ArticleInternational journal of pediatrics2014
Off-label medicine use in pediatric inpatients: a prospective observational study at a tertiary care hospital in India.
Article in International journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- 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
- Prevalence of drug-drug interactions in children with cardiac disorders receiving off-label drugs in a single centre in Pakistan: a cross-sectional study.BMJ paediatrics open · 2025Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia.SAGE open medicine · 2022Article
- Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study.Hospital pharmacy · 2021Article
- Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.Italian journal of pediatrics · 2020Article
- 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
- Unlicensed and off-label use of drugs in pediatric surgical units at tertiary care hospitals of Pakistan.International journal of clinical pharmacy · 2017Observational
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P < 0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.
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Registered trials
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