Unlicensed and off-label drug use: A prospective study in French NICU

Acta Paediatrica, International Journal of Paediatrics

Volumn 104, Issue 5, 2015, Pages e228-e231

  Riou, Stéphanie ^a   Plaisant, Frank ^a   Maucort Boulch, Delphine ^a   Kassai, Behrouz ^b   Claris, Olivier ^a   Nguyen, Kim An ^a,b  

^a UNIVERSITÉ LYON 1   (France)

^b Inserm   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; AMIKACIN; AMOXICILLIN; ANTIBIOTIC AGENT; ASCORBIC ACID; CAFFEINE CITRATE; CEFOTAXIME; FERROUS FUMARATE; FOLINATE CALCIUM; MIDAZOLAM; PARACETAMOL; PHYTOMENADIONE; RETINOL; RIFAMYCIN; SODIUM CHLORIDE; VANCOMYCIN; VITAMIN D;

ARTICLE; BIRTH WEIGHT; DESCRIPTIVE RESEARCH; DRUG EXPOSURE; DRUG LABELING; FEMALE; FOLLOW UP; GESTATIONAL AGE; HOSPITALIZATION; HUMAN; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; NEWBORN; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; TREATMENT DURATION; UNLICENSED DRUG USE; FRANCE; NEWBORN INTENSIVE CARE; PREMATURITY; STATISTICS AND NUMERICAL DATA;

FEMALE; FRANCE; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; INTENSIVE CARE UNITS, NEONATAL; INTENSIVE CARE, NEONATAL; MALE; OFF-LABEL USE; PROSPECTIVE STUDIES;

EID: 84937637865     PISSN: 08035253     EISSN: 16512227     Source Type: Journal    
DOI: 10.1111/apa.12924     Document Type: Article

References (15)

1. Cuzzolin L, Atzei A, Fanos V,. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf 2006; 5: 703-18.
2. Pandolfini C, Bonati M,. A literature review on off-label drug use in children. Eur J Pediatr 2005; 164: 552-8.
3. Dessi A, Salemi C, Fanos V, Cuzzolin L,. Drug treatments in a neonatal setting: focus on the off-label use in the first month of life. Pharm World Sci 2010; 32: 120-4.
4. Khdour MR, Hallak HO, Alayasa KS, AlShahed QN, Hawwa AF, McElnay JC,. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm 2011; 33: 650-5.
5. Neubert A, Lukas K, Leis T, Dormann H, Brune K, Rascher W,. Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis. Eur J Clin Pharmacol 2010; 66: 87-95.
6. Kimland E, Nydert P, Odlind V, Bottiger Y, Lindemalm S,. Paediatric drug use with focus on off-label prescriptions at Swedish hospitals-a nationwide study. Acta Paediatr 2012; 101: 772-8.
7. Nguyen KA, Claris O, Kassai B,. Unlicensed and off-label drug use in a neonatal unit in France. Acta Paediatr 2011; 100: 615-7.
8. Tafuri G, Trotta F, Leufkens HG, Martini N, Sagliocca L, Traversa G,. Off-label use of medicines in children: can available evidence avoid useless paediatric trials?: The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease. Eur J Clin Pharmacol 2009; 65: 209-16.
9. Franz AR, Mihatsch WA, Sander S, Kron M, Pohlandt F,. Prospective randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams. Pediatrics 2000; 106: 700-6.
10. Haiden N, Schwindt J, Cardona F, Berger A, Klebermass K, Wald M, et al., Effects of a combined therapy of erythropoietin, iron, folate, and vitamin B12 on the transfusion requirements of extremely low birth weight infants. Pediatrics 2006; 118: 2004-13.
11. Van Winckel M, De Bruyne R, Van De Velde S, Van Biervliet S,. Vitamin K, an update for the paediatrician. Eur J Pediatr 2009; 168: 127-34.
12. Clarke P,. Vitamin K prophylaxis for preterm infants. Early Hum Dev 2010; 86 (Suppl 1): 17-20.
13. Sweileh WM,. A prospective comparative study of gentamicin- and amikacin-induced nephrotoxicity in patients with normal baseline renal function. Fundam Clin Pharmacol 2009; 23: 515-20.
14. Siddiqi A, Khan DA, Khan FA, Razzaq A,. Therapeutic drug monitoring of amikacin in preterm and term infants. Singapore Med J 2009; 50: 486-9.
15. Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, et al., Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr 2013; 163: e1-2.