Profile of Adverse Events at a Brazilian University Hospital

Abstract

Introduction: The University Hospital of Sao Paulo of the University of São Paulo (HU/USP) is part of the Sentinel Network, a program managed by the National Agency of Sanitary Surveillance in Brazil (ANVISA). Institutions shall notify the ANVISA and in case of alert returns with a signal for the whole country1. Aim: To analyze the adverse drug events (ADEs) on between the adult and pédiatrie groups, from January 2012 to May 2012, reported to the Pharmacy Service of the HU/USP. Methods: We included only those ADEs detected by a multidisciplinary team of HU/USP and notified by Pharmacovigilance to ANVISA, during the period of study. We compiled the following data; age, sex, ward, classification of the medicine according to the Anatomicai Tiierapeulicai Cliemical (ATC) in the first level and the adverse drug reaction was classified according to the Adverse Reaction Terminoiogy from the World Health Organization (WHO-ART). Results: During this period were reported 47 ADEs, 59.6% male and 40.4 female. Most reported ADEs occurred in adults (70.2%, n = 33) with a mean age of 43 years old. In this group 33.3% (n= II) of events occurred at surgical ward, followed by 21.2% at medical ward, 15.2% at ICU and 9.1% at surgical center. According to the ATC, it was observed that the ADEs were directly linked to the medicines classified as General antiinfective for systemic use (51.5%) and nervous system drugs (42.4%). Using the WHO-ART, the most frequent adverse event was skin (48.5%) followed by general disorders (24.2%). Pédiatrie patients accounted for 29.8% (n=14) of ADEs and age ranging from 7 days to 15 years old. Most of ADEs was detected in the pédiatrie ICU (42.9%), followed by the Emergency Service (21.4%), pédiatrie ward and neonatology ICU both with 14.3% and pédiatrie ward with 7.1%. According to ATC, 85.7% of ADEs were related to General anti-infective for systemic. The ADEs with skin represents 42.9% of pédiatrie patients. Conclusions; The present study shows that adults hospitalized at surgical, medical and ICU had a higher frequency in the occurrence of event adverse. For pédiatrie patients the frequency was higher in pediatric ICU or at the emergency room. Both groups showed that the anti-infective drugs are the main causes of adverse event and skin reactions were more significant.