Evaluation of off-label medication use and drug safety in a pediatric intensive care unit

Soojin Lee; Mi Hee Yang; Jung Sun Kim; Yoonsuk Cho; Nigh Choi; Eun Jung Cho; June Dong Park; Yu Hyeon Choi; Kyung Hee Choi

doi:10.1016/j.jsps.2023.101704

Evaluation of off-label medication use and drug safety in a pediatric intensive care unit

Saudi Pharm J. 2023 Sep;31(9):101704. doi: 10.1016/j.jsps.2023.101704. Epub 2023 Jul 17.

Authors

Soojin Lee^{1

2}, Mi Hee Yang¹, Jung Sun Kim^{1

3}, Yoonsuk Cho¹, Nigh Choi¹, Eun Jung Cho¹, June Dong Park⁴, Yu Hyeon Choi⁵, Kyung Hee Choi⁶

Affiliations

¹ Department of Pharmacy, Seoul National University Hospital, Seoul 03080, Korea.
² College of Pharmacy, Seoul National University, Seoul 03080, Korea.
³ College of Pharmacy, Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Korea.
⁴ Department of Pediatrics, Seoul National University College of Medicine, Seoul 03080, Korea.
⁵ Department of Pediatrics, Seoul Medical Center, Seoul 02054, Korea.
⁶ College of Pharmacy, Gachon University, Incheon 21936, Korea.

Abstract

Safety and efficacy are essential in the process of disease treatment. However, off-label medication use is inevitable because various medications do not contain regulatory labels for pediatric use. We aimed to examine off-label medication use and analyze the risk factors correlated with adverse drug reactions (ADRs). This study was performed retrospectively using electronic medical data from a pediatric intensive care unit (PICU) of a tertiary hospital in Korea from July 2019 to June 2020. A total 6,183 prescribed medications from 502 PICU patients were examined in the present study. A total of 80% were infants or children, and 96.0% of them were treated with off-label medications. It was discovered that 4,778 off-label cases (77.2%) of the top 100 drugs had prescriptions with dosage (67.8%). Drugs prescribed to patients admitted to the cardiothoracic department (odds ratio [OR], 3.248; p = 0.019), total number of medications (OR, 1.116; p = 0.001), and length of PICU stay of ≥ 7 days (OR, 4.981; p = 0.008) were significantly associated with ADRs. ADRs were noted to be more severe in off-label use (p = 0.0426). For appropriate medication use, evidence regarding the safety of off-label medications is required and ultimately reflected in the official regulation.

Keywords: Adverse drug reactions; Drug labeling; Off-label use; Patient safety; Pediatric Intensive Care Units; Pediatrics.