OBJECTIVE OF THE STUDY: To determine the extent and nature of unlicensed/off-label prescribing patterns in hospitalised children in Palestine. SETTING: Four paediatric wards in two public health system hospitals in Palestine [Caritas children's hospital (Medical and neonatal intensive care units) and Rafidia general hospital (Medical and surgical units)]. METHOD: A prospective survey of drugs administered to infants and children <18 years old was carried out over a five-week period in the four paediatric wards. MAIN OUTCOME MEASURE: Drug-licensing status of all prescriptions was determined according to the Palestinian Registered Product List and the Physician's Desk Reference. RESULTS: Overall, 917 drug prescriptions were administered to 387children. Of all drug prescriptions, 528 (57.5%) were licensed for use in children; 65 (7.1%) were unlicensed; and 324 (35.3%) were used off-label. Of all children, 49.6% received off-label prescriptions, 10.1% received unlicensed medications and 8.2% received both. Seventy-two percent of off-label drugs and 66% of unlicensed drugs were prescribed for children <2 years. Multivariate analysis showed that patients who were admitted to the neonatal intensive care unit and infants aged 0-1 years were most likely to receive a greater number of off-label or unlicensed medications (OR 1.80; 95% CI 1.03-3.59 and OR 1.99; 95% CI 0.88-3.73, respectively). CONCLUSION: The present findings confirmed the elevated prevalence of unlicensed and off-label paediatric drugs use in Palestine and strongly support the need to perform well designed clinical studies in children.
OBJECTIVE OF THE STUDY: To determine the extent and nature of unlicensed/off-label prescribing patterns in hospitalised children in Palestine. SETTING: Four paediatric wards in two public health system hospitals in Palestine [Caritaschildren's hospital (Medical and neonatal intensive care units) and Rafidia general hospital (Medical and surgical units)]. METHOD: A prospective survey of drugs administered to infants and children <18 years old was carried out over a five-week period in the four paediatric wards. MAIN OUTCOME MEASURE: Drug-licensing status of all prescriptions was determined according to the Palestinian Registered Product List and the Physician's Desk Reference. RESULTS: Overall, 917 drug prescriptions were administered to 387children. Of all drug prescriptions, 528 (57.5%) were licensed for use in children; 65 (7.1%) were unlicensed; and 324 (35.3%) were used off-label. Of all children, 49.6% received off-label prescriptions, 10.1% received unlicensed medications and 8.2% received both. Seventy-two percent of off-label drugs and 66% of unlicensed drugs were prescribed for children <2 years. Multivariate analysis showed that patients who were admitted to the neonatal intensive care unit and infants aged 0-1 years were most likely to receive a greater number of off-label or unlicensed medications (OR 1.80; 95% CI 1.03-3.59 and OR 1.99; 95% CI 0.88-3.73, respectively). CONCLUSION: The present findings confirmed the elevated prevalence of unlicensed and off-label paediatric drugs use in Palestine and strongly support the need to perform well designed clinical studies in children.
Authors: Paulo R A Carvalho; Clarissa G Carvalho; Patrícia T Alievi; Jaqueline Martinbiancho; Eliana A Trotta Journal: J Pediatr (Rio J) Date: 2003 Sep-Oct Impact factor: 2.197