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 .

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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
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
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
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
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
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
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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