YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
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OTC医薬品における添付文書記載状況調査
島内 あかり長沼 美紗笹岡 沙也加畠平 春奈元岡 佑美長谷川 栞福田 昌穂中尾 智史堺 千紘横山 聡伊野 陽子中村 光浩井口 和弘
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2018 年 138 巻 2 号 p. 259-267

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 The “self-medication tax deduction” system began in Japan in January 2017, allowing people to encourage the use of OTC drugs. Package inserts contain important information for consumers regarding their use. In this study, we first checked whether the items, as required in the notifications of the Japanese Ministry of Health, Labour and Welfare, are described in the package inserts of cold remedies and analgesic antipyretics in OTC drugs. The descriptions of almost all packages checked in this study were based on the notifications, but those of a small number of them were not. Next, we examined the description of the items, unrequired in the notification, but worthy for proper use of drugs; e.g., the description of prohibition for use by “patients with severe hypertension” in case of ibuprofen-containing products, and the description was found in only seven of 180 products. Manufactures should make package inserts along with notifications, including the description for proper use of drugs.

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© 2018 The Pharmaceutical Society of Japan
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