The Canadian Medical Association urges Canadian medical schools to include in their curricula material related to the deleterious effect of negative stereotyping of Aboriginal peoples suffering from mental illnesses and substance use disorders.
The Canadian Medical Association urges Canadian medical schools to include in their curricula material related to the deleterious effect of negative stereotyping of Aboriginal peoples suffering from mental illnesses and substance use disorders.
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The Canadian Medical Association urges Canadian medical schools to include in their curricula material related to the deleterious effect of negative stereotyping of Aboriginal peoples suffering from mental illnesses and substance use disorders.
The Canadian Medical Association will work with stakeholders to develop standardized processes to ensure access to comprehensive psychiatric assessment and treatment for people detained within the correctional system.
The Canadian Medical Association will work with stakeholders to develop standardized processes to ensure access to comprehensive psychiatric assessment and treatment for people detained within the correctional system.
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The Canadian Medical Association will work with stakeholders to develop standardized processes to ensure access to comprehensive psychiatric assessment and treatment for people detained within the correctional system.
The Canadian Medical Association, while recognizing the need for better management of chronic illnesses and vulnerable populations, considers that such an emphasis should not be detrimental to the efforts aimed at guaranteeing access to family physicians.
The Canadian Medical Association, while recognizing the need for better management of chronic illnesses and vulnerable populations, considers that such an emphasis should not be detrimental to the efforts aimed at guaranteeing access to family physicians.
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The Canadian Medical Association, while recognizing the need for better management of chronic illnesses and vulnerable populations, considers that such an emphasis should not be detrimental to the efforts aimed at guaranteeing access to family physicians.
ACHIEVING PATIENT-CENTRED COLLABORATIVE CARE
(2008)
The Canadian Medical Association (CMA) recognizes that collaborative care is a desired and necessary part of health care delivery in Canada and an important element of quality, patient-centred care. The CMA considers patient-centred care to be the cornerstone of good medical practice. This is reflected in the first principle of the CMA Code of Ethics, which states that physicians have a fundamental responsibility to "Consider first the well-being of the patient." As patient advocates, physicians strive to ensure that their patients receive the best possible care.
The CMA supports greater collaboration among providers in the interest of better patient care. In the context of clinical practice, the CMA defines collaborative care as follows:
"Collaborative care entails physicians and other providers using complementary skills, knowledge and competencies and working together to provide care to a common group of patients based on trust, respect and an understanding of each others' skills and knowledge. This involves a mutually agreed upon division of roles and responsibilities that may vary according to the nature of the practice personalities and skill sets of the individuals. The relationship must be beneficial to the patient, and acceptable to the physician and other providers.
If designed appropriately, collaborative care models have the potential to:
* improve access to care;
* enhance the quality and safety of care;
* enhance the coordination and efficiency of care; and
* enhance provider morale and reduce burnout within health professions.
To realize this full potential, the profession acknowledges and accepts that it has a central role to play in the evolution of a team-based approach to care.
These policy principles have been prepared by the Canadian Medical Association in order to ensure that the evolution of collaborative care in Canada is built around the needs of individual patients and groups of patients. This policy is founded on the CMA's document, Putting Patients' First: Patient-Centred Collaborative Care - A Discussion Paper.
Principles for Collaborative Care
The medical profession supports collaborative care, both in the hospital and in the community, as one of the essential elements of health care delivery in Canada. In the interests of enhancing the evolution of patient-centred collaborative care, the CMA proposes the following "critical success factors" and principles to address meaningfully the issues and barriers identified by physicians and bring clarity to the discussions.
1. PATIENT-CENTRED CARE
First and foremost, medical care delivered by physicians and health care delivered by others should be aligned around the values and needs of patients.
Collaborative care teams should foster and support patients, and their families, as active participants in their health care decision-making. New models should have the potential to empower patients to enhance their role in prevention and self-care.
Models of collaborative care must be designed to meet the needs of patients.
Collaborative models of practice must reduce fragmentation and enhance the quality and safety of care provided to patients.
It is the patient who ultimately must make informed choices about the care he or she will receive.
2. RECOGNITION OF THE PATIENT-PHYSICIAN RELATIONSHIP
The mutual respect and trust derived from the patient-physician relationship is the cornerstone of medical care. This trust is founded on the ethical principles that guide the medical profession as defined in the CMA Code of Ethics. The impact of collaborative models of practice on this relationship, and hence the patient's satisfaction and experience with their care, is unknown.
Models of collaborative care must support the patient-physician relationship.
Entry into and exit from a formal collaborative care arrangement must be voluntary for both the patient and the physician.
A common Code of Ethics should guide the practice of collaborative care teams.
Every resident of Canada has the right to access a personal family physician. †
3. PHYSICIAN AS THE CLINICAL LEADER
Effective teams require effective leadership. A defined clinical leader is required to ensure proper functioning of the team and to facilitate decision-making, especially in complex or emergent situations. In collaborative care the clinical leader is responsible for maximizing the expertise and input of the entire team in order to provide the patient with comprehensive and definitive care.
It is important to differentiate "clinical leadership" from "team coordination."
The CMA defines a clinical leader as:
"The individual who, based on his or her training, competencies and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient. The clinical leader is ultimately accountable to the patient for making definitive clinical decisions."
Whereas, the team coordinator is defined as:
"The individual, who, based on his or her training, competencies and experience, is best able to coordinate the services provided by the team so that they are integrated to provide the best care for the patient."
The concept of "most responsible physician" has been and continues to be used to identify the individual who is ultimately responsible for the care of the patient. The "most responsible physician" is responsible for collecting, synthesizing and integrating the expert opinion of physician and non physician team members to determine the clinical management of the patient. Similarly, the presence of a defined clinical leader in a collaborative care setting creates clarity for patients, their families and the health care team by making lines of communication and responsibility clear, ultimately improving the quality and safety of care.
In the CMA's opinion, the physician is best equipped to provide clinical leadership. This does not necessarily imply that a physician must be the team coordinator. Many teams will exist in which the physician will have a supporting role, including those focused on population health and patient education. We believe the most effective teams are ones in which the leadership roles have been clearly defined and earned. Some physicians may be prepared to play both roles; however, other members of the team may be best suited to serve as team coordinator.
Currently, patients rely on, and expect, physicians to be clinical leaders in the assessment and delivery of the medical care they receive. In a collaborative care environment this expectation of physician leadership will not change. Team members will have specific knowledge and expertise in their respective disciplines. Physicians, by virtue of their broad and diverse knowledge, training and experience, have a unique appreciation of the full spectrum of health and health care delivery in their field of practice and are therefore best qualified to evaluate and synthesize diverse professional perspectives to ensure optimal patient care.
The physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume the role of clinical leader in collaborative care teams. There may be some situations in which the physician may delegate clinical leadership to another health care professional. Other health care professionals may be best suited to act as team coordinator.
4. MUTUAL RESPECT AND TRUST
Trust between individuals and provider groups evolves as knowledge and understanding of competencies, skills and scopes of practice are gained. Trust is also essential to ensuring that the team functions efficiently and maximizes the contributions of all members.
Funders and providers should recognize the importance of team building in contributing to team effectiveness. Collaborative care funding models should support a more formalized and integrated approach to both change management and team building.
As relationships are strengthened within the team, so too are trust and respect. Physicians and all team members have an opportunity to be positive role models to motivate and inspire their colleagues. All team members ought to make a commitment to respect and trust each other with the knowledge that it will lead to enhanced care for patients and a more productive work environment for all.
To serve the health care needs of patients, there must be a collaborative and respectful interaction among health care professionals, with recognition and understanding of the contributions of each provider to the team.
In order to build trust and respect within the team it is essential that members understand and respect the professional responsibility, knowledge and skills that come with their scope of practice within the context of the team.
5. CLEAR COMMUNICATION
In collaborative care environments, it is essential that all members of the team communicate effectively to provide safe and optimal care. Effective communication is essential to ensure safe and coordinated care as the size of the team expands to meet patient needs. It is the responsibility of all team members to ensure that the patient is receiving timely, clear and consistent messaging.
Physicians can take a leadership role in modeling effective communications throughout the team. In particular, there is an opportunity to enhance the consultation and referral process, in order to provide clear and concise instructions to colleagues and optimize care. Sufficient resources, including dedicated time and support, must be available to the team to maximize these communication requirements.
Effective communication within collaborative care teams is critical for the provision of high quality patient care. Planning, funding and training for collaborative care teams must include measures to support communication within these teams.
Mechanisms must be in place within a collaborative team to ensure that both the patients, and their caregiver(s) where appropriate, receive timely information from the most appropriate provider.
Effective and efficient communications within the collaborative care team, both with the patient and among team members, should be supported by clear documentation that identifies the author.
A common, accessible patient record in collaborative care settings is desirable to ensure appropriate communication between physicians and other health care professionals, to prevent duplication, coordinate care, share information and protect the safety of patients.
An integrated electronic health record is highly desirable to facilitate communication and sharing among team members.
6. CLARIFICATION OF ROLES AND SCOPES OF PRACTICE
In order for the team to function safely and efficiently, it is critically important that the scope of practice, roles and responsibilities of each health care professional on the team be clearly defined and understood. In turn, the patient, as a team member, should also have a clear understanding of the roles and scopes of practice of their providers.
Collaborative care must first and foremost serve the needs of patients, with the goal of enhancing patient care; collaborative care is not contingent upon altering the scope of practice of any provider group and must not be used as a means to expand the scope of practice and/or independence of a health professional group.
Changes in the scope of practice of all provider groups must be done with oversight from the appropriate regulatory authority.
Where non-physicians have been provided with an opportunity to undertake activities related to patient care typically unique to the practice of medicine (e.g., ordering tests), they must not do so independently but undertake these activities within the context of the team and in a manner acceptable to the clinical leader.
The role and scope of practice of each member of the collaborative care team should be clearly understood and delineated in job descriptions and employment contracts.
A formal process for conflict resolution should be in place so that issues can be dealt with in a timely and appropriate manner.
7. CLARIFICATION OF ACCOUNTABILITY AND RESPONSIBILITY
In the context of providing optimal care, providers must be accountable and responsible for the outcome of their individual practice, while sharing responsibility for the proper functioning of the collaborative care team. This individual responsibility is required so that regardless of the number and diversity of providers involved in the team, patients can be assured that their well-being is protected and that the team is working toward a common goal.
In collaborative care teams, a physician should be identified as the person most responsible for the clinical care of individual patients, and as such must be accountable for the care rendered to patients. This is consistent with the commitment made by the physician in the doctor-patient relationship, mirrors the clinical training of the physician relative to other providers, is reflective of the current state of tort law as it applies to medical practice, and is compatible with the structure of care delivery in hospitals and in the community. Clearly, this type of arrangement does not eliminate the necessity for all providers to be accountable for the care that they provide.
It is essential that all providers be responsible and accountable for the care that they provide and for the well-being of the patient.
As clinical leader, the physician should be responsible for the clinical oversight of an individual patient's care.
8. LIABILITY PROTECTION FOR ALL MEMBERS OF THE TEAM
As discussed earlier in this paper, the resolution of the multiplicity of liability issues that result from care delivered by teams requires clearly defined roles and responsibilities in the team setting and the absolute requirement for appropriate and sufficient liability coverage for each health professional. The August 2006 statement of the Canadian Medical Protective Association, Collaborative Care: A medical liability perspective, identifies issues of concern to physicians and proposes solutions to reduce those risks.
All members of a collaborative care team must have adequate professional liability protection and/or insurance coverage to accommodate their scope of practice and their respective roles and responsibilities within the collaborative care team.
Physicians, in their role as clinical leaders of collaborative care teams, must be satisfied with the ongoing existence of appropriate liability protection as a condition of employment of, or affiliation with, other members on collaborative care teams.
Formalized procedures should be established to ensure evidence of this liability protection.
9. SUFFICIENT HUMAN RESOURCES AND INFRASTRUCTURE
Collaborative models of health care delivery hold the promise of enhancing access to care for patients at a time of serious health human resource shortages. However, effective patient-centred collaborative care depends on an adequate supply of physicians, nurses and other providers. Governments and decision-makers must continue to enhance their efforts to increase the number of physicians and nurses available to provide health care services.
Collaborative care should not be seen as an opportunity for governments to substitute one care provider for another simply because one is more plentiful or less costly than the other.
In addition, governments must understand that co-location of individuals in a team is not a requirement for all collaborative care. Where team co-location does not exist, appropriate resources must be dedicated to ensure communication can be timely, effective and appropriate between providers.
Governments, at all levels, must address the serious shortage of physicians to ensure quality patient care for Canadians.
The effective functioning of a collaborative care team depends on the contribution of a physician.
Governments must enhance access to medical care by increasing the number of physicians and providers, and not by encouraging or empowering physician substitution.
10. SUFFICIENT FUNDING & PAYMENT ARRANGEMENTS
Funding must be present to support all aspects of the development of collaborative care teams. At the practice level, remuneration methods for physicians, irrespective of their specialty, must be available to facilitate collaborative care arrangements and environments in which physicians practice. All care delivery models, including collaborative care teams, must have access to adequate and appropriate resources. This includes, but should not be limited to, funding for health human resources, administration/management infrastructure, liability protection, clinical and team/administrative training, team building, and information technology.
Remuneration models should be established in a manner that encourages providers to participate effectively in the delivery of care and team effectiveness.
Reimbursement models must be configured to remunerate the communicator, coordinator, manager, and other roles and responsibilities of providers necessary for the success of collaborative care practice.
The ability of a physician to work in a collaborative care team must not be based on the physician's choice of remuneration. Similarly, patients should not be denied access to the benefits of collaborative practice as a result of the physician's choice of payment model.
Collaborative care relationships between physicians and other health care providers should continue to be encouraged and enhanced through appropriate resource allocation at all levels of the health care system.
Physicians should be appropriately compensated for all aspects of their clinical care and leadership activities in collaborative care teams.
Physicians should not be expected to incur the cost of adopting and maintaining health information technology capabilities that facilitate their ability to participate in collaborative practice teams. Governments must fund and support in an ongoing manner, both financially and technically, the development and integration of electronic health records.
11. SUPPORTIVE EDUCATION SYSTEM
Canada is renowned for a quality medical education system and for the early efforts to enhance interprofessional training. The success of collaborative care requires a commitment towards interprofessional education and is contingent upon the positive attitudes and support of educators. To facilitate a sustainable shift toward collaborative practice, these efforts must be continued and enhanced in a meaningful way. However, governments and educators must ensure that the availability and quality of medical education is not compromised for medical trainees.
Interprofessional education, at the undergraduate, postgraduate and continuing education levels, is necessary to facilitate a greater understanding of the potential roles, responsibilities and capabilities of health professions, with the overall goal of building better health care teams founded on mutual respect and trust.
Governments must understand the importance of interprofessional education and fund educational institutions appropriately to meet these new training needs.
Educational opportunities must exist at all levels of training to acquire both clinical knowledge and team effectiveness/leadership training.
Interprofessional education opportunities must not come at the expense of core medical training. High quality medical education must be available to all medical trainees as a first priority.
12. RESEARCH AND EVALUATION
More research and evaluations are necessary to demonstrate the benefits of collaborative care, to foster greater adoption by providers and to attract the necessary investment by governments. Quality management systems must be built into the team to ensure efficiencies can be recorded. Measures of the quality of care, cost effectiveness and patient and provider satisfaction should be evaluated.
Research into the effectiveness of collaborative care models on health outcomes, patient and provider satisfaction and health care cost effectiveness should be ongoing, transparent and supported by governments.
Quality assessment measures must be incorporated into the ongoing work of collaborative care teams.
† Where the term "family physician" is used, it is also meant to include general practitioners.
The Canadian Medical Association and provincial/territorial medical associations will work with governments to implement transparent and publicly available principles for the supply and effective management of functional acute care beds.
The Canadian Medical Association and provincial/territorial medical associations will work with governments to implement transparent and publicly available principles for the supply and effective management of functional acute care beds.
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The Canadian Medical Association and provincial/territorial medical associations will work with governments to implement transparent and publicly available principles for the supply and effective management of functional acute care beds.
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, strongly urges governments that decisions regarding the allocation of resources for new and existing health care treatments, programs, policies and products be consistent with the best available scientific evidence.
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, strongly urges governments that decisions regarding the allocation of resources for new and existing health care treatments, programs, policies and products be consistent with the best available scientific evidence.
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The Canadian Medical Association, in collaboration with provincial/territorial medical associations, strongly urges governments that decisions regarding the allocation of resources for new and existing health care treatments, programs, policies and products be consistent with the best available scientific evidence.
The Canadian Medical Association and provincial/territorial medical associations advocate for a management strategy for patients requiring an alternate level of care that alleviates the pressure on acute care hospital resources.
The Canadian Medical Association and provincial/territorial medical associations advocate for a management strategy for patients requiring an alternate level of care that alleviates the pressure on acute care hospital resources.
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The Canadian Medical Association and provincial/territorial medical associations advocate for a management strategy for patients requiring an alternate level of care that alleviates the pressure on acute care hospital resources.
The Canadian Medical Association calls on the Association of Faculties of Medicine of Canada, faculties of medicine, College of Family Physicians of Canada and Royal College of Physicians and Surgeons of Canada to greatly expand efforts to familiarize medical students and residents with the application of evidence-based medicine, including systematic reviews, clinical practice guidelines, care pathways and related techniques to improve quality, safety and efficiency in medicine.
The Canadian Medical Association calls on the Association of Faculties of Medicine of Canada, faculties of medicine, College of Family Physicians of Canada and Royal College of Physicians and Surgeons of Canada to greatly expand efforts to familiarize medical students and residents with the application of evidence-based medicine, including systematic reviews, clinical practice guidelines, care pathways and related techniques to improve quality, safety and efficiency in medicine.
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The Canadian Medical Association calls on the Association of Faculties of Medicine of Canada, faculties of medicine, College of Family Physicians of Canada and Royal College of Physicians and Surgeons of Canada to greatly expand efforts to familiarize medical students and residents with the application of evidence-based medicine, including systematic reviews, clinical practice guidelines, care pathways and related techniques to improve quality, safety and efficiency in medicine.
The Canadian Medical Association will continue to collaborate with the Council of the Federation – Health Care Innovation Working Group to help ensure that Canada delivers on better health, better care and better value.
The Canadian Medical Association will continue to collaborate with the Council of the Federation – Health Care Innovation Working Group to help ensure that Canada delivers on better health, better care and better value.
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The Canadian Medical Association will continue to collaborate with the Council of the Federation – Health Care Innovation Working Group to help ensure that Canada delivers on better health, better care and better value.
Building a Comprehensive Post-Market Surveillance System : Canadian Medical Association Response to Health Canada’s Discussion Paper “Designing a Mandatory System for Reporting Serious Adverse Reactions”
Building a Comprehensive Post-Market Surveillance System
Canadian Medical Association Response to Health Canada’s Discussion Paper
“Designing a Mandatory System for Reporting Serious Adverse Reactions”
Submitted to Health Canada
July 28, 2005
Overview
The CMA believes that all stakeholders should work together to improve adverse drug reaction (ADR) reporting, in the interests of improving patients’ safety and health. However, we believe that activity in pursuit of this end must be based on two fundamental premises:
a) Reporting is only one part of a comprehensive post-market surveillance system. In order to effectively monitor the safety of Canada’s drug supply, this system should include:
* a simple, comprehensive and user-friendly reporting process;
* rigorous analysis of reports to identify significant threats to drug safety;
* a communications system that produces useful information, distributed to health care providers and the public in a timely, easily understood manner.
There is no point in enacting a mandatory reporting requirement until all of these elements are in place. We wonder why mandatory reporting has been singled out for discussion when a holistic approach to reforming Canada’s drug safety system is called for.
b) Health care providers should be encouraged to participate willingly and voluntarily in the reporting process. To be successful, Canada’s post-market surveillance system will depend on the active participation of physicians and other health professionals. Experience with health system quality and safety improvement efforts over the past several years has demonstrated that meaningful acceptance is most effectively obtained when those involved are willing participants.
If you build a comprehensive, efficient and effective post-market surveillance system, physicians will participate actively in it. Forcing them to participate before the system has been built will result in alienation, frustration and failure.
Comments on Discussion Paper
a) Is Mandatory Reporting Necessary?
This is a fundamental question and the discussion paper does not satisfactorily address it. There are two reasons why we question the necessity for imposing an ADR reporting requirement on health professionals.
First, as awareness of the drug-safety system’s importance has increased, the number of ADR reports has increased along with it - more than 10% in 2004, as the discussion paper notes - without a mandatory reporting requirement. Given this trend, it is highly probable that time, education, adequate resources and increasing familiarity with the surveillance system will raise reporting rates to the desired level (however defined) without mandatory reporting.
Second, as the discussion paper points out, there is no evidence that mandatory reporting has been effective in other jurisdictions where it has been implemented. The paper offers no clear explanation for this lack of success. More importantly, it does not indicate how Health Canada plans to ensure that mandatory reporting will succeed in this country when it has proven ineffective elsewhere. A primary principle of any system change is that we should not repeat the mistakes of others. Before launching a program whose success has not been proven, other viable, and possibly more effective, alternatives should be examined.
b) Addressing known barriers to reporting
The CMA acknowledges that ADRs are under-reported, in Canada and worldwide. The discussion paper identifies a number of barriers to reporting, and its list mirrors the observations and experiences of our own members. We believe most of these barriers can, and should, be overcome.
We also agree that it is necessary to raise health professionals’ awareness of the importance of, and process for, ADR reporting. But we question the curious assertion that “Mandatory reporting could raise awareness of the value of reporting simply by virtue of the public debate.” Surely there are more positive ways to raise awareness than publicly speculating about the punitive consequences of non-compliance. We suggest that instead, Health Canada work with physicians and other health professionals to address the existing barriers to reporting. Specifically, we recommend that Health Canada implement:
* a well-funded and targeted awareness-raising campaign focused on provider education and positive messaging,
* a user-friendly reporting system, including appropriate forms, efficient processes and adequate fees.
These measures are within Health Canada’s purview in the existing policy and legislative environment. We believe they would increase reporting without the need for coercive measures. At a minimum, positive system improvements should be tried first before considering a mandatory-reporting requirement.
With regard to specific questions posed in the discussion paper:
Question 1: Health professionals should be explicitly protected from any liability as a result of reporting an adverse drug reaction. This should be the case regardless of whether reporting is voluntary or mandatory.
Question 2: Professionals should be compensated for all meaningful work including the completion of forms and any follow-up required as a result of the information they have provided. We would be happy to expand further on this issue on request.
Question 3: Issues of confidentiality should be covered in legislation. The CMA has developed an extensive and authoritative body of knowledge on privacy issues in health care, which we would be pleased to share with Health Canada.
c) Improved report quality
We agree that increasing the quality and richness of ADR reports is as important as increasing their number. Perhaps it is even more important, since high-quality reports allow for high-quality analysis. Mandatory reporting will not improve the quality of ADR reports; it will simply increase their quantity. It may even compromise the system’s efficiency and effectiveness by increasing the volume of clinically insignificant reports. Experience elsewhere has taught us that true quality cannot be legislated or imposed; any attempt to do so would be pointless.
If ADR reports included the information listed in Table 4, this would improve their usefulness and the effectiveness of the overall surveillance process. However, it is unrealistic to expect all reports to contain this level of information. The treating physician may not be able to provide all of it, especially if he or she is not the patient’s regular primary care provider. Some of this information, particularly about outcomes, may not be available at the time of the reporting, and gathering it would require follow-up by Health Canada.
Health Canada should consider measures other than mandatory reporting to improve the quality of ADR reports. The CMA suggests that consideration be given to:
* Improving follow-up capacity. We agree that it should be made easier for Health Canada officials to contact reporters and request details on follow-up or outcomes. This should be considered as part of a comprehensive initiative to improve Health Canada’s capacity to analyze ADR reports.
* Establishing a sentinel system. Another option for increasing high-quality reports would be to establish a “sentinel” group of practicing physicians who would contract to report all ADRs in detail. These physicians, because of their contractual obligation, would be committed to assiduous reporting. Sentinel systems could be established concurrently with efforts to increase voluntary ADR reporting by the broader health professional community.
In addition to the current information provided, consideration should be given to including on reporting forms the option to allow Health Canada officials to act on information the physician provides; for example, in the reporting of sexually transmitted diseases physicians provide certain information and have the option to request that public health officials undertake follow-up and contact tracing.
d) Minimize administrative burden
We agree that Health Canada should give consideration to making the ADR reporting system user-friendly, non-complex and easy to integrate into the patient-care work stream. These reforms can and should be implemented regardless of whether a mandatory requirement is in place. They do not need mandatory reporting to make them work; in fact, they are more likely to encourage ADR reporting than any form of coercive legislation.
Rather than making a mandatory reporting requirement “fit” with the traditional patient-care framework, we invite Health Canada to work with us to increase health professionals’ capacity to report ADRs voluntarily.
We are already working with Health Canada to improve physicians’ access to drug safety material. Health Canada’s ADR reporting form can now be downloaded from the cma.ca web site, which also posts the latest drug alerts from Health Canada and from the Food and Drug Administration in the U.S. We have developed an on-line course in partnership with Health Canada, to teach physicians when and how to make ADR reports.
We hope to build on this collaboration, with the goal of making it possible for physicians to report ADRs online via cma.ca. This will permit them to fit reporting more conveniently into their daily workflow. (Note: the “MedEffects” Web portal now being developed at Health Canada does not fit well into the workflow and therefore will not make reporting easier for health professionals.)
In the future, we hope that ADR reporting can be built directly into the Electronic Medical Record (EMR). We think this will be a critical element in the bi-directional communicating that ADR reporting requires. It will also enable rapid integration of advisories into the EMR so that they can be available to physicians at the time they are writing a prescription. Before electronic ADR reporting can work, a standard for electronic data should be in place (at present it is not) and Health Canada should develop the capacity to accept data electronically.
Health Canada’s discussion paper makes reference to cost-benefit analysis. We recommend that you take great care not to over-emphasize cost-benefit when it comes to enhancing patient safety. Meaningful improvements in the post-market surveillance system will be costly whatever solution Health Canada eventually embraces, and it is impossible to measure financially the value of safety. What is an acceptable cost for one life saved?
e) Minimize Over-Reporting
The discussion paper acknowledges that not all adverse reactions need be reported. We strongly agree that one of the dangers of mandatory reporting is its potential to overwhelm the system with an unmanageable flood of reports. There is no reason to require reports of minor side effects that are already known to be associated with given drugs.
We agree that the reactions Health Canada most needs to know about are those which are severe and/or unexpected. If Health Canada insists on implementing a mandatory reporting system, it should be limited to these reactions (possibly with the corollary that well known serious ADRs would not need to be reported). However, the operating definitions may need clarification, and we recommend that Health Canada consult with health professionals and others on operational guidelines for defining “serious adverse reaction.”
Health Canada’s desire to encourage reports on drugs approved within the last 5 years is understandable (though some drugs may be on the market for longer than this before their true risks are known). In practice, however, many physicians do not know which drugs these are, and seeking out this information may impose a heavy administrative burden. As we move toward an EMR-based reporting system, a tag on the Drug Identification Number to tell when the drug was approved will allow physicians to identify which medications require special vigilance.
Appropriate reporting could be encouraged, and over-reporting discouraged, by clear guidelines as to what should be reported as well as appropriate compensation for reporting.
f) Match Assessment Capacities
In our opinion, this is one of the most important sections in the document. What happens once the reports have been received is crucial if we want to identify a serious drug risk as quickly as possible. Under the current system, one of the most significant barriers to physicians’ reporting is lack of confidence that anything meaningful will be done with their reports.
Enhancements to the analysis function must be made concurrently with efforts to increase ADR reporting. ADR reports are only cyber-bytes or stacks of paper unless we can learn from them.
This requires rigorous data analysis that can sort “signal from noise” – in other words, sift through thousands of reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. This requires substantial resources, including an adequate number of staff with the expertise and sensitivity required for this demanding task. Unless Health Canada has this capacity, increasing the number of reports will only add to the backlog in analysts’ in-boxes.
The CMA recommends that Health Canada allocate sufficient resources to enable it to effectively analyze and respond to ADR reports and other post-market surveillance information.
g) Respect privacy
Privacy of both patient and physician information is a significant concern. Physicians’ ethical obligation to maintain patient confidentially is central to the patient-physician relationship and must be protected.
We acknowledge that issues of privacy and confidentiality must be resolved when designing an ADR reporting system, particularly as we work toward electronic communication of drug surveillance data and its incorporation into an EMR. For example, regulations should explicitly state that ADR reports are to be used only for the purpose for which they were submitted, i.e. for post-market drug surveillance. In addition, Health Canada should ensure that any privacy provisions it develops meet the legislative test outlined in Section 3.6 of CMA’s Health Information Privacy Code (Attachment I).
Health Canada can be assured that physicians take their privacy obligations seriously. The CMA has been a strong and pro-active player in debate on this issue, and our Privacy Code lays the groundwork on which we believe any privacy policies involving ADR reporting should be based.
h) Compliance through sanctions
Physicians are motivated to report ADRs by their concern for public health and their patients’ well-being. In addition, they are guided by the CMA Code of Ethics and governed by regulatory authorities in every province.
A clear ethical and professional obligation already exists to report anything that poses a serious threat to patient safety. If physicians do not comply with this obligation, sanctions are available to the provincial regulatory authorities. In fact, the most serious threat for physicians is loss of standing with the professional regulatory authority, not the courts or any external judicial system. It would be superfluous to add a second level of regulation or scrutiny when remedies already exist.
The discussion paper presents few alternatives to the existing self-regulatory system.
As the paper itself acknowledges, it is unrealistic to impose sanctions based on failure to report an ADR, since it is not always easy to determine whether an adverse effect is attributable to a health product. But the only suggested alternatives - requiring physicians to demonstrate knowledge, or to have the required reporting forms in their office - seem intrusive, crude and unreasonable; they are also meaningless since they have no direct relation to a physician’s failure to report. If Health Canada is considering a large outlay of taxpayers’ dollars for post-market surveillance, we suggest they target those funds to education and awareness raising, and to enhancing the system’s ability to generate and communicate meaningful signal data, rather than to enforcing a mandatory reporting system based on weak compliance measures, with no evidence of its effectiveness in other jurisdictions.
Physicians who are in serious breach of their ethical and legal responsibility to report are subject to sanctions by provincial regulatory authorities. Most provincial colleges have policies or guidelines regarding timely reporting and appropriate enforcement mechanisms. Medicine’s tradition of self-regulation has served it well, and we recommend that Health Canada respect and support existing regulatory authorities as they maintain the standards for appropriate professional behaviour.
As we have said before - the preferred quality improvement tools to enhance performance and encourage compliance are education and positive reinforcement, not legislation and the threat of sanctions.
Conclusion
In its discussion paper Health Canada has invited stakeholders to provide their input on how best to develop a mandatory system for reporting ADRs. The Canadian Medical Association believes that the best way to do this is not to develop one at all. Instead, we believe stakeholders should concentrate on building a sustainable, robust and effective post-market surveillance system which:
* encourages and facilitates voluntary reporting, by designing a simple and efficient process that can be incorporated into a physician’s daily workflow;
* effectively uses reporting data to identify major public health risks;
* communicates drug safety information to providers and the public in a timely, meaningful and practical way.
The CMA is committed to working, in partnership with Health Canada and other stakeholders, toward the ultimate goal of a responsive, efficient and effective post-market drug surveillance system. This is part of our long-standing commitment to optimizing Canadians’ safety and health, and achieving our vision of a healthy population and a vibrant medical profession.
