Objective: To retrospectively analyze the application status of off-label drug use in pediatric outpatient department of Northwest Women and Children’s Hospital in 2017

and to analyze the risk factors of off-label drug use

so as to provide data support for standardizing clinical medication in pediatrics. Methods: Prescriptions of pediatric outpatient department in our hospital in 2017 were randomly selected. According to drug instructions

off-label drug use of prescriptions of all selected children were analyzed

including the category of off-label drug use

off-label drug use in children of different ages and incidence of off-label drug use with different category of drugs. Meanwhile

the correlation between off-label drug use and basic information (age

gender) and drug information (essential drugs

OTC classification) was analyzed. Results: A total of 2

640 outpatient pediatric prescriptions with 4

435 medical orders were extracted

including 155 kinds of drugs. According to prescriptions

medication orders and drug categories

the incidence of off-label drug use were 35.55%

46.76% and 91.61%

respectively. Off-label drug use were more common in the following three clinical medications: (1) no pediatric information (34.28%)

(2) irrational frequency of administration (28.45%)

(3) over dose (16.42%). The age group with the highest incidence of off-label drug was adolescents (50.00%) and infants (47.64%). The top three drug categories ranked by off-label drug use were respectively respiratory system drugs (33.50%)

traditional Chinese patent medicine (18.74%) and systemic anti-infectives (17.95%). There is no statistically significant difference in the risk of off-label drug use for children of all ages in the outpatient department of our hospital. And there is no statistically significant difference in the risk of off-label drug use in children’s gender. Non-essential drugs and OTC had a higher risk of off-label use. Conclusion: Off-label drug use in pediatric outpatient department of our hospital in 2017 is relatively common. It is necessary to further standardize the use of drugs by clinicians and promote the rational use of drugs

so as to avoid medication risks in children