Neonatal Med.  2015 Nov;22(4):187-191. 10.5385/nm.2015.22.4.187.

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

• Kwon KA
• Kim HS
• Nam YH
• Kim MJ

• KMID: 2130686
• DOI: http://doi.org/10.5385/nm.2015.22.4.187

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.

Keyword

Adverse drug reactions; Newborn

MeSH Terms

Anti-Bacterial Agents
Birth Weight
Drug-Related Side Effects and Adverse Reactions*
Electrolytes
Gestational Age
Humans
Hypnotics and Sedatives
Infant
Infant, Newborn
Intensive Care, Neonatal*
Korea
Medical Records
Parenteral Nutrition, Total
Parturition
Retrospective Studies
World Health
Anti-Bacterial Agents
Electrolytes
Hypnotics and Sedatives