Evaluation of off-label medication use and drug safety in a pediatric intensive care unit
- Authors
- Lee, Soojin; Yang, Mi Hee; Kim, Jung Sun; Cho, Yoonsuk; Choi, Nigh; Cho, Eun Jung; Park, June Dong; Choi, Yu Hyeon; Choi, Kyung Hee
- Issue Date
- Sep-2023
- Publisher
- ELSEVIER
- Keywords
- Adverse drug reactions; Drug labeling; Off-label use; Patient safety; Pediatric Intensive Care Units; Pediatrics
- Citation
- Saudi Pharmaceutical Journal, v.31, no.9
- Journal Title
- Saudi Pharmaceutical Journal
- Volume
- 31
- Number
- 9
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/89078
- DOI
- 10.1016/j.jsps.2023.101704
- ISSN
- 1319-0164
- 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. © 2023 The Author(s)
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