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Improving the Reporting and Assessment of Harms

Monday July 15th – 15:30

Draft Abstract

Individual case reports of suspected harm from medicines are collected worldwide and shared internationally. They inform most drug regulatory safety decisions, and ideally provide just the right information to assess causality in a specific case. However, many reports lack key information including what the reporter found interesting with the case, what made them think the drug had caused the adverse event and which other possible causes (if any) they had ruled out in their assessment.

At the same time, electronic medical records and commercial claims databases are a source of routinely collected health data that may complement individual case reports, and that have been actively researched in international collaborations. However, these data are collected for administrative purposes without consideration of subsequent causality assessment, so must be interpreted with caution – diagnosis codes do not always reflect the real conditions of the patient and recorded dates may not correspond to when the drug was started or the adverse event first occurred.

Beyond that, there are initiatives to use mobile devices and wearables to capture information related to suspected harm from medicines, and to identify or better understand adverse reactions to medicines from patient-generated information on the internet.

This will be an open discussion with three brief initial presentations after which all participants are encouraged to engage and contribute to a discussion of a vision for how the reporting and assessment of harm may best be done in the future.

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