Saint-Vil Laurent, Jean-Baptiste Thaïna-Rafi, Martel-Côté Nicolas, Lebel Denis, Bussières Jean-François
, Unité de recherche en pratique pharmaceutique, département de pharmacie, CHU Sainte-Justine, et Faculté de pharmacie, Université de Montréal, Montréal (Québec).
, B. Sc., Unité de recherche en pratique pharmaceutique, département de pharmacie, CHU Sainte-Justine, Montréal (Québec).
Can J Hosp Pharm. 2024 Feb 14;77(1):e3489. doi: 10.4212/cjhp.3489. eCollection 2024.
Since 2019, health care facilities have been required to report serious adverse drug reactions (ADRs) to Health Canada.
To describe the availability of information required for reporting an ADR to Health Canada from medical records using 2 methods (systematic and in-depth reporting) and to compare the time required to find the information.
This retrospective and prospective descriptive study involved serious ADRs occurring in a mother-child centre and reported between April 1, 2021, and March 31, 2023. The variables needed to complete the Health Canada reporting form were collected using 2 distinct methods.
Among the 270 serious ADRs reported retrospectively, 140 were sampled. The average availability of variables was 82.3% (standard deviation [SD] 11.3%), with average data collection time of 50 (SD 25) minutes. For the prospective part of the study, 15 serious ADRs were studied. The availability of variables was 82.8% (SD 6.9%) and 91.9% (SD 7.8%), for systematic and in-depth reporting, respectively, with data collection times of 44 (SD 17) and 130 (SD 33) minutes, respectively.
The challenge of finding, in patients' medical records, all of the information needed for reporting an ADR to Health Canada required an in-depth approach. However, the in-depth method took 3 times as long as a search limited to places in the record where specific information should be found. To improve record keeping, additional training for clinicians could be considered and, potentially, development of a computerized clinical record that includes a dedicated form for documenting ADRs.
自2019年以来，医疗机构被要求向加拿大卫生部报告严重药物不良反应（ADR）。
使用两种方法（系统报告和深入报告）描述从医疗记录中获取向加拿大卫生部报告ADR所需信息的情况，并比较查找信息所需的时间。
这项回顾性和前瞻性描述性研究涉及2021年4月1日至2023年3月31日期间在母婴中心发生并报告的严重ADR。使用两种不同方法收集填写加拿大卫生部报告表所需的变量。
在回顾性报告的270例严重ADR中，抽取了140例。变量的平均可获得率为82.3%（标准差[SD]11.3%），平均数据收集时间为50（SD 25）分钟。对于研究的前瞻性部分，研究了15例严重ADR。系统报告和深入报告的变量可获得率分别为82.8%（SD 6.9%）和91.9%（SD 7.8%），数据收集时间分别为44（SD 17）分钟和130（SD 33）分钟。
要在患者的医疗记录中找到向加拿大卫生部报告ADR所需的所有信息存在挑战，这需要采用深入的方法。然而，深入方法所需时间是仅限于在记录中特定信息应所在位置进行搜索的3倍。为了改进记录保存，可以考虑对临床医生进行额外培训，并可能开发一种计算机化临床记录，其中包括用于记录ADR的专用表格。
