Pharmacovigilance knowledge in family paediatricians. A survey study in Italy.

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.

[1]  I. Choonara Educational Paper: Aspects of clinical pharmacology in children—pharmacovigilance and safety , 2013, European Journal of Pediatrics.

[2]  Sherael D. Webley,et al.  Pharmacovigilance teaching in UK undergraduate pharmacy programmes , 2013, Pharmacoepidemiology and drug safety.

[3]  J. Collin,et al.  Risk Perception and Reasons for Noncompliance in Pharmacovigilance , 2009, Drug safety.

[4]  M. Lewis,et al.  Drug use and adverse event monitoring in German children. , 2009, International journal of clinical pharmacology and therapeutics.

[5]  R. Leone,et al.  Allergic reactions to oral drugs: A case/non-case study from an Italian spontaneous reporting database (GIF). , 2008, Pharmacological research.

[6]  Inman Wh Attitudes to adverse drug reaction reporting. , 1996 .

[7]  B. Bégaud,et al.  Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system , 1998, European Journal of Clinical Pharmacology.

[8]  Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia–Romagna region) , 2013, European Journal of Clinical Pharmacology.

[9]  M. T. Herdeiro,et al.  An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. , 2006, JAMA.

[10]  L. Hazell,et al.  Under-Reporting of Adverse Drug Reactions , 2006, Drug safety.

[11]  E. Napoleone,et al.  From pharmacovigilance to therapy amelioration in paediatric patients: the role of the clinical pharmacologists and family paediatricians. Part of a series on Paediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni. , 2012, Pharmacological research.

[12]  M. T. Herdeiro,et al.  Physicians’ Attitudes and Adverse Drug Reaction Reporting , 2005, Drug safety.

[13]  Prerna Upadhyaya,et al.  Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college , 2012, Therapeutics and clinical risk management.

[14]  M. T. Herdeiro,et al.  Improving the Reporting of Adverse Drug Reactions , 2008, Drug safety.

[15]  E. Puijenbroek,et al.  Application of Quantitative Signal Detection in the Dutch Spontaneous Reporting System for Adverse Drug Reactions , 2003, Drug safety.

[16]  K. Belton,et al.  Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union , 1997, European Journal of Clinical Pharmacology.

[17]  P Impicciatore,et al.  Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. , 2001, British journal of clinical pharmacology.

[18]  F. Zeng,et al.  Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. , 2004, Chinese medical journal.

[19]  E. Clementi,et al.  Perceptions and patterns of use of generic drugs among Italian family pediatricians: first round results of a web survey. , 2012, Health policy.