Guide for using the Standardized Health Product Risk Communication Template

2015-11-23

Purpose

This guide is intended to assist in the drafting of risk communications, using the standardized template to communicate health product safety information to both health professionals and the public. A consistent approach to format and organization of content will also contribute to effective messaging.

Writing in Plain Language

Plain language should be used throughout the document.

• Plain language can be described as clear, succinct writing designed to ensure the reader understands as quickly and completely as possible. Plain language is easy to read, understand, and use. It avoids verbose, convoluted language and jargon. If technical words need to be used, provide an explanation or define them.
• Note: Plain Language is not "dumbing down" the text. The primary goal of plain language is to organize and present information in a way that is easy to read and understand for your intended audience.
• If your audience consists of medical professionals, it would be acceptable to include terminology they will understand, having considered your audience's knowledge, level of education and literacy skills.
• If your target audience is the general public, consider using text at a grade 8 level, which is consistent with Canada's adult literacy statistics (Adult Literacy and Life Skills Survey 2003 -Statistics Canada).
• The Canadian Style (Le guide du rédacteur) provides further information on Plain Language in the Canadian context and its application.
• Throughout the template, the language in the specific sections should be targeted to the intended audience (e.g., in the Information to Consumer section, the language should be geared to the lay public.)

Detailed Instructions for using of the Template:

This section provides detailed step-by-step instructions for developing a risk communication using the headings provided in the template. Suggested content material and examples are given to add clarity and assist in developing effective and consistent messaging.

Standard Content under Each Heading:

Audience

• Who is impacted by this information? (e.g., who prescribes, dispenses, distributes, administers or uses this product?)
• Where needed, identify specific health care professionals (e.g., specialists).
• Provide any special instructions for further distribution (e.g., post in your institution).

Key messages

• A description of the issue/health risk
  • What is the issue? Identify the reason for the risk communication (e.g., product recall for quality related issues).
  • What is the health risk? Identify the product and the associated health risk.
• What health professionals can do, or what the public can do
  • What information do health professionals need? What action can they take or what should they change in their practice?
  • If applicable, provide specific instructions to consumers/patients so they know what to do about the risk.
  • e.g., what instructions are required in the case of a recall?
• Any other important information
  • What action has the MAH/Health Canada taken to mitigate the risk? (e.g., updating label or PM, providing additional or revised usage recommendations, etc.)

What is the issue?

• Identify clearly in a short paragraph, the product and the risk being communicated.
• How is the product associated with the health risk?

Products affected

• Information presented in this section should be neatly organized in such a way that the reader can easily identify the relevant details about the products affected.
• At a minimum, include the product's Brand Name and (ingredient).
• In some situations (e.g., product recalls), additional details about the lots of the affected products may be required. A table, as seen below, can be used to organize the information.

Details about the products affected

Manufacturer	Product	DIN #	Product Code	Lot #	Expiry Date

Background information

This section is intended to provide additional information about the product itself, as well as the risk.

The opening paragraph under this section should describe:

• the product name, what it is used/indicated for (provide a brief description of the Health Canada approved indication), how it is used (e.g., orally taken, injected, etc.).

The second paragraph can describe:

• the identified risk and how it is associated with the product;
• why there is cause for concern;
• any adverse events reported, and their seriousness (e.g., hospitalization, transplantation, fatality, etc.);
• the rationale for suspecting a causal relationship.

Subsequent paragraphs can include:

• whether the event is linked to an unapproved indication or unapproved condition of use;
• the number of events of interest reported domestically and internationally with estimations of patient exposure;
• contraindications;
• warnings (e.g., comprehensive list of signs, symptoms, laboratory findings, time course, clinical outcome, laboratory monitoring, risk factors, recommended actions in the event of prodromal symptoms, reinforced warnings concerning metabolic drug interactions);
• adverse reactions (e.g., extended list of post-market adverse events); and
• information regarding risk mitigation measures taken by the MAH.

Information for consumers

Note: It may be necessary to repeat information from other sections that is important for consumers to know such as the product's indication and a description of the risk

• In plain language (grade 8 level is recommended for consumers), provide information relevant to consumers (e.g., description of the product and what it is used for, identify the risk and possible consequences, identify any signs or symptoms they need to watch out for).
• Identify what consumers need to know or learn about the product and what they need to do regarding the risk.
• Tell patients how they can get more information (e.g., to consult their health care professionals).

Information for health care professionals

Note: This section could contain more detailed and technical information geared towards health professionals

• What information is relevant for health professionals? (e.g., description of risk and possible consequences, warnings regarding prodromal symptoms)
• What exactly do they need to know and what is the clinical impact? Provide information to prepare them to help their patients.

Action taken by Health Canada

If available, provide text describing any risk management measures taken by Health Canada (e.g., [specific section] of the product monograph will be updated to reflect the new information).

• What is the status of any recommendations or risk mitigation activities taken by Health Canada? (e.g., Health Canada is working with the manufacturer to update the product information)

Minimally, the following standard text should be considered for inclusion in the risk communication:

• Health Canada is communicating this important safety information to healthcare professionals and to the public through its MedEffect Canada website.

Other examples of action taken by Health Canada that may be relevant:

• Health Canada is monitoring the situation and the implementation of necessary corrective and preventative actions.
• The Product Monograph for <<Product>> has been updated with this new information.
• Health Canada will be working with <<manufacturer>> to update the Product Monograph to reflect this safety concern.

Report health or safety concerns

This section uses the standard text below. Fill in the relevant product, manufacturer and safety risk information.

"Managing marketed health product-related adverse reactions depends on health care professionals reporting them. Any case of serious [SPECIFIC ADVERSE REACTION] or other serious or unexpected adverse reactions in patients receiving [BRAND NAME] should be reported to [NAME OF SPONSOR] or Health Canada at the following addresses:"

Note: Please use the standard text in the French template provided for this section when translating the finalized English risk communication document.