ArticleEuropean journal of clinical pharmacology2016
Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.
Article in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 49 citations in OpenAlex.
- Antimicrobial-associated adverse events in neonates: an integrated literature review and FAERS pharmacovigilance analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Toward governance of artificial intelligence in pediatric healthcare.NPJ digital medicine · 2025Review
- Frequency and types of antibiotic usage in a referral neonatal intensive care unit, based on the world health organization classification (AwaRe).BMC pediatrics · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Antibiotics, Analgesic Sedatives, and Antiseizure Medications Frequently Used in Critically Ill Neonates: A Narrative Review.Children (Basel, Switzerland) · 2024Review
- The evaluation of antimicrobial stewardship for bacterial meningitis in neonates.Pediatric discovery · 2024Article
- Grading the level of evidence of neonatal pharmacotherapy: midazolam and phenobarbital as examples.Pediatric research · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Massive presence of off-label medicines in Danish neonatal departments: A nationwide survey using national hospital purchase data.Pharmacology research & perspectives · 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
- Advancing evidence-based treatment of infectious diseases in children with real-world data: Opportunities and challenges.Frontiers in pharmacology · 2022Article
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective.Vaccines · 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
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.The Journal of the Oklahoma State Medical Association · 2018Article
- Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.BMC pediatrics · 2018Observational
- Large differences in neonatal drug use between NICUs are common practice: time for consensus?British journal of clinical pharmacology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe use of medicines among newborns admitted to intensive care units is characterized by a high prevalence of off-label/unlicensed use and a wide variability in the absence of international guidelines. A prospective cross-sectional study was organized with the aim to analyse drug prescriptions among all 107 Italian level III neonatal intensive care units.
methodsAn online questionnaire was used to collect detailed information for each newborn, and a classification was made about the license status of all prescriptions. In addition, prescriptions were analysed taking into account a practical guide prepared by the Italian Society of Neonatology (ISN).
resultsThe 1-day survey (May–July 2014) regarded 220 newborn infants admitted to 36/107 Italian neonatal intensive care units: 191 prematures and 29 born at term. In total, 720 prescriptions (corresponding to 79 different drugs) were analysed: 191 (26.5 %) followed the terms of the product license, 529 (73.5 %) were off-label or unlicensed: 193/220 newborns (87.7 %) received at least one off-label/unlicensed prescription. Antiinfectives were the most common medicine used, followed by respiratory drugs and antianaemics; in an off-label manner, the most common was cardiovascular and central nervous system (CNS) drugs, gastrointestinals and antiinfectives. The most common categories of off-label use were age (34.4 %) and dosing frequency (20.6 %). Compared to ISN practical guide, prescriptions adhered more frequently to indications (100 % for ampicillin/sulbactam, >80 % for ampicillin, fluconazole, fentanyl, ranitidine and vancomicin).
conclusionsOur results confirm the high prevalence of off-label/unlicensed drug use in the neonatal population and underline a better adherence to indications based on clinical practice, suggesting the need to update information contained in the data sheets of medicines.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.