Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

Maher R. Khdour, Hussein Othman Hallak, Kawther Shab’an Atallah Alayasa, Qusai Nabeel AlShahed, Ahmed F. Hawwa, James C. McElnay

Research output: Contribution to journalArticlepeer-review

30 Citations (Scopus)


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 387 children. 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.
Original languageEnglish
Pages (from-to)650-655
Number of pages6
JournalInternational Journal of Clinical Pharmacy
Issue number4
Publication statusPublished - Aug 2011

ASJC Scopus subject areas

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

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