and to support intergovernmental collaboration. 2. That the federal government re-establish and adequately resource the F/P/T Advisory Network on Mental Health with a broader mandate to encompass mental health, mental illness and addiction. 3. That the federal government work with the provinces, territories and the Canadian Alliance on Mental Illness and Mental Health to establish a Pan Canadian Mental Health, Mental Illness and Addiction Network to develop a national mental health strategy, mental health goals and action plan; and serve as a forum for inter-provincial cooperation and collaboration on mental health, mental illness and addiction. 4. That the federal government, through the Institute of Neurosciences, Mental Health and Addiction, undertake a program of surveillance and research to determine actual availability of services for mental health, mental illness and addiction across the country. 5. That the federal government in consultation with provincial and territorial governments, health care providers and patients/clients establish national standards and targets for access to services. 6. That the Institute of Neurosciences, Mental Health and Addiction and the Institute of Health Services and Policy Research within Canadian Institutes of Health Research establish a joint competition for research on ways of integrating the delivery of mental health services between institutions and community settings. 7. That the federal government undertakes an evaluation of those Health Transition Fund and Primary Health Care Transition Fund projects in the mental health, mental illness and addiction field to determine the feasibility and scalability of collaborative care initiatives. 8. That the federal government works with the provinces and territories to develop a health human resource strategy for the field of mental health, mental illness and addiction. 9. That performance indicators for mental health services and support, based on the work of the F/P/T Advisory Network on Mental Health, are incorporated in the federal, provincial and territorial reporting of comparable indicators on health status, health outcomes and quality of services called for in the 2003 First Ministers’ Accord on Health Care Renewal. 10. The federal, provincial and territorial governments establish resource targets based on national standards for access to services and minimum wait times to determine and commit to sustainable funding levels. 11. That the Health Council of Canada report on the performance of the mental health, mental illness and addiction system. 1 Stephens T and Joubert N, The Economic Burden of Mental Health Problems in Canada, Chronic Disease in Canada, 2001:22 (1) 18-23. 2 Health Canada. A Report on Mental Illnesses in Canada. Ottawa, Canada 2002. 3 Health Care Access and Canadians, Ipsos-Reid for the CMA, 2004. 4 2004 National Report Card on the Sustainability of Health Care, Ipsos-Reid for the CMA, 2004. 5 Hospital Waiting Lists in Canada (13th edition), Critical Issues Bulletin, The Fraser Institute, October 2003. 6 National Physician Survey, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada, College of Family Physicians of Canada, 2004, (http://www.cfpc.ca/nps/English/home.asp), accessed April 6, 2005. 7 Better Access Better Health: Accessible, Available and Sustainable Health Care For Patients, CMA September 2004 , attached as Appendix I.
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The Right Drugs, at the Right Times, for the Right Prices: Toward a Prescription Drug Policy for Canada : CMA Presentation to House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1955
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada. Prescription drugs have benefited both the health of Canadians, and the health care system itself; they have meant dramatically improved quality of life for many Canadians, and have saved the country a great deal in hospitalization, social benefits and other expenses. However, it could be questioned whether all of Canada’s prescription drug use is appropriate; patients may be receiving too few medications, too many medications or suboptimal medications for their conditions. In addition, prescription drugs carry a price tag of their own. Since 1975, expenditures on prescription medication have risen faster than any other category in the health sector in Canada, and more is now spent on prescription drugs than on physician services. Governments, health care providers, drug manufacturers and the public must constantly strive to ensure that Canadians receive optimal and appropriate prescription drug therapy: the right drugs, at the right times, for the right prices. A considered, coherent, comprehensive, “made in Canada” approach to prescription drug policy should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. Prescription drug policy in Canada should address: Access: to * efficacious new drugs within an appropriate time; * coverage for medically necessary drugs for catastrophic care; * generic drugs at reasonable prices; * a patient/physician consultation as part of the prescribing process; * continued research and development capacity in Canada. Information for health care providers and the public that is balanced and accurate. Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors are committed to working with others to ensure that Canadians receive the right drugs, at the right times, for the right prices. Summary of CMA Recommendations: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to all drugs that demonstrate a substantial improvement over products already on the market. 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for all Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship which exists between the patient and the physician. 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. PURPOSE The Canadian Medical Association (CMA) has prepared this submission for the House of Commons Standing Committee on Health’s review of prescription drugs in Canada. We applaud this review and welcome the opportunity to present the views of Canada’s medical community. Our vision is simple: that all Canadians should receive, if appropriate, the right drugs for their conditions, at the right times, for the right prices. Governments, health care providers, drug manufacturers and the public should all work together to develop a “made in Canada” prescription drug policy to realize this vision. This policy must be considered, coherent and comprehensive, and should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. In developing this policy we consider it particularly important to address the issues of: Access to quality health care In this context, the CMA’s vision of a National Access Strategy includes appropriate access to * efficacious new drugs within an appropriate time, * coverage for medically necessary drugs for catastrophic care, * generic drugs at reasonable prices, * a patient/physician consultation as part of the prescribing process, * continued research and development capacity in Canada. * Information for health care providers and the public that is balanced and accurate. * Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors look forward to working with others to realize our vision. In this submission we will discuss the steps that the CMA recommends be taken. INTRODUCTION The value of prescription medications Prescription drugs play an important role in preventing and treating health conditions. Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada1. In recent years, powerful new medications have meant dramatically improved quality of life, or substantial change in modes and patterns of treatment, for many Canadians. Anti-retroviral treatment has saved thousands of people with HIV infection from rapid, fatal progression to AIDS. Thanks to selective serotonin reuptake inhibitors (SSRIs) millions of people with chronic depression who might otherwise have been incapacitated or institutionalized can lead normal, productive lives in the community. Drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. Though the cumulative savings on hospital care, lost workforce productivity, social benefits and disability insurance payments due to prescription drug use have not been quantified, they have undoubtedly been significant. Areas of Concern In short, prescription drugs have benefited both the health of Canadians, and the health care system itself. However, they have also created concerns that must be addressed. Utilization: is it Appropriate? Experts have questioned whether all of Canada’s prescription drug use is appropriate: are patients receiving too many medications, too few medications, or suboptimal medications for their conditions? Over-utilization of prescription drugs has been a topic of some attention, but under-utilization also exists. For example, as many as 60% of people with high blood pressure may not be receiving treatment; many of these people do not even know they have the condition.2 In addition, patient compliance with prescription drug therapy is increasingly recognized as a problem, especially for long-term or chronic conditions. Compliance is a potential issue in all treatments but is of special concern in conditions where few clinical symptoms are present: for example in hypertension, where lack of treatment over the long term may result in kidney damage, vascular and opthalmological damage, stroke or heart disease. One study found that only 50% of patients comply with long-term drug therapy, and an even smaller percentage comply with lifestyle alterations.3 Partial compliance with antibiotic therapy for infectious diseases is well recognized as one cause of anti-microbial resistance to common infectious pathogens. Cost: is it too high? More is now spent on prescription medicine than on physician services. Since 1975, expenditures on prescription medication have risen faster than any other category;4 during the 1990’s they rose more than twice as quickly as overall spending on health care.5 In 2002 retail spending on drugs in Canada (prescribed and non-prescribed) was estimated to be at least 16% of total health care spending. Prescription medication accounts for 80% of this category, up from 70.3% in 1990. What drives drug expenditure in Canada? There is considerable debate on this subject, but some of the drivers are believed to be: * Increased utilization: as the population ages there is an increased prevalence of conditions such as hypertension, type 2 diabetes mellitus and osteoarthritis, which often require pharmacological treatment. * Newer (patented) drugs, which are more expensive than generics, dominate the prescription market. Between 1995 and 2000, five drug categories (including cholesterol lowering agents, high blood pressure drugs, acid-reducing agents and anti-depressants) contributed significantly to the overall rise in drug costs.5 These categories are dominated by newer, patented drugs, many of which are heavily promoted. * Prices of generic drugs, though lower than those of patented drugs, are higher in Canada than in some other countries. For example, generic drug prices are 26% lower in Germany and 68% lower in New Zealand.6 * Marketing practices such as mass media direct to consumer advertising (DTCA) in the United States, and its attendant “spillover” into the Canadian marketplace, may contribute to increased utilization. In Canada the Patent Medicine Prices Review Board (PMPRB) maintains price controls on brand-name drugs. Similar price-control mechanisms exist in European Union countries. However, no such controls exist for generic medications in Canada. All in all, prescription medications can be costly for Canadians, especially for those who lack any kind of insurance coverage. The Role of Physicians and the Canadian Medical Association Canada’s doctors are committed to ensuring that Canadians have access to the right drugs, at the right times, at the right prices, to help them achieve the right results – in other words, the best possible health outcomes. The goal of drug therapy is to improve patients’ health and quality of life by preventing, eliminating or controlling diseases or symptoms. Patients, physicians and pharmacists must work in collaboration to achieve this goal. The physician’s role in drug therapy goes well beyond the act of writing out a prescription; it encompasses: * Diagnosing diseases, assessing the need for drug therapy and designing the medication regime; * Working with patients to set treatment goals and monitor progress toward them; * Monitoring the patient’s response to drug therapy, revising the care plan when necessary to support compliance and achieve the best possible health outcomes; * Sharing with the patient specific information about the diseases and the drug therapy, including its effects and potential side effects (including, in some cases, the potential for prescription drug addiction).7 The CMA’s activity has been focused on promoting excellence in prescribing, and on disseminating drug information to physicians.8 In 1999, the CMA worked with Health Canada and the Canadian Pharmacists Association (CPhA) to convene an expert roundtable on the subject of “Best Practices in Prescribing”. This was but one effort of the profession to explore why some therapies appear to be under-prescribed, while others may be over-prescribed. CMA has developed principles on the issues of physician information and of providing information on prescription drugs to consumers; both these documents will be discussed later in this submission. CMA and CPhA have also developed a joint policy statement on approaches to enhancing the quality of drug therapy (attached as Appendix I). In addition CMA is co-funding, with the Canadian Institute of Health Research, an interdisciplinary research team focussed on Drug Policy Futures. The team’s identified areas of study include: financing and public expectations; improving quality; health care evaluation and technology assessment; and public advice-seeking in the era of e-health. The CMA publishes Drugs of Choice, a definitive Canadian guide to first- and second-line drug therapies for hundreds of clinical conditions. It is now in its third edition. In addition CMA maintains an extensive database of clinical practice guidelines, including prescribing guidelines, available to physicians and the public through the CMA Web site, and has developed an on line course for physicians on Safe Medication Practices. The cma.ca web site also provides access to a Canadian online drug database that can be downloaded and used with state-of-the-art PDA (personal device) technology at the point of clinical care. CMA’S PRIORITIES FOR ACTION A) Access to quality health care CMA’s history of advocating for access to needed health care services goes back many years. In 2004, a National Access Strategy will be one of the association’s highest-priority activities. With respect to prescription drugs there are several access-related problems: slow approval of new drugs, uneven insurance coverage, and the possible consequences of cross-border shopping on the availability of drugs in Canada. i) Drug Approvals: The Right Drug at the Right Time CMA recommends: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to drugs that demonstrate a substantial improvement over products already on the market. Stakeholders have repeatedly drawn attention to the slowness of Canada’s drug review process. Between 1996 and 1998 Canadian approval times (median 518 days) were significantly longer than Sweden (median 371 days), the UK (median 308 days) and the United States (median 369 days). These have not improved significantly even after Health Canada implemented a cost-recovery approach to funding the drug review process. Delays in the drug review process mean delays in access to new, potentially life-saving medications. For example, 15 other countries approved Singulair, a major breakthrough in asthma therapy, before it was approved in Canada, even though the drug was developed in Montreal! Approximately 10% of children between 5 and 14 years of age have asthma and could have benefited from this relatively safe drug. Intravenous tissue plasminogen activator (tPA), a medication for treatment of acute stroke, was approved for use in the United States in 1996 but was not approved in Canada until 1999. Canada’s long drug review times are mainly attributed to lack of resources at Health Canada. CMA recommends that Canada implement a timely and efficient drug review process to reduce these times to an appropriate level. The 2003 federal budget announcement of $190 million over five years to improve the timeliness of the regulatory process was encouraging. We hope that this will soon translate into a significant reduction in drug review times. Many drugs submitted for approval are not genuinely innovative; some are virtual copies of drugs already on the market. Others, however, could offer substantial improvement over what is currently available. They could be more clinically effective; or they could have fewer side effects; or their mechanism of delivery could increase compliance (for example, medication that can be taken only once a day instead of three or four times a day). CMA recommends that the pharmaceutical industry give priority to research and development on products and delivery mechanisms that offer substantial additional benefit to Canadian patients. It seems logical that drugs that offer benefits not yet available to Canadians should reach patients who need them more quickly. Recently, Health Canada implemented a priority review process for drugs to treat serious, life threatening or debilitating conditions, for which there is substantial evidence that the drug is a significant improvement over existing therapies. This is a promising step. CMA recommends that Health Canada apply a priority review process to all drugs deemed to offer substantial improvement over what is already on the market. This will also serve as an incentive to the pharmaceutical industry to emphasize drugs that offer substantial benefit in their research and development plans. ii) Coverage: Making the System Work CMA recommends: 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. Coverage for all Canadians. Prescription drugs are Canada’s most notable example of a public/ private partnership in health services delivery. Our country’s blend of public and private drug insurance coverage has worked reasonably well; but there is room for improvement. The Canada Health Act’s mandate covers “drugs, biologicals and related preparations when administered in the hospital”. Provincial and territorial drug programs vary with most covering only seniors and people on social assistance.9 Many Canadians get their drug coverage through private plans offered by their employers. But many people in Canada lack any kind of drug coverage. We do not know exactly how many. According to a report prepared for the Canadian Life and Health Insurance Association, 2% to 4% of Canadians have no coverage, but other reports place the number closer to 10%.10,11 At a minimum, 1 million to 3 million Canadians are in need of basic prescription drug coverage. Drug therapy may be more cost-efficient than some forms of hospital care. Is the current health care system promoting inefficiency by covering hospital services more completely than prescription drug therapy? In 1997 the National Forum on Health recommended that drugs become part of the publicly funded system. However, such a system would be prohibitively expensive; estimates range from $12.4 billion for a combined public and private model (with co-payments) to $13.8 billion for fully funded, public only model (no co-payments).12 The report of the Romanow Commission acknowledged this when it emphasized the need to “move in a gradual but deliberate and dedicated way to integrate prescription drugs more fully into the continuum of care”. For the short term, the report recommended a Catastrophic Drug Transfer to ensure that Canadians who face the greatest financial burden can continue to access the medications they need. The Trillium program in Ontario is an example of such a program. We need to know more about both the number of people who need drug coverage and the best means of providing them with it. As a first step, CMA recommends that the government, insurance providers and all partners in the public and private sectors conduct research to more accurately identify current gaps in prescription drug coverage, and develop policy options for bridging them. Given the ever larger role that prescription drug therapy is playing in health care in Canada, governments should consider expanding the current basket of “core services” to include prescription drugs. Under the Canada Health Act provinces and territories must ensure that medically necessary physician and hospital services are provided on a first-dollar basis. CMA has recommended that the scope of the basket of core services be updated regularly to reflect the realities of health care delivery and the needs of Canadians. Given the potential of prescription drugs to improve the system’s cost-effectiveness, we believe that Canadian governments must consider whether the concept of “core services” needs to be revised to reflect their importance, provided that this does not further compromise access to medically necessary hospital and physician services. Drug Pricing Policies: Toward a Policy for All Drugs in Canada. As mentioned previously, PMPRB controls the prices of brand-name patent medications in Canada. However, generic drug make up 40% of the drugs prescribed in this country. Canada has no mechanism to control the prices of generic drugs, as do some other countries (France, for example, has a decree stating that the price of a generic product must be at least 30% less than the price of the original patented brand.) 6 Most provinces have policies encouraging substitution of a brand drug by a comparable generic where appropriate. CMA believes it is time for Canadian governments to explore mechanisms for ensuring appropriate pricing of generic medications. Product Substitution: Making health the first priority. Even under their current system of limited coverage, federal and provincial governments have expressed concern about the cost of their drug programs, and implemented measures to reduce this cost. One of these is drug product substitution. Generic substitution, discussed in the previous section, is now commonplace; British Columbia has taken the concept further with its system of reference-based pricing. While CMA recognizes the motives behind drug product substitution, we believe that it should only be implemented if it does not jeopardize quality of care or patient confidentiality. Doctors would be happy to participate in discussion of initiatives around drug product substitution, to ensure that the health of the patient continues to be the highest priority to all stakeholders. iii) Access and Cross-Border Prescribing CMA recommends: 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship that exists between the patient and the physician. Prices of brand-name prescription drugs prices are higher in the US, where no price review body exists, than they are in Canada. As a result access to the need for prescription medication can pose considerable financial hardship, particularly for America’s elderly and poor. The rising cost of brand-name medications in the United States has led many Americans to look to Canada for less expensive alternatives. At least one US city, Springfield, Massachusetts, has begun a voluntary program to purchase prescription medication from Canada for its workers and retirees13 and the State of Illinois is examining the feasibility of following Springfield’s lead.14 US drug costs have also spurred a growth industry in Canada: Internet pharmacies. According to estimates in US media, approximately $650 million (US) worth of prescriptions are sold online every year.15 The prospect of accessing cheaper Canadian drugs is particularly appealing to elderly Americans who have turned to the Internet to purchase prescriptions they would be unable to afford at home. The burgeoning cross-border export of pharmaceuticals has had its consequences. Several brand-name multinational pharmaceutical manufactures have moved to stop or limit supplies to those Canadian pharmacies they believe are selling drugs over the Internet. They must now order directly from the manufacturer instead of from wholesalers.16 The brand-name companies have also held out the prospect of boycotting Canada in response to legislation passed by the US House of Representatives that would allow the importation of drugs by Americans.17 This legislation is now before the US Senate Health, Education, Labor and Pensions Committee. The US Food and Drug Administration has opposed importation on safety grounds. The CMA shares the increasingly prevalent concern that cross-border export will result in reduced access to prescription drugs in Canada, and damage the research and development capacity of brand-name prescription drug manufacturers in Canada. Therefore the CMA recommends that Canada monitor and, if necessary, regulate the export of brand-name drugs to ensure their continued availability in this country. Many Internet pharmacies offer the services of physicians who will sign prescriptions without seeing the patient in a consultation. This is not acceptable to the CMA, or to the regulatory Colleges of Physicians and Surgeons or the Canadian Medical Protective Association. It is clear that, in principle, to form an appropriate therapeutic relationship a physician must take a history, perform an appropriate physical examination, and order and interpret appropriate diagnostic tests on her patients. The role of the physician in drug therapy is a complex one; to be most effective it requires a strong ongoing professional relationship between patient and physician. This relationship is the foundation of medical practice; it is key to a prescribing decision and it must be maintained. Our position is discussed in greater detail in CMA’s Statement on Internet Prescribing (attached as Appendix II). B) Consumer Drug Information: From DTCA to DTCI CMA recommends: 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. In the past few years an increasing amount of information on prescription medication has become available to consumers. Much of this reaches Canadians in the form of direct to consumer advertising (DTCA) for specific brands, transmitted across the border from the United States, where it is a billion-dollar-a-year business. DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, advertisers have taken advantage of loopholes in the law to promote brand-name drugs in this country – for example, the controversial television campaign for Viagra. DTCA is also transmitted by print and TV across the border from the United States, and worldwide through the Internet. There is a strong lobby for a relaxation of the DTCA restrictions in Canada. DTCA boosts sales of advertised drugs. In 1999, 25 drugs accounted for 40% of that year’s increase in retail drug spending in the US; all these drugs were advertised to the public.18 Further, DTCA adversely affects the patient/physician relationship. Doctors report feeling pressure and ambivalence when patients ask them to prescribe a specific brand-name drug. 19,20 About 20% of respondents to the CMA’s 2003 physician survey felt patients’ request for advertised drugs had a negative impact on the patient/physician relationship.21 Advocates for DTCA maintain that it provides “consumers” with the information they need to become partners in their own health care. They maintain that DTCA does not undermine the patient/physician relationship, because it does not alter the fact that ultimate prescribing authority remains in the hands of the physician. However, the CMA believes that direct to consumer advertising of prescription drugs is inappropriate. DTCA * does not communicate risk adequately, or provide enough information to allow the consumer to make appropriate drug selections. Generally it does not provide information about other products or therapies that could be used to treat the same condition, * stimulates demand by exaggerating the risks of a disease and generating unnecessary fear, * contributes to a culture of “overmedicalization” by treating normal human conditions such as aging and baldness as diseases, and offering “a pill for every ill”. Brand-specific direct to consumer prescription drug advertising should not be permitted in Canada. CMA calls on the federal government to enforce the existing restrictions on DTCA found in the Food and Drug Act and its regulations to the full extent of the law. We believe that the public has a right to accurate, unbiased direct to consumer information (DTCI) on drugs and other therapies, to enable patients to make decisions regarding their own health care. This information may increase the appropriateness of prescription drug use. For example, it may encourage consumers to get treatment for conditions that are currently under-treated. However, there are more effective ways to provide this information than brand-name advertising. CMA has developed “Principles for Providing Information about Prescription Drugs to Consumers” as an alternative to DTCA; these are attached as Appendix III. We call on Canadian stakeholders, including governments, health professionals, consumer groups and industry, to work together to provide information for the public based on these principles. Further, the CMA calls on the federal government to develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. C) Safety: Ensuring Best Practices in Prescribing CMA recommends: 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. The health care system is complex, involving many inter-related and interdependent factors which could influence the frequency and intensity of medication incidents. Such “systems factors” might include * shortage of qualified health professionals (physicians, nurses and others), * inappropriate use of new technology, * unclear labeling or similar-looking drug preparations, * prescription drug misuse, including over-prescribing or under-prescribing of certain medications. Canada’s doctors are working to promote drug safety on a number of fronts. For example, CMA is working with governments at all levels to ensure that we do not “enrich the nation’s urine” through unnecessary prescribing. The Canadian Medical Association Journal regularly publishes research on prescribing practices. CMA also publishes Safe Medication Practices, a physician guide to patient safety; a companion online course is available on the cma.ca web site. We propose that the health care system work to create a culture that promotes optimal prescribing, by fostering outcomes research, creating supportive infrastructures, strengthening the capacity for post-marketing surveillance, and making the best possible use of technology. Our suggestions are discussed below. Closing the Care Gap. Given our present knowledge base, it is often difficult to ascertain whether current drug utilization patterns lead to improvements in health. For example, research on compliance with drug therapy, and the factors that improve it, is in its infancy and though we know that direct-to-consumer advertising affects drug sales we have yet to determine whether it affects health outcomes. A commitment to outcome-based research on drug utilization would help us find the answers to these and other questions. Research on prescribing patterns should respect the conditions outlined in CMA’s “Principles Concerning Physician Information” (attached as Appendix IV). The CMA calls on all stakeholders (governments, health professionals and the private sector) to join in supporting and encouraging outcome-based research to ascertain best practices in drug utilization and prescribing, and close care gaps when they are identified. Creating an infrastructure for safety. The CMA has no doubt of the overall quality of the prescription medications approved for use in Canada. However, the more drugs are used, the greater their potential for unintended harm. Studies in the United States have found that almost 2% of patients admitted to hospitals experienced a significant adverse drug event, and that the number of deaths due to medications increased over 200% over five years.22 Though studies are still in progress in Canada, we assume that rates of adverse medication events are similar in the two countries. The 2003 federal budget committed $10 million per year to establish a Patient Safety Institute to monitor and prevent medical incidents. This is an important step toward building a safer health care system, and Canada’s doctors are committed to moving this initiative forward. The CMA, with 11 other health care organizations, is a member of the Canadian Coalition on Medication Incident Reporting and Prevention. This initiative is led by Health Canada and has recently been funded through the Patient Safety Initiative. The federal government has also recently funded the Canadian Medication Incident Reporting and Prevention System to collect data on medication incidents and disseminate information designed to reduce their risk. The CMA believes that to be effective a patient safety initiative must * be voluntary, * be non-punitive; and * protect the privacy and confidentiality of physicians and patients. Further, efforts towards ensuring patient safety should address in a timely manner the “systems” issues referred to above, supporting and fostering a culture of safety. CMA is calling on governments to accelerate activities to establish the Patient Safety Institute using a “systems” approach. Strengthening Post-Marketing Surveillance. No matter how rigourous the drug approval and review process, it cannot identify all of a medication’s effects; many of these are only identified once the drug is in widespread use in the general population. A strong post-marketing surveillance system is needed to gather this knowledge and ensure patient safety. A post marketing surveillance system should include timely collection of data related to * adverse drug reactions, * medication incidents, * targeted drug effectiveness studies, * optimal utilization of medications. The goal of an enhanced post-marketing surveillance system is to monitor the ongoing safety and risk/benefit ratio of medications once they have been approved and are being used in the broad population. An ideal surveillance system would go beyond collecting and collating data, to analyze it and produce information that health care professionals and policy makers can use in decision-making at the population level. For example, data could be used to * communicate product related risks to health professionals and patients, * determine the incidence of adverse drug reactions and medication incidents in the Canadian population as a whole and various subgroups over time, as well as their health and economic impact. Currently post-marketing surveillance of drugs in Canada is inadequate, relying on reporting which is often erratic and inconsistent, and for which reporters are not compensated. Canada needs a coordinated post-marketing surveillance system to monitor the ongoing safety of marketed drugs. Surveillance should include medication incidents and adverse drug reactions, and should document and consider the effect of the “systems factors” contributing to these events. Making use of supportive technology. We mentioned that the current reporting system is erratic and inconsistent. An investment in supportive technology would reduce inconsistencies by increasing physicians’ capacity to report and even prevent medication incidents. Under the September 2000 federal/provincial Health Accord, the Government of Canada announced $500 million to expand the use of health information and communications technologies, including the adoption of electronic health records (EHRs). One of the advantages cited for a pan-Canadian EHR is that it could reduce the occurrence of adverse drug events – for example, handwritten prescription and interpretation errors. Progress has been slow, but CMA will follow with interest the pilot EHR program just announced in Alberta. While we expect improvement in prescribing practices and outcomes under such programs, we expect them to respect the principles of patient confidentiality and the right of prescribers to the privacy of their prescribing information. Technology can also make real-time communication within the health care system much easier. and CMA strongly recommends an investment in systems that can link physicians to one another and to the rest of the health care system. In its 2003 brief to the Finance Committee’s pre budget hearings, CMA recommended that the federal government immediately fund dedicated Internet connectivity for all physicians in Canada. CMA has also repeatedly called for sustained and substantial investment in a “REAL” (rapid, effective, accessible and linked) Health Communications and Coordination Initiative to improve technical capacity to communicate with front-line health providers in real time. Real-time information is essential for effective day-to-day health care and will form the cornerstone of an adverse drug reaction communication program for the 21st century. Conclusion It is vital to Canada’s physicians that our patients receive the right medications for their condition, at the right times, at the right prices. CMA calls on the federal government and all other stakeholders to work together to develop a comprehensive “made in Canada” prescription drug policy to realize this vision – one that promotes optimal prescribing, puts the health of patients first, respects the relationships of patient and physician and of patient and pharmacist, and honours the principle of patient confidentiality and the privacy of patient and prescriber information. The reports of the Romanow Commission on the Future of Health Care in Canada and the Senate Standing Committee on Science, Social Affairs and Technology review discussed issues surrounding prescription drug policy in Canada. We hope that the review by this parliamentary committee will lead to prompt and decisive action. APPENDIX I CMA POLICY APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy. Goal of This Joint Statement The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider. Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy. This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements. This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices. Goal of Drug Therapy The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research. Working Together for Optimal Drug Therapy Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient physician pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others. For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects. Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other. Strategies for Collaborating to Optimize Drug Therapy Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following. Respecting and supporting patients' rights to make informed decisions regarding their drug therapy. Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all. Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers. Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy. Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care. Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients. Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care. Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues. Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians. Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education. Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy). Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy. Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making. The Physician's Responsibilities Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role. Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate. Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate. Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate. Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities. Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy. Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public. Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate. Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures. The Pharmacist's Responsibilities Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably. Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber. Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations). Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate. Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician. Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments. Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department. Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities. Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient. Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public. Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures. APPENDIX II CMA POLICY Statement on Internet Prescribing The act of prescribing medication is a medical act carried out in the context of a patient-physician relationship. As such, it is subject to the clinical standards of practice, as well as the ethical guidelines of the medical profession and applicable law. Physicians should be aware of and comply with the legal requirements in their province or territory. If a physician wishes to sign a prescription for an individual who has not previously been his/her patient or a patient of his/her group practice or shared call group, basic principles of assessment and diagnosis must be applied. It is incumbent upon the physician to obtain an adequate history and perform an appropriate physical examination to reach a diagnosis which will ensure that the prescribed medications are appropriate. The physician should be expected to provide advice about any prescribed medication, and, where appropriate, would be expected to provide advice about appropriate monitoring requirements. The physician is advised to fully document the encounter. It is not acceptable for a physician to sign a prescription without properly assessing the patient. APPENDIX III CMA POLICY Principles for Providing Information about Prescription Drugs to Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990’s expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada23, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the “biological revolution”, e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 24 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient’s condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. APPENDIX IV CMA POLICY PRINCIPLES CONCERNING PHYSICIAN INFORMATION In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing. Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed “custodians,” and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code,25 which holds patient health information sacrosanct. Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection. The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence. The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below. 1. Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met. 2. Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information. 3. Conditions for collection, use, access and disclosure: The information should: * be limited to the minimum necessary to carry out the stated purpose(s), * be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician’s duty of confidentiality with respect to that information. 4. Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician’s consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that: * the stated purpose(s) could not be met or would be seriously compromised if consent were required, * the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician’s right to privacy and right of consent in a free and democratic society, and * that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy. 5. Physician’s access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access. 6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted. 7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information. 8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed. 9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians. 10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians. 11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures. 1 Romanow R. Building on Values: the Future of Health Care in Canada. Report of the Commission on the Future of Health Care in Canada; November 2002. 2 Chobanian et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. JAMA 2003; 289. 3 Butler C, Rollnick S, Stott N. The practitioner, the patient and resistance to change. Recent Ideas on Compliance 1996;14(9):1357-62. 4 Canadian Institute for Health Information. Health spending to top $112 billion in 2002, reports CIHI. Media release. December 18, 2002. http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_18dec2002_e 5 Patent Medicine Prices Review Board. Pharmaceutical Trends, 1995/96 – 1999/00. Prepared for the Federal/Provincial/Territorial Working Group on Drug Prices; September 2001. 6 Patent Medicine Prices Review Board, A study of the Prices of the Top Selling Multiple Source Medicines in Canada. November 2002. 7 Approaches to Enhancing the Quality of Drug Therapy.” Joint policy of the Canadian Medical Association and Canadian Pharmacists Association. 8 It should be noted that the CMA does not have the authority to enforce directives on physicians with regard to prescribing. The provincial and Territorial Colleges of Physicians handle licensing and regulatory matters. 9 Manitoba, British Columbia and Saskatchewan provide some coverage to all residents after the co-payments and deductibles are paid. Quebec provides universal coverage to those not in a private plan. 10 Fraser Group/Tristat Resources. Drug Expense Coverage in the Canadian Population – Protection from Severe Drug Expenses. CLHIA. August 2002. 11 Palmer D’Angelo Consulting Inc. National Pharmacare Cost Impact Update Study. Executive Summary. September 4, 2002. 12 Ibid 13 Tynan T. Cash-strapped Springfield, Mass., begins buying Canadian prescription drugs. Edmonton Journal July 29, 2003. http://www.canada.com/edmonton/story.asp?id=21FB8445-1143-4C13-B282-76F380CB4FE1 14 CBSNews.com. Illinois looks to Canada for drugs. CBS News September 15, 2003. http://www.cbsnews.com/stories/2003/07/29/health/main565611.shtml 15Kedrosky P. Dangerous popularity of online pharmacies. National Post August 13, 2003. 16 Harris G. Pfizer moves to stem Canadian drug imports. New York Times August 7, 2003. http://www.nytimes.com/2003/08/07/business/07DRUG.html 17 Cusack B., Stinson S. US drug firms set to boycott Canada. National Post August 7, 2003. http://www.nationalpost.com/home/story.html?id=363CC2EA-1832-42F2-954C-0F52D1828E23 18 “Prescription Drugs and Mass Media Advertising.” National Institute for Health Care Management Research. Washington, DC, 2001. 19 Mintzes B, Barer ML, Kravitz RL at al. How does direct to consumer advertising affect prescribing? a survey in primary care environments with and without legal DTCA. CMAJ 169 (2003): 405 –412. 20 Food and Drug Administration. Direct to consumer advertising of prescription drugs: physician survey preliminary results. Accessed at www.fda.gov/cder/ddmac. 21Survey shows strong opposition to direct to consumer advertising. Accessed at http://www.cma.ca/cma/ 22 Canadian Coalition on Medication Incident Reporting and Prevention. A medication incident reporting and prevention system for Canada: business Plan. March 2002. 23 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, “information-seeking” advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 24 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general. 25 Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.
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