The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1
Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety.
Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite.
The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3
In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.*
CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult.
Public health approach to addiction
Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components.
Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program).
Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5
Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential.
Harm reduction is part of health practice
Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms.
Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs.
The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. 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. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9
Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10
Supervised Consumption Sites are evidence-based
Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment.
Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12
Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services.
Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15
Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been:
* A reduction in the overall rate of needle sharing in the area;19
* A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21
* Increased access to addiction counseling and increased enrolment in detox programs;22 23
* Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24
* Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and
* No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26
* Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28
Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence.
Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety.
Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation.
The CMA has the following concerns with Bill C-2:
1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation."
2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation.
3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances".
4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need.
It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.
* "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services.
1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4
2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do
3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3
4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23
5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967
6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf
8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf
9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf
10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf
13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm
14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services
15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics
16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf
17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404.
19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18.
20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351.
21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7.
22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919.
23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence.
24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36.
25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34.
26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76.
28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36.
29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper.
30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction.
31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374.
32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136
33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20)
34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
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 of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act.
The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care.
Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan.
The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end.
1) Clarify ministerial authority and responsibility
The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety.
The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3):
* Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening.
* Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety.
In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority.
Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3.
2) Oversight of natural health products
The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting.
To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety.
Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products.
3) Comprehensive post-market surveillance and response system
The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings.
A) Increasing accountability and public transparency
Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks.
Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4
Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear.
The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data.
Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication.
Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks.
B) Improving the reporting and communication system
The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place.
Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness.
When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting.
In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes:
* Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care.
* Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line.
* Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting.
* Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis.
Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health.
In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report.
Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it.
Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes:
* Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records;
* Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and
* Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public.
Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting.
Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution".
Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective.
1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf
Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf
Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf
Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf
Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf
Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf
Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf
2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada.
http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30)
3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21)
4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2)
5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from:
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation.
Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke.
Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs.
Impact of Price on Smoking
Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi
With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required.
Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii
Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii
Excise Tax Adjustments
The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future.
The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy.
There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions.
Investing Tobacco Taxes in Health Promotion
The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16.
The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy.
The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required.
A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations.
For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations.
The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues.
The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada.
Summary of Recommendations
The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products.
The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling.
The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy.
The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use.
The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use.
i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14
Frank J. Chaloupka, Rosalie Liccardo Pacula
ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis
Pearl Bader, David Boisclair, Roberta Ferrence
Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118
iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14
Frank J. Chaloupka, Rosalie Liccardo Pacula
Good afternoon. My name is Dr. Maura Ricketts and I am the Director of Public Health for the Canadian Medical Association. The CMA appreciates the opportunity to appear before this Committee today as part of your study of clinical trials and drug approvals.
The CMA represents more than 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with all Canadians, for the highest standards of health and health care.
Because prescription drugs are an essential component of health care, the CMA has developed a considerable body of policy on pharmaceutical issues. This work can be distilled into one fundamental principle: The CMA believes that our country requires a National Pharmaceutical Strategy to ensure every individual has timely access to safe, effective and affordable prescription drugs. Despite the commitment in the 2004 Health Accord to the creation of such a strategy, Canadians continue to wait for government leadership on this issue. Drugs replace more costly and invasive medical interventions. They are an essential tool in the physician's tool box.
To ensure safety and effectiveness, the CMA also believes in the need for a strong, unbiased, evidence-based system for research and approval. This is at the heart of our commitment to patient-centred care.
In evaluating whether to prescribe a new drug to a patient, a physician will weigh several factors: Does this product offer any benefits over what I am prescribing now? Will it be more effective? Will this new drug be safer? Will it solve any tricky clinical problems, such as drug interactions, or reduce side effects that prevent a medication from being used properly? The physician may also ask: What is the evidence that this new drug is an improvement? Can I trust the evidence? Where can I get access to accurate, reliable information and data on this drug?
Pre-approval drug research must provide answers to these fundamental questions.
I will now focus on two particular issues of concern to practising physicians with regard to clinical trials:
* First, what is being compared to what? Clinical trials may be sufficient for Health Canada's regulatory purposes, but may provide only part of the information a physician needs. For example, is a new cholesterol drug effective on all patients, or only on some of them? Would other patients derive equal benefit from an already existing drug, or from a lifestyle change such as diet or exercise? The CMA recommends that researchers compare a new product to other drugs on the market - and to other interventions, as well.
* Second, is timely, reliable and objective information available on all clinical trial results, not just the positive ones? Canadians need to be informed when a drug has performed disappointingly in trials if they are to make informed decisions about their health care. The CMA, therefore, recommends the results of all clinical trials, not just those with positive results, be made available to health professionals and the public.
I would like to add that the current documentation is not very user-friendly. We recommend that Health Canada prepare summaries of the most essential data, not only for physicians, but for all Canadians to be able to access this information.
The Drug Approval Process
Turning now to the drug approval process, the CMA believes the following principles should apply:
* The primary criteria for approval should be whether the drug improves health outcomes and offers an improvement over products currently on the market.
* The review process should be as timely as is consistent with ensuring optimal health outcomes and the safety of the drug supply.
* The review process should be impartial and founded on the best available scientific evidence.
* The review process should be open and transparent.
* Finally, approval of a drug is not an endpoint, but rather one step in that drug's life cycle. It is not uncommon to identify serious safety hazards after a drug has been approved, because that's when it first goes into wide use. It is important that the approval process be complemented by a rigorous and vigilant post-market surveillance process. We look forward to presenting our recommendations on this subject to your Committee at a future session.
Before closing, I would like to briefly address two other matters:
First, the issue of drugs for rare disorders. We are aware that the current clinical trial and approval processes, which place a high value on studies with large population samples, may be unable to adequately capture the value of drugs that are prescribed to only a handful of people. Some patient groups active in the area of rare disorders, such as the Canadian MPS Society and Alpha-1 Canada, have shared their concerns about this with us. These groups, along with the Canadian Organization for Rare Disorders, have been advocating for years for a fair process for evaluating drugs for rare diseases. Because Canada doesn't have a rare disorders strategy, Canadian patients have access to fewer therapies than patients in other developed countries. The issue of how to approve drugs for rare disorders merits closer consideration. The CMA recommends that the federal government develop a policy on drugs for rare disorders that encourages their development, call for ongoing evaluation of their effectiveness, and ensures fairness so that all patients who might benefit have reasonable access to them.
The second matter is that Health Canada's review process provides little guidance on another question which physicians are increasingly asking: Can my patient afford this drug? It is not sufficient that the Common Drug Review conducts reviews of the cost effectiveness of drugs and that provincial/territorial formularies undertake similar studies, as the fact remains that cost is one of the factors physicians need to consider when deciding whether to prescribe a new drug. This is especially true in the case of new biologics, which are very expensive. Canadian doctors believe that the difficulty of making effective prescribing decisions without information about cost needs to be overcome. This only underscores the necessity of a National Pharmaceutical Strategy.
Thank you. We would be happy to answer your questions.
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for consideration as part of its study on drug supply in Canada. The severe impact of the disruption in production at one pharmaceutical company's manufacturing facility has demonstrated the significant shortcomings in how drug shortages are managed in Canada. This submission focuses on what is needed to ensure Canada's health care system delivers patient-centred care.
In order to deliver the best possible care to patients, physicians require timely, comprehensive and accurate information about current and anticipated drug supply shocks and constraints. With this objective in mind, we have provided input to the government and to the pharmaceutical industries. Further, Canada requires an uninterrupted supply of medically necessary medication for patients.
Impacts on Patients and the Health Care System
Canada's doctors are deeply concerned about the persistent shortages of drugs that they and their patients are encountering. Prescription drugs can prevent serious disease, reduce hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Pharmaceuticals benefit the health care system by reducing costs in other areas such as hospital stays and disability payments. Disruptions in the supply of pharmaceuticals can impact patient care, patient health and the efficiency of the overall health care system.
At the CMA, patient organizations are telling us about the anxiety, pain and harm that drug shortages are inflicting on patients. Below are excerpts of these experiences:
* According to the Brain Injury Association of Canada: "Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered."
* The interim-president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote CMA to say: "Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line."
* Sharon Baxter, Executive Director, of the Canadian Hospice Palliative Care Association, says: "All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada."
Among the impacts of drug shortages are:
* delays in access to needed medication;
* delays or disruptions to clinical treatment;
* delayed or cancelled surgeries;
* loss of therapeutic effectiveness when an appropriate alternate therapy is not available;
* increased risk of side effects when alternate therapies are used; and
* increased non-compliance when patients, particularly those on long-term therapy, find it harder to comply with a new medication regime.
Any one of these situations can impact patient health, particularly in patients with complex problems. In many instances, this in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments.
In a survey of physicians conducted by the CMA in 2011, two-thirds of respondents said that the shortage of generic drugs had had negative consequences for their patients or practice.
Of these physicians, 22 per cent indicated that the consequences were that their patient suffered clinical deterioration because an alternate drug was substituted. Similarly, in a survey of pharmacists by the Canadian Pharmacists Association in 2011, 69 per cent of respondents indicated that they believed that patients' health outcomes had been adversely affected by drug shortages.
Notably, of the physicians who indicated the shortage of generics resulted in consequences to their patients or practice, 28 per cent reported that their patient did not fill the substitution prescription due to the cost of the medication. Numerous respondents raised concerns about the financial impact of substitute medications on patients.
Survey responses also shed light on the increased demand on the health care system created by the lack of information on drug shortages provided to physicians. When physicians are not made aware of a drug shortage, and prescribe that medication, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Better informing physicians about drug shortages can reduce demand on the health care system by eliminating the inefficiencies associated with drug shortages.
Scope of Drug Shortages
In an attempt to outline the scope of the problem, the Canadian Agency for Drugs and Technologies in Health (CADTH) stated that:
"It is difficult to quantify and determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply to Health Canada and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight."i
Surveys by the CMA and the Canadian Pharmacists Association (CPA) shed light on the lack of drug shortages management in Canada. Taken together, the results of these surveys paint an alarming picture of drug shortages management in Canada and underscore the need to improve our system.
In terms of notification, the majority of physicians and pharmacists indicated they never (51 per cent and 29 per cent) or infrequently (32 per cent and 33 per cent) receive advance notice of shortages. Ironically, given the high proportion of pharmacists reporting they never or infrequently receive notice, 65 per cent of physicians indicated that they receive notification from pharmacists. Meanwhile, 30 per cent of physicians also indicated that they were notified of drug shortages by their patients.
Alarmingly, 81 per cent of the pharmacists surveyed indicated they had trouble locating medications to fill a prescription during their last shift prior to completing the survey and 93 per cent had difficulty over the week prior.
This is not a new problem, but since we surveyed CMA members in the fall of 2011, the situation has worsened. Currently about 250 medications are listed on Canadian drug shortage websites. Before the dire impact of the loss of production at Sandoz, Canadian hospitals were already dealing with shortages in the supply of sterile injectables - critical in specialties like surgery, oncology and anesthesia.
What Canada's Doctors Require to Provide Care
Physicians have expressed their frustration at the time it takes to find an appropriate drug for substitution - time taken from the physician, the pharmacy and the patient. Time better spent with patients is being used by physicians to work with pharmacists to identify alternative drugs and therapies.
Of greatest concern are those drugs that are single sourced. When single source medications are in short supply, there are no clear substitutes. The impact of this is being felt now in hospitals across the country as they grapple with the loss of numerous Sandoz products and are forced to ration the remaining stock.
The majority of physicians surveyed by the CMA indicated that greater knowledge of drug supply issues would allow them to deliver better patient care.
To this end, the CMA strongly supports the development of a comprehensive system for monitoring and responding to domestic shortages of medically necessary drugs. Canada needs a sustainable, adequately resourced system to: identify shortages, rapidly and proactively inform health care professionals, and respond quickly to allocate supply as needed to resolve shortages.
The CMA has provided input to both industry and government on the key information needs of doctors. These are:
* Information about the product in short supply;
* Expected duration of the shortage;
* Therapeutic alternatives;
* Regions affected;
* Notification of the end of the shortage.
While the recent establishment of the online inventories by the pharmaceutical industry associations marks an improvement in Canada's management of drug shortages, significant issues remain to be addressed. These include the need for: complete and more consistent information; automatic notifications to alert physicians, pharmacists and other health care providers; a mechanism to prevent potential disruptions; and a mechanism to seek new or interim sources of supply during a shortage.
The CMA recognizes that other countries are also grappling with drug shortages. Canada must also work with its partners abroad to find an international solution to this phenomenon.
Drug shortages management in Canada has significant shortcomings that impact patients, doctors and the health care system. With the current shortage of injectable drugs teetering on the verge of a crisis, quick action and cooperation are required to address the supply shock.
The CMA calls on Members of Parliament to exercise leadership to ensure that Canada's health care providers have access to the information necessary for them to care for their patients, and that Canadians have access to medically necessary drugs.
i Canadian Agency for Drugs and Technologies in Health. (2011) "Environmental Scan: Drug Supply Disruptions." Ottawa: CADTH, accessed online at: http://www.cadth.ca/media/pdf/Drug_Supply_Disruptions_es-18_e.pdf, 1.
CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences.
In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan.
In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage.
1) Addressing shortages in the supply of prescription medication
Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication.
Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all.
The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting.
The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions.
The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care.
To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care.
2) Addressing the misuse and abuse of prescription medication
The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution.
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.
Opioid prescription pharmaceuticals 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. It must be recognized that 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.
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 problem of prescription drug misuse and abuse in Canada. Such a strategy should include:
a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include:
* Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose;
* Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy.
b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response.
c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain.
d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances 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. 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. This should include the development of national standards for prescription monitoring, 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, including:
* Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers.
* Deterring inter-provincial fraud.
* Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications.
* Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues.
We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, 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.
3) Improving post-market surveillance and reporting tools
Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes:
a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies.
b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally.
c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available.
The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future.
4) Supporting Optimal Prescribing
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 encourages collaborative efforts toward the achievement of this ideal.
For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences:
* The risk of adverse drug reactions is several-fold higher for older patients than for younger;
* Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and,
* Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors.
It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use.
This strategy should include, among other elements:
a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow.
At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways:
* Well-crafted online continuing medical education (CME), funded by objective sources.
* Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them.
* Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records.
* Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour.
Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use.
b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could:
* List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud;
* Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking.
* Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and
* Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error.
The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing.
5) Addressing gaps in insurance coverage for prescription medication
Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost.
The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety.
The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada.
Summary of Recommendations
1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care.
2) 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 problem of prescription drug misuse and abuse in Canada.
3) 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.
4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to:
* Make it easier for health professionals to submit voluntary ADR reports
* Analyze the data that has been gathered, in a rigorous and timely manner; and
* Communicate essential information to health care providers and the public in a timely and user-friendly manner.
5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use.
6) The CMA supports the development and dissemination of prescribing information that is:
* based on the best available scientific evidence;
* relevant to clinical practice; and,
* easy to incorporate into a physician's workflow.
7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing.
8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing.
9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
The Canadian Medical Association is pleased to take part in the second phase of the study of prescription pharmaceuticals by the Senate Standing Committee on Social Affairs, Science and Technology. During the first phase, we presented the CMA's policy position regarding clinical trials and the process for approving new drugs for use. In this phase we will discuss our position and recommendations on post-approval surveillance of prescription drugs.
The Canadian Medical Association represents 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care.
Prescription drugs are a very important part of high quality and cost-effective health care. They can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Therefore, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription drugs.
The essence of our position is contained in our first recommendation:
The CMA recommends that federal and provincial/territorial governments collaborate to develop and implement a national pharmaceutical strategy to ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs.
This recommendation has two elements: "safe and effective" and "adequate supply," both of which we will discuss in this submission.
2) Ensuring Safety and Effectiveness
As we have previously told this Committee, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products. But however strong Canada's pre-approval system is, it will not identify all potential problems with a new drug. Pre-approval clinical trials tend to focus on small numbers of patients, and exclude vulnerable groups such as children and the elderly. They also tend to be of short duration, whereas in the real world, patients may take these drugs for years. As a consequence, problems with a drug are often identified only after widespread, long-term use in the general population. For this reason, it is essential that Canada have in place a robust regulatory framework that includes a timely system to monitor the performance of prescription drugs after they come on the market.
The Government of Canada has taken several recent steps to enhance its drug surveillance system. In 2009, it established the Drug Safety and Effectiveness Research Network. In 2008, it introduced Bill C-51, An Act to Amend the Food and Drugs Act, to improve drug safety and effectiveness monitoring by Health Canada. Unfortunately, the bill died with the 2008 election call and has not been re-introduced. That is why we are pleased that the Senate has chosen to re-open this issue.
What would a comprehensive post-approval surveillance regulatory framework and system look like? In order to effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes it should include:
a) Comprehensive processes for gathering drug safety and effectiveness data
In gathering data about adverse drug reactions (ADRs) in Canada, Health Canada has traditionally relied on spontaneous reports from manufacturers and health professionals. The government could enhance its capacity to gather information by:
* making it easier for physicians and other health professionals to report ADRs voluntarily. This can be accomplished by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of ADR reports over the past 10 years. The reporting process could be made even more efficient by incorporating it directly into the Electronic Medical Record (EMR) as this is developed.
* augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report ADRs in detail, and who, because of these contractual obligations, would be committed to assiduous reporting.
b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety.
Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received.
Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally.
Post-market monitoring should do more than identify safety risks. It should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition?
c) Communication of useful information to health care providers and the public.
When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available.
The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to:
* Make it easier for health professionals to submit voluntary ADR reports;
* Analyze the data that has been gathered in a rigorous and timely manner; and
* Communicate essential information to health care providers and the public in a timely and user-friendly manner.
d) Increased regulatory authority for Health Canada
Drug safety is a serious issue; recent research has revealed that nearly a quarter of new drugs approved in Canada will eventually receive a serious safety warning1. Given the potential risks to patient safety we believe Health Canada should have the legal authority to take strong action when a safety problem is identified.
The CMA recommends that Health Canada should be given the authority to:
* require post-market studies of newly approved drugs if clinical trials identify possible safety risks;
* require manufacturers to disclose information if Health Canada thinks it germane to making a decision in the interest of patient safety; and
* take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or pulling a product off the market.
Granting Health Canada this regulatory authority is only the first step. Health Canada should not hesitate to use this authority if the situation warrants.
3) Ensuring an Adequate Drug Supply
In the past few years Canada's doctors have become deeply concerned about the persistent shortages of drugs that they and their patients are encountering. In a survey of physicians conducted by the CMA in September 2012, two-thirds of respondents said that the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes. Of these physicians, 70 per cent indicated that their patient received a less effective medication, and 20 per cent had patients who had suffered clinical deterioration because an alternate drug was substituted. This in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. Twenty-three per cent reported that their patient suffered financially due to the cost of the substituted medication, since many of the drugs in short supply are older, low-cost generics.
The lack of information about shortages compounds the stress of dealing with them. When physicians prescribe a medication, unaware that it is in short supply, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Physicians have expressed their frustration at the time it takes to find an appropriate substitute drug - time which could better be spent in patient care.
As a consequence, the CMA strongly supports the development of a comprehensive system for monitoring domestic shortages of medically necessary drugs. To be of greatest benefit to doctors, such a system should include:
* Information about the product in short supply;
* Expected duration of the shortage;
* Therapeutic alternatives;
* Regions affected;
* Notification of the end of the shortage.
Although pharmaceutical industry associations and drug manufacturers are now supporting a drug shortage reporting website (http://www.drugshortages.ca/drugshortages.asp), there is room for improvement. The reporting website does not yet capture all of the drug product shortages. It must become more user friendly for health practitioners and the public, with search and sort functions to easily find product listings. In addition, a mechanism to obtain information on possible therapeutic substitutions would be of value to practitioners.
The CMA recommends that Health Canada work with provincial and territorial governments, industry groups and health professionals to enhance the current system for reporting drug shortages and ensure its sustainability.
Finally, while a reporting system to provide information to health professionals and Canadians on drug shortages is valuable, it is essential that Canada address the root causes of drug shortages. A review of the supply processes, both domestic and international, is strongly recommended.
While the CMA acknowledges that provinces are responsible for purchasing drugs, we believe that solutions will be stronger if all provinces, and the federal government, work together on them. And since drug shortages are an international concern, it is the responsibility of the Government of Canada to work with other countries in seeking solutions.
The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada.
4) Other Important Elements of a National Pharmaceutical Strategy
As Recommendation 1 states, the CMA believes that Canada's federal and provincial/territorial governments should implement a national pharmaceutical strategy, one of whose objectives would be to ensure an adequate supply of prescription drugs. The strategy should address other important objectives, as well, notably:
* ensuring comprehensive prescription drug coverage for all Canadians. According to a recent CMA survey, one in 10 Canadians has gone without a prescription drug because they couldn't afford it. Governments should work with private insurers and other stakeholders to develop a system to provide equitable, comprehensive prescription drug coverage to all Canadians.
* encouraging optimal prescribing by health professionals. To accomplish this, the CMA has recommended a strategy that includes education, user-friendly guidelines and practice tools, and the provision of impartial information to health professionals and the public.
Once again, we commend the Senate Social Affairs Committee for bringing this issue to your table. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective and in adequate supply.
1 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.4444.