篇名

「冠脂妥」僞藥事件在實務與法規適用之探討   免費試閱

並列篇名

On the Application of Crestor Fake Drug in Practice and Law Regulation

作者
中文摘要

「冠脂妥」成分為Rosuvstatin,係衛生福利部核准自英國原廠製造輸入之降血脂藥品。2016年10月出廠批號MV503之「冠脂妥」10毫克膜衣錠劑,經藥師機警懷疑產品色澤有異而向原廠查證,嗣經檢調機關查獲市面上有仿製原廠之外盒及鋁箔包裝,內容成分為Atorvastin,在醫療機構及藥局流通,民眾已有取得偽品情事。衛生福利部食品藥物管理署與原廠AstraZeneca合作,要求所有醫療機構、藥局及藥商對於可能涉及偽造之相同批號「冠脂妥」10毫克膜衣錠劑,進行全面預防性下架回收。本案涉及真品併同偽品同時下架回收,以及藥事人員涉有買賣及調劑偽藥之事實,如何適用相關法規條文,以及藥事人員如何主張阻卻其違法性,本文即就各事實行為,探討如何分別適用藥事法、消費者保護法、藥師法及全民健康保險法等相關規定,提供藥界參考。

英文摘要

The Food and Drug Administration (FDA) approved the “Crestor” tablets ingredient is Rosuvstatin. A pharmacist in New Taipei City noticed “Crestor” (MV530 batch) 10mg has different color that might be “fake Crestor” tablet and reported to AstraZeneca. Unfortunately, AstraZeneca confirmed the “Crestor” (MV530 batch) 10mg film-coated tablets were mixed fake drugs. The illigle “fake Crestor” ingregient is Atorvastin. Many pharmacists reported that most of the “Crestor” (MV530 batch) has already been sold and people gate “fake Crestor” by prescription dispencing or buying. FDA has requested the assistance of the AstraZeneca in recalling and replacing the fake products. What source of the law by preventive recalling the “fake Crestor”? What laws convinced of the two suspects and pharmacists who involved in manufacturing, selling, prescription dispensing? How pharmacists to affirmative defence? According to this case, this article will discuss Pharmacist Law, Drug Law, Cunsumer Protection Law and National Health Insurance associate with pharmacists.

起訖頁

155-164

出版單位
DOI

10.3966/241553062018010015012  複製DOI  DOI查詢

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