Abstract: Objective To investigate the features and general pattern of the adverse drug reaction/event(ADR/ADE), and provide references of clinical rational and safty use of drug and evaluate the quality of ADR/ADE reports. Methods A total of 168 ADR/ADE cases collected in our hospital from Jan.2007 to June 2009 were analyzed retrospectively. Results A total of 104 drugs were involved in the 168 ADR/ADE,mainly anti-infective drugs(45.2%), followed by Traditional Chinese Medicines(25.6%). The main route of administration was by intravenous drip(61.9%). The ADR/ADE were chiefly characterized by the lesions of skin and appendages(46.4%). There were four severe cases and most of ADR/ADE occurred within 24 hours after medication(112 cases); 52 cases were given symptomatic treatment and 60 cases were left untreated. The number of ADR/ADE reports was less than expected and the quality of ADR/ADE reports was poor. Conclusion ADR monitoring and reporting should be strengthened to ensure safe, effective and rational drug use in the clinic. The ADR/ADE occurred in our hospital were mainly induced by the use of anti-infectives and Chinese materia medica preparation administered by intravenous drip. Measures should be taken to tighten control on rational drug use.

Key words: adverse drug reaction/event(ADR/ADE), analysis of reports, rational use of drugs