ArticleEuropean journal of clinical pharmacology2008
Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil.
Article in European journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
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Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Age-related off-label drug prescribing in pediatric patients in South Korea and consistency of labeling compared to the United States, Europe, and Japan.Clinical and translational science · 2024Article
- Use of antimicrobials in pediatric wards of five Brazilian hospitals.BMC pediatrics · 2024Observational
- Assessment of Antimicrobial Consumption in Multi-Field Hospitals with Pediatric Inpatients: Conventional vs. Novel Pediatric-Adjusted Methodologies.Antibiotics (Basel, Switzerland) · 2023Article
- The use of special approval medicines among pediatric patients in a tertiary care hospital: A reality check.Exploratory research in clinical and social pharmacy · 2022Article
- Intravenous drug use in neonatal intensive care units.European journal of hospital pharmacy : science and practice · 2021Observational
- 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 antibiotic use among paediatric in-patients: a mixed-method prospective study at a tertiary hospital in southwestern Uganda.International journal of clinical pharmacy · 2021Article
- International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.Clinical pharmacology and therapeutics · 2020Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Article
- Magistral drugs in hospitalized newborns and children.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2016Article
- Antihistamines prescribed off-label among paediatric patients at a tertiary care hospital setting in Malaysia.International journal of clinical pharmacy · 2016Observational
- Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.BMC pediatrics · 2016Article
- Drug utilisation and off-label use of medications in anaesthesia in surgical wards of a teaching hospital.Indian journal of anaesthesia · 2015Article
- Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia.International journal of clinical pharmacy · 2015Article
- Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital.PloS one · 2015Article
- Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital.British journal of clinical pharmacology · 2014Article
- Incidence of unlicensed and off-label prescription in children.Italian journal of pediatrics · 2014Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate the use of drugs, the extent and pattern of unlicensed and off-label use, and the potential relationship between off-label drug use and adverse drug reactions in northeastern Brazil.
methodsA follow-up study of drug utilization in a general ward of a pediatric reference hospital, involving patients hospitalized for more than 24 h. Prescriptions and medical records were reviewed daily from August to December 2001. Drug licensing status of all prescriptions given to these patients was determined.
resultsA total of 272 patients were admitted during the study, 265 (97.4%) of whom received one or more drugs. The median number of drugs/patient was 6 (1-18), and the most frequent diagnosis was pneumonia (29.4% of patients). The therapeutic class most prescribed was anti-infectives for systemic use (68.8% of all children). In all, 82.6% of children received at least one unlicensed or off-label drug, and 17% received both an unlicensed and an off-label drug. Dose/frequency was the most common form of off-label drug use. Off-label drug use was significantly associated with adverse drug reactions (relative risk 2.44; 95% CI 2.12, 2.89).
conclusionsAlthough off-label drug use is a complex issue and is not synonymous with inappropriate drug use, a high rate of unlicensed/off-label drug use was found and was also associated with an increased risk of adverse drug reactions. More efforts are needed to increase rational drug use in children.
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