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

Autor: Soojin Lee, Mi Hee Yang, Jung Sun Kim, Yoonsuk Cho, Nigh Choi, Eun Jung Cho, June Dong Park, Yu Hyeon Choi, Kyung Hee Choi
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Saudi Pharmaceutical Journal, Vol 31, Iss 9, Pp 101704- (2023)
Druh dokumentu: article
ISSN: 1319-0164
DOI: 10.1016/j.jsps.2023.101704
Popis: 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.
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