Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital : a cohort study
Articolo
Data di Pubblicazione:
2018
Citazione:
Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital : a cohort study / F. Mazhar, S. Akram, N. Haider, M.A. Hadi, J. Sultana. - In: INTERNATIONAL JOURNAL OF CLINICAL PHARMACY. - ISSN 2210-7703. - 40:3(2018), pp. 700-703. [10.1007/s11096-018-0630-z]
Abstract:
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Evidence-based medicine; Neonates; Off-label use; Saudi Arabia; Unlicensed drug use; Drug Approval; Drug Utilization; Female; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Male; Off-Label Use; Prospective Studies; Risk Factors; Saudi Arabia; Tertiary Care Centers; Pharmacy; Toxicology; Pharmacology; 3003; Pharmacology (medical)
Elenco autori:
F. Mazhar, S. Akram, N. Haider, M.A. Hadi, J. Sultana
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