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Policies that advocate for the medical profession and Canadians


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Antibiotics in animals

https://policybase.cma.ca/en/permalink/policy10534
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Text
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
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CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology - Prescription Drugs: Clinical Trials and Approval

https://policybase.cma.ca/en/permalink/policy10437
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Good afternoon. My name is Dr. Maura Ricketts and I am the Director of Public Health for the Canadian Medical Association. The CMA appreciates the opportunity to appear before this Committee today as part of your study of clinical trials and drug approvals. The CMA represents more than 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with all Canadians, for the highest standards of health and health care. Because prescription drugs are an essential component of health care, the CMA has developed a considerable body of policy on pharmaceutical issues. This work can be distilled into one fundamental principle: The CMA believes that our country requires a National Pharmaceutical Strategy to ensure every individual has timely access to safe, effective and affordable prescription drugs. Despite the commitment in the 2004 Health Accord to the creation of such a strategy, Canadians continue to wait for government leadership on this issue. Drugs replace more costly and invasive medical interventions. They are an essential tool in the physician's tool box. To ensure safety and effectiveness, the CMA also believes in the need for a strong, unbiased, evidence-based system for research and approval. This is at the heart of our commitment to patient-centred care. In evaluating whether to prescribe a new drug to a patient, a physician will weigh several factors: Does this product offer any benefits over what I am prescribing now? Will it be more effective? Will this new drug be safer? Will it solve any tricky clinical problems, such as drug interactions, or reduce side effects that prevent a medication from being used properly? The physician may also ask: What is the evidence that this new drug is an improvement? Can I trust the evidence? Where can I get access to accurate, reliable information and data on this drug? Pre-approval drug research must provide answers to these fundamental questions. Clinical Trials I will now focus on two particular issues of concern to practising physicians with regard to clinical trials: * First, what is being compared to what? Clinical trials may be sufficient for Health Canada's regulatory purposes, but may provide only part of the information a physician needs. For example, is a new cholesterol drug effective on all patients, or only on some of them? Would other patients derive equal benefit from an already existing drug, or from a lifestyle change such as diet or exercise? The CMA recommends that researchers compare a new product to other drugs on the market - and to other interventions, as well. * Second, is timely, reliable and objective information available on all clinical trial results, not just the positive ones? Canadians need to be informed when a drug has performed disappointingly in trials if they are to make informed decisions about their health care. The CMA, therefore, recommends the results of all clinical trials, not just those with positive results, be made available to health professionals and the public. I would like to add that the current documentation is not very user-friendly. We recommend that Health Canada prepare summaries of the most essential data, not only for physicians, but for all Canadians to be able to access this information. The Drug Approval Process Turning now to the drug approval process, the CMA believes the following principles should apply: * The primary criteria for approval should be whether the drug improves health outcomes and offers an improvement over products currently on the market. * The review process should be as timely as is consistent with ensuring optimal health outcomes and the safety of the drug supply. * The review process should be impartial and founded on the best available scientific evidence. * The review process should be open and transparent. * Finally, approval of a drug is not an endpoint, but rather one step in that drug's life cycle. It is not uncommon to identify serious safety hazards after a drug has been approved, because that's when it first goes into wide use. It is important that the approval process be complemented by a rigorous and vigilant post-market surveillance process. We look forward to presenting our recommendations on this subject to your Committee at a future session. Before closing, I would like to briefly address two other matters: First, the issue of drugs for rare disorders. We are aware that the current clinical trial and approval processes, which place a high value on studies with large population samples, may be unable to adequately capture the value of drugs that are prescribed to only a handful of people. Some patient groups active in the area of rare disorders, such as the Canadian MPS Society and Alpha-1 Canada, have shared their concerns about this with us. These groups, along with the Canadian Organization for Rare Disorders, have been advocating for years for a fair process for evaluating drugs for rare diseases. Because Canada doesn't have a rare disorders strategy, Canadian patients have access to fewer therapies than patients in other developed countries. The issue of how to approve drugs for rare disorders merits closer consideration. The CMA recommends that the federal government develop a policy on drugs for rare disorders that encourages their development, call for ongoing evaluation of their effectiveness, and ensures fairness so that all patients who might benefit have reasonable access to them. The second matter is that Health Canada's review process provides little guidance on another question which physicians are increasingly asking: Can my patient afford this drug? It is not sufficient that the Common Drug Review conducts reviews of the cost effectiveness of drugs and that provincial/territorial formularies undertake similar studies, as the fact remains that cost is one of the factors physicians need to consider when deciding whether to prescribe a new drug. This is especially true in the case of new biologics, which are very expensive. Canadian doctors believe that the difficulty of making effective prescribing decisions without information about cost needs to be overcome. This only underscores the necessity of a National Pharmaceutical Strategy. Thank you. We would be happy to answer your questions.
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CMA's Submission to the House of Commons Standing Committee on Health: Drug Shortages

https://policybase.cma.ca/en/permalink/policy10382
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for consideration as part of its study on drug supply in Canada. The severe impact of the disruption in production at one pharmaceutical company's manufacturing facility has demonstrated the significant shortcomings in how drug shortages are managed in Canada. This submission focuses on what is needed to ensure Canada's health care system delivers patient-centred care. In order to deliver the best possible care to patients, physicians require timely, comprehensive and accurate information about current and anticipated drug supply shocks and constraints. With this objective in mind, we have provided input to the government and to the pharmaceutical industries. Further, Canada requires an uninterrupted supply of medically necessary medication for patients. Impacts on Patients and the Health Care System Canada's doctors are deeply concerned about the persistent shortages of drugs that they and their patients are encountering. Prescription drugs can prevent serious disease, reduce hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Pharmaceuticals benefit the health care system by reducing costs in other areas such as hospital stays and disability payments. Disruptions in the supply of pharmaceuticals can impact patient care, patient health and the efficiency of the overall health care system. At the CMA, patient organizations are telling us about the anxiety, pain and harm that drug shortages are inflicting on patients. Below are excerpts of these experiences: * According to the Brain Injury Association of Canada: "Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered." * The interim-president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote CMA to say: "Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line." * Sharon Baxter, Executive Director, of the Canadian Hospice Palliative Care Association, says: "All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada." Among the impacts of drug shortages are: * delays in access to needed medication; * delays or disruptions to clinical treatment; * delayed or cancelled surgeries; * loss of therapeutic effectiveness when an appropriate alternate therapy is not available; * increased risk of side effects when alternate therapies are used; and * increased non-compliance when patients, particularly those on long-term therapy, find it harder to comply with a new medication regime. Any one of these situations can impact patient health, particularly in patients with complex problems. In many instances, this in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. In a survey of physicians conducted by the CMA in 2011, two-thirds of respondents said that the shortage of generic drugs had had negative consequences for their patients or practice. Of these physicians, 22 per cent indicated that the consequences were that their patient suffered clinical deterioration because an alternate drug was substituted. Similarly, in a survey of pharmacists by the Canadian Pharmacists Association in 2011, 69 per cent of respondents indicated that they believed that patients' health outcomes had been adversely affected by drug shortages. Notably, of the physicians who indicated the shortage of generics resulted in consequences to their patients or practice, 28 per cent reported that their patient did not fill the substitution prescription due to the cost of the medication. Numerous respondents raised concerns about the financial impact of substitute medications on patients. Survey responses also shed light on the increased demand on the health care system created by the lack of information on drug shortages provided to physicians. When physicians are not made aware of a drug shortage, and prescribe that medication, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Better informing physicians about drug shortages can reduce demand on the health care system by eliminating the inefficiencies associated with drug shortages. Scope of Drug Shortages In an attempt to outline the scope of the problem, the Canadian Agency for Drugs and Technologies in Health (CADTH) stated that: "It is difficult to quantify and determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply to Health Canada and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight."i Surveys by the CMA and the Canadian Pharmacists Association (CPA) shed light on the lack of drug shortages management in Canada. Taken together, the results of these surveys paint an alarming picture of drug shortages management in Canada and underscore the need to improve our system. In terms of notification, the majority of physicians and pharmacists indicated they never (51 per cent and 29 per cent) or infrequently (32 per cent and 33 per cent) receive advance notice of shortages. Ironically, given the high proportion of pharmacists reporting they never or infrequently receive notice, 65 per cent of physicians indicated that they receive notification from pharmacists. Meanwhile, 30 per cent of physicians also indicated that they were notified of drug shortages by their patients. Alarmingly, 81 per cent of the pharmacists surveyed indicated they had trouble locating medications to fill a prescription during their last shift prior to completing the survey and 93 per cent had difficulty over the week prior. This is not a new problem, but since we surveyed CMA members in the fall of 2011, the situation has worsened. Currently about 250 medications are listed on Canadian drug shortage websites. Before the dire impact of the loss of production at Sandoz, Canadian hospitals were already dealing with shortages in the supply of sterile injectables - critical in specialties like surgery, oncology and anesthesia. What Canada's Doctors Require to Provide Care Physicians have expressed their frustration at the time it takes to find an appropriate drug for substitution - time taken from the physician, the pharmacy and the patient. Time better spent with patients is being used by physicians to work with pharmacists to identify alternative drugs and therapies. Of greatest concern are those drugs that are single sourced. When single source medications are in short supply, there are no clear substitutes. The impact of this is being felt now in hospitals across the country as they grapple with the loss of numerous Sandoz products and are forced to ration the remaining stock. The majority of physicians surveyed by the CMA indicated that greater knowledge of drug supply issues would allow them to deliver better patient care. To this end, the CMA strongly supports the development of a comprehensive system for monitoring and responding to domestic shortages of medically necessary drugs. Canada needs a sustainable, adequately resourced system to: identify shortages, rapidly and proactively inform health care professionals, and respond quickly to allocate supply as needed to resolve shortages. The CMA has provided input to both industry and government on the key information needs of doctors. These are: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. While the recent establishment of the online inventories by the pharmaceutical industry associations marks an improvement in Canada's management of drug shortages, significant issues remain to be addressed. These include the need for: complete and more consistent information; automatic notifications to alert physicians, pharmacists and other health care providers; a mechanism to prevent potential disruptions; and a mechanism to seek new or interim sources of supply during a shortage. The CMA recognizes that other countries are also grappling with drug shortages. Canada must also work with its partners abroad to find an international solution to this phenomenon. Conclusion Drug shortages management in Canada has significant shortcomings that impact patients, doctors and the health care system. With the current shortage of injectable drugs teetering on the verge of a crisis, quick action and cooperation are required to address the supply shock. The CMA calls on Members of Parliament to exercise leadership to ensure that Canada's health care providers have access to the information necessary for them to care for their patients, and that Canadians have access to medically necessary drugs. i Canadian Agency for Drugs and Technologies in Health. (2011) "Environmental Scan: Drug Supply Disruptions." Ottawa: CADTH, accessed online at: http://www.cadth.ca/media/pdf/Drug_Supply_Disruptions_es-18_e.pdf, 1.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology - Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals

https://policybase.cma.ca/en/permalink/policy10631
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association is pleased to take part in the second phase of the study of prescription pharmaceuticals by the Senate Standing Committee on Social Affairs, Science and Technology. During the first phase, we presented the CMA's policy position regarding clinical trials and the process for approving new drugs for use. In this phase we will discuss our position and recommendations on post-approval surveillance of prescription drugs. The Canadian Medical Association represents 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription drugs are a very important part of high quality and cost-effective health care. They can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Therefore, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription drugs. The essence of our position is contained in our first recommendation: Recommendation 1: The CMA recommends that federal and provincial/territorial governments collaborate to develop and implement a national pharmaceutical strategy to ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs. This recommendation has two elements: "safe and effective" and "adequate supply," both of which we will discuss in this submission. 2) Ensuring Safety and Effectiveness As we have previously told this Committee, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products. But however strong Canada's pre-approval system is, it will not identify all potential problems with a new drug. Pre-approval clinical trials tend to focus on small numbers of patients, and exclude vulnerable groups such as children and the elderly. They also tend to be of short duration, whereas in the real world, patients may take these drugs for years. As a consequence, problems with a drug are often identified only after widespread, long-term use in the general population. For this reason, it is essential that Canada have in place a robust regulatory framework that includes a timely system to monitor the performance of prescription drugs after they come on the market. The Government of Canada has taken several recent steps to enhance its drug surveillance system. In 2009, it established the Drug Safety and Effectiveness Research Network. In 2008, it introduced Bill C-51, An Act to Amend the Food and Drugs Act, to improve drug safety and effectiveness monitoring by Health Canada. Unfortunately, the bill died with the 2008 election call and has not been re-introduced. That is why we are pleased that the Senate has chosen to re-open this issue. What would a comprehensive post-approval surveillance regulatory framework and system look like? In order to effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes it should include: a) Comprehensive processes for gathering drug safety and effectiveness data In gathering data about adverse drug reactions (ADRs) in Canada, Health Canada has traditionally relied on spontaneous reports from manufacturers and health professionals. The government could enhance its capacity to gather information by: * making it easier for physicians and other health professionals to report ADRs voluntarily. This can be accomplished by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of ADR reports over the past 10 years. The reporting process could be made even more efficient by incorporating it directly into the Electronic Medical Record (EMR) as this is developed. * augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report ADRs in detail, and who, because of these contractual obligations, would be committed to assiduous reporting. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. Post-market monitoring should do more than identify safety risks. It should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition? c) Communication of useful information to health care providers and the public. When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Recommendation 2: The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports; * Analyze the data that has been gathered in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. d) Increased regulatory authority for Health Canada Drug safety is a serious issue; recent research has revealed that nearly a quarter of new drugs approved in Canada will eventually receive a serious safety warning1. Given the potential risks to patient safety we believe Health Canada should have the legal authority to take strong action when a safety problem is identified. The CMA recommends that Health Canada should be given the authority to: * require post-market studies of newly approved drugs if clinical trials identify possible safety risks; * require manufacturers to disclose information if Health Canada thinks it germane to making a decision in the interest of patient safety; and * take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or pulling a product off the market. Granting Health Canada this regulatory authority is only the first step. Health Canada should not hesitate to use this authority if the situation warrants. 3) Ensuring an Adequate Drug Supply In the past few years Canada's doctors have become deeply concerned about the persistent shortages of drugs that they and their patients are encountering. In a survey of physicians conducted by the CMA in September 2012, two-thirds of respondents said that the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes. Of these physicians, 70 per cent indicated that their patient received a less effective medication, and 20 per cent had patients who had suffered clinical deterioration because an alternate drug was substituted. This in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. Twenty-three per cent reported that their patient suffered financially due to the cost of the substituted medication, since many of the drugs in short supply are older, low-cost generics. The lack of information about shortages compounds the stress of dealing with them. When physicians prescribe a medication, unaware that it is in short supply, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Physicians have expressed their frustration at the time it takes to find an appropriate substitute drug - time which could better be spent in patient care. As a consequence, the CMA strongly supports the development of a comprehensive system for monitoring domestic shortages of medically necessary drugs. To be of greatest benefit to doctors, such a system should include: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. Although pharmaceutical industry associations and drug manufacturers are now supporting a drug shortage reporting website (http://www.drugshortages.ca/drugshortages.asp), there is room for improvement. The reporting website does not yet capture all of the drug product shortages. It must become more user friendly for health practitioners and the public, with search and sort functions to easily find product listings. In addition, a mechanism to obtain information on possible therapeutic substitutions would be of value to practitioners. Recommendation 3: The CMA recommends that Health Canada work with provincial and territorial governments, industry groups and health professionals to enhance the current system for reporting drug shortages and ensure its sustainability. Finally, while a reporting system to provide information to health professionals and Canadians on drug shortages is valuable, it is essential that Canada address the root causes of drug shortages. A review of the supply processes, both domestic and international, is strongly recommended. While the CMA acknowledges that provinces are responsible for purchasing drugs, we believe that solutions will be stronger if all provinces, and the federal government, work together on them. And since drug shortages are an international concern, it is the responsibility of the Government of Canada to work with other countries in seeking solutions. Recommendation 4: The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. 4) Other Important Elements of a National Pharmaceutical Strategy As Recommendation 1 states, the CMA believes that Canada's federal and provincial/territorial governments should implement a national pharmaceutical strategy, one of whose objectives would be to ensure an adequate supply of prescription drugs. The strategy should address other important objectives, as well, notably: * ensuring comprehensive prescription drug coverage for all Canadians. According to a recent CMA survey, one in 10 Canadians has gone without a prescription drug because they couldn't afford it. Governments should work with private insurers and other stakeholders to develop a system to provide equitable, comprehensive prescription drug coverage to all Canadians. * encouraging optimal prescribing by health professionals. To accomplish this, the CMA has recommended a strategy that includes education, user-friendly guidelines and practice tools, and the provision of impartial information to health professionals and the public. 5) Conclusion Once again, we commend the Senate Social Affairs Committee for bringing this issue to your table. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective and in adequate supply. 1 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.4444.
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Coverage for all forms of contraception

https://policybase.cma.ca/en/permalink/policy10533
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC12-113
The Canadian Medical Association supports full coverage for all forms of contraception.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC12-113
The Canadian Medical Association supports full coverage for all forms of contraception.
Text
The Canadian Medical Association supports full coverage for all forms of contraception.
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Drug manufacturing and distribution

https://policybase.cma.ca/en/permalink/policy10535
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC12-115
The Canadian Medical Association calls for the modernization of the federal Food and Drugs Act relating to drug manufacturing and distribution processes.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC12-115
The Canadian Medical Association calls for the modernization of the federal Food and Drugs Act relating to drug manufacturing and distribution processes.
Text
The Canadian Medical Association calls for the modernization of the federal Food and Drugs Act relating to drug manufacturing and distribution processes.
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Essential drugs for the exclusive use of developing countries

https://policybase.cma.ca/en/permalink/policy415
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC00-221
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
Policy Type
Policy resolution
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC00-221
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
Text
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
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Pan-Canadian standardized vaccination protocol

https://policybase.cma.ca/en/permalink/policy10474
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-63
The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Population health/ health equity/ public health
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-63
The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
Text
The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
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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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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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