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(ii) The neonates (0 to 27 days) had higher risk in off-label drug use than the other three children age groups. (iii) The dermatological medicines (D), nervous system medicines (N), traditional Chinese medicines, and respiratory drugs (R) were high-risk off-label medicines whose labels should be updated more frequently. (iv) The great factors of off-label drug use are those influence health status and relate to health services (ICD-10:Z00-Z99) (mainly in the clinic of child care and growth development, and in the ward of chemotherapy). (v) Off-label drug use in the ward was 4.4 times than that in clinic service (P http://www.selleck.cn/products/MK-1775.html The risk of off-label Rx drug use was 3.2% higher than that of OTC (Over-The-Counter) drug use, without a significant difference. (i) A management guideline for off-label drug use is urgently needed, with which we can guide medical institutions to establish the management regulations of off-label drug http://www.selleckchem.com/PD-1-PD-L1.html use. (ii) Pediatric clinical research should be promoted actively, and pharmaceutical enterprises should be encouraged to completely provide pediatric drug information. (iv) Academic organizations should be invited to join in for best professional drug use. (v) Pediatric patients and their families should receive the education on rational drug use. Off-label drug use is defined as drug uses that are not included in the indications or dosage regimens listed in the US Food and Drug Administration (FDA)-approved labeling, http://www.selleckchem.com/products/Adriamycin.html which is also called ��unlabeled uses�� [1]. Low-quality evidence of pediatric drug use and its high risk are serious global problems [2]. Off-label drug use is caused by different factors, and it is apt to be one of the key factors of pediatric drug use risks. We conducted a series of off-label drug use studies which have been published in Chinese Journal of Evidence-Based Medicine in 2011 and 2012 [3, 4]. This study is based on detailed data of previous original studies, and to analyze factors related to off-label drug use in the hospital. Combining the results of the Evidence-based research of the policies of the off-label drug use in 15 countries [5] with the analysis of risk factors, we propose the management strategies for the pediatric off-label drug use policy in China. The West China Second University Hospital of Sichuan University (West China Women's and Children's Hospital) is the only women's and children's hospital affiliated to the Ministry of Health (MoH) of China. It is a regional health centre of the MoH, and the Women's and Children's Referral Center for emergency and severe cases in southwest China.