Abstract
Background Unlicensed and off-label use of medicines in paediatrics is widespread. However, the incidence of this practice in Malaysia has not been reported. Objective To determine the extent of unlicensed and off-label use of medicines in hospitalised children in the intensive care units of a tertiary care teaching hospital. Methods A prospective, observational exploratory study was conducted on medicines prescribed to children admitted to the 3 intensive care units of Universiti Kebangsaan Malaysia Medical Centre (UKMMC). Results A total of 194 patients were admitted to UKMMC, 168 of them received one or more drugs. Of 1,295 prescriptions, 353 (27.3 %) were unlicensed and 442 (34.1 %) were for off-label use. Forty-four percent of patients received at least one medicine for unlicensed use and 82.1 % received at least one medicine off-label. Preterm infants, children aged 28 days to 23 months, patients with hospital stays of more than 2 weeks, and those prescribed increasing numbers of medicines were more likely to receive medicines for unlicensed use. Term neonates and patients prescribed increasing numbers of medicines had increased risk of receiving medicines for off-label use. Conclusion Prescribing of medicines in an unlicensed or off-label fashion to the children in the intensive care units of UKMMC was common. Further detailed studies are necessary to ensure the delivery of safe and effective medicines to children.
References
Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ. 1998;316:343–5.
Weiss CF, Glazko AJ, Weston JK. Chloramphenicol in the newborn infant. N Engl J Med. 1960;262:787–94.
Silverman WA, Andersen DH, Blanc WA, Crozier DN. A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics. 1956;18(4):614–25.
Gazarian M. Why are children still therapeutic orphans? Aust Prescr. 2003;26(6):122–3.
Shah SS, Hall M, Goodman DM, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161:282–90.
Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed. 1999;80:F142–5.
‘t Jong GW, Vulto AG, de Hoog M, Schimmel KJM, Tibboel D, van den Anker JN. A survey of the use of off-label and unlicensed drugs in a Dutch Children’s Hospital. Pediatrics. 2001;108(5):1089–93.
Bajcetic M, Jelisavcic M, Mitrovic J, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol. 2005;61:775–9.
Dessi A, Salemi C, Fanos V, Cuzzolin L. Drug treatments in a neonatal setting: focus on the off-label use in the first month of life. Pharm World Sci. 2010;32:120–4.
Lass J, Kaar R, Jogi K, Varendi H, Metsvaht T, Lutsar I. Drug utilization pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol. 2011;67(12):1263–71.
Bavdekar SB, Sadawarte PA, Gogtay NJ, Jain SS, Jadhav S. Off-label drug use in a pediatric intensive care unit. Indian J Pediatr. 2009;76:1113–8.
O’Donnelle CPF, Stone RJ, Morley C. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002;110(5):e52.
Khdour MR, Hallak HO, Alayasa KSA, 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):650–5.
National Pharmaceutical Control Bureau. List of Registered Product Drug Control Authority, Ministry of Health Malaysia [Internet]. Selangor: Ministry of Health; 1985 [updated 2012; cited 2013 July 31]. Available from: http://portal.bpfk.gov.my/product_search.cfm.
UBM Medica. MIMS Malaysia [Internet]. 2012 [cited 2013 July 31]. Available from: http://www.mims.com.my/Malaysia.
Ernest TB, Craig J, Nunn A, Salunke S, Tuleu C, Breitkreutz J, Alex R, Hempenstall J. Preparation of medicines for children—a hierarchy of classification. Int J Pharm. 2012;435(2):124–30.
Acknowledgments
The authors would like to thank Dr. Juriza Ismail, paediatrician at the UKMMC for her assistance in this research. Special thanks to the staff of the PICU, PHDU and NICU, UKMMC for the support throughout the research.
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No funding was received for this research.
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Lee, J.L., Md Redzuan, A. & Mohamed Shah, N. Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia. Int J Clin Pharm 35, 1025–1029 (2013). https://doi.org/10.1007/s11096-013-9846-0
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DOI: https://doi.org/10.1007/s11096-013-9846-0