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Development of an automated process for performing pharmacovigilance case assessments Cooke, Kendrick
Abstract
Pharmacovigilance is the reporting and documentation of adverse drug events. The effective tracking of these events is crucial for ensuring drugs in Canada are safe and effective for Canadians. Pharmaris Canada’s adverse event tracking from the Canada Vigilance database is done through manual data entry. This process is tedious, laborious, and prone to human error. The purpose of this project is to eliminate the need for manual data entry in pharmacovigilance for Pharmaris, an industry partner of UBCs, and to investigate how the implementation of an automated method would increase the efficiency and accuracy of the Canada Vigilance case assessment. An automated method was developed using R. The automated method proposed showed good accuracy compared to the manual case assessment process. A comparison between the differences of the methods was reported and found that there were some discrepancies between the two methods. The assessment of these methods was not accurate due to the differences in export data from the automated and manual methods. After adjusting the results for these time discrepancies, the automated method produced the same adverse reaction case assessment summary statistics as the manual method. By automating the assessment of the Canada Vigilance adverse event cases Pharmaris will be able to assess the cases much more efficiently, saving time and more accurately tracking Canada Vigilance adverse events.
Item Metadata
Title |
Development of an automated process for performing pharmacovigilance case assessments
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Creator | |
Date Issued |
2024-04
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Description |
Pharmacovigilance is the reporting and documentation of adverse drug events. The effective
tracking of these events is crucial for ensuring drugs in Canada are safe and effective for
Canadians. Pharmaris Canada’s adverse event tracking from the Canada Vigilance database is
done through manual data entry. This process is tedious, laborious, and prone to human error.
The purpose of this project is to eliminate the need for manual data entry in pharmacovigilance
for Pharmaris, an industry partner of UBCs, and to investigate how the implementation of an
automated method would increase the efficiency and accuracy of the Canada Vigilance case
assessment. An automated method was developed using R. The automated method proposed
showed good accuracy compared to the manual case assessment process. A comparison
between the differences of the methods was reported and found that there were some
discrepancies between the two methods. The assessment of these methods was not accurate
due to the differences in export data from the automated and manual methods. After adjusting
the results for these time discrepancies, the automated method produced the same adverse
reaction case assessment summary statistics as the manual method. By automating the
assessment of the Canada Vigilance adverse event cases Pharmaris will be able to assess the
cases much more efficiently, saving time and more accurately tracking Canada Vigilance adverse
events.
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Genre | |
Type | |
Language |
eng
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Series | |
Date Available |
2025-04-30
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution-NonCommercial-NoDerivatives 4.0 International
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DOI |
10.14288/1.0448656
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URI | |
Affiliation | |
Peer Review Status |
Unreviewed
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Scholarly Level |
Undergraduate
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Rights URI | |
Aggregated Source Repository |
DSpace
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Item Media
Item Citations and Data
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International