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

Information about the definitions, sources and limitations of the data used to create these summaries of mandatory hospital reports.

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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:

Monitoring these reports helps us:

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