Study on Clinical Management Methods and Process of Off-label Drug Use in Guangdong General Hospital_Chinese Journal of Evidence-Based Medicine

Authors：

 LAOHai-yan ¹ , WANGQi-yi ¹ , YANGMin ^1,2 , ZENGYing-tong ¹ , LIUXiao-qi ¹ , LINLu ¹ , ZHANGXiao-juan ¹ ,  LIYou-ping ³

1. Guangdong General Hospital(Guangdong Academy of Medical Sciences), Guangzhou 510080, China;
2. Guangdong Provincial Cardiovascular Research Institute, Guangzhou 510080, China;
3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LIYou-ping, Email: yzmylab@hotmail.com

Keywords：

Guangdong General Hospital; Off-label drug use; Clinical management method and process

DOI：

10.7507/1672-2531.20140169

Video：

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Abstract Full text Figures/Tables Video References Cited by

A study on clinical management methods and process of off-label drug use (OLDU) is carried out at managerial level in the Guangdong General Hospital to develop management regulations, processes and strategies of OLDU, so as to regulate OLDU behaviour in clinic. The hospital officially initiated the application-recording-approval process of OLDU in February, 2013, receiving 22 OLDU applications from 5 clinical departments in the first batch. The pharmacy management and pharmacotherapeutics committee approved eight applications and rejected one application according to regulation procedures. In this way, the Guangdong General Hospital well regulate the OLDU behaviour of physicians, which is significant to the further studies in OLDU in this hospital.

Citation： LAOHai-yan, WANGQi-yi, YANGMin, ZENGYing-tong, LIUXiao-qi, LINLu, ZHANGXiao-juan, LIYou-ping. Study on Clinical Management Methods and Process of Off-label Drug Use in Guangdong General Hospital. Chinese Journal of Evidence-Based Medicine, 2014, 14(9): 1025-1029. doi: 10.7507/1672-2531.20140169 Copy

1.	American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006-2008.
2.	广东省药学会.药品未注册用法专家共识.[2010-03-18].
3.	Knopf H, Wolf IK, Sarganas G, et al. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health, 2013, 13(1):631.
4.	Choonara I. Unlicensed and off-label drug use in children: implications for safety. Expert Opin Drug Saf, 2004, 3(2):81-83.
5.	Porta A, Esposito S, Menson E, et al. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol, 2010, 66(9):919-927.
6.	Horowitz E, Bergman LC, Ashkenazy C, et al. Off-label use of sodium valproate for schizophrenia. PLoS One, 2014, 9(3):e92573.
7.	徐梦丹, 周碧霞, 党丽娟, 等.医院门诊处方超说明书用药的调查分析.中国医药导报, 2014, 11(1):100-104.
8.	张蔚.门诊超药品说明书用药的调查分析.中国医院用药评价与分析, 2010, 10(2):186-187.
9.	赵继芳, 贾铮.药品未注册用法的门诊处方分析.药物流行病学杂志. 2013, 22(4):182-186.
10.	张伶俐, 李幼平, 梁毅, 等.全球门诊儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(3):305-313.
11.	张伶俐, 李幼平, 梁毅, 等.全球住院儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(2):176-187.
12.	Radley DC, Finkelstein SN, Stafford RS. Off-label Prescribing Among Office-Based Physicians. Arch Intern Med, 2006, 166(9):1021-1026.
13.	张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价.中国循证医学杂志, 2012, 12(4):426-435.
14.	王春梅.李大魁委员呼吁-规范我国临床超说明书用药管理.中国医药报, 2011, 3(8):5.
15.	Wittich CM, Burkle CM, Lanier WL. Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clin Proc, 2012, 87(10):982-990.
16.	Epstein RS, Huang SM. The Many Sides of Off-Label Prescribing. Clin Pharmacol Ther, 2012, 91(5):755-758.
17.	Gillick MR. Controlling off-label medication use. Ann Intern Med, 2009, 150(5):344-347.
18.	赵常军, 贾东岗, 雷招宝. "超说明书用药"的现状、危害性及对策.医学理论与实践, 2012, 25(8):984-986.
19.	张波, 李大魁, 杨晓.药品说明书之外的用法的若千问题及对策.中华风湿病学杂志, 2004, 8(8):451-453.
20.	张文丽.超药品说明书用药的问题及对策.中国医药, 2010, 5(8):765-766.

1. American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006-2008.
2. 广东省药学会.药品未注册用法专家共识.[2010-03-18].
3. Knopf H, Wolf IK, Sarganas G, et al. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health, 2013, 13(1):631.
4. Choonara I. Unlicensed and off-label drug use in children: implications for safety. Expert Opin Drug Saf, 2004, 3(2):81-83.
5. Porta A, Esposito S, Menson E, et al. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol, 2010, 66(9):919-927.
6. Horowitz E, Bergman LC, Ashkenazy C, et al. Off-label use of sodium valproate for schizophrenia. PLoS One, 2014, 9(3):e92573.
7. 徐梦丹, 周碧霞, 党丽娟, 等.医院门诊处方超说明书用药的调查分析.中国医药导报, 2014, 11(1):100-104.
8. 张蔚.门诊超药品说明书用药的调查分析.中国医院用药评价与分析, 2010, 10(2):186-187.
9. 赵继芳, 贾铮.药品未注册用法的门诊处方分析.药物流行病学杂志. 2013, 22(4):182-186.
10. 张伶俐, 李幼平, 梁毅, 等.全球门诊儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(3):305-313.
11. 张伶俐, 李幼平, 梁毅, 等.全球住院儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(2):176-187.
12. Radley DC, Finkelstein SN, Stafford RS. Off-label Prescribing Among Office-Based Physicians. Arch Intern Med, 2006, 166(9):1021-1026.
13. 张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价.中国循证医学杂志, 2012, 12(4):426-435.
14. 王春梅.李大魁委员呼吁-规范我国临床超说明书用药管理.中国医药报, 2011, 3(8):5.
15. Wittich CM, Burkle CM, Lanier WL. Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clin Proc, 2012, 87(10):982-990.
16. Epstein RS, Huang SM. The Many Sides of Off-Label Prescribing. Clin Pharmacol Ther, 2012, 91(5):755-758.
17. Gillick MR. Controlling off-label medication use. Ann Intern Med, 2009, 150(5):344-347.
18. 赵常军, 贾东岗, 雷招宝. "超说明书用药"的现状、危害性及对策.医学理论与实践, 2012, 25(8):984-986.
19. 张波, 李大魁, 杨晓.药品说明书之外的用法的若千问题及对策.中华风湿病学杂志, 2004, 8(8):451-453.
20. 张文丽.超药品说明书用药的问题及对策.中国医药, 2010, 5(8):765-766.

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Chinese Journal of Evidence-Based Medicine

Study on Clinical Management Methods and Process of Off-label Drug Use in Guangdong General Hospital

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