Off-Label and Unlicensed Medication Use and Associated Adverse Drug Events in a Pediatric Emergency Department

Abstract

The frequency of reported ADEs associated with OL/UL medications was less than the frequency of ADEs from licensed medication use, with overall ADE frequency of less than 1%.

Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

“…This concurred with a recent study conducted in the US where inhaled bronchodialators (30.4%) and antimicrobials (14.8%) were the most commonly prescribed unlicensed/off-label medication classes in a paediatric emergency department [24]. In the present study, however, antibiotic use (44% of total medications) was high compared to other reports from similar studies in other countries [25][26][27].…”

Medication-Related Emergency Department Visits in Pediatrics: a Prospective Observational Study

“…Those studies that have been performed in pediatric patients have used retrospective design or significantly limited prospective methodologies, which preclude accurate determination of the magnitude of this issue. 16,[45][46][47][48][49][50][51][52][53][54][55] Retrospective evaluation, often conducted by using medical record review or use of administrative databases, has inherent limitation for reporting bias, challenges with event ascertainment, as well as causality and preventability assessment, and has reported much lower event rates compared with prospective studies. 11,56 Finally, no study has prospectively explored this issue in Canada, so the impact in our own country remains uncertain.…”

Off-label prescriptions for adult neurological patients: a pilot survey in China

“…Most of the previously published studies on off-label prescriptions typically only described the extent of offlabel drug use [5][6][7], and few conducted an evaluation of supporting evidence. Furthermore, only the DRUGDEX system was used when searching for supporting evidence [8].…”