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 OrganizationUppsala 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 antiinflammatory 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.