Drug Evaluation Committee Slide "Provision of Adverse Reaction Information: The Way of Information Provision for the Next Generation" (July 25, 2025, 16th Annual Meeting of the Japanese Association of Pharmaceutical Medicine)
Pharmacovigilance Subcommittee
August 2025
This document consists of lecture slides at the following symposium.
Annual Meeting of the Japanese Association of Pharmaceutical Medicine
"Delivering the Drug Information Patients Need - From a Pharmaceutical Company's Perspective" (July 25, 2025, 16th Annual Meeting of the Japanese Association of Pharmaceutical Medicine)
With the introduction of innovative new drugs, the provision of drug safety information is becoming increasingly important to ensure appropriate treatment choices and patient safety. Pharmaceutical companies are required to provide information necessary for the proper use of drugs. In recent years, an increasing number of companies have introduced "adverse drug reaction DB tools" that allow medical professionals and MRs to view information in each company's adverse drug reaction database (DB) and provide information.
The first half of the presentation reported the results of a survey conducted by the Pharmaceutical Manufacturers Association of Japan (PMAJ) in 2023 to understand the needs of healthcare professionals regarding drug safety information. This survey was conducted on physicians (252 respondents) and pharmacists (109 respondents) regarding the criteria and information sources they consider important when obtaining safety information. The survey results indicate that both physicians and pharmacists have a high need for safety information, with particular need for information on the frequency of adverse drug reactions, how to deal with them, and when they occur. On the other hand, the criteria and information sources emphasized when obtaining safety information tended to differ between physicians and pharmacists during and after office hours, as well as between physicians and pharmacists. Based on these results, the current status and issues of safety information provision in medical practice were summarized, and more appropriate ways of providing information were discussed.
The latter half of the presentation summarized the results of a questionnaire survey on the "Adverse Reaction DB Tool," which was conducted in October 2023 among 75 member companies of the PV Committee of the Pharmaceutical Manufacturers Association of Japan. 10 companies had already introduced the tool and 10 companies were considering its introduction. While the introduction of the tool has shown positive effects, such as timely provision of information and reduction of inquiries to the head office, some companies expressed concern about the regulatory operation, such as preventing the data from becoming proprietary and misinterpreted. In this presentation, the rules and precautions that should be followed to appropriately utilize adverse drug reaction DB tools were discussed.
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