Background Off-label and unlicensed (OLUL) prescribing has been prevalent in pediatric
practice. Using data from a prospective cohort study of adverse drug reactions (ADRs) …

Aims To examine the impact of off‐label and unlicensed (OLUL) prescribing on adverse
drug reactions (ADR s) causing unplanned admissions to a paediatric hospital. Methods …

Background and objective: Many drugs that are used to treat children are either not licensed
for use in paediatric patients (unlicensed) or prescribed outside the terms of the product …

The use of unlicensed and off-label medicines in children is common because trials in
children have not usually been performed during the drug development process …

Background: Worldwide, in the absence of standard pediatric prescribing information,
clinicians often use medicines in children in a dosage form or for an indication that has not …

BACKGROUND: The lack of specific medicines and labeling recommendations for the
pediatric population is a long-standing problem. Using data from an observational study of …

To determine the incidence of adverse drug reactions (ADRs) to unlicensed and off‐label
drugs used in paediatric inpatients, we carried out prospective surveillance on five different …

A significant number of children receive either an unlicensed or an off-label drug during their
stay in hospital. Studies throughout Europe have shown that at least one-third of children in …

OBJECTIVE: To study the characteristics of off-label prescribing and adverse drug reaction
(ADR) occurrence in a sample of pediatric outpatients treated by general practitioners …

Objectives To investigate the use of drugs, the extent and pattern of unlicensed and off-label
use, and the potential relationship between off-label drug use and adverse drug reactions in …