Serious adverse drug reactions and medical device incidents reported by Canadian hospitals: Monthly summary :
- Last updated: 2023-06-02
A summary of serious adverse drug reactions and medical device incidents reported by hospitals and tracked in the Canada Vigilance database.
This page was last updated on with data up to and including .
On this page
Mandatory reporting by hospitals
When a serious adverse drug reaction (ADR) or medical device incident (MDI) is documented in a hospital, the hospital must submit a report to Health Canada within 30 calendar days. Health Canada monitors these reports in the interest of public health and patient safety.
Summary of reports
All reports submitted in
All reports submitted between December 16, 2019 and
Notes
- Data are based on reports that were:
- submitted between December 16, 2019 (when the new regulations came into effect) and
- entered into the Canada Vigilance database as a mandatory hospital report further to the mandatory reporting requirements for hospitals
Reports over time
Figure 1. Number of reports submitted to Health Canada over time
Figure 1: Text description
Number of reports submitted to Health Canada over time
Year | Month | ADR Counts | MDI Counts | All |
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Notes
- The spikes in April and May 2020 were due to a large number of reports about personal protective equipment.
- On average, reports were submitted per month since January 2020, including:
- serious ADR reports
- MDI reports
- Averages exclude December 2019, as this was an incomplete month of data.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Reports by jurisdiction
Figure 2. of reports submitted, by province or territory
Figure 2: Text description
Number of all reports submitted by province or territory
Province/Territory | ADR Reports | MDI Reports | ALL Reports | ADR reports per 100K | MDI reports per 100K | ALL reports per 100K |
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Notes
- This figure shows the number of reports by province and territory, as well as the reporting rate by province and territory (number of reports submitted per 100,000 population).
- Numbers from the Northwest Territories, Nunavut and Yukon are too small to display for confidentiality reasons.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Timeliness of reporting
When a serious ADR or MDI is documented in a hospital, the hospital must submit a report to Health Canada within 30 calendar days. The following data shows how long it took hospitals to submit these reports.
Timeliness of submissions,
[VALUE]
Average number of days
[VALUE]
Median number of days
[VALUE]%
On time
Figure 3. Distribution of the number of days taken to report a serious ADR or MDI,
Figure 3: Text description
Distribution of the number of days taken to report an event, serious ADR and MDI reports, Canada
Province/Territory | Days to report | Serious ADR | MDI |
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Notes
- When an MDI or serious ADR is documented in a hospital, the hospital must report it to Health Canada within 30 calendar days.
- Numbers from the Northwest Territories, Nunavut and Yukon are too small to display for confidentiality reasons.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Outcomes for serious ADRs
Figure 4. of key outcomes in serious ADR reports over time
Figure 4: Text description
Number of key outcomes in serious ADR reports over time.
Outcomes | Counts | Percentage of reports |
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Notes
- Outcomes are determined by the hospital and coded according to MedDRA terminology.
- The term ‘sequelae’ refers to any condition which is the result of an ADR.
- A report may contain information about more than 1 outcome.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Figure 5. of 5 most common in serious ADR reports
Figure 5: Text description
Number of 5 most common anatomical therapeutic chemical groups of suspect products/system organ classes in serious ADR reports, latest month/over time
Time Period | ATC | ATC Counts | ATC Proportion | SOC | SOC Counts | SOC Proportion |
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Notes
- The anatomical therapeutic chemical system (ATC) is a drug classification system. It divides drugs into different groups based on their properties and the organ or system they act upon.
- Although 5 ATC levels exist, only the 2 top levels (anatomical main group and therapeutic subgroup) are reported here.
- A System Organ Class (SOC) contains several similar adverse reaction terms that relate to one specific organ system of the body. The adverse reactions are coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology.
- Hospitals report adverse reactions because they suspect that an adverse event may be related to a health product (‘suspect product’).
- A report may contain information about more than 1 ATC group or system organ class.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Outcomes for MDIs
Figure 6. of 5 most common in MDI reports over time
Figure 6: Text description
Number of 5 most common device categories in MDI reports, over time
Device Category | Device Category Counts | Device Category Proportion | Device Problem | Device Problem Counts | Device Problem Proportion | Patient Problem | Patient Problem Counts | Patient Problem Proportion |
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Notes
- At the start of the COVID-19 pandemic, there was a large increase in the number of MDI reports about imported masks. Because this skewed the MDI report outcome statistics, we’ve removed reports about masks as personal protective equipment from this figure.
- A report may contain information about more than 1 medical device category, medical device problem or health effect.
- This figure includes all data since mandatory reporting came into effect (December 16, 2019).
- The most recent month of data always lags by 3 months to allow reports to be processed in the Canada Vigilance database.
Acknowledgements
This monthly report would not be possible without the collaboration of hospitals, integrated centres and regional health authorities across Canada. We would like to thank everyone involved in the mandatory reporting of MDIs and serious ADRs in Canada.
Suggested citation
Health Canada. Serious adverse drug reactions and medical device incidents reported by Canadian hospitals. Ottawa: Health Canada; . https://health-infobase.canada.ca/hospital-adverse-events-dashboard/
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