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

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.

Peresepan Obat “Off-Label” Pada Anak Dengan Penyakit Infeksi Saluran Pernapasan Akut

“…Banyaknya variasi penggunaan obat pada pasien ISPA anak akan berdampak pada penggunaan obat off-label. Off-label adalah penggunaan obat untuk indikasi, kontraindikasi, usia, dosis, dan rute pemberian yang tidak disebutkan dalam label produk yang telah disetujui oleh Food and Drug Administration (FDA) (Tefera et al, 2017). Prevalensi penggunaan obat off-label pada populasi anak berdasarkan hasil dari beberapa studi yang dilakukan berkisar antara 3-75% (Purwadi et al, 2014).…”

“…Adverse drug events (ADEs) merupakan kejadian yang tidak diinginkan yang berkaitan dengan pengobatan pada pasien, termasuk adverse drug reactions (ADRs) dan medication errors (MEs). Penggunaan obat off-label pada populasi anak dapat menyebabkan peningkatan risiko medication error (Tefera et al, 2017).…”

Off-label Drug Prescribing: Deciphering the Ambiguity

“…The anti-microbial agents formed the highest used class of off-label pharmacological products (60.6%) followed by central nervous system drugs (14.3%) and Cardiovascular drugs (8.6%). 9 A higher trend of off label use of anti-microbial agents is particularly seen in developing countries due to widespread incidence of infective diseases. However, start of antimicrobial agents in non-approved indications at an early age leads to higher chances of anti-microbial resistance and therapeutic failure at a later stage of life.…”

Uso off-label de medicamentos en la población pediátrica: aplicación del modelo de regresión logística binaria

“…Se considera como limitante el número de encuestas completadas, ya que se esperaba más colaboración por parte del gremio. Sin embargo, el número de casos y los resultados de este estudio son respaldados por diversas publicaciones que se han realizado en otros países, siendo la prescripción off-label un aspecto global a considerar (1)(2)(3)(4)(5)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(21)(22)(23)25,27,(30)(31)(32)34) .…”