The use of off label drugs increases the risk of adverse reactions in children.Pediatricians should pay more attention when they are recommented drugs.One of the problems of pharmacovigilance is the lack of knowledge due to absence of instructions. The problem of the incorrect use of drugs in pediatrics has become a public health concern.

In this context, the Family Pediatricians – Research Network on Medicines for Children (FP–MCRN) plays an important role in pediatric pharmacovigilance both through improved training and through a proper research methodology. There is a need for a cultural approach, implementing the culture of diseases related to adverse events. We must take into account the importance of post–authorization safety studies (PASS) according to GCP, GVP and

ENCePP Code of Conduct.

PASS can provide on one hand training and information regarding the proper use of drugs inchildrenand, the other to constitute a territorial survey inthe prescriptive appropriateness and safety of pediatric drugs aimed at assessing the risk ratio.