Key result
Implementation of Vanessa's Law did not increase reporting, as 0% of serious adverse events among 260 hospitalized antiplatelet users were reported to Health Canada before or after the law.
Why the study?
Vanessa's Law introduced mandatory serious adverse event reporting to protect patients from drug side effects, but its effect on reporting among antiplatelet users was unknown.
Does the implementation of Vanessa's Law increase the reporting of serious adverse events among hospitalized antiplatelet users?
Observational (n=260)
No
Does the implementation of Vanessa's Law increase the reporting of serious adverse events among hospitalized antiplatelet users?
Absolute Event Rate: 0% vs 0%
The implementation of mandatory reporting policies (Vanessa's Law) did not improve the reporting of serious adverse events to Health Canada among hospitalized antiplatelet users, highlighting significant underreporting.
Vanessa's Law did not increase reporting in this cohort; leaves open whether mandatory policies can improve pharmacovigilance.
Background: Antiplatelet drugs, such as clopidogrel, ticagrelor, prasugrel, and acetylsalicylic acid, may be associated with a risk of adverse events (AEs). Vanessa's Law was enacted to strengthen regulations to protect Canadians from drug-related side effects (with mandatory reporting of serious adverse events [SAEs]). Objective: To determine whether Vanessa's Law has led to an increase in SAE reporting among antiplatelet users. Methods: This descriptive retrospective study was conducted from January, 2018-December, 2021. Included are 260 adult antiplatelet users (cohorts: 2018 [n = 64]; 2019 [n = 79]; 2020 [n = 73]; 2021 [n = 44]) hospitalized at the Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval. The main diagnostic of hospitalization was coded using the International Classification of Diseases,10th revision, Canadian version, and data related to demographic characteristics, hospitalization length-of-stay, drugs administered, and AEs were extracted. Results: The 260 antiplatelet users were hospitalized mainly for diseases of the circulatory system (codes [I00-I99]; 2018, 75 %; 2019, 71 %; 2020, 71 %; 2021, 77 %) or diseases of the respiratory system (codes [J00-J99]; 2018, 6 %; 2019, 8 %; 2020, 4 %; 2021, 7 %). The median age was 70 years. The median duration of hospital stay was 3 days. Among the 1395 AEs recorded during the study, 12 % were SAEs. None of the SAEs (or AEs) was reported to Health Canada, either before or after Vanessa's Law implementation. Conclusions: These results provide the first picture of reporting trends for SAEs among antiplatelet users in Canada. Investigation of the underreporting of SAEs is needed, as the implementation of a mandatory policy does not seem to have had a favourable impact. Clinical Trial Registration: 135263.
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Djiokeng et al. (2024) conducted an observational in Hospitalized antiplatelet users (n=260). Vanessa's Law implementation (mandatory reporting of serious adverse events) vs. Pre-Vanessa's Law period was evaluated on Reporting of serious adverse events to Health Canada. Implementation of Vanessa's Law did not increase reporting, as 0% of serious adverse events among 260 hospitalized antiplatelet users were reported to Health Canada before or after the law.
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