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KMID : 1038020140220020058
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Translational and Clinical Pharmacology
2014 Volume.22 No. 2 p.58 ~ p.63
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Off-label use and designation of age groupspecific contraindications for pharmacotherapy in children in Korea
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Park Min-Soo
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Abstract
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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.
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KEYWORD
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Children, Drug Safety, Off-label, Contraindication, Clinical Trials
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