APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY
A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION
This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy.
Goal of This Joint Statement
The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider.
Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy.
This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements.
This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices.
Goal of Drug Therapy
The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research.
Working Together for Optimal Drug Therapy
Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient-physician-pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others.
For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects.
Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other.
Strategies for Collaborating to Optimize Drug Therapy
Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following.
- Respecting and supporting patients' rights to make informed decisions regarding their drug therapy.
- Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all.
- Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers.
- Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy.
- Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care.
- Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients.
- Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care.
- Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues.
- Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians.
- Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education.
- Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy).
- Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy.
- Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making.
The Physician's Responsibilities
Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role.
- Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate.
- Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate.
- Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate.
- Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities.
- Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy.
- Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public.
- Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate.
- Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures.
The Pharmacist's Responsibilities
Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably.
- Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber.
- Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations).
- Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate.
- Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician.
- Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments.
- Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department.
- Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities.
- Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient.
- Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public.
- Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures.
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.
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.
Direct-to-Consumer Advertising (DTCA) Policy Statement
Canadians have a right to information about prescription drugs and other therapeutic interventions, to enable them to make informed decisions about their own health. This information must be evidence based and provide details about side effects and health risks as well as benefits.
Brand-specific direct-to-consumer advertisements, such as those permitted in the United States, do not provide optimal information on prescription drugs. We are concerned that DTCA:
* is not information but marketing, and sends the message that a prescription drug is a “consumer good” rather than a health care benefit.
* may not provide enough information to allow the consumer to make appropriate drug choices. For example, it generally does not provide information about other products or therapies that could be used to treat the same condition. In addition, it may stimulate demand by exaggerating the risks of a disease and generating unnecessary fear.
* may strain the relationship between patients and providers, for example if a patient’s request for an advertised prescription drug is refused.
* drives up the cost of health care, and undermines the efforts of physicians, pharmacists and others to promote optimal drug therapy.
Patient groups, health care providers, governments and pharmaceutical manufacturers should be supported in activities to develop objective, reliable plain-language information about prescription drugs to ensure that Canadians are able to make informed health care decisions.
* Support the provision of objective, evidence-based, reliable plain-language information for the public about prescription drugs.
* Oppose direct-to-consumer prescription drug advertising in Canada.
It has been over three years since the Social Union Framework Agreement (SUFA) was signed by the federal and provincial/territorial governments, with the exception of Quebec. At the time, it was heralded as an important breakthrough in federal-provincial relations that would clear the way for greater intergovernmental cooperation on pressing social policy issues such as health care renewal.
Functional federalism is essential to achieving social policy objectives that will be of benefit to Canadians from coast to coast. While SUFA may not be perfect, it is better than the alternative of federal-provincial paralysis and dysfunction. And as SUFA acknowledges, Canada’s social union is about more that how governments relate to each other: it is about how governments can and should work with external stakeholders and individual Canadians to improve the social policies and programs.
The health sector is an important test case for SUFA. It is the most cherished of Canada’s social programs. Canadians want and expect their governments to work together to improve the health care system and ensure its future sustainability. Ironically, it is also the area where government intergovernmental discord has been the greatest. On the eve of the final report of the Commission on the Future of Health Care in Canada, it is timely to reflect on SUFA and its role in the renewal of Canada’s health system.
SUFA and the Health Sector – Strengths and Weaknesses
The attached table provides a summary of the key elements of SUFA and the CMA’s assessment of how well SUFA provisions have been applied in the health sector.
On the positive side, the health sector has fared relatively well in the area of mobility within Canada. Physicians and other regulated health care providers generally enjoy a high degree of mobility. Portability of hospital and medical benefits is largely ensured through interprovincial eligibility and portability agreements. There are, however, two areas of concern. First, there is the longstanding failure to resolve the non-portability of medical benefits for Quebec residents. Second, there is growing disparity in coverage for services that are currently not subject to national standards under the Canada Health Act, particularly prescription drugs and home care.
In the area of dispute avoidance and resolution, governments have agreed to a formal process to address concerns with the Canada Health Act. This is a positive step, though few details have been made public. The real test will be whether this new process accelerates the resolution of non-compliance issues (most of which, as the Auditor-General recently pointed out, have remained unresolved for five years or longer), and whether the federal government will have the political will to levy discretionary penalties for non-compliance.
There has also been progress on public accountability and transparency as governments have begun reporting results in 14 health indicator areas pursuant to the September 2000 health accord. The CMA is disappointed, however, that governments did not fulfil their pledge to involve stakeholders at all levels in the development of these indicators. Moreover, governments have short-changed Canadians by not providing them with a national roll-up of indicators that would facilitate comparisons across jurisdictions. Looking to the future, it will be critical to put in place a process that moves from benchmarks (indicators) to the bedside (best practices, better outcomes). This must be done in collaboration with health care researchers, providers and health managers—those individuals who understand the importance of taking research and importing it into practice. Clinical researchers across the country are doing this work and must to be supported.
Overshadowing these relative successes in the first three years of the Social Union Framework Agreement are three key challenges that must be addressed:
* inadequate institutional mechanisms to improve accountability across the system
* failure to reduce uncertainty about what the health system will deliver, now and into the future
* resistance on the part of governments to engage stakeholders in a true partnership for health system renewal
The CMA is concerned that if these fundamental weaknesses are not addressed, they will undermine future attempts to renew Canada’s health system.
With the adoption of SUFA, governments have significantly increased emphasis on performance measurement and public reporting. While this is a positive development, it also has the potential to lead towards information overload and paralysis, unless two critical elements are addressed. First, there is a need for a clear accountability framework that sets out the roles, rights and responsibilities of all key players in Canada’s health system: patients, health care providers and governments. This, in turn, requires the creation of a credible arm’s length institution to monitor compliance with this framework and rise above the fray to give Canadians the straight goods on health care. One has to look no further that the recent rekindling of the so-called “shares debate” between the federal and provincial governments as an example of why these changes are necessary.
Over the past decade, Canada’s health system has been plagued by an escalating crisis of uncertainty. Patients have faced increasing uncertainty about the accessibility and timeliness of essential health care services. Health care providers have seen working conditions deteriorate. Employers and private insurers have seen their contribution to funding health services increase unpredictably as governments have scaled back their funding commitments. Furthermore, provincial and territorial governments have had to contend with an unstable federal funding partner.
Canadians deserve better. They need more certainty that their public health system will care for them when they need it most. They need more transparency from governments about “what’s in” and “what’s out” in terms of public or private coverage. They need their governments to act on their SUFA undertaking to make service commitments for social programs publicly available such as establishing standards for acceptable waiting times for health care. And they need governments to follow through with their SUFA commitment to ensure stable and adequate funding for the health system and other social programs.
Fostering real partnerships
In the health care field, deliberations and agreements have taken place behind closed doors and governments have discounted the role that non-governmental organizations and citizens should play in decision-making. It is these very providers and patients who are expected to implement and live with the results of such cloistered decision-making. The consequences of this systematic exclusion are all too evident in the current critical and growing shortages of physicians, nurses and other health professionals. If we are to achieve the vision of a sustainable Medicare program, it is critical that governments come clean on their SUFA commitment to work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs.
CMA’s Prescription for Sustainability – Building on SUFA
The Social Union Framework Agreement has created the necessary, but not sufficient, conditions for health system renewal. It has codified the emerging consensus on federal-provincial relations and has clarified the "rules of the game". However, it is an enabling framework that is of limited value in the health sector unless it is given life through institutional mechanisms that establish enduring partnerships not just between governments, but between governments health care providers, and patients.
In its final submission to the Commission on the Future of Health Care in Canada entitled “Prescription for Sustainability”, the CMA proposes the implementation of three integrated “pillars of sustainability” that together would improve accountability and transparency in the system: a Canadian Health Charter, a Canadian Health Commission, and federal legislative renewal.
Canadian Health Charter
A Canadian Health Charter would clearly articulate a national health policy that sets out our collective understanding of Medicare and the rights and mutual obligations of individual Canadians, health care providers, and governments. It would also underline governments’ shared commitment to ensuring that Canadians will have access to quality health care within an acceptable time frame. The existence of such a Charter would ensure that a rational, evidence-based, and collaborative approach to managing and modernizing Canada’s health system is being followed.
Canadian Health Commission
In conjunction with the Canadian Health Charter, a permanent, independent Canadian Health Commission would be created to promote accountability and transparency within the system. It would have a mandate to monitor compliance with and measure progress towards Charter provisions, report to Canadians on the performance of the health care system, and provide ongoing advice and guidance to the Conference on Federal-Provincial-Territorial ministers on key national health care issues. Recognizing the shared federal and provincial/territorial obligations to the health care system, one of the main purposes of the Canadian Health Charter is to reinforce the national character of the health system.
Federal legislative renewal
Finally, the CMA’s prescription calls for the federal government to make significant commitments in three areas: 1) a review of the Canada Health Act, 2) changes to the federal transfers to provinces and territories to provide increased and more targeted support for health care, and 3) a review of federal tax legislation to realign tax instruments with health policy goals.
While these three “pillars” will address the broader structural and procedural problems facing Canada’s health care system, there is many other changes required to meet specific needs within the system in the short to medium term. The CMA’s Prescription for Sustainability provides specific recommendations in the following key areas:
* Defining the publicly-funded health system (e.g. a more rational and transparent approach to defining core services, a “safety valve” if the public system fails to deliver, and increased attention to public health and Aboriginal health)
* Investing in the health care system (e.g. human resources, capital infrastructure, surge capacity to deal with emergencies, information technology, and research and innovation)
* Organization and delivery of services (e.g. consideration of the full continuum of care, physician compensation, rural health, and the role of the private sector, the voluntary sector and informal caregivers)
On balance, the Social Union Framework Agreement has been a positive step forward for social policy in Canada, though its potential is far from being fully realized.
The CMA’s proposal for a Canadian Health Charter, a Canadian Health Commission and federal legislative review entail significant changes to the governance of Canada’s health system. These changes would be consistent with the Social Union Framework Agreement and would help “turn the corner” from debate to action on health system renewal.
The early, ongoing and meaningful engagement of health care providers is the sine qua non of securing the long-term sustainability of Canada’s health system. Canada’s health professionals, who have the most to contribute, and next to patients – who have the most at stake – must be at the table when the future of health and health care is being discussed.
The CMA’s Assessment of the Social Union Framework Agreement ANNEX
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1. All Canadians to be treated with fairness and equity
2. Promote equality of opportunity for all Canadians
3. Respect for the equality, rights and dignity of all Canadian women and men and their diverse needs
4. Ensure access for all Canadians to essential social programs and services of reasonably comparable quality
5. Provide appropriate assistance to those in need
6. Respect the principles of Medicare: comprehensiveness, universality, portability, public administration and accessibility
7. Promote the full and active participation of all Canadians in Canada’s economic and social life
8. Work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs
9. Ensure adequate, affordable, stable and sustainable funding for social programs
10. Respect Aboriginal treaties and rights
[#4] Progress towards the objective of ensuring access to essential health services of reasonably comparable quality is difficult to assess. First, there is no agreed-upon definition of essential health services. Second there the development of indicators and benchmarks of health care quality is still in its infancy. However, the CMA is very concerned that the system is not headed in the right direction, with growing shortages of physicians, nurses and other health care providers. According to Statistics Canada’s recently released survey on access to health care services, an estimated 4.3 million Canadians reported difficulties accessing first contact services and approximately 1.4 million Canadians reported difficulties accessing specialized services.
[#6]Although there is broad support for the five principles of Medicare, there continue to be a number of longstanding violations of Canada Health Act that are not being addressed, including the portability of medical benefits for Quebec residents. The emergence of privately-owned clinics that charge patients for medically-necessary MRI scans is also cause for concern.
[#8] There is no formal, ongoing mechanism for input from stakeholders and the individual Canadians in debates about national health policy issues. (See also #17 below).
[#9] Ensuring adequate, affordable, and stable funding for Canada’s health system is essential to its long-term sustainability. During the 1990s, billions of dollars were siphoned out of the system to eliminate government deficits. To put Medicare back on a sustainable path, governments must make long-term funding commitments to meet the health care needs of Canadians. The CMA has recommended that the federal government should significantly increase its financial contribution to restore the federal-provincial partnership in health care, and increase accountability and transparency through a new earmarked health transfer.
Mobility within Canada
11. Removal of residency-based policies governing access to social services
12. Compliance with the mobility provisions of the Agreement on Internal Trade
[#11] Residency-based policies are generally not an issue for physician and hospital services, where inter-provincial portability is guaranteed through reciprocal billing arrangements. As noted above, however, the portability of medical benefits for many Quebec residents is limited because the province only reimburses out-of-province services at home-province (as opposed to host-province) rates.
[#12] Regulatory authorities initiated work towards meeting the obligations of the Labour Mobility Chapter of the Agreement on Internal Trade in fall 1999. A Mutual Recognition Agreement has been developed and endorsed by all physician licensing authorities.
Public accountability & transparency
13. Performance measurement and public reporting
14. Development of comparable indicators to measure progress
15. Public recognition of roles and contributions of governments
16. Use funds transferred from another order of government for purposes agreed and pass on increases to residents
17. Ensure effective mechanisms for Canadians to participate in developing social priorities and reviewing outcomes
18. Make eligibility criteria and service commitments for social programs publicly available
19. Have mechanisms in place to appeal unfair administrative practices
20. Report publicly on appeals and complaints
[#13-14] Pursuant to the September 2000 Health Accord, the federal government and provinces have developed common health indicators in 14 areas and have released a first slate of reports. However, the usefulness of these reports is hampered by missing data elements on quality of care (access and waiting times in particular) and the absence of a national roll-up to facilitate inter-provincial comparisons.
[#15] Continuing federal-provincial bickering about shares of health funding makes it clear that this provision is not being met.
[#16] The CMA’s analysis of the Medical Equipment Fund found that incremental spending by provinces on medical technology accounted for only 60% of the $500 million transferred by the federal government for this purpose.
[#17] There is no mechanism in place to ensure ongoing input from Canadians and health care providers in national health policy development. The CMA has recommended the creation of a Canadian Health Commission, with representation from the public and stakeholders to provide advice and input to governments on key national health policy issues.
[#18] Although there have been proposals to this effect in a couple of provinces, governments currently do not make explicit commitments about the quality and accessibility of health services. In order to reduce the uncertainty Canadians are feeling with respect to Medicare, the CMA has recommended the creation of a Canadian Health Charter that would set out the rights and responsibilities of patients, health care providers and governments. In particular, the health charter would require all governments to set out care guarantees for timely access to health services based on the best available evidence.
[#19-20] The Auditor-General recently reported that Health Canada provides inadequate reporting on the extent of compliance with the Canada Health Act.
Governments working in partnership
21. Governments to undertake joint planning and information sharing, and work together to identify priorities for collaborative action
22. Governments to collaborate on implementation of joint priorities when this would result in more effective and efficient service to Canadians.
23. Advance notice prior to implementation of a major policy or program change that will substantially affect another government
24. Offer to consult prior to implementing new social policies and programs that are likely to substantially affect other governments.
25. For any new Canada-wide social initiative, arrangements made with one province/territory will be made available to all provinces/territories.
26. Governments will work with the Aboriginal peoples of Canada to find practical solutions to address their pressing needs
The requirement for governments to work together collaboratively is perhaps the most important part of SUFA, yet there it is impossible for organizations and individuals outside of government to assess the degree to which these provisions have been met. This so-called “black box of executive federalism” is not serving Canadians well. In the health sector, there are too many examples of governments developing policy and making decisions with little or no input from those who will ultimately have to implement change.
To achieve a true social union, the tenets of good collaborative working relationships – joint planning, advance notice and consultation prior to implementation – must be extended beyond the ambit of federal-provincial decision-making. The CMA’s proposal for a Canadian Health Commission would go some distance in addressing these concerns. A key part of its mandate would be to bring the perspective of health providers and patients into national health policy deliberations and decision-making.
Federal spending power
27. Federal government to consult with P/T governments at least one year prior to renewal or significant funding changes in social transfers
28. New Canada-wide initiatives supported by transfers to provinces subject to:
a) collaborative approach to identify Canada wide objectives and priorities
b) Agreement of a majority of provincial governments
c) Provincial discretion to determine detailed design to meet agreed objectives
d) Provincial freedom to reinvest funding in related area if objectives are already met
e) Jointly developed accountability framework
29. For new Canada-wide initiatives funded through direct transfers to individuals or organizations, federal government to provide 3-months notice and offer to consult
There have been three new Canada-wide health initiatives supported by the federal spending power: the $500M Medical Equipment Fund, the $800 Primary Health Care Transition Fund and the $500M fund for health information technology.
The Medical Equipment Fund was created to respond to a genuine need for more modern diagnostic and treatment equipment. However, objectives were vague, money was transferred with no strings attached, and there was no accountability framework. The result, as the CMA’s analysis has shown, is that a significant portion of the funding did not reach its destination.
The jury is still out in the case of the Primary Care Transition Fund. Delivery of this program through normal government machinery will entail a higher degree of accountability than in the case of the Medical Equipment Fund. However, objectives of this initiative may be too broad to have a significant steering effect on the system as a whole.
Canada Infoway Inc. is an arm’s length body created by the federal government to disburse the $500M in health information technology funding. While this model has the advantage of being less politicized than government-run programs; accountability to Parliament and to Canadians is weaker.
Dispute avoidance & resolution
30. Governments committed to working together and avoiding disputes
31. Sector negotiations to resolve disputes based on joint fact-finding, including the use of a third party
32. Any government can require a decision to be reviewed one year after it enters into effect
33. Governments will report publicly on an annual basis on the nature of intergovernmental disputes and their resolution
Federal and provincial governments have agreed to a formal dispute avoidance and resolution process under the Canada Health Act. The Canadian Health Commission recommended by the CMA could play a useful role as an independent fact-finder.
Review of SUFA
34. By the end of the 3rd year, governments will jointly undertake a full review of the Agreement and its implementation. This review will ensure significant opportunities for input and feedback from Canadians and all interested parties, including social policy experts, the private sector and voluntary organizations.
[#34] Governments have taken a minimalist approach to the SUFA review by opting for an internet-based consultation and closed meetings with invited external representatives.
This approach is not sufficient. Future reviews should be more inclusive of all stakeholders.