Antidepressants and antipsychotics authorised for use in children and adolescents. Legal and ethical challenges associated with the range of drug authorisation
Piotr Niwiński

Introduction: When practicing the profession of a physician, not only medical principles, but also legal regulations must be followed. The legal regulations are associated, for instance, with consent to treatment and drug authorisation principles. Drugs are authorised for strictly specified indications in given groups of patients. Off-label use may be interpreted as performing a medical experiment. The guidelines for drug usage are formulated by academic societies. In child and adolescent psychiatry, numerous drugs are unauthorised for use in patients under the age of 18 years, which means that a doctor, after collecting appropriate information, must obtain a written consent to treatment from a parent or legal guardian. Aim: The aim of the study was to review drugs used for depression and psychotic disorders in children and adolescents in terms of patient age specified in the registered indications. Method: Based on the Physician’s Desk Reference, summaries of product characteristics were analysed. Results: Of 226 antipsychotics and antidepressants authorised for use in Poland, 149 are not indicated or are contraindicated in patients younger than 18 years of age. Twenty-nine drugs are authorised for use in children but for different indications than depression and psychotic disorders. Moreover, various drug formulations or formulations manufactured by different pharmaceutical companies can be registered differently. Conclusions: No authorisation of psychiatric drugs for use in children and adolescents is a legal and financial threat to doctors and might evoke parents’ distrust.