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8 records – page 1 of 1.

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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Antibiotics in animals

https://policybase.cma.ca/en/permalink/policy10534

Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Text
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
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Canadian Medical Association submission to the Standing Senate Committee on Banking, Trade and Commerce: Higher rate now: Why excise tax on tobacco is long overdue for an increase

https://policybase.cma.ca/en/permalink/policy11129

Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula

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Complementary and alternative medicine (update 2015)

https://policybase.cma.ca/en/permalink/policy11529

Date
2015-05-30
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Date
2015-05-30
Replaces
Complementary and alternative medicine (Update 2008)
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. CAM in Canada CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories: * Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. * Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. * Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. * Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: * Resist any influence or interference that could undermine their professional integrity;9 * Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 * Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: * Instructions for use; * Indications that the product or therapy has been convincingly proven to treat; * Contraindications, side effects and interactions with other medications; * Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients. i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.

Documents

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National and provincial/territorial legislation to address drug-impaired driving

https://policybase.cma.ca/en/permalink/policy11247

Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Text
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
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Opioid overdose prevention tools and services

https://policybase.cma.ca/en/permalink/policy11248

Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Text
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295

Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; 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 recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.

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8 records – page 1 of 1.