https://orcid.org/0000-0002-6639-7210
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Linda Velta Graudins, Adverse medication reactions: raising a red flag locally, sharing lessons globally, and improving safety and quality in health care, International Journal for Quality in Health Care, Volume 37, Issue 1, 2025, mzae117, https://doi.org/10.1093/intqhc/mzae117
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The study by Lavallee et al. (2024) [1], just published in the Journal, describes an audit of medication-related serious adverse events (SAEs) to evaluate the effect of ‘Vanessa’s law’ (the Protecting Canadians from Unsafe Drugs Act) on SAE reporting. The law, implemented in 2019, requires reporting of serious medication-related adverse reactions to Health Canada. Extended in 2023 to mandate reporting of events involving ‘ņatural health’ products, it includes fines for noncompliance of up to 5 million dollars or 2 years in prison [2]. The law was passed after the death of Vanessa Young, attributed to cisapride-induced arrhythmia. In the same year, following years of reported fatal adverse reactions and significant medication interactions, cisapride was withdrawn from the global market [3].
Despite the Canadian requirement for mandatory reporting [4], Lavallee et al. identified 302 SAEs, none of which had been reported to Canada Health. In fact, in the 2 years after the enactment, 76 SAEs had been reported by their institution to Health Canada, none of which were detected in the study sample. The red flag flown by Lavallee et al. indicates that mandating was not the answer to improving pharmacovigilance. It may seem a forcing function to increase reports, but without enforcement, mandating had limited effectiveness.
