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

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.