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.
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.
Authors: Maher R Khdour; Hussein Othman Hallak; Kawther Shab'an Atallah Alayasa; Qusai Nabeel AlShahed; Ahmed F Hawwa; James C McElnay Journal: Int J Clin Pharm Date: 2011-05-13
Authors: Samir S Shah; Matthew Hall; Denise M Goodman; Pamela Feuer; Vidya Sharma; Crayton Fargason; Daniel Hyman; Kathy Jenkins; Marjorie L White; Fiona H Levy; James E Levin; David Bertoch; Anthony D Slonim Journal: Arch Pediatr Adolesc Med Date: 2007-03
Authors: Terry B Ernest; Jo Craig; Anthony Nunn; Smita Salunke; Catherine Tuleu; Joerg Breitkreutz; Rainer Alex; John Hempenstall Journal: Int J Pharm Date: 2012-06-05 Impact factor: 5.875
Authors: Petra Czarniak; Lewis Bint; Laurent Favié; Richard Parsons; Jeff Hughes; Bruce Sunderland Journal: PLoS One Date: 2015-03-10 Impact factor: 3.240
Authors: H Christine Allen; M Connor Garbe; Julie Lees; Naila Aziz; Hala Chaaban; Jamie L Miller; Peter Johnson; Stephanie DeLeon Journal: J Okla State Med Assoc Date: 2018-10