医療用医薬品添付文書の課題 〜承認条件の在り方に関する検討〜

Abstract

Background: The guidelines for prescription drug labeling were developed by the Ministry of Health and Welfare in 1997. More than ten years have passed, and various problems have arisen in the use of the prescription drug labels in clinical practice. The purpose of this study was to extract the problems regarding conditions for approval and to consider the measures for improvement.Methods: A questionnaire survey on the attitudes of hospital pharmacists, community pharmacists, and doctors towards the conditions for approval for prescription drug labeling was conducted. The conditions for approval regarding newly approved drugs from March 2009 to March 2011 were also surveyed.Results: In this survey, 43.3% of hospital pharmacists, 18.6% of community pharmacists, and 20.3% of doctors were aware that the conditions for approval are described in the prescription drug labels. Thirty-six of 131 newly approved drugs had 65 conditions for approvals, 60 (92.4%) of which concerned the appropriate use in clinical practice.Conclusion: In order to attract medical professionals' attention, the conditions for approval should be described in the first part of the label. In addition, the contents of the conditions for approval should be described in a user friendly manner for health care professionals. Since there are some differences in the frequency of using the labels between pharmacists and doctors, if pharmacists would have a good understanding of the conditions for approval and communicate the contents to doctors, this may contribute to improve doctor's recognition of the conditions for approval. (Jpn J Clin Pharmacol Ther 2012; 43(6): 381-386)