Drug Evaluation Committee Adverse Reaction Database (DB) Tool Terms of Use Creation Guide
Pharmacovigilance Subcommittee
June 2026
As of October 2023, 10 companies have already implemented so-called “Adverse Reaction Database (DB) Tools”—systems that allow healthcare professionals and medical representatives (MRs), among others, to view adverse reaction information collected by the companies.This is a next-generation safety information provision mechanism enabled by digital transformation (DX). While it has demonstrated benefits such as enabling timely information sharing and reducing inquiries to headquarters, there are concerns that data could be misinterpreted or taken out of context depending on how MRs present the information and how healthcare professionals interpret it.
The Adverse Event DB Tool is positioned as “supplementary information” to public information such as “electronic package inserts, RMPs, and RMP materials.”When implementing this system for the first time, proper operation—including compliance with the user terms of service and training to ensure such compliance—is essential. Given the various considerations involved in implementation, we have created a guide for drafting terms of service specifically designed for situations where “in-house personnel, such as MRs, present search results to healthcare professionals.” We hope this guide will serve as a reference for companies as they consider implementation in the future.
Terms of Use for the Adverse Reaction Database Tool (Draft)
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1.1The Adverse Reaction Database Tool provides supplementary information to basic public information such as electronic package inserts, RMPs, and RMP materials; therefore, users must always refer to the latest electronic package inserts, etc., when using this tool.
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1.2This tool is intended to provide information on proper use and must not be used for sales or promotional purposes.
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1.3Information must be presented as facts, without including the interpretations of the presenter (e.g., MRs).
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1.4Presentation to healthcare professionals for secondary use must comply with each company’s internal regulations.
(e.g., prohibition on disclosure, confirmation of purpose of use)
- *Please add additional notes as appropriate based on each company’s regulations and the information provided (it is acceptable to add the operational considerations from Chapter 2).
- *Sections 1.2 and 1.3 are linked to Section 1.1; they must be configured in conjunction with one another. Section 1.4 should be modified as appropriate in accordance with each company’s regulations.
- *Please note that this Terms of Use Creation Guide was prepared as a set of precautions for internal personnel, such as Medical Representatives (MRs), when using the Adverse Reaction Database (ARDB) tool to provide information to healthcare professionals; separate terms of use must be established for cases where healthcare professionals use the ARDB tool directly.
