ArticleJournal of Korean medical science2018
Safety and Efficacy of Off-label and Unlicensed Medicines in Children.
Article in Journal of Korean medical science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Evaluation of the safety of using propofol for paediatric procedural sedation: A systematic review and meta-analysis.Scientific reports · 2019Pooled it
- A multi-method study of unlicensed medicine risk assessment: a cross-sectional survey of pharmacy procurement leads and policy analysis across NHS trusts in England.International journal of clinical pharmacy · 2026Article
- Feasibility of a German High-Frequency Neonatal and Pediatric Intensive Care Dataset (AIx-Neo-Guard Dataset): Secondary Data Cohort Study.JMIR pediatrics and parenting · 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
- 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
- Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines.BMJ public health · 2024Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
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- Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review.Pharmaceutics · 2023Review
- Gaps in Accessibility of Pediatric Formulations: A Cross-Sectional Observational Study of a Teaching Hospital in Northern Thailand.Children (Basel, Switzerland) · 2022Article
- Application of natural language processing techniques to identify off-label drug usage from various online health communities.Journal of the American Medical Informatics Association : JAMIA · 2021Article
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to explore the use of off-label/unlicensed drugs to confirm the safety and efficacy of their prescription in children in Korea.
methodsIn this retrospective study, we analyzed data of patients who received any of the 32 drugs between January-December 2014 in tertiary hospitals in Korea, including demographics, diagnoses, reasons for the medication, administration route, and details of adverse drug reactions. Additionally, the mortality in the cohort was assessed. The primary outcomes were efficacy and safety, including mortality, of these drugs in pediatric patients. The secondary outcomes were the current statuses of the use of off-label/unlicensed drugs in two centers.
resultsTotally, 5,130 prescriptions were found in 2,779 patients. Age (73.5%) and indication (11.7%) were the most frequent reasons for prescriptions being off-labeled/unlicensed. Approximately 88% of the prescriptions were effective, and 19% of the patients developed adverse drug reactions. The number of prescriptions was significantly higher in children with adverse drug reactions than it was in those without (2.8 vs. 1.5;
conclusionChildren are still prescribed medicines that are not authorized in terms of age, weight, indications, or routes of administration. Therefore, many old products require re-assessment of authorization. More prospective clinical studies should be performed to confirm the efficacy and safety of drugs in the pediatric population.
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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.