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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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Cannabis for Medical Purposes

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

https://policybase.cma.ca/en/permalink/policy9919
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Text
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
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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
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2019-03-03
Date
2012-08-15
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Population health/ health equity/ public health
Resolution
GC12-113
The Canadian Medical Association supports full coverage for all forms of contraception.
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Last Reviewed
2019-03-03
Date
2012-08-15
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GC12-113
The Canadian Medical Association supports full coverage for all forms of contraception.
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The Canadian Medical Association supports full coverage for all forms of contraception.
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Drug manufacturing and distribution

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2012-08-15
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GC12-115
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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2019-03-03
Date
2012-08-15
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GC12-115
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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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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Pan-Canadian standardized vaccination protocol

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2019-03-03
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2012-08-15
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GC12-63
The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
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Date
2012-08-15
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GC12-63
The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
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The Canadian Medical Association calls for the development of a pan-Canadian standardized vaccination protocol.
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A Prescription for Optimal Prescribing

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