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A Comparative Study of the Communication of Drug Safety Information by Governmental Agencies in Japan and Western Countries: The Case of Asthma Medications

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Abstract

Drug safety information (DSI) aimed ut health professionals and patients is crucial for providing appropriate treatment. It is important to evaluate whether the communication of DSI issued by regulatory agencies is adequate. We investigated DSI communicated through the Internet by official bodies in Japan and in several Western countries from 2000 to 2006, with regard to medicines recommended by therapeutic guidelines for the long-term management of asthma. Furthermore, if there were differences, we investigated how they arose. In Japan, DSI from the evidence of clinical studies conducted outside the country has a tendency to be issued with a significant time lag when compared with Western countries. However, the Japanese agency tended to provide rapid dissemination of adverse reactions to drugs commonly used in Japan. Although there are several types of official DSI provided in Japan, duplication often results in unnecessary complexity for health professionals, and there is no DSI issued directly to patients. Thus, Japan needs to provide DSI in a form that is more accessible and comprehensive to both health professionals and consumers.

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Authors and Affiliations

  1. Faculty of Pharmaceutical Sciences, Suzuka University of Medical Sciences, Mie, Japan

    Michiko Yamamoto PhD

  2. Division of Safety Information on Drug, Food and Chemicals, National Institute of Health Sciences, Tokyo, Japan

    Michiko Yamamoto PhD

  3. Department of Health Informatics, Kyoto University of Public Health, Yoshida-Konoe, Sakyo-ku, City of Kyoto, 606-8501, Japan

    Takeo Nakayama MD, PhD

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  1. Michiko Yamamoto PhD
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  2. Takeo Nakayama MD, PhD
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Correspondence to Takeo Nakayama MD, PhD.

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Yamamoto, M., Nakayama, T. A Comparative Study of the Communication of Drug Safety Information by Governmental Agencies in Japan and Western Countries: The Case of Asthma Medications. Ther Innov Regul Sci 42, 583–596 (2008). https://doi.org/10.1177/216847900804200612

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