OFF-LABEL USE OF MEDICINES IN CHILDREN

Although plenty of information relating to drug utilization among adults is available, the literature pertaining to children is scarce. The majority of drugs prescribed have not been tested in children and safety and efficacy of children's medicines are frequently supported by low quality of evidence. This is explained by the lack of clinical research in this population, caused by ethical, scientific and technical issues, besides commercial priorities. Therefore, most of the therapies prescribed to children are on an off-label or unlicensed basis. The off-label and unlicensed use of medicines is widespread and variable depending on the level of health care available, speciality concerned and patient characteristics. In the recent years, various laws and guidelines from the competent authorities have come up regulating the drug use and clinical research among children. This article reviews various pros and cons of the off-label use of medicines in children including various types, incidence rates, reasons, risks, consequences, management modalities, national and international guidelines related to the same.