Prevalence and nature of off-label antibiotic prescribing for children in a tertiary setting: A descriptive study from Jordan
Objective: The aim of the present study was to evaluate the use of off-label antibiotics in neonatal intensive care units (NICUs) and paediatric wards in Jordan.
Methods: Data of patients admitted to the neonatal intensive care units and paediatric wards in King Abdulla University Hospital were collected over an 8-week survey between May and July 2012. Data collected in this study included patients’ age, weight, medical history, diagnosis and the details of antibiotics prescribed to each patient.
Results: The study involved a total of 250 children (80 admitted to the NICU and 170 admitted to the wards). A total of 598 antibiotic prescriptions were issued for these patients (244 in NICUs and 354 in paediatricwards). The results of the present study show that off-label antibiotic prescribing to paediatric patients is very common. Off-label antibiotic prescribing to paediatric patients is related mostly to doses and indications, and rarely to age. The majority of admitted patients received at least one off-label antibiotic during their hospital stay.
Conclusion: This study reveals the high prevalence of off-label use of antibiotic among paediatric children in Jordan. There is a serious need for robust and continuous educational programs to improve the awareness of paediatricians of guidelines surrounding the use of antibiotics in paediatric patients. Furthermore, true collaboration between paediatricians and clinical pharmacists towards safe and effective antibiotic prescribing in paediatric patients is crucial.
2. 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.
3. Mukattash TL, Nuseir K, Alzoubi KH, Al-Azzam SI, Shara M, Jarab AS. Sources of Information used when prescribing for children, a survey of hospital based pediatricians. Curr Clin Pharmacol. 2014;9(4):395-398.
4. Sammons H, Conroy S. How do we ensure safe prescribing for children? Arch Dis Child. 2008;93(2):98-99. doi: 10.1136/adc.2007.122648
5. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002;54(6):665-670.
6. Conroy S, Carroll WD. Prescribing in pediatrics. Arch Dis Child Educ Pract Ed. 2009;94(2):55-59. doi: 10.1136/adc.2008.141754
7. Mukattash T, Hawwa AF, Trew K, McElnay JC. Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol. 2011;67(5):449-461. doi: 10.1007/s00228-010-0978-z
8. Schirm E, Tobi H, Jong-Van D, den Berg LTW. Unlicensed and off label drug use by children in the community: cross sectional study. BMJ. 2002;324(7349):1312-1313.
9. Mukattash TL, Wazaify M, Khuri N, Jarab A, Hawwa AF, McElnay JC. Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing. Int J Clin Pharm. 2011;33(6):964-973. doi: 10.1007/s11096-011-9569-z
10. McLay JS, Tanaka M, Ekins-Daukes S, Helms PJ. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch Dis Child. 2006;91(7):584-587.
11. Porta A, Esposito S, Menson E, Spyridis N, Tsolia M, Sharland M, Principi N. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol. 2010;66(9):919-927. doi: 10.1007/s00228-010-0842-1
12. Pandolfini C, Campi R, Clavenna A, CazzatoT, Bonati M. Italian paediatricians and off-label prescriptions: loyal to regulatory or guideline standards? Acta Paediatr. 2005;94(6):753-757.
13. Tafuri G, Trotta F, Leufkens HGM, Martini N, Sagliocca L, Traversa G. Off-label use of medicines in children: can available evidence avoid useless pediatric trials? Eur J Clin Pharmacol. 2009;65(2):209-216. doi: 10.1007/s00228-008-0560-0
14. Burke C. Perinatal sepsis. J Perinat Neonatal Nurs. 2009;23(1):42-51. doi: 10.1097/JPN.0b013e31819614ed
15. Fernando AM, Heath PT, Menson EN. Antimicrobial policies in the neonatal units of the United Kingdom and Republic of Ireland. J Antimicrob Chemother. 2008;61(3):743-745. doi: 10.1093/jac/dkm543
16. Simonsen KA, Anderson-Berry AL, Delair SF, Davies HD. Early-Onset Neonatal Sepsis. Clin Microbiol Rev. 2014;27(1):21-47. doi: 10.1128/CMR.00031-13
17. Arrieta A. Use of meropenem in the treatment of serious infections in children: review of the current literature. Clin Infect Dis. 1997;24(Suppl 2):S207-S212.
18. Principi N, Marchisio P. Meropenem compared with ceftazidime in the empiric treatment of acute severe infections in hospitalized children. J Chemother. 1998;10(2):108-113.
19. Mandell LA, Peterson LR, Wise R, Hooper D, Low DE, Schaad UB, Klugman KP, Courvalin P. The battle against emerging antibiotic resistance: should fluoroquinolones be used to treat children? Clin Infect Dis. 2002;35(6):721-727.
20. Schaad UB, Suter S, Gianella-Borradori A, Pfenninger J, Auckenthaler R, Bernath O, Cheseaux JJ, Wedgwood J. A comparison of ceftriaxone and cefuroxime for the treatment of bacterial meningitis in children. N Engl J Med. 1990;322(3):141-147.
21. Schaad UB . Fluoroquinolone antibiotics in infants and children. Infect Dis Clin North Am. 2005;19(3):617-628.
22. Hagen I, Øymar K. Pharmacological differences between once daily and twice daily gentamicin dosage in newborns with suspected sepsis. Pharm World Sci. 2009;31(1):18-23. doi: 10.1007/s11096-008-9255-y
23. Rao SC, Ahmed M, Hagan R. One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates. Cochrane Database Syst Rev. 2006;(1):CD005091.
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