ArticleItalian journal of pediatrics2020
Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.
Article in Italian journal of pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 18 citations in OpenAlex.
- Off-Label Medication Use in a Serbian Neonatal Intensive Care Unit: A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Antimicrobial stewardship in neonatal intensive care units in resource-limited regions of China: a protocol for a multicenter, before-and-after, interrupted time series quality improvement study.Frontiers in public health · 2026Article
- Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists.Children (Basel, Switzerland) · 2025Article
- Off-label use of medicines in South Africa: a review.Orphanet journal of rare diseases · 2024Review
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Younger Children with Respiratory Tract Infections Are More Exposed to Off-Label Treatments: An Exploratory Retrospective Study in a Pediatric Emergency Setting.Children (Basel, Switzerland) · 2024Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia.SAGE open medicine · 2022Article
- Review of Drug Utilization Studies in Neonatal Units: A Global Perspective.International journal of environmental research and public health · 2020Review
- Furosemide use in Italian neonatal intensive care units: a national survey.Italian journal of pediatrics · 2020Article
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOff- label drug use refers to the use of medicines outside of their marketing authorization with respect to dose, dosage form, route of administration, indication or age. Off-label/unlicensed drug use significantly associated with adverse drug reactions and medication errors in neonates and critically ill neonates are more vulnerable to these problems.
objectiveTo assess the prevalence and associated factors with off-label and unlicensed drug use in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital.
methodsA cross-sectional study was conducted from March 01,2019 to April 30, 2019 in neonatal intensive care unit of Ayder Comprehensive Specialized Hospital. Neonates admitted for 24 h and took at least one medicine were included in the study. Data was collected from prescription and medical charts. The off-label and license status of the medicine was verified based on European medicine Agency electronic medicine compendium. Data was analyzed by SPSS version 21.0. Binary and multivariate logistic regression was done to assess the predictors of off-label/unlicensed medicine use at p-value ≤0.05 significance level.
resultA total of 364 medicines prescribed for 122 neonates were analyzed. The prevalence of off-label and unlicensed drug use was 246 (67.58%), and 86 (23.63%) respectively. Of the total 122 neonates, 114(93.44%), and 57(46.72%) of them were exposed to at least one off-label and unlicensed drug respectively. Antibiotics were the most commonly prescribed off-label and unlicensed drugs. No statistically significant association was found between demographic as well as health related variables with off-label/unlicensed medicine use at p-value of ≤0.05 significance level.
conclusionOff-label and unlicensed medicine use was high among neonates admitted to intensive care unit of the hospital. Selecting the safest medicines for such vulnerable patients is crucial to promote rational prescribing and better therapeutic benefit.
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