Incidence of unlicensed and off-label prescription in children

Italian Journal of Pediatrics

Karel Urbánek¹  Jiří Vrtal¹  Petra Langerová¹ 

[1] Department of Pharmacology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Hněvotínská 3, 77515 Olomouc, Czech Republic

关键词: Pediatric outpatient clinics;    Off-label drug use;    Prescribing habits;   

Others  :  805063
DOI  :  10.1186/1824-7288-40-12

 received in 2013-08-29, accepted in 2014-01-15,  发布年份 2014

【 摘 要 】

Background

Many common drugs have not been licensed for use in children.

Methods

This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.

Results

Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.

Conclusions

This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.

【 授权许可】

   
2014 Langerová et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Turner S, Longworth A, Nunn AJ, Choonara I: Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998, 316(7128):343-345.
• [2]Mason J, Pirmohamed M, Nunn T: Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature. Eur J Clin Pharmacol 2012, 68(1):21-28.
• [3]Strnadová V: O čem se diskutuje v oblasti klinických studií. Klin Farmakol Farm 2007, 21(3–4):119-121.
• [4]Napoleone E: Children and ADRs (Adverse Drug Reactions). Ital J Pediatr 2010, 36:4. BioMed Central Full Text
• [5]European Medicines Agency: The European paediatric initiative: History of the Paediatric Regulation. London: EMEA; 2007. Doc. Ref: EMEA/17967/04 Rev 1
• [6]Santos DB, Clavenna A, Bonati M, Coelho HL: Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur J Clin Pharmacol 2008, 64(11):1111-1118.
• [7]Pandolfini C, Bonati M: A literature review on off-label drug use in children. Eur J Pediatr 2005, 164(9):552-558.
• [8]Lindell-Osuagwu L, Korhonen MJ, Saano S, Helin-Tanninen M, Naaranlahti T, Kokki H: Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther 2009, 34(3):277-287.
• [9]Hsien L, Breddemann A, Frobel AK, Heusch A, Schmidt KG, Läer S: Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharm World Sci 2008, 30(5):497-502.
• [10]Zhou XH, Hui ZY, Li Y: Clinical and pathological features of a neonate with autosomal recessive polycystic kidney disease caused by a nonsense PKHD1 mutation. World J Pediatr 2013, 9(1):76-79.
• [11]Grantham JJ, Nair V, Winklhoffer F: Cystic diseases of the kidney. In Brenner & Rector’s The Kidney. Vol. 2. 6th edition. Edited by Brenner BM. Philadelphia: WB Saunders Company; 2000:1699-1730.
• [12]Yang SJ, Kim S, Park H, Kim SM, Choi KM, Lim Y, et al.: Sex-dependent association between angiotensin-converting enzyme insertion/deletion polymorphism and obesity in relation to sodium intake in children. Nutrition 2013, 29(3):525-530.
• [13]Rancière F, Nikasinovic L, Momas I: Dry night cough as a marker of allergy in preschool children: the PARIS birth cohort. Pediatr Allergy Immunol 2013, 24(2):131-137.
• [14]Del Cuvillo A, Sastre J, Montoro J, Jáuregui I, Ferrer M, Dávila I, et al.: Use of antihistamines in pediatrics. J Investig Allergol Clin Immunol 2007, 17(Suppl 2):28-40.
• [15]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(4):650-655.
• [16]Ballard CD, Peterson GM, Thompson AJ, Beggs SA: Off-label use of medicines in paediatric inpatients at an Australian teaching hospital. J Paediatr Child Health 2013, 49(1):38-42.
• [17]Ribeiro M, Jorge A, Macedo AF: Off-label drug prescribing in a Portuguese Paediatric Emergency Unit. Int J Clin Pharm 2013, 35(1):30-36.
• [18]Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS: Off-label prescribing to children: attitudes and experience of general practitioners. Br J Clin Pharmacol 2005, 60(2):145-149.
• [19]Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, et al.: Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 2000, 320(7227):79-82.
• [20]‘t Jong GW, Vulto AG, de Hoog M, Schimmel KJ, Tibboel D, et al.: A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics 2001, 108(5):1089-1093.
• [21]Schirm E, Tobi H, de Jong-van den Berg LT: Unlicensed and off label drug use by children in the community: cross sectional study. BMJ 2002, 324(7349):1312-1313.