We used a clinical database to investigate the relationship between a PMDA alert and changes in monitoring behavior for hepatitis B infection in patients receiving immunosuppressive agents. We also investigated this relationship in subgroups stratified by type of disease or immunosuppressive drug.

Results indicated that a clinical database could be used to quantitatively verify the impact of risk minimization activities like this alert, which could support implementation of future risk minimization activities and verification of their impact.

Although the use of clinical databases to measure the effectiveness of risk minimization activities in pharmacovigilance is necessary for the appropriate use of drugs, the use of clinical databases is not yet common in Japan. We expect this study to encourage similar research in the future.