Risk Communication Regarding Drugs:The FDA Strategic Plan for Risk Communication
10.3820/jjpe.15.11
- VernacularTitle:医薬品に関するリスクコミュニケーション―米国FDAリスクコミュニケーション戦略計画を中心に―
- Author:
Michiko YAMAMOTO
;
Wakako HORIKI
;
Hiroki SUGIMORI
;
Takeo NAKAYAMA
- Publication Type:Journal Article
- Keywords:
risk communication;
FDA;
pharmacovigilance;
drug safety information;
consumer medication information
- From:Japanese Journal of Pharmacoepidemiology
2010;15(1):11-21
- CountryJapan
- Language:Japanese
-
Abstract:
In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.
