台灣非處方藥品資訊易讀性精進與推動：從專業到大眾化

The Legibility of Non-Prescription Medications' Package Insert in Taiwan: From Professional to Patients-centered

陳宜萱(YI-HSUAN CHEN) ； 何暐(WEI HO) ； 鄧書芳(SHU-FANG TENG) ； 潘香櫻(SHIR-LEY PAN) ； 王兆儀(CHAO-YI WANG)

《食品藥物研究年報》 8期 (2017/11) Pp. 279-284

摘要

為增進民眾對於非處方藥使用的安全性及仿單外盒資訊易讀易懂性，衛生福利部食品藥物管理署參考各先進國家相關法律規範，在105年3月8日公告 「西藥非處方藥仿單外盒格式及規範」及實施方法(1)。根據此規範，凡申請電視、電影廣告的非處方藥品許可證持有者，須於105年12月31日前，取得仿單外盒易讀易懂變更核備函。為輔導業者順利完成變更，本研究蒐集國內非處方藥業者依據公告辦理辦理變更之困難，並針對輔導措施進行成效評估，以利國內非處方藥品資訊易讀性精進與推動。

關鍵字

非處方藥品 ； 易讀性 ； 消費者語言

並列摘要

To improve the safety of non-prescription medications (NPM) usage and the legibility of their labeling for the general population, Taiwan Food and Drug Administration (TFDA) referred to the guideline of developed countries about the formats and wording of legible NPM package insert and formulated a regulation on March, 8, 2016. According to the regulation, the first stage targeted on those advertised on television and movies. Moreover, the modification should be done before the end of 2016. However, pharmaceutical companies started to report difficulties while making the alternation following the regulation. This study collected information of difficulties encountered by the companies and evaluate efficacy of counseling measures.

並列關鍵字

legibility ； non-prescription medications ； user-friendly