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- W1986278494 abstract "In pharmacovigilance, it has been recognized that it is essential to share the information regarding the risk of drugs among stakeholders and to have risk communication (RC) which enables consumers to make their own judgments regarding the risk. In particular, RC between the governmental agencies and consumers is given a high priority. Hence, its provisions and initiatives should be considered thoroughly. I present a brief overview of current proactive approaches for RC to protect the patient's rights, to increase openness and transparency and to share information in the US and EU. Following the Food and Drug Administration Amendment Act (FDAAA), Institute of Medicine of the National Academies (IOM) recommended that FDA makes efforts for RC. The RC Advisory Committee was established and consumers are involved as its members. FDA published Guidance Drug Safety Information in 2007 and Strategic Plan for RC in 2009. Thus, its framework has been developed. European Medicines Agency (EMA) issued Work programme 2010 and EMA Communication on safety related issues, which indicated its policies and measures. EMA is promoting development of the framework for Patient Involvement (e.g., members of scientific committees). Regarding the direct patient reporting of adverse drug reactions, FDA began that in 2003 and EMA recommends to encourage it for EU Member States, and it has already started in some countries. RC has important roles to take safety measures for drugs and to protect patient's rights, therefore such an approach for it be implemented is expected in Japan." @default.
- W1986278494 created "2016-06-24" @default.
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- W1986278494 date "2012-05-01" @default.
- W1986278494 modified "2023-09-27" @default.
- W1986278494 title "Risk Communication Efforts for Drug Safety in the US and EU, and Its Present Situation in Japan" @default.
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- W1986278494 doi "https://doi.org/10.1248/yakushi.132.533" @default.
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