The DOI matches its Crossref record; 26 of the 27 references it cites were found in a registry or an index.
Off-label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia
Open accessAbstract
Most of the medications which are currently used for the treatment of childhood diseases are either not licensed or being prescribed outside the terms of the product license (off-label prescribing). This study aimed at determining the extent of unlicensed and off-label drug uses and associated factors in children hospitalized in Gondar University Referral Hospital, Northwest Ethiopia. An institution-based prospective cross-sectional study was employed from April 15 to July 15, 2016. A total of 243 pediatric patients admitted to Gondar university referral hospital were included in the study using simple random sampling method. Data were collected using structured questionnaire, and the data collected were entered and analyzed using Statistical Packages for Social Sciences (SPSS) version 20. From the total of 800 drugs prescribed, 607 (75.8%) were off-label. Off-label medicine use was frequently observed in antimicrobials (60.6%) followed by central nervous system drugs (14.3%). The extent off-label prescribing was highest in age group of 6–13 years (30%). Inappropriate dosing and frequency (42.3%) were the most common reason for off-label medicine use. Having other variables controlled, age group and undergoing surgical procedure remained to be significant predictors of off-label prescribing in the multivariate regression analysis. Implementing evidence-based approach in prescribing by generating more quality literatures on the safety profile and effectiveness of off-label would improve the injudicious use of drugs in pediatric population.
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“transplanting adult evidence into children can yield sub-therapeutic dosing, diminished efficacy, or an elevated risk of adverse reactions [2-4].”
From PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels (2025) · cites this paper as [3]
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“Because growth and maturation reshape both pharmacokinetics and disease biology”
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Survey of unlicensed and off label drug use in paediatric wards in European countries
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Unlicensed and off label drug use in paediatric wards: prospective study
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Drug use in children: cohort study in three European countries
Sturkenboom, M., Verhamme, K. M. C., Nicolosi, A., Murray, M. L., Neubert, A. C., Caudri, D., Picelli, G., Sen, E. F., Giaquinto, C., Cantarutti, L., et al. (2008) · BMJ · doi:10.1136/bmj.a2245 · Cited by 234
Off-Label Drug Use in Pediatric Patients
Kimland, E. E., & Odlind, V. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.26 · Cited by 223
Off-label Drug Use in Hospitalized Children
Shah, S. S., Hall, M., Goodman, D. M., Feuer, P., Sharma, V., Fargason, C. A., Hyman, D., Jenkins, K. J., White, M. L., Levy, F. H., et al. (2007) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/archpedi.161.3.282 · Cited by 222
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Using antibiotics responsibly: right drug, right time, right dose, right duration
Dryden, M., Johnson, A. P., Ashiru-Oredope, D. A. I., & Sharland, M. (2011) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkr370 · Cited by 141
Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital
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The status of paediatric medicines initiatives around the world—what has happened and what has not?
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Research works printed but not linked: 1
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Sorted by citations
Off-label and unlicensed drug use in children population
Moulis, F., Durrieu, G., & Lapeyre‐Mestre, M. (2018) · Therapies · doi:10.1016/j.therap.2018.02.002 · Cited by 56
Gidey, M. T., Gebretsadkan, Y. G., Tsadik, A. G., Welie, A. G., & Assefa, B. T. (2020) · The Italian Journal of Pediatrics/Italian journal of pediatrics · doi:10.1186/s13052-020-0809-5 · Cited by 20
Off‑label and unapproved pediatric drug utilization: A meta‑analysis
Yuan, X., Gao, J., Yang, L., Tan, Y., & Bajinka, O. (2024) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2024.12701 · Cited by 17
Kotb, M. A., Mosallam, D., Basanti, C. W. S., Sorogy, S. T. M. E., Badr, A., Baky, H. A. E., & Draz, I. H. (2020) · Medicine · doi:10.1097/md.0000000000018730 · Cited by 12
Obura, B., Alele, P. E., & Obua, C. (2020) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-020-01175-1 · Cited by 5
Metadata
- Authors
- Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B.
- Affiliations
- University of Gondar (ET)
- Department of Pharmaceutical Chemistry; School of Pharmacy; university of Gondar; Gondar Amhara Ethiopia
- Corresponding author
- Tefera, Yonas G.
- Venue
- Pharmacology Research & Perspectives
- Publisher
- Wiley
- Published
- 2017-03-17
- Volume
- 5
- Issue
- 2
- Pages
- e00304
- ISSN
- 2052-1707 (ISSN-L)
- PMC
- PMC5368968
- OpenAlex
- W2595606553
- Cited by
- 21
- References
- 27
- Citations by year
- 2025: 2 · 2024: 5 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 1 · 2018: 1 · 2017: 1
- FWCI
- 2.39
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Pharmacology Research & Perspectives (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Griffith Research Online (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- off-label drug use, pediatric drug use, hospitalized children, antimicrobial agents, inappropriate dosing, surgical procedures, evidence-based prescribing
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- CoChat. (2026). Citation check: Off-label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. https://app.cochat.ai/papers/10.1002/prp2.304
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- Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off-label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. Pharmacology Research & Perspectives. https://doi.org/10.1002/prp2.304
