Adverse Drug Reaction in the Neonatal Intensive Care Unit: A Single Center Study

ABSTRACT

PURPOSE: Little research has been conducted on adverse drug reactions in neonates, particularly in Korea, where no studies have been reported. METHODS: We conducted a retrospectively study using medical records in a neonatal intensive care unit from August 1, 2013 to July 31, 2014. The adverse drug reactions were evaluated according to the Naranjo algorithm, World Health Organization-Uppsala Monitoring Centre, and the Korean adverse drug reaction algorithm. RESULTS: Of the 410 infants hospitalized during the study period, 57 cases of adverse drug reactions were reported in 40 infants (9.8%). The average gestational age was 28.4+/-4.3 weeks, the average birth weight was 1,184.1+/-622.0 g, and the adverse drug reactions were reported at an average of 21.0+/-29.7 days after birth. Causative agents were identified as electrolytes (36.8%), respiratory medication (14.0%), total parenteral nutrition (12.3%), lipid emulsion (10.5%), antibiotics (7.0%), non-steroidal anti-inflammatory drugs (NSAIDs, 7.0%), sedatives (7.0%), vaccine (3.5%), and an antiviral medication (1.8%). Of the 57 cases, 55 (96.5%) cases demonstrated meaningful adverse drug reactions, defined as those given a score of "possible or above" in all 3 adverse drug reaction algorithms. CONCLUSION: More emphasis is warranted in the field of neonatal adverse drug reactions.