Samuel Akinola1, Carolina Galli da Silveira2, Sonia Corbin3, Maude Lavallée3, Magalie Thibault3, Jennifer Gonella2, Fernanda Raphael Escobar Gimenes2, Jacinthe Leclerc4,5,6. 1. Department of Nursing, Faculty of Health Sciences, University of Pécs, Pécs, Hungary. 2. Ribeirão Preto College of Nursing, University of São Paulo, Riberao Preto, Brazil. 3. Département des Sciences infirmières, Université du Québec à Trois-Rivières, 3351, Boul. Des Forges, Local 4849, Santé, C.P. 500, Trois-Rivières, QC, G9A 5H7, Canada. 4. Département des Sciences infirmières, Université du Québec à Trois-Rivières, 3351, Boul. Des Forges, Local 4849, Santé, C.P. 500, Trois-Rivières, QC, G9A 5H7, Canada. Jacinthe.leclerc@uqtr.ca. 5. Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Canada. Jacinthe.leclerc@uqtr.ca. 6. Faculté de Pharmacie, Université Laval, Québec, Canada. Jacinthe.leclerc@uqtr.ca.
Abstract
INTRODUCTION: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 anticoagulants were marketed. The proportion of missing data varied from 0 to 98%, but most important variables were all available. It was not possible to distinguish brand names and generic drugs in the database. CONCLUSION: It seems feasible to use data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for academic drug safety research. Upcoming studies should validate the quality of reports compared to actual medical charts.
INTRODUCTION: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 anticoagulants were marketed. The proportion of missing data varied from 0 to 98%, but most important variables were all available. It was not possible to distinguish brand names and generic drugs in the database. CONCLUSION: It seems feasible to use data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for academic drug safety research. Upcoming studies should validate the quality of reports compared to actual medical charts.