Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013-2023.

Abstract

Background: A decade since Japan introduced risk management plans offers an opportunity to analyze their characteristics and support future pharmacovigilance efforts.

Objectives: To describe (1) the types of post-marketing studies (PMSs) and the number of safety concerns and efficacy concerns by drug classification and (2) the distribution of important identified and important potential risks by type of safety concern.

Methods: We extracted data and examined the characteristics of the Japanese risk management plans (J-RMP). The following information from J-RMPs available as of May 2023 and the corresponding package inserts of the drugs was extracted: the brand name, the active ingredient, the first submission and the last update dates of J-RMP, safety concerns with their safety specifications, efficacy concerns, the type of PMSs, and the drug classification codes.

Results: A total of 637 J-RMPs were included in the analysis. The median number of safety and efficacy concerns per J-RMP was 8, with category-specific medians as follows: 4 important identified risks, 2 important potential risks, 0 important missing information, and 1 efficacy concerns. Among the 481 J-RMPs listing at least one PMS, 86.5% included only use-result surveys (primary data collection), 9.4% included only database PMSs, and 4.2% included both. Safety concerns related to neoplasms and pregnancy/birth defects were most commonly listed as important potential risks.

Conclusions: Japanese PMSs more commonly rely on primary data collection. Adverse events with delayed effects tend to be classified as important potential risks. The information contained in J-RMPs is valuable for gaining insights into pharmacovigilance activities.