Survey on Off-Label Drug Use in Pediatric Outpatients of West China Second University Hospital in 2010_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Lingli ^1,2 ,  LI Youping ¹ , HUANG Liang ² , HU Die ^2,3 , ZENG Linan ² , YANG Chunsong ² , CHEN Min ^2,3

1. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;2. West China Second University Hospital, Sichuan University, Chengdu 610041, China;3. West China School of Pharmacy, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Off-label drug use; Pediatrics; Pediatric outpatient; Risk factors analysis; Drug safety

DOI：

10.7507/1672-2531.20120044

Video：

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Objective　 To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use.
Methods　 The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs.
Results　 A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label.
Conclusion　 Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.

Citation： ZHANG Lingli,LI Youping,HUANG Liang,HU Die,ZENG Linan,YANG Chunsong,CHEN Min. Survey on Off-Label Drug Use in Pediatric Outpatients of West China Second University Hospital in 2010. Chinese Journal of Evidence-Based Medicine, 2012, 12(3): 267-273. doi: 10.7507/1672-2531.20120044 Copy

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1. 张伶俐, 李幼平. 基于风险与责任, 促进中国儿童合理用药的思考. 中国循证医学杂志, 2011, 11(9): 983-984.
2. NLM (2010), MeSH NLM Controlled Vocabulary. [2011-03-15] Available at: http://www.ncbi.nlm.nih.gov/mesh/68056687.
3. 广东省药学会. 药品未注册用法专家共识. 2010年3月18日.
4. American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hospital Pharm, 1992, 49(655): 2006.
5. 黄亮, 申向黎, 陈力, 等. 正确认识并有效规范超说明书用药行为.中国医院药学杂志, 2009, 29(11): 949-951.
6. 张伶俐, 李幼平, 黄亮, 等. 四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查. 中国医院药学杂志, 2011, 11(10): 1120-1124.
7. 张伶俐, 李幼平, 梁毅, 等. 全球住院儿童超说明书用药的系统评价. 中国循证医学杂志, 2012, 12(2): 176-187.
8. 张伶俐, 李幼平, 胡蝶, 等. 四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查. 中国循证医学杂志, 2012, 12(2): 161-167.
9. Chalumeau M, Tréluyer JM, Salanave B, et al. Off-label and unlicensed drug use among French office based pediatricians. Arch Dis Child, 2000, 83(6): 502-505.
10. 薛辛东. 儿科学. 第1版. 北京: 人民卫生出版社, 2005: 302-305.
11. 陈新谦, 等. 新编药物学. 第17版. 北京:人民卫生出版社, 2011: 959.
12. Guidance for Industry E11 Clinical Investigation of Medicinal Products in the Pediatric Population.
13. Schirm E, Tobi H, de Jong-van den Berg LT. Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital. Pediatrics, 2003, 111(2): 291-295.
14. 孙振球. 医学统计学. 第3版. 北京: 人民卫生出版社, 2010: 279.
15. 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.
16. WHO. 药物: 儿童药物.2010年6月, 实况报道第341号. [2012-02-04]. Available at: http://www.who.int/mediacentre/factsheets/fs341/zh/.
17. 张伶俐, 梁毅, 张川, 等. 循证制定我国国家儿童基本药物目录的探索与思考. 中国循证医学杂志, 2010, 9(增刊): 3.
18. 张伶俐, 张川, 李幼平. 我国基本药物目录与WHO儿童基本药物目录比较分析.中国循证医学杂志, 2010, 9(增刊): 2-3.

Chinese Journal of Evidence-Based Medicine

Survey on Off-Label Drug Use in Pediatric Outpatients of West China Second University Hospital in 2010

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