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Current Pediatric Reviews

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ISSN (Print): 1573-3963
ISSN (Online): 1875-6336

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Research Article

The Unlicensed and Off-label Prescription of Medications in General Paediatric Ward: An Observational Study

Author(s): Alícia Dorneles Dornelles, Lisiane Hoff Calegari, Lucian de Souza, Patrícia Ebone, Tiago Silva Tonelli and Clarissa Gutierrez Carvalho*

Volume 15, Issue 1, 2019

Page: [62 - 66] Pages: 5

DOI: 10.2174/1573396314666181113101506

Abstract

Background: Unlicensed (UL) and Off-label (OL) prescription of medications is common in paediatrics and does not constitute negligent practice since there is often no approved alternative according to FDA bulary.

Aim: The study aimed to determine the current frequency of UL and OL prescriptions in children from one month to 12 years of age in a Paediatric Inpatient Unit (PIU).

Methods: This is an observational, prospective study, reviewing the prescriptions of all patients admitted to the PIU in a university hospital in a single week in August 2014 and a single week in January 2015.

Results: We included 157 patients of median age 18 months and median length of stay 24 days. There were 1,328 prescription items (average of 8.4 items/patient) and only two patients without UL/OL use. During the winter season (August), 27% of prescriptions were classified as UL and 44.6% as OL, and during summer (January), 29.6% as UL and 45.1% as OL. We identified 188 medications, of which the most prescribed were paracetamol (11%) and dipyrone (9.5%). The most frequent OL classification was regarding drug formulation (15.8%). In the winter week, the most frequent reasons for admission were respiratory (44%), followed by other clinical causes (CC) (17.3%), while in the summer week, they were CC (26.3%), followed by surgical and gastrohepatic (23.7%).

Conclusion: The OL prescription of medicines for children in Brazil is in accordance with the international literature. The higher prevalence of OL due to formulation found in this study is related to the use of formulations other than those used by the FDA.

Keywords: Off-label, prescribing, paediatric medication, unlicensed, prescription, paediatric pharmacology, hospital pharmacology, formulation.

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[1]
Shirkey H. Therapeutic orphans. J Pediatr 1968; 72(1): 119-20.
[2]
Frattarelli DA, Galinkin JL, Green TP, et al. Off-label use of drugs in children. Pediatrics 2014; 133(3): 563-7.
[3]
Meadows WA, Hollowell BD. ‘Off-label’ drug use: an FDA regulatory term, not a negative implication of its medical use. Int J Impot Res 2008; 20(2): 135-44.
[4]
Turner S, Longworth A, Nunn AJ, et al. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 1998; 316(7128): 343-5.
[5]
O’Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 2002; 110(5): e52.
[6]
McIntyre J, Conroy S, Avery A, et al. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 2000; 83(6): 498-501.
[7]
Jong GW, Eland IA, Sturkenboom MC, et al. Determinants for drug prescribing to children below the minimum licensed age. Eur J Clin Pharmacol 2003; 58(10): 701-5.
[8]
Thompson DF, Heflin NR. Frequency and appropriateness of drug prescribing for unlabeled uses in pediatric patients. Am J Hosp Pharm 1987; 44(4): 792-4.
[9]
Carvalho PR, Carvalho CG, Alievi PT, et al. Prescription of drugs not appropriate for children in a Pediatric Intensive Care Unit. J Pediatr (Rio J) 2003; 79(5): 397-402.
[10]
Carvalho CG, Ribeiro MR, Bonilha MM, et al. Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores. J Pediatr (Rio J) 2012; 88(6): 465-70.
[11]
Dos Santos L, Heineck I. Drug utilization study in pediatric prescriptions of a university hospital in southern Brazil: Off-label, unlicensed and high-alert medications. Farm Hosp 2012; 36(4): 180-6.
[12]
Costa PQ, Rey LC, Coelho HL. Lack of drug preparations for use in children in Brazil. J Pediatr (Rio J) 2009; 85(3): 229-35.
[13]
Dell’Aera M, Gasbarro AR, Padovano M, et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci 2007; 29(4): 361-7.
[14]
Rocchi F, Paolucci P, Ceci A, et al. The European paediatric legislation: Benefits and perspectives. Ital J Pediatr 2010; 36: 56.
[15]
Lindell-Osuagwu L, Hakkarainen M, Sepponen K, et al. Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation. J Clin Pharm Ther 2014; 39(2): 144-53.
[16]
Marchetti F, Bua J, Ventura A, et al. The awareness among paediatricians of off-label prescribing in children: A survey of Italian hospitals. Eur J Clin Pharmacol 2007; 63(1): 81-5.
[17]
Ceci A, Felisi M, Baiardi P, et al. Medicines for children licensed by the European Medicines Agency (EMEA): The balance after 10 years. Eur J Clin Pharmacol 2006; 62(11): 947-52.
[18]
’t Jong GW, Vulto AG, de Hoog M, et al. Unapproved and off-label use of drugs in a children’s hospital. N Engl J Med 2000; 343(15): 1125.
[19]
Doherty DR, Pascuet E, Ni A, et al. Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies. Can J Anaesth 2010; 57(12): 1078-88.
[20]
[Available from: http://www.accessdata.fda.gov/SCRIPTS/CDER/ DRUGSATFDA/index.cfm
[21]
Ferreira LeA, Ibiapina CaC, Machado MG, et al. High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit. Rev Assoc Med Bras 2012; 58(1): 82-7.
[22]
Khdour MR, Hallak HO, Alayasa KS, et al. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm 2011; 33(4): 650-5.
[23]
Tramontina MY, Heineck I, Dos Santos L. Use of non-formulary drugs in children at a Brazilian teaching hospital: A descriptive study. Pharm Pract (Granada) 2013; 11(1): 17-23.

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