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Analysis of Off-Label Drug Use in Pediatric Inpatients: A Single Tertiary Center Experience
J. Kor. Soc. Health-syst. Pharm. 2021;38:342-350
Published online August 31, 2021;
© 2021 Korean Society of Health-System Pharmacists

Yeijee Shin, Chanyoung Kim, Geun-Mi Park, Joowon Chung, Hye-Won Han

Departments of Pharmacy, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
Correspondence to: 박근미 Tel:02-3010-4767
Received April 1, 2021; Revised May 6, 2021; Accepted July 1, 2021.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background : Because of the lack of clinical research and drug evaluation for children, off-label prescribing has been widely observed in children. However, studies on the prevalence of off-label prescribing in children are rare in Korea. The purpose of this study was to investigate the characteristics of off-label prescribing in pediatric inpatients at a tertiary university hospital in Korea.
Methods : All pediatric patients age 0-18 years were included Jun 1-7, 2020 at Asan Medical Center. We retrospectively collected patient characteristics and medication profiles and off-label prescriptions were defined based on the Korea Food and Drug Administration–approved labeling.
Results : Of the 286 inpatients, 229 (80.1%) patients received at least one off-label drug use. Additionally, 380 drugs were used, and 129 (33.9%) drugs are not approved in children. Of 1,784 prescriptions, 722 (40.5 %) were for off-label use. The proportion (n=107, 46.7%) of children under age two was higher in the off-label group than in the No off-label group. Gastrointestinal agents (n=183, 25.3%) were the most common causative drugs, followed by cardiovascular agents (n=111, 15.4%), and anti-Infective agents (n=82, 11.4%).
Conclusion : Off-label prescribing is common among pediatric patients, especially in premature and neonates. Thus, pediatric pharmacists should be actively engaged in off-label drug use for safe and effective medication use in pediatric patients. A practical guideline for off-label drug use in children, and further research on adverse drug reactions from off-label drug use is needed.
Keywords : Adolescents, Children, Infants, Off-label use, Pediatrics, Drug prescription

August 2021, 38 (3)