Objective: To probe into the off-label drug use of pediatric microecological preparations in China

so as to provide reference for clinical rational drug use. Methods: Text analysis method was adopted

according to the drug instructions and literature

questionnaire on the clinical use of microecological preparations in pediatrics was prepared

distributed and recovered in 36 hospitals in 6 administrative regions

21 provinces and cities in China

and the survey results were statistically analyzed. Results: There were a total of 213 valid questionnaires

among which 31 hospitals had bifidobacteria quadruplicate viable tablets and 23 hospitals had bacillus subtilis diplicate viable tablets. The most common indications for the use of microecological preparations were respectively acute and chronic diarrhea

functional dyspepsia and antibiotic-related diarrhea. There were 207 questionnaires (97.18%) of off-label drug use

including 184 cases (86.38%) of off-label indications

4 cases (1.88%) of off-label administration route

191 cases (89.67%) of overdose and 134 cases (62.91%) of overuse. Conclusion: The incidence of off-label drug use in children with microecological preparations is relatively high. The prescribing behavior of clinical clinicians should be standardized to promote rational clinical use of drugs. Meanwhile

it is necessary to encourage and improve the information of children’s drug use in the drug instructions to ensure the safety and effectiveness of drug use.