Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection among Inpatients in Guangdong General Hospital in 2012_Chinese Journal of Evidence-Based Medicine

Authors：

ZHOUJing ^1,3 , CHENWen-ying ¹ , LAOHai-yan ¹ , HUANGBi-yu ¹ , LIUXiao-qi ¹ , LIYou-ping ⁴ , HUANGMin ³ ,  YANGMin ^1,2

1. Department of Pharmacy, Guangdong General Hospital(Guangdong Academy of Medical Sciences), Guangzhou 510080, China;
2. Guangdong Provincial Cardiovascular Research Institute, Guangzhou 510080, China;
3. School of Pharmaceutical Sciences, SUN YAT-SEN University, Guangzhou 510006, China;
4. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

YANGMin, Email: mnmyang@aliyun.com

Keywords：

Ambroxol hydrochloride injection; Off-label drug use; Drug utilization index; Inpatient; Guangdong General Hospital

DOI：

10.7507/1672-2531.20140170

Video：

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Objective To retrospectively analyze off-label drug use (OLDU) situation of ambroxol hydrochloride injection (AHI) among inpatients in the Guangdong General Hospital in 2012, so as to provide references for AHI OLDU. Methods All medical orders of AHI for inpatients in the Guangdong General Hospital in 2012 were included, and OLDU was judged according to drug labels. We summarized situation of drug use in all departments, analyzed OLDU incidence in administration path and in dose, calculated prescribed daily dose (PDD) and utilization index (DUI) in each department to evaluate the degree of OLDU in dose. Results a) A total of inpatients 138 227 patient-days who used AHI were included. OLDU occurred in all departments in this hospital and the total OLDU incidence was 67.06%. b) OLDU in dose occurred in 71.43% of the departments (25/35) with an incidence of 29.53%; the top 4 departments were cardiac surgery intensive care unit department (CICU) (97.74%), cardiac surgery department (97.51%), pediatric cardiac surgery department (72.30%) and pediatric intensive care unit department (PICU) (70.28%) in order. c) The PDDs in CICU department, cardiac surgery department, PICU departments, pediatric cardiac surgery department, oncological surgery ward, neurosurgery ward and intensive care unit (ICU) were higher than the defined daily dose (DDD), of which, the DUI/cDUI in CICU, cardiac surgery department, PICU and pediatric cardiac surgery department were 1 to 3 times higher than normal level. d) No relevant adverse drug reaction/adverse event (ADR/AE) reports were received in this hospital in 2012. Conclusion AHI is widely used in the Guangdong General Hospital, and AHI OLDU is commonly-seen. Further studies should be conducted to analyze the influence factors of AHI OLDU in dose and to evaluate the rationality of its application.

Citation： ZHOUJing, CHENWen-ying, LAOHai-yan, HUANGBi-yu, LIUXiao-qi, LIYou-ping, HUANGMin, YANGMin. Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection among Inpatients in Guangdong General Hospital in 2012. Chinese Journal of Evidence-Based Medicine, 2014, 14(9): 1030-1037. doi: 10.7507/1672-2531.20140170 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.	Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
4.	Gillick MR. Controlling off-label medication use. Ann Intern Med, 2009, 150(5):344-347.
5.	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.
6.	Beeh KM, Beier J, Esperester A, et al. Antiinflammatory properties of ambroxol. Eur J Med Res, 2008, 13(12):557-562.
7.	Malerba M, Ragnoli B. Ambroxol in the 21st century:pharmacological and clinical update. Expert Opin Drug Metab Toxicol, 2008, 4(8):1119-1129.
8.	Paleari D, Rossi GA, Nicolini G, et al. Ambroxol:a multifaceted molecule with additional therapeutic potentials in respiratory disorders of childhood. Expert Opin Drug Discov, 2011, 6(11):1203-1214.
9.	楼洪刚, 刘芳, 翟所迪.氨溴索雾化吸入治疗肺炎的系统评价.中国循证医学杂志, 2006, 6(5):421-429.
10.	王明丽, 谢陶吟, 许建平.注射用氨溴索雾化吸入致呼吸困难1例分析.中国药房, 2011, 22(40):3791-3792.
11.	邢丽娟.雾化吸入盐酸氨溴索过敏1例报告.山东医药, 2010, 50(18):16.
12.	谢陶吟, 许建平.盐酸氨溴索冻干粉针剂雾化吸入的安全性探讨.药学与临床研究, 2012, 20(4):308-310.
13.	许申.氨溴索的临床应用进展.临床肺科杂志, 2009, 14(8):1053-1055.
14.	李剑峰.一种吸入用盐酸氨溴索溶液.中国:CN103462942A, 2013-12-25.
15.	中国医师协会胸外科医师分会, "胸外科围手术期肺部并发症"研讨会.胸外科围手术期肺部并发症防治专家共识.中华胸心血管外科杂志, 2009, 25(4):217-218.
16.	Romanini BM, Sandri MG, Tosi M, et al. Ambroxol for prophylaxis and treatment of bronchopulmonary complications after chest surgery. Int J Clin Pharmacol Res, 1986, 6(2):123-127.
17.	Refai M, Brunelli A, Xiume F, et al. Short-term perioperative treatment with ambroxol reduces pulmonary complications and hospital costs after pulmonary lobectomy:a randomized trial. Euro J Cardio-Thorac Surg, 2009, 35(3):469-473.
18.	陈渊, 马彬, 杨克虎, 等.围手术期使用盐酸氨溴索对肺保护作用的系统评价.中国循证医学杂志, 2009, 9(5):558-564.
19.	周海洋, 常业恬, 吕志平, 等.盐酸氨溴索对瓣膜置换患者围术期肺损伤的保护作用.中南大学学报(医学版), 2004, 29(6):732-724.
20.	冯旭, 何巍, 林善昌, 等.心脏不停跳二尖瓣置换术中应用沐舒坦对血栓素变化的影响.广西医科大学学报, 2006, 23(3):408-409.
21.	张亚军, 施东辉, 顾明忠, 等.盐酸氨溴索对体外循环心脏直视手术肺保护作用的临床研究.中国心血管病研究杂志, 2005, 3(3):189-191.
22.	Ulas MM, Hizarci M, Kunt A, et al. Protective effect of ambroxol on pulmonary function after cardiopulmonary bypass. J Cardiovasc Pharmacol, 2008, 52(6):518-523.
23.	World Health Organization. Introduction to Drug Utilization Research. Oslo, Norway, 2003. Available at:http://www.whocc.no/filearchive/publications/drug_utilization_research.pdf.
24.	Ghodse AH, Baigent B, Evans TC, et al. The use of a drug utilisation index to monitor psychotropic drug use in hospitals. Journal of Social Psychiatry, 1987, 33(1):21-29.
25.	韩璐, 曾力楠, 张伶俐, 等. 329例汶川地震妇女儿童伤病员药物利用分析.中国循证医学杂志, 2009, 9(3):265-272.
26.	张伶俐, 李幼平, 曾力楠, 等.用儿童药物利用指数评价儿科用药剂量合理性的思考与探索.中国循证医学杂志, 2012, 12(2):125-128.

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. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
4. Gillick MR. Controlling off-label medication use. Ann Intern Med, 2009, 150(5):344-347.
5. 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.
6. Beeh KM, Beier J, Esperester A, et al. Antiinflammatory properties of ambroxol. Eur J Med Res, 2008, 13(12):557-562.
7. Malerba M, Ragnoli B. Ambroxol in the 21st century:pharmacological and clinical update. Expert Opin Drug Metab Toxicol, 2008, 4(8):1119-1129.
8. Paleari D, Rossi GA, Nicolini G, et al. Ambroxol:a multifaceted molecule with additional therapeutic potentials in respiratory disorders of childhood. Expert Opin Drug Discov, 2011, 6(11):1203-1214.
9. 楼洪刚, 刘芳, 翟所迪.氨溴索雾化吸入治疗肺炎的系统评价.中国循证医学杂志, 2006, 6(5):421-429.
10. 王明丽, 谢陶吟, 许建平.注射用氨溴索雾化吸入致呼吸困难1例分析.中国药房, 2011, 22(40):3791-3792.
11. 邢丽娟.雾化吸入盐酸氨溴索过敏1例报告.山东医药, 2010, 50(18):16.
12. 谢陶吟, 许建平.盐酸氨溴索冻干粉针剂雾化吸入的安全性探讨.药学与临床研究, 2012, 20(4):308-310.
13. 许申.氨溴索的临床应用进展.临床肺科杂志, 2009, 14(8):1053-1055.
14. 李剑峰.一种吸入用盐酸氨溴索溶液.中国:CN103462942A, 2013-12-25.
15. 中国医师协会胸外科医师分会, "胸外科围手术期肺部并发症"研讨会.胸外科围手术期肺部并发症防治专家共识.中华胸心血管外科杂志, 2009, 25(4):217-218.
16. Romanini BM, Sandri MG, Tosi M, et al. Ambroxol for prophylaxis and treatment of bronchopulmonary complications after chest surgery. Int J Clin Pharmacol Res, 1986, 6(2):123-127.
17. Refai M, Brunelli A, Xiume F, et al. Short-term perioperative treatment with ambroxol reduces pulmonary complications and hospital costs after pulmonary lobectomy:a randomized trial. Euro J Cardio-Thorac Surg, 2009, 35(3):469-473.
18. 陈渊, 马彬, 杨克虎, 等.围手术期使用盐酸氨溴索对肺保护作用的系统评价.中国循证医学杂志, 2009, 9(5):558-564.
19. 周海洋, 常业恬, 吕志平, 等.盐酸氨溴索对瓣膜置换患者围术期肺损伤的保护作用.中南大学学报(医学版), 2004, 29(6):732-724.
20. 冯旭, 何巍, 林善昌, 等.心脏不停跳二尖瓣置换术中应用沐舒坦对血栓素变化的影响.广西医科大学学报, 2006, 23(3):408-409.
21. 张亚军, 施东辉, 顾明忠, 等.盐酸氨溴索对体外循环心脏直视手术肺保护作用的临床研究.中国心血管病研究杂志, 2005, 3(3):189-191.
22. Ulas MM, Hizarci M, Kunt A, et al. Protective effect of ambroxol on pulmonary function after cardiopulmonary bypass. J Cardiovasc Pharmacol, 2008, 52(6):518-523.
23. World Health Organization. Introduction to Drug Utilization Research. Oslo, Norway, 2003. Available at:http://www.whocc.no/filearchive/publications/drug_utilization_research.pdf.
24. Ghodse AH, Baigent B, Evans TC, et al. The use of a drug utilisation index to monitor psychotropic drug use in hospitals. Journal of Social Psychiatry, 1987, 33(1):21-29.
25. 韩璐, 曾力楠, 张伶俐, 等. 329例汶川地震妇女儿童伤病员药物利用分析.中国循证医学杂志, 2009, 9(3):265-272.
26. 张伶俐, 李幼平, 曾力楠, 等.用儿童药物利用指数评价儿科用药剂量合理性的思考与探索.中国循证医学杂志, 2012, 12(2):125-128.

Chinese Journal of Evidence-Based Medicine

Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection among Inpatients in Guangdong General Hospital in 2012

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