The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3
As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5
Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market.
However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8
Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16
Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction.
Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21
Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB.
Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids.
In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing.
There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary.
These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias.
In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted.
The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community.
The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism.
The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use.
The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers.
The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding.
The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed.
1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17).
2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17).
3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17).
4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17).
5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17).
6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42.
7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4.
8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207.
9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10.
10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142.
11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84.
12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59.
13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605.
14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27.
15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962.
16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26.
17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17).
18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4.
19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81.
20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791.
21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46.
22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17).
23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17).
24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17).
25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17).
26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17).
27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada.
The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying.
The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country.
The CMA would like to raise the following critical areas for your consideration:
1. Definitions/parameters of terms
There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example:
a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient?
b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined.
c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure?
d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point.
e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity.
2. Collection and protection of data
We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular:
a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data.
b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation.
c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined.
d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD.
3. Additional requirements
Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient.
These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”.
It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation.
4. Lack of clarity of reasons for ineligibility
There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed.
The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation.
As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach.
1. Protection and disclosure of the information
This is a foundational component of any regulatory framework for both practitioners and patients/requestors. The CMA recommends placing greater emphasis on the protection of privacy by
a. conducting a privacy impact assessment, with input from the Federal Privacy Commissioner (if that hasn't already been done).
b. requiring, as part of the regulations, privacy/data sharing agreements in instances when
o data is shared to meet the objectives outlined (p. 2); and
o information collected under the framework will be made available to designated provincial and territorial government bodies for their use (p. 3). This is particularly important given that this involves the collection of identifiable (private) information about practitioners and patients/requestors.
c. using aggregate data where applicable.
d. providing greater detail on how the "Rigorous protection of all personal information (patient and practitioner) will be a paramount feature of the monitoring regime" - such detail is essential even in the preliminary stages of developing a monitoring and reporting system.
2. Further specification of what constitutes a request
As is currently stated, what constitutes a request is not sufficiently defined, i.e., what constitutes a "written request"? Is any written request a request? What about for those who can't (or who can no longer) write? Further specifying what constitutes a request is especially important since the practitioner has to document the circumstances of the request in every instance, including where follow-up is required and a report has to be filed as part of a follow-up.
A timeframe of 10 days to file a report is alarmingly short. It is commonly known that physicians already feel burdened by paperwork and it is highly likely that they would find it nearly impossible to meet this requirement. This could conceivably deter physicians from choosing to provide assistance in dying or participate in an assessment under threat of criminal sanction, potentially significantly impacting patient access.
Information required for this category includes "results of the eligibility assessment". It should be required to explicitly include reasons why the patient/requestor was deemed ineligible.
5. MAiD self-administered
a. The application of safeguards should be a specific category requiring reporting (and not simply used an example).
b. To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to require stating whether the practitioner was present during the self-administration.
6. Coroners and medical examiners
When the monitoring regime (periodically) requests information from Chief Coroners or Medical Examiners:
To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to gather data on who completes the death certificate and the information included on the death certificate.