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Policies that advocate for the medical profession and Canadians


13 records – page 1 of 2.

Antibiotics for agricultural use

https://policybase.cma.ca/en/permalink/policy10916
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Text
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
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Antibiotics for use in food animals

https://policybase.cma.ca/en/permalink/policy10913
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Text
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
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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 Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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Direct-to-consumer advertising (DTCA)

https://policybase.cma.ca/en/permalink/policy188
Last Reviewed
2020-02-29
Date
2002-09-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2002-09-30
Replaces
Position paper on direct to consumer prescription drug advertising (1986)
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Direct-to-Consumer Advertising (DTCA) Policy Statement Canadians have a right to information about prescription drugs and other therapeutic interventions, to enable them to make informed decisions about their own health. This information must be evidence based and provide details about side effects and health risks as well as benefits. Brand-specific direct-to-consumer advertisements, such as those permitted in the United States, do not provide optimal information on prescription drugs. We are concerned that DTCA: * is not information but marketing, and sends the message that a prescription drug is a “consumer good” rather than a health care benefit. * may not provide enough information to allow the consumer to make appropriate drug choices. For example, it generally does not provide information about other products or therapies that could be used to treat the same condition. In addition, it may stimulate demand by exaggerating the risks of a disease and generating unnecessary fear. * may strain the relationship between patients and providers, for example if a patient’s request for an advertised prescription drug is refused. * drives up the cost of health care, and undermines the efforts of physicians, pharmacists and others to promote optimal drug therapy. Patient groups, health care providers, governments and pharmaceutical manufacturers should be supported in activities to develop objective, reliable plain-language information about prescription drugs to ensure that Canadians are able to make informed health care decisions. Therefore we: * Support the provision of objective, evidence-based, reliable plain-language information for the public about prescription drugs. * Oppose direct-to-consumer prescription drug advertising in Canada.
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The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada: Canadian Medical Association Submission to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy11035
Date
2013-11-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-11-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the government's role in addressing prescription drug abuse in Canada. It is increasingly recognized that while prescription medication has an important role in health care, the misuse and abuse of controlled psychoactive prescription medications, notably opioids such as oxycodone, fentanyl and hydromorphone, is emerging as a significant public health and safety issue. The use of prescription opioids is on the rise, in Canada and internationally. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The CMA is particularly concerned about the impact of prescription drug abuse and misuse on vulnerable populations; notably, seniors, youth and First Nations. We note, for example, that in 2011 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. Though many patients are prescribed controlled drugs to treat medical conditions, it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Canada's physicians believe that the misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Therefore, the CMA makes the following recommendations to the Committee: 1) A National Strategy to Address the Abuse and Misuse of Prescription Medication The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA has consistently recommended a comprehensive national strategy to address the problems of drug abuse in Canada, whether of illegal or prescription-based substances. The Canadian Centre on Substance Abuse, in its report First Do No Harm: Responding to Canada's Prescription Drug Crisis, has offered nearly 60 recommendations toward the development of a strategy to combat misuse of prescription medications. The CMA believes that such a strategy should include: a) Prevention: Existing community programs and social marketing campaigns to address prescription drug abuse are generally aimed at young recreational users. For example, since many such users report that they get drugs from their parents' or friends' medicine cabinets, many jurisdictions have implemented prescription "take-back" programs, and education campaigns to promote safe storage and disposal of medications. Prevention strategies aimed at other types of prescription drug abuse, and targeting other populations such as health care providers, are still required. b) Treatment: Appropriate services for the treatment of addiction to prescription drugs are also a vital part of a national strategy. The CMA recommends that all partners work to improve and promote access to treatment programs - not only for treatment of addiction, such as pharmacological interventions, support and counselling, and withdrawal management, but also to treat and manage pain. In particular, the CMA recommends improving access to culturally appropriate treatment, counselling and withdrawal management programs in rural and remote areas, and for First Nations. c) Consumer Protection: There are several ways in which consumer protection strategies may form part of a strategy. One is modifications to the drugs themselves. For example, opioid manufacturers have developed formulations of their products intended to minimize their abuse potential, such as "slow-release" formulations and other forms of tamper-proofing to reduce a drug's potential for abuse. CMA supports further investigation into abuse-deterrent technologies. d) Surveillance and Research: Our knowledge of the extent of the prescription drug abuse problem in Canada, and the effectiveness of strategies proposed to combat it, is limited by a number of factors. These will be more specifically addressed later in this brief. 2) Strategies to Enhance Optimal Prescribing in Canada The CMA recommends that governments at all levels work with prescribers and the public, industry and other stakeholders to develop and implement a nationwide strategy to support optimal prescribing and medication use in Canada. In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA acknowledges that we have not yet achieved that ideal, but believes that optimal prescribing in Canada is a goal worth achieving. Our 2010 position statement "A Prescription for Optimal Prescribing" (Appendix A) recommends a national strategy to promote best practices in prescribing, and its recommendations can be applied to the specific situation of prescription drug abuse. Key elements of this strategy are: * Relevant, objective and easily accessible information for prescribers, which can readily be incorporated into every day practice. This can include clinical decision-support tools for use at the point of care. * Ongoing development and dissemination of clinical guidance in pain management. A Canadian practice guideline for use of opioids to treat chronic non-cancer pain, prepared under the direction of the multi-stakeholder National Opioid Use Guideline Group (NOUGG), was published in the Canadian Medical Association Journal on June 15, 2010. A number of plans for dissemination of this guideline are under way, under the direction of the Michael G. DeGroote National Pain Centre at McMaster University. They include an online CME module, co-sponsored by the CMA, which is now being finalized by MDcme.ca, a professional education group based at Memorial University. * Educational programs for prescribers in pain management and in the management of addictions. Both addiction treatment and pain management should be part of the educational curriculum in medical school and residency training as well as in continuing education. Educational programs could also provide prescribers with advice on how to recognize addiction in a patient, or on how to deal with fraudulent or aggressive patients. * Ensuring that prescribers have access to expert advice if required. This could be achieved through such means as: o Academic detailing programs, which use personalized one-on-one techniques to deliver impartial prescribing information to practitioners. o Communities of practice and clinical support networks that link practitioners with experts in the field. Experts can not only provide clinical information, but can provide mentorship and personal advice on best practices. 3) Monitoring and Surveillance of Prescription Drug Abuse The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. One of the challenges in dealing with prescription drug abuse is the incompleteness of our knowledge of the extent of the problem, or of the most effective ways to address it. This means that physicians do not have access in real time to the information they need, at the point of care. For example, except in Prince Edward Island, physicians do not have the ability to look up a patient's medical history to determine if he or she has received a prescription from another source. Prescription monitoring programs exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. Some are administered by regulatory colleges, others by governments. The CMA recommends that national standards be developed for prescription monitoring programs, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects: * It can help identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * It can help deter cross-provincial fraud. * It can help professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, it will help researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. The CMA also recommends that this system be electronic and that it be compatible with electronic medical and pharmacy record systems, and with provincial pharmaceutical databases such as British Columbia's. Provincial and territorial governments should work with the federal government and with health care providers to improve the standardization and sharing of information where appropriate. Prescription monitoring programs should be evaluated to ascertain their effectiveness in reducing misuse and abuse. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on issues related to prescription drug abuse, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. In conclusion, the Canadian Medical Association reiterates the deep concern of Canada's physicians about prescription drug abuse and misuse in this country. We are committed to enhancing optimal prescribing and to working with governments to develop and implement a strong, coherent plan of action to address this pressing national problem.
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Position statement on prescription drug shortages in Canada

https://policybase.cma.ca/en/permalink/policy10756
Last Reviewed
2017-03-04
Date
2013-05-25
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2017-03-04
Date
2013-05-25
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Position Statement on Prescription Drug Shortages in Canada The escalation in shortages of prescription drugs in the past few years and the ongoing disruptions to supply experienced in Canada and globally are matters of grave concern to the Canadian Medical Association (CMA) and its members. Drug shortages are having a detrimental impact on the delivery of patient care and treatment and the availability of health care services across the country. CMA has advocated for a thorough examination of the drug supply system to identify points where we in Canada can influence supply problems. Solutions will have to involve the various players in the drug supply chain, from manufacturers through to healthcare providers and levels of government. Background Drug shortages are not a problem confined to Canada. In the United States the number of drug shortages from 2006 to 2010 grew by more than 200 per cent.1 In 2011, 251 shortages were reported to the FDA. 2 Canada has not had an accurate record of the number of drugs in short supply over past years but in April 2013 253 drugs were listed on the industry sponsored Canadian Drug Shortage Website.3 Factors that influence the occurrence of a drug shortage can occur at any stage of the drug supply chain and any disruptions can ripple through the system. Figure 1 Drug supply chain in Canada4 [See PDF] There are many causes that can lead to a drug shortage. Disruptions in the supply of an active or key ingredient contribute to drug shortages and this is exacerbated when the active ingredient is produced by a single raw material supplier. If the supplier is unable to meet demand than all manufacturers relying on that supply become vulnerable to disruptions. The sourcing of raw materials from outside of North America, primarily China and India, whose safety and regulatory standards may not be stringently enforced can result in regulatory authorities closing down facilities thereby impacting supply of active ingredients or necessitating a lengthy search for a new supplier. Additional manufacturing issues contributing to shortages can include complex manufacturing processes like those used to make sterile injectables, changes in product formulations, problems in the production process or regulatory enforcement of good manufacturing processes, limited capacity, an unexpected surge in demand, regulatory delays in product approvals and business decisions. 5 Shortages may also be due to factors outside the manufacturers control such as various interruptions in the normal delivery of medicines through the pharmacy supply chain and distribution network6. Just in time inventory management practices can lead to a reduction of available drug inventories. In addition procurement strategies that lead to sole source contracts for bulk purchases has been identified as the single most avoidable cause of drug shortages. 7 Health Consequences Disruptions in the supply of medications have the potential to impact patient care, patient health and the efficiency of the overall health care system. 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; - increased non-compliance when changes in medication make it confusing and harder to comply with a new medication regime particularly for those on long term therapy.8 Any and all of these situations can result in a disruption to clinical stability and deterioration, particularly in patients with complex problems. Drug substitution can also result in unintended consequences. In 2010 an Institute of Safe Medication Practices survey of 1800 US health professionals revealed that in one year drug shortages caused over 1000 incidents involving negative side effects or medical errors. 9 In many instances shortages can lead to an increase in the use of the health care system, be it in physician or emergency room visits or treatments. A CMA survey of physicians in September 2012 found that 66% of respondents indicated that drug shortages have gotten worse since 2010 and 64% stated that the shortages have had consequences for their patients or practice. Similarly, the results of the 2012 Canadian Pharmacists Association (CPhA) survey of pharmacists found that over 91% of pharmacists indicated that patients had been inconvenienced by shortages and 51% indicated that patients' care had been compromised.10 Drug shortages also have an impact on the practices of physicians and pharmacists. Sixty seven percent of the respondents to the CMA survey stated that drug shortages do have an impact on their practice most notably by increasing time spent on research or consultation with health professional colleagues to source alternative medicine, increase in length of patient visits due to medication substitution concerns, and increase in time spent on forms such as insurance claims. Seventy six percent of hospital pharmacists and 76 percent of community pharmacists also report an impact on their workload and practice.11 Recommendations Since as early as 2005, the CMA has supported a comprehensive strategy and adequately resourced system for monitoring domestic drug supply. In response to a Health Canada consultation in October 2005 on a report entitled "Developing a Drug Supply Network" CMA recommended that Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. In March 2011 this position was reinforced in communication with the Government of Canada stating that Canada needs a sustainable, adequately resourced process to identify shortages, rapidly communicate them to health professionals and respond quickly to resolve them. 1. The Canadian Medical Association supports an investigation into the underlying causes of prescription drug shortages in Canada. 2. The Canadian Medical Association recommends the creation of a monitoring unit to track drug production disruptions in Canada and abroad. The communication of information to health professionals once a shortage occurs, or is expected, is critical to their ability to make patient centered decisions and provide continuity of optimum care. CMA has participated on a Multi Stakeholder Working Group on Drug Shortages that has had the pharmaceutical industry and health professional organizations working together to establish a national drug shortage reporting website. CMA provided key input on the needs of needs of physicians to ensure that information required to provide optimum care when managing a drug shortage such as product information including name, manufacturer, formulation, strength, package size, expected duration of shortage, notification that shortage is resolved as well as automatic alerts and search and sort functionality was included on the website. The establishment of the Canadian drug shortage website marks an improvement in the management of drug shortages but significant issues remain. Of great concern are drugs that are 'single sourced'. When there are shortages of single sourced medications there are no clear substitutes. Related to this are the unintended consequences of sole sourcing products from one manufacturer to secure a lower price. This introduces a vulnerability to the marketplace if the sole supplier experiences production disruptions. The 2011 production stoppage at a Sandoz facility in Quebec due to regulatory compliance issues and a subsequent fire in the plant resulted in a scramble to find alternate sources of many essential medications. The CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The inclusion of incentives or penalties for guaranteed supplies, or a contingency plan for supply disruptions should be inserted into purchase contracts. We must be extremely careful not to exacerbate supply problems while trying to address cost issues. 3. The Canadian Medical Association calls for a review of the supply processes in place for drugs and equipment considered essential for medical practice. 4. The Canadian Medical Association supports strategies to discourage single-source purchasing decisions for prescription medications. Advance notice, by manufacturers to Health Canada, of expected drug shortages can provide a window of opportunity for the manufacturer and regulators to work together to resolve production problems or identify alternate supply. We are encouraged by recent initiatives by Health Canada to collect information on planned discontinuances from manufacturers. 5. The Canadian Medical Association calls for the establishment of a legislative framework requiring pharmaceutical companies to provide advance notice of production stoppages and any forecast disruptions in the drug supply. Because of the complexity of the drug supply system, to effectively identify the situations that lead to drug shortages and find Canadian based solutions that can decrease the incidence of shortages or mitigate their impact requires the involvement and cooperation of all players in the process. CMA has consistently asked the government of Canada to work with the provinces and territories, the private sector and health professionals to address this potentially dangerous threat to the lives of Canadian patients. 6. The CMA supports the provinces and territories in their efforts to prevent drug shortages. We are heartened by actions of Health Canada in 2012 to bring together representatives of industry, federal, provincial and territorial governments and health professional associations in a Multi Stakeholder Steering Committee on Drug Shortages to respond to the need for the mitigation of drug shortages. We trust that processes can be put in place and supported by key players to allow Canada to respond in a coordinated, transparent and accountable fashion to future or actual drug shortages. Conclusions Drug Shortages represent an ongoing worry for physicians. The impact on patients, health professionals and the health care system can be significant. Substantial progress has been made since 2011 in terms of gathering and sharing drug shortage information and improving our understanding of the drug supply processes but much still remains to be done. Although complex and challenging, ongoing attention to the issue is required to ensure that Canadians can count on a secure supply of medication into the future. The CMA will continue to represent the best interests of patients and physicians to ensure that Canada's health care system delivers on patient-centered care. References 1 DRUG SHORTAGES FDA's Ability to Respond Should be Strengthened, Statement of Marcie Cross, Director, Health Care, United States Government Accountability Office, Testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate, December 15, 2011. 2 FDA is asking the public to send in ideas for combatting drug shortages, FDA Voice, Feb. 13, 2013, U.S. Food and Drug Administration, available at http://blogs.fda.gov/fdavoice/index.php/tag/drug-shortages/ (accessed 2013 April 2). 3 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013 April 5). 4 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012. 5 Drug Supply Disruptions, Environmental Scan, Canadian Agency for Drugs and Technologies in Health, Issue 17, March 2011. 6 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013April 5). 7 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012. 8 Prescription Drug Shortages, E Panel Survey, Canadian Medical Association, December 2010. 9 Drug Shortages, Recommendations of the Working Group on Drug Shortages, Ordre des Pharmaciens du Québec, March 2012. 10 Impact of Drug Shortages, Member survey, Canadian Pharmacists Association, October 2012. 11 BACKGROUNDER - DRUG SHORTAGES SURVEY, Canadian Pharmacists Association, Canadian Society of Hospital Pharmacists, Canadian Medical Association, January 2013, available at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2013/Backgrounder-Drug-shortages_en.pdf ( assessed 2013 April 2).
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A Prescription for Optimal Prescribing

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

https://policybase.cma.ca/en/permalink/policy1961
Last Reviewed
2010-02-27
Date
2002-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health systems, system funding and performance
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2002-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health systems, system funding and performance
Text
It has been over three years since the Social Union Framework Agreement (SUFA) was signed by the federal and provincial/territorial governments, with the exception of Quebec. At the time, it was heralded as an important breakthrough in federal-provincial relations that would clear the way for greater intergovernmental cooperation on pressing social policy issues such as health care renewal. Functional federalism is essential to achieving social policy objectives that will be of benefit to Canadians from coast to coast. While SUFA may not be perfect, it is better than the alternative of federal-provincial paralysis and dysfunction. And as SUFA acknowledges, Canada’s social union is about more that how governments relate to each other: it is about how governments can and should work with external stakeholders and individual Canadians to improve the social policies and programs. The health sector is an important test case for SUFA. It is the most cherished of Canada’s social programs. Canadians want and expect their governments to work together to improve the health care system and ensure its future sustainability. Ironically, it is also the area where government intergovernmental discord has been the greatest. On the eve of the final report of the Commission on the Future of Health Care in Canada, it is timely to reflect on SUFA and its role in the renewal of Canada’s health system. SUFA and the Health Sector – Strengths and Weaknesses The attached table provides a summary of the key elements of SUFA and the CMA’s assessment of how well SUFA provisions have been applied in the health sector. On the positive side, the health sector has fared relatively well in the area of mobility within Canada. Physicians and other regulated health care providers generally enjoy a high degree of mobility. Portability of hospital and medical benefits is largely ensured through interprovincial eligibility and portability agreements. There are, however, two areas of concern. First, there is the longstanding failure to resolve the non-portability of medical benefits for Quebec residents. Second, there is growing disparity in coverage for services that are currently not subject to national standards under the Canada Health Act, particularly prescription drugs and home care. In the area of dispute avoidance and resolution, governments have agreed to a formal process to address concerns with the Canada Health Act. This is a positive step, though few details have been made public. The real test will be whether this new process accelerates the resolution of non-compliance issues (most of which, as the Auditor-General recently pointed out, have remained unresolved for five years or longer), and whether the federal government will have the political will to levy discretionary penalties for non-compliance. There has also been progress on public accountability and transparency as governments have begun reporting results in 14 health indicator areas pursuant to the September 2000 health accord. The CMA is disappointed, however, that governments did not fulfil their pledge to involve stakeholders at all levels in the development of these indicators. Moreover, governments have short-changed Canadians by not providing them with a national roll-up of indicators that would facilitate comparisons across jurisdictions. Looking to the future, it will be critical to put in place a process that moves from benchmarks (indicators) to the bedside (best practices, better outcomes). This must be done in collaboration with health care researchers, providers and health managers—those individuals who understand the importance of taking research and importing it into practice. Clinical researchers across the country are doing this work and must to be supported. Overshadowing these relative successes in the first three years of the Social Union Framework Agreement are three key challenges that must be addressed: * inadequate institutional mechanisms to improve accountability across the system * failure to reduce uncertainty about what the health system will deliver, now and into the future * resistance on the part of governments to engage stakeholders in a true partnership for health system renewal The CMA is concerned that if these fundamental weaknesses are not addressed, they will undermine future attempts to renew Canada’s health system. Improving accountability With the adoption of SUFA, governments have significantly increased emphasis on performance measurement and public reporting. While this is a positive development, it also has the potential to lead towards information overload and paralysis, unless two critical elements are addressed. First, there is a need for a clear accountability framework that sets out the roles, rights and responsibilities of all key players in Canada’s health system: patients, health care providers and governments. This, in turn, requires the creation of a credible arm’s length institution to monitor compliance with this framework and rise above the fray to give Canadians the straight goods on health care. One has to look no further that the recent rekindling of the so-called “shares debate” between the federal and provincial governments as an example of why these changes are necessary. Reducing uncertainty Over the past decade, Canada’s health system has been plagued by an escalating crisis of uncertainty. Patients have faced increasing uncertainty about the accessibility and timeliness of essential health care services. Health care providers have seen working conditions deteriorate. Employers and private insurers have seen their contribution to funding health services increase unpredictably as governments have scaled back their funding commitments. Furthermore, provincial and territorial governments have had to contend with an unstable federal funding partner. Canadians deserve better. They need more certainty that their public health system will care for them when they need it most. They need more transparency from governments about “what’s in” and “what’s out” in terms of public or private coverage. They need their governments to act on their SUFA undertaking to make service commitments for social programs publicly available such as establishing standards for acceptable waiting times for health care. And they need governments to follow through with their SUFA commitment to ensure stable and adequate funding for the health system and other social programs. Fostering real partnerships In the health care field, deliberations and agreements have taken place behind closed doors and governments have discounted the role that non-governmental organizations and citizens should play in decision-making. It is these very providers and patients who are expected to implement and live with the results of such cloistered decision-making. The consequences of this systematic exclusion are all too evident in the current critical and growing shortages of physicians, nurses and other health professionals. If we are to achieve the vision of a sustainable Medicare program, it is critical that governments come clean on their SUFA commitment to work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs. CMA’s Prescription for Sustainability – Building on SUFA The Social Union Framework Agreement has created the necessary, but not sufficient, conditions for health system renewal. It has codified the emerging consensus on federal-provincial relations and has clarified the "rules of the game". However, it is an enabling framework that is of limited value in the health sector unless it is given life through institutional mechanisms that establish enduring partnerships not just between governments, but between governments health care providers, and patients. In its final submission to the Commission on the Future of Health Care in Canada entitled “Prescription for Sustainability”, the CMA proposes the implementation of three integrated “pillars of sustainability” that together would improve accountability and transparency in the system: a Canadian Health Charter, a Canadian Health Commission, and federal legislative renewal. Canadian Health Charter A Canadian Health Charter would clearly articulate a national health policy that sets out our collective understanding of Medicare and the rights and mutual obligations of individual Canadians, health care providers, and governments. It would also underline governments’ shared commitment to ensuring that Canadians will have access to quality health care within an acceptable time frame. The existence of such a Charter would ensure that a rational, evidence-based, and collaborative approach to managing and modernizing Canada’s health system is being followed. Canadian Health Commission In conjunction with the Canadian Health Charter, a permanent, independent Canadian Health Commission would be created to promote accountability and transparency within the system. It would have a mandate to monitor compliance with and measure progress towards Charter provisions, report to Canadians on the performance of the health care system, and provide ongoing advice and guidance to the Conference on Federal-Provincial-Territorial ministers on key national health care issues. Recognizing the shared federal and provincial/territorial obligations to the health care system, one of the main purposes of the Canadian Health Charter is to reinforce the national character of the health system. Federal legislative renewal Finally, the CMA’s prescription calls for the federal government to make significant commitments in three areas: 1) a review of the Canada Health Act, 2) changes to the federal transfers to provinces and territories to provide increased and more targeted support for health care, and 3) a review of federal tax legislation to realign tax instruments with health policy goals. While these three “pillars” will address the broader structural and procedural problems facing Canada’s health care system, there is many other changes required to meet specific needs within the system in the short to medium term. The CMA’s Prescription for Sustainability provides specific recommendations in the following key areas: * Defining the publicly-funded health system (e.g. a more rational and transparent approach to defining core services, a “safety valve” if the public system fails to deliver, and increased attention to public health and Aboriginal health) * Investing in the health care system (e.g. human resources, capital infrastructure, surge capacity to deal with emergencies, information technology, and research and innovation) * Organization and delivery of services (e.g. consideration of the full continuum of care, physician compensation, rural health, and the role of the private sector, the voluntary sector and informal caregivers) Conclusion On balance, the Social Union Framework Agreement has been a positive step forward for social policy in Canada, though its potential is far from being fully realized. The CMA’s proposal for a Canadian Health Charter, a Canadian Health Commission and federal legislative review entail significant changes to the governance of Canada’s health system. These changes would be consistent with the Social Union Framework Agreement and would help “turn the corner” from debate to action on health system renewal. The early, ongoing and meaningful engagement of health care providers is the sine qua non of securing the long-term sustainability of Canada’s health system. Canada’s health professionals, who have the most to contribute, and next to patients – who have the most at stake – must be at the table when the future of health and health care is being discussed. The CMA’s Assessment of the Social Union Framework Agreement ANNEX [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] SUFA provisions CMA assessment Principles 1. All Canadians to be treated with fairness and equity 2. Promote equality of opportunity for all Canadians 3. Respect for the equality, rights and dignity of all Canadian women and men and their diverse needs 4. Ensure access for all Canadians to essential social programs and services of reasonably comparable quality 5. Provide appropriate assistance to those in need 6. Respect the principles of Medicare: comprehensiveness, universality, portability, public administration and accessibility 7. Promote the full and active participation of all Canadians in Canada’s economic and social life 8. Work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs 9. Ensure adequate, affordable, stable and sustainable funding for social programs 10. Respect Aboriginal treaties and rights [#4] Progress towards the objective of ensuring access to essential health services of reasonably comparable quality is difficult to assess. First, there is no agreed-upon definition of essential health services. Second there the development of indicators and benchmarks of health care quality is still in its infancy. However, the CMA is very concerned that the system is not headed in the right direction, with growing shortages of physicians, nurses and other health care providers. According to Statistics Canada’s recently released survey on access to health care services, an estimated 4.3 million Canadians reported difficulties accessing first contact services and approximately 1.4 million Canadians reported difficulties accessing specialized services. [#6]Although there is broad support for the five principles of Medicare, there continue to be a number of longstanding violations of Canada Health Act that are not being addressed, including the portability of medical benefits for Quebec residents. The emergence of privately-owned clinics that charge patients for medically-necessary MRI scans is also cause for concern. [#8] There is no formal, ongoing mechanism for input from stakeholders and the individual Canadians in debates about national health policy issues. (See also #17 below). [#9] Ensuring adequate, affordable, and stable funding for Canada’s health system is essential to its long-term sustainability. During the 1990s, billions of dollars were siphoned out of the system to eliminate government deficits. To put Medicare back on a sustainable path, governments must make long-term funding commitments to meet the health care needs of Canadians. The CMA has recommended that the federal government should significantly increase its financial contribution to restore the federal-provincial partnership in health care, and increase accountability and transparency through a new earmarked health transfer. Mobility within Canada 11. Removal of residency-based policies governing access to social services 12. Compliance with the mobility provisions of the Agreement on Internal Trade [#11] Residency-based policies are generally not an issue for physician and hospital services, where inter-provincial portability is guaranteed through reciprocal billing arrangements. As noted above, however, the portability of medical benefits for many Quebec residents is limited because the province only reimburses out-of-province services at home-province (as opposed to host-province) rates. [#12] Regulatory authorities initiated work towards meeting the obligations of the Labour Mobility Chapter of the Agreement on Internal Trade in fall 1999. A Mutual Recognition Agreement has been developed and endorsed by all physician licensing authorities. Public accountability & transparency 13. Performance measurement and public reporting 14. Development of comparable indicators to measure progress 15. Public recognition of roles and contributions of governments 16. Use funds transferred from another order of government for purposes agreed and pass on increases to residents 17. Ensure effective mechanisms for Canadians to participate in developing social priorities and reviewing outcomes 18. Make eligibility criteria and service commitments for social programs publicly available 19. Have mechanisms in place to appeal unfair administrative practices 20. Report publicly on appeals and complaints [#13-14] Pursuant to the September 2000 Health Accord, the federal government and provinces have developed common health indicators in 14 areas and have released a first slate of reports. However, the usefulness of these reports is hampered by missing data elements on quality of care (access and waiting times in particular) and the absence of a national roll-up to facilitate inter-provincial comparisons. [#15] Continuing federal-provincial bickering about shares of health funding makes it clear that this provision is not being met. [#16] The CMA’s analysis of the Medical Equipment Fund found that incremental spending by provinces on medical technology accounted for only 60% of the $500 million transferred by the federal government for this purpose. [#17] There is no mechanism in place to ensure ongoing input from Canadians and health care providers in national health policy development. The CMA has recommended the creation of a Canadian Health Commission, with representation from the public and stakeholders to provide advice and input to governments on key national health policy issues. [#18] Although there have been proposals to this effect in a couple of provinces, governments currently do not make explicit commitments about the quality and accessibility of health services. In order to reduce the uncertainty Canadians are feeling with respect to Medicare, the CMA has recommended the creation of a Canadian Health Charter that would set out the rights and responsibilities of patients, health care providers and governments. In particular, the health charter would require all governments to set out care guarantees for timely access to health services based on the best available evidence. [#19-20] The Auditor-General recently reported that Health Canada provides inadequate reporting on the extent of compliance with the Canada Health Act. Governments working in partnership 21. Governments to undertake joint planning and information sharing, and work together to identify priorities for collaborative action 22. Governments to collaborate on implementation of joint priorities when this would result in more effective and efficient service to Canadians. 23. Advance notice prior to implementation of a major policy or program change that will substantially affect another government 24. Offer to consult prior to implementing new social policies and programs that are likely to substantially affect other governments. 25. For any new Canada-wide social initiative, arrangements made with one province/territory will be made available to all provinces/territories. 26. Governments will work with the Aboriginal peoples of Canada to find practical solutions to address their pressing needs [#21-25] The requirement for governments to work together collaboratively is perhaps the most important part of SUFA, yet there it is impossible for organizations and individuals outside of government to assess the degree to which these provisions have been met. This so-called “black box of executive federalism” is not serving Canadians well. In the health sector, there are too many examples of governments developing policy and making decisions with little or no input from those who will ultimately have to implement change. To achieve a true social union, the tenets of good collaborative working relationships – joint planning, advance notice and consultation prior to implementation – must be extended beyond the ambit of federal-provincial decision-making. The CMA’s proposal for a Canadian Health Commission would go some distance in addressing these concerns. A key part of its mandate would be to bring the perspective of health providers and patients into national health policy deliberations and decision-making. Federal spending power 27. Federal government to consult with P/T governments at least one year prior to renewal or significant funding changes in social transfers 28. New Canada-wide initiatives supported by transfers to provinces subject to: a) collaborative approach to identify Canada wide objectives and priorities b) Agreement of a majority of provincial governments c) Provincial discretion to determine detailed design to meet agreed objectives d) Provincial freedom to reinvest funding in related area if objectives are already met e) Jointly developed accountability framework 29. For new Canada-wide initiatives funded through direct transfers to individuals or organizations, federal government to provide 3-months notice and offer to consult [#27-28] There have been three new Canada-wide health initiatives supported by the federal spending power: the $500M Medical Equipment Fund, the $800 Primary Health Care Transition Fund and the $500M fund for health information technology. The Medical Equipment Fund was created to respond to a genuine need for more modern diagnostic and treatment equipment. However, objectives were vague, money was transferred with no strings attached, and there was no accountability framework. The result, as the CMA’s analysis has shown, is that a significant portion of the funding did not reach its destination. The jury is still out in the case of the Primary Care Transition Fund. Delivery of this program through normal government machinery will entail a higher degree of accountability than in the case of the Medical Equipment Fund. However, objectives of this initiative may be too broad to have a significant steering effect on the system as a whole. Canada Infoway Inc. is an arm’s length body created by the federal government to disburse the $500M in health information technology funding. While this model has the advantage of being less politicized than government-run programs; accountability to Parliament and to Canadians is weaker. Dispute avoidance & resolution 30. Governments committed to working together and avoiding disputes 31. Sector negotiations to resolve disputes based on joint fact-finding, including the use of a third party 32. Any government can require a decision to be reviewed one year after it enters into effect 33. Governments will report publicly on an annual basis on the nature of intergovernmental disputes and their resolution [#30-33] Federal and provincial governments have agreed to a formal dispute avoidance and resolution process under the Canada Health Act. The Canadian Health Commission recommended by the CMA could play a useful role as an independent fact-finder. Review of SUFA 34. By the end of the 3rd year, governments will jointly undertake a full review of the Agreement and its implementation. This review will ensure significant opportunities for input and feedback from Canadians and all interested parties, including social policy experts, the private sector and voluntary organizations. [#34] Governments have taken a minimalist approach to the SUFA review by opting for an internet-based consultation and closed meetings with invited external representatives. This approach is not sufficient. Future reviews should be more inclusive of all stakeholders. [TABLE END]
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