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. 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.

Highlights

  • Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics

  • Because the study is conducted in only one referral hospital, the results found regarding Off-label use may not be representative of patients outside Gondar region

  • The finding of our study revealed that magnitude of offlabel prescribing in pediatric inpatients is considerably high

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Summary

Introduction

‘Off-label use’ is the use of a drug which has a marketing authorization, but is used for a condition, at a dose, via a route or for an age that is not listed in its product characteristics (Maria 2014). Medicines of major clinical importance including essential medicines are not tested and officially approved for use in this age group. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

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