日本の医薬品添付文書における使用上の注意（臨床検査結果に及ぼす影響，過量投与，臨床成績，その他の注意）の記載内容に関する研究
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概要
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Purpose: To investigate better ways of providing information in package inserts for prescription drugs to make them easier for medical staff to use.Methods: We investigated 100 randomly selected medicines, with or without high alert, to determine how frequently the four items: lab test considerations; overdosage; clinical studies; and miscellaneous information, are printed in the package inserts. We also sent a questionnaire to physicians and pharmacists at three hospitals in Showa University to investigate how these four items are being used.Results: Documentation for lab test considerations, overdosage, clinical studies, and miscellaneous information, was included in 7%, 58%, 71%, and 92% of inserts, respectively. Response rate for physicians was 68% (198 of 290 questionnaires were returned) and 100% for pharmacists (107 of 107 questionnaires were returned). Collected data suggested that only half of physicians who participated in the study used the four insert items being investigated in this study. One reason given for items not being used was that the clinician had no opportunity for use. Forty-three percent of physicians and 69% of pharmacists reported that they were able to access the information they needed. It was also suggested that categories for which there was no information should be listed with contact details for alternative information sources.Conclusion: The results above demonstrate that product information is useful and itemization of practical documentation would be helpful in providing medication to patients. Numbering of each item in package inserts is also helpful, and items for which there is no clinical information should also be included and the lack of information documented.(Jpn J Clin Pharmacol Ther 2013; 44(6): 451-458)
- 一般社団法人 日本臨床薬理学会の論文
一般社団法人 日本臨床薬理学会 | 論文
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