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    6. 論臺灣處方藥仿單外使用之管制

    論臺灣處方藥仿單外使用之管制

    Author 廖建瑜
    Publisher 華藝數位 /索引數位股份有限公司
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    Released
    2016/06/01
    Language
    Traditional Chinese
    File format
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    Pages
    486
    ID
    206435
    ISBN
    9789869290876
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    在台灣、美國和日本的藥品主管機關,只有在藥商證明其藥品具 有安全性及有效性後始准新藥上市,主管機關並不會容許一種藥品概括 性的用途,因此,藥商必須提出藥品之安全性與有效性之三階段人體試 驗的研究報告、生產該藥品之成分、方法以及該藥品預定使用之仿單標 示。藥品主管機關將審查包括適應症、用法、患者族群、禁忌症、警示、 劑量、副作用、藥理學、其他藥品的資料,以及所有宣稱該藥的好處 與風險之所有標示。當藥品如同其所申請上市的特定用途是有效且安全 的,主管機關將會核准該新藥以及其藥品特定專業的標示。依主管機關 所核准之用途而使用該藥品被稱為仿單內使用,若使用方法非在核准之 仿單之上,即被定義為仿單外使用。

    藥品經主管機關核准上市,醫師可能用於任何目的,因此,仿單 外使用是常見並且為醫師團體所接受是有利於患者的。仿單外使用的態 樣,可能是非依仿單所載適應症、劑量、患者族群,特別盛行於末期癌 症,或者常見於兒童患者身上,因藥商無法在兒童族群身上進行人體試 驗取得正當性,該藥可能僅核准使用於成人。本文認為醫師行使合理醫 學判斷,具有臨床上的自由去仿單外使用處方藥品,藉以促進創新,導 致新治療方法的發展。此外,依據處方藥仿單外使用的特徵,在台灣藥 事法規定下,仿單外使用不應該被認為是新藥、實驗性藥品或者人體試 驗。然而,在一些事例中,學者調查一些仿單外使用發現它們是危險或 無療效的。因此,醫師進行仿單外使用時有責任對於患者告知該藥品, 並且是基於實證醫學進行該醫療決策。在台灣,衛生署認為醫師有法律 上義務去告知患者該藥品相關重要風險,包括使用方式未經衛生署核准 本身,就醫師仿單外使用之處方,其告知範圍就規定與法院判決與美國 有顯著不同。此外,就我國2011 年就藥害救濟法第13 條第8 款的修正 與日本藥害救濟的規定,就仿單外使用之藥害補償仍有不適當之限制。

    其次,雖為僅違反仿單所載之內容不足以建構醫師違反注意義務之 證據,但本文主張仿單上所載之資訊,在醫療過失訴訟中可提供重要協 助在確認醫師注意義務之內容,仿單各項記載可以協助判斷,去決定處 方藥品仿單外使用對於患者是否呈現不可被接受的風險。然而,如同上 揭所述,創新的仿單外使用(定義為有合理使用之正當性,但無充足實 證醫學去減少安全性與有效性),通常不是一種標準治療並且常見是對 於醫療慣行的挑戰,這樣的用藥行為很容易被認為是違反注意義務。本 文主張此時法院應適用可尊敬少數原則去評價醫師處方藥品仿單外使用 之行為。另一方面,隨著藥品基因體學的發展,醫師疏於提供基因檢驗 去確認仿單外使用之安全性,可能會有過失責任。藥品基因體學已經成 為評估仿單外使用之安全性與有效性的工具。

    最後,在台灣,藥商與醫師有著密切財務聯結,藥商創造此關係 藉由提供經濟上的誘因去影響醫師獨立理性的用藥行為。藥商提供醫師 登記及旅行費用(如餐費及住宿費)去參與專業醫療會議和醫學繼續教 育,並且提供醫師小禮物,例如筆、藥物樣品、辦公用品等,作為處方 他們藥品仿單內/ 外使用的誘因。藥商也藉由選擇藥商所支持的主題, 試圖透過醫學繼續教育及醫療會議促銷他們藥品的仿單外使用。台灣缺 欠規制藥商對於醫師贈送禮物及資助行為,僅依賴醫師與藥商自律的利 益衡突之行為指引及行為準則。本文提出不同策略來解決利益衝突,創 造明確倫理準則去指導可能利益衝突行為及揭露利益衝突,並且醫師具 有契約義務(受託義務)去向患者揭露有向藥商收受禮物或報酬。藉由 確認此一法律義務,醫師將能確保患者利益仍為其所關注,因而重回以 病人為中心的醫療慣行。台灣也缺乏透過不實申報法加諸藥商仿單外使 用行銷之限制。本文也討論基於不實申報法及其他規定在仿單外使用的 管制措施。如此制度修正提議,應該被考慮為解決仿單外使用行銷問題 的適當方法。
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    Released
    2016/06/01
    Language
    Traditional Chinese
    File format
    PDF: Fit in large screen
    Provide Adobe DRM
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    ID
    206435
    ISBN
    9789869290876

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