Serious adverse drug reactions and medical device incidents reported by Canadian hospitals: Understanding the data :

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Overview

Health Canada monitors the use of drugs and medical devices to protect public health and patient safety.

As of December 16, 2019, it's mandatory for hospitals to submit a report to Health Canada within 30 calendar days of any:

• serious adverse drug reactions
• medical device incidents

Monitoring these reports helps us:

• promote the safe use of health products in Canada
• detect new, rare or serious adverse drug reactions or medical device incidents
• take action against products that may pose a risk to health and safety

Definitions

Anatomical Therapeutic Chemical (ATC) group

The ATC classification system divides drugs into different groups based on their chemical, pharmacological and therapeutic properties and the organ or system on which they act.

Serious adverse drug reaction report

Report of a serious adverse drug reaction, determined by the reporter at the time of reporting. Health Canada defines a serious adverse drug reaction as:

"A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death." Food and Drug Regulations

Suspected health product

The reporter suspects that the health product caused the adverse reaction. Cause-and-effect relationships have not been established.

Data source

The reports included in this summary are available in the Canada Vigilance database for health products and medical devices. The database is updated monthly to include reports received up to 90 days before the posting date. Health Canada uses this 90-day period to review the new reports submitted, code the information and perform quality assurance activities.

Data limitations

• There may be reactions or incidents that we've received but haven't yet entered into the database.
• Some important medical events may not be immediately life-threatening or result in death or hospitalization. However, they may jeopardize the patient or require intervention to prevent more serious outcomes. These events may also be considered serious.
• A report can contain more than 1 reaction or incident.
• Some reports may be missing information.
• Population size estimates were calculated using the most recent and reliable information available at Statistics Canada. Approximations and rounding were applied to the data when defining these groups, so these numbers are estimates. The true size of these populations may be larger or smaller, which could affect reporting rate estimates.
• Data from the Northwest Territories, Nunavut and Yukon are too small to display for confidentiality reasons.
• More details on the limitations of the Canada Vigilance data can be found in the instructions for the Canada Vigilance database.