DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20183932

Off-label use of antibiotics in hospitalised children in a tertiary care teaching hospital

Puja ., Dhasmana D. C., Saurabh Kohli, Vipin Chander

Abstract


Background: Children constitute one-third of the population and they suffer from a variety of infectious diseases and are commonly prescribed antibiotics. Most of the antibiotics lack sufficient information on safety and efficacy in children and are thus prescribed off-label. This study was envisaged to assess the off-label use of antibiotics in hospitalized children.

Methods: Total 120 patients were included in the study. Off-label use was determined on the basis of product literature and National Formulary of India. Descriptive statistics was used to present the data i.e. percentage; proportions, frequency, mean and standard deviation using Microsoft excel worksheet.

Results: A total of 791 drugs from different classes were prescribed to 120 patients with a mean of 6.6±2.68 drugs described per patient during their stay in the hospital. 100 out of 120 (83%) patients were prescribed at least one antibiotic during their stay in the hospital. Out of the 204 antibiotics prescribed, 43(21%) were prescribed off-label. Antibiotic dose was the most common reason followed by age (1month-1 year more than 2-6 years of age) and frequency in off-label use.

Conclusions: Antibiotics are commonly prescribed to children with substantial off-label use. The same must be seriously addressed by the policy makers and stakeholders in order to promote their rational use.


Keywords


Antibiotics, Hospitalized children, Off-label

Full Text:

PDF

References


Children in India; 2012. A statistical appraisal social statistics division central statistics office ministry of statistics and programme implementation government of India. Available at: http://www.mospi.children_in_india_2012_rev_pdf_.nic.in

Drug treatment. Graeme S Avery. 2nd Edition. Adis press, New York. 1980.

Viren B, Montastruc JL, Lapeyere M. Adverse drug reaction and off label drug use in pediatric outpatients. Br J Club Pharma. 2002;54(6):665-70.

WHO Drug Information. 2009;23(1). Available at: http://apps.who.int/medicinedocs/en/d/Js17560en/.

Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000 Jan 8;320(7227):79-82.

Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature.

Christensen ML, Helms RA, Chesney RW. Is pediatric labeling really necessary?. Pediatrics. 1999 Sep 1;104(Supplement 3):593-7.

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Eng J Med. 2003 Sep 18;349(12):1157-67.

Ajapuje P, Dhengre P, Giri VC, Khakse GM. Drug prescription practices among paediatric patients in Yavatmal, Central India. Int J Recent Trends Sci and Technology. 2012;5(2):104-6.

Fort B. Assessment of drug utilization in hospitalized children at a tertiary care teaching hospital. J Chem Pharmaceut Res. 2014;6(2):592-8.

Kline JM, Wietholter JP, Kline VT, Confer J. Pediatric antibiotic use: a focused review of fluoroquinolones and tetracyclines. US Pharm. 2012;37(8):56-9.

Sweileh WM. A prospective comparative study of gentamicin‐and amikacin‐induced nephrotoxicity in patients with normal baseline renal function. Fundamental Clin Pharmacol. 2009 Aug;23(4):515-20.

Ioannidou M, Apostolidou-Kiouti F, Haidich AB, Niopas I, Roilides E. Efficacy and safety of linezolid for the treatment of infections in children: a meta-analysis. Eur J Pediatr. 2014 Sep 1;173(9):1179-86.

Porta A, Esposito S, Menson E, Spyridis N, Tsolia M, Sharland M, et al. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol. 2010 Sep 1;66(9):919-27.