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

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.