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Off-label Drug Use in Neonatal Intensive Care Unit : a Tertiary Center Experience
J. Kor. Soc. Health-syst. Pharm. 2019;36:325-334
Published online August 31, 2019;
© 2019 Korean Society of Health-System Pharmacists

Hye Jung Baea*, Yun Ju Shina*, Hyun Jung Shina, Jung Mi Lima, Sung Yun Suha, Yun Hee Joa, Yoon Sook Choa, Seung Han Shinb† and Kyung Hee Choic†

Department of Pharmacy, Seoul National University Hospitala, Department of Pediatrics, Seoul National University Children’s Hospitalb, College of Pharmacy, The Sunchon National University of Koreac 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Koreaa,b 255, Jungang-ro, Suncheon-si, Jeollanam-do, Republic of Koreac
Correspondence to: 신승한 Tel:02-2072-3555
최경희 Tel:061-750-3763

*배혜정과 신윤주는 공동 제1저자로서 본 논문에 동등하게 기여함.
Received January 26, 2019; Revised February 25, 2019; Accepted June 26, 2019.
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 : For a drug to be approved in a specific patient group, valid results are required through extensive clinical researches. However, it is often challenging to develop a drug for neonates due to distinct characteristics and limitations of clinical trials, making it often unavoidable to use off-label drugs in neonates. The objective of this study was to investigate the use of off-label drugs in neonatal intensive care unit (NICU) in a single institution in Korea.
Methods : All neonates admitted to NICU of Seoul National University Children’s Hospital between January and June 2017 were retrospectively studied. Demographic data and patient medication profile were collected for the study. All the drugs were investigated with respect to: indications, dose, treatment route, duration of treatment, contraindications and warnings specified in the specific marketing authorization, and classified as licensed or off-label according to their licensing status.
Results : 226 neonates were subjected to the study. Of the 226 neonates, 137 (60.6%) were preterm infants and 89 (39.4%) were term infants. Of the 1,797 prescriptions, 1,366 (76.0%) were used off-label drug, 155 (8.6%) were‘ Approved for neonatal and pediatric period but off-label use for dose and/or frequency’, 651 (36.2%) were ‘Off-label for neonatal period but on-label for pediatric period’, 481 (26.8%) were‘ Undetermined approval state for neonates and pediatric’, and 79 (4.4%) were‘ Contraindicated for neonates and pediatric’.
Conclusions : Off-label drug use rates were as high as 76% of total prescriptions. Thus, the NICU pharmacist should be alert to this, and put more efforts to examine prescriptions, provide appropriate information through various literature reviews, and closely monitor drug side effects. In addition, further research should be done to obtain clinical evidence for the use of 'off-label drugs' in neonates.
Keywords : Infant, Newborn, Intensive care unit, Neonatal, Off-label use

August 2019, 36 (3)