Abstract
BackgroundAntiplatelet 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 drugs-related side effects (mandatory reporting of serious adverse events [SAE]). ObjectiveTo determine whether Vanessa's Law has led to an improvement of SAEs reporting among antiplatelet users. MethodsDescriptive retrospective study was conducted from 01/2018 to 12/2021. 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 - Université Laval are included. The main diagnostic of hospitalization was coded using the International Classification of Diseases-10th revision, Canadian version (ICD-10-CA), and data relate to demographic characteristics, hospitalization length of stay, drugs administered, and AEs were extracted. ResultsThe 260 antiplatelet users were mainly hospitalized for diseases of the circulatory system (ICD-10-CA code [I00-I99]; 2018:75%; 2019:71%; 2020:71%; 2021:77%) or diseases of the respiratory system ([J00-J99], 2018:6%; 2019:8%; 2020:4%; 2021:7%). The median age was 70 years old. Median duration of hospital stay was 3 days. Among the 1,395 AEs recorded through the study, 12% were SAEs. None of the SAEs (or AEs) was reported to Health Canada, either before or after Vanessa’s Law implementation. ConclusionThese results provide the first picture of reporting trends for SAEs among antiplatelet users in Canada. There is a need to investigate the underreporting of SAEs, as the implementation of a mandatory policy does not seem to have had a favourable impact.
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