Unlicensed and off-label drug use in children: implications for safety.
Throughout the world, many drugs prescribed for children are used in an off-label or unlicensed manner. The incidence of unlicensed and off-label drug prescriptions appears to be greatest in critically ill neonates and children and lowest in the general population. The risk associated with unlicensed and off-label drug use appears to be greater than for prescribing in accordance with the product licence. Health professionals, however, usually have no alternative but to use unlicensed and off-label medicines. More clinical trials for medicines in children are required to provide the evidence base for safe and effective drug prescribing.
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D002648:Child; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000145:classification / Q000331:legislation & jurisprudence; D004358:Drug Therapy / Q000706:statistics & numerical data; D004363:Drug Utilization; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010818:Practice Patterns, Physicians'