Unlicensed and off-label drug use in hospitalized children in Croatia: A cross-sectional survey

European Journal of Clinical Pharmacology

Volumn 68, Issue 7, 2012, Pages 1073-1077

  Palčevski, Goran ^a   Skočibušić, Nataša ^b   Vlahović Palčevski, Vera ^a  

^a KBC RIJEKA   (Croatia)

^b UNIVERSITY OF RIJEKA   (Croatia)

Author keywords

Children; Drug prescribing; Off label; Unlicensed

Indexed keywords

CAPTOPRIL; CEFTRIAXONE; COLECALCIFEROL; ESOMEPRAZOLE; FLUCONAZOLE; GRANISETRON; IRON; MACROGOL; NYSTATIN; OXYMETAZOLINE; PANTOPRAZOLE; PROTON PUMP INHIBITOR; RANITIDINE; VALPROIC ACID;

ADOLESCENT; ADULT; ARTICLE; CHILD; CHILD HEALTH CARE; CLINICAL DECISION MAKING; CROATIA; CROSS-SECTIONAL STUDY; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; INAPPROPRIATE PRESCRIBING; INFANT; LICENSING; MAJOR CLINICAL STUDY; NEWBORN; OFF LABEL DRUG USE; PRESCHOOL CHILD; PRIORITY JOURNAL; PROSPECTIVE STUDY; SCHOOL CHILD;

ADOLESCENT; ADOLESCENT, HOSPITALIZED; CHILD; CHILD, HOSPITALIZED; CHILD, PRESCHOOL; COHORT STUDIES; CROATIA; CROSS-SECTIONAL STUDIES; DRUG APPROVAL; DRUG LABELING; DRUG UTILIZATION REVIEW; ELECTRONIC HEALTH RECORDS; HOSPITALS, PEDIATRIC; HOSPITALS, UNIVERSITY; HUMANS; INFANT; INFANT, NEWBORN; OFF-LABEL USE; PHYSICIAN'S PRACTICE PATTERNS; PROSPECTIVE STUDIES; YOUNG ADULT;

EID: 84864289714     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1221-x     Document Type: Article

References (12)

1. Turner S, Longworth A, Nunn AJ, Choonara I (1998) Unlicensed and off-label drug use in paediatric wards: prospective study. BMJ 316:343-345 (Pubitemid 28121257)
2. Pandolfini C, Bonati M (2005) A literature review on off-label drug use in children. Eur J Pediatr 164:552-558 (Pubitemid 41225059)
3. Grégoire MC, Finley A (2007) Why were we abandoned? Orphan drugs in paediatric pain. Paediatr Child Health 12(2):95-96
4. Conroy S, Choonara I, Impicciatore et al (2000) Survey on unlicensed and off label drug use in paediatric wards in European countries. BMJ 320:79-82 (Pubitemid 30173044)
5. Schirm E, Tobi H, de Jong-van den Berg TW (2002) Unlicensed and off label drug use by children in the community: cross sectional study. BMJ 324:1312-1313 (Pubitemid 34606774)
6. Hsien L, Breddemann A, Frobel AK, Heusch A, Schmidt KG, Läer S (2008) Off-label drug use among hospitalized children. Identifying areas with the highest need for research. Pharm World Sci 30:497-502
7. Di Paolo ER, Stoetter H, Cotting J, Frey P, Gebri M, Beck-Popović M, Tolsa JF, Fanconi S, Pannatier A (2006) Unlicensed and offlabel drug use in a Swiss paediatric university hospital. Swiss Med Wkly 136:218-222
8. t Jong GW, van der Linden PD, Bakker EM, van der lely N, Eland IA, Stricker BHC, van der Anker JN (2002) Unlicensed and offlabel drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 58:293-297 (Pubitemid 34827859)
9. O'Donnell CP, Stone RJ, Morley CJ (2002) Unlicensed and off-label drug use in an Australian intensive care unit. Paediatrics 110:e52
10. Tafuri G, Trotta F, Leufkens HGM, Martini N, Sagliocca L, Traversa G (2009) Off-label use of medicines in children: can available evidence avoid useless paediatric clinical trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease. Eur J Clin Pharmacol 65:209-216
11. Gazarian M, Kella M, McPhee JR, Graudins LV, Ward RL, Campbell TJ (2006) Off-label use of medicines: consensus recommendations for evaluating appropriateness. MJA 185:544-548 (Pubitemid 44816941)
12. EC (2006) Regulation (EC) No 1901/2006 of 12 December 2006on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.http://ec. europa.eu/health/files/eudralex/vol-1/reg-2006-1901/reg-2006-1901-en.pdf, Accessed 26 August 2011