Background

Federal legislative mandatory reporting requirements of SADRs and MDIs for hospitals came into effect on December 16, 2019 in relation to “Vanessa’s Law”.

What is reported

Any serious documented Adverse Drug Reaction (whether it is suspected or confirmed) and any Medical Device Incidents need to be reported immediately, prior to the end of the shift/workday to your direct supervisor/manager. Please refer to the guidance document on Management of Serious Adverse Drug Reactions and Medical Device Incidents Checklist.

How do I report

Complete the applicable Health Canada Form. i.e.) Health Canada Serious Adverse Drug Reaction Reporting Form for Hospitals and/or the Medical Device Problem Reporting Form for Health Care Professionals.

Submission

Scan all completed documents to: [email protected]

What happens to these documents after I submit?

Patient Safety will compile and track all received reports and submit on behalf of the region to Health Canada prior to 30 calendar days of first documentation of event. As part of the tracking process, an annual report has been created to be shared as a learning opportunity with healthcare providers within Southern Health Santé Sud. Please review the annual report and summary report. Site and program leads are to share relevant information with their respective teams.

Submitted by: Pamela Gunn, Regional Patient Safety Coordinator
For more information contact Pamela at 204-903-7762