杉森 裕樹 スポーツ・健康科学部 看護学科 教授
Pharmaceutical company perspectives on current safety risk communications in Japan.
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
Urushihara H(1), Kobashi G(2), Masuda H(3), Taneichi S(4), Yamamoto M(5),Nakayama T(6), Kawakami K(1), Matsuda T(2), Ohta K(3), Sugimori H(4).
共著 Springerplus 24(3),pp.51 2014/01
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