Off-Label Drug Use in Global Cancer Patients: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 LIUDuo , WUDong-yuan , LIUMeng-meng , YANCun-ling ,  DONGMei

Department of Pharmacy, Harbin Medical University Cancer Hospital, Harbin 150080, China;

Corresponding author：

DONGMei, Email: mdhappy2006@hotmail.com

Keywords：

Cancer patients; Off-label; Systematic review

DOI：

10.7507/1672-2531.20150086

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To systematically review the global situation of off-label drug use in cancer patients. Methods We searched PubMed, EMbase, CNKI, CBM and VIP databases from their inception to October 2014, to collect studies on off-label drug use in cancer patients. The publication language was limited to English and Chinese. Combieg criteria was used for methodological quality assessment of included studies. A describe analysis was used to analyze the incidence and the proportion of different off-label used drugs. Results A total of 14 cross-sectional studies were included. Among them, 1 was from Switzerland, 1 was from Italy, 1 was from Australia, and the other 11 studies were from China. Seven included studies reported the investigated patients' number, containing 3 713 cancer patients and 13 238 prescriptions. The incidences of off-label drug were 2 844, accounting for 21.48%. There were similar rates of off-label prescriptions in Europe, Asia and Australia, but the average off-label prescriptions of European cancer patients were lower than Asia and Australia. The total rate of "unapproved dose", "unapproved indication", and "unapproved solvents" were more than 80% in off-label drug use. Conclusion The average off-label prescriptions of European cancer patients are lower than Asian and Australian. "Unapproved dose", "unapproved indication" and "unapproved solvents" are the most common off-label prescription in off-label drug use.

Citation： LIUDuo, WUDong-yuan, LIUMeng-meng, YANCun-ling, DONGMei. Off-Label Drug Use in Global Cancer Patients: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2015, 15(5): 508-513. doi: 10.7507/1672-2531.20150086 Copy

1.	NLM (2010), MeSH NLM Controlled Vocabulary.[2011-09-13] Available at:http://www.ncbi.nlm.nih.gov/mesh/68056687.
2.	Levêque D. Off-label use of anticancer drugs. Lancet Oncol, 2008, 9(11):1102-1107.
3.	Crombie I:The pocket guide to critical appraisal. BMJ Publishing Group, 1996, London.
4.	Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1):159-174.
5.	Joerger M, Schaer-Thuer C, Koeberle D, et al. Off-label use of anticancer drugs in eastern Switzerland:a population-based prospective cohort study. Eur J Clin Pharmacol, 2014, 70(6):719-725.
6.	Roila F, Ballatori E, Labianca R, et al. Off-label prescription of antineoplastic drugs:an Italian prospective, observational, multicenter survey. Tumori, 2009, 95(6):647-651.
7.	Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer, 2004, 12(2):302-305.
8.	Wang WL, Zhu M, Guo D, et al. Off-Label and Off-NCCN Guidelines Uses of Antineoplastic Drugs in China. Iran J Public Health, 2013, 42(5):472-479.
9.	万正兰, 林米花. 抗肿瘤药超说明书使用调查分析. 中国医院药学杂志, 2013, 33(12):1003-1004.
10.	任海霞. 我院胸外科2008-2010年化疗患者用药调查及合理性分析. 天津医科大学硕士学位论文, 2011.
11.	刘红, 张关敏, 刘颖, 等. 我院儿童肿瘤患者用药回顾性监测分析. 中国药学杂志, 2012, 45(23):1871-1873.
12.	楼亚玲,万斌. 我院抗肿瘤药物处方使用情况分析. 海峡药学, 2012, 24(4):237-239.
13.	刘广宣, 赵茜. 抗肿瘤药物11 030例处方分析. 中国医院药学杂志, 2011, 31(1):72-73.
14.	赵欢, 吴志强, 王建华. 某院静脉用药调配中心抗肿瘤药物不合理医嘱分析. 现代医药卫生, 2013, 29(20):3074-3075.
15.	何抒帆, 陈奇. PIVAS 不合理化疗用药分析与干预. 广东药学院学报, 2012, 28(6):657-660.
16.	倪美鑫, 姚敏, 顾海娟. 静脉药物配置中心静脉用抗肿瘤药不合理应用及干预效果分析. 中国医院用药评价与分析, 2013, 13(9):821-823.
17.	王明辉, 张艳华, 丁奕. 注射用抗肿瘤药调配医嘱的审核、干预与分析. 中国药房, 2011, 22(18):1656-1658.
18.	林丽钦. 我院 PIVAS 抗肿瘤药物不合理医嘱的处理及分析. 海峡药学, 2013, 25(8):159-161.
19.	张天泽, 徐光炜. 肿瘤学. 天津:天津科学技术出版社, 1996:723-724.
20.	金宜纫, 黄天木, 杨一昆, 等. 卡铂的稳定性研究. 中国医药工业杂志, 1994, 25(2), 69-72.
21.	陈新谦, 金有豫, 汤光. 新编药物学 (第17版). 北京:人民卫生出版社, 2011.
22.	高文桂, 杨一昆, 普绍平, 等. 铂(Ⅱ)类抗癌药物的溶液化学反应特性. 贵金属, 2001, 22(4):54-59.
23.	张艳华, 宁华. 抗肿瘤药的配伍与用药安全评价. 中国医院用药评价与分析, 2008, 8(1):12-14.

1. NLM (2010), MeSH NLM Controlled Vocabulary.[2011-09-13] Available at:http://www.ncbi.nlm.nih.gov/mesh/68056687.
2. Levêque D. Off-label use of anticancer drugs. Lancet Oncol, 2008, 9(11):1102-1107.
3. Crombie I:The pocket guide to critical appraisal. BMJ Publishing Group, 1996, London.
4. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics, 1977, 33(1):159-174.
5. Joerger M, Schaer-Thuer C, Koeberle D, et al. Off-label use of anticancer drugs in eastern Switzerland:a population-based prospective cohort study. Eur J Clin Pharmacol, 2014, 70(6):719-725.
6. Roila F, Ballatori E, Labianca R, et al. Off-label prescription of antineoplastic drugs:an Italian prospective, observational, multicenter survey. Tumori, 2009, 95(6):647-651.
7. Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer, 2004, 12(2):302-305.
8. Wang WL, Zhu M, Guo D, et al. Off-Label and Off-NCCN Guidelines Uses of Antineoplastic Drugs in China. Iran J Public Health, 2013, 42(5):472-479.
9. 万正兰, 林米花. 抗肿瘤药超说明书使用调查分析. 中国医院药学杂志, 2013, 33(12):1003-1004.
10. 任海霞. 我院胸外科2008-2010年化疗患者用药调查及合理性分析. 天津医科大学硕士学位论文, 2011.
11. 刘红, 张关敏, 刘颖, 等. 我院儿童肿瘤患者用药回顾性监测分析. 中国药学杂志, 2012, 45(23):1871-1873.
12. 楼亚玲,万斌. 我院抗肿瘤药物处方使用情况分析. 海峡药学, 2012, 24(4):237-239.
13. 刘广宣, 赵茜. 抗肿瘤药物11 030例处方分析. 中国医院药学杂志, 2011, 31(1):72-73.
14. 赵欢, 吴志强, 王建华. 某院静脉用药调配中心抗肿瘤药物不合理医嘱分析. 现代医药卫生, 2013, 29(20):3074-3075.
15. 何抒帆, 陈奇. PIVAS 不合理化疗用药分析与干预. 广东药学院学报, 2012, 28(6):657-660.
16. 倪美鑫, 姚敏, 顾海娟. 静脉药物配置中心静脉用抗肿瘤药不合理应用及干预效果分析. 中国医院用药评价与分析, 2013, 13(9):821-823.
17. 王明辉, 张艳华, 丁奕. 注射用抗肿瘤药调配医嘱的审核、干预与分析. 中国药房, 2011, 22(18):1656-1658.
18. 林丽钦. 我院 PIVAS 抗肿瘤药物不合理医嘱的处理及分析. 海峡药学, 2013, 25(8):159-161.
19. 张天泽, 徐光炜. 肿瘤学. 天津:天津科学技术出版社, 1996:723-724.
20. 金宜纫, 黄天木, 杨一昆, 等. 卡铂的稳定性研究. 中国医药工业杂志, 1994, 25(2), 69-72.
21. 陈新谦, 金有豫, 汤光. 新编药物学 (第17版). 北京:人民卫生出版社, 2011.
22. 高文桂, 杨一昆, 普绍平, 等. 铂(Ⅱ)类抗癌药物的溶液化学反应特性. 贵金属, 2001, 22(4):54-59.
23. 张艳华, 宁华. 抗肿瘤药的配伍与用药安全评价. 中国医院用药评价与分析, 2008, 8(1):12-14.

Chinese Journal of Evidence-Based Medicine

Off-Label Drug Use in Global Cancer Patients: A Systematic Review

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content