Lavallée Maude, Corbin Sonia, Pradhan Pallavi, Guefack Laura Blonde, Thibault Magalie, Méthot Julie, Bérard Anick, Piché Marie-Eve, Gimenes Fernanda Raphael Escobar, Darveau Rosalie, Cloutier Isabelle, Leclerc Jacinthe
Faculty of Pharmacy, Université Laval, Quebec, Quebec G1V 0A6, Canada.
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval, Quebec, Quebec G1V 4G5, Canada.
Int J Qual Health Care. 2024 Dec 25;36(4). doi: 10.1093/intqhc/mzae109.
An adverse event (AE) is any undesirable medical manifestation in an individual who has received pharmacological treatment. To be considered serious (SAE), it needs to meet minimally one of the severity criteria by Health Canada. The most recent data (2006) suggested that AEs were underreported (<6%) to health authorities. In Canada, since the implementation of Vanessa's Law (2019), hospitals are required to report SAEs; however, this law remains relatively unknown. The objectives of the study were: (i) to document the incidence of any AE and SAE over time in a 'real' clinical context, (ii) to quantify SAEs reported to Health Canada, and (iii) to assess whether Vanessa's Law has led to an increase in mandatory reporting to Health Canada.
We carried out a descriptive retrospective study at the Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, including 500 patients hospitalized between 1 January 2018 and 31 December 2021 and randomized into 4 cohorts (125 patients/year). Descriptive and comparative analyses were performed.
The characteristics of the cohorts were: 43.6% women; median age: 69 years (min-max: 21-96 years), number of comorbidities: 4 (1-12). During their hospitalization, patients consumed 18 different drug products (2-56) and the median of observed SAEs/patients was 0 (0-10) (total: 302). The overall percentage of SAEs reported to Health Canada was 0%, before and following the implementation of Vanessa's Law.
According to 500 electronic medical records, SAEs were underreported to Health Canada, even after the implementation of Vanessa's law.
不良事件（AE）是指接受药物治疗的个体出现的任何不良医学表现。若要被视为严重不良事件（SAE），则需至少符合加拿大卫生部的一项严重程度标准。最新数据（2006年）表明，向卫生当局报告的不良事件比例较低（<6%）。在加拿大，自《瓦妮莎法案》（2019年）实施以来，医院被要求报告严重不良事件；然而，这项法律仍然相对鲜为人知。本研究的目的是：（i）在“真实”临床环境中记录随时间推移的任何不良事件和严重不良事件的发生率，（ii）量化向加拿大卫生部报告的严重不良事件，以及（iii）评估《瓦妮莎法案》是否导致向加拿大卫生部的强制报告有所增加。
我们在魁北克大学拉瓦尔大学附属心脏病与肺病研究所开展了一项描述性回顾性研究，纳入了2018年1月1日至2021年12月31日期间住院的500例患者，并将其随机分为4个队列（每年125例患者）。进行了描述性和比较性分析。
各队列的特征为：女性占43.6%；中位年龄：69岁（最小 - 最大：21 - 96岁），合并症数量：4种（1 - 12种）。住院期间，患者使用了18种不同的药品（2 - 56种），观察到的严重不良事件/患者的中位数为0（0 - 10）（总计：302例）。在《瓦妮莎法案》实施之前和之后，向加拿大卫生部报告的严重不良事件的总体百分比均为0%。
根据500份电子病历，即使在《瓦妮莎法案》实施之后，严重不良事件向加拿大卫生部的报告率仍然很低。
