TY - JOUR
T1 - Pharmacovigilance knowledge in family paediatricians. A survey study in Italy
AU - Pellegrino, Paolo
AU - Carnovale, Carla
AU - Cattaneo, Dario
AU - Perrone, Valentina
AU - Antoniazzi, Stefania
AU - Pozzi, Marco
AU - Napoleone, Ettore
AU - Filograna, Maria Rosaria
AU - Clementi, Emilio
AU - Radice, Sonia
PY - 2013/11
Y1 - 2013/11
N2 - 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.
AB - 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.
KW - Adverse drug reaction
KW - Paediatrics
KW - Pharmacovigilance
KW - Underreporting
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U2 - 10.1016/j.healthpol.2013.08.006
DO - 10.1016/j.healthpol.2013.08.006
M3 - Article
C2 - 24012386
AN - SCOPUS:84887553752
VL - 113
SP - 216
EP - 220
JO - Health Policy
JF - Health Policy
SN - 0168-8510
IS - 1-2
ER -