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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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Antibiotics used in the raising of farm animals

https://policybase.cma.ca/en/permalink/policy10211
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC11-88
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
Policy Type
Policy resolution
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC11-88
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
Text
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
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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
Documents
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Insite: CMA submission regarding Insite supervised injection site and program.

https://policybase.cma.ca/en/permalink/policy14129
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Court submission
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
S.C.C. File No.: 33556 IN THE SUPREME COURT OF CANADA (APPEAL FROM THE BRITISH COLUMBIA COURT OF APPEAL) BETWEEN: ATTORNEY GENERAL OF CANADA AND MINISTER OF HEALTH FOR CANADA Appellants (Appellants/Cross-Respondents) —and — PHS COMMUNITY SERVICES SOCIETY, DEAN EDWARD WILSON and SHELLY TOMIC, VANCOUVER AREA NETWORK OF DRUG USERS (VANDU) Respondents (Respondents/Cross-Appellants) —and — ATTORNEY GENERAL OF BRITISH COLUMBIA Respondent (Respondent) —and — ATTORNEY GENERAL OF QUEBEC, DR. PETER AIDS FOUNDATION, VANCOUVER COASTAL HEALTH AUTHORITY, CANADIAN CIVIL LIBERTIES ASSOCIATION, CANADIAN HIV/AIDS LEGAL NETWORK, INTERNATIONAL HARM REDUCTION ASSOCIATION AND CACTUS MONTREAL, CANADIAN NURSES ASSOCIATION, REGISTERED NURSES' ASSOCIATION OF ONTARIO AND ASSOCIATION OF REGISTERED NURSES OF BRITISH COLUMBIA, CANADIAN PUBLIC HEALTH ASSOCIATION, CANADIAN MEDICAL ASSOCIATION, BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION, BRITISH COLUMBIA NURSES'S UNION Interveners FACTUM OF THE INTERVENER, CANADIAN MEDICAL ASSOCIATION BORDEN LADNER GERVAIS LLP 100 Queen Street — Suite 1100 Ottawa, ON KIP 1J9 Guy J. Pratte/Nadia Effendi Tel: (613) 237-5160 Fax: (613) 230-8842 Counsel for the Intervener, Canadian Medical Association 2 TO: Roger Bilodeau, Q.C. REGISTRAR SUPREME COURT OF CANADA AND TO: Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.fratergustice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Attorney General of Canada Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.frater@justice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Minister of Health for Canada Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, PHS Community Services Society Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, PHS Community Services Society 3 Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, Dean Edward Wilson and Shelly Tomic John W. Conroy, Q.C. Conroy & Company 2459 Pauline St Abbotsford, British Columbia V2S 3S1 Telephone: (604) 852-5110 FAX: (604) 859-3361 E-mail: jconroy@johnconroy.com Counsel for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Craig E. Jones Attorney General of British Columbia 1001 Douglas Street, 6th floor Victoria, British Columbia V8V 1X4 Telephone: (250) 387-3129 FAX: (250) 356-9154 E-mail: craigjones@gov.bc.ca Counsel for Respondent, the Attorney General of British Columbia Hugo Jean Procureur general du Quebec 1200 Route de l'Èglise, 2e etage Ste-Foy, Quebec G1V 4M1 Telephone: (418) 643-1477 FAX: (418) 644-7030 E-mail: hjean@justice.gouv.qc.ca Counsel for Intervener, Attorney General of Quebec Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, Dean Edward Wilson and Shelly Tomic Henry S. Brown, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St P.O. Box 466, Stn "D" Ottawa, Ontario KIP 1C3 Telephone: (613) 233-1781 FAX: (613) 788-3433 E-mail: henry.brown@gowlings.com Agent for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Robert E. Houston, Q.C. Burke-Robertson 70 Gloucester Street Ottawa, Ontario K2P 0A2 Telephone: (613) 566-2058 FAX: (613) 235-4430 E-mail: rhouston@burkerobertson.com Agent for Respondent, the Attorney General of British Columbia Pierre Landry Noel & Associes 111, rue Champlain Gatineau, Quebec J8X 3R1 Telephone: (819) 771-7393 FAX: (819) 771-5397 E-mail: p.landry@noelassocies.com Agent for Intervener, Attorney General of Quebec 4 Andrew I. Nathanson Fasken Martineau DuMoulin LLP 2900 - 550 Burrard Street Vancouver, British Columbia V6C 0A3 Telephone: (604) 631-4908 FAX: (604) 631-3232 Counsel for Intervener, Dr. Peter AIDS Foundation Ryan D. W. Dalziel Bull, Housser & Tupper LLP 3000 - 1055 West Georgia Street Vancouver, British Columbia V6E 3R3 Telephone: (604) 641-4881 FAX: (604) 646-2671 E-mail: rdd@bht.com Counsel for Intervener, British Columbia Civil Liberties Association Sheila Tucker Davis LLP 2800 Park Place 666 Burrard Street Vancouver, British Columbia V6C 2Z7 Telephone: (604) 643-2980 FAX: (604) 605-3781 E-mail: stuckergdavis.ca Counsel for Intervener, Vancouver Coastal Health Authority Paul F. Monahan Fasken Martineau DuMoulin LLP 333 Bay Street, Suite 2400 Bay Adelaide Centre, Box 20 Toronto, Ontario M5H 2T6 Telephone: (416) 366-8381 FAX: (416) 364-7813 E-mail: pmonahan@fasken.com Counsel for Intervener, Canadian Civil Liberties Association Scott M. Prescott Fasken Martineau DuMoulin LLP 1300 - 55 Metcalfe Street Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: sprescott@fasken.com Agent for Intervener, Dr. Peter AIDS Foundation Brian A. Crane, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St Ottawa, Ontario K1P 1C3 Telephone: (613) 233-1781 FAX: (613) 563-9869 E-mail: brian.crane@gowlings.com Agent for Intervener, British Columbia Civil Liberties Association Marie-France Major McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: mane-france.maior@mcmillan.ca Agent for Intervener, Vancouver Coastal Health Authority Julia Kennedy Fasken Martineau DuMoulin LLP 55 Metcalfe Street Suite 1300 Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: ikennedy(&fasken.com Agent for Intervener, Canadian Civil Liberties Association Michael A. Feder McCarthy Tétrault LLP Suite 1300, 777 Dunsmuir Street Vancouver, British Columbia V7Y 1 K2 Telephone: (604) 643-5983 FAX: (604) 622-5614 E-mail: mfeder(qmccarthv.ca Counsel for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Rahool P. Agarwal Ogilvy Renault LLP 3800 - 200 Bay Street Toronto, Ontario M5J 2Z4 Telephone: (416) 216-3943 FAX: (416) 216-3930 E-mail: ragarwal(iogilvyrenaul1.com Counsel for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontario and Association of Registered Nurses of British Columbia Owen M. Rees Stockwoods LLP 77 King Street West Suite 4130, P.O. Box 140 Toronto, Ontario M5K IHI Telephone: (416) 593-7200 FAX: (416) 593-9345 E-mail: owenr~stockwoods.ca Counsel for Intervener, Canadian Public Health Association 5 Brenda C. Swick McCarthy Tétrault LLP 200 - 440 Laurier Avenue West Ottawa, Ontario KIR 7X6 Telephone: (613) 238-2000 FAX: (613) 563-9386 Agent for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Sally A. Gomery Ogilvy Renault LLP 1500 - 45, O'Connor Street Ottawa, Ontario KIP lA4 Telephone: (613) 780-8661 FAX: (613) 230-5459 E-mail: sgomery(qogilvyrenaul1.com Agent for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontaro and Association of Registered Nurses of British Columbia Dougald E. Brown Nelligan O'Brien Payne LLP 1500 - 50 O'Connor S1. Ottawa, Ontario KIP 6L2 Telephone: (613) 231-8210 FAX: (613) 788-3661 E-mail: dougald.brown(inelligan.ca Agent for Intervener, Canadian Public Health Association Marjorie Brown Victory Square Law Office 100 West Pender Street Suite 500 Vancouver, British Columbia V6B 1R8 Telephone: (604) 684-8421 FAX: (604) 684-8427 E-mail: mbrown(avslo.ca Counsel for Intervener, British Columbia Nurses' Union Michael A. Chambers Maclaren Corlett 50 O'Connor Street, Suite 1625 Ottawa, Ontario KIP 6L2 Telephone: (613) 233-1146 FAX: (613) 233-7190 E-mail: mchambers(amacorlaw.com Counsel for Intervener, Real Women Canada 6 Colleen Bauman Sack Goldblatt Mitchell LLP 500 - 30 Metcalfe St. Ottawa, Ontario KIP 5L4 Telephone: (613) 235-5327 FAX: (613) 235-3041 E-mail: cbauman~sgmlaw.com Agent for Intervener, British Columbia Nurses' Union TABLE OF CONTENTS Part I — Statement of Facts ........................................................................................................... .1 A. Overview ......................................................................................................................... 1 B. CMA's Interest in the Appeal ............................................................................................ 1 C. CMA's Position on the Facts ............................................................................................ 1 Part II — Statement of the Questions in Issue ................................................................................3 Part III — Statement of Argument .................................................................................................3 A. Charter Interpretation Must be Guided by Reality, Not Ideology ......................................... 3 B. The Impugned Provisions Infringe Section 7 of the Charter ................................................. 5 (1)Denying Access to Necessary Health care Infringes Section 7 of the Charter.................. 5 (2)The Rights to Life and Security of Patients Have Been Infringed ................................... 5 (3)Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment .................................................................................................................. 6 (4)The Rights to Liberty of the Individual Respondents Have Been Infringed ..................... 8 (5)The Principles of Fundamental Justice Have Not Been Respected ................................. 8 a) The Impugned Provisions Are Arbitrary ..................................................................... 8 b) The Impugned Provisions Are Overbroad ................................................................... 9 C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter ................................................................................................................................ 9 D. Remedy ......................................................................................................................... 10 Part IV — Submissions as to Costs .............................................................................................. 10 Part V — Order Sought ................................................................................................................10 Part VI — Table of Authorities .................................................................................................... 11 Part VII — Statutes, Regulations, Rules ...................................................................................... 13 PART I — STATEMENT OF FACTS A. Overview 1. Fair and equitable access to medically necessary, evidenced-based health care is of fundamental importance to Canadian patients and physicians, as this Court recognized in Chaoulli. 2. Where life and security of a person is at risk because of a medical condition, like drug addiction, the Court's delineation of a government or legislature's constitutional obligations should be guided by facts. Unfounded ideological assumptions about the character of patients must not trump clinical judgment based on the best medical evidence available; otherwise, the life, liberty and security of patients is put at risk arbitrarily, contrary to section 7 of the Charter. 3. The Appellants' position that those addicted to drugs have foregone any right to access medical treatment is antithetical to the raison d'être of the Canadian health care system and inconsistent with the federal government's obligations under section 7 of the Charter. 4. Neither the statutory law nor the Constitution allows the state to deny access to health care because of "lifestyle" choices or presumed waiver of legal or constitutional rights. B. CMA's Interest in the Appeal 5. The Canadian Medical Association ("CMA") is the national voice of Canadian physicians with over 74,000 members across the country. Its mission is to serve and to unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and heath care. 6. Critical to CMA's role is the upholding of harm reduction as one pillar in a comprehensive public health approach to disease prevention and health promotion. Further, the CMA possesses a distinct expertise and broad-based knowledge of many aspects of policy and law concerning harm reduction as a clinically mandated and ethical method of care and treatment. C. CMA's Position on the Facts 7. By Order dated February 17, 2011, the CMA was granted leave to intervene in this Appeal. 2 8. The CMA accepts the facts as stated by the Respondents. 9. This appeal flows from separate actions commenced by some of the Respondents seeking relief that would obviate the need for exemptions granted by the Federal Minister of Health under section 56 of the Controlled Drugs and Substances Act (the "Act"), S.C. 1996 c. 19. Thus, when within the confines of the Vancouver Safe Injection Site ("Insite"), patient drug users were not liable to prosecution for possession of a controlled substance contrary to section 4(1) of the Act, or staff for trafficking contrary to section 5(1). The initial exemptions, based on "necessity for a scientific purpose", were granted for a term of three years commencing September 12, 2003. They were thereafter extended to December 31, 2007, and then to June 30, 2008. Insite's ability to operate was dependent upon the exemptions. However, no further extensions were forthcoming. 10. In their actions, the Respondents, in addition to the division of powers argument, contended that sections 4(1) and 5(1) of the Act violated section 7 of the Charter, were unconstitutional, and should be struck down. The Respondents were successful before the Applications Judge and the Court of Appeal. 11. The Applications Judge found that sections 4(1) and 5(1) of the Act infringed section 7 of the Charter and declared them to be of no force and effect. 12. On appeal by the Attorney General of Canada and cross-appeal by the Respondents, PHS, Wilson and Tomic, the majority of the Court of Appeal found that sections 4(1) and 5(1) of the Act were inapplicable to Insite by reason of the application of the doctrine of interjurisdictional immunity. 13. In concurring reasons, Rowles J.A. also found that sections 4(1) and 5(1) engaged section 7 of the Charter and that such application did not accord with the principles of fundamental justice because of overbreadth. 14. The findings of the Applications Judge and Rowles J.A. under the Charter are, the CMA submits, premised on the correct and supported fact that harm reduction is an evidenced-based form of medical treatment for patient drug addicts suffering from the illness of addiction. It is unconstitutional for governments to prevent access to treatment on pain of criminal penalty and deprivations of life, liberty and security of the person on grounds informed by ideological 3 assumptions and not the evidence. PART II - STATEMENT OF THE QUESTIONS IN ISSUE 15. The following constitutional questions, as stated by the Chief Justice on September 2, 2010, are to be determined in this appeal: 1. Are ss. 4(1) and 5(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, constitutionally inapplicable to the activities of staff and users at Insite, a health care undertaking in the Province of British Columbia? 2. Does s. 4(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 3. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 4. Does s. 5(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 5. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 16. Questions two to five, which relate to the Charter, are of particular importance for the CMA, and are addressed in more detail below. The CMA submits that sections 4(1) and 5(1) of the Act infrnge the rights guaranteed by section 7 of the Charter and are not justified under section 1. PART III - STATEMENT OF ARGUMENT A. Charter Interpretation Must be Guided by Reality, Not Ideology 17. When determining whether or not impugned legislation infringes the Charter, courts must not play host to political debates, but instead must rise above them by ensuring that public policy passes constitutional muster. Chaoull v. Québec (Attorney General), (2005) 1 S.c.R. 791, at para. 89 (CMA Authorities, Tab 2). R. v. Morgentaler, (1988)1 S.C.R. 30 at 45-46 (CMA Authorities, Tab 13). 18. The Appellants' position is clearly premised on ideological preconceptions with regard to individuals suffering from addictions. Yet, as the history of birth control legislation in Canada shows, a legal framework informed by ideological assumptions about the morality of patients seeking to control their reproduction can violate a person's most fundamental rights. See R. v. Morgentaler, supra at 62 where the Court rejected arguments that it should assess administrative structures in the abstract: "when denial of a right as basic as security of the person is infringed by the procedure and administrative structures created by the law itself, the courts are empowered to act" (CMA Authorities, Tab 13). 4 19. In order for the courts to meet their role in determining whether a particular piece of legislation is constitutional, it must consider Parliament's enactments by relying on the available evidence. In fact, it is well established that a deprivation of the rights to life, liberty or security of the person must be proven by solid evidence. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 [CMA Authorities, Tab 20]. 20. The presentation of facts is not a mere technicality, but rather it is essential to a proper consideration of Charter issues: Charter cases will frequently be concerned with concepts and principles that are of fundamental importance to Canadian society. For example, issues pertaining to freedom of religion, freedom of expression and the right to life, liberty and the security of the individual will have to be considered by the courts. Decisions on these issues must be carefully considered as they will profoundly affect the lives of Canadians and all residents of Canada. In light of the importance and the impact that these decisions may have in the future, the courts have every right to expect and indeed to insist upon the careful preparation and presentation of a factual basis in most Charter cases. The relevant facts put forward may cover a wide spectrum dealing with scientific, social, economic and political aspects. Often expert opinion as to the future impact of the impugned legislation and the results of the possible decisions pertaining to it may be of great assistance to the courts. MacKay v. Manitoba, [1989] 2 S.C.R. 357 at 361 [CMA Authorities, Tab 5]. 21. Specifically, with respect to section 7 of the Charter, this Court has confirmed that the task of the courts is to evaluate the issue in "the light, not just of common sense or theory, but of the evidence". The Court dispenses with unsubstantiated theoretical arguments, relying instead on empirical and scientific evidence presented by the parties: In support of this contention, the government called experts in health administration and policy. Their conclusions were based on the "common sense" proposition that the improvement of health services depends on exclusivity (R.R., at p. 591). They did not profess expertise in waiting times for treatment. Nor did they present economic studies or rely on the experience of other countries. They simply assumed, as a matter of apparent logic, that insurance would make private health services more accessible and that this in turn would undermine the quality of services provided by the public health care system. The appellants, relying on other health experts, disagreed and offered their own conflicting "common sense" argument for the proposition that prohibiting private health insurance is neither necessary nor related to maintaining high quality in the public health care system. Quality public care, they argue, depends not on a monopoly, but on money and management. They testified that permitting people to buy private insurance would make alternative medical care more accessible and reduce the burden on the public system. The result, they assert, would be better care for all [...] To this point, we are confronted with competing but unproven "common sense" arguments, amounting to little more than assertions of belief. We are in the realm of theory. But as discussed above, a theoretically defensible limitation may be arbitrary if in fact the limit lacks a connection to the goal. This brings us to the evidence called by the appellants at trial on the experience of other developed countries with public health care systems which permit access to private health care. The experience of these countries suggests that there is no real connection in fact between prohibition of health insurance and the goal of a quality public health system. 5 Chaoulli, supra at paras. 136-149 (see also paras. 115, 117, 136-149, 150, 152 where the Court refers to Statistics Canada studies and evidence from other western democracies) [CMA Authorities, Tab 2]. See also Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 at 601-602 [CMA Authorities, Tab 16]. 22. Drug addicts suffer from a medical condition that can be treated. Hence, Insite is designed as a health treatment aimed at reducing the harmful consequences of drug use as well as exposing its vulnerable patients to other health care options. In this context, the federal legislation and government actions at issue amount to a denial of evidence-based medical treatment whose effect is to put the life and security of patients at great risk. 23. Charter interpretation should generally be grounded on fact rather than speculation or ideological assumptions, especially where life and security of the person (i.e., the patient) is at risk because of a medical condition (such as addiction). In such cases, the Court's delineation of the state's constitutional obligations should be guided by evidence-based medicine and independent clinical judgment. Chaoulli, supra at paras. 85, 107 [CMA Authorities, Tab 2]. See also Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 at 452-454 [CMA Authorities, Tab 7]; Auton (Guardian ad litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657, at para. 66 [CMA Authorities, Tab 1]. 24. Accordingly, CMA submits that, at the very least, in the health care field where lives are at risk, there must be sound evidentiary basis for legislative and government action that deny medical care. B. The Impugned Provisions Infringe Section 7 of the Charter (1) Denying Access to Necessary Health care Infringes Section 7 of the Charter 25. While the legislature is generally entitled to enact legislation prohibiting drug use or trafficking, this legislation (however well-intended) cannot have the effect of putting the lives of affected persons at risk. This Court has already found in Chaoulli that section 7 of the Charter was infringed when governments impeded timely patient access to care. (2) The Rights to Life and Security of Patients Have Been Infringed 26. Both the Applications Judge and the Court of Appeal found that the right to life and security was engaged in the present case. The evidence on these issues was plentiful: 1. Addiction is an illness. One aspect of the illness is the continuing need or craving to consume the substance to which the addiction relates; 6 2. Injection drug use leads to an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis A, B and C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; increased hospital and emergency service utilization; 3. The risk of morbidity and mortality associated with addiction and injection is ameliorated by injection in the presence of qualified health professionals at Insite; 4. User of Insite who are addicted to heroin, cocaine and other controlled substances are not engaged in recreation. Their addiction is an illness frequently, if not invariably, accompanied by serious infections and the real risk of overdose. Reasons for Judgment of the Applications Judge, paras. 87, 89, 135-136, Appellants' Record, Vol. I, pp. 24-25, 34. See also Reasons for Judgment of the B.C. Court of Appeal, para. 30, Appellants' Record, Vol. I, p. 65. (3) Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment 27. The Appellants did not really dispute the medical evidence to the effect that addiction to drugs was a disease. They sought instead to justify their position by claiming that drug addicts had "chosen" their lifestyle and were solely responsible for their medical condition. For the following reasons, this "rationale" does not pass constitutional muster. 28. The Appellants assert that the section 7 rights are not engaged as they stem from an alleged "choice made by the consumer", relying on the fact that 95% of the injections in the downtown east side of Vancouver do not take place at Insite. The Appellants do not explain how this assertion demonstrates why addicts are able to make a choice not to inject themselves, given that it only addresses where they inject themselves. In any event, contrary to the Appellants' choice theory, the evidence before the Applications Judge and his findings were to the contrary: the reasons for the addiction and resulting need are based on a complicated combination of personal, governmental and legal factors, some of which lend themselves to choice and others that do not.' Further, the Applications Judge found that it is the illness of addiction, and the failure to manage it, that has led to further illness and death. Reasons for Judgment of the Applications Judge, paras. 65, 89, 142, Appellants' Record, Vol. I, pp. 21, 24-25, 35. See also Reasons for Judgment of the B.C. Court of Appeal, para. 39, Appellants' Record, Vol. I, p. 67. Contra the facts in R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 [Malmo-Levine] [CMA Authorities, Tab 12]. 29. The Appellants' position amounts to a claim that the users of Insite have effectively waived their constitutional rights under section 7. Notwithstanding that the jurisprudence is In fact, the evidence is clear that in the case of the Respondent Tomic, her first experience with illegal drugs was not a personal choice [Reasons for Judgment of the Applications Judge, para. 65, Appellants' Record, Vol. I, p. 21]. 7 unclear as to whether a right under section 7 can actually be waived, it is well established that a waiver or a renunciation of any right under the Charter must be voluntary, freely expressed and accompanied with a clear understanding of the purpose the right was meant to serve and the consequences of declining its protection. There is no evidence whatsoever that the patients of Insite who suffer from addiction, knowingly and unequivocally waived their rights under the Charter, and more specifically their right to access medical treatment. See e.g. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844, at paras. 71-72; Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551, at paras. 96-102; R. v. Richard, [1996] 3 S.C.R. 525, at paras. 22-26; R. v. L.T.H., [2008] 2 S.C.R. 739, at paras. 41-42; R. v. Clarkson, [1986] 1 S.C.R. 383 at 394-396; Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 at 49; Yorkton Union Hospital v. S.U.N. (1993), 16 Admin. L.R. (2d) 272, at para. 44 (C.A.) [CMA Authorities, Tabs 3, 17, 15, 11, 8, 4, 18 respectively]. 30. Indeed, Canadians do not forego their right to health care or to protection from section 7 violations because of their "choice" of lifestyles. The Appellants' position that addicts must take responsibility for the choice they make undermines the raison d'être of the Canadian health care system, namely (as found by the Applications Judge and the Court of Appeal) the fundamental right of Canadians to access medical treatment and the ethical and clinical responsibilities of their health care providers. 31. The Appellants' position skirts the clinical question at issue for physicians and their patients: physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. In Canada, neither the ethical obligations of physicians to treat patients, nor the patients' legal right to treatment, are subject to a moral assessment of a patient's lifestyle. Behaviours that might be deemed "risky" do not deprive patients of their rights of access to clinically required medical care. 32. Section 31 of CMA's Code of Ethics (relied on by the Court in the past e) provides that all physicians must "[r]ecognize the responsibility of physicians to promote fair access to health care resources". The patients at Insite would be deprived of positive health outcomes if Insite were to close or even continue to operate under the ongoing threat of closure. 33. Adopting the Appellants' approach to Charter interpretation would set an extremely dangerous precedent. Thus, if one were to apply the rationale of "choice" to other medical 2 See e.g. R. v. Dersch, [1993] 3 S.C.R. 768 at 784-785, where the Court refers to CMA's Code of Ethics [CMA Authorities, Tab 9]. 8 contexts, such as chronic disease, patients suffering from diabetes because of contributing factors such as poor nutrition and lack of exercise would, under the same logic, be denied medical care. Indeed, many of the complex elements beyond individual choice such as socio-economic and genetic factors found by the Applications Judge in the case at bar to shape addiction as an ilness are prevalent in other diseases. This approach would be not only unethical and clinically unsound, but unconstitutionaL. (4) The Rights to Liberty of the Individual Respondents Have Been Infringed 34. The courts have recognized that the threat of criminal prosecution and possibility of imprisonment for an offence is suffcient to trigger the liberty interest and scrutiny under section 7. Malmo-Levine, supra at para. 84 ICMA Authorities, Tab 12). R. v. Parker (2000),188 D.L.R. 4th 385, at para. 101 (Ont. C.A.) ICMA Authorities, Tab 14). 35. Vulnerable patients suffering from addiction and the health care providers who provide treatment at Insite suffer violations of their constitutionally guaranteed rights (section 7 of the Charter) because of the threat of prosecution under the Act. The uncertainty associated with a ministerial exemption mechanism for Insite from certain provisions of the Act imposes a great burden on those already labouring under the weight of addiction. Moreover, health care providers are also put at risk in their ability to provide medically necessary and evidence-based health care services in a timely manner to all citizens by the capricious exemption mechanism contained in the Act. (5) The Principles of Fundamental Justice Have Not Been Respected 36. It is well established that a law that is arbitrary or overbroad will constitute a breach of the principles of fundamental justice. The CMA submits that the Applications Judge was correct when he found that the impugned provisions were arbitrary, or if not arbitrary, grossly disproportionate and overbroad. The Court of Appeal agreed that the provisions were overbroad. P. Hogg, Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1 ICMA Authorities, Tab 19). R. v. Heywood, (1994) 3 S.c.R. 761 at 792-794 ICMA Authorities, Tab 10). Chaoull, supra at para. 127 ICMA Authorities, Tab 2). Rodriguez, supra at 590-591 ICMA Authorities, Tab 16). a) The Impugned Provisions Are Arbitrary 37. A law is arbitrary when it bears no relation to, or is inconsistent with, the objective that 9 lies behind it. In order not to be arbitrary, a limit on the section 7 right requires not only a theoretical connection between the limit and the legislative goal, but a real connection on the facts. Chaoulli, supra at paras. 130-131 [CMA Authorities, Tab 2]. 38. In the present case, by prohibiting access to evidence-based, medically necessary care, the government has contributed to the very harm it claims it seeks to prevent, i.e. drug possession and addiction. The best available medical evidence suggests that clinics such as Insite not only protect life, but offer positive health outcomes and care alternatives to vulnerable patients. 39. Moreover, the justification of any denial of access to necessary medical care based on ideology rather than facts is arbitrary since, by definition, it bears no real connection to the facts. b) The Impugned Provisions Are Overbroad 40. It is a well-established principle of fundamental justice that criminal legislation must not be overbroad. If the government, in pursuing a legitimate objective, uses means which are broader than is necessary to accomplish that objective, the principles of fundamental justice will be violated. Heywood, supra at 792-793 [CMA Authorities, Tab 10]. See also Malmo-Levine, supra at paras. 130-131 [CMA Authorities, Tab 12]. 41. A fortiori, that will be true when the state itself has a particular interest in acting to protect vulnerable persons. In the present case, the evidence before the Applications Judge demonstrated that harm reduction has been a component of Canada's drug strategy for many years. In 2002, the House of Commons Special Committee on the Non-Medical Use of Drugs rejected the dichotomy between harm reduction and an abstinence-based treatment model. It also specifically considered the creation of a safe injection facility in the downtown east side of Vancouver because it recognized that that community presented a "public health disaster". 42. Hence, while the government may be justified in preventing drug possession and trafficking, it cannot cast a legislative prohibition so widely that it captures persons in need of medical care. C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter 43. Should the Court find that sections 4(1) and 5(1) of the Act infringe the rights guaranteed Guy Pratt /Nadia ffend Borden L dner Gervais L 1 0 by section 7 of the Charter, the CMA submits that the provisions cannot be justified under section 1 of the Charter as any law that offends the principles of fundamental justice cannot be justified, and more specifically, meet the minimal impairment branch of the section 1 analysis. See e.g. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46, at para. 99 [CMA Authorities, Tab 6]; Heywood, supra at 802-803 [CMA Authorities, Tab 10]. D. Remedy 44. Fundamental justice requires either permanent exemptions or a declaration that the impugned law, as it applies to users of supervised injection sites, is invalid. The CMA submits that this position is consistent with sound constitutional interpretation of section 7 of the Charter, while protecting the most vulnerable patient populations in accordance with evidence-based medicine and physicians' ethical obligations. PART IV — SUBMISSIONS AS TO COSTS 45. The CMA seeks no costs and asks that none be awarded against it. PART V — ORDER SOUGHT 46. The CMA submits that constitutional questions two and four should be answered affirmatively. Should the Court answer these questions in the affirmative, however, constitutional questions three and five should be answered negatively. 47. The CMA seeks leave of this Court, pursuant to rule 59(2) of the Rules of the Supreme Court of Canada, to present oral argument at the hearing of this appeal. Rules of the Supreme Court of Canada, SOR/83-74, as amended, Rule 59(2) [Part VII of Factum]. ALL OF WHICH IS RESPECTFULLY SUBMITTED THIS 13th DAY OF APRIL, 2011. OTTO1 \ 4423086 \ 7 11 PART VI — TABLE OF AUTHORITIES TAB SOURCES Paras. in factum where cited Cases 1. Auton (Guardian a litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657 23 2. Chaoulli v. Quebec (Attorney General), [2005] 1 S.C.R. 791 17, 21, 23, 36, 37 3. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844 29 4. Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 29 5. MacKay v. Manitoba, [1989] 2 S.C.R. 357 20 6. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46 43 7. Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 23 8. R. v. Clarkson, [1986] 1 S.C.R. 383 29 9. R. v. Dersch, [1993] 3 S.C.R. 768 32 10. R. v. Heywood, [1994] 3 S.C.R. 761 36, 40, 43 11. R. v. L.T.H., [2008] 2 S.C.R. 739 29 12. R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 28, 34, 40 13. R. v. Morgentaler, [1988] 1 S.C.R. 30 17, 18 14. R. v. Parker (2000), 188 D.L.R. 4th 385 (Ont. C.A.) 34 15. R. v. Richard, [1996] 3 S.C.R. 525 29 16. Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 21, 36 17. Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551 29 18. Yorkton Union Hospital v. S. UN. (1993), 16 Admin. L.R. (2d) 272 (Sask. C.A.) 29 12 TAB SOURCES Paras. where in factum cited Secondary Sources 19. Hogg, P., Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1. 36 20. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 19 13 PART VII — STATUTES, REGULATIONS, RULES
Canadian Charter of Rights and Freedom, sections 1 and 7
Controlled Drugs and Substances Act, S.C. 1996, c. 19, sections 4(1), 5(1), 56
Rules of Supreme Court of Canada, SOR/83-74, as amended, Rule 59 14 Canadian Charter of Rights and Freedoms PART I OF THE CONSTITUTION ACT, 1982 Charte canadienne des droits et libertes PARTIE I DE LA LOI CONSTITUTIONNELLE DE 1982 Rights and freedoms in Canada 1. The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society. Life, liberty and security of person 7. Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice. Droits et libertes au Canada 1. La Charte canadienne des droits et libertes garantit les droits et libertós qui y sont enonces. Its ne peuvent etre restreints que par une regle de droit, dans des limites qui soient raisonnables et dont la justification puisse se demontrer dans le cadre d'une society libre et democratique. Vie, liberte et securite 7. Chacun a droit a la vie, a la liberte et a la securite de sa personne; it ne peut etre porte atteinte a ce droit qu'en conformite avec les principes de justice fondamentale. 15 Controlled Drugs and Substances Act S.C. 1996, c. 19 Possession of substance 4. (1) Except as authorized under the regulations, no person shall possess a substance included in Schedule I, II or III. Trafficking in substance 5. (1) No person shall traffic in a substance included in Schedule I, II, III or IV or in any substance represented or held out by that person to be such a substance. Exemption by Minister 56. The Minister may, on such terms and conditions as the Minister deems necessary, exempt any person or class of persons or any controlled substance or precursor or any class thereof from the application of all or any of the provisions of this Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. Loi reglementant certaines drogues et autres substances L.C. 1996, ch. 19 Possession de substances 4. (1) Sauf dans les cas autorises aux termes des reglements, la possession de toute substance inscrite aux annexes I, II ou III est interdite. Trafic de substances 5. (1) Il est interdit de faire le trafic de toute substance inscrite aux annexes I, II, III ou IV ou de toute substance presentee ou tenue pour telle par le trafiquant. Exemption par le ministre 56. S'il estime que des raisons medicales, scientifiques ou d'interet public le justifient, le ministre peut, aux conditions qu'il fixe, soustraire a l'application de tout ou partie de la presente loi ou de ses reglements toute personne ou categorie de personnes, ou toute substance designee ou tout precurseur ou toute categorie de ceux-ci. 16 Rules of the Supreme Court of Canada (in force on October 13, 2006) Regles de la Cour supreme du Canada. (en vigueur le 13 octobre 2006) 59. (1) In an order granting an intervention, the judge may (a) make provisions as to additional disbursements incurred by the appellant or respondent as a result of the intervention; and (b)impose any terms and conditions and grant any rights and privileges that the judge may determine, including whether the intervener is entitled to adduce further evidence or otherwise to supplement the record. (2)In an order granting an intervention or after the time for filing and serving all of the memoranda of argument on an application for leave to appeal or the facta on an appeal or reference has expired, a judge may, in their discretion, authorize the intervener to present oral argument at the hearing of the application for leave to appeal, if any, the appeal or the reference, and determine the time to be allotted for oral argument. (3)An intervener is not permitted to raise new issues unless otherwise ordered by a judge. 59. (1) Dans l'ordonnance octroyant l'autorisation d'intervenir, le juge petit : a) prevoir comment seront supportes les &pens supplementaires de l'appelant ou de l'intime resultant de l'intervention; b) imposer des conditions et octroyer les droits et privileges qu'il determine, notamment le droit d'apporter d'autres elements de preuve ou de completer autrement le dossier. (2)Dans l'ordonnance octroyant l'autorisation d'intervenir ou aprês l'expiration du Mai de depOt et de signification des memoires de demande d'autorisation d'appel, d'appel ou de renvoi, le juge peut, a sa discretion, autoriser l'intervenant a presenter une plaidoirie orale a l'audition de la demande d'autorisation d'appel, de l'appel ou du renvoi, selon le cas, et determiner le temps alloue pour la plaidoirie orale. (3) Sauf ordonnance contraire d'un juge, l'intervenant n'est pas autorise a soulever de nouvelles questions.
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Medication use and seniors (Update 2017)

https://policybase.cma.ca/en/permalink/policy10151
Last Reviewed
2019-03-03
Date
2011-05-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2011-05-28
Replaces
Medication use and seniors
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Older Canadians represent the fastest-growing segment of our population and are the largest users of prescription drugs. Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. According to the Canadian Institute for Health Information, in 2012, nearly two-thirds of seniors had claims for 5 or more drug classes, and more than one-quarter of seniors had claims for 10 or more drug classes. The number of drugs used by seniors increased with age. The use of multiple medications, or polypharmacy, is of concern in the senior population. The risk of drug interactions and adverse drug reactions is several-fold higher for seniors than for younger people. This phenomenon is associated with pharmacokinetic and pharmacodynamics factors in seniors, including changes in renal and hepatic function, increased sensitivity to drugs and, potentially, multiple medical problems. In older persons, adverse drug reactions are often complex and may be the direct cause of hospital admissions for acute care. Cognitive and affective disorders, for example, may be due to adverse reactions to sedatives or hypnotic drugs. Chronic pain is a common issue, and it is important to carry out research into and education for health care providers concerning the unique challenges of managing pain in older adults. The CMA supports the development of a coordinated national approach to reduce polypharmacy and prevent adverse drug reactions. Prescribers must be vigilant to optimize pharmacotherapy and in reconciling medications, taking into consideration physiological changes as a person ages. Deprescribing should be considered, reducing or stopping medications that may be harmful or no longer be of benefit, seeking to improve quality of life. There has been considerable interest in determining which factors affect prescribing behavior and how best to influence these factors. Strategies that improve prescribing practices include evidence-based drug information provided through academic detailing; objective continuing medical education; accessible, user-friendly decision support tools available at point of care; and electronic prescribing systems that allow physicians access to their patient's treatment and medication profiles. The following principles define the basic steps to appropriate prescribing for seniors.
Know the patient.
Know the diagnosis.
Know the drug history. Keep a medication list for each patient and review, update, reconcile and evaluate adherence at each visit. Instruct the patient to bring all prescription and over-the-counter medications, including medications prescribed by other physicians, and natural health products, to each appointment. In some provinces, pharmacists conduct medication use reviews for patients on public drug benefit programs.
Know the history of use of other substances such as alcohol, tobacco, cannabis, opioids and caffeine.
Consider non-pharmacologic therapy, including diet, exercise, psychotherapy or community resources. Continuing medical education in specific non-pharmacologic therapies is valuable. For example, evaluation and management of behavioural and psychological symptoms of dementia should be considered before anti-psychotic therapy. As well, Canadian standardized non-pharmacologic order sets should be developed for the treatment of delirium.
Know the drugs. Critically evaluate all sources of drug information and use multiple sources such as clinical practice guidelines, medical journals and databases, continuing medical education and regional drug information centres. Monitor patients continually for adverse drug reactions. Appropriate drug dosage depends on factors such as age, sex, body size, general health, concurrent illnesses and medications, and hepatic, renal and cognitive function (for example, older people are particularly sensitive to drugs that affect the central nervous system).
Keep drug regimens simple. Avoid mixed-frequency schedules when possible. Try to keep the number of drugs used for long-term therapy under five to minimize the chance of drug interactions and improve adherence.
Establish treatment goals. Determine how the achievement of goals will be assessed. Regularly re-evaluate goals, adequacy of response and justification for continuing therapy. Time to benefit of prescribed medications should be a key consideration when providing care to seniors at end of life.
Encourage patients to be responsible medication users. Verify that the patient and, if necessary, the caregiver, understands the methods and need for medication. Recommend the use of daily or weekly medication containers, calendars, diaries or other reminders, as appropriate, and monitor regularly for compliance. Encourage the use of one dispensary. The Institute for Safe Medication Practices Canada has developed a program, Knowledge is the best medicine (https://www.knowledgeisthebestmedicine.org), that can be helpful to seniors and their healthcare team manage medicines safely and appropriately. Approved by the Board on May 28, 2011 Update approved by the Board on March 02, 2019
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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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Principles for providing information about prescription drugs to consumers

https://policybase.cma.ca/en/permalink/policy189
Last Reviewed
2019-03-03
Date
2003-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2003-03-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Principles For Providing Information About Prescription Drugs To Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada1, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 2 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. 1 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 2 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general.
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The Right Drugs, at the Right Times, for the Right Prices: Toward a Prescription Drug Policy for Canada : CMA Presentation to House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1955
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada. Prescription drugs have benefited both the health of Canadians, and the health care system itself; they have meant dramatically improved quality of life for many Canadians, and have saved the country a great deal in hospitalization, social benefits and other expenses. However, it could be questioned whether all of Canada’s prescription drug use is appropriate; patients may be receiving too few medications, too many medications or suboptimal medications for their conditions. In addition, prescription drugs carry a price tag of their own. Since 1975, expenditures on prescription medication have risen faster than any other category in the health sector in Canada, and more is now spent on prescription drugs than on physician services. Governments, health care providers, drug manufacturers and the public must constantly strive to ensure that Canadians receive optimal and appropriate prescription drug therapy: the right drugs, at the right times, for the right prices. A considered, coherent, comprehensive, “made in Canada” approach to prescription drug policy should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. Prescription drug policy in Canada should address: Access: to * efficacious new drugs within an appropriate time; * coverage for medically necessary drugs for catastrophic care; * generic drugs at reasonable prices; * a patient/physician consultation as part of the prescribing process; * continued research and development capacity in Canada. Information for health care providers and the public that is balanced and accurate. Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors are committed to working with others to ensure that Canadians receive the right drugs, at the right times, for the right prices. Summary of CMA Recommendations: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to all drugs that demonstrate a substantial improvement over products already on the market. 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for all Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship which exists between the patient and the physician. 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. PURPOSE The Canadian Medical Association (CMA) has prepared this submission for the House of Commons Standing Committee on Health’s review of prescription drugs in Canada. We applaud this review and welcome the opportunity to present the views of Canada’s medical community. Our vision is simple: that all Canadians should receive, if appropriate, the right drugs for their conditions, at the right times, for the right prices. Governments, health care providers, drug manufacturers and the public should all work together to develop a “made in Canada” prescription drug policy to realize this vision. This policy must be considered, coherent and comprehensive, and should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. In developing this policy we consider it particularly important to address the issues of: Access to quality health care In this context, the CMA’s vision of a National Access Strategy includes appropriate access to * efficacious new drugs within an appropriate time, * coverage for medically necessary drugs for catastrophic care, * generic drugs at reasonable prices, * a patient/physician consultation as part of the prescribing process, * continued research and development capacity in Canada. * Information for health care providers and the public that is balanced and accurate. * Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors look forward to working with others to realize our vision. In this submission we will discuss the steps that the CMA recommends be taken. INTRODUCTION The value of prescription medications Prescription drugs play an important role in preventing and treating health conditions. Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada1. In recent years, powerful new medications have meant dramatically improved quality of life, or substantial change in modes and patterns of treatment, for many Canadians. Anti-retroviral treatment has saved thousands of people with HIV infection from rapid, fatal progression to AIDS. Thanks to selective serotonin reuptake inhibitors (SSRIs) millions of people with chronic depression who might otherwise have been incapacitated or institutionalized can lead normal, productive lives in the community. Drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. Though the cumulative savings on hospital care, lost workforce productivity, social benefits and disability insurance payments due to prescription drug use have not been quantified, they have undoubtedly been significant. Areas of Concern In short, prescription drugs have benefited both the health of Canadians, and the health care system itself. However, they have also created concerns that must be addressed. Utilization: is it Appropriate? Experts have questioned whether all of Canada’s prescription drug use is appropriate: are patients receiving too many medications, too few medications, or suboptimal medications for their conditions? Over-utilization of prescription drugs has been a topic of some attention, but under-utilization also exists. For example, as many as 60% of people with high blood pressure may not be receiving treatment; many of these people do not even know they have the condition.2 In addition, patient compliance with prescription drug therapy is increasingly recognized as a problem, especially for long-term or chronic conditions. Compliance is a potential issue in all treatments but is of special concern in conditions where few clinical symptoms are present: for example in hypertension, where lack of treatment over the long term may result in kidney damage, vascular and opthalmological damage, stroke or heart disease. One study found that only 50% of patients comply with long-term drug therapy, and an even smaller percentage comply with lifestyle alterations.3 Partial compliance with antibiotic therapy for infectious diseases is well recognized as one cause of anti-microbial resistance to common infectious pathogens. Cost: is it too high? More is now spent on prescription medicine than on physician services. Since 1975, expenditures on prescription medication have risen faster than any other category;4 during the 1990’s they rose more than twice as quickly as overall spending on health care.5 In 2002 retail spending on drugs in Canada (prescribed and non-prescribed) was estimated to be at least 16% of total health care spending. Prescription medication accounts for 80% of this category, up from 70.3% in 1990. What drives drug expenditure in Canada? There is considerable debate on this subject, but some of the drivers are believed to be: * Increased utilization: as the population ages there is an increased prevalence of conditions such as hypertension, type 2 diabetes mellitus and osteoarthritis, which often require pharmacological treatment. * Newer (patented) drugs, which are more expensive than generics, dominate the prescription market. Between 1995 and 2000, five drug categories (including cholesterol lowering agents, high blood pressure drugs, acid-reducing agents and anti-depressants) contributed significantly to the overall rise in drug costs.5 These categories are dominated by newer, patented drugs, many of which are heavily promoted. * Prices of generic drugs, though lower than those of patented drugs, are higher in Canada than in some other countries. For example, generic drug prices are 26% lower in Germany and 68% lower in New Zealand.6 * Marketing practices such as mass media direct to consumer advertising (DTCA) in the United States, and its attendant “spillover” into the Canadian marketplace, may contribute to increased utilization. In Canada the Patent Medicine Prices Review Board (PMPRB) maintains price controls on brand-name drugs. Similar price-control mechanisms exist in European Union countries. However, no such controls exist for generic medications in Canada. All in all, prescription medications can be costly for Canadians, especially for those who lack any kind of insurance coverage. The Role of Physicians and the Canadian Medical Association Canada’s doctors are committed to ensuring that Canadians have access to the right drugs, at the right times, at the right prices, to help them achieve the right results – in other words, the best possible health outcomes. The goal of drug therapy is to improve patients’ health and quality of life by preventing, eliminating or controlling diseases or symptoms. Patients, physicians and pharmacists must work in collaboration to achieve this goal. The physician’s role in drug therapy goes well beyond the act of writing out a prescription; it encompasses: * Diagnosing diseases, assessing the need for drug therapy and designing the medication regime; * Working with patients to set treatment goals and monitor progress toward them; * Monitoring the patient’s response to drug therapy, revising the care plan when necessary to support compliance and achieve the best possible health outcomes; * Sharing with the patient specific information about the diseases and the drug therapy, including its effects and potential side effects (including, in some cases, the potential for prescription drug addiction).7 The CMA’s activity has been focused on promoting excellence in prescribing, and on disseminating drug information to physicians.8 In 1999, the CMA worked with Health Canada and the Canadian Pharmacists Association (CPhA) to convene an expert roundtable on the subject of “Best Practices in Prescribing”. This was but one effort of the profession to explore why some therapies appear to be under-prescribed, while others may be over-prescribed. CMA has developed principles on the issues of physician information and of providing information on prescription drugs to consumers; both these documents will be discussed later in this submission. CMA and CPhA have also developed a joint policy statement on approaches to enhancing the quality of drug therapy (attached as Appendix I). In addition CMA is co-funding, with the Canadian Institute of Health Research, an interdisciplinary research team focussed on Drug Policy Futures. The team’s identified areas of study include: financing and public expectations; improving quality; health care evaluation and technology assessment; and public advice-seeking in the era of e-health. The CMA publishes Drugs of Choice, a definitive Canadian guide to first- and second-line drug therapies for hundreds of clinical conditions. It is now in its third edition. In addition CMA maintains an extensive database of clinical practice guidelines, including prescribing guidelines, available to physicians and the public through the CMA Web site, and has developed an on line course for physicians on Safe Medication Practices. The cma.ca web site also provides access to a Canadian online drug database that can be downloaded and used with state-of-the-art PDA (personal device) technology at the point of clinical care. CMA’S PRIORITIES FOR ACTION A) Access to quality health care CMA’s history of advocating for access to needed health care services goes back many years. In 2004, a National Access Strategy will be one of the association’s highest-priority activities. With respect to prescription drugs there are several access-related problems: slow approval of new drugs, uneven insurance coverage, and the possible consequences of cross-border shopping on the availability of drugs in Canada. i) Drug Approvals: The Right Drug at the Right Time CMA recommends: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to drugs that demonstrate a substantial improvement over products already on the market. Stakeholders have repeatedly drawn attention to the slowness of Canada’s drug review process. Between 1996 and 1998 Canadian approval times (median 518 days) were significantly longer than Sweden (median 371 days), the UK (median 308 days) and the United States (median 369 days). These have not improved significantly even after Health Canada implemented a cost-recovery approach to funding the drug review process. Delays in the drug review process mean delays in access to new, potentially life-saving medications. For example, 15 other countries approved Singulair, a major breakthrough in asthma therapy, before it was approved in Canada, even though the drug was developed in Montreal! Approximately 10% of children between 5 and 14 years of age have asthma and could have benefited from this relatively safe drug. Intravenous tissue plasminogen activator (tPA), a medication for treatment of acute stroke, was approved for use in the United States in 1996 but was not approved in Canada until 1999. Canada’s long drug review times are mainly attributed to lack of resources at Health Canada. CMA recommends that Canada implement a timely and efficient drug review process to reduce these times to an appropriate level. The 2003 federal budget announcement of $190 million over five years to improve the timeliness of the regulatory process was encouraging. We hope that this will soon translate into a significant reduction in drug review times. Many drugs submitted for approval are not genuinely innovative; some are virtual copies of drugs already on the market. Others, however, could offer substantial improvement over what is currently available. They could be more clinically effective; or they could have fewer side effects; or their mechanism of delivery could increase compliance (for example, medication that can be taken only once a day instead of three or four times a day). CMA recommends that the pharmaceutical industry give priority to research and development on products and delivery mechanisms that offer substantial additional benefit to Canadian patients. It seems logical that drugs that offer benefits not yet available to Canadians should reach patients who need them more quickly. Recently, Health Canada implemented a priority review process for drugs to treat serious, life threatening or debilitating conditions, for which there is substantial evidence that the drug is a significant improvement over existing therapies. This is a promising step. CMA recommends that Health Canada apply a priority review process to all drugs deemed to offer substantial improvement over what is already on the market. This will also serve as an incentive to the pharmaceutical industry to emphasize drugs that offer substantial benefit in their research and development plans. ii) Coverage: Making the System Work CMA recommends: 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. Coverage for all Canadians. Prescription drugs are Canada’s most notable example of a public/ private partnership in health services delivery. Our country’s blend of public and private drug insurance coverage has worked reasonably well; but there is room for improvement. The Canada Health Act’s mandate covers “drugs, biologicals and related preparations when administered in the hospital”. Provincial and territorial drug programs vary with most covering only seniors and people on social assistance.9 Many Canadians get their drug coverage through private plans offered by their employers. But many people in Canada lack any kind of drug coverage. We do not know exactly how many. According to a report prepared for the Canadian Life and Health Insurance Association, 2% to 4% of Canadians have no coverage, but other reports place the number closer to 10%.10,11 At a minimum, 1 million to 3 million Canadians are in need of basic prescription drug coverage. Drug therapy may be more cost-efficient than some forms of hospital care. Is the current health care system promoting inefficiency by covering hospital services more completely than prescription drug therapy? In 1997 the National Forum on Health recommended that drugs become part of the publicly funded system. However, such a system would be prohibitively expensive; estimates range from $12.4 billion for a combined public and private model (with co-payments) to $13.8 billion for fully funded, public only model (no co-payments).12 The report of the Romanow Commission acknowledged this when it emphasized the need to “move in a gradual but deliberate and dedicated way to integrate prescription drugs more fully into the continuum of care”. For the short term, the report recommended a Catastrophic Drug Transfer to ensure that Canadians who face the greatest financial burden can continue to access the medications they need. The Trillium program in Ontario is an example of such a program. We need to know more about both the number of people who need drug coverage and the best means of providing them with it. As a first step, CMA recommends that the government, insurance providers and all partners in the public and private sectors conduct research to more accurately identify current gaps in prescription drug coverage, and develop policy options for bridging them. Given the ever larger role that prescription drug therapy is playing in health care in Canada, governments should consider expanding the current basket of “core services” to include prescription drugs. Under the Canada Health Act provinces and territories must ensure that medically necessary physician and hospital services are provided on a first-dollar basis. CMA has recommended that the scope of the basket of core services be updated regularly to reflect the realities of health care delivery and the needs of Canadians. Given the potential of prescription drugs to improve the system’s cost-effectiveness, we believe that Canadian governments must consider whether the concept of “core services” needs to be revised to reflect their importance, provided that this does not further compromise access to medically necessary hospital and physician services. Drug Pricing Policies: Toward a Policy for All Drugs in Canada. As mentioned previously, PMPRB controls the prices of brand-name patent medications in Canada. However, generic drug make up 40% of the drugs prescribed in this country. Canada has no mechanism to control the prices of generic drugs, as do some other countries (France, for example, has a decree stating that the price of a generic product must be at least 30% less than the price of the original patented brand.) 6 Most provinces have policies encouraging substitution of a brand drug by a comparable generic where appropriate. CMA believes it is time for Canadian governments to explore mechanisms for ensuring appropriate pricing of generic medications. Product Substitution: Making health the first priority. Even under their current system of limited coverage, federal and provincial governments have expressed concern about the cost of their drug programs, and implemented measures to reduce this cost. One of these is drug product substitution. Generic substitution, discussed in the previous section, is now commonplace; British Columbia has taken the concept further with its system of reference-based pricing. While CMA recognizes the motives behind drug product substitution, we believe that it should only be implemented if it does not jeopardize quality of care or patient confidentiality. Doctors would be happy to participate in discussion of initiatives around drug product substitution, to ensure that the health of the patient continues to be the highest priority to all stakeholders. iii) Access and Cross-Border Prescribing CMA recommends: 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship that exists between the patient and the physician. Prices of brand-name prescription drugs prices are higher in the US, where no price review body exists, than they are in Canada. As a result access to the need for prescription medication can pose considerable financial hardship, particularly for America’s elderly and poor. The rising cost of brand-name medications in the United States has led many Americans to look to Canada for less expensive alternatives. At least one US city, Springfield, Massachusetts, has begun a voluntary program to purchase prescription medication from Canada for its workers and retirees13 and the State of Illinois is examining the feasibility of following Springfield’s lead.14 US drug costs have also spurred a growth industry in Canada: Internet pharmacies. According to estimates in US media, approximately $650 million (US) worth of prescriptions are sold online every year.15 The prospect of accessing cheaper Canadian drugs is particularly appealing to elderly Americans who have turned to the Internet to purchase prescriptions they would be unable to afford at home. The burgeoning cross-border export of pharmaceuticals has had its consequences. Several brand-name multinational pharmaceutical manufactures have moved to stop or limit supplies to those Canadian pharmacies they believe are selling drugs over the Internet. They must now order directly from the manufacturer instead of from wholesalers.16 The brand-name companies have also held out the prospect of boycotting Canada in response to legislation passed by the US House of Representatives that would allow the importation of drugs by Americans.17 This legislation is now before the US Senate Health, Education, Labor and Pensions Committee. The US Food and Drug Administration has opposed importation on safety grounds. The CMA shares the increasingly prevalent concern that cross-border export will result in reduced access to prescription drugs in Canada, and damage the research and development capacity of brand-name prescription drug manufacturers in Canada. Therefore the CMA recommends that Canada monitor and, if necessary, regulate the export of brand-name drugs to ensure their continued availability in this country. Many Internet pharmacies offer the services of physicians who will sign prescriptions without seeing the patient in a consultation. This is not acceptable to the CMA, or to the regulatory Colleges of Physicians and Surgeons or the Canadian Medical Protective Association. It is clear that, in principle, to form an appropriate therapeutic relationship a physician must take a history, perform an appropriate physical examination, and order and interpret appropriate diagnostic tests on her patients. The role of the physician in drug therapy is a complex one; to be most effective it requires a strong ongoing professional relationship between patient and physician. This relationship is the foundation of medical practice; it is key to a prescribing decision and it must be maintained. Our position is discussed in greater detail in CMA’s Statement on Internet Prescribing (attached as Appendix II). B) Consumer Drug Information: From DTCA to DTCI CMA recommends: 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. In the past few years an increasing amount of information on prescription medication has become available to consumers. Much of this reaches Canadians in the form of direct to consumer advertising (DTCA) for specific brands, transmitted across the border from the United States, where it is a billion-dollar-a-year business. DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, advertisers have taken advantage of loopholes in the law to promote brand-name drugs in this country – for example, the controversial television campaign for Viagra. DTCA is also transmitted by print and TV across the border from the United States, and worldwide through the Internet. There is a strong lobby for a relaxation of the DTCA restrictions in Canada. DTCA boosts sales of advertised drugs. In 1999, 25 drugs accounted for 40% of that year’s increase in retail drug spending in the US; all these drugs were advertised to the public.18 Further, DTCA adversely affects the patient/physician relationship. Doctors report feeling pressure and ambivalence when patients ask them to prescribe a specific brand-name drug. 19,20 About 20% of respondents to the CMA’s 2003 physician survey felt patients’ request for advertised drugs had a negative impact on the patient/physician relationship.21 Advocates for DTCA maintain that it provides “consumers” with the information they need to become partners in their own health care. They maintain that DTCA does not undermine the patient/physician relationship, because it does not alter the fact that ultimate prescribing authority remains in the hands of the physician. However, the CMA believes that direct to consumer advertising of prescription drugs is inappropriate. DTCA * does not communicate risk adequately, or provide enough information to allow the consumer to make appropriate drug selections. Generally it does not provide information about other products or therapies that could be used to treat the same condition, * stimulates demand by exaggerating the risks of a disease and generating unnecessary fear, * contributes to a culture of “overmedicalization” by treating normal human conditions such as aging and baldness as diseases, and offering “a pill for every ill”. Brand-specific direct to consumer prescription drug advertising should not be permitted in Canada. CMA calls on the federal government to enforce the existing restrictions on DTCA found in the Food and Drug Act and its regulations to the full extent of the law. We believe that the public has a right to accurate, unbiased direct to consumer information (DTCI) on drugs and other therapies, to enable patients to make decisions regarding their own health care. This information may increase the appropriateness of prescription drug use. For example, it may encourage consumers to get treatment for conditions that are currently under-treated. However, there are more effective ways to provide this information than brand-name advertising. CMA has developed “Principles for Providing Information about Prescription Drugs to Consumers” as an alternative to DTCA; these are attached as Appendix III. We call on Canadian stakeholders, including governments, health professionals, consumer groups and industry, to work together to provide information for the public based on these principles. Further, the CMA calls on the federal government to develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. C) Safety: Ensuring Best Practices in Prescribing CMA recommends: 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. The health care system is complex, involving many inter-related and interdependent factors which could influence the frequency and intensity of medication incidents. Such “systems factors” might include * shortage of qualified health professionals (physicians, nurses and others), * inappropriate use of new technology, * unclear labeling or similar-looking drug preparations, * prescription drug misuse, including over-prescribing or under-prescribing of certain medications. Canada’s doctors are working to promote drug safety on a number of fronts. For example, CMA is working with governments at all levels to ensure that we do not “enrich the nation’s urine” through unnecessary prescribing. The Canadian Medical Association Journal regularly publishes research on prescribing practices. CMA also publishes Safe Medication Practices, a physician guide to patient safety; a companion online course is available on the cma.ca web site. We propose that the health care system work to create a culture that promotes optimal prescribing, by fostering outcomes research, creating supportive infrastructures, strengthening the capacity for post-marketing surveillance, and making the best possible use of technology. Our suggestions are discussed below. Closing the Care Gap. Given our present knowledge base, it is often difficult to ascertain whether current drug utilization patterns lead to improvements in health. For example, research on compliance with drug therapy, and the factors that improve it, is in its infancy and though we know that direct-to-consumer advertising affects drug sales we have yet to determine whether it affects health outcomes. A commitment to outcome-based research on drug utilization would help us find the answers to these and other questions. Research on prescribing patterns should respect the conditions outlined in CMA’s “Principles Concerning Physician Information” (attached as Appendix IV). The CMA calls on all stakeholders (governments, health professionals and the private sector) to join in supporting and encouraging outcome-based research to ascertain best practices in drug utilization and prescribing, and close care gaps when they are identified. Creating an infrastructure for safety. The CMA has no doubt of the overall quality of the prescription medications approved for use in Canada. However, the more drugs are used, the greater their potential for unintended harm. Studies in the United States have found that almost 2% of patients admitted to hospitals experienced a significant adverse drug event, and that the number of deaths due to medications increased over 200% over five years.22 Though studies are still in progress in Canada, we assume that rates of adverse medication events are similar in the two countries. The 2003 federal budget committed $10 million per year to establish a Patient Safety Institute to monitor and prevent medical incidents. This is an important step toward building a safer health care system, and Canada’s doctors are committed to moving this initiative forward. The CMA, with 11 other health care organizations, is a member of the Canadian Coalition on Medication Incident Reporting and Prevention. This initiative is led by Health Canada and has recently been funded through the Patient Safety Initiative. The federal government has also recently funded the Canadian Medication Incident Reporting and Prevention System to collect data on medication incidents and disseminate information designed to reduce their risk. The CMA believes that to be effective a patient safety initiative must * be voluntary, * be non-punitive; and * protect the privacy and confidentiality of physicians and patients. Further, efforts towards ensuring patient safety should address in a timely manner the “systems” issues referred to above, supporting and fostering a culture of safety. CMA is calling on governments to accelerate activities to establish the Patient Safety Institute using a “systems” approach. Strengthening Post-Marketing Surveillance. No matter how rigourous the drug approval and review process, it cannot identify all of a medication’s effects; many of these are only identified once the drug is in widespread use in the general population. A strong post-marketing surveillance system is needed to gather this knowledge and ensure patient safety. A post marketing surveillance system should include timely collection of data related to * adverse drug reactions, * medication incidents, * targeted drug effectiveness studies, * optimal utilization of medications. The goal of an enhanced post-marketing surveillance system is to monitor the ongoing safety and risk/benefit ratio of medications once they have been approved and are being used in the broad population. An ideal surveillance system would go beyond collecting and collating data, to analyze it and produce information that health care professionals and policy makers can use in decision-making at the population level. For example, data could be used to * communicate product related risks to health professionals and patients, * determine the incidence of adverse drug reactions and medication incidents in the Canadian population as a whole and various subgroups over time, as well as their health and economic impact. Currently post-marketing surveillance of drugs in Canada is inadequate, relying on reporting which is often erratic and inconsistent, and for which reporters are not compensated. Canada needs a coordinated post-marketing surveillance system to monitor the ongoing safety of marketed drugs. Surveillance should include medication incidents and adverse drug reactions, and should document and consider the effect of the “systems factors” contributing to these events. Making use of supportive technology. We mentioned that the current reporting system is erratic and inconsistent. An investment in supportive technology would reduce inconsistencies by increasing physicians’ capacity to report and even prevent medication incidents. Under the September 2000 federal/provincial Health Accord, the Government of Canada announced $500 million to expand the use of health information and communications technologies, including the adoption of electronic health records (EHRs). One of the advantages cited for a pan-Canadian EHR is that it could reduce the occurrence of adverse drug events – for example, handwritten prescription and interpretation errors. Progress has been slow, but CMA will follow with interest the pilot EHR program just announced in Alberta. While we expect improvement in prescribing practices and outcomes under such programs, we expect them to respect the principles of patient confidentiality and the right of prescribers to the privacy of their prescribing information. Technology can also make real-time communication within the health care system much easier. and CMA strongly recommends an investment in systems that can link physicians to one another and to the rest of the health care system. In its 2003 brief to the Finance Committee’s pre budget hearings, CMA recommended that the federal government immediately fund dedicated Internet connectivity for all physicians in Canada. CMA has also repeatedly called for sustained and substantial investment in a “REAL” (rapid, effective, accessible and linked) Health Communications and Coordination Initiative to improve technical capacity to communicate with front-line health providers in real time. Real-time information is essential for effective day-to-day health care and will form the cornerstone of an adverse drug reaction communication program for the 21st century. Conclusion It is vital to Canada’s physicians that our patients receive the right medications for their condition, at the right times, at the right prices. CMA calls on the federal government and all other stakeholders to work together to develop a comprehensive “made in Canada” prescription drug policy to realize this vision – one that promotes optimal prescribing, puts the health of patients first, respects the relationships of patient and physician and of patient and pharmacist, and honours the principle of patient confidentiality and the privacy of patient and prescriber information. The reports of the Romanow Commission on the Future of Health Care in Canada and the Senate Standing Committee on Science, Social Affairs and Technology review discussed issues surrounding prescription drug policy in Canada. We hope that the review by this parliamentary committee will lead to prompt and decisive action. APPENDIX I CMA POLICY APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy. Goal of This Joint Statement The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider. Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy. This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements. This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices. Goal of Drug Therapy The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research. Working Together for Optimal Drug Therapy Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient physician pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others. For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects. Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other. Strategies for Collaborating to Optimize Drug Therapy Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following. Respecting and supporting patients' rights to make informed decisions regarding their drug therapy. Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all. Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers. Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy. Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care. Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients. Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care. Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues. Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians. Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education. Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy). Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy. Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making. The Physician's Responsibilities Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role. Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate. Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate. Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate. Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities. Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy. Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public. Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate. Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures. The Pharmacist's Responsibilities Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably. Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber. Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations). Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate. Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician. Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments. Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department. Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities. Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient. Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public. Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures. APPENDIX II CMA POLICY Statement on Internet Prescribing The act of prescribing medication is a medical act carried out in the context of a patient-physician relationship. As such, it is subject to the clinical standards of practice, as well as the ethical guidelines of the medical profession and applicable law. Physicians should be aware of and comply with the legal requirements in their province or territory. If a physician wishes to sign a prescription for an individual who has not previously been his/her patient or a patient of his/her group practice or shared call group, basic principles of assessment and diagnosis must be applied. It is incumbent upon the physician to obtain an adequate history and perform an appropriate physical examination to reach a diagnosis which will ensure that the prescribed medications are appropriate. The physician should be expected to provide advice about any prescribed medication, and, where appropriate, would be expected to provide advice about appropriate monitoring requirements. The physician is advised to fully document the encounter. It is not acceptable for a physician to sign a prescription without properly assessing the patient. APPENDIX III CMA POLICY Principles for Providing Information about Prescription Drugs to Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990’s expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada23, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the “biological revolution”, e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 24 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient’s condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. APPENDIX IV CMA POLICY PRINCIPLES CONCERNING PHYSICIAN INFORMATION In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing. Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed “custodians,” and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code,25 which holds patient health information sacrosanct. Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection. The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence. The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below. 1. Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met. 2. Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information. 3. Conditions for collection, use, access and disclosure: The information should: * be limited to the minimum necessary to carry out the stated purpose(s), * be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician’s duty of confidentiality with respect to that information. 4. Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician’s consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that: * the stated purpose(s) could not be met or would be seriously compromised if consent were required, * the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician’s right to privacy and right of consent in a free and democratic society, and * that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy. 5. Physician’s access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access. 6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted. 7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information. 8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed. 9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians. 10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians. 11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures. 1 Romanow R. Building on Values: the Future of Health Care in Canada. Report of the Commission on the Future of Health Care in Canada; November 2002. 2 Chobanian et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. JAMA 2003; 289. 3 Butler C, Rollnick S, Stott N. The practitioner, the patient and resistance to change. Recent Ideas on Compliance 1996;14(9):1357-62. 4 Canadian Institute for Health Information. Health spending to top $112 billion in 2002, reports CIHI. Media release. December 18, 2002. http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_18dec2002_e 5 Patent Medicine Prices Review Board. Pharmaceutical Trends, 1995/96 – 1999/00. Prepared for the Federal/Provincial/Territorial Working Group on Drug Prices; September 2001. 6 Patent Medicine Prices Review Board, A study of the Prices of the Top Selling Multiple Source Medicines in Canada. November 2002. 7 Approaches to Enhancing the Quality of Drug Therapy.” Joint policy of the Canadian Medical Association and Canadian Pharmacists Association. 8 It should be noted that the CMA does not have the authority to enforce directives on physicians with regard to prescribing. The provincial and Territorial Colleges of Physicians handle licensing and regulatory matters. 9 Manitoba, British Columbia and Saskatchewan provide some coverage to all residents after the co-payments and deductibles are paid. Quebec provides universal coverage to those not in a private plan. 10 Fraser Group/Tristat Resources. Drug Expense Coverage in the Canadian Population – Protection from Severe Drug Expenses. CLHIA. August 2002. 11 Palmer D’Angelo Consulting Inc. National Pharmacare Cost Impact Update Study. Executive Summary. September 4, 2002. 12 Ibid 13 Tynan T. Cash-strapped Springfield, Mass., begins buying Canadian prescription drugs. Edmonton Journal July 29, 2003. http://www.canada.com/edmonton/story.asp?id=21FB8445-1143-4C13-B282-76F380CB4FE1 14 CBSNews.com. Illinois looks to Canada for drugs. CBS News September 15, 2003. http://www.cbsnews.com/stories/2003/07/29/health/main565611.shtml 15Kedrosky P. Dangerous popularity of online pharmacies. National Post August 13, 2003. 16 Harris G. Pfizer moves to stem Canadian drug imports. New York Times August 7, 2003. http://www.nytimes.com/2003/08/07/business/07DRUG.html 17 Cusack B., Stinson S. US drug firms set to boycott Canada. National Post August 7, 2003. http://www.nationalpost.com/home/story.html?id=363CC2EA-1832-42F2-954C-0F52D1828E23 18 “Prescription Drugs and Mass Media Advertising.” National Institute for Health Care Management Research. Washington, DC, 2001. 19 Mintzes B, Barer ML, Kravitz RL at al. How does direct to consumer advertising affect prescribing? a survey in primary care environments with and without legal DTCA. CMAJ 169 (2003): 405 –412. 20 Food and Drug Administration. Direct to consumer advertising of prescription drugs: physician survey preliminary results. Accessed at www.fda.gov/cder/ddmac. 21Survey shows strong opposition to direct to consumer advertising. Accessed at http://www.cma.ca/cma/ 22 Canadian Coalition on Medication Incident Reporting and Prevention. A medication incident reporting and prevention system for Canada: business Plan. March 2002. 23 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, “information-seeking” advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 24 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general. 25 Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.
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