The Analysis Of The Off-label Druge Use In Which 464 Cases Of Adverse Drug Reactions

Objective A retrospective analysis of the characteristics of the adverse drug reactions and the off-label drug use with 464 cases of adverse drug reactions were reported actively in our hospital in 2014. In order to determine the relationship between the off-label drug use and the extent of damage of adverse drug reactions.Methods Describing the characteristics of adverse drug reactions and counting the rate and the category of off-label drug use. Analyzing the differences of the off-label drug use in different age groups, between the off-label drug use and label drug use in different extent of damage of adverse drug reactions, between normal dosage and over-dosage in different extent of damage of adverse drug reactions of antimicrobial agents.Results The children group(2-11 years) of adverse drug reactions was most common(64%). The rate of adverse reactions was higher in males(64.7%) than females. Respiratory infection of all the disease diagnosis and the symptoms of skin system(85.7%) were common. Respectively, according to the number of drugs and patients, the rate of off-label drug use was 49.1%, 52%. The main category of off-label drug use was no pediatric information(59.9%). According to formulary, US Food Drug Administration, the category of off-label drug use was just dosage of antimicrobial agents. The rate of the off-label drug use was highest in infant and young children group(67.3%). There were statistically significant differences of the off-label drug use in the different age groups(P <0.001) and the different extent of damage of adverse drug reactions(P=0.042). The rate of the off-label drug use was higher in moderate-to-severe adverse drug reactions than mild adverse drug reactions. There were statistically significant differences of the different extent of damage on adverse drug reactions between over-dosage and normal dosage of antimicrobial agents(P=0.021).Conclusion The rate of the off-label drug use was high in adverse drug reactions. Adverse reactions of antimicrobial drugs may be dose-related. Over-dosage of antimicrobial agents may be one reason of worse extent of damage on adverse drug reactions.