title: Pharmaceutical company perspectives on current safety risk communications in Japan.
abstract: In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501 Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Urushihara
authors.affiliation: Department of Pharmaceutical and Medical Device Regulatory Science, Graduate School of Medical Science, Yamagata University, Iida-Nishi, Yamagata, Yamagata, 990-9585 Japan.
authors.forename: Gen
authors.initials: G
authors.lastname: Kobashi
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Anagawa, Inage-ku, Chiba, 263-8555 Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Masuda
authors.affiliation: Department of Preventive Medicine, Graduate School of Sports and Health Science, Daito Bunka University, 560 Iwadono, Higashi-Matsuyama-shi, Saitama, 355-8501 Japan.
authors.forename: Setsuko
authors.initials: S
authors.lastname: Taneichi
authors.affiliation: Education Centre for Clinical Pharmacy Practice, Showa Pharmaceutical University, Higashi-Tamagawagakuen, Machida, Tokyo, 194-8543 Japan.
authors.forename: Michiko
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Department of Health Informatics, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501 Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501 Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Kawakami
authors.affiliation: Department of Pharmaceutical and Medical Device Regulatory Science, Graduate School of Medical Science, Yamagata University, Iida-Nishi, Yamagata, Yamagata, 990-9585 Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Matsuda
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Anagawa, Inage-ku, Chiba, 263-8555 Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Ohta
authors.affiliation: Department of Preventive Medicine, Graduate School of Sports and Health Science, Daito Bunka University, 560 Iwadono, Higashi-Matsuyama-shi, Saitama, 355-8501 Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Sugimori
keywords: Drug company; Drug risk; Questionnaire survey; Regulation; Safety communication