Off-label drug information: regulation, distribution, evaluation, and related controversies.
作者信息
Ventola C Lee
出版信息
P T. 2009 Aug;34(8):428-40.
Abstract
摘要
相似文献
1
2
Regulating off-label drug use in India: The arena for concern.规范印度的药品非标签使用：令人担忧的领域。
Perspect Clin Res. 2015 Jul-Sep;6(3):129-33. doi: 10.4103/2229-3485.159935.
3
[Controversies with the "off label" use of medications in the paediatrics--research on the selected paediatricians].
Przegl Lek. 2010;67(1):28-30.
4
Controversies in off-label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies.皮肤科超适应证处方的争议：患者、医生和制药公司的观点。
Int J Dermatol. 2019 Jul;58(7):788-794. doi: 10.1111/ijd.14222. Epub 2018 Aug 31.
5
Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?商业言论与药品未标示用途：广泛接受、普遍认可及研究激励措施能发挥何种作用？
Am J Law Med. 2011;37(2-3):258-77. doi: 10.1177/009885881103700203.
6
Is off-label repeat prescription of ketamine as a rapid antidepressant safe? Controversies, ethical concerns, and legal implications.氯胺酮作为快速抗抑郁药的超说明书重复处方是否安全？争议、伦理问题及法律影响。
BMC Med Ethics. 2016 Jan 14;17:4. doi: 10.1186/s12910-016-0087-3.
7
The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.未获许可及超说明书用药对儿科患者药物不良反应的影响。
Drug Saf. 2004;27(13):1059-67. doi: 10.2165/00002018-200427130-00006.
8
Dissemination of information on the off-label (unapproved) use of medication: a comparative analysis.关于药物未获批准用途信息的传播：一项比较分析。
Med Law. 2011 Mar;30(1):115-32.
9
[Off-label use: update and relevance for urology].[非适应证用药：泌尿外科领域的更新与相关性]
Aktuelle Urol. 2007 Jul;38(4):301-4. doi: 10.1055/s-2007-980077.
10
Off-label use of drugs in pain medicine and palliative care: an algorithm for the assessment of its safe and legal prescription.疼痛医学与姑息治疗中药物的超说明书用药：安全合法处方评估算法
Pain Pract. 2008 May-Jun;8(3):157-63. doi: 10.1111/j.1533-2500.2008.00189.x. Epub 2008 Mar 27.
引用本文的文献
1
Real-world treatment outcomes of medicines used in special situations (off-label and compassionate use) in oncology and hematology: A retrospective study from a comprehensive cancer institution.真实世界中肿瘤学和血液学中特殊情况下（超适应证和同情用药）使用药物的治疗结局：来自综合癌症机构的回顾性研究。
Cancer Med. 2023 Aug;12(16):17112-17125. doi: 10.1002/cam4.6360. Epub 2023 Jul 26.
2
Off-label use information in electronic drug information resources.电子药物信息资源中的标签外使用信息。
J Med Libr Assoc. 2022 Oct 1;110(4):471-477. doi: 10.5195/jmla.2022.1419.
3
The Use of Psychotropic Medication in Pediatric Oncology for Acute Psychological and Psychiatric Problems: Balancing Risks and Benefits.精神药物在儿科肿瘤学中用于治疗急性心理和精神问题：权衡风险与益处。
Children (Basel). 2022 Nov 30;9(12):1878. doi: 10.3390/children9121878.
4
DrugCentral 2023 extends human clinical data and integrates veterinary drugs.DrugCentral 2023 扩展了人类临床数据并整合了兽药。
Nucleic Acids Res. 2023 Jan 6;51(D1):D1276-D1287. doi: 10.1093/nar/gkac1085.
5
Association of Supporting Trial Evidence and Reimbursement for Off-Label Use of Cancer Drugs.支持试验证据与癌症药物标签外使用报销的关联。
JAMA Netw Open. 2021 Mar 1;4(3):e210380. doi: 10.1001/jamanetworkopen.2021.0380.
6
The evidence-based choice for antipsychotics in children and adolescents should be guaranteed.应当保障儿童和青少年抗精神病药物的循证选择。
Eur J Clin Pharmacol. 2019 Jun;75(6):769-776. doi: 10.1007/s00228-019-02641-0. Epub 2019 Feb 7.
7
Off-label use of drugs in regional anesthesia: A need for setting up policies.区域麻醉中药物的超说明书用药：制定政策的必要性。
J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):448-449. doi: 10.4103/joacp.JOACP_341_15.
8
Short-term effects of intravitreal ranibizumab and bevacizumab administration on 24-h ambulatory blood pressure monitoring recordings in normotensive patients with age-related macular degeneration.玻璃体内注射雷珠单抗和贝伐单抗对年龄相关性黄斑变性正常血压患者24小时动态血压监测记录的短期影响。
Eye (Lond). 2017 May;31(5):677-683. doi: 10.1038/eye.2016.305. Epub 2017 Jan 6.
9
Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.制药行业的药品未按批准说明书用药推广与自我监管：对英国药品使用规范管理局2003 - 2012年未按批准说明书用药推广裁决的文件分析
PLoS Med. 2016 Jan 26;13(1):e1001945. doi: 10.1371/journal.pmed.1001945. eCollection 2016 Jan.
10
Drug utilisation and off-label use of medications in anaesthesia in surgical wards of a teaching hospital.教学医院外科病房麻醉用药的使用情况及药品的超说明书用药情况。
Indian J Anaesth. 2015 Nov;59(11):721-7. doi: 10.4103/0019-5049.170032.
本文引用的文献
1
2
Shifting terrain in the regulation of off-label promotion of pharmaceuticals.药品未标示用途推广监管方面不断变化的形势。
N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.
3
Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions.知情同意与共同决策：向患者披露药品未标示用途处方的要求。
PLoS Med. 2008 Nov 11;5(11):e223. doi: 10.1371/journal.pmed.0050223.
4
Off-label promotion, on-target sales.未标靶推广，目标明确销售。
PLoS Med. 2008 Oct 28;5(10):e210. doi: 10.1371/journal.pmed.0050210.
5
ASHP guidelines on the pharmacy and therapeutics committee and the formulary system.美国卫生系统药师协会关于药事与治疗学委员会及药品目录系统的指南。
Am J Health Syst Pharm. 2008 Jul 1;65(13):1272-83. doi: 10.2146/ajhp080086.
6
FDA guidance on off-label promotion and the state of the literature from sponsors.美国食品药品监督管理局关于药品未标示用途推广的指南及申办方的文献状况。
JAMA. 2008 Apr 23;299(16):1949-51. doi: 10.1001/jama.299.16.1949.
7
Experts weigh in on promotion, prescription of off-label drugs.专家就非标签药物的推广及处方发表意见。
JAMA. 2007 Feb 21;297(7):683-4. doi: 10.1001/jama.297.7.683.
8
Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.未标示用途还是越界行为？开处方者和营销商对FDA批准药物的未批准用途所承担的责任。
Ann Health Law. 2003 Summer;12(2):295-324, table of contents.
9
The role of marketing in pharmaceutical research and development.营销在药物研发中的作用。
Pharmacoeconomics. 2002;20 Suppl 3:77-85. doi: 10.2165/00019053-200220003-00008.
Zotero 插件