단일기관 신생아중환자실에서의 허가외 약물 사용 현황
Off-label Drug Use in Neonatal Intensive Care Unit : a Tertiary Center Experience
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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.
Abstract
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.
참고문헌 (21)
- Heimann G, "Enteral absorption and bioavailability in children in relation to age", Eur J Clin Pharmacol, 18(1), pp.43~50 (1980)
- Kearns GL, "Developmental pharmacology--drug disposition, action, and therapy in infants and children", N Engl J Med, 349(12), pp.1157~1167 (2003)
- Tayman C, "Neonatal pharmacology : extensive interindividual variability despite limited size", J Pediatr Pharmacol Ther, 16(3), pp.170~184 (2011)
- Neubauer D, "Guide to Paediatric Clinical Research", pp.38~46 (2007), Karger
- 출산관련행태 변화에 따른 신생아건강 동향과 정책과제, "최정수", 한국보건사회연구원, ~ (2011)
- Neubert A, "Drug utilisation on a preterm and neonatal intensive care unit in Germany : a prospective, cohortbased analysis", Eur J Clin Pharmacol, 66(1), pp.87~95 (2010)
- Laforgia N, "Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy", Pediatr Int, 56(1), pp.57~59 (2014)
- Riou S, "Unlicensed and off-label drug use: a prospective study in French NICU", Acta Paediatr, 104(5), pp.e228~e231 (2015)
- Kieran EA, "Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study", Acta Paediatr, 103(4), pp.e139~e142 (2014)
- Pandolfini C, "A literature review on off-label drug use in children", Eur J Pediatr, 164(9), pp.522~528 (2005)
- Cuzzolin L, "Off-label and unlicensed drug treatments in neonatal intensive care units : an Italian multicenter study", Eur J Clin Pharmacol, 72(1), pp.117~123 (2016)
- 이주영, "한국의 신생아 대상 임상시험", Neonatal medicine, 21(1), pp.1~9 (2014), 대한신생아학회
- "식품의약품안전처 온라인의약도서관" (2017)[URL]
- Girardi A, "Pattern of drug use among preterm neonates : results from an Italian neonatal intensive care unit", Ital J Pediatr, 43(1), pp.37~ (2017)
- Selewski DT, "Neonatal acute kidney injury", Pediatrics, 136(2), pp.e463~e473 (2015)
- Girardi A, "Druginduced renal damage in preterm neonates : state of the art and methods for early detection", Drug Saf, 38(6), pp.535~551 (2015)
- Pandey V, "Non-dialytic management of acute kidney injury in newborns", J Renal Inj Prev, 6(1), pp.1~11 (2016)
- "Drugs" (2017)[URL]
- Rangasamy Ramanathan, "Bronchopulmonary dysplasia and diuretics", NeoReviews, 9(6), pp.e260~e266 (2008)
- Iyengar A, "Drug therapy for the prevention and treatment of bronchopulmonary dysplasia", Front Pharmacol, 6, pp.12~ (2015)
- Segar JL, "Neonatal diuretic therapy : furosemide, thiazides, and spironolactone", Clin Perinatol, 39(1), pp.209~220 (2012)