Drug Evaluation Committee Considerations for the Development of a Pharmaceutical Risk Management Plan (RMP) Based on the Utilization by Healthcare Professionals
Pharmacovigilance Subcommittee
March 2017
Regarding the utilization of RMPs, in December 2014, the Japan Hospital Pharmacists Association issued a proposal for the utilization of RMPs for hospital pharmacist services. In this proposal, RMPs are positioned as a useful source of information for understanding risks during new drug hearings, providing information to patients, and monitoring patients in hospital wards. The survey results also indicate that pharmacists are increasingly aware of and utilizing RMPs.
On the other hand, some pharmaceutical companies that create RMPs still consider them only as a communication tool with the authorities, and are not fully aware that they are also a communication tool with healthcare professionals.
Therefore, with the aim of further promoting the use of RMPs in medical institutions, we have compiled a list of points to keep in mind when formulating RMPs, taking into account their use by healthcare professionals.
These points to keep in mind were prepared based on the results of a survey conducted by the Japan Agency for Medical Research and Development (AMED) in FY 2015 and other information received from healthcare professionals. In preparing this document, we also exchanged opinions in advance with the Japan Hospital Pharmaceutical Association, which issued the above-mentioned proposal for the utilization of RMPs following the "Outline of RMPs". We hope that the contents of the RMP, together with the JPMA guidance below, will provide more science-based information and have a clear message to the medical community.
Drug Evaluation Committee PMS Subcommittee Continuing Issues Team 1 (KT1)