Report a side effect
In the context of Health Canada's side effect reporting program(the Canada Vigilance Program), personal information is collected pursuant to section 4 of the Department of Health Act, for the purpose of monitoring licensed products, detecting potential emerging safety issues and trends, mitigating the risks and improving the safe use and efficacy of the health products. Information related to the identity of the patient and/or reporter will be protected as personal information under the Privacy Act, and in the case of an access to information request, under the Access to Information Act. Suspected health product side effect-related information that is voluntarily submitted to Health Canada is maintained in a secure computerized database. The program endeavours to use and disclose only de-identified information but may use and disclose personal information that is not de-identified as permitted under the Privacy Act.
For further details regarding the personal information collected under this program, visit the Personal Information Bank; Health Canada; Health Products and Food Branch; Branch Incident Reporting System; PIB#PPU 088 at: http://www.hc-sc.gc.ca/ahc-asc/activit/atip-aiprp/infosource/index-eng.php#a2. Every Canadian individual has the right to access their own personal information and is entitled to request correction to ensure accuracy of their information. If you wish to exercise this right, contact the Treasury Board of Canada Secretariat.
Complete all mandatory fields, marked by a *, and provide as much detail as possible for the remaining fields.
Under 'Patient Identifier', you should write a word or code that would remind you in the future who this report is about: yourself, or another person who experienced a side effect. When doctors fill out this report, for example, they might use the patient's chart number as the identifier. In any case, personal information like your name, initials, birth date or social insurance number, should not be used.
The 'Reference #' field, should be used by the reporter as a way to easily locate the side effect report should Health Canada need to follow up for more information. If this report is a follow up to a previously submitted report, the DHPR number assigned to the original report should be entered in this field. Do not use the name of the person who had the side effect.
What is a Side Effect?
Side effects are troublesome symptoms or feelings that occur when taking a health product. Side effects can range from minor irritations, such as a skin rash, to serious and life-threatening reactions, such as a heart attack of liver damage. A side effect can also be when a product has no effect or has not performed the intended treatment. They can occur within minutes after taking a medicine, or can take years to develop.
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. Side effects are sometimes also called adverse reactions, especially by doctors and other health professionals.
What types of Side Effects should be reported?
All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.