Using Data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for Drug Safety Research: A Feasibility Study.

Pharmaceutical Medicine
Samuel AkinolaJacinthe Leclerc

Abstract

Post-marketing studies involve the detection and interpretation of potential problems associated with the use of a given drug. Post-marketing spontaneous pharmacovigilance systems, such as the Canada Vigilance program, may constitute a gold mine of free data for drug safety research. However, the quantity and the quality of data remain to be demonstrated. To assess the feasibility to use the Canada Vigilance database for academic drug safety research, and to document the characteristics of data that are extractable. This is a descriptive retrospective analysis study design. The beta-blocker and anticoagulant adverse reactions (AR) in Canada were analyzed. Tests for data extraction from the Canada Vigilance database were performed in October 2019; data were then available from January 1, 1966 to June 30, 2019. There were 41 variables with extractable data. For anticoagulants, data were extracted in Excel and.pdf file format, while it was only plain text.pdf files for beta-blockers. Overall, there were 4707 reported ARs with the use of anticoagulants and 6332 cases reported for beta-blockers. The trend of ARs related to anticoagulants steadily increased in the study period, with a notable increase in 2009 while direct oral antico...Continue Reading

References

Nov 8, 2017·The Canadian Journal of Cardiology·Justin A EzekowitzBruce Sussex
Nov 25, 2018·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Jacinthe LeclercPaul Poirier

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