1. |
American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hospital Pharm, 1992, 49(8): 2006-2008.
|
2. |
廣東省藥學會, 藥品未注冊用法專家共識, 2010年3月18日.
|
3. |
Herring C, McManus A, Weeks A. Off-label prescribing during pregnancy in the UK: an analysis of 18,000 prescriptions in Liverpool Women’s Hospital. The International Journal Of Pharmacy Practice, 2010, 18(4): 226-229.
|
4. |
Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ, 2000, 320(7227): 79-82.
|
5. |
Hames A. Unlicensed and off-label drug use in elderly people. Age And Ageing, 2001, 30(6): 530-531.
|
6. |
Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s Disease. N Engl J Med, 2006, 355(15): 1525-1538.
|
7. |
Huntzinger A. FDA warns against off-label use of antipsychotic drugs. Am Fam Physician, 2005, 71(61): 2205.
|
8. |
Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9): 1021-1026.
|
9. |
孫紐云, 王莉, 周軍, 等. 美英加澳和中國臺灣地區醫療風險管理機構、法規與運行機制的比較研究. 中國循證醫學雜志, 2011, 11(2): 117-124.
|
10. |
賈莉英, 袁蓓蓓, 王健, 等. 衛生政策系統評價方法探討. 中國循證醫學雜志, 2009, 9(10): 1037-1043.
|
11. |
王莉, 喻佳潔, 周幫旻, 等. 17國國家藥物政策的系統評價. 中國循證醫學雜志, 2009, 9(7): 715-729.
|
12. |
宋儒亮. 對超說明書用藥多種意義上的完善思考. 中國處方藥, 2010, 103: 26-27.
|
13. |
Miller JL. Rules set for dissemination of off-label-use information.Am J Health-Syst Pharm, 1999, 56(3): 204-206.
|
14. |
Verordnungsfähigkeit von zugelassenen Arzneimitteln in nicht zugelassenen Anwendungsgebieten. Richtlinie des Gemeinsamen Bundesausschusses, 2009. Available at: URL: http://www.g-ba.de/downloads/62-492-470/AM-RL-2010-09-16_4.pdf.
|
15. |
Gijsen R, Jochemsen H, van Dijk L, et al. Frequency of ill-founded off-label prescribing in Dutch general practice. Pharmacoepidemiology and Drug Safety, 2009, 18(1): 84-91.
|
16. |
Bernardi A, Pegoraro R. The ethics of off-label use of drugs: oncology pharmacy in Italy. Journal of Clinical Pharmacy and Therapeutics, 2008, 33(2): 95-99.
|
17. |
Aguggia M, Cavallini M, Varetto L. Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription. Neurol Sci, 2006, 27(suppl 2): S198-S202.
|
18. |
Medsafe. Patient consent and off-label use of medicines (April 1998). Available at: URL: http://www. medsafe.govt.nz/profs/RIss/unapp.asp.
|
19. |
Sharma DC. Indian experts protest against off-label drug use. Medline and Health Policy. 2004.
|
20. |
「醫師法」(昭和23年7月30日法律第二百一號)(1948)最終改正:平成19年6月27日法律第九六號(2008). Available at:URL:http:// www.law.e-gov.go.jp.
|
21. |
立法機関.「薬事法」(昭和35年8月10日法律第百四十五號)(1960年)最終改正:平成18年6月21日法律第八四號(2007). Available at: URL:http:// www.law.e-gov.go.jp.
|
22. |
厚生労働省健康政策局研究開発振興課,厚生労働省醫薬安全局審査管理課. 「適応外使用に係る醫療用醫薬品の取り扱いについて」 平成11年2月1日(2000年). Available at:http:// www.mhlw.go.jp.
|
23. |
MHRA. Off-label use or unlicensed medicines: prescribers’ responsibilities. Drug Safety Update, 2009, 9(2): 6.
|
24. |
Irish Medicines Board, FAQ Categories. Question: Can a registered medical doctor/dentist use a medicine off-label? Available at: URL: http://www.imb.ie/EN/FAQs.aspx? page=1&categoryid= &letter=C&q= &faqid=154&pagecategoryid=-1.
|
25. |
FDA.“Off-Label”and Investigational Use of Marketed Drugs, Biologics, and Medical Devices - Information Sheet.Guidance for Institutional Review Boards and Clinical Investigators(2010).Available at: URL:http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm.
|
26. |
General Medical Council. Good Practice in Prescribing Medicines. 2008-09.
|
27. |
MEB. off-label-use Human medicine-Medicinal products-off label use. off-label-use. Available at: URL:http://www.cbg-meb.nl/CBG/en/human-medicines/medicinal%20products/Off-label%20use/default.htm.
|
28. |
Australian Government Department of Health and Ageing.Changes to the Definition of Therapeutic Substance. (Nov.2010). Available at: URL: http://www.health.gov.au/internet/mbsonline/publishing.nsf/Content/News-201001-Therapeutic-Substance.
|
29. |
Medsafe. Unapproved Use of Medicines. Prescriber Update, 2003, 24(1): 8-11.
|
30. |
寺岡章雄, 津谷喜一郎. 未承認薬のコンパッショネート使用. Jpn Pharmacol Ther薬理と治療, 2010, 38(2): 109-150.
|
31. |
國立醫薬品食品衛生研究所安全情報部. 醫薬品安全性情報(2009/05/28). Available at: URL: http://www.nihs.go.jp/dig/sireport/index.html.
|
32. |
JansenRM, Gouws C. Clinical, legal and ethical implications of the intra-ocular (off-label) use of bevacizumab (Avastin)–a South African perspective. S Afr Med J, 2009, 99(6): 446-449.
|
33. |
ASHP. ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System. Formulary Management-Guidelines (2008): 142-151.
|
34. |
IMB. Question: Should a registered medical doctor/dentist inform the IMB when they supply an unauthorised medicine? Available at:URL: http://www.imb.ie/EN/FAQs.aspx?page=1&categoryid=&letter=S&q=&faqid=152&pagecategoryid=-1.
|
35. |
Brockmeyer NH, Brucklacher U, Potthoff A, et al.Off-label use in dermatology in Germany: What has changed since 2004? J Dtsch Dermatol Ges. 2009, 7(11): 938-945.
|
36. |
厚生労働省ワーキンググループ. ワーキンググループ検討結果報告書. 平成18年1月19日(2007). Available at: URL: http://www.mhlw.go.jp.
|
37. |
Levêque D. Off -label use of anticancer drugs. Lancet Oncol, 2008, 9(11): 1102-1107.
|
38. |
ASHP. ASHP Drug Information:off label uses.2010. Available at: URL:http://www.Ahfsdrug information.com/off_label/overview.aspx.
|
39. |
Johnson PE. Pharmaceutical reimbursement:An overview. Am J Health-Syst Pharm, 2008, 65 (Suppl 1): S4-S10.
|
40. |
British National Formulary(BNF-57), BMJ Group and RPS Publishing. 2009.
|
41. |
BMJ Group. British national formulation for children. 2009.
|
42. |
Gazarian M, Kelly M, McPhee JR, et al. Health Care Off-label use of medicines: consensus recommendations for evaluating appropriateness. MJA, 2006, 185(10): 544-548.
|
43. |
A Working Group of NSW TAG Inc. Off-Label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals (September 2003).
|
44. |
FDA. Social Media Working Group. Pharmaceutical Industry Approaches for Engagement in Online Communities 2009. Available at: URL:http://www.fda.gov/downloads/AboutFDA/Centers Offices/ CDER/ UCM 194608.pdf.
|
45. |
Cohen PJ. “Off-label” use of prescription drugs: Legal, clinical and policy considerations. Eur J Anaesthesiol, 1997, 14(3): 307-309.
|
46. |
Interim Report of the Review of Unlicensed Medicines. Review of UK regulatory arrangements established under Article 5.1 of European Directive 2001/83/EC.
|
47. |
張恩娟. 科學管理, 為超說明書用藥“保駕護航”. 中國處方藥, 2010, 103(3): 23-25.
|
48. |
FDA. Guidance for Industry - Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices(2009). Available at: URL:http://www.fda.gov/oc/op/goodreprint.htm.
|
49. |
Anonymous. FDA Releases Draft Guidance on Reprint Practices for Dissemination of Articles on Drugs or Medical Devices.(February 25,2008). Available at: http://www.wsgr.com/wsgr/Display.aspx?SectionName=publications/PDFSearch/clientalert_FDA-Guidance.htm.
|
50. |
Tanne JH. FDA is criticised for poor oversight of drug companies’promotion of off-label drug use. BMJ, 2008, 337: a1163.
|
51. |
FDA. Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs(2010). Available at: URL: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm079099.htm.
|
52. |
Cheng AC, Robinson PM, Harvey K. Off-label use of medicines: consensus recommendations for evaluating appropriateness. MJA, 2007, 186(7): 379-380.
|
53. |
Akaza H, Ohashi Y, Shimada Y, et al. Post launch studies. Gan To Kagaku Ryoho, 2002, 29(32): 2037-2048.
|
54. |
Johnson PE. Pharmaceutical reimbursement: an overview. Am J Health-Syst Pharm,2008, 65(suppl 1): S4-S10.
|
55. |
Kaa K. Medicare challenges and solutions: reimbursement issues in treating the patient with colorectal cancer. J Manag Care Pharm, 2007, 13(6 suppl C): S19-S26.
|
56. |
American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(13): 2006-2008.
|
57. |
Allen C Cheng, Priscilla M Robinson and Ken Harvey. Off-label use of medicines: consensus recommendations for evaluating appropriateness. MJA, 2007, 186(7): 379-380.
|
58. |
張鈺瑩, 于麗. 超說明書用藥理與法的考量.中國處方藥, 2010, 103(3): 71-72.
|
59. |
李玉珍, 任曉蕾. 超說明書用藥,醫療機構需謹慎對待. 中國社區醫師, 2011-04-22,23.
|