International Journal of Clinical Pharmacy

, Volume 40, Issue 3, pp 700–703 | Cite as

Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital: a cohort study

  • Faizan Mazhar
  • Shahzad AkramEmail author
  • Nafis Haider
  • Muhammad Abdul Hadi
  • Jabeen Sultana
Short Research Report


Objective To determine the extent of off-label and unlicensed prescribing in hospitalized newborns and to identify patient-related risk factors associated with off-label prescribing. Methods A prospective cohort study was conducted between January and March 2016 at a neonatology department of a tertiary-care hospital in the Eastern province. All consecutive admissions to all neonatal care levels meeting the inclusion and exclusion criteria were eligible for enrollment. All prescriptions were classified as off-label or unlicensed according to drug product monograph. Clinical and prescription data were extracted using a pilot-tested structured data collection sheet. Results During the study period 583 prescriptions were made for 138 newborns, of which 29.7% (173/583) and 12.9% (75/583) were classified as off-label and unlicensed drugs respectively for use in neonates. Thirty-four percent (47/138) of patients received at least one off-label/unlicensed medicine. Mechanical ventilation, admission to the neonatal intensive care unit and length of hospital stay were identified as independent risk factors associated with prescribing of at least one off-label medication. Conclusion Use of off-label and unlicensed drugs in hospitalized newborns seems to be a common practice in this Saudi hospital. Future research should evaluate safety and efficacy of off-label and/or unlicensed use of drugs in neonates.


Evidence-based medicine Neonates Off-label use Saudi Arabia Unlicensed drug use 




Conflicts of interest

We have no conflict of interest to disclose.


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Faizan Mazhar
    • 1
  • Shahzad Akram
    • 2
    Email author
  • Nafis Haider
    • 3
  • Muhammad Abdul Hadi
    • 4
  • Jabeen Sultana
    • 5
  1. 1.Unit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco, ‘Luigi Sacco’ University HospitalUniversità di MilanoMilanItaly
  2. 2.Pharmaceutical Care departmentKing Abdulaziz Medical CityRiyadhSaudi Arabia
  3. 3.Prince Sultan Military College of Health SciencesKing Fahd Military Medical ComplexDhahranSaudi Arabia
  4. 4.Leicester School of PharmacyDe Montfort UniversityLeicesterUK
  5. 5.Department of PharmacyAga Khan University HospitalKarachiPakistan

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