Attitude survey of spontaneous adverse drug-reaction reporting by general practitioners in Sicily

Filippo Drago; Lucia Gozzo; Daniela Vitale; Laura Longo

doi:10.35352/gioenia.v55i385.100

Filippo Drago Department of Biomedical and Biotechnological Sciences, University of Catania, Via S. Sofia, 97, I-95123 Catania, Italy; Unit of Clinical Pharmacology and Pharmacovigilance, University Hospital “Policlinico G. Rodolico-San Marco”, Via S. Sofia, 78, I-95123 Catania, Italy
Lucia Gozzo Department of Biomedical and Biotechnological Sciences, University of Catania, Via S. Sofia, 97, I-95123 Catania, Italy; Unit of Clinical Pharmacology and Pharmacovigilance, University Hospital “Policlinico G. Rodolico-San Marco”, Via S. Sofia, 78, I-95123 Catania, Italy http://orcid.org/0000-0002-7512-269X
Daniela Vitale Unit of Clinical Pharmacology and Pharmacovigilance, University Hospital “Policlinico G. Rodolico-San Marco”, Via S. Sofia, 78, I-95123 Catania, Italy
Laura Longo Unit of Clinical Pharmacology and Pharmacovigilance, University Hospital “Policlinico G. Rodolico-San Marco”, Via S. Sofia, 78, I-95123 Catania, Italy

DOI: https://doi.org/10.35352/gioenia.v55i385.100

Keywords: Adverse drug-reaction, Spontaneous reporting system, General Practitioners, Under-reporting

Abstract

Spontaneous adverse drug reaction (ADR) reporting is fundamental for drug safety surveillance. However, under-reporting is one of the main limitations of the pharmacovigilance system and may cause bias for data interpretation. The purpose of the present study was to assess the general practitioners’ (GPs) knowledge about Pharmacovigilance in Sicily (Italy) and their spontaneous reporting attitude, in order to identify the reasons for under-reporting, and to determine which steps to pursue to increase the reporting rates. A self-administered questionnaire has been sent to a sample of 440 GPs in Sicily. After two weeks, the same questionnaire was administered by telephone to non-responders. When the response rate was significantly high (> 40%), data were evaluated. Four-hundred-and-forty GPs were contacted, but only 41.3% of them completed the interviews. Reasons for under-reporting included ‘lack of time’, ‘lack of adequate feed-back by the Pharmacovigilance’s Service’, ‘fear of legal liability or appearing foolish’, ‘reluctance to admit that harm had been caused to a patient’. These results showed that there is a scope for further development of such techniques and their use on a wider basis in Italy.