CJC open · 2024
Impact of Vanessa's Law on the Reporting of Serious Adverse Events: A Retrospective Study Among Antiplatelet Users in a Tertiary-Care Cardiology Centre.
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Guefack Djiokeng Laura Blonde, Todkar Shweta, Corbin Sonia, Lavallée Maude, Pradhan Pallavi, Thibault Magalie, Piché Marie-Eve, Méthot Julie, Bérard Anick, Gonella Jennifer Midiani, Escobar Gimenes Fernanda Raphael, Darveau Rosalie, Cloutier Isabelle, Leclerc Jacinthe
Аннотация
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.
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.