Off-label prescriptions in child and adolescent psychiatry. Why, when and how?

Abstract

In the paediatric population, paticulary in the field of child and adolescent psychiatry, off-label indications are the rule rather than the exception. This may occur when a drug is indicated for a pathology, age, route of administration or treatment length other than those described in the product label. Argentina, unlike other countries, has no explicit regulation on off-label prescribing. Therefore, the prescription of a medicine in a manner different from that approved by the National Administration of Medicines, Food and Medical Technology (ANMAT) does not have a regulatory framework regarding the conditions that must be met at the time of treatment. Although off-label use is not prohibited, it carries an additional risk. In order to encourage research in paediatrics, regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have introduced legislative reform. The following paper will review the current framework of the regulatory agencies that are relevant to the paediatric population and will analyse criteria to guide physicians in the rational use of off-label pharmacotherapy.