A joint body should be created with representatives from Health Canada, provincial Ministries of Health, College of Physicians and Surgeons, College of Pharmacy, the pharmaceutical companies and consumer interest groups in order to examine the efficacy of the information delivery system among all concerned parties relating to the safe and effective use of drug products. This joint body should review all communication tools and techniques such as product monographs, warning letters, media releases, and fact sheets used to inform health care professionals and the general public with a view to improving and standardizing this procedure. This body should report its findings including any recommendations for improvement to the Coroner within one year of the date of this verdict.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Communicating Drug Safety Information Workshop (November 2001)

Health Canada responded to this recommendation for a joint body by convening a group as suggested on November 29-30, 2001, with representatives from the pharmaceutical industry, health professional associations, consumer interest groups, and regulatory authorities, to discuss how to enhance the reporting and distribution of adverse event information.

Participants identified partnership opportunities to assist them in the sharing and communication of drug safety information. Participants also noted one key challenge is finding ways to integrate safety information into daily professional practice; that is, getting the right (tailored) information into the right (targeted) hands at the right (point of care) time.

Final summary report (PDF Version) with suggested next steps to be posted on the Health Canada website.

Health Canada to reconvene this group to further pursue issues related to enhanced reporting and distribution of adverse event information.

August 2002

Fall 2002/Winter 2003

The Canadian Coalition on Medication Incident Reporting and Prevention

This coalition is comprised of: Marketed Health Products Directorate, Health Products and Foods Branch, Health Canada, Canadian Association of Chain Drug Stores, Canadian Healthcare Association, Canadian Institute for Health Information, Canadian Nurses Association, Canadian Pharmacists Association, Canada's Research Based Pharmaceutical Companies, Canadian Society of Hospital Pharmacists, Consumers Association of Canada, Institute for Safe Medication Practices Canada, The Royal College of Physicians and Surgeons of Canada, and Canadian Medical Association.

Chaired by Health Canada this coalition has produced a proposed Business Plan for a Canadian Medication Incident Reporting and Prevention System (CMIRPS).

The desired outcome is the implementation of a system that aims at reducing harm caused by preventable medication incidents.

The purpose of the proposed CMIRPS is to coordinate the capture, analysis and dissemination of information on medication incidents; enhance the safety of the medication use system for Canadians; and support the effective use of resources through the reduction of potential or actual harm caused by preventable medication incidents.CMIRPS intends to:

• collect and analyze standardized data on medication incidents;
• facilitate the implementation of standardized reporting of medication incidents;
• develop and disseminate timely and targeted information designed to reduce the risk of medication incidents; and,
• develop and disseminate information on best practices in safe medication use systems.

The Draft Business Plan identifies nine important issues to be further developed in order to present a more detailed Plan for such a system. This includes a more detailed definition of proposed governance and management models for a CMIRPS, as well as more detailed definition of funding options for such a program.

Preparation of a plan of action that will allow the Coalition to finalize the business plan for the proposed CMIRPS. As noted below, the CMIRPS Report is being distributed to over 40 health care organizations and individuals to inform them of the Coalition's work and seek support for the proposed initiative.

The Coalition intends to coordinate work on CMIRPS with the National Steering Committee on Patient Safety's efforts to address the overarching issue of patient safety.

Action Plan to be developed in September 2002 to address outstanding questions raised in the proposed business plan.

Enhanced Linkages with Health Care Related Associations

Family Physicians and Surgeons
Health Canada held a meeting on June 19, 2001 with the College of Family Physicians of Canada and the Royal College of Physicians and Surgeons of Canada to further discuss the Colleges's interest in incorporating new risk information into their Professional development/maintenance of competency programme (MOCOMP) for physicians.

As part of this program in the fall of 2001, the Royal College initiated a new Internet portal, MAINPORT, for specialists to record and manage their continuing professional development activities that are required for them to maintain their certification.

As of November 2001, following discussions with Health Canada, this portal carries links to the Canadian Adverse Reaction Newsletter and other HC resource sites thereby increasing access to information relating to the safe and effective use of drug products for physicians and surgeons using the Royal College site.

Arthritis Society of Canada
Health Canada is working with the Arthritis Society of Canada on a project that is looking at the development of a national patient-centred surveillance system to enhance reporting and distribution of adverse event information.

The Canadian Pediatric Surveillance Program, a proposed project with the Canadian Pediatric Society, will collect information from 2300 pediatricians and sub-specialists on a monthly basis. The focus of reporting is serious and life-threatening Adverse Drug Reactions (ADRs) in children and youth 0-18 years of age. In addition to the reporting of information, physicians will be sent educational information concerning adverse drug reactions on a monthly basis in a form known as "tips of the month".

This is an ongoing program. Health Canada databases will continue to be updated to ensure the linked information is the most up to date available for health care professionals.

Discussions ongoing regarding potential project plan.

Discussions ongoing

March 2003

March 2003

Work with Provinces and Territories

Health Canada has been and continues to work with provincial and territorial partners on other initiatives to enhance the safe and effective use of drug products.

The National Prescription Drug Utilization Information System will quantify the extent of use of drug products, informing decision makers of the extent of the problem, once a problem with a particular drug product is identified.

The Common Drug Review Initiative will result in a single review of drugs for formulary listing and common listing recommendations for consideration by participating jurisdictions. This reduces duplication of existing provincial and territorial drug reviews and will ensure a high level of rigour in the therapeutic reviews of drugs.

This initiative has been approved and is currently being put into operation by the Patented Medicine Prices Review Board and the Canadian Institute for Health Information.

Federal, provincial and territorial Ministers of Health are anticipated to consider approval of this initiative at their September 2002 meeting. This initiative is ongoing.

Ongoing

September 2002 - approval by Ministers of Health

In the interim:
Health Canada mandate pharmaceutical companies to clearly indicate information relating to adverse effects/ contra-indications on documents such as product monograph (PM), promotional material and prescribing information.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Enhancing Product Monographs

Currently, the content and format of the product monograph is outlined in the Product Monograph guidance document last revised in 1990.

The product monograph is produced by the manufacturer and submitted to Health Canada as part of the New Drug Submission Process. Health Canada reviews the information submitted, including the product monograph, to determine whether the drug complies with the regulatory requirements outlined in the Food and Drug Regulations. These requirements speak specifically to the safety, quality and efficacy of the drug.

The proposed new format for the Product Monograph will include the following changes:

• the Adverse Drug Reaction section of the product monographs is being standardized and expanded to include even more comprehensive information about the risks posed by drugs; and,
• a consumer information section has been added to the product monograph to include a list of possible side effects related to a drug.

Nation wide public focus groups were held in September 2001. A revised Guidance Document and Product Monograph Template were developed in December 2001. These documents are intended to guide pharmaceutical companies on how to develop the new product monograph. The documents have undergone internal consultation (January - February 2002) and have been tested with pharmaceutical industry representatives to determine their usability and readability (June 2002).

Communicate with stakeholders and conduct public consultation on the revised Guidance Document and Product Monograph Template (targeted mail-out and web posting).

Finalize Guidance Document and Product Monograph Template.

Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

September - October 2002

December 2002

Ongoing - results expected in early 2003

Advertising Standards Canada (ASC) and Pharmaceutical Advertising Advisory Board

Drug advertisements are reviewed and pre-cleared by independent agencies endorsed by Health Canada to pre-clear promotional material to health professionals for all drugs. These are the Advertising Standards Canada (ASC) and the Pharmaceutical Advertising Advisory Board (PAAB). ASC reviews advertising material for non-prescription drugs directed to consumers, while PAAB reviews advertisements for all drugs directed to health professionals. ASC and PAAB review and pre-clear advertising material in order to determine compliance with the regulatory provisions of the Food and Drug Act and Regulations and various codes of advertising.

Health Canada is the national regulatory authority for drug advertisements. The Department may intervene when an advertisement poses a significant safety concern, in the event that resolution is not achieved through the independent agencies' complaints mechanism, or when an unauthorized drug product is promoted. In addition, Health Canada sets the standards for drug advertising and develops policies and guidelines for regulations. Although it is not mandatory, various manufacturer associations support pre-clearance by ASC and PAAB. Health Canada strongly encourages all sponsors to comply with voluntary pre-clearance review prior to exposure to health care professionals and consumers.

Ongoing

Ongoing

In the interim:
All Dear Health Care Professional (DHCP) letters should be approved and issued by Health Canada in conjunction with the pharmaceutical companies. These letters should highlight any new information relating to adverse effect or contraindications of any drug product. These letters should be sent immediately in a form that clearly identifies the information as important drug safety information.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Dear Health Care Professional Letters

When Health Canada considers it necessary, manufacturers are directed to prepare Dear Health Care Professional Letters. These are then approved by Health Canada. The target for these letters is health care professionals. Distribution could include physicians, dentists, veterinarians, pharmacists, hospitals and others. The distribution list will be tailored to the safety issue being addressed.

Currently Health Canada works actively with the manufacturer on Dear Health Care Professional letters, taking a proactive role in ensuring they are issued when there is a need. These letters are issued either by the manufacturer independently or by the manufacturer in response to instructions from Health Canada or by Health Canada independently.

Most Dear Health Care Professional Letters produced by the manufacturer are provided to Health Canada. The Department then reviews and publishes them, with a disclaimer, on the Departmental website as a service to health care professionals and consumers.

Developing Standard Operating Procedures for Dear Health Care Professional Letters
In order to ensure that new information relating to adverse effects or contraindications of a drug product are clearly and quickly identified, draft Standard Operating Procedures have been developed to initiate the issuance of Dear Health Care Professional letters from manufacturers. These procedures are used by Health Canada officials to communicate our expectations in letters to the manufacturer requesting the issuance of a Dear Health Care Professional letter.

This is an ongoing activity.

These draft Standard Operating Procedures will be provided to industry and other interested parties for review and input with the intent that they will be converted into a guidance document for manufacturers.

Ongoing

Guidance Document: March 2003

Enhancing effectiveness of Dear Health Care Professional Letters
Recent enhancements to the procedures include:

• sending letters in envelopes that say: "Important New Safety Information Concerning (Product X)"; and
• including a boxed warning at the top of the first page of the letter that reads "Important Safety Information" to attract attention.

Mechanisms to enhance the effectiveness of Dear Health Care Professional letters were discussed at the November 2001 Communicating Drug Safety Information Workshop and will be pursued in future discussions with industry, health professionals and consumer groups. As a result of the meeting the following changes were made:

• posting Dear Health Care Professional letters, warnings and public advisories on the main Health Canada website and the Therapeutic Products Directorate (TPD) website (manufacturers are being encouraged to post these notices on their websites as well); and,
• publishing quarterly summaries of Dear Health Care Professional letters and advisories in the Canadian Adverse Reactions Newsletter .

A statement similar to the following should be included in all correspondence relating to the product monographs or changes to product monographs: due to varied regulations in some jurisdictions, numbers of officially reported adverse reactions represent only a small fraction of actual reactions. As only a small portion of suspected adverse reactions are usually reported, caution should be exercised in estimating the incidence of adverse reactions.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Product Monographs

The issue of precautionary statements was raised at an April 2001 session held with consumer, patient, industry, and health professional representatives to discuss user requirements for information contained in the Product Monograph.

Precautionary statements for consumers will be built into the new standardized format of the product monograph and clearly identified on the website and other relevant documents.

See timelines for the Product Monograph Project in response to Recommendation 2a.

Dear Health Care Professional Letters

The requirement for similar precautionary statements has been included in new draft Standard Operating Procedures for preparing Dear Health Care Professional letters. The suggested statement reads: "Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with [drug treatment/medical device use]" This statement has already been incorporated into many Dear Health Care Professional letters.

Draft Standard Operating Procedures will be provided to industry and other interested parties for review and input with the intent that they will be converted into a guidance document for manufacturers.

March 2003

Information in Newsletters

Canadian Adverse Reactions Newsletter
The Canadian Adverse Reactions Newsletter, which is distributed to physicians through the Canadian Medical Association Journal (CMAJ), the Health Canada web site and other means, now contains a similar precautionary statement. The statement reads: "Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain under-reported and patient exposure is unknown."

Ongoing

Ongoing

Office of Consumer Affairs and Public Involvement (OCAPI) Newsletter

A piece has been developed for the September version of the OCAPI Newsletter entitled "Involving You" to advertise the Canadian Adverse Reaction Newsletter and let people know how they can subscribe to the newsletter. This will reach approximately 800 consumer organizations across Canada.

NOTE: The Office of Consumer Affairs and Public Involvement is part of the Health Products and Food Branch of Health Canada.

September 2002

Pharmaceutical companies should continue to use a multi-faceted approach to communicate new risk information to health care professionals. For example: Dear Health Care Professional Letters, promotional brochures with a balanced message, detail/sales representatives visits to physicians, continuing medical education programs with key opinion leaders, web-based materials, information telephone lines, etc.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Information Sources at Health Canada

All Health Canada work in this area will continue to support and facilitate the adoption of a multi-faceted approach by the industry in communicating risk information.Currently, new drug safety information is available through:

• the Health Canada website
• Dear Health Care Professional Letters;
• the Canadian Adverse Reaction Newsletter;
• public advisories and warnings; and,
• information provided through many other Departmental publications and communications materials.

Health care professionals and others can subscribe to a listserv service called Health _Prod_ Info where they will receive up to date information, electronically via e-mail as soon as it is available, including warnings, advisories, the newsletter and other relevant drug safety information. Address for subscription.

Ongoing

Ongoing

Work with Professional Associations

Health Canada has communicated this recommendation to pharmaceutical associations representing manufacturers through regular meetings between the Department and pharmaceutical associations.Health Canada uses the opportunity of regular bilateral meetings with pharmaceutical associations representing manufacturers to make them aware of and encourage the use of the variety of approaches available.

Ongoing

Ongoing

It should be mandatory for health care professionals to forward to Health Canada information on all serious adverse drug reactions within 48 hours. Definition of a serious adverse drug reaction - a noxious and unintended response to a drug that occurs at any dose and that requires inpatient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Enhancing the Current System for Adverse Reaction and Medication Incident Reporting

Current regulations require that manufacturers report serious adverse drug reactions to Health Canada.

Health care professionals and the practice of medicine are regulated by provincial authorities independent of provincial governments.

The Marketed Health Products Directorate is continuously seeking more effective ways to strengthen its ability to detect drug safety problems in a timely manner. That ability largely depends on the timely reporting of suspected adverse drug reactions by health professionals either through the drug manufacturer or directly to Health Canada. However, the effectiveness of the system is compromised by low reporting rates. Some international studies estimate reporting rates as low as 1-10%, and there is no reason to suspect that Canadian rates are higher.

Active surveillance projects to complement the current voluntary system of adverse reaction and medication incident reporting have been started. The focus is currently on areas (professions, specialists, health facilities etc.) internationally recognized as having poor reporting rates. These projects involve the development of a targeted surveillance system to stimulate reporting by pediatricians regarding serious adverse reactions in children [Note: mentioned in more detail on page 12], development of a consumer reporting module to actively solicit reports from HIV/AIDS patients, and collaboration on development of a reporting system with patient interest groups in certain chronic diseases.

Health Canada continually examines the barriers to adverse reaction and medication incident reporting and attempts to find alternate strategies to increase reporting rates. These barriers (e.g. lack of awareness about adverse drug reaction reporting) are a widely acknowledged international reality in the field of adverse drug reaction and medication incident reporting. Health Canada is collaborating with foreign regulators to use partnership and information sharing, among other strategies, to counteract and overcome these barriers.

Mandatory Reporting by Health Care Professionals

Based on a review of this issue, Health Canada does not yet have clear evidence that a mandatory reporting system would increase the number of adverse reaction reports or the quality of the information submitted. In fact, the results of a questionnaire sent to contacts in foreign jurisdictions showed no significant increase in quantity or quality of adverse reaction reporting under a scheme of mandatory reporting.

Assessing the International Experience
The Department recently collected information on the effectiveness of mandatory reporting by Health Care Professionals from several foreign jurisdictions. Reporting by Health professionals is considered vital but the experiences of jurisdictions like France, Sweden and Italy indicate that the implementation of mandatory schemes had little impact on reporting rates. Any increase in reporting rates was attributed to better information about the importance of reporting and, in some countries, this increase was marked by a worsening of the quality of the information submitted.

The experience of these countries with mandatory systems is also notable in that they do not detect drug safety problems at a higher rate than countries with voluntary systems. Officials in these jurisdictions believe it is more important to promote their programs and emphasize the reasons for reporting and not the sanctions to encourage physicians and pharmacists to report.

Enhancing the Quality of the Information Received
Effective monitoring systems not only rely on the quantity of reports but also on the quality of the information submitted. The most successful strategies will increase reporting rates while maintaining or increasing the quality of the reports.

The experiences of these jurisdictions will help Health Canada evaluate the potential of such a system in Canada. Moreover, Health Canada will enlist the support of the provincial professional licensing bodies and health professional groups to determine which approach will have maximum impact on increasing adverse reaction reporting to marketed drugs in Canada.

Approaches to Stimulate Adverse Reaction Reporting

To prompt the reporting of adverse reactions, a monthly Health Canada journal advertisement has been published in the CMAJ since April 2002 to promote the recently implemented Health Canada toll-free telephone and fax lines specifically established for adverse reaction reporting. The advertisement also includes Health Canada's internet address to subscribe to the newsletter, as well as to health professional/consumer advisories. This advertisement has since been picked-up by other journals. Address for subscription.

The proposed Canadian Pediatric Society Surveillance Program project will collect information from 2300 pediatricians and sub-specialists on a monthly basis. The focus of reporting is serious and life-threatening Adverse Drug Reactions (ADRs) in children and youth 0-18 years of age. In addition, the partnership will encourage pediatricians to report adverse drug reactions through regular reminders and monthly feedback to reporters.

Ongoing

Ongoing

Enhancing Surveillance/Coordination with the United States

Health Canada is currently negotiating with the U.S. FDA to create a combined U.S. - Canada Adverse Event Reporting System (AERS), which would be one of the largest databases of its kind in the world. This partnership will provide Canada with an even more powerful tool to detect drug safety problems swiftly.

This project, in addition to the promotion activities and enhancements to the voluntary reporting system, contributes to the objective that the program receives sufficient information/data to identify and respond to safety issues arising with marketed drugs in a timely manner.

Discussions Ongoing

Agreement expected in late Fall 2002

Work with Provinces and Territories

Health Canada has been and continues to work with provincial and territorial partners on other initiatives to enhance the safe and effective use of drug products.

The National Prescription Drug Utilization Information System will quantify the extent of use of drugs products, informing decision makers of the extent of the problem, once a problem with a particular drug product is identified.

The Common Drug Review will result in a single review of drugs for formulary listing and common listing recommendations for consideration by participating jurisdictions. This reduces duplication of existing provincial and territorial drug reviews and will ensure a high level of rigour in the therapeutic reviews of drugs.

This initiative has been approved and is currently being put into operation by the Patented Medicine Prices Review Board and the Canadian Institute for Health Information.

Federal, provincial and territorial Ministers of Health are anticipated to consider approval of this initiative at their September 2002 meeting. This initiative is ongoing.

Ongoing

September 2002 - approval by Ministers of Health

Health Canada should develop a template for Drug Information for Patients to be completed and submitted by the pharmaceutical companies for approval with the product monograph. This Drug Information for Patient must be clear, concise and easily understood by the general public. It should also contain maximum dosage information and date of last revision.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Enhancing Product Monographs

Currently, the content and format of the product monograph is outlined in the Product Monograph (PM) guidance document last revised in 1990.The product monograph is produced by the manufacturer and submitted to Health Canada as part of the New Drug Submission Process. Health Canada reviews the information submitted, including the product monograph, to determine whether the drug complies with the regulatory requirements outlined in the Food and Drug Regulations. These requirements speak specifically to the safety, quality and efficacy of the drug.The proposed new format for the Product Monograph will include the following changes:

• the Adverse Drug Reaction (ADR) section of the product monographs is being standardized and expanded to include even more comprehensive information about the risks posed by drugs; and,
• a consumer information section has been added to the PM to include a list of possible side effects related to a drug.

Nation wide public focus groups were held in September 2001.

A revised Guidance Document and Product Monograph Template were developed in December 2001. These documents are intended to guide pharmaceutical companies on how to develop the new product monograph. The documents have undergone internal consultation (January - February 2002) and have been tested with pharmaceutical industry representatives to determine their usability and readability (June 2002).

Information on recommended dosage is currently contained in the Dosage and Administration section (Recommended Dose and Dosage Adjustment subsection) of the Product Monograph. This section must, among other things, include "maximum daily dosage".Guidelines for the revised Product Monograph indicate the need to include the date of preparation. When a change is made to the monograph, the date will be updated as well.

Communicate with stakeholders and conduct public consultation on the revised Guidance Document and Product Monograph Template (targeted mail-out and web posting).

Finalize Guidance Document and Product Monograph Template.

Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

September - October 2002

December 2002Ongoing - results expected in early 2003

Health Canada, in conjunction with the College of Pharmacists, should ensure that only the Health Canada approved Drug Information for Patients is distributed in pharmacies either manually or electronically.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Providing information to patients is part of the practice of pharmacy and medicine which fall under provincial jurisdiction.

In an effort to enhance the availability of information to consumers, Health Canada will be working in collaboration with provincial and territorial authorities on the Product Monograph Project.

Enhancing Product Monographs

Currently, the content and format of the product monograph is outlined in the Product Monograph (PM) guidance document last revised in 1990.

The product monograph is produced by the manufacturer and submitted to Health Canada as part of the New Drug Submission Process. Health Canada reviews the information submitted, including the product monograph, to determine whether the drug complies with the regulatory requirements outlined in the Food and Drug Regulations. These requirements speak specifically to the safety, quality and efficacy of the drug.

The proposed new format for the Product Monograph will include the following changes:

• the Adverse Drug Reaction (ADR) section of the product monographs is being standardized and expanded to include even more comprehensive information about the risks posed by drugs; and
• a consumer information section has been added to the PM to include a list of possible side effects related to a drug.

Nation wide public focus groups were held in September 2001.

A revised Guidance Document and Product Monograph Template were developed in December 2001. These documents are intended to guide pharmaceutical companies on how to develop the new product monograph. The documents have undergone internal consultation (January - February 2002) and have been tested with pharmaceutical industry representatives to determine their usability and readability (June 2002).

Communicate with stakeholders and conduct public consultation on the revised Guidance Document and Product Monograph Template (targeted mail-out and web posting).

Finalize Guidance Document and Product Monograph Template.

Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

September - October 2002

December 2002

Ongoing - results expected in early 2003

Pharmacies should distribute Drug Information for Patients for a specific drug and review this information with patients every time a prescription is filled.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Providing information to patients is part of the practice of pharmacy and medicine which fall under provincial jurisdiction. In an effort to enhance the availability of information to consumers, Health Canada will be working in collaboration with provincial and territorial authorities on the Product Monograph Project.

Enhancing Product Monographs

Currently, the content and format of the product monograph is outlined in the Product Monograph (PM) guidance document last revised in 1990. The product monograph is produced by the manufacturer and submitted to Health Canada as part of the New Drug Submission Process. Health Canada reviews the information submitted, including the product monograph, to determine whether the drug complies with the regulatory requirements outlined in the Food and Drug Regulations. These requirements speak specifically to the safety, quality and efficacy of the drug.The proposed new format for the Product Monograph will include the following changes:

• the Adverse Drug Reaction (ADR) section of the product monographs is being standardized and expanded to include even more comprehensive information about the risks posed by drugs; and,
• a consumer information section has been added to the PM to include a list of possible side effects related to a drug.

Nation wide public focus groups were held in September 2001. A revised Guidance Document and Product Monograph Template were developed in December 2001. These documents are intended to guide pharmaceutical companies on how to develop the new product monograph. The documents have undergone internal consultation (January - February 2002) and have been tested with pharmaceutical industry representatives to determine their usability and readability (June 2002).

Communicate with stakeholders and conduct public consultation on the revised Guidance Document and Product Monograph Template (targeted mail-out and web posting). Finalize Guidance Document and Product Monograph Template.Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

September - October 2002 December 2002Ongoing - results expected in early 2003

That Health Canada produce a monthly bulletin highlighting new important drug information referencing information published in medical journals, Dear Health Care Professional Letters, etc.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Canadian Adverse Reaction Newsletter

The Department currently publishes an adverse reaction newsletter called the Canadian Adverse Reaction Newsletter.

The Newsletter alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. It is a useful mechanism to disseminate information on suspected adverse reactions to Health products occurring in humans before comprehensive risk-benefit evaluations and regulatory decisions are undertaken.

In addition, each Newsletter contains a summary of health professional and consumer advisories issued for that period.

The Department has published the Canadian Adverse Reaction Newsletter (former Canadian Adverse Drug Reaction Newsletter) since 1991. It is currently distributed by mail to approximately 92,000 health professionals (64,000 physicians with the distribution of the Canadian Medical Association Journal and 28,000 individuals including pharmacists, libraries, international partners and others interested in the area of pharmacovigilance etc.). It is also posted on Health Canada's Website and distributed by the newly created listserv called Health_Prod_Info where individuals can sign up to receive up to date information electronically via e-mail as soon as it become available.Address for subscription

Health Canada has renewed a contract with the Canadian Medical Association to re-design the Newsletter in April 2002. Now the Newsletter will be published as a separate document and sent, in the same package, as the Canadian Medical Association Journal to all its subscribers. The new look and revised method of dissemination is intended to increase its visibility.

An information piece has been developed for the September version of Health Canada's Office of Consumer Affairs and Public Involvement Newsletter entitled "Involving You" to advertise the Canadian Adverse Reactions Newsletter and let people know how they can subscribe to the Canadian Adverse Reaction Newsletter. This will reach approximately 800 consumer organizations across Canada.

In addition, the partnership with the Canadian Pediatric Society will provide monthly feedback to adverse reaction reporters in the form of updates to enhance safe medicines use.

Disseminating Urgent Information

Health Canada does not believe that a newsletter is the most timely tool to disseminate important new drug safety information. Dear Health Care Professional Letters, public advisories/warnings and the electronic list-serve are the preferred vehicles for disseminating urgent information. The address for subscription to the automatic listserv.

Provincial drug information centers and poison information centers also have an important role to play in dissemination of advice and information on medicines. In addition to providing access by phone to consumers, these more local resources are better positioned to liaise with local health care delivery to provide patient specific advice, which is outside the federal mandate because it is considered part of the practice of medicine.

Ongoing

The Canadian Adverse Reaction Newsletter is currently published quarterly. A feasibility study on the potential for a monthly newsletter is currently underway.

Ongoing

September 2002

Promotion/Education

To prompt the reporting of adverse reactions, a monthly Health Canada journal advertisement has been published in the CMAJ since April 2002 to promote the recently implemented Health Canada toll-free telephone and fax lines, specifically established for adverse reaction reporting. The advertisement also includes Health Canada's URL to subscribe to the newsletter, as well as to health professional/consumer advisories. This advertisement has since been picked-up by other journals.

A monthly announcement is also being sent to other health professional journals who have agreed to include it in their journal. The College of Family Physicians of Canada and the Canadian Pharmacists Association have agreed to use the announcement.

Agreements have also been reached in the summer 2002 with the editors of the Canadian Pharmacists Journal and Family Physician Journal to include extracts of the Canadian Adverse Reaction Newsletter articles in their journals and to refer to the Website for access to the complete issue.

Work continues to increase the number of associations and publications disseminating this important information.

Conferences
Increased participation at health professional conferences by Health Canada staff either through attendance or the provision of information through a booth or display table is being encouraged to promote a culture of adverse drug reaction and medication incident reporting among health care professionals as well as to encourage safe medicine use and best practices.

Participation is confirmed for three conferences starting in August 2002 including:

• Canadian Society of Hospital Pharmacists;
• International Society of Blood Transfusions; and,
• College of Family Physicians of Canada.

Brochure
A brochure has been developed to raise awareness of adverse reaction reporting, regional reporting centres and access to drug safety information. This brochure is available at forums such as conferences and is targeted to a generic audience.

Ongoing

Agreements reached in Summer 2002

Ongoing

Ongoing

Ongoing

Ongoing

Completed
Distribution ongoing

Fact Sheet

A fact sheet on How Adverse Reaction Information on Health Products is Used has been developed to better explain current procedures. This information is targeted at the general public.

Currently available on the Health Canada website

Completed Distribution ongoing

e-mail Information Sharing

Health Canada implemented a listserv project in September 2001 called Health_Prod_Info. This is a database service that anyone can subscribe to and receive regular documentation and new drug safety information updates electronically and automatically via e-mail. The purpose is to disseminate current information in a timely way to parties who have registered with the service. Address for subscription

Promotion of this service was done by letters to health professional associations and through the continued publication of announcements in the Canadian Adverse Reaction Newsletter and the Canadian Medical Association Journal; and for the Summer/Fall 2002 in the Heath Products and Food Branch Office of Consumer Affairs and Public Involvement Newsletter, Canadian Pharmacists Journal and Family Physician Journal.

This is an ongoing activity.

As of July 2, 2002 there were 3017 subscribers to the "Health_Prod_Info" listserv.

Ongoing

Health Canada should be encouraged to work with other nations to promote global harmonization of drugs. Health Canada should initiate discussions with other regulatory bodies regarding a centralized data base of international Adverse Drug Reaction Reports and corresponding regulatory actions.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Ongoing Communication with United States FDA and other Foreign Regulatory Bodies

Health Canada has always worked and communicated regularly with international regulatory bodies on a variety of health issues.

Since early 1998, the Department conducts bi-monthly teleconferences with the U.S. Food and Drug Administration (FDA), and more recently, with Australia's Therapeutic Goods Administration (TGA) and the New Zealand Ministry of Health (Medsafe) to discuss drug safety issues. These discussions are held in confidence.

The Department is also exploring participation in teleconferences to be held regularly between the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA).

Ongoing

Linking in with FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) teleconferences.

Health Canada is also discussing access to the U.S. FDA database (AERS) on adverse drug reactions, in order to identify public health and safety risks as quickly as possible.

Ongoing

Preliminary talks initiated and are on-going

Agreement expected Fall 2002

The International Conference on Harmonization (ICH)

One example of the Health Canada's international work on drug safety is The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Health Canada participates in two working groups related to drug safety issues:

Safety Expert Working Group
The Safety Expert Working Group is currently preparing a guideline on non-clinical tests to identify cardiac safety problems with new drugs. Health Canada is participating actively in this project.

Post-Market Surveillance Expert Working Group
There are three post-market surveillance ICH Working Groups on which Health Canada is participating as observers.

The ICH guideline on non-clinical tests for cardiac safety problems is currently in the public domain for consultation. This is relevant in view of the fact that cardiac problems have been said to be associated with cisapride. Information on how to participate in the consultation.

The next meeting of the expert working group is planned for September to continue the development of post-market safety guidance documents.

Ongoing

Next meeting of Safety Expert Working Group: September 2002

Next meeting - September 2002

Pharmaceutical companies should be required to report to Health Canada, in a timely fashion, any significant changes to foreign product monographs or any rejection of products for similar indications in other countries.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

International Teleconferences

To share information and increase awareness of activities in other countries and jurisdictions, Health Canada conducts bi-monthly tele-conferences with the U.S. Food and Drug Administration (FDA).

More recently calls have been initiated with Australia's Therapeutic Goods Administration (TGA) and the New Zealand Ministry of Health (Medsafe).

Health Canada is exploring participation in similar teleconferences, to be held regularly between the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA).

Continue to pursue opportunities for information sharing with foreign regulatory bodies.

Ongoing

Legal Requirement to Inform

Pharmaceutical companies have a duty under the current Food and Drug Regulations to update their product monograph if the risk/benefit profile of the drug has changed significantly from that which was submitted and approved by Health Canada.

Health Canada monitors a number of information sources which would indicate a need for a change to a product monograph if a significant event were to occur. These information sources include Periodic Safety Update Reports, information from international regulatory agencies and adverse drug reaction reports.

Ongoing

Ongoing

Health Canada should be encouraged to continue to make website development a priority. This website should include but not be limited to: new cautions and warnings, Adverse Drug Reaction Report summaries, ability to be searched by product/generic name, layman's terms, product monographs, warnings to professionals, electronic mailing capabilities for information such as the Adverse Drug Reaction Reports.

Health Canada Activities to Date

Continuous Enhancements to the Health Canada Website

Enhancements to the website continue to have priority. Recent enhancements include:

• posting of Dear Health Care Professional letters and public warnings;
• enhancement of the Adverse Reaction Information feature so that all pertinent documents are even more easily accessible; and,
• implementation of Health_Prod_Info - a listserv (an information service whereby anyone can subscribe to and automatically receive electronic documentation and updates by e-mail to enable timely dissemination of current information to parties who have registered with Health Canada. Address for subscription.

Health Canada ensures that advisories and warnings appear prominently on the main page of the Health Canada Portal with direct links to full text information.

Health Canada continues to enhance the Health Canada website on an ongoing basis to ensure that accurate, up to date information is widely available. This is key to the Department's mandate of helping Canadians maintain and enhance their health and is consistent with the federal government commitment to enhance service delivery and the availability of public information to Canadians.

Ongoing

Posting of Product Monographs on the Health Canada Website

Further to a Notice of Intent dated March 6, 2001, the Product Monograph Project is looking at dissemination issues and has met with consumer, health professional, industry and HC representatives to discuss the user requirements for the electronic posting of product monographs.

Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

Ongoing - results expected in early 2003

Health Canada should set up a toll free 1-800 number for general inquiries regarding drug information for the general public.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Individual Inquiries

Inquiries and information about personal choices of therapy must be based on advice relating to an individual's situation and treatment options most suited to their needs. For this reason, when inquiries of this type come to Health Canada, callers are directed to discuss the problem with their physician or pharmacist and to report any suspected adverse drug reaction using the reporting form available for printing.

Sources of Drug Information

Health Canada, as the regulator, is not mandated to become involved in the practice of medicine or pharmacy, which are provincially regulated. It is important that individuals speak to their health care provider regarding specific advice on matters relating to choices of therapies, including drug therapies.

Provincial drug information centers and poison information centers also have an important role to play in dissemination of advice and information on medicines. In addition to providing access by phone to consumers, these more local resources are better positioned to liaise with local health care delivery to provide patient specific advice.

Health Canada does not intend to provide such a service because it is considered that such information is more safely and appropriately provided by the provincial/local sources. Although the recommendation is not specific about whether a 1 800 line would provide information about personal choices of therapy or information about approved drugs/indications, Health Canada's mandate does not include the general Practice of Medicine or Pharmacy which both involve provision of patient-specific drug information.

Information on most prescription drugs is also published in the Compendium of Pharmaceuticals and Specialities (CPS) - a reference available in most retail pharmacies and public libraries. Further to this, the proposed new format for Product Monographs will provide pertinent information in consumer-friendly terminology.

Up to date professional literature including textbooks, journals and industry publications are also important resources for Health care professionals and to a lesser extent, the general public

Health Canada
Health Canada ensures that drug advisories and warnings appear prominently on the main page of the Health Canada Portal with direct links to full text information. For information about the enhancements to the website, see the activities under the response to recommendation #10.

Members of the public are invited to join the Health_Prod_Info mailing list to receive e-mail updates of new drug safety information from Health Canada, the most recent publication of the Canadian Adverse Reaction Newsletter, and notices of health professional or consumer advisories for therapeutic products.Address for subscription.

The Canadian Adverse Reaction Newsletter is a reputable source of adverse reaction information and is published quarterly, in January, April, July and October of each year. In addition, excerpts and notices from the newsletter are included in monthly journals for physicians and pharmacists. Health Care Professionals and consumers can subscribe.

In all communications, whether printed or electronic, readers are advised to consult with their Health Care Professional to help them interpret and use the information they are being provided.

Ongoing

Toll Free Adverse Drug Reaction Reporting Line

In August 2001, the Department implemented a new health professional/consumer toll-free telephone and fax lines to facilitate the reporting and receipt of adverse drug reactions. Calls are automatically routed to the appropriate regional or national Adverse Drug Reaction (ADR) centre. Reporting for manufacturers continues through the existing national ADR centre direct lines.

Health professionals and consumers can contact Health Canada to report adverse reactions toll free at: Telephone (866) 234-2345 or Fax (866) 678-6789.

ADR Regional Centre contact lists and telephone numbers appear on the Adverse Reaction Information Section of the Health Canada website and in the new Marketed Health Products Directorate brochure.

In addition, provincial drug information centers and poison information centers have an important role to play in dissemination of advice and information on medicines.

Health Canada will continue to enhance the existing variety of mechanisms for providing information and for referring callers to the most appropriate and immediate expertise for specific advice.

Ongoing

A concerted effort be made to raise awareness in young adults, teenagers and even pre-teens of the very serious health risks associated with eating disorders, particularly Anorexia and Bulimia Nervosa, and to encourage parents to discuss these issues with their children.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Policy Work on Mental Health Promotion

Eating disorders are a serious health issue and remain among the most common psychiatric disorders; they occur most commonly in young women.

Health Canada's role and actions in support of the mental health of children and youth are organized primarily around the health-related functions of health protection, disease prevention and health promotion.

Recently the Department has begun preliminary conceptual work, information gathering and informal consultations towards the development of a proposed Canadian Strategy for Mental Health Promotion. The proposed strategy would take into consideration all developmental groups across the lifespan of an individual, as well as in key settings -- family, school, community, and workplace.

Mental health promotion for children and youth, and the prevention of mental health problems, would be addressed in this context.

This work will also be informed by a Canadian Mental Health Association project, approved under the Government's Voluntary Sector Initiative, in which consumer and family groups, service providers and government representatives will be brought together in a series of regional mental health forums to develop strategies on the role of communities in national mental health policy development.

Health Canada will continue internal discussions of federal policy options for promoting mental health, and discussions with the Canadian Mental Health Association about how their project can best inform Health Canada's policy in the area of mental health.

To be determined

Report on Mental Illness in Canada

Health Canada is collaborating with non-government organization (NGO) partners to produce a report entitled "Mental Illnesses in Canada", which will include a chapter on eating disorders.

Completion and publication of the report and posting on the HC website.

March 31, 2003
(to be completed and posted on website)

Mental Health Promotion in Schools

In 2001-2002, in order to determine the scope and nature of mental health promotion in the school setting, Health Canada contracted to conduct a curriculum and program scan and gaps analysis regarding mental health promotion content. The findings from this report will help to inform future directions regarding mental health promotion targeting the school age population.

A highlights and key findings report will be developed and posted on the HC web site.

March 2003

Providing Information to Canadians

The Canadian Health Network (CHN) is a national, bilingual Internet-based health information service. Health Canada, its founding partner, provides funding for CHN. Information about healthy eating, healthy weights, body image and eating disorders can be found on the CHN site.

The Canadian Health Network continually updates its databases to provide Canadians with health information providers across Canada.

Ongoing

Health Canada and drug companies should review product package inserts to ensure that they meet the needs of consumers. This should not supersede the Health Canada approved Drug Information for Patients.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Patient Package Inserts

Patient package inserts are already mandatory for certain types of drugs. In addition, a new consumer information section contained in the revised product monograph template will be reviewed as part of the drug approval process. The consumer information section is specifically designed to meet the needs of consumers.

Ongoing

Ongoing

Enhancing Product Monographs

Currently, the content and format of the product monograph is outlined in the Product Monograph (PM) guidance document last revised in 1990.

The product monograph is produced by the manufacturer and submitted to Health Canada as part of the New Drug Submission Process. Health Canada reviews the information submitted, including the product monograph, to determine whether the drug complies with the regulatory requirements outlined in the Food and Drug Regulations. These requirements speak specifically to the safety, quality and efficacy of the drug.

The proposed new format for the Product Monograph will include the following changes:

• the Adverse Drug Reaction (ADR) section of the product monographs is being standardized and expanded to include even more comprehensive information about the risks posed by drugs; and
• a consumer information section has been added to the product monograph to include a list of possible side effects related to a drug.

Nation wide public focus groups were held in September 2001.

A revised Guidance Document and Product Monograph Template were developed in December 2001. These documents are intended to guide pharmaceutical companies on how to develop the new product monograph. The documents have undergone internal consultation (January - February 2002) and have been tested with pharmaceutical industry representatives to determine their usability and readability (June 2002).

Communicate with stakeholders and conduct public consultation on the revised Guidance Document and Product Monograph Template (targeted mail-out and web posting).

Finalize Guidance Document and Product Monograph Template.

Develop and conduct feasibility study to assess costs (time and resources) and work involved for the electronic posting and maintenance of product monographs by Health Canada and/or another party.

September - October 2002

December 2002

Ongoing - results expected in early 2003

Appropriate resources should be allocated to Health Canada to ensure that the preceding recommendations can be achieved.

Health Canada Activities to Date

Next Steps

Targeted Timeframes

Marketed Health Products Directorate

The Marketed Health Products Directorate of Health Canada, which coordinates surveillance, assessment and communications activities of all health products on the market, will have initial funding of approximately $10M and an initial workforce of 35 scientific and support staff. Of this $10M, seven million dollars is new funding provided in the 2002-03 fiscal year to strengthen safety and effectiveness post-market surveillance activities in the Department. More specifically, this directorate:

• monitors marketed health products safety data such as adverse reaction and medication incident reports, evaluating product effectiveness, conducting risk/benefit assessments, and recommending appropriate action when problems are identified;
• looks for ways to ensure greater access to Canadian and foreign adverse reaction information through national and international collaborations, and through increased use of expert scientific advice and consumer input;
• partners with others to promote adverse reaction and medication incident reporting, study product effectiveness and communicate to health care professionals and the public; and,
• disseminates risk-related information to health professionals and the public through means such as the Canadian Adverse Reaction Newsletter, health product advisories and warnings, the Health_Prod_Info electronic mailing list, and Health Canada's website. Address for subscription.

The directorate ensures a consistent approach to monitoring, assessing and intervening with respect to all regulated marketed health products.

Personnel in the Marketed Health Products Directorate will work directly with their counterparts in product specific Directorates (e.g., Therapeutic Products Directorate, Biologic and Genetic Therapies Directorate, Veterinary Drugs Directorate, Natural Health Products Directorate) to develop appropriate post-approval assessment activities.

Ongoing

Ongoing

Drug Safety - A Federal Government and Health Canada Priority

Resources for all of Health Canada's programs that deal with the safe and effective use of drug products are considered and allocated as part of the following:

• Health Canada's Strategic Planning process;
• the Business and Operational Planning process of the Health Products and Food Branch; as well as,
• the Government of Canada's Budget process.

Protecting the health of Canadians through an appropriately resourced drug safety system continues to be a priority for Heath Canada and the Government of Canada.

Ongoing

Ongoing