Development of an automated process for performing pharmacovigilance case assessments

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.