Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview

From Health Canada

Overview

This guidance document provides hospitals with information on how to comply with the Food and Drug Regulations and the Medical Devices Regulations with respect to the mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to therapeutic products. Serious ADRs and MDIs for marketed therapeutic products within the scope of this guidance document are to be reported to the Canada Vigilance Program of the Marketed Health Products Directorate (MHPD) of Health Canada.

This guidance document covers the collection of individual serious ADR and MDI reports by MHPD for the following marketed therapeutic products:

• pharmaceuticals (prescription and non-prescription);
• biologic drugs (biotechnology products, fractionated blood products, plasma proteins, as well as vaccines, excluding those administered under a routine immunization program of a province or territory);
• radiopharmaceutical drugs;
• disinfectants;
• drugs for an urgent public health need;
• medical devices.

Who this guide is for

• 1. The guide is intended for regulated parties (hospitals) who are affected by the regulations as they pertain to the mandatory reporting of serious adverse drug reactions and medical device incidents for therapeutic products.

In this guide

• 1 Introduction
  • 1.1 Objective
  • 1.2 Scope and application
• 2 The Regulations and their Purpose
  • 2.1 Purpose of the amended regulations
  • 2.2 Definition of a serious adverse drug reaction
  • 2.3 Definition of a medical device incident
• 3 Roles and Responsibilities
  • 3.1 The role of hospitals
  • 3.2 The role of health care professionals
  • 3.3 Outpatient clinics
  • 3.4 Other types of health care institutions
  • 3.5 Other situations
• 4 Applicability of the Regulations According to Product Type
  • 4.1 Applicable therapeutic products
    • 4.1.1 Drugs for an urgent public health need, regulated under Part C, Division 10 of the Food and Drug Regulations
  • 4.2 Applicable types of medical devices
  • 4.3 Non-applicable therapeutic products
    • 4.3.1 Drugs and medical devices subject to the Clinical Trial (drugs)/Investigational Testing (medical devices) and Special Access Programme regulatory frameworks
    • 4.3.2 Vaccines administered under a routine immunization program of a province/territory
    • 4.3.3 Adverse reactions to cells, tissues and organs, blood and blood components, and semen/ova
  • 4.4 Determination of applicability of drug/medical device combination products
• 5 Serious Adverse Drug Reactions and Medical Device Incidents to be Reported by Hospitals
  • 5.1 Serious adverse drug reactions associated with off-label use
  • 5.2 Examples of serious adverse drug reactions
  • 5.3 Serious adverse drug reaction associated with multiple patients
  • 5.4 Reporting criteria for medical device incidents
    • 5.4.1 An incident has occurred
    • 5.4.2 Considerations in assessing reportability
  • 5.5 The incident led to one of the following outcomes
    • 5.5.1 Death of a patient, user or other person
    • 5.5.2 Serious deterioration in health of a patient, user or other person
    • 5.5.3 Potential for death or serious deterioration in health of a patient, user or other person
  • 5.6 Medical device incident associated with off-label/abnormal use
  • 5.7 Examples of medical device incidents
  • 5.8 Non-applicable medical device incidents
    • 5.8.1 Deficiency of a device found by the user prior to patient use
    • 5.8.2 Incident caused by a patient's condition
    • 5.8.3 Malfunction protection operated correctly
  • 5.9 Causality assessment between the therapeutic product and serious adverse drug reaction or medical device incident
  • 5.10 Adverse drug reaction or medical device incident associated with multiple suspect products or devices
  • 5.11 Examples of serious adverse drug reaction and medical device incident documentation in a hospital setting
• 6 Information Requirements for Serious Adverse Drug Reaction and Medical Device Incident Reports
  • 6.1 Information required for serious adverse drug reaction and medical device incident reports
  • 6.2 Information 'in the control' of the hospital
  • 6.3 Information required to be submitted in the adverse drug reaction report
  • 6.4 Information required to be submitted in the medical device incident report
  • 6.5 Additional information encouraged to be submitted to Health Canada to enhance the value of an adverse reaction report/medical device incident report
• 7 When and How to Submit Serious Adverse Drug Reaction and Medical Device Incident Reports
  • 7.1 Timeline for reporting serious adverse drug reactions and medical device incidents to Health Canada
  • 7.2 Follow-up on reports submitted Health Canada
  • 7.3 Submission methods and formats
  • 7.4 Reporting forms
  • 7.5 Submitting reports to Health Canada using a third party such as a regional health authority
  • 7.6 Feedback
• 8 Privacy
  • 8.1 Management of potential privacy issues associated with patient information in serious adverse drug reaction and medical device incident reports
• 9 Additional Reporting Considerations
  • 9.1 Submission of reports to manufacturers by hospitals
    • 9.1.2 Identification of duplicate reports associated with the same event submitted by different reporters
  • 9.2 Canadian Medical Devices Sentinel Network (CMDSNet)
• 10 Compliance and Enforcement
  • 10.1 Health Canada compliance and enforcement actions for hospitals
• Appendix 1 – Glossary: Acronyms, Definitions and Terminology
• Appendix 2 - Authorization for Reporting via a Third Party
• Appendix 3 - Summary of the reporting requirements for therapeutic products not subject to the mandatory reporting requirements for hospitals under section C.01.020(4) of the Food and Drug Regulations and section 61(4) of the Medical Device Regulations
• Appendix 4 - Quick Reference Guide

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Details and history

Published: June 26, 2019
Consulted: June 28, 2017

For assistance

Canada Vigilance Program
Health Products Surveillance and Epidemiology Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1908C
Ottawa, Ontario
K1A 0K9

E-mail: hc.canada.vigilance.sc@canada.ca
Telephone: 1-866-234-2345 (toll-free)
Facsimile: 1-866-678-6789

Hospitals

The regulations define a hospital as a facility that:

• is licensed, approved or designated as a hospital by a province or territory, in accordance with the laws of the province or territory, to provide care or treatment to persons suffering from any form of disease or illness; or
• is operated by the Government of Canada and provides health services to in-patients.