Adverse drug reactions to unlicensed and off‐label drugs on paediatric wards: a prospective study

TLDR

The study prospectively determined the incidence of adverse drug reactions to unlicensed and off‑label drugs in paediatric inpatients by monitoring five wards over 13 weeks. Prospective surveillance of 4,455 drug courses in 936 patients across five wards involved comparing each drug to its product characteristics to classify use and applying predefined criteria to identify adverse drug reactions. Unlicensed or off‑label drugs were used in 48% of admissions, and 11% of admissions experienced adverse drug reactions, which occurred in 3.9% of licensed and 6% of unlicensed/off‑label prescriptions, underscoring the widespread use and significant risk. Keywords: adverse drug reactions, children, off‑label, unlicensed.

Abstract

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 paediatric wards in a regional children's hospital for 13 wk. Comparison of the use of each drug with its summary of product characteristics was made to determine whether the drug was used in an unlicensed or off‐label manner. The presence of an ADR was determined using previously defined criteria. In total, 4455 courses of drugs were administered to 936 patients in 1046 admissions. In 507 (48%) of the 1046 admissions, patients received one or more unlicensed or off‐label drugs. ADRs occurred in 116 (11%) of the 1046 patient admissions. ADRs were associated with 112 (3.9%) of the 2881 licensed drug prescriptions and 95 (6%) of the 1574 unlicensed or off‐label drug prescriptions. Use of drugs in an off‐label or unlicensed manner to treat children is widespread. ADRs are a significant problem following unlicensed or off‐label drug prescriptions. □ Adverse drug reactions, children, off‐label, unlicensed