抄録
Among various sources of information on ethical drugs, many medical personnel refer to the “package insert” in many occasions because of its reliability and availability. Every new drug is subject to “re-examination” usually after 8 years of marketing approval, in which its efficacy and safety are reexamined based on data obtained from post-marketing studies and others. The package insert is usually revised based on the result of re-examination and the revised insert contains information on adverse drug reactions reported both in clinical trials for marketing approval and post-marketing studies. Therefore the revision may be considered to be a major milestone, which provides a general idea of the safety profile of a new drug at marketing approval as well as after being on the market. In the present study, we compared adverse drug reaction rates at the time of new drug approval and at re-examination based on the revised package inserts to which safety information from postmarketing studies was added. The result showed that the rate of adverse drug reactions at re-examination had decreased compared to that at marketing approval for most of the new drugs investigated. In recent years, more and more new drugs are approved with less domestic clinical trial data. Therefore, pharmacists, as specialists on pharmaceuticals, are expected to understand correctly and provide safety information on pharmaceuticals based on proper understanding of the background of new drug development and not solely confined to the figures in the package inserts.
(Jpn J Clin Pharmacol Ther 2013; 44(6): 463-468)
