Impact of Vanessa's Law on the Reporting of Serious Adverse Events: A Retrospective Study Among Antiplatelet Users in a Tertiary-Care Cardiology Centre

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CJC Open Pub Date : 2024-12-01 DOI:10.1016/j.cjco.2024.09.003

Laura Blonde Guefack Djiokeng BSc , Shweta Todkar RN, PhD , Sonia Corbin RN, BSc , Maude Lavallée RN, MSc , Pallavi Pradhan MSc , Magalie Thibault BA, MSc , Marie-Eve Piché MD, PhD , Julie Méthot BPharm, PhD , Anick Bérard PhD , Jennifer Midiani Gonella RN, PhD , Fernanda Raphael Escobar Gimenes RN, PhD , Rosalie Darveau PharmD, MSc , Isabelle Cloutier BPharm, MSc , Jacinthe Leclerc RN, PhD

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引用次数: 0

Abstract

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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凡妮莎法律对严重不良事件报告的影响：在三级保健心脏病中心抗血小板使用者中的回顾性研究。

背景：抗血小板药物，如氯吡格雷、替格瑞、普拉格雷和乙酰水杨酸，可能与不良事件（ae）的风险相关。凡妮莎法案的颁布是为了加强监管，保护加拿大人免受与药物有关的副作用（强制报告严重不良事件[SAEs]）。目的：确定凡妮莎定律是否导致抗血小板使用者中SAE报告的增加。方法：描述性回顾性研究于2018年1月- 2021年12月进行。纳入260名成人抗血小板使用者(队列：2018年[n = 64]；2019 [n = 79]；2020 [n = 73]；2021年[n = 44])在拉瓦尔大学心脏病和肺病研究所住院。使用国际疾病分类，第10版，加拿大版对住院的主要诊断进行编码，并提取与人口统计学特征、住院时间、给药和ae相关的数据。结果：260例抗血小板使用者住院主要原因为循环系统疾病(代码[I00-I99]；2018年，75%；2019年，71%；2020年，71%；2021, 77%)或呼吸系统疾病(代码[J00-J99]；2018年，6%；2019年，8%；2020年，4%；2021年，7%)。中位年龄为70岁。中位住院时间为3天。在研究期间记录的1395例ae中，12%为sae。在凡妮莎的法律实施之前或之后，都没有向加拿大卫生部报告任何突发事件（或突发事件）。结论：这些结果提供了加拿大抗血小板使用者中SAEs报告趋势的第一张图片。由于强制性政策的实施似乎并没有产生有利的影响，因此需要对sae的少报情况进行调查。临床试验注册：135263。

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