The Canadian Medical Association (CMA) welcomes the opportunity to provide comments to the Senate Committee on Legal and Constitutional Affairs concerning its study of Bill C-2 (An Act to amend the Criminal Code and to make consequential amendments to other Acts). We will confine our comments to the portion of the proposed legislation that relates to impaired driving.
Canada's physicians support measures aimed at reducing the incidence of drug-impaired driving. We believe impaired driving, whether by alcohol or another drug, to be an important public health issue for Canadians that requires action by all governments and other concerned groups.
Published reports indicate that the prevalence of driving under the influence of cannabis is on the rise in Canada. We note that:
* Results from the Canadian Addictions Survey suggest that 4% of the population have driven under the influence of cannabis in the past year, an increase from the 1.5% in 2003 and that rates are higher among young people.1
* It was estimated that in 2003, 27.45% of traffic fatalities involved alcohol, 9.15% involved alcohol and drugs, and 3.66% involved drugs alone while 13.71% of crash injuries involved only alcohol, 4.57% involved alcohol and drugs, and 1.83% involved drugs alone.2
* In a 2002 survey, 17.7% of drivers reported driving within 2 hours of using a prescribed medication, over-the-counter remedy, marijuana, or other illicit drug during the past 12 months.
* These results suggest that an estimated 3.7 million Canadians drove after taking some medication or drug that could potentially affect their ability to drive safely.
* The most common drugs used were over-the-counter medications (15.9%), prescription drugs (2.3%), marijuana (1.5%), and other illegal drugs (0.9%).
* Young males were most likely to report using marijuana and other illegal drugs.
* While 86% of the drivers were aware that a conviction for impaired driving results in a criminal record, 66% erroneously believed that the penalties for drug-impaired driving were less severe than those for alcohol-impaired driving. In fact, the penalties are identical.
* Over 80% of drivers agreed that drivers suspected of being under the influence of drugs should be required to participate in physical coordination testing for drug impairment. However, only about 70% of drivers agreed that all drivers involved in a serious collision or suspected of drug impairment should be required to provide a blood sample.3
The CMA has, on several occasions, provided detailed recommendations on legislative changes concerning impaired driving. In 1999, the CMA presented a brief to the House of Commons Standing Committee on Justice and Human Rights during its review of the impaired driving provisions of the Criminal Code. While our 1999 brief focused primarily on driving under the influence of alcohol, many of the recommendations are also relevant to the issue of driving under the influence of drugs.
In June 2007, the CMA provided comments to the Standing Committee on Justice and Human Rights of the House of Commons during their study of Bill C-32 (An Act to amend the Criminal Code (impaired driving) and to make consequential amendments to other Acts) which was later incorporated in the omnibus Bill now before your Committee.
Last year, the CMA published the 7th edition of its guide, Determining Medical Fitness to Operate Motor Vehicles. It includes chapters on the importance of screening for alcohol or drug dependency and states that the abuse of such substances is incompatible with the safe operation of a vehicle. This publication is widely viewed by clinical and medical-legal practitioners as the authoritative Canadian source on the topic of driver competence.
While changing the Criminal Code is an important step, the CMA believes further actions are also warranted. In our 2002 presentation to the Special Senate Committee on Illegal Drugs, the CMA put forth our long standing position regarding the need for a comprehensive long-term effort that incorporates both deterrent legislation and public awareness and education campaigns. We believe such an approach, together with comprehensive treatment and cessation programs, constitutes the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers.
Drug-impaired drivers may be occasional users of drugs or they may also suffer from substance dependence, a well-recognized form of disease. Physicians should be assisted to screen for drug dependency, when indicated, using validated instruments. Government must create and fund appropriate assessment and treatment interventions.
Physicians can assist in establishing programs in the community aimed at the recognition of the early signs of dependency. These programs should recognize the chronic, relapsing nature of drug addiction as a disease, as opposed to simply viewing it as criminal behaviour.
While supporting the intent of the proposed legislation, the CMA urges caution on several significant issues, with regard to Clause 20 that amends the act as follows:
254.1 (1) The Governor in Council may make regulations
(a) respecting the qualifications and training of evaluating officers;
(b) prescribing the physical coordination tests to be conducted under paragraph 254(2)(a); and
(c) prescribing the tests to be conducted and procedures to be followed during an evaluation under subsection 254(3.1).
CMA contends that it is important that medical professionals and addiction medicine specialists in particular, should be consulted regarding the training offered to officers to conduct roadside assessment and sample collection.
Provisions in the Act conferring upon police the power to compel roadside examination raises the important issue of security of the person and the privacy of health information. As well, information obtained at the roadside is personal medical information and regulations must ensure that it be treated with the same degree of confidentiality as any other element of an individual's medical record. Thus, the CMA would respectfully submit that Clause 25 of Bill-C2 on the issue of unauthorized use or disclosure of the results needs to be strengthened because the wording is too broad, unduly infringes privacy and shows insufficient respect for the health information privacy interests at stake.
For instance, clause 25(2) would permit the use, or allow the disclosure of the results "for the purpose of the administration or enforcement of the law of a province". This latter phrase needs to be narrowed in its scope so that it would not, on its face, encompass such a broad category of laws.
Moreover, clause 25(4) would allow the disclosure of the results "to any other person, if the results are made anonymous and the disclosure is made for statistical or other research purposes" CMA would expect the federal government to exercise great caution in this instance, particularly since the results could concern individuals who are not actually convicted of an offence.
One should query whether the Clause 25(4) should even exist in a Criminal Code as it would not appear to be a matter required to be addressed. If it is, then CMA would ask the government to conduct a rigorous privacy impact assessment on these components of the Bill, studying in particular, such matters as sample size, degree of anonymity, and other privacy related issues, especially given the highly sensitive nature of the material.
CMA would ask whether clause 25(5) should specify that the offence for improper use or disclosure should be more serious than a summary conviction. Finally, it is important to base any roadside testing methods and threshold decisions on robust biological and clinical research.
CMA also notes with interest Clause 21, specifically the creation of a new offence of being "over 80" (referring to 80mg of alcohol in 100ml of blood, or a .08 blood alcohol concentration level or BAC) and causing an accident that results in bodily harm which will carry a maximum sentence of 10 years and life imprisonment for causing an accident resulting in death. (Clause 21)
We would also urge the Committee to take the opportunity that the review of this proposed legislation provides to recommend to Parliament a lower BAC level. Since 1988 the CMA has supported 50 mg% as the general legal limit. Studies suggest that a BAC limit of 50 mg% could translate into a 6% to 18% reduction in total motor vehicle fatalities or 185 to 555 fewer fatalities per year in Canada.4 A lower limit would recognize the significant detrimental effects on driving-related skills that occur below the current legal BAC.5
In our 1999 response to the Standing Committee on Justice and Human Rights' issue paper on impaired driving6 and again in 2002 when we joined forces with Mothers Against Drunk Driving (MADD), CMA has consistently called for the federal government to reduce Canada's legal BAC to .05. Canada continues to lag behind countries such as Austria, Australia, Belgium, Denmark, France and Germany, which have set a lower legal limit. 7
CMA expressed the opinion that injuries and deaths resulting from impaired driving must be recognized as a major public health concern. Therefore we once again recommend lowering the legal BAC limit to 50 mg%. or .05%.
We also wanted to note our support for Clause 23 which addresses the issue of liability by extending the existing umbrella of immunity for qualified medical practitioners to the new provision under 254(3.4)
23. Subsection 257(2) of the Act is replaced by the following:
(2) No qualified medical practitioner by whom or under whose direction a sample of blood is taken from a person under subsection 254(3) or (3.4) or section 256, and no qualified technician acting under the direction of a qualified medical practitioner, incurs any criminal or civil liability for anything necessarily done with reasonable care and skill when taking the sample.
Finally, CMA believes that comprehensive long-term efforts that incorporate deterrent legislation, such as Bill C-2, must be accompanied by a public awareness and education strategy. This constitutes the most effective long-term approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers. The CMA supports this multidimensional approach to the issue of the operation of a motor vehicle regardless of whether impairment is caused by alcohol or drugs.
Again, the CMA appreciates the opportunity to provide input into the legislative proposal on drug-impaired driving. We stress that these legislative changes alone would not adequately address the issue of reducing injuries and fatalities due to drug-impaired driving, but support their intent as a partial, but important measure.
Brian Day, MD
1 Bedard, M, Dubois S, Weaver, B. The impact of cannabis on driving, Canadian Journal of Public Health, Vol 98, 6-11, 2006
2 G. Mercer, Estimating the Presence of Alcohol and Drug Impairment in Traffic Crashes and their Costs to Canadians: 1999 to 2003 (Vancouver: Applied Research and Evaluation Services, 2005).
3 D. Beirness, H. Simpson and K. Desmond, The Road Safety Monitor 2002: Drugs and Driving (Ottawa: Traffic Injury Research Foundation, 2003). Online: www.trafficinjuryResearch.com/whatNew/newsItemPDFs/RSM_02_Drugs_and_ Driving.pdf
4 Mann, Robert E., Scott Macdonald, Gina Stoduto, Abdul Shaikh and Susan Bondy (1998) Assessing the Potential Impact of Lowering the Blood Alcohol Limit to 50 MG % in Canada. Ottawa: Transport Canada, TP 13321 E.
5 Moskowitz, H. and Robinson, C.D. (1988). Effects of Low Doses of Alcohol on Driving Skills: A Review of the Evidence. Washington, DC: National Highway Traffic Safety Administration, DOT-HS-800-599 as cited in Mann, et al., note 8 at page 12-13
6 Proposed Amendments to the Criminal Code of Canada (Impaired Driving): Response to Issue Paper of the Standing Committee on Justice and Human Rights. March 5, 1999
7 Mann et al
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.
Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
By 2015, e-prescribing will be the means by which prescriptions are generated for Canadians.
e-Prescribing is the secure electronic creation and transmission of a prescription between an authorized prescriber and a patient's pharmacy of choice, using clinical Electronic Medical Record (EMR) and pharmacy management software.
Health Information Technology (HIT) is an enabler to support clinicians in the delivery of health care services to patients. The Canadian Medical Association (CMA) and the Canadian Pharmacists Association (CPhA) each have identified e-prescribing as a key tool to deliver better value to patients. The integration of HIT into clinics and health care facilities where physicians and pharmacists provide care is a priority for both associations1.
As part of its Health Care Transformation initiative, the CMA highlighted the need to accelerate the introduction of e-prescribing in Canada to make it the main method of prescribing. In its policy on optimal prescribing the CMA noted that one of the key elements was the introduction of electronic prescribing. The CPhA, as part of its Blueprint for Pharmacy Implementation Plan, highlights information and communication technology, which includes e-prescribing, as one of five priority areas.
We applaud the ongoing efforts of Canada Health Infoway, provinces and territories to establish Drug Information Systems (DIS) and the supporting infrastructure to enable e-prescribing. We urge governments to maintain e-prescribing as a priority and take additional measures to accelerate their investments in this area.
It is our joint position that e-prescribing will improve patient care and safety. e-Prescribing, when integrated with DIS, supports enhanced clinical decision-making, prescribing and medication management, and integrates additional information available at the point of care into the clinical workflow.
The following principles should guide our collective efforts to build e-prescribing capability in all jurisdictions:
* Patient confidentiality and security must be maintained
* Patient choice must be protected
* Clinicians must have access to best practice information and drug cost and formulary data
* Work processes must be streamlined and e-prescribing systems must be able to integrate with clinical and practice management software and DIS
* Guidelines must be in place for data sharing among health professionals and for any other use or disclosure of data
* The authenticity and accuracy of the prescription must be verifiable
* The process must prevent prescription forgeries and diversion
* Pan-Canadian standards must be set for electronic signatures
Benefits of e-Prescribing
A number of these benefits will be realized when e-prescribing is integrated with jurisdictional Drug Information Systems (DIS).
o Improves patient safety and overall quality of care
o Increases convenience for dispensing of new and refill prescriptions
o Supports collaborative, team-based care
o Supports a safer and more efficient method of prescribing and authorizing refills by replacing outdated phone, fax and paper-based prescriptions
o Eliminates re-transcription and decreases risk of errors and liability, as a prescription is written only once at the point-of-care
o Supports electronic communications between providers and reduces phone calls and call-backs to/from pharmacies for clarification
o Provides Warning and Alert systems at the point of prescribing, supporting clinician response to potential contraindications, drug interactions and allergies
o Facilitates informed decision-making by making medication history, drug, therapeutic, formulary and cost information available at the point of prescribing
* Health Care System:
o Improves efficiency and safety of prescribing, dispensing and monitoring of medication therapy
o Supports access to a common, comprehensive medication profile, enhancing clinical decision-making and patient adherence
o Increases cost-effective medication use, through improved evidence-based prescribing, formulary adherence, awareness of drug costs and medication management
o Improves reporting and drug use evaluation
While evidence of the value of e-prescribing is established in the literature, its existence has not fostered broad implementation and adoption. In Canada, there are a number of common and inter-related challenges to e-prescribing's implementation and adoption. These include:
* Improving access to relevant and complete information to support decision-making
* Increasing the level of the adoption of technology at the point of care
* Focusing on systems-based planning to ensure continuum-wide value
* Integrating e-prescribing into work processes to gain support from physicians, pharmacists and other prescribers
* Increasing leadership commitment to communicate the need for change, remove barriers and ensure progress
* Updating legislation and regulation to support e-prescribing
Enabling e-Prescribing in Canada
CMA and CPhA believe that we can achieve the vision that is set out in this document and address the aforementioned challenges by working collectively on five fronts:
* Health care leadership in all jurisdictions and clinical organizations must commit to make e-prescribing a reality by 2015
* Provinces and territories, with Canada Health Infoway, must complete the building blocks to support e-prescribing by increasing Electronic Medical Record (EMR) adoption at the point of care, finishing the work on the Drug Information Systems (DIS) in all jurisdictions and building the connectivity among the points of care and the DIS systems
* Pharmacist and medical organizations in conjunction with provinces, territories and Canada Health Infoway must identify clear benefits for clinicians (enhancing the effectiveness of care delivery and in efficiencies in changing workflows) to adopt e-prescribing and focus their efforts on achieving these benefits in the next three years
* Provinces, territories and regulatory organizations must create a policy/regulatory environment that supports e-prescribing which facilitates the role of clinicians in providing health care to their patients
* Provinces and territories must harmonize the business rules and e-health standards to simplify implementation and conformance by software vendors and allow more investment in innovation.
1 Health Care Transformation in Canada, Canadian Medical Association, June 2010; Blueprint for Pharmacy Implementation Plan, Canadian Pharmacists Association, September 2009