Standardized Health Product Risk Communication Template

2015-11-23

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Also available in French: Modèle normalisé pour les communications des risques liés aux produits de santé

[Insert urgency: Alert or Important Safety Information] on [Health Product] with [insert specific adverse reaction]

[Sponsor logo]

[Date (yyyy/mm/dd)]

Audience

Indicate for whom this information is targeted (consumers, caregivers, or specific health care professionals, ex: surgeons, rheumatologists…)

Key messages

Key points (in bullet form) to summarize the information for readers, including:

• a description of the health risk,
• what health professionals can do, or what the public can do, and
• any other important information.

What is the issue?

Text describing the health risk.

Products affected

Manufacturers, names, lot numbers, expiry dates and other information about the health products involved in the risk.

Background information

Additional information pertinent to the communication or providing more details as to why the risk was communicated. Can include information on the [product], what it is used for, data summary charts or tables if studies have been reviewed, and/or what the manufacturer is currently doing about it.

Information for consumers

Additional detailed instructions on how the consumer should use the new safety information.

Minimally indicate that consumers should contact their health care professional for more information.

Information for health care professionals

Additional detailed instructions on how the health professional should use the new safety information.

Action taken by Health Canada

Text describing any risk management measures (e.g., [specific section] of the product monograph will be updated to reflect the new information)

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of (specific side effect) or other serious or unexpected side effects in patients receiving [brand name] should be reported to [name of sponsor] or Health Canada.

[Name and address of sponsor in Canada]

To correct your mailing address or fax number, contact [name of sponsor.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax.
  

For other health product inquiries related to this communication, contact Health Canada at:

Lead Directorate
E-mail: (Generic e-mail address)
Telephone:
Fax:

[If Health Canada endorsed, the following information about who developed the risk communication should be added:]

Signature Block
Original signed by
<Name>

References

1....

Images

Image(s) of product related to the health risk.