Health Canada's Response to the Carlin Jury Recommendations Aimed at the Department or Directly Relevant to its Mandate

July 12, 2011

Introduction

Health Canada's top priority is protecting the health and safety of Canadians. The department has a strong record of enhancing drug safety in Canada and is continually looking for ways to strengthen it.

The Department assisted in the inquest proceedings by providing a witness who gave detailed information on how risk communications are developed and what communications have been issued with respect to the use of anti-depressant Paxil and other Selective Serotonin Reuptake Inhibitors.

Health Canada has taken the time needed to thoroughly review the recommendations of the Coroner's Jury and determine the appropriate actions to address them as necessary.

Drug Safety

In Canada, all drugs are subject to the same rigorous assessment before they are made available for sale. Our country has one of the safest and most rigorous drug approval systems in the world; and we have highly qualified professionals and scientists conducting health-risk assessments for drugs that are being approved.

Health Canada's regulations require drug manufacturers to maintain the most up-to-date risk information for each product, so healthcare professionals and patients can make informed decisions about appropriate treatments.

In order to identify public health and safety risks as quickly as possible, Health Canada experts promote adverse reaction reporting domestically by consumers and health professionals. Health Canada experts also collaborate with foreign drug regulatory agencies to increase the effectiveness of safety risk identification.

When safety concerns are identified and cause and effect relationships established, Health Canada takes the appropriate action. This may range from distributing new product safety information to the public and/or the health care community, to directing the manufacturer to change a product's labelling or to stop selling a product.

Risk Communications

Timely and effective risk communication is an essential strategy in maximizing the safety of marketed health products. Health Canada is taking steps to enhance the effectiveness of its risk communication tools and the Department is actively building on its capacity to reach target audiences. To strengthen its capacity to communicate important health product safety information to the health professional audience, Health Canada has developed a process to enable the delivery of urgent risk communications to health professionals and medical institutions on a 24-hour a day basis, as required.

Responsibility for the dissemination of risk information is a shared responsibility among industry, regulators, and health professionals. Health Canada communicates new safety information to healthcare professionals and the public by means of a variety of vehicles, e.g. Health Canada Public Advisories, recall notices, etc. Industry communicates using Health Professional Communication and Public Communications. (see Guidance Document for Industry - Issuance of Health Professional Communications and Public Communications by Market Authorization Holders, Health Canada, 2010).

The Marketed Health Products Directorate is taking a leadership role in developing an overarching strategy for risk communication evaluation across all product lines, including pharmaceuticals, biologics, medical devices, and natural health products. The objective of this strategy is to build on previous efforts while developing a systematic approach to evaluating the effectiveness of Health Canada risk communications.

Initiatives are underway to strengthen the integration of various health information sites and portals such as the MedEffect Canada site and the Consumer Information Portal to facilitate access to safety and recall information for all products. The objective is to develop a one-stop information portal that will bring together the various risk communications issued by Health Canada.

Health Canada is also working to finalize a Departmental policy on Public Access to Health Risk Information to enable a consistent risk communications approach for all product lines within the Department.

MedEffect Canada, launched in 2005, is a Health Canada communications initiative that provides online centralized access to relevant and reliable health product safety information originating from both industry and Health Canada.  The easy-to-find Web site informs and educates Canadians about new health risks associated with marketed health products.

In March 2009, a Social Marketing campaign was launched by Health Canada in an effort to encourage the use of MedEffect Canada by health professionals and consumers for reporting adverse reactions and for accessing the latest health product safety information. The campaign served to remind Canadians that not only can consumers and health professionals report side effects through MedEffect Canada, but they can also find the latest communications about health product safety issues on the MedEffect Canada Web site or receive them automatically by subscribing to the MedEffect e-Notice. In addition to the MedEffect e-Notice, risk communications are also being disseminated using social media tools such as Twitter, RSS Feeds, Widgets and posting of safety videos to the Health Canada Web site and on You Tube. It is very important for health professionals to be aware of these resources because having access to the latest safety information can assist them in helping their patients make informed decisions about the use of health products.

Note: Response Code is a reference system used by the Office of the Chief Coroner Province of Ontario.

Coroner's Jury Recommendation #10

Health Canada

Issuing Regulatory Warnings

In order to maximize the effect of Health Advisories detailing drug-related adverse events, Health Canada should consider that the Health Advisories:

• be succinct
• clearly set out the warning
• should clearly set out the body of evidence giving rise to the warning
• should be specific
• should be profiled in a way to attract physician's attention

Consideration should be given to utilizing knowledge translation experts to assist in providing this information to physicians.

Health Canada Response and Activities to Date

Response Code 1: has been implemented.

Health Canada provides information on health products to both health care professionals and the general public through a variety of risk communication tools such as - Advisories, Information Updates and Foreign Product Alerts for all types of products.

As part of the Food and Consumer Safety Action Plan, the Consumer Information Strategy and Healthy Canadians Web site aims to provide more relevant, timely, consumer friendly, accessible and trustworthy information to Canadians so that they can make informed decisions about their health. To this end, in May 2010, the Department launched a new and simplified Health Canada Advisory template; the new design takes into account advice from Health Canada Expert Advisory Committee on Vigilance of Health Products, and aligns with current formats adopted by international regulators. The enhancements represent a shift from a media-focused format to one that is now more consumer-focused, and which clearly identifies the health risks, Health Canada's actions to address the identified risks, and ways that Canadians can protect themselves from the risks in question. Major formatting revisions include: placing important messages first, and using boxed text and key bullets for quick and easy identification of important safety information. Additionally, enhanced use of plain language ensures clear and easy-to-read titles, in order for busy readers to quickly determine the message's relevance. To further this enhancement, a Departmental reference tool, A Clear Message, was developed for staff to promote consumer-friendly writing and to provide a basis for reviewing health product, food and consumer safety-related information.

In the development of Health Canada-endorsed risk communications about health products (e.g., Health Care Professional and Public Communications, Notices to Hospitals), Health Canada works closely with industry early in the risk communication development process to provide a consistent approach to communicating the most accurate, relevant and complete safety information. In this regard, in 2010, the Health Products and Food Branch published a guidance document for industry, Issuance of Health Professional Communications and Public Communications by Market Authorization Holders (MAH), which provides instructions and templates to assist MAHs in developing and disseminating risk communications. The Templates place emphasis on document format (structure, paragraph order, etc.), use of key bullets in text boxes (to identify critical points), accurate title descriptions, and consistent use of product names (i.e. Brand Name (generic name convention). In 2011 a Fact Sheet on Risk Communication: Protecting Canadians through Information was developed for stakeholders to outline the many different organizations and individuals who play a role in communicating risks associated with the use of health products.

Health Canada continues to monitor and evaluate the effectiveness of its health product safety and risk communication tools and dissemination methods. By regularly engaging stakeholders and expert groups through consultations as well as public surveys, Health Canada has been able to collect important data to inform the Department of the effectiveness of current methods used to communicate drug safety information and to identify areas where the Department needs to make improvements. Preliminary testing (2008) on 21 Health Canada - issued/endorsed public communications revealed that an average grade level of 16 (graduate school education) was required to read and understand the text.

Recent activities to evaluate the effectiveness of risk communications include:

• Health Canada's plan to evaluate the effectiveness of its new Public Advisory (PA) template in reducing the health literacy burden on Canadians. Health Canada will work with knowledge translation experts in this evaluation process.
• All health product Public Advisories issued by Health Canada 6 months prior to and 6 months following use of the new template will be assessed using a variety of readability tests (Flesch Reading Ease Test, Flesch Reading Grade level, Gunning Fog Index, SMOG etc.) to assess changes in the reading grade level required to read and understand the text.
• Data are being collected to determine whether health professionals' prescribing and utilization practices have changed based on information provided in 'Dear Health Professional Letters' issued and/or endorsed by Health Canada.

A strategy and evaluation framework for measuring the effectiveness of health product risk communications issued by the Health Products and Food Branch of Health Canada is being developed. This evaluation strategy will look into issues/questions about the effectiveness of risk communications such as: Are the risk communication tools reaching their intended target population? Do the risk communication tools bring about the action intended? Do the risk communication tools benefit the intended user?

Coroner's Jury Recommendation #11

Health Canada

Drug Manufacturers Reporting Clinical Trials with Negative Results

Health Canada, as a regulator of companies seeking drug approval, should make their approval contingent on receiving results of all clinical trials from the drug manufacturers.

Health Canada Response and Activities to Date

Response Code 2: under consideration.

Enhancing Health Canada's ability to obtain all relevant information about drugs, including clinical trial information, is part of an initiative investigating regulatory modernization options so that assessments on drug products are as thorough as possible.

Between October 2010 and January 2011, the Department held a series of technical discussions with stakeholders on regulatory modernization for therapeutic products (drugs and medical devices). These sessions were designed to test and validate proposed activities related to the regulation of a product throughout its lifecycle. The sessions covered a broad range of topics, including pre-market submission requirements for drugs, transparency and information sharing, and post-market authorities. The proposals introduced for discussion at these sessions included pre-market requirements for manufacturers to submit information on all clinical trials performed on the drug and post-market authorities to request information from manufacturers, such as the results of clinical trials conducted in a post-market environment. The feedback received from these sessions is currently being analysed and will inform future development of regulations.

Health Canada will continue to engage stakeholders, international partners and the public, particularly on the subject of transparency, trials results and the provision of information to the public. Regulatory modernization projects would proceed through the Canada Gazette process, where all parties will have the opportunity to consider and comment on proposed regulations.

Coroner's Jury Recommendation #12

The Regulated Professionals

Reporting of Serious Adverse Drug Reactions

All colleges legislated under the Regulated Health Professions Act, 1991 should require mandatory reporting to Health Canada by its members of serious drug-related adverse events as defined by Health Canada.

Health Canada's Comments

Not Assigned to Health Canada.

Currently, reporting of adverse drug reactions in Canada consists of two components: reporting by manufacturers on a mandatory basis in accordance with the federal Food and Drug Regulations; and reporting by health professionals, patients/consumers, health facilities on a voluntary basis, through either the drug manufacturer or directly to Health Canada.

Although this recommendation was not directed at the Department, it is consistent with current Health Canada efforts to increase reporting rates and the Department's examination of the feasibility and advantages of a hospital-based reporting system as a better way to address the key reporting barriers and increase the reporting of serious adverse reactions related to federally regulated pharmaceuticals.  In 2005, Health Canada began consultations on a set of preliminary issues associated with creating a mandatory adverse reaction reporting system for all health professionals. Overall, input from the provinces and territories, health professionals, industry, international regulatory bodies and the Canadian public did not support the use of mandatory reporting by all health professionals as an effective method to address the under-reporting of adverse reactions. Many stakeholders were concerned about the inability of a broad regulatory requirement to directly address the principle barriers to reporting. However, feedback received revealed the potential advantages of a more targeted and practical approach such as a requirement for health care institutions to report serious adverse reactions. Most serious adverse reactions result in visits to health care institutions such as hospitals. The Department believes that these institutions are in a position to play a unique role in the detection and reporting of serious adverse reactions.

In 2007/08 Health Canada had further discussions with the provinces and territories regarding the proposal for a hospital-based mandatory reporting system and will consult with other key stakeholders as the proposal develops.

The Department has also undertaken a number of non-regulatory initiatives to encourage and facilitate adverse reaction reporting by health professionals. For example, Health Canada has made it as simple and efficient as possible for health professionals to complete and file reports, developed educational modules, and enhanced the promotional role of the regional offices while building awareness about the importance of reporting adverse reaction reports to Health Canada, and how this information is used to identify and communicate potential risks.

As follow-up to one of the recommendations from provinces and territories during the 2007/08 bilateral meetings, Health Canada has also initiated work with Accreditation Canada to develop adverse reaction reporting standards as part of their accreditation system for Canadian hospitals. The standards are expected to be integrated into Accreditation Canada's program by September 2012.

Coroner's Jury Recommendation #15

Canadian Drug Manufacturer's Association

Reporting of Serious Adverse Drug Reactions

Drug companies should be required to report to Health Canada all serious adverse events associated with their drugs from all foreign jurisdictions within thirty (30) days of the adverse event.

Health Canada's Comments

Not assigned to Health Canada.

In accordance with the Food and Drug Regulations, manufacturers must report all foreign serious unexpected adverse reactions to Health Canada within 15 days after becoming aware of the information. This regulatory requirement is in line with the requirements of our international counterparts including the United States Food and Drug Administration and the European Union, and with established international standards.

A recent regulatory amendment registered February 2011 to the Food and Drug Regulations gives stronger powers to the Minister of Health for the purposes of assessing the safety and effectiveness of a drug. It requires manufacturers to notify the Minister when they identify significant safety signals in preparing their annual summary reports, and clarifies the Minister's authority to obtain case reports or summary reports of adverse reactions. It also specifies that manufacturers are expected to maintain records of these reports for 25 years.

In addition to the information available as a result of foreign adverse reaction reporting requirements, Health Canada actively communicates with other regulatory agencies for information gathering and sharing purposes. For example, Health Canada participates every two months in a teleconference with 3 other regulatory agencies to discuss product safety issues of common interest: the United States Food and Drug Administration (US-FDA), the Australian Therapeutic Goods Administration (TGA) and New Zealand Medicines and Medical Devices Safety Authority, Medsafe program.

Coroner's Jury Recommendation #16

Canadian Federal Government

Drug Safety Board

There should be an arm's length body independent from Health Canada called the Drug Safety Board which is solely dedicated to drug safety, which reports to Parliament, which is funded by the Federal Government and which receives no money from drug companies. Amongst its mandated responsibilities should be drug safety research, investigating adverse reactions and issuing warnings to the public and healthcare professionals and hospitals.

Health Canada Response and Activities to Date

Response Code 8: Content or intent of recommendation is already in place

Canada has one of the safest and most rigorous health product approval systems in the world. We have highly qualified professionals and scientists monitoring the benefit-to-risk profile of these products available to Canadians on an ongoing basis.

Health Canada agrees that there is a need for a separate and dedicated focus on the pre- and post-market assessment of health products, thus the creation of the Marketed Health Products Directorate (MHPD) in 2002. With its own budget, MHPD is responsible solely for post-market surveillance of health products including drugs and has developed focussed activities and expertise in this area that is separate from pre-market review. This approach is consistent with that of other regulatory authorities around the world. Between 2005 and 2007, MHPD's full-time staff more than doubled to reflect its increasing importance and responsibilities in monitoring the post-market safety of drugs and other health products. The Food and Consumer Safety Action Plan invested in additional post-market surveillance activities, such as the review of pharmacovigilance plans, periodic safety update reports, and risk management plans. In the current context and regulatory framework, MHPD works effectively to address safety risks in a timely manner.

In 2009 the Government of Canada committed $32 million over the first five years, and $10 million per year thereafter to establish the Drug Safety and Effectiveness Network (DSEN). Implemented within the Canadian Institute for Health Research (CIHR), the DSEN will support independent research on the safety and effectiveness of drugs in the marketplace. The outcomes of this research will enhance decision-making by regulators, policy-makers, health care providers and patients.