Psychotropic drugs-AIFA


Over the past few years there has been an increasing spread of the use of psychotropic drugs among children, especially stimulants and antidepressants. This phenomenon is followed by an increase in prescriptions in preschool children and a more widespread off-label use of these products. However, studies conducted to define the risk / benefit of this type of medication in the pediatric population are still limited. It is believed that it is possible to re-evaluate the risk-profile benefit through the establishment of a monitoring system of prescriptions and adverse reactions of drugs belonging to the categories ATC N05A and N06A in a sample of pediatric patients representative of the Italian pediatric population. 

The aim of this observational, prospective study was obtaining prescription data (prevalence / incidence) related to the use of different types of drugs used in the treatment of childhood depression and psychotic disorders and the collection and assessment of adverse reactions associated with the use of these drugs to the end of a re-assessment of their risk / benefit ratio in the pediatric population. 

Study population consisted of 300 pediatric patients who receive, in the period between September 2008-September 2009, prescription drugs belonging to the N05A and N06A therapeutic categories for the first time. The survey data of interest were performed at baseline, 6 and 12 months after the first prescription. 

Were performed descriptive statistics of the variables. Were also calculated the incidence and prevalence of prescriptions of psychotropic drugs by age and sex and was calculated the incidence of adverse drug reactions. Was also rated the causal link between adverse reactions and medication prescribed.

Partecipants and Collaborations


Dr. Carlo Giaquinto 
Department of Paediatrics 


147 Pediatricians related to the Network Pedianet 


Consorzio per Valutazioni Biologiche e Farmacologiche 
Via Palestro 26, 27100 Pavia