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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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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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Scope-of-practice expansion

https://policybase.cma.ca/en/permalink/policy10875
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-77
The Canadian Medical Association recommends that conflict-of-interest issues be considered when any scope-of-practice expansion that allows allied health professionals to both prescribe and dispense medication is considered.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-77
The Canadian Medical Association recommends that conflict-of-interest issues be considered when any scope-of-practice expansion that allows allied health professionals to both prescribe and dispense medication is considered.
Text
The Canadian Medical Association recommends that conflict-of-interest issues be considered when any scope-of-practice expansion that allows allied health professionals to both prescribe and dispense medication is considered.
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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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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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