:::

詳目顯示

回上一頁
題名:論臺灣處方藥仿單外使用之管制
作者:廖建瑜
作者(外文):Chien-YuLiao
校院名稱:國立成功大學
系所名稱:法律學系
指導教授:侯英泠
學位類別:博士
出版日期:2013
主題關鍵詞:仿單外使用告知後同意利益衝突醫療過失醫師注意義務仿單外行銷Off-Label UseInformed ConsentConflict of InterestMedical NegligencePhysician Duty of CareOff-Label Promotion
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(3) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:3
  • 共同引用共同引用:0
  • 點閱點閱:2
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。
In the United States, Japan, and Taiwan, the drug administration authority(FDA, PMDA, TFDA)only allows new drugs in the market after pharmaceutical industries prove that they are both safe and effective. The agency does not approve a new drug for general use. Therefore pharmaceutical manufacturers must provide full three-phased clinical trial reports of investigations into the drug's safety and effectiveness, the comp onents and production methods used to manufacture the drug, and specimens of the labeling proposed to be used for the drug.The drug administration authority reviews the proposed “labeling” for the drug, which includes indications, usages, patient populations, contraindications, warnings, dosages, side effect, pharmacology and other drug data, all proposed claims about the drug's risks and benefits. If the agency agrees that a new drug is safe and effective for its intended use, as reflected in the marketing application, it approves the application and the drug's professional labeling. The uses that are approved by the agency are sometimes referred to as “on-labeled uses” because they appear in the drug's approved labeling. Uses that do not appear in the labeling and are not approved by the agency are referred to as “off-label use”.
Once a drug has been approved by the agency and placed on the market, physicians may prescribe it for any purpose. The use of a drug “off-label use” is therefore common in and accepted as beneficial by the health care community. Examples of off-label uses include using a drug to treat a condition for which it is not indicated, treating an indicated condition with different doses than those specified on the label, and prescribing a drug for a different patient population than that indicated. Off-label uses are especially prevalent when the cancer (such as lung cancer) has reached an advanced stage. These uses are also particularly prevalent among conditions commonly diagnosed in children (if a drug has only been approved to treat adults), where pharmaceutical manufacturers are justifiably reluctant to subject children to experimental clinical trials.
This article argues that physicians may have clinical freedom, exercising reasonable medical judgment, to prescribe drugs for off-label use, which fosters innovation, leading to the development of new treatments. Besides, according to characters of off-label use of prescribing drugs, off-label uses of drugs should not be regarded as a “new drug (or investigational drug)or human experiment ” that falls under Pharmaceutical Affairs Acts regulation in Taiwan. However, in some instances, scholars have investigated off-label uses and found them to be ineffective or dangerous. Therefore, a physician who engages in off-label uses has the responsibility to be well informed about the drug, and to base the decision to use it on evidence-based medicine. In Taiwan, Department of Health claims that physicians have a legal obligation to inform their patients about the material risks associated with the drug, including the use of a drug in a manner that was not approved by the TFDA. The remarkable differences related to the scope of disclosure that physicians prescribe off-label uses between our current regulations and judicial cases are made to compare with those of the United States. In addition, compare to Japan’s Adverse Drug Reaction Relief System, section 13(h)of the Drug Hazard Relief Act of 2011 still inappropriately constitutes restriction against the remedy for adverse drug reactions of prescribing drugs off-label in Taiwan.
Next, although proof of a departure from the recommendations in a drug's labeling is not alone sufficient to prove a breach of the standard of care, this article adopt that a drug’s label can provide significant assistance in identifying the physician's standard of care in a medical malpractice case. Accordingly, this article argues that a prescription drug's labeling is admissible to assist the judge to determine whether the off-label use of prescription drugs presented an unacceptable risk to the patient. As mentioned above, however, because innovative off-label medication use(defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety and effectiveness)is not a standard therapy and a common challenge to medical practice, such use is easily considered as a violation of the standard of care. This article argues that courts shall apply the respectable minority rule in evaluating a physician's prescribing off-label use of drugs. On the other hand, by the development of pharmacogenomics, physicians also may be subject to malpractice liability for failing to to provide pharmacogenomic screening tests to ascertain the safety of off-label use. Pharmacogenomics has become a tool to evaluate the safety and effectiveness of off- label use of prescription drugs.
Finally, in Taiwan, Pharmaceutical industries have had close financial ties to physicians. They create financial relationships that influence physicians’ independent judgment and rational prescribing by offering physicians financial incentives to prescribe their drugs. They reimburse attending physicians for registration fees and travel expenses(such as meals, hotel expenses) for professional meetings and continuing medical education; and provide gifts(such as pens, sample drugs, medical and office supplies)to physicians as enticements for writing prescriptions for their drugs for both approved and off-label uses. They also attempt to promote prescription Drugs for off-label uses through CME and professional meetings by choosing topics they support. Taiwan lacks a statute that oversees gifts and Pharmaceutical industries funding for all physicians. It relies on voluntary medical organization conflict of interest guidelines and Pharmaceutical Research and Manufacturers Association codes of conduct. This Article proposes using various strategies to solve conflicts of interest. It can create clearly ethical standards to guide conduct; or disclose conflicts of interest. In addition, physicians have a contractual obligation(or fiduciary duty)for their patients to disclose that they have received gifts or compensation from Pharmaceutical industries. By recognizing this legal duty, physicians will ensure that the well-being of their patients remains their focus and thereby return the practice of medicine to what should be its patient-centered focus. Taiwan lacks to impose constraints that affect off-label use through enforcement actions under the False Claims Act (“FCA”) against pharmaceutical manufacturers for off-label marketing practices This article also discusses that the control strategy - based on the False Claims Act and regulation off-label promotion. As such, regulation revision proposals should be considered appropriate solutions to Off-Label promotion and marketing problems.
中文專書
1、王澤鑑,〈契約責任與侵權責任之競合〉,《民法學說與判例研究》第一冊,自刊:台北,1992年
2、王澤鑑,《債法原理(三)侵權行為(1)》,自刊:台北,2001年
3、王澤鑑,《侵權行為法(一)基本理論一般侵權行為》,自刊:台北,2001年
4、史尚寬,《債法總論》,自版:台北,1990年
5、朱懷祖,《藥物責任與消費者保護》,五南出版:台北,1997年
6、邱聰智,〈醫療過失與侵權行為〉,收錄於《民法研究一》,五南出版:台北,2000年
7、李元春譯,《搶救心跳》,Bernard Lown, “The Lost Art of Healing,天下文化出版:台北,2000年
8、吳志正,《解讀醫病關係Ⅰ-醫療契約篇》,元照出版:台北,2006年
9、吳志正,《解讀醫病關係Ⅱ-醫療責任體系篇》,元照出版:台北,2006年
10、吳建昌,〈「研究」與「治療」之區分:過去之未決性與簡單任務? 以台灣醫學會雜誌關於治療的報告(1946-1965)與英美判決為例〉,邱文聰主編,《2009科技發展與法律規範雙年刊科學管制、學術研究自由與多元民主價值》,中央研究院法律研究所籌備處:台北,頁25-59,2010年
11、吳俊穎、賴惠蓁、陳榮基,《法官,我說明夠了嗎?醫師告知義務的法院判決評析》,橘井文化出版:台北,2011年
12、林誠二,《民法債編總論(上)》,自版:台北,2000年
13、林東茂,《刑法綜覽》,一品文化出版:台北,2006年
14、林三欽,〈論行政訴訟之判斷基準時─兼評最高行政法院94 年度判字第588 號判決〉,收錄於:湯德宗、劉淑範主編,《2005 行政管制與行政爭訟》,中央研究院法律學研究所籌備處專書(2):台北,頁47-48,2006年
15、姚志明,《誠信原則與附隨義務之研究》,元照:台北,2003年
16、侯英泠,《論院內感染之民事契約責任:以爆發SARS院內感染為例》,正典:台北,2004 年
17、孫森焱,《民法債編總論(下冊)》,自刊:台北,2009年
18、黃立,《民法債編總論》,元照出版:台北,1999 年
19、黃丁全,《醫事法》,元照:台北,2000年
20、黃苓嵐,《醫學倫理教育─由理論到實踐》,新文京開發出版:台北,2009年
21、鄭玉波,《民法債編總則》,三民:台北,1990年
22、劉正雄編譯,《應用生物藥劑學與藥物動力學》,Leon Shargel, Andrew Yu, Applied Biopharmaceutics and Pharmacokinetics Prentice Hall合記圖書出版:台北,1996年
23、劉春堂,《判解民法債編通則》,三民:台北,2000年
24、劉建宏,〈課予義務訴訟之訴訟標的及判決之既判力─兼評最高行政法院97年12月份第3次庭長法官聯席會議決議〉,收錄於:王必芳主編,《2008 行政管制與行政爭訟》,中央研究院法律學研究所籌備處專書(10):台北,頁335-380,2008年
25、劉宏恩,〈論生物醫學研究中利益衝突(Conflict of Interest)問題之規範〉,收錄於《基因科技倫理與法律》,五南:台北,頁142-148,2009年
26、謝博生、楊泮池、林肇堂、李明濱,《一般醫學─醫療與用藥》,台北:國立台灣大學醫學院出版:台北,2001年
27、嚴久元,《當代醫事倫理學》,橘井文化公司:台北,1999年


中文期刊
1、王以均、陳芳瑜、張展維,〈淺談Trastuzumab於乳癌治療〉,《藥學雜誌》,第26卷第4期,頁58-62,2010年12月
2、王蓉君、陳恆德,〈法規新知:藥物基因體學資料檢送原則〉,《當代醫藥法規月刊》,第1期,頁1-2,2010年
3、古承宗譯,〈醫療刑法的「假設同意」〉,Wolfgang Mitsch, Die hypothetische Einwilligung im Arztstrafrecht, JZ 2005, Heft 6, S. 279 – 285,《世新法學》,第4期,頁1-23,2007年
4、吳耀宗,〈德國強制罪第二項可非難性概念之研究〉,《中央警察大學學報》,第34期,頁171-182,1999年
5、汪紹銘〈藥品仿單外之使用(Off-label Use)之法律問題〉,《全國律師雜誌》,第11卷第12期,頁73-81,2007年
6、肖健、嚴金海、呂群蓉,〈彼彻姆和查瑞斯的原則主義進路及其改進〉,《醫學與哲學(人文社會醫學版)》,第11期,頁42,2008年?
7、邱琦,〈醫師沒有告訴我的話:論告知義務與不完全給付〉,《月旦法學雜誌》,第164期,頁37-50,2009年
8、吳俊穎,〈醫師告知義務急速擴張的時代:法界的期待與醫界的臨床實務之間的鴻溝〉,《法學新論》,第14期,頁98-101,2009年
9、何建志,〈藥物基因體學之政策與法律議題分析〉,《法律與生命科學》,第4期,頁1-17,2008年
10、何建志、溫珮君,〈藥物仿單標示外使用之合法性問題研究〉,《法律與生命科學》,第4卷第3期,頁1-23,2010年
11、吳淑莉,〈從柔沛案論處方藥之消保法商品製造人責任〉,《國立中正大學法學集刊》,第32期,頁1-48,2011年
12、李志宏 施肇榮,〈藥害救濟法修正案:藥物使用依醫囑或仿單?〉,《台灣醫界》,第54卷第6期,頁30-36,2011年
13、余玓瑾,〈醫藥科技評估方法學研討會報導〉,《當代醫藥法規月刊》,第7期,頁12,2011年
14、林慧,〈淺談統計與臨床試驗〉,《數學傳播》,第19卷2期,頁2,1995年
15、周麗芳、陳曾基,〈健康保險藥品參考價格制度〉,《台灣醫界》,43卷第10期,頁48,2000年10月
16、林欣柔、楊秀儀,〈告別馬偕肩難產事件?新醫療法第82條第2項評析〉,《月旦法學雜誌》,第112期,頁30,2004年9月
17、林首愈,〈美國學名藥品仿單的著作權問題〉,《萬國法律》,第148期,頁33-36,2006年8月
18、林首愈、賴文智,〈我國學名藥品的仿單著作權問題〉,《智慧財產權》,第106期,頁74-93,2007年10月
19、林俊農、楊致慧、程法彰,〈非署核適應症藥物使用法律問題之探討〉,《醫事法學》,16(1):41-46,2009年1月
20、林杏麟、吳淑莉,〈醫師是否有仿單核准適應症外使用的權利(off-label use)-探討美國FDA及台灣藥事法之相關規定〉,《台灣醫界》,第53卷第5期,頁45-48,2010年5月
21、侯英泠,〈從德國法論醫師之契約上說明義務〉,《月旦法學雜誌》,第112期,頁9-23,2004年9月
22、侯英泠,〈醫療行為的民事上賠償責任(上)─從德國醫師責任法Arzthaftungsrecht)切入探討〉,《月旦法學雜誌》,第72期,頁121-130,2001年5月
23、陳志龍,〈開放性構成要件理論-探討構成要件與違法性之關係〉,《台大法學論叢》,第21卷第1期,頁141-169,1991年12月
24、陳汝吟,〈論網路DTC廣告之法律規範-以藥物DTC廣告對隱私權及產品責任影響為例〉,《玄奘法律學報》,第2期,頁281-331,2004年12月
25、陳聰富〈告知後同意與醫師說明義務(上)〉,《月旦法學教室》,第80期,頁75-91,2009年6月
26、陳聰富,〈告知後同意與醫師說明義務(中)〉,《月旦法學教室》,第81期,頁77-87,2009年7月
27、陳聰富,〈告知後同意與醫師說明義務(下)〉,《月旦法學教室》,第81期,頁66-80,2009年8月
28、陳杰峰、王慈蜂,(醫學文獻評讀概念、方法與等級介紹),《醫療爭議審議報導》42期,頁19-20, 2009年9月
29、馬躍中譯,〈醫療專斷行為中之醫師的說明義務與德國法上關於器官捐贈的說明義務〉,Ulrich Schroth, Der eigenmächtige Heileinggriff, die Aufklärungsverpflichtung von Ärzten Sowie die Aufklärungspflicht im Rahmen der Lebendspende nach Deutschem Recht,《法學新論》,第26期,頁41-50,2010年10月
30、陳冠蓁、姚孟昌、董道興、王嬿婷、劉榮宏,〈病患最大利益原則之法規與倫理觀點〉,《醫事法學》,第18卷第1期,頁45-52,2011年6月
31、陳怡珊、謝維清,〈ADR通報之藥品分析Carbamazepine〉,《藥物安全簡訊》,第35期,頁23(2011)
32、徐育安,〈三角詐欺之實務與理論─最高法院95年度台上字第740號及台渹高等法院99年度上易字第2187號判決評析〉,《月旦法學雜誌》,第194期,頁240-250,2011年7月
33、孫大偉,〈探尋一種更具解釋力的侵權法理論─對矯正正義與經濟分析理論的解析〉,《當代法學》,第25卷第2期,頁77-83,2011年3月
34、張明偉,〈刑事過失責任之探討:以美國刑事醫療案例為例〉,《台大法學論叢》,第39卷第1期,2010年3月
35、張孟媛,〈嚴重藥物過敏,可以預防〉,《科學人雜誌》 第27期,頁13-14,2004年5月
36、張其祿,〈美國醫療證照管制政策之政治經濟分析〉,《歐美研究》,第33卷第1期,頁1-56,2003年3月
37、黃俊杰,〈特別公課類型化及其課徵正義之研究〉,《台北大學法學論叢》第50期,頁101-143,2002年6月
38、黃慧嫺、王怡蘋,藥品仿單涉及的著作權問題之另一種思考─從禾利行VS美時化學製藥案談起,科技法律透析,21卷第8期,頁36-60,2009年8月
39、彭立婷,〈認識藥物副作用〉,《人醫心傳》,第73期,頁66,2011年
40、葉宏明 顏裕庭,〈雷氏症候群與流行病學〉,《台灣醫界》,第46卷第5期,頁12-13,2003年5月
41、楊秀儀,〈美國「告知後同意」法則之考察分析〉,《月旦法學雜誌》,第121期,頁138-152,2005年6月
42、楊秀儀,〈論病人自主權─我國法上「告知後同意」之請求權基礎探討〉,《台大法學論叢》,第36卷第2期,頁229-268,2007年6月
43、楊秀儀,〈告知後同意之倫理法律再思考:縮小理論與實務的落差〉,《月旦法學雜誌》,第162期,頁5-16,2008年11月
44、溫軒琳、張谷州,〈由藥害救濟法修正案談適應症外使用阿斯匹靈〉,台灣腦中風學會會訊》,第18卷第2期,頁7,2011年6月
45、楊麗珍、楊志勛、鐘文宏〈過敏藥物之藥物基因體學與藥物基因檢測〉,《長庚醫訊》,第32卷第9期,頁284(2011),
46、廖建瑜,〈論醫師說明義務之建構與發展-兼評最高法院94年度台上字第2676號刑事判決〉,《成大法學》,第10期,頁231-293,2005年
47、鄭逸哲,〈告知義務與術前評估義務並非注意義務─台灣高等法院高雄分院98年度醫上訴字第1號刑事判決〉,《月旦裁判時報》,第5期,頁94-99,2010年12月
48、趙西巨,〈醫師對新療法的使用和告知〉,《東方法學》,第6期,頁24,2009年
49、蔡甫昌、李明濱,〈生命倫理〉,醫藥基因生物技術教學資源中心主編《後基因體時代之生物技術》,頁503-516,2003年7月
50、遲蘭慧、高純琇、回德仁,〈藥害救濟案例分析—Allopurinol〉,《藥物安全簡訊》第13期,頁13,2006年
51、劉峻宇、王緯書、陳博明,〈種族差異性對癌症治療的影響〉,《臨床醫學》,第59卷第6期,頁414-424,2007年6月
52、劉斌、阮志偉、蘇棋楓、羅乾烘、蔡宏志,〈以clomiphene為例探討仿單外藥物使用〉,《台灣醫界》,第53卷第4期,頁22-23,2010年4月
53、劉邦揚,〈「告知」並非萬能—醫療行為有關「告知後同意」法則之再定位〉,《軍法專刊》,頁168-178,2010年4月
54、盧映潔、周慶東、葛建成,〈醫療準則之意義與功能〉,《輔大法學》,第40期,頁59-83,2010年12月
55、蕭嘉玲,〈臨床藥物基因體學法規新知〉,《當代醫藥法規月刊》,第7期,頁3,2011年


碩博士論文
1、王皇玉,《醫療行為於刑法上之評價─以患者之自我決定權為中心》,國立台灣大學法律學研究所碩士論文,1995年
2、方尚文,《人體試驗對既有醫療法制之研究─以當事人利益衝突為中心》,私立中原大學財經法律研究所碩士論文,2004年
3、宋睿祺,《台灣地區騎乘機車強制配戴安全帽措施與機車竊案關聯性之研究》,中央警察大學犯罪防治研究所碩士論文,2000年
4、何亮儀,《論藥品責任、藥害救濟與藥品回收制度》,國立成功大學法律學系碩士論文,2005年
5、宋家桾,《藥品標示外使用之定性與損害責任研究》,國立清華大學科技法律研究所碩士論文,2007年
6、林元祥,《契約效力主觀範圍之研究》,輔仁大學法律學系博士論文,2000年
7、林恩萱,《Carbamazepine藥品核准標示外使用(Off-label Use)之研究》,國立陽明大學衛生福利研究所碩士論文,2005年
8、林信樺,《藥品資訊傳遞機能之探討-醫師獲取藥品資訊現況調查》,國立台灣大學醫學院臨床藥學研究所碩士論文,2005年
9、林俊農,《藥物標示外使用之法律問題研究》,國立高雄第一科技大學科技法律研究所碩士論文,2010年
10、施孟甫,《論醫療行為與強制罪》,東吳大學法律系研究所碩士論文,2011年
11、陳俞潓,《台北地區醫學中心醫師對藥品核准標示外使用的認知、態度與使用概況》,國立臺灣大學衛生政策與管理研究所碩士論文,1999年
12、陳錦華,《論刑事不法與行政不法的界限─以社會秩序法為例》,國立中正大學犯罪研究所碩士論文,2006年
13、秦誌佑,《論我國藥品廣告管制-基本權利限制的觀點》,國立中正大學法律學研究所碩士論文,2008年
14、徐圭璋,《醫療糾紛訴訟中因果關係的實證醫學分析》,國立成功大學法律學研究所碩士論文,2009年
15、陳偉熹,《藥品仿單核准適應症外使用之法律研究-以醫療人權為中心》,國立高雄第一科技大學科技法律研究所碩士論文,2010年
16、許純琪,《醫病關係中的告知後同意》,國立台灣大學法律研究所碩士論文,2002年
17、張永健,《論藥品、健康食品、食品之管制》,國立台灣大學法律研究所碩士論文,2003年
18、張睿元,「我國藥品管制架構之初探」,國立交通大學科技法律研究所,2005年
19、許杏如,《藥品仿單標示外使用(Off-label Use)之民事責任與藥害填補機制》,國立成功大學科技法律研究所碩士論文,2009年
20、張承元,《關係行銷與關係強度對醫師處方行為之研究》,私立元智大學管理研究所碩士論文,2009年
21、楊慧鈴,《醫生說明義務之研究》,國立政治大學法律研究所碩士論文,1990年
22、楊志宏,《醫療行為適用消費者保護法之研究》,中正大學法律研究所碩士論文,2001年
23、黃維民,《刑事醫療過失與醫事鑑定之研究》,成功大學法律研究所碩士論文,2002年
24、黃崇呈,《使用仿單核准適應症外處方之責任》,國立清華大學科技法律研究所碩士論文,2006年
25、曾靖雯,《新藥人體試驗契約之探討》,國立成功大學法律研究所碩士論文,2006年
26、溫珮君,《仿單標示外使用(off-label use)與用藥安全》,台北醫學大學醫學人文研究所碩士論文,2011年
27、趙志婷,《藥物基因組學的臨床倫理問題探究─醫學與倫理共同體語境下的對比研究》,山西大學碩士論文,2007年
28、廖建瑜,《論醫師之說明義務》,國立成功大學法律學系碩士論文,2005年
29、蔡佩玲,《醫療糾紛中民事過失之認定—論「醫療水準」與「醫療常規》,國立政治大學法律學系研究所,2007年
30、劉綺,《醫療過失之犯罪與醫療傷害補償制度之研究》,國立台灣大學社會科學院國家發展研究所碩士論文,2009年
32、劉屏鐘,《論中層原則主義於醫療倫理決策上的適用性》,南華大學哲學系碩士論文,2008年


研討會論文
1、古承宗譯,醫療錯誤之刑事責任,Ulrich Schroth, Die strfrechtliche Verantwortlichkeit des Arztes bei Behandlungsfehlern,,論文發表於新世紀醫事法律學術研討會,頁5,2009年
2、何建志,醫療科技評估與正義,二代健保法制議題研討會,演講講義第24頁,2011年
3、吳振吉,耳鼻喉科簡介&實務案例分析,司法人員研習所100年第1期醫事案件實務研討會上課講義,頁81,2011年
4、林瑞宜,〈藥品適應症外使用之藥害救濟案例討論〉,發表於2011年9月24日全人照護與關懷醫療安全暨品質研討會,講義頁18-19(2011)
5、陳聰富,〈醫療過失的判斷標準〉,台北醫法論壇(III)-實務判決評析研討會論文集,頁17,2010年
6、郭英調,盤尼西林皮膚敏感試驗(PST)的實驗醫學研究,盤尼西林皮膚敏感試驗施行準則制定會議,講義頁9、11,2011年
7、盧映潔,醫療行為常見問題之刑事與民事責任探討,發表於高雄律師公會100年度第1次律師在職進修法律專題研討會,講義頁11,2011年


網路文章及報導
1、王起杰,青春之泉威而剛,http://www.kmu.edu.tw/~kmcj/data/8708/4044.htm, last visited on 2011/03/05
2、王重隆,藥師說藥:認識藥物副作用,http://www.tmh.org.tw/tn5_2.aspx,visited on 08/03/2011
3、中華日報,波斯卡(保列治, Proscar) 兼治攝護腺肥大及雄性禿,2011年11月3日,http://www.hairway.org/show.aspx?id=1335,last visited on 2012/05/05
4、汪紹銘,藥品之仿單外使用(OFF-LABEL USE)之法律問題http://www.rootlaw.com.tw/blog/wanglawyer2/?p=441,visited on 01/03/201
5、吳筱珈,〈我該使用抗生素嗎?〉《奇美醫訊》,第72期
http://www.chimei.org.tw/left/left02/magazin/vol72/26.html ,visited
on 2011/03/21
6、李樹人,〈妳用的催生藥可能是胃藥〉,聯合晚報健康醫藥版,2008年12月8日
http://mag.udn.com/mag/life/storypage.jsp?f_ART_ID=165185,last visited on 2010/01/02
7、林湧達,口服藥品劑型大不同,http://www.tzuchi.com.tw/a_f/f_tc/newPHA/education3-12.html,visited on 28/03/2011
8、周恬弘,美國健保制度(5)-公營健保,http://thchou.blogspot.com/2008/03/5.html, last visited on 2012/02/01
9、施靜茹、趙容萱,〈癌思停衛署未許可治眼疾小心副作用〉,聯合報,2011年7月25 日http://udn.com/NEWS/HEALTH/HEA1/6483418.shtml,last visited on 2012/05/05
10、陳昌慶,〈本院用來治療慢性B型肝炎病毒的藥物有那些?〉,健仁藥訊(2010),http://www.jiannren.org.tw/jiannren/upload/health_area/9909.pdf visited on 28/03/2011
11、徐俊生、謝永宏、劉孟基、楊東寶、陳俊源〈藥品資料庫暨外觀辨識系統設置〉,《藥學雜誌電子報》,第104期(2010),http://www.bcart.com.tw/pharmacy/104/093-098.html, visited on 2011/04/21
12、許淑霞著,再談醫療糾紛─醫師的解釋義務,http://vereine.freepage.de/taiwan/law0105.htm last visited on 2011/09/06
13、梁金銅,〈簡介大腸直腸癌基因多型性與抗癌藥物基因體學〉,《台灣醫界》,第49卷第10期(2006),http://www.tma.tw/magazine/ShowRepID.asp?rep_id=2374, visited on 2011/09/11
14、楊宗樺,Thalidomide, http://www.ohayoo.com.tw/Thalidomide.htm, last visited on 2011/02/21
15、賴其萬,〈請保護無辜的病人〉,《和信治癌中心醫院與您》,第50期,2005/10/15
http://www.kfsyscc.org/index.php?article_id=2350,visited on 2010/7/30
16、自由時報2011年7月13日生活新聞版「癲通引發史蒂文強森症侯群 婦死醫遭訴」 http://www.libertytimes.com.tw/2011/new/jul/13/today-life13.htm, last visited on 2011/07/30
17、鄭言,〈女性泌尿科問題,醫師竟開治療攝護腺肥大的用藥〉,http://tw.myblog.yahoo.com/hyc0629/article?mid=5265,last visited on 2010/01/02



研究計劃及政府報告
1、許宗力,行政法規變更涉及的新舊法適用問題,行政院國家科學委員會專題研究計畫成果報告,2003年
2、蔡淑鈴、龐一鳴、劉家慧,〈DRGs支付制度下之審查模式與品質監測機制報告〉,《行政院及所屬各機關出國報告》,2008年
3、計劃主持人湯澡薰、研究人員莊博雅、巢杏悠,各國藥品支付制度及藥價政策分析及評估,行政院衛生署九十八年度委託研究計畫,2009年
4、錢林慧君、趙昌平,監察院糾正案─「台南署立醫院控管高價抗生素不當減量」,2009年


英文專書
1、BEAUCHAMP, T. L. AND CHILDRESS, J. F., PRINCIPLES OF BIO MEDICAL ETHICS, 5th edition, Oxford University Press, New York(2001)
2、GUYATT, G., et al. USER’S GUIDES TO THE MEDICAL LITERATURE-ESSENTIALS OF EVIDENCE-BASED CLINICAL PRACTICE, American Medical Association, Chicago(2002)
3、JOSEPH H. KING, THE LAW OF MEDICAL MALPRACTICE IN A NUTSHELL, 2nd ed, West Publishing Co., San Francisco(1986)
4、ROBERT S. MENDELSOHN, CONFESSIONS OF A MEDICAL HERETIC, Contemporary Books(1980)
5、STEPHEN WEAR, INFORMED CONSENT:PATIENT AUTONOMY AND PHYSICIAN BENEFICENCE WITHIN CLINICAL MEDICINE, Kluwer Academic Publishers(1993)


英文期刊
1、Aaron S. Kesselheim, Off-Label Drug Use And Promotion: Balancing Public Health Goals And Commercial Speech, 37 AM. J.L. & MED. 225-257(2011)
2、Alfonso. R. Oddo, Healthcare Ethics: A Patient-Centered Decision Model, JOURNAL OF BUSINESS ETHICS 29:125-134(2001)
3、Alisa B. Goldberg, Mara B. Greenberg., Philip D. Darney, Misoprostol And Pregnancy, N ENGL J MED, Vol. 344, No. 1, 38-47(2001)
4、American Society of Clinical Oncology, Reimbursement For Cancer Treatment: Coverage Of Off-Label Drug Indications, JOURNAL OF CLINICAL ONCOLOGY, 24(19):3206-3208.( 2006)
5、Amy E. Todd, NO NEED FOR MORE REGULATION: PAYORS AND THEIR ROLE IN BALANCING THE COST AND SAFETY CONSIDERATIONS, 37 AM. J.L. & MED. 422-443(2011)
6、Andrea Ahn, WYETH V. LEVINE: MOVING AWAY FROM THE GEIER TREND, 87 DENV. U. L. REV. 561-579(2010)
7、Anita Bernstein, Joseph Bernstein, AN INFORMATION PRESCRIPTION FOR DRUG REGULATION, 54 BUFF. L. REV. 569-618(2006)
8、Anna Bartow Laakmann, THE IMPACT OF SYSTEMS BIOLOGY ON THE PHARMACOGENOMICS REVOLUTION, 4 NANOTECHNOLOGY L. & BUS. 325(2007)
9、Anna B. Laakmann, Collapsing The Distinction Between Experimentation And Treatment In The Regulation Of New Drugs, 62 ALA. L. REV. 305-349(2011)
10、Ansani N; Sirio C; Smitherman T; Fedutes-Henderson B; Skledar S; Weber RJ; Zgheib N; Branch R, Designing A Strategy To Promote Safe, Innovative Off-Label Use Of Medications, AM J MED QUAL, 21(4): 255-261(2006)
11、Anthony Szczygiel, Beyond Informed Consent, 21 OHIO N.U. L. REV. 171-262(1994)
12、Arnold J. Rosoff, Evidence-Based Medicine And The Law: The Courts Confront Clinical Practice Guidelines, 26 J. HEALTH POL., POL'Y & L. 327 -366(2001)
13、Ashley Wazana, Physicians And The Pharmaceutical Industry: Is A Gift Ever Just A Gift? JAMA, 283(3):373-380(2000)
14、Backonja MM., Anticonvulsants (Antineuropathics) For Neuropathic Pain Syndromes., CLIN J PAIN. 16(Suppl 2):67–72.(2000 )
15、Barbara Ann Binzak, How Pharmacogenomics Will Impact The Federal Regulation Of Clinical Trials And The New Drug Approval Process, 58 FOOD DRUG L.J. 103-127(2003)
16、Bridget M. hmann, Erin M. Verneris, Name Brand Exposure For Generic Drug Use: Prescription For Liability, 32 HAMLINE L. REV. 767-790(2009)
17、Bryan J. Warren, Pennsylvania Medical Informed Consent Law: A Call To Protect Patient Autonomy Rights By Abandoning The Battery Approach, 38 DUQ. L. REV. 917 -948(2000).
18、CAPRIE Steering Committee, A Randomised, Blinded, Trial Of Clopidogrel Versus Aspirin In Patients At Risk Of Ischaemic Events (Caprie), THE LANCET,Vol. 348 No. 9038,1329-1339(1996)
19、Charleen Hsuan, Medicaid Coverage For Race-Based Drugs, 41 COLUM. J.L. & SOC. PROBS. 443-477(2008)
20、Clifford J Woolf, Richard J Mannion, Neuropathic Pain: Aetiology, Symptom S , Mechanisms , And Management, THE LANCET, Volume 353, Issue 9168,1959 – 1964(1999)
21、Corrine Propas Parver, Ashley Goren, Significant Details From The 2010 Health Care Fraud And Abuse Control Program Report, 13 No. 3 J. HEALTH CARE COMPLIANCE. 9-22(2011)
22、Cynthia A. Moyer, OFF-LABEL USE AND THE MEDICAL NEGLIGENCE STANDARD UNDER MINNESOTA LAW, 31 WM. MITCHELL L. REV. 927-938(2005.)
23、Daniel B. Klein & Alexander Tabarrok, DO OFF-LABEL DRUG PRACTICES ARGUE AGAINST FDA EFFICACY REQUIREMENTS? A CRITICAL ANALYSIS OF PHYSICIANS' ARGUMENTATION FOR INITIAL EFFICACY REQUIREMENTS, 67 AM. J. ECON. & SOC. 743-775 (2008)
24、Danielle Holley, Balancing On The Edge: The Implications And Acceptability Of Off-Label Drug Use, 19 ALB. L.J. SCI. & TECH. 633-657(2009)
25、Daniel W. Whitney, Guide To Preemption Of State-Law Claims Against Class Iii Pma Medical Devices, 65 FOOD & DRUG L.J. 113-139(2010)
26、David A. Kessler, Regulating The Prescribing Of Human Drugs For Nonapproved Uses Under The Food, Drug, And Cosmetic Act, 15 HARV. J. ON LEGIS.693-760(1978);
27、David C.Radley, Stan N. Finkelstein., Randall S Stafford, Off-Label Prescribing Among Office-Based Physicians, 166 ARCH. INTERN. MED. 1021 -1026(2006).
28、David M. Eddy, The Use Of Evidence And Cost Effectiveness By The Courts: How Can It Help Improve Health Care? 26 J. HEALTH POL. POL'Y & L. 387-407(2001)
29、David M. Studdert, Michelle M. Mello, Marin K. Levy,Russell L. Gruen, Edward J. Dunn, E. John Orav, and Troyen A. Brennan, Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks,4 J EMPIRICAL LEG STUD. 103-124(2007)
30、D. C. Hadorn et al., “Rating The Quality Of Evidence For Clinical Practice Guidelines, JOURNAL OF CLINICAL EPIDEMIOLOGY 49, no. 7, 749-754 (1996):
31、Donna T. Chen et al., U.S. Physician Knowledge Of The Fda-Approved Indications And Evidence Base For Commonly Prescribed Drugs: Results Of A National Survey, PHARMACOEPIDEMIOLOGY & DRUG SAFETY .18(11):1094-1100 (2009).
32、Edward P. Lansdale, Used As Directed? How Prosecutors Are Expanding The False Claims Act To Police Pharmaceutical Off-Label Marketing, 41NEW ENG. L. REV. 159-198(2006)
33、Elizabeth A. Weeks, Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Drug Use Under The Food And Drug Administration Modernization Act Of 1997, 54 FOOD & DRUG L.J. 645-665(1999)
34、Eric G. Campbell et al., A National Survey Of Physician-Industry Relationships, 356 N. ENGL. J. MED. 1742-1750 (2007).
35、Gazarian M, et al., Off-Label Use Of Medicines: Consensus Recommendations For Evaluating Appropriateness, MED J AUST, 185 (10) , 544-548(2006)
36、Gerald F. Tietz, Informed Consent In The Prescription Drug Context: The Special Case, 61 WASH. L. REV. 367-417(1986)
37、Glenn E. Bradford, The “Respectable Minority Doctrine In Missouri Medical Negligence Law, 56 J. MO. B. 326-334(2000)
38、Grant H. Morris, Dissing Disclosure: Just What The Doctor Ordered, 44 ARIZ. L. REV. 313-371(2002)
39、Hofmeyr GJ, Gülmezoglu AM, Vaginal Misoprostol For Cervical Ripening And Induction Of Labour., COCHRANE DATABASE SYST REV. Issue 1. Art. No.: CD000941. DOI: 10.1002/14651858.CD000941 (1998)
40、Hofmeyr GJ, Gülmezoglu AM, Alfirevic Z., Misoprostol For Induction Of Labour: A Systematic Review, BR J OBSTET GYNAECOL,106:798-803(1999)
41、Jaime A. Wilsker, Note And Comment: One-Half Phen In The Morning/ One Fen Before Dinner:A Proposal For Fda Regulation Of Off-Label Uses Of Drugs, 6 J.L. & POL'Y. 795-850(1998)
42、James D. Chambers, Peter J. Neumann., Listening To Provenge — What A Costly Cancer Treatment Says About Future Medicare Policy, N ENGL J MED. 364(18):1687-1689(2011)
43、James M. Beck & Elizabeth D. Azari, Fda, Off-Label Use, And Informed Consent: Debunking Myths And Misconceptions, 53 FOOD & DRUG L.J. 71 -104(1998)
44、James O’Reilly & Amy Dalal, Off-Label Or Out Of Bounds? Prescriber And Marketer Liability For Unapproved Use Of Fda-Approved Drugs, 12 ANNALS HEALTH L. 295- 324 (2003)
45、James P. Orlowski, Leon Wateska, The Effects Of Pharmaceutical Firm Enticements On Physician Prescribing Patterns. There's No Such Thing As A Free Lunch, CHEST 102:270-273(1992)
46、James R. Bird, Comment, Package Inserts For Prescription Drugs As Evidence In Medical Malpractice Suits, 44 U.CHI.L.REV. 398 -456(1977).
47、Janet Leach Richards, Geography Is Destiny: Disparate Insurance Coverage For Cancer Clinical Trials Demands A Federal Mandate, 76 UMKC L REV.141-176(2007)
48、Jerry R. Mendell & Zarife Sahenk, Painful Sensory Neuropathy, N ENGL J MED. 348 (13): 1243-1255 (2003)
49、Jennifer L. Herbst, The Short-Sighted Value Of Inefficiency: Why We Should Mind The Gap In The Reimbursement Of Outpatient Prescription Drugs, 2 CASE W. RESERVE J.L. TECH. & INTERNET. 1-46(2011)
50、J. K. Baruah, Lancinating Pain In Post-Laminectomy Chronic Sciatica, ACTA NEUROCHIRURGICA Volume 76, Numbers 3-4, 129-130(1985)
51、Joshua Cohen, Andrew Wilson, Laura Faden, Off-Label Use Reimbursement, 64 FOOD & DRUG L.J. 391-403(2009)
52、John Baker, Tardive Dyskinesia: Reducing Medical Malpractice Exposure Through A Risk –Benefit Analysis, 1 DEPAUL J. HEALTH CARE L. 799-853(1997)
53、John E. Osborn, Can I Tell You The Truth? A Comparative Perspective On Regulating Off-Label Scientific And Medical Information, 10 YALE J. HEALTH POL'Y, L. & ETHICS. 299-356(2010)
54、John M. Boltri et al., Effect Of Antihypertensive Samples On Physician Prescribing Patterns, FAMILY MED. 34(10): 729-731 (2002)
55、Joseph S. Ross, Kevin P. Hill, David S. Egilman, Harlan M. Krumholz, Guest Authorship And Ghostwriting In Publications Related To Rofecoxib : A Case Study Of Industry Documents From Rofecoxib Litigation, JAMA. 299(15):1800-1812(2008)
56、Julie E. Kass, John S. Linehan, Fostering Healthcare Reform Through A Bifurcated Model Of Fraud And Abuse Regulation, 5 J. HEALTH & LIFE SCI. L. 75-129(2012)
57、Karen G. Biagi, Moore V. Regents Of The University Of California : Patients, Property Rights, And Public Policy, 35 ST. LOUIS U. L.J. 433-462(1991)
58、Kathryn Young, Will Everyone Get Their Best Medicine? Implications For Off-Label Use Of Pharmaceuticals In An American Universal Healthcare Regime, 2 ST. LOUIS U. J. HEALTH L. & POL'Y. 233-263(2008)
59、Kimberly A. Quaid, Ruth R. Faden, Eileen P. Vining and John M. Freeman, Informed Consent For A Prescription Drug: Impact Of Disclosed Information On Patient Understanding And Medical Outcomes, PATIENT EDU.& COUNS. 15 (3):249-259(1990)
60、Klaus Lindpaintner, Pharmacogenetics And Pharmacogenomics In Drug Discovery And Development: An Overview, 41CLIN CHEM LAB MED. 398-410(2003)
61、Lars Noah, Constraints On The Off-Label Uses Of Prescription Drug Products, 16 JOURNAL OF PRODUCTS & TOXICS LIABILITY. 139 -165(1994)
62、Lars Noah, Informed Consent And The Elusive Dichotomy Between Standard And Experimental Therapy, 28 AM. J.L. & MED. 361-408(2002)
63、Leslie Pickering Francis, Legitimate Expectations, Unreasonable Beliefs, And Legally Mandated Coverage Of Experimental Therapy, 1 IND. HEALTH L. REV. 213-251(2004)
64、Lisa D. Chew et al., A Physician Survey Of The Effect Of Drug Sample Availability On Physicians' Behavior, J. GEN. INTERNAL MED. 15(7):478-483 (2000).
65、Lovell J., Carbamazepine And Sciatica., AUST FAM PHYSICIAN., 21(6):784-786(1992)
66、Mahnu Davar, Whose Pen Is Being Used To Write Your Prescriptions? Nominal Gifts, Conflicts Of Interest, And Continuing Medical Education, 29 J. LEGAL MED. 199-217(2008)
67、Marc A. Rodwin, Strains In The Fiduciary Metaphor: Divided Physician Loyalties And Obligations In A Changing Health, AM. J.L. & MED. 21: 241-257(1995)
68、Marc J. Scheineson, Shannon Thyme Klinger, Lessons From Expanded Government Enforcement Efforts Against Drug Companies, 60 FOOD & DRUG L.J. 1-16(2005)
69、Margaret Z .Johns , Informed Consent: Requiring Doctors To Disclose Off-Label Use Prescription And Conflicts Of Interest, 58 HASTINGS L.J. 967-1024(2007)
70、Marjorie Maguire Shultz, From Informed Consent To Patient Choice: A New Protected Interest, 95 YALE L.J. 219-299(1985)
71、Mark A. Hall, Caring, Curing, And Trust: A Response To Gatter, 39 WAKE FOREST L. REV. 447-451(2004)
72、Mark A. Rothstein, Liability Issues In Pharmacogenomics, 66 LA. L. REV. 117-124(2005)
73、Mark Herrmann, Pearson Bownas, Keeping The Label Out Of The Case, 103 NW. U. L REV. COLLOQUY. 477-489(2009)
74、Matt Altshuler, J.Kyden Creekpaum, Jim Fang, Health Care Fraud, 45 AM. CRIM. L. REV. 607-664(2008)
75、Megan Lee, Defining The Limits Of A Physician's Duty To Disclose In Massachusetts, 11 SUFFOLK J. TRIAL & APP. ADVOC. 139-165(2006)
76、Melody L. Harness, What Is “Experimental Medical Treatment?: A Legislative Definition Is Needed, 44 CLEV. ST. L. REV. 67-98(1996)
77、Michael D. Greenberg, Medical Malpractice And New Devices: Defining An Elusive Standard Of Care, 19 HEALTH MATRIX. 423-445(2009)
78、Michael G. Ziegler, Pauline Lew, Brian C. Singer, The Accuracy Of Drug Information From Pharmaceutical Sales Representatives, 273 JAMA. 1296-1298(1995)
79、Michael J. Donovan, Legal Issues Stemming From The Advancement Of Pharmacogenomics, 14 UCLA J.L. & TECH. 1-26(2010)
80、Michael Jon Andersen, Bound Guidance: Fda Rulemaking For Off-Label Pharmaceutical Drug Marketing, 60 CASE W. RES. L. REV. 531-558(2010)
81、Michael Kowalski, Applying The “Two Schools Of Thought Doctrine To The Repressed Memory Controversy, 19 J. LEGAL MED. 503-547(1998)
82、Michael Wilkes, Margaret Johns, Informed Consent And Shared Decision-Making: A Requirement To Disclose To Patients Off-Label Prescriptions, PLOS MED. 5(11), 1553-1556(2008)
83、Muriel R. Gillick, Controlling Off-Label Medication Use, 150 ANN INTERN MED.344-347(2009)
84、Nadia N. Sawicki, Character, Competence, And The Principles Of Medical Discipline, 13 J. HEALTH CARE L. & POL'Y. 285-323(2010)
85、Nancy K. Plant, The Learned Intermediary Doctrine: Some New Medicine For An Old Ailmet, 81 IOWA L.REV. 1007-1078(1996)
86、Natalie de Paulsen, The Regulatory Gap: Off-Label Drug Use In Canada, 63 U.T. FAC. L. REV. 183-211(2005)
87、Norbert H. Brockmeyer, Ulrike Brucklacher, Anja Potthoff, Stefanie Reich-Schupke, Off-Label Use In Dermatology In Germany: What Has Changed Since 2004? JDDG; Volume 7, Issue 11, 931–1036(2009)
88、Note, Comparative Approaches To Liability For Medical Maloccurrences, 84 YALE L. J. 1141-1163(1975)
89、Peggy Chen, Education Or Promotion?: Industry-Sponsored Continuing Medical Education (Cme) As A Center For The Core/Commercial Speech Debate, 58 FOOD & DRUG L.J. 473-509(2003)
90、Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899 -959 (1994)
91、Philip G. Peters, The Role Of The Jury In Modern Malpractice Law, 87 IOWA L. REV. 909-969(2002)
92、Philip M. Rosoff, Doriane Lambelet Coleman, The Case For Legal Regulation Of Physicians' Off-Label Prescribing, 86 NOTRE DAME L. REV. 649-691(2011)
93、Rachael C. Casey, Wyeth V. Levine: Fda Attempt To Preempt Common Law Claims Deemed Procedurally Deficient But Sets The Stage For Future Consideration Of Substantive Sufficiency, 48 HOUS. L. REV. 163-196(2011)
94、Ralph F. Hall & Elizabeth S. Sobotka, Inconsistent Government Policies: Why Fda Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans, 62 FOOD & DRUG L.J. 1-48(2007).
95、Randall S. Stafford, Perspective: Regulating Off-Label Drug Use: Rethinking The Role Of The FDA, 358 N. ENGL J MED. 1427-1429(2008)
96、Rayburn & Farmer, Off-Label Prescribing During Pregnancy, OBSTET. & GYNECOL. CLIN N AM. 24(3):471-84 (1997)
97、Raymond G. Mullady Jr., Everything You Needed And Wanted To Know About Black Boxed Warnings, 68 DEF. COUNS. J. 50-64(2001)
98、Rebecca Dresser, At Law: The Curious Case Of Off-Label Use, HASTINGS CENTER REP. 37(3), 9-11 (2007).
99、Rebecca Dresser, Joel Frader, Off-Label Prescribing: A Call For Heightened Professional And Government Oversight, 37 J.L. MED. & ETHICS. 476-484(2009)
100、Richard C. Ausness, Will More Aggressive Marketing Practices Lead To Greater Tort Liability For Prescription Drug Manufacturers? 37 WAKE FOREST L. REV. 97 -139(2002)
101、Richard C. Ausness, “There's Danger Here, Cherie!: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, 73 BROOK. L. REV. 1253-1326 (2008).
102、Richard E. Shugrue, Kathryn Linstromberg, The Practitioner's Guide To Informed Consent, 24 CREIGHTON L. REV. 881-928(1991)
103、Richard F. Adair & Leah R. Holmgren, Do Drug Samples Influence Resident Prescribing Behavior? A Randomized Trial, 118 AM. J. MED. 881-884 (2005).
104、Rikin S. Mehta, Why Self-Regulation Does Not Work: Resolving Prescription Corruption Caused By Excessive Gift-Giving By Pharmaceutical Manufacturers, 63 FOOD & DRUG L.J. 799-821(2008)
105、R. Harbour and J. Miller, “A New System For Grading Recommendations In Evidence Based Guidelines, BMJ 323, no. 7308, 334-336(2001)
106、Rikke Sørensen, Morten L Hansen, Steen Z Abildstrom, Steen Z Abildstrom, Charlotte Andersson, Casper Jørgensen, Jan K Madsen, Peter R Hansen, Lars Køber, Christian Torp-Pedersen, Gunnar H Gislason, Risk Of Bleeding In Patients With Acute Myocardial Infarction Treated With Different Combinations Of Aspirin, Clopidogrel, And Vitamin K Antagonists In Denmark: A Retrospective Analysis Of Nationwide Registry Data, THE LANCET,Vol. 374 No. 9706 , 1967-1974(2009)
107、Roland Solensky, Drug Hypersensitivity, MEDICAL CLINICS OF NORTH AMERICA. Volume 90, Issue1, p233-260 ( 2006)
108、Ross D. Silverman, Regulating Medical Practice In The Cyber Age: Issues And Challenges For State Medical Boards, AM. J.L. & MED. 26 (2–3): 255-276(2000)
109、Sachidanandam, D. Weissman et al., A Map Of Human Genome Sequence Variation Containing 1.42 Million Single Nucleotide Polymorphisms, 409 NATURE. 928-933(2001)
110、Sackett, Rosenberg, Gray, Haynes and Richardson, Evidence Based Medicine: What It Is And What It Isn't, BMJ 312, no.7023,71-72(1996)
111、Santosh V. Coutinho, License To Promote, Or Just What The Doctor Ordered? The New Fda Guidance On Dissemination Of Off-Label Reprints By Pharmaceutical Companies, 28 TEMP. J. SCI. TECH. & ENVTL. L. 279-306(2009)
112、Sean D. Sullivan, John Watkins, Brian Sweet, Scott D. Ramsey, Health Technology Assessment In Health-Care Decisions In Theunited States, INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH, Volume 12(Supplement 2), 39-44(2009)
113、S. Swaroop Vedula, Lisa Bero, Robert W. Scherer & Kay Dickersin, Outcome Reporting In Industry-Sponsored Trials Of Gabapentin For Off-Label Use, NEW ENG. J. MED. 361(20):1963-1971 (2009).
114、Stephanie Greene, False Claims Act Liability For Off-Label Promotion Of Pharmaceutical Products, 110 PENN ST. L. REV. 41-68(2005)
115、Stephen A. Talmadge, Influencing Physicians' Prescribing Behavior: Ethical Issues Related To Pharmaceutical Gifts, 11 MICH. ST. U. J. MED. & L. 303-321(2007)
116、Steven R. Salbu, Off-Label Use, Prescription, And Marketing Of Fda-Approved Drugs: An Assessment Of Legislative And Regulatory Policy, 51 FLA. L. REV. 181-227(1999)
117、Stoffelmayr, Products Liability And “Off-Label Uses Of Prescription Drugs, 63U.CHI.L.REV. 275-305(1996)
118、Susan A. Fuchs, Will The Fda's 2010 Warfarin Label Changes Finally Provide The Leg- Al Impetus For Warfarin Pharmacogenetic Testing? 12 N.C. J. L. & TECH. 99-157(2010)
119、Susan L. Coyle, Physician–Industry Relations. Part 1: Individual Physicians, ANN INTERN MED.136:396-402(2002)
120、Tamar Frankel, Fiduciary Law, 71 CAL. L. REV. 795-836(1983)
121、Teresa Moran. Schwartz, Consumer-Directed Prescription Drug Advertising And The Learned Intermediary Rule, 46 FOOD DRUG COSM. L.J. 829-848(1991)
122、Thomas L. Hafemeister, Sarah P. Bryan, Beware Those Bearing Gifts: Physicians' Fiduciary Duty To Avoid Pharmaceutical Marketing, 57 U. KAN. L. REV. 491-537(2009)
123、Tilo Mandry, Legal Implications Of Pharmacogenomics Regarding Drug Trials, Drug Labeling, And Genetic Testing Fordrug Prescription: An International Approach, 59 FOOD DRUG L.J. 519-535(2004)
124、Tim Mackey, Bryan A. Liang, Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, 45 U. MICH. J.L. REFORM. 1-54(2011)
125、Veronica Henry, Off-Label Prescribing Legal Implications, 20 J. LEGAL MED. 365-383(1999)
126、Victor E. Schwartz, Phil Goldberg, A Prescription For Drug Liability And Regulation, 58 OKLA. L. REV. 135-178(2005)
127、W.E. Evans & H.L. McLeod, Pharmacogenomics Drug Disposition, Drug Targets, And Side Effects, 348 NEW ENG. J. MED. 538-549(2003).
128、Wen-Hung Chung, Shuen-Iu Hung, Hong-Shang Hong, Mo-Song Hsih, Li-Cheng Yang, Hsin-Chun Ho, Jer-Yuarn Wu & Yuan-Tsong Chen, Medical Genetics: A Marker For Stevens-Johnson Syndrome, NATURE. Volume 428, Issue 6982, 486 (2004)
129、Wing DA, Paul RH., A Comparison Of Differing Dosing Regimens Of Vaginally Administered Misoprostol For Preinduction Cervical Ripening And Labor Induction, AM J OBSTET GYNECOL, 175:158-164(1996)
130、Yann Joly, Georgia Koutrikas, Anne-Marie Tassé, Amalia Issa, Bruce Carleton, Michael Hayden, Michael J. Rieder, Emma Ramos-Paque, Denise Avard, Regulatory Approval For New Pharmacogenomic Tests: A Comparative Overview, 66 FOOD & DRUG L.J. 1-24(2011)
報紙
Anna Wilde Mathews& David Armstrong, Pfizer Case Signals Tougher Action on Off-Label Drug Use, Wall St. J. 2004/5/14, at B1


日文專書
1、三輪亮寿,〈薬剤の選択及び使用における注意義務〉,浅井富美彦・園尾隆司編著《現代裁判法大系7医療過誤》,新日本法規出版:東京(1998年)
2、中村哲,〈医師の說明義務とその範圍〉,太田幸夫編,《医療過誤訴訟法》,新‧裁判実務大系(1),青林書院:東京,頁75-77(2003年)
3、山口斉昭,〈医療水準─注意義務の基準〉,伊藤文夫・押田茂實編集,《医療事故紛争の予防・対応の実務》,新日本法規出版:東京(2006年)
4、菅野耕毅,《醫療過誤責任の理論》,信山社出版:東京,增補新版(2001年)


日文期刊
1、山口斉昭,〈「医療水準論」の形成過程とその未来〉,《早稲田法学会誌》47 号,頁361-425(1997)
2、小野輝治,〈製薬会社における法務実務〉,《法の支配》第141期,日本法律家協会出版,頁63-73(2006)
3、古川俊治,〈診療上の医師の注意義務と「医療水準」〉,《慶應法學》第7號,頁337-505(2007)
4、寺沢知子,〈医療水準の相対化と「医療水準論」の質的転換〉,《阪大法学》,第47卷第1号,頁69-99(1999年4月)
5、伊藤文夫・山口斉昭,「医薬品の添付文書、医療慣行と医師の注意義務」,判例タイムズ 49(4),頁42-54(1998年2月)
6、岡林伸幸,ガイドライン能書きが矛盾する場合の医師の過失,法律時報81卷6號,頁133-137(2009年6月)
7、植垣勝裕,医薬品の添付文書(能書)に記載された使用上の注意事項と医師の注意義務,判例タイムズ主要民事判例解説945号(臨時増刊),頁70-71(1997年9月)

研究計劃
研究計劃主持人望月眞弓教授,医薬品適正使用のための学術情報提供に係る規制方策に関する研究,平成21年度厚生労働省科學研究費補助金計劃(2010.03)


德文期刊
1、Gerhard H.Schuld, Umfang und Grenzen der ärztlichen Aufklärungspflicht, ArztRecht:32-41(2004)
2、L. Grell & M. Rieger, Off-Label-Therapie aus der Perspektive des MDK, Zeitschrift für Rheumatologie, 2012 71:101–104(2012)

 
 
 
 
第一頁 上一頁 下一頁 最後一頁 top