Risk Communication - Protecting Canadians through Information

2011
ISBN: 978-1-100-18263-6 (PDF Version)
Cat. No.: H164-134/2011E (PDF Version)

Communicating about risk is a key component of any risk management plan. At Health Canada, communicating risks about health productsFootnote 1 involves developing and disseminating the most current information on potential or known health risks, to aid health professionals and patients in making better informed treatment decisions. Risk communications are not intended as medical advice.

A Shared Responsibility

In Canada, many different organizations and individuals play a role in communicating risks associated with health products, including:

Information on how to report an adverse reaction is available at the
.

Health Canada considers many factors in the evaluation of an emerging health product safety concern (e.g., availability and reliability of data, seriousness of the event) and the urgency of the communication. The lead in issuing a risk communication may be Health Canada and/or the Market Authorization Holder. A risk communication may be targeted to various audiences, including the general public and/or health professionals and hospitals.

Lead for Issuance of Risk Communications Products

Health Canada

  • Public Advisory
  • Health Canada-issued Health Professional Communication: 'Dear Health Care Professional' Letter
  • Health Canada-issued Health Professional Communication: 'Notice to Hospitals'
  • Information Update
  • Foreign Product Alert
  • Canadian Adverse Reaction Newsletter
  • It's Your Health Publication
  • Fact Sheets and Backgrounders

Market Authorization Holders (i.e., Industry)

  • Industry-issued Health Professional Communication: 'Dear Health Care Professional' Letter
  • Industry-issued Health Professional Communication: 'Notice to Hospitals'
  • Public Communication
  • Health Product Recall Notice (refers to a Type I or Type II health hazard)

The chart below outlines the urgency level of each communication product disseminated by Health Canada and/or industry for public and professional audiences.

Urgency of communication and target audience

Communication Urgency Scale for Health Professionals and Hospitals:

High

  • Health Product Recall Notice (refers to a Type I health hazard)

Medium

  • Health Professional Communication: "Dear Health Care Professional" Letter
  • Health Professional Communication: "Notice to Hospitals"
  • Health Product Recall Notice (refers to a Type II health hazard)

Low

  • Canadian Adverse Reaction Newsletter

Communication Urgency Scale for the Public:

High

  • Health Product Recall Notice (refers to a Type I health hazard)

Medium

  • Health Canada Public Advisory
  • Industry-issued Public Communication
  • Health Product Recall Notice (refers to a Type II health hazard)
  • Health Canada Foreign Product Alert

Low

  • It's Your Health publication
  • Fact Sheets and Backgrounders

A Collaborative Approach

Industry has a responsibility for timely and effective communication regarding the safe use of its products. 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 addition to working with provincial and territorial ministries and organizations, Health Canada engages with health professionals, their associations, academia, industry members, and consumer and patient groups to enhance the collection and communication of information on health product benefits and risks.

Getting the Word Out

Different audiences have different preferences in how they receive health product risk information. Therefore, each of Health Canada's risk communications has a specific dissemination strategy. Dissemination methods depend on the targeted audience and may include:

To provide health product risk information to Canadians as quickly as possible, Health Canada posts risk communications on the MedEffect™ Canada Web site. This central hub of health product safety information offers the most comprehensive coverage and access to both Health Canada-issued and industry-issued risk communication products.

More information about these and other risk communication products can be found in Health Canada's Guidance Document: Description of Current Risk Communication Documents for Marketed Health Products for Human Use.

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