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

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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.	廣東省藥學會.藥品未注冊用法專家共識, 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.	張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價.中國循證醫學雜志, 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.	樓洪剛, 劉芳, 翟所迪.氨溴索霧化吸入治療肺炎的系統評價.中國循證醫學雜志, 2006, 6(5):421-429.
10.	王明麗, 謝陶吟, 許建平.注射用氨溴索霧化吸入致呼吸困難1例分析.中國藥房, 2011, 22(40):3791-3792.
11.	邢麗娟.霧化吸入鹽酸氨溴索過敏1例報告.山東醫藥, 2010, 50(18):16.
12.	謝陶吟, 許建平.鹽酸氨溴索凍干粉針劑霧化吸入的安全性探討.藥學與臨床研究, 2012, 20(4):308-310.
13.	許申.氨溴索的臨床應用進展.臨床肺科雜志, 2009, 14(8):1053-1055.
14.	李劍峰.一種吸入用鹽酸氨溴索溶液.中國:CN103462942A, 2013-12-25.
15.	中國醫師協會胸外科醫師分會, "胸外科圍手術期肺部并發癥"研討會.胸外科圍手術期肺部并發癥防治專家共識.中華胸心血管外科雜志, 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.	陳淵, 馬彬, 楊克虎, 等.圍手術期使用鹽酸氨溴索對肺保護作用的系統評價.中國循證醫學雜志, 2009, 9(5):558-564.
19.	周海洋, 常業恬, 呂志平, 等.鹽酸氨溴索對瓣膜置換患者圍術期肺損傷的保護作用.中南大學學報(醫學版), 2004, 29(6):732-724.
20.	馮旭, 何巍, 林善昌, 等.心臟不停跳二尖瓣置換術中應用沐舒坦對血栓素變化的影響.廣西醫科大學學報, 2006, 23(3):408-409.
21.	張亞軍, 施東輝, 顧明忠, 等.鹽酸氨溴索對體外循環心臟直視手術肺保護作用的臨床研究.中國心血管病研究雜志, 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.	韓璐, 曾力楠, 張伶俐, 等. 329例汶川地震婦女兒童傷病員藥物利用分析.中國循證醫學雜志, 2009, 9(3):265-272.
26.	張伶俐, 李幼平, 曾力楠, 等.用兒童藥物利用指數評價兒科用藥劑量合理性的思考與探索.中國循證醫學雜志, 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. 廣東省藥學會.藥品未注冊用法專家共識, 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. 張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價.中國循證醫學雜志, 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. 樓洪剛, 劉芳, 翟所迪.氨溴索霧化吸入治療肺炎的系統評價.中國循證醫學雜志, 2006, 6(5):421-429.
10. 王明麗, 謝陶吟, 許建平.注射用氨溴索霧化吸入致呼吸困難1例分析.中國藥房, 2011, 22(40):3791-3792.
11. 邢麗娟.霧化吸入鹽酸氨溴索過敏1例報告.山東醫藥, 2010, 50(18):16.
12. 謝陶吟, 許建平.鹽酸氨溴索凍干粉針劑霧化吸入的安全性探討.藥學與臨床研究, 2012, 20(4):308-310.
13. 許申.氨溴索的臨床應用進展.臨床肺科雜志, 2009, 14(8):1053-1055.
14. 李劍峰.一種吸入用鹽酸氨溴索溶液.中國:CN103462942A, 2013-12-25.
15. 中國醫師協會胸外科醫師分會, "胸外科圍手術期肺部并發癥"研討會.胸外科圍手術期肺部并發癥防治專家共識.中華胸心血管外科雜志, 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. 陳淵, 馬彬, 楊克虎, 等.圍手術期使用鹽酸氨溴索對肺保護作用的系統評價.中國循證醫學雜志, 2009, 9(5):558-564.
19. 周海洋, 常業恬, 呂志平, 等.鹽酸氨溴索對瓣膜置換患者圍術期肺損傷的保護作用.中南大學學報(醫學版), 2004, 29(6):732-724.
20. 馮旭, 何巍, 林善昌, 等.心臟不停跳二尖瓣置換術中應用沐舒坦對血栓素變化的影響.廣西醫科大學學報, 2006, 23(3):408-409.
21. 張亞軍, 施東輝, 顧明忠, 等.鹽酸氨溴索對體外循環心臟直視手術肺保護作用的臨床研究.中國心血管病研究雜志, 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. 韓璐, 曾力楠, 張伶俐, 等. 329例汶川地震婦女兒童傷病員藥物利用分析.中國循證醫學雜志, 2009, 9(3):265-272.
26. 張伶俐, 李幼平, 曾力楠, 等.用兒童藥物利用指數評價兒科用藥劑量合理性的思考與探索.中國循證醫學雜志, 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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