Art

J-GLOBAL ID：201802258887878027   Reference number：18A0318722

Evaluation of a Newly Developed Post Marketing Surveillance Method to Verify the Efficacy and Safety of Rx-to-OTC Switch Drugs

RxからOTCスイッチ薬の効果および安全性を検証する新しく開発された市販後調査方法の評価

Author (3)： Nakajima Rie (Social and Administrative Pharmacy Science, School of Pharmacy, Nihon University) ,  Oki Fumika (Social and Administrative Pharmacy Science, School of Pharmacy, Nihon University) ,  Shiragami Makoto (Social and Administrative Pharmacy Science, School of Pharmacy, Nihon University)
Material： 医薬品情報学  (Japanese Journal of Drug Informatics)
Volume： 19  Issue： 3  Page： 121-126(J-STAGE)  Publication year： 2017 
JST Material Number： L5202A  ISSN： 1345-1464  Document type： Article
Article type： 原著論文  Country of issue： Japan (JPN)  Language： ENGLISH (EN)

Thesaurus term： *post marketing surveillance ,...
Semi thesaurus term： switch over the counter drug ,...

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Author keywords (5)： Rx to-OTC switch drugs ,  post marketing surveillance ,  efficacy ,  safety ,  patient adherence

JST classification (1)： Pharmaceutical affairs,pharmaceutical practice  (GU01020R)

Substance index (1)： Fexofenadine hydrochloride

Reference (9)：

• 1) Shiragami M, Mukaida T, Murayama J. Iyaku Jitsumu Yougo Shuu. 16th ed., Yakujinippou-sha, 2007: 216 (in Japanese).
• 2) Izumisawa M. OTC Medication Toranomaki. 3rd ed., Nikkei BP-sha, 2014: 28-9 (in Japanese).
• 3) Ministry of Health Labor and Welfare Japan, “Post marketing surveillance for Rx-to-OTC switch drugs,” http://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000016539.pdf (accessed 15 Dec, 2016).
• 4) Britten N. Medication errors: the role of the patient. Br J Clin Pharmacol 2009; 67: 646-50.
• 5) Jarernsiripornkul N, Krska J, Capps PAG, et al. Patient reporting of potential adverse drug reactions: a methodological study. Br J Clin Pharmacol 2002; 53: 318-25.

Terms in the title (6)： OTC ,  安全性 ,  検証 ,  開発 ,  市販後調査 ,  評価