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2014 (v.22 no.2)

Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics
ISSN: 2289-0882

  • Off-label use and designation of age groupspecific contraindications for pharmacotherapy in children in Korea

    Min Soo Park

    TCP | v.22, no.2, pp.58-63, Dec, 2014


    Children should be treated with medicines that have been tested for efficacy and safety in the given
    age groups. In reality the majority of drugs being used in children lack such information, inevitably
    leading to the “off-label use.” Over decades there have been concerns regarding risk of adverse
    effects with such off-label uses. However, in most countries rational application of off-label uses
    have not been prohibited, since it may be the only available and perhaps the best possible treatment
    option. In contrast, in an effort to minimize such use and per se ‘protect’ children from possible
    harm associated with it, Korea has launched “Drug Utilization Review” system, which included age
    group-specific contraindications, based on the labeling information approved by Ministry of Food
    and Drug Safety. The problem lies in the definition and scope of ‘contraindication.’ Lack of evidence
    for safety and concern for risk of serious adverse drug reactions are the basis for contraindication.
    This leads to branding of off-label uses as contraindications in certain age groups. This policy is
    restricting the already scarce treatment options and suffocating the initiative for developing better
    pharmacotherapy for children. We should learn from other countries that have travailed more to
    provide better medicines to children. Clinical trials of new drugs as well as existing drugs in pediatric
    populations are strongly encouraged. Simple prohibition of off-label use is not the answer, but
    rather systematized management of off-label use as well as conduct of clinical trials in pediatric age
    groups must be encouraged and supported.


    Children,Drug Safety,Off-label,Contraindication,Clinical Trials