Cristiana Scasserra
Italy
Review Article
Pharmacovigilance in Pediatric Age: The Role of Family Pediatricians- Medicines for Children Research Network (FP-MCRN)
Author(s): Ettore Napoleone and Cristiana ScasserraEttore 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.. View More»
DOI:
10.4172/2329-6887.1000168