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：

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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

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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. 萬正蘭, 林米花. 抗腫瘤藥超說明書使用調查分析. 中國醫院藥學雜志, 2013, 33(12):1003-1004.
10. 任海霞. 我院胸外科2008-2010年化療患者用藥調查及合理性分析. 天津醫科大學碩士學位論文, 2011.
11. 劉紅, 張關敏, 劉穎, 等. 我院兒童腫瘤患者用藥回顧性監測分析. 中國藥學雜志, 2012, 45(23):1871-1873.
12. 樓亞玲,萬斌. 我院抗腫瘤藥物處方使用情況分析. 海峽藥學, 2012, 24(4):237-239.
13. 劉廣宣, 趙茜. 抗腫瘤藥物11 030例處方分析. 中國醫院藥學雜志, 2011, 31(1):72-73.
14. 趙歡, 吳志強, 王建華. 某院靜脈用藥調配中心抗腫瘤藥物不合理醫囑分析. 現代醫藥衛生, 2013, 29(20):3074-3075.
15. 何抒帆, 陳奇. PIVAS 不合理化療用藥分析與干預. 廣東藥學院學報, 2012, 28(6):657-660.
16. 倪美鑫, 姚敏, 顧海娟. 靜脈藥物配置中心靜脈用抗腫瘤藥不合理應用及干預效果分析. 中國醫院用藥評價與分析, 2013, 13(9):821-823.
17. 王明輝, 張艷華, 丁奕. 注射用抗腫瘤藥調配醫囑的審核、干預與分析. 中國藥房, 2011, 22(18):1656-1658.
18. 林麗欽. 我院 PIVAS 抗腫瘤藥物不合理醫囑的處理及分析. 海峽藥學, 2013, 25(8):159-161.
19. 張天澤, 徐光煒. 腫瘤學. 天津:天津科學技術出版社, 1996:723-724.
20. 金宜紉, 黃天木, 楊一昆, 等. 卡鉑的穩定性研究. 中國醫藥工業雜志, 1994, 25(2), 69-72.
21. 陳新謙, 金有豫, 湯光. 新編藥物學 (第17版). 北京:人民衛生出版社, 2011.
22. 高文桂, 楊一昆, 普紹平, 等. 鉑(Ⅱ)類抗癌藥物的溶液化學反應特性. 貴金屬, 2001, 22(4):54-59.
23. 張艷華, 寧華. 抗腫瘤藥的配伍與用藥安全評價. 中國醫院用藥評價與分析, 2008, 8(1):12-14.

Chinese Journal of Evidence-Based Medicine

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

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