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  • Off-label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia

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    Erku440186-Published.pdf (206.1Kb)
    Author(s)
    Tefera, Yonas G
    Gebresillassie, Begashaw M
    Mekuria, Abebe B
    Abebe, Tamrat B
    Erku, Daniel A
    Seid, Nurahmed
    Beshir, Habiba B
    Griffith University Author(s)
    Erku, Daniel
    Year published
    2017
    Metadata
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    Abstract
    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. ...
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    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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    Journal Title
    Pharmacology Research & Perspectives
    Volume
    5
    Issue
    2
    Publisher URI
    https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1002/prp2.304
    Copyright Statement
    © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
    Subject
    Medicinal and Biomolecular Chemistry
    Pharmacology and Pharmaceutical Sciences
    Science & Technology
    Life Sciences & Biomedicine
    Pharmacology & Pharmacy
    Children
    Ethiopia
    Publication URI
    http://hdl.handle.net/10072/400874
    Collection
    • Journal articles

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