Investigation of Off-label Drug Use Prescriptions in Pediatric Outpatients and Analysis of Risk Factors

OBJECTIVE: To investigate the situation of off-label drug use in pediatric outpatients of Nanjing Red Cross Hospital( hereinafter referred to as hospital),and to probe into the risk factors so as to provide reference for the medication safety in children. METHODS: Prescriptions for pediatric outpatients admitted to our hospital in 2014 were collected. The medical orders were judged for off-label drug use according to the drug instructions. The types of off-label drug use,children in different ages,and correlation between off-label drug use and factors of the patients' age,gender and essential drugs were analyzed. RESULTS: 2 077 pediatric outpatient prescriptions were selected,including 5684 medical orders; in which,the incidence of prescriptions and medical orders that in off-label drug use were respectively 5. 87%( 122 /2 077) and 2. 39%( 136 /5 684). Of the 136 off-label drug use medical orders,the main categories of off-label drug use were dosage( 58 medical orders,42. 65%),frequency of administration( 36 medical orders,26. 47%) and pediatric drug use information that not mentioned( 22 medical orders,16. 18%) etc. The top two groups with highest incidence of off-label drug use were childhood( 2- 12 years old) and adolescents( 12- 18 years old). There was no statistically significant difference between the patients' age,gender and the risk factors of off-label drug use( P 0. 05); the risks of national essential drugs of off-label drug use were higher than that of non national essential drugs( P 0. 05). CONCLUSIONS: Off-label use in pediatric outpatients has been noted in our hospital. On the one hand,it is necessary to regulate the clinical drug use; on the other hand,it indicates that drug instructions are short of pediatric information. Thus,relevant administrative departments should formulate the corresponding laws,regulations or guidelines to ensure the medication safety in children.