2022 Volume 12 Issue 2 Pages 209-220
The risk minimization measures, which is one of the three components of the risk management plan (RMP), is classified into two types: routine and additional. In daily medical practice, various materials for healthcare professionals and patients are distributed in addition to the materials specified in RMP. Most of these materials are well documented; however, it is unclear how effective they are in preventing the occurrence of important risks and reducing their severity at the time of occurrence, which is the original purpose of risk minimization. In Europe and the United States, it is stipulated that companies should formulate additional risk minimization measures proportionate to the risk characteristics and evaluate their effectiveness after considering the impact on the resources of healthcare workers and patients and their feasibility. In this paper, we summarize the research results regarding the optimization of risk minimization measures and the evaluation of their effectiveness conducted under a research grant from the Japan Agency for Medical Research and Development (AMED), and introduce recommendations for improvement in Japan.
