Canada has long had a more open system for reporting and searching adverse drug events.  They provide an easy to use online form for healthcare providers and consumers to make direct reports, which contrasts significantly to the cumbersome reporting form provided by FDA here in the U.S.   They provide a web-based search tool that enables anyone to search through adverse event reports submitted to Health Canada.  Nothing like that exists from FDA in the U.S.

Now comes word that Canada is taking a step toward something that we’ve long believed to be a crucial factor in improving and increasing adverse event reporting – requiring reporting from healthcare providers. 

In both the U.S. and Canada, only pharma companies are currently required to report adverse events.  While reporting in the U.S. has increased dramatically over the past few years, issues of causality, accuracy, and report completeness persist.  The one reporting ‘class’ best equipped to combat those issues are front-line healthcare providers.

Requiring healthcare providers to promptly report drug and device adverse events to a regulatory body is a difficult ask – it takes time, effort, and money that healthcare providers scarcely have to spare.  Still, the Canadian government believes that requiring adverse event reporting will be time and money well spent.

The current proposed regulations are detailed in full here and summarized below:

  • Mandatory reporting requirements should apply to all hospitals that provide acute care services, as these hospitals are most likely to treat patients with serious ADRs and MDIs and are therefore well-positioned to make and report these observations.
  • By targeting hospitals that provide acute care services, there is also the potential to capture serious ADRs and MDIs that occurred from other institutions through patient transfers. 
  • Hospitals that provide acute care are more likely to have the infrastructure to effectively support quality serious ADR and MDI reporting. 
  • Outreach and education could be used effectively as tools in hospitals that provide acute care services for influencing health care professional reporting behavior with respect to both the identification of reportable events and recording the necessary information to ensure quality reporting. 
  • It is proposed that timelines for institutions to report be set at 30 days for both serious ADR and MDI reporting, with the  regulatory reporting time clock starting on the day on which the serious ADR/MDI is first documented.

The proposed regulations are in comment and revision stage right now, but it seems that this is on the glide path to ultimate approval and implementation.

It’s gratifying to see that Health Canada understands that underreporting of adverse drug events is a serious threat to patient safety and that requiring reporting can establish a framework for more accurate and timely action from regulatory bodies.

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I’m sure this topic will stir some conflicting viewpoints, so I’m curious to hear people’s thoughts about this in the comments.  Also, I would be interested to hear from anyone with first-hand knowledge of the actual status and timeframe for this proposed regulation.

It will be interesting to watch as this process is rolled out.  It will be even more interesting to see if FDA takes notice and considers following suit.  Selfishly, we certainly hope so.

To learn more about how Advera Health is helping to drive drug safety science forward, download our recent white paper, Drug Safety Data to Support the Entire Life-Cycle: An Introduction to Evidence Aggregation Platforms.

Topics: FDA, FAERS

Brian Overstreet

Written by Brian Overstreet