Purchasing:Health Canada Communication Tools

Health Canada Communication Tools

These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.

1.Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)

• Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada.html then scroll down to Guidance Documents and Guidelines.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.

1. Risk communications

Risk Communication tools may also be familiar to healthcare professionals: Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)

• The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.
• For more information:

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/medeffect-canada-canadian-medical-devices-sentinel-network-pilot-project.html

Annual Trends Report

• The primary objective of the Annual Trends Report is to provide the numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada on an annual basis. The data are based on reports submitted to Health Canada through the Canada Vigilance Adverse Reaction Online Database (more below) for reporting adverse reactions to drugs, the CV-MDS (where people report problems with medical devices), and CMDSNet.

- https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/annual-trends-adverse-reaction-case-reports-health-products-medical-device-problem-incidents.html

Health Product InfoWatch This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.

-https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html

Recalls and Safety Alerts

• Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.

a) Health Product Risk Communications (HPRC’s): Includes three types of communications o Dear Healthcare Professional Letter (DHCPL); o Public communication; and, o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada. b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more. c) Public advisory: Health Canada’s communication to warn the public of a potential hazard. d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below). e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.

• You can search for recalls and safety alerts through this link:

- http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3

1. Health Product Safety Information

• Health Product Safety Information tools may also be familiar to healthcare professionals and industry:

• Health-related products in Canada must be safe and effective. Each drug product has information associated with it, and this information is easily accessible through the drugs and health products portion of the Health Canada website. In addition, Health Canada has specific guidelines for each product that includes providing clear directions and ensuring the proper labelling of products.

Product Monographs

• A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

Directions for use/Product Labelling

• These are the directions and labels on each product.

The Drug and Health Product Register (DHPR)

• The DHPR was created to make information on health products available to Canadians.

- https://hpr-rps.hres.ca/index.php?lang=en

1. Communications around Transparency/Transparency Initiatives for the Public

• Transparency tools may also be familiar to healthcare professionals and industry:

• Summary Safety Reviews (SSRs)

• SSRs are Health Canada’s summaries of its safety reviews of products and drugs on the market. These are intended to provide greater transparency to Canadians. They are brief 3-page summaries that outline what was assessed, what was found and what action was taken by Health Canada, if any. These are found in the DHPR. Here is the link:

- https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=

New Safety and Effectiveness Reviews

• Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.

- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html

Medical Devices Online Incidents Database The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download. https://hpr-rps.hres.ca/mdi_landing.php MedEffect Canada MedEffect Canada provides consumers, patients, and health professionals with an easy way to: report an adverse reaction or side effect; obtain new safety information on drugs and other health products; and, learn and better understand the importance of reporting side effects. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html Canada Vigilance Adverse Reaction Online Database The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html