ArticleBMC pediatrics2016
Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.
Article in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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The trial behind it
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Who cites it
33 citing papers in PubMed.
- Off-Label Medication Use in a Serbian Neonatal Intensive Care Unit: A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.Current pediatric reviews · 2026Article
- Neonatology: First Exposure to Antibiotics from the Ethical Perspective of Parents, Physicians, and Regulators.Antibiotics (Basel, Switzerland) · 2025Article
- Medication use in the neonatal intensive care unit in a tertiary hospital in China from 2020 to 2023.Italian journal of pediatrics · 2025Article
- Use of antimicrobials in pediatric wards of five Brazilian hospitals.BMC pediatrics · 2024Observational
- Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- 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
- Off-label use of drugs in pediatrics: a scoping review.European journal of pediatrics · 2022Article
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Medication Use in the Neonatal Intensive Care Unit and Changes from 2010 to 2018.The Journal of pediatrics · 2022Article
- Compounded medications for cardiovascular use in neonatology: an integrative review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2022Review
- SwissPKCPT: pharmacometrics & systems pharmacology · 2021Article
- Intravenous drug use in neonatal intensive care units.European journal of hospital pharmacy : science and practice · 2021Observational
- Off-Label Medication: From a Simple Concept to Complex Practical Aspects.International journal of environmental research and public health · 2021Review
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2021Article
- Drug Utilisation and Off-Label Use on a German Neonatal Intensive Care Unit: A Retrospective Cohort Study and 10-Year Comparison.Pharmacy (Basel, Switzerland) · 2020Article
- Review of Drug Utilization Studies in Neonatal Units: A Global Perspective.International journal of environmental research and public health · 2020Review
- Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.Italian journal of pediatrics · 2020Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeonates admitted to neonatal intensive care units (NICU) are exposed to a wide variety of drugs, most without any data on safety and efficacy.
objectiveTo describe the drugs prescribed to different groups of neonates hospitalized in a NICU, and to analyze off-label use and harmful potential of drugs, in terms of the potential risks.
methodsThis was a six-month retrospective cohort study of drug use in a NICU, with neonates who were inpatients for a period of over 24 hours, and using prescription data from electronic medical records. Drug information found in the package leaflets, in the British National Formulary for Children 2012-2013, and in the Thomson Micromedex database were compared. Drugs and excipients considered potentially harmful were evaluated according to the literature.
resultsOne hundred ninety-two neonates were included in the study, with a mean gestational age (GA) of 33.3 weeks (SD ± 4.3), 75.0 % were preterm, with an average of 18.8 days of hospitalization (SD ± 18.1), and a total of 3617 neonates-day. 3290 prescriptions were registered, on average 17.1 prescriptions/neonate (SD ± 17.9) and 8.8 drugs/neonate (SD ± 5.9). The number of prescriptions and drugs was higher in neonates with GA <31 weeks (p <0.05). Anti-infectives for systemic use, blood, alimentary tract and metabolism drug groups were more frequent, varying according to the GA. Neonates (99.5 %) were exposed to unlicensed drugs (UL) and off label use (OL), more frequently in GA <28 weeks (p <0.05). Most OL drugs used were indicated for newborns. 15 potentially harmful drugs were used in more than 70 % of the neonates, and most were OL; exposure to harmful excipients occurred in 91.6 % of the neonates, a percentage even higher when considering immature neonates.
conclusionsImmature neonates in a Brazilian NICU are exposed to a variety of OL, UL and potentially harmful drugs and excipients.
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