Abstract: Objective To retrospectively analyze off-label medications among neonatal inpatients in our hospital in 2018, and to identify the risk factors for drug use so as to provide data for reducing the risk of drug use and optimizing off-label drug use policies in our hospital. Methods Neonatological cases and related doctors' instructions in 2018 were randomly chosen using the method of equal number distribution. The basic information of the patients, incidence of off-label instructions, types of drugs used, and the incidence of adverse events were statistically analyzed. Results Based on the number of children and the number of medication orders, the incidence of off-label drug use was 98.13% and 65.48% respectively. The average number of off-label drugs used per child was 11.9±1.5. The most common drugs that were used off-label were contrast agents (100.00%), followed by hematopoietic drugs (96.03%), and respiratory drugs (95.38%). Off-label use of drugs often involved drugs whose usage for newborns was not mentioned (61.89%), over-indication drugs (15.83%) and over-dose drugs (8.66%). The proportion of adverse events caused by off-label drug use was 55.56%. Conclusion The incidence of off-label drug use among newborns in our hospital is high, involving a wide range of varieties, Therefore, hospitals should improve the documentation of off-label drug use, ensure informed consent of patients, and work out emergency measures and monitor the risk of off-label drug use daily.

Key words: newborn, hospitalized children, off‐label use, drug analysis, risk analysis