Disponibilité de l'information médicale requise pour la déclaration d'une réaction indésirable médicamenteuse à Santé Canada: une étude exploratoire.

Abstract

Background: Since 2019, health care facilities have been required to report serious adverse drug reactions (ADRs) to Health Canada.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.