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Off-label and unlicensed drug use in children admitted to Pediatric Intensive Care Units (PICU)

Neha Jobanputra, Sushma U Save, Sandeep B Bavdekar

    The International Journal of Risk & Safety in Medicine
    |September 28, 2015
    PubMed

    Insights

    Off-label (OL) and unlicensed drug (UL) use is common in pediatric intensive care units (PICUs), especially in infants and those on ventilation. This high prevalence compromises children's access to safe medications, necessitating regulatory action.

    Area of Science:

    • Pediatric Intensive Care
    • Pharmacology
    • Drug Safety

    Background:

    • Limited data exists on off-label (OL) and unlicensed drug (UL) use in pediatric intensive care units (PICUs).
    • Understanding drug utilization patterns in critically ill children is crucial for patient safety.

    Purpose of the Study:

    • To determine the prevalence of off-label (OL) and unlicensed drug (UL) use in children admitted to a PICU.
    • To identify factors associated with OL and UL drug use in this population.

    Main Methods:

    • A prospective observational study was conducted in a PICU in Mumbai, India.
    • Prescriptions for 482 consecutive pediatric patients (28 days to 12 years) over 12 months were analyzed.
    • Data collected included drug details (dose, route, indication) and patient demographics, with statistical analysis to identify significant associations.

    Main Results:

    • A high prevalence of OL drug use (41.25%) and UL drug use (21.01%) was observed.
    • OL drug use was most frequent in infants (56.52%), with off-label indications being the most common reason.
    • Unlicensed drug use was solely due to extemporaneously prepared drugs (EPDs), significantly associated with infancy and mechanical ventilation.

    Conclusions:

    • The study highlights a significant prevalence of OL and UL drug use in PICU patients, potentially compromising medication safety.
    • Legislative and regulatory initiatives are needed to incorporate existing evidence and experience into drug licensing for pediatric use.
    Abstract

    Keywords:
    Drug approvaldrug labelingintensive care units

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