<b>A Proposal of New Prescription Drug Labeling </b>

DOI 1 Citations
  • KOBAYASHI Eriko
    Department of Clinical Education and Research, Graduate School of Pharmaceutical Sciences, Chiba University
  • ASADA Kazuhiro
    Post Marketing Surveillance Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • ABE Tomomi
    Department of Clinical Education and Research, Graduate School of Pharmaceutical Sciences, Chiba University
  • ARATA Naoko
    Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development
  • OYAMA Kunio
    Center for the Advancement of Pharmaceutical Education, Department of Pharmacy, Tokyo University of Pharmacy and Life Science
  • KAWAKAMI Akemi
    Department of Pharmacy Services, Showa University Hospital
  • KUDO Kenzo
    Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University
  • KOMURA Makoto
    Department of Pharmacy, National Center for Child Health and Development
  • SHIMADA Yasuhiro
    National Cancer Hospital, Department of Gastrointestinal Medical Oncology
  • TORIYAMA Satsuki
    Post Marketing Surveillance Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • HATTORI Yoko
    Post Marketing Surveillance Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
  • MIYAMURA Mitsuhiko
    Kochi Medical School Hospital
  • MURASHIMA Atsuko
    Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development
  • MURAYAMA Jun-Ichiro
    Department of Pharmacy Services, Showa University Hospital Department of Hospital Pharmaceutics, School of Pharmacy, Showa University
  • SATOH Nobunori
    Department of Clinical Education and Research, Graduate School of Pharmaceutical Sciences, Chiba University

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Other Title
  • <b>新しい医療用医薬品添付文書モデル(案)の提案 </b>

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Abstract

Prescription drug labeling currently used in clinical practice is legally required drug information, and is regulated by the MHLW notification entitled “Guidance to describe prescription drug labeling” issued in 1997. Previous research has revealed that the majority of physicians and pharmacists, who are real users of the drug labeling, acknowledged the importance of drug labeling and recognized that the order of description in the labeling is appropriate. However, over a half of them did not recognize that “conditions for approval” are described in the labeling. The aim of the present study was to develop new format and contents of prescription drug labeling and to verify the new labeling by a large-scale questionnaire survey on physicians and pharmacists who work in clinical practice. New format and contents of prescription drug labeling were created to solve the problems indicated by previous studies. The questionnaire was distributed by post to 2,004 physicians and pharmacists to verify the new format and contents of prescription drug labeling, and 1,100 questionnaires were returned (response rate: 54.9%). Over 85% of respondents agreed to number all the items in drug labeling. Over 84% of them agreed to group the information of patients included in “administration with caution”, “pediatrics”, “pregnant and lactating women” and “elderly” into a single item of “information on special populations”. Regarding the newly created item “information on medical insurance coverage”, the majority of the respondents (over 96%) agreed. The proposed new format and contents of prescription drug labeling were verified and supported by physicians and pharmacists. Further activities are needed to distribute the proposed new format and contents of prescription drug labeling to a wide range of medical professionals to collect more opinions.

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