title: Pharmacovigilance knowledge in family paediatricians. A survey study in Italy.
abstract: Drugs prescription in children correlates with a high risk of developing unknown or rare adverse drug reactions (ADRs). In the absence of appropriate clinical trials in the paediatric population, the spontaneous reporting of suspected ADRs is an important means to promote reasonable warning signals. In this context, family paediatricians (FPs) play a crucial role although a general poor compliance in their ability of reporting of ADR is widely described. To understand the reasons beyond this situation we performed a survey, the first of its kind in Italy, to evaluate FPs knowledge, feeling and compliance in ADR reporting. A total of 552 FPs evenly distributed throughout the Italian territory provided a feedback to the survey. Knowledge of pharmacovigilance (PV) resulted to be poor, mainly due to the absence of adequate training in academy; despite this, the majority of FPs declared to be interested to PV and aware of its positive impact on their clinical practice. Yet, FPs reported a poor compliance to the reporting of ADRs. A very high variability in ADRs reporting however, was observed among the regions, possibly because of variability of regional educational programmes dedicated to PV.
authors.affiliation: Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pellegrino
authors.forename: Carla
authors.initials: C
authors.lastname: Carnovale
authors.forename: Dario
authors.initials: D
authors.lastname: Cattaneo
authors.forename: Valentina
authors.initials: V
authors.lastname: Perrone
authors.forename: Stefania
authors.initials: S
authors.lastname: Antoniazzi
authors.forename: Marco
authors.initials: M
authors.lastname: Pozzi
authors.forename: Ettore
authors.initials: E
authors.lastname: Napoleone
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Filograna
authors.forename: Emilio
authors.initials: E
authors.lastname: Clementi
authors.forename: Sonia
authors.initials: S
authors.lastname: Radice
mesh_terms: D000328:Adult; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010372:Pediatrics; D060735:Pharmacovigilance; D010821:Physicians, Family; D011795:Surveys and Questionnaires
keywords: Adverse drug reaction; Paediatrics; Pharmacovigilance; Underreporting