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단일기관 신생아중환자실에서의 허가외 약물 사용 현황

Off-label Drug Use in Neonatal Intensive Care Unit : a Tertiary Center Experience

병원약사회지 2019년 36권 3호 p.325 ~ 334
배혜정 (  ) - 서울대학교병원 약제부

신윤주 ( Shin Yun-Ju ) - 서울대학교병원 약제부
신현정 ( Shin Hyun-Jung ) - 서울대학교병원 약제부
임정미 ( Im Jeong-Mi ) - 서울대학교병원 약제부
서성연 ( Seo Seong-Yeon ) - 서울대학교병원 약제부
조윤희 ( Jo Yun-Hee ) - 서울대학교병원 약제부
조윤숙 (  ) - 서울대학교병원 약제부
신승한 ( Shin Seung-Han ) - 서울대학교병원 어린이병원 소아청소년과
최경희 ( Choi Kyung-Hee ) - 순천대학교 약학대학


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.


Infant; Newborn; Intensive care unit; Neonatal; Off-label use
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