Drug Evaluation Committee Points to keep in mind for formulating a drug risk management plan (RMP) based on 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 becoming more 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 following guidance from the Pharmaceutical Manufacturers Association of Japan (PMAJ), will provide more science-based information with a clear message to the medical community.

Points to keep in mind when formulating RMPs for utilization by healthcare professionals (377KB)

PMS Subcommittee of the Drug Evaluation Committee, Continuing Issues Response Team 1 (KT1)

The Pharmaceutical Manufacturers Association's Guidance on RMPs (as of March, 2017)

Objective	Guidance
Formulating a more science-based RMP	Developing a Drug Risk Management Plan: An Introduction - Minimum Preparation for Communication between Companies and PMDA (PMS Subcommittee KT1, published December 2016)
Formulating a more science-based RMP	Establishment of Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Plan (RMP) Practice (Published August 2014, Data Science Subcommittee TF1)
How to develop an RMP (focusing on your manners)	Guidance for Developing a Drug Risk Management Plan (RMP) - Tentative Version (Revised August 2014) - (Issued August 2014, prepared by PMS Subcommittee TF1).
Internal Operating Procedures for RMPs	Model for Operational Procedures for Drug Risk Management Plan." (Issued September 2014, prepared by PMS Subcommittee TF1)
Creating an RMP outline	Overview of the Pharmaceutical Risk Management Plan (RMP) -Consideration on Creation and Utilization (Issued May, 2015, prepared by PMS Subcommittee TF1)

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Drug Evaluation Committee Points to keep in mind for formulating a drug risk management plan (RMP) based on utilization by healthcare professionals

The Pharmaceutical Manufacturers Association's Guidance on RMPs (as of March, 2017)

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