Analysis and Recommendations of Risk Minimization Materials

Abstract

Risk management plan may require elements to assure safe use such as mandatory training for prescribing physicians, preparation of instructions for additional Risk Minimization Measures (aRMM). In order for additional Risk Minimization Measures to be effective, it is necessary for the instructions to reach, use, understand, and act on the target person. According to our research, it is possible that aRMM instructions have not been sufficiently delivered to physicians or pharmacists. Organizations such as building a risk management system by team medical care and implementing using an electronic medical record system in order to reliably and efficiently carry out the clinical examination necessary for managing identified risk described in aRMM instructions in busy medical setting. RMP Guide for Patients should be structured so that it is easy to understand the roles and actions that patients should play in order to minimize identified risk. It was found that the necessary knowledge was described in the latter half of the RMP Guide for Patients, and the situation was dominated by other information. In some cases, RMP Guide for Patients were set for potential risks. It is considered that the aRMM for potential risks may not lead to the correct understanding of physicians and pharmacists because the reason why it is necessary is not fully explained. In order to resolve these issues, it was considered necessary for stakeholders belonging to pharmaceutical companies, healthcare professionals, and regulatory agencies to work to foster mutual understanding regarding the implementation of RMP and the confirmation of its effectiveness.