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Pharmacovigilance in Pediatric Age: The Role of Family Pediatricians- Medicines for Children Research Network (FP-MCRN)

Ettore Napoleone and Cristiana Scasserra

The conduct of pharmacovigilance for paediatric use medicines requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents. Lack of clinical studies in the paediatric population leads as a consequence to drug prescriptions on an unlicensed or ‘off-label’ basis, because they have not been adequately tested and/or formulated and authorised for use in appropriate paediatric age groups.

Spontaneously reported suspected adverse drug reactions remain the most important source in order to promote reasonable warning signals. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Post Authorization Safety Studies (PASS), give much more reliable estimates of the risk of ADRs than those resulting from spontaneous reports.

An improvement Family Paediatricians (FP) Pharmacovigilance training and continuous family information on the correct use of paediatric drugs may generate a better compliance of ADRs understanding.

In this context, Family Paediatricians -Medicines for Children Research Network (FP-MCRN), ENPREMA and ENCEPP member, established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric Pharmacovigilance (PV), through an improvement of PV paediatricians training, a correct research methodology and very strong relationship with the families.