Health Canada Announces New Reporting Requirements for Hospitals


New regulations requiring hospital staff to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to Health Canada will take effect in December 2019.


Each event must be reported within 30 days of documentation at the institution where it occurred. The monitoring of therapeutic products plays an important role in public health and patient safety.

Reports of serious ADRs and MDIs help promote the safe use of health products by Canadians and may be the first sign of previously unrecognized rare or serious occurrences. Additionally, they help the Canadian government take action against products that may pose a risk to health and safety.


WHAT TO REPORT

The mandatory reporting requirements for hospitals apply to the following therapeutic products:

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

NOT NECESSARY TO REPORT

Hospitals are not required to report on:

  • semen and ova
  • cells, tissues and organs
  • blood and blood components
  • vaccines administered under a routine immunization program of a province or territory
  • natural health products
  • drugs and devices used under the Special Access Program for drugs, for clinical trials or investigational testing for medical devices.

When in doubt, Health Canada encourages hospitals to report. Further information on reporting an adverse reaction or medical device problem can be found on the Government of Canada website.