Research on the Utilization of Risk Management Plan

Abstract

The purpose of this study was to examine the relationship between the revision of the information in the “Clinically Significant Adverse Reactions” section in the package insert and the description in the RMP at the time of drug approval, to verify the usefulness of the information in the RMP and propose a direction for the utilization of RMP. The subject drugs were ones containing new active ingredients approved from April 2013 until March 2016 that were listed in National Health Insurance Drug Price Standards and marketed as of March 31, 2021. The subject revisions of the package inserts were ones in the “Clinically Significant Adverse Reactions” section which were made during the reexamination period of the drug and notified by the Ministry of Health, Labour and Welfare. Of the 116 drugs, the package inserts of 37 (31.9%) drugs were revised. 30 (81.1%) of them for which the RMPs at the time of approval were available were included in the analysis. The 30 drugs had 54 revisions. 16 (29.6%) revisions of them were listed in RMP at the time of approval, and 15 of these revisions were already listed in the “Other Adverse Reactions” section etc. in each package insert before the revision. Among the many adverse reactions listed in the “Other Adverse Reactions” section, focusing on ones that are also listed in the RMP may provide more important information. This study has shown that the RMP is a useful source in addition to the package insert. The RMPs will be useful for monitoring the safety of drugs.