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ORIGINAL RESEARCH article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1465313
This article is part of the Research Topic Errors and Biases in Modern Healthcare: Public Health, Medico-legal and Risk Management Aspects View all 4 articles

Has risk management plan system influenced the speed of package insert revisions in Japan?

Provisionally accepted
Natsuko Kameyama Natsuko Kameyama 1,2Aoi Hosaka Aoi Hosaka 1Hideki Maeda Hideki Maeda 1*
  • 1 Meiji Pharmaceutical University, Kiyose, Japan
  • 2 CMIC Co., Ltd., Tokyo, Japan

The final, formatted version of the article will be published soon.

    The system of Risk Management Plan in Japan (J-RMP) is a relatively new system, implemented in 2013; thus, its effect on safety measures is still unclear. One of the purposes of J-RMP is to enhance the postmarketing safety measures to be ensured by publishing J-RMP and sharing information on risk management among healthcare professionals. We hypothesized that this might enable information about postmarketing adverse events to be accumulated rapidly, potentially accelerating the identification of adverse reactions (ARs). Herein, we focused on the speed of adding clinically significant ARs (CSARs) to package inserts (PIs) as an indicator of the rapidity of AR identification, investigated the impact of the J-RMP system on PI revisions. Methods: We investigated the "Notice of Revision of Precautions" on the website of Pharmaceuticals and Medical Devices Agency (PMDA), targeting PI revisions with the addition of CSARs from April 2003 to March 2023, which corresponds to 10 years before and after J-RMP implementation in April 2013. We created an original database from public information of PMDA and investigated the speed of adding CSARs to PIs.Results: Comparing the time lapse from drug approvals to PI revisions after J-RMP implementation to that before implementation, the median value was 32 months vs. 32 months (149 vs. 318 cases), and no significant difference was observed. Regarding the time lapse when the additional CSARs were listed and unlisted as safety concerns at the time of approvals, it was 35 months vs. 32 months (14 cases vs. 126 cases, p = 0.7820), with no statistically significant difference. Conversely, there were significant differences within each AR and each drug therapeutic category.Discussion and Conclusions: This study revealed that the rapidity of risk identification as ARs was not affected by J-RMP, and it may be affected by the characteristics of each AR and each drug therapeutic category. It is expected that other J-RMP benefits, such as risk prevention before the occurrence, will be utilized to further develop strategies for the effective utilization of the J-RMP for safety measures in Japan.

    Keywords: risk management plan in Japan, Risk management plan, package insert revision, adverse reaction, drug safety, Pharmacovigilance

    Received: 16 Jul 2024; Accepted: 18 Oct 2024.

    Copyright: © 2024 Kameyama, Hosaka and Maeda. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Hideki Maeda, Meiji Pharmaceutical University, Kiyose, Japan

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.