Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in malaysia

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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.

Original languageEnglish
Pages (from-to)1025-1029
Number of pages5
JournalInternational Journal of Clinical Pharmacy
Volume35
Issue number6
DOIs
Publication statusPublished - Dec 2013

Fingerprint

Off-Label Use
Intensive care units
Malaysia
Medicine
Intensive Care Units
Labels
Hospitalized Child
Tertiary Healthcare
Premature Infants
Teaching Hospitals
Observational Studies
Prescriptions
Length of Stay
Newborn Infant
Pediatrics
Incidence
Pharmaceutical Preparations
Teaching

Keywords

  • Drug information
  • Hospitalised children
  • Intensive care unit
  • Malaysia
  • Off-label prescribing
  • Unlicensed prescribing

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmaceutical Science
  • Pharmacology
  • Toxicology
  • Pharmacy

Cite this

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title = "Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in malaysia",
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.",
keywords = "Drug information, Hospitalised children, Intensive care unit, Malaysia, Off-label prescribing, Unlicensed prescribing",
author = "Lee, {Jian Lynn} and {Md Redzuan}, Adyani and {Mohamed Shah}, Noraida",
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T1 - Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in malaysia

AU - Lee, Jian Lynn

AU - Md Redzuan, Adyani

AU - Mohamed Shah, Noraida

PY - 2013/12

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N2 - 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.

AB - 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.

KW - Drug information

KW - Hospitalised children

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KW - Off-label prescribing

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