ArticleRevista Brasileira de terapia intensiva
Prescription of off-label and unlicensed drugs for preterm infants in a neonatal intensive care unit.
Article in Revista Brasileira de terapia intensiva. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Assessment of Piperacillin-Tazobactam Population Pharmacokinetic Models in Neonates: An External Validation.European journal of drug metabolism and pharmacokinetics · 2025Pooled it
- Neonatology: First Exposure to Antibiotics from the Ethical Perspective of Parents, Physicians, and Regulators.Antibiotics (Basel, Switzerland) · 2025Article
- Prevalence and Patterns of Potentially Inappropriate Prescribing by Brazilian Dentists for Pediatric Patients: A Cross-Sectional Study.BioMed research international · 2025Article
- Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.Health research policy and systems · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Prescription of off-label and unlicensed medication for newborns hospitalized in the Intensive Care Unit.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2023Observational
- Medicine manipulation: An alternative to mitigate therapeutic gaps in the Brazilian Unified Health System?PloS one · 2022Article
Corrections and comments
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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
objectiveTo evaluate the use of off-label and unlicensed medications in preterm infants hospitalized in a neonatal intensive care unit.
methodsThis nonconcurrent cohort study included preterm infants admitted to 3 neonatal intensive care units in 2016 and 2017 who were followed up during the neonatal period. The type and number of medications used were recorded for the entire period and classified based on the Anatomical Therapeutic Chemical. Descriptive and bivariate data analyses were performed to assess associations between the number of drugs used (total, off-label and unlicensed) and the explanatory variables of interest.
resultsFour hundred preterm infants received 16,143 prescriptions for 86 different pharmaceuticals; 51.9% of these medications were classified as off-label and 23.5% as unlicensed. The most prescribed drugs were gentamicin and ampicillin (17.5% and 15.5% among off-label, respectively) and caffeine (75.5% among unlicensed). The results indicated significant associations between the use of off-label drugs and lower gestational age, low birth weight, lower 5-minute Apgar score, advanced resuscitation maneuver in the delivery room and death. The prescription of unlicensed drugs was associated with lower gestational age, low birth weight and 5-minute Apgar score below 7.
conclusionNeonates admitted to neonatal intensive care units are highly exposed to off-label and unlicensed medications. Further studies are needed to achieve greater safety and quality of drug therapy used in neonatology.
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