Checking Pharmaceutical Package Inserts Among Japanese Junior Residents: a Nation-Wide Survey

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  • KURIHARA Masaru
    Department of Patient Safety, Nagoya University Hospital, Aichi, Japan
  • UMEMURA Tomomi
    Department of Patient Safety, Nagoya University Hospital, Aichi, Japan
  • FUKAMI Tatsuya
    Department of Patient Safety, Nagoya University Hospital, Aichi, Japan
  • TOKUDA Yasuharu
    Muribushi Okinawa Center for Teaching Hospitals, Okinawa, Japan
  • NAGAO Yoshimasa
    Department of Patient Safety, Nagoya University Hospital, Aichi, Japan

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  • 初期研修医の医療用医薬品添付文書確認行動についての全国調査
  • ショキ ケンシュウイ ノ イリョウヨウ イヤクヒン テンプ ブンショ カクニン コウドウ ニ ツイテ ノ ゼンコク チョウサ

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Abstract

Purpose: A pharmaceutical package insert is an only drug information based on the Japanese law. By revised rule of pharmaceutical package inserts and paperless movement, the digitization has been considered. However, it is unclear how doctors are checking pharmaceutical package inserts. Methods: In January 2020, a questionnaire was provided to participants in the General Medicine In-Training Examination (GM-ITE). Results: A total of 6,869 residents (539 hospitals) participated in the GM-ITE. Of these, we analyzed the responses of 5,468 residents who fully responded to the survey. 537 residents (9.8%) belonged to Special Functioning Hospitals, and 4,931 residents (90.2%) belonged to other hospitals. 1,749 (32.0%) residents responded that they checked all pharmaceutical package inserts they ordered, 3,497 (64.0%) checked them among high-risk drugs only, and 222 (4.1%) never checked. There was no significant difference between the status of checking pharmaceutical package inserts and the affiliation (p=0.20). Discussion: This is the first nation-wide survey to investigate the status of checking pharmaceutical package inserts. Since some serious drug errors have occurred due to inadequate confirmation of the package insert, it is desirable to consider how to provide a practical package insert and to develop a method to disseminate and educate the public about the revised content.

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