一般用医薬品点鼻薬の適正使用に対する外箱情報提供とリスクマネジメントに関する日米比較

• 大塚 邦子

  昭和大学医学部 神戸大学都市安全研究センター

• 安原 一

  昭和大学医学部

• 鎌江 伊三夫

  神戸大学都市安全研究センター

• 大塚 誠

  神戸薬科大学

• 斉藤 洋

  日本大学薬学部

• Jorgenson James A.

  University Hospital Pharmacy, University of Utah, USA

書誌事項

タイトル別名

• Comparative Study between United States and Japan Regarding Drug Information on Labeling of Over-the-counter Nasal Decongestant Drops and Sprays, and their Risk Managements

抄録

Labeling on the packages of over-the-counter (OTC) drugs contains very important information to help consumers select and use them safely and effectively. In the present study, we investigated the differences in drug information and risk management given for OTC nasal decongestants and sprays between the United States and Japan. The American products had the new standardized Drug Facts label demanded by the Food and Drug Administration, but there was still no standardized label in Japan. The Drug Facts list the active ingredients, uses, warnings, inactive ingredients, purpose, and directions. They use plain language so that consumers may easily understand the benefits and risks. There were “Specific Warnings” consisting of one telling people under what circumstances they should consult a doctor or pharmacist, a pregnancy/nursing warning, and those concerning accidental overdose and side effects. For the Japanese labeling, “Precaution” was used instead of “Warning”, and there were no specific precautions. While age limits were given on all of the American labeling to prevent overdosing in infants, some of the Japanese labels did not provide such information.<BR>In addition, the American labeling included emergency contact numbers that consumers could phone in case of accidents. There were 65 poison control centers, which could be called 24 hours a day toll-free. In contrast, numbers were only given for 2 such centers in Japan, and they were not toll-free, deterring wide use due to the cost involved.<BR>We found many differences in the labeling of OTC nasal decongestants and sprays between the U.S. and Japan, which would depend on consumers' rights and product liability. The results of this study suggest that OTC drug labeling in Japan must be improved and a standardized format established for this purpose.

収録刊行物

• 医療薬学

  医療薬学 30 (7), 483-491, 2004

  一般社団法人日本医療薬学会

キーワード

• Labeling on OTC drugs
• nasal decongestants sprays
• drug information
• FDA-Drug Facts
• risk management
• consumers' rights

詳細情報

• CRID: 1390282679753166976
• NII論文ID: 110001166829
• NII書誌ID: AA11527197
• DOI: 10.5649/jjphcs.30.483
• ISSN: 18821499
• ISSN: 1346342X
• ISSN: http://id.crossref.org/issn/1346342X
• Web Site: http://dl.ndl.go.jp/info:ndljp/pid/10558248
• Web Site: https://search.jamas.or.jp/link/ui/2004285872
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • Crossref
  • NDL-Digital
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可