Underreporting of adverse events to health authorities by healthcare professionals: a red flag-raising descriptive study.

ABSTRACT:

Background

An adverse event (AE) is any undesirable medical manifestation in an individual who has received pharmacological treatment. To be considered serious (SAE), it needs to meet minimally one of the severity criteria by Health Canada. The most recent data (2006) suggested that AEs were underreported (<6%) to health authorities. In Canada, since the implementation of Vanessa's Law (2019), hospitals are required to report SAEs; however, this law remains relatively unknown. The objectives of the study were: (i) to document the incidence of any AE and SAE over time in a 'real' clinical context, (ii) to quantify SAEs reported to Health Canada, and (iii) to assess whether Vanessa's Law has led to an increase in mandatory reporting to Health Canada.

Methods

We carried out a d

SUBMITTER: Lavallee M 

PROVIDER: S-EPMC11879413 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature