Education modules to meet requirements for mandatory hospital reporting

Hospitals must report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs). This reporting is mandated by under the following regulations:

• Food and Drug Regulations for serious adverse drug reactions
• Medical Devices Regulations for medical device incidents

Four modules on the new hospital reporting requirements have been developed to help hospitals, health care providers, patients/families and educators:

• explain the new reporting requirements
• promote the reporting of serious ADRs and MDIs

The modules are:

• Module 1 – overview of Vanessa's Law and reporting requirements
• Module 2 – reporting processes to Health Canada
• Module 3 – strategies to promote and support mandatory reporting
• Module 4 – Health Canada's review and communication of safety findings

They can be used as a set or as individual slides, depending on your needs. For example:

• Hospitals - share information at local, regional or provincial lunch and learn sessions, presentations or staff orientation programs
• Health care educators – use in presentations or as part of a curriculum
• Professional associations, regulatory organizations and training colleges for health care workers – include in accredited courses or continuing education certification programs
• Patient and consumer organizations – circulate to raise awareness

For more information on how to use these modules for your specific needs, please contact:

• email: hc.canada.vigilance.sc@canada.ca
• phone: 1-866-234-2345

Related links

• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals (poster)
• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - overview