Consultation paper on Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions

Health Canada is conducting a consultation on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs). The regulatory proposals are presented in the discussion paper titled Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions. The development of this paper has been informed by consultations with provincial and territorial ministries of health, health professional associations (including CSHP) and the general public since March 2015; an issue identification paper summarizes the feedback received with respect to how a new reporting requirement could affect the provincial and territorial healthcare environments.

As you know, Health Canada has no jurisdiction over healthcare delivery, solely over health products. Therefore the proposed regulatory changes pertain to the reporting of serious adverse drug reactions (i.e., drug toxicity), not to the reporting of serious adverse events (i.e., patient safety incidents, near misses and hazards = medication errors).

Before pre-publication of the proposed changes in Part I of the Canada Gazette, Health Canada is seeking feedback from stakeholders on the proposed design for regulations. Specifically, it is asking for comments in the following 5 areas:

  • the type of healthcare institution that should report;
  • the types of serious ADRs and MDIs that should be reported;
  • which health products should be reported on;
  • what information should be included in a report; and
  • what timelines for reporting should be in place.

Please forward your comments to Cathy Lyder (clyder@cshp.ca) by Tuesday, August 8, 2017.