ArticleInternational journal of clinical pharmacy2012
Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study.
Article in International journal of clinical pharmacy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- 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
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- Review of Drug Utilization Studies in Neonatal Units: A Global Perspective.International journal of environmental research and public health · 2020Review
- Attitudes, knowledge and views on off-label prescribing in children among healthcare professionals in Malaysia.International journal of clinical pharmacy · 2019Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing.BMC pediatrics · 2018Observational
- Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review.European journal of hospital pharmacy : science and practice · 2018Review
- Article
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
- Magistral drugs in hospitalized newborns and children.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2016Article
- Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.European journal of clinical pharmacology · 2016Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecently several developed countries have improved the safety and efficacy of drugs used in infants and pediatric patients. Most drugs administered to adults have licensed approvals outlining indications, doses, and the recommended route of administration. However, many drugs that are given to children are unlicensed or used off-label.
objectivesTo assess the extent and nature of unregistered and off-label drug use in neonatal intensive care units (NICUs) in Turkey, and to explore awareness and views of the general public on the unlicensed use of medicine in preterm and term infants in developing countries. STUDY
designA prospective observational study of a dynamic cohort of 464 neonates from 17 NICUs in Turkey. All medications administered to neonates who were hospitalized and admitted to the NICU over a 24-h period were recorded. The prescriptions were analyzed to determine whether the medicines were used in a licensed or unlicensed manner.
resultsIn total, 1,315 prescriptions comprising 93 different medicines were written. We found that 62.3% of the drugs prescribed to the neonates over the 24-h period were unlicensed or off-labeled.
conclusionsThe present study indicates that unlicensed and off-label medicines are frequently used in preterm and term infants in Turkish NICUs. This finding is consistent and reported in other countries. We believe that the needs of the neonatal population must be a priority and access to safe and appropriate medicines requires urgent attention.
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