Triage individual case safety reports using prediction model

The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing world-wide. New methods are required to support scientific assessors in  processing these reports.

Currently, scientific assessors at the Pharmacovigilance Centre Lareb manually review the majority of received reports to decide which reports need further clinical assessment. Reasons for further clinical assessment are for instance that the report could lead to a safety signal. This triage of reports is a very labor-intensive process. To speed up this procedure and reduce the workload, we aimed to develop a prediction model to identify ICSRs that require clinical review.

The prediction model we have thus far is an important first step in the development of a tool that could assist scientific assessors in prioritizing reports. Further optimization of the model is required before the model can be implemented.

Read our full publication in Pharmacoepidemiology & Drug Safety.