Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district.
Attitudes to adverse drug reaction (ADR) spontaneous reporting were investigated among all the National Health Service (NHS) doctors operating in the territory of the Area Health Authority n.1 of Varese (Italy), to assess their awareness of the reporting system and to identify reasons for under reporting. Three hundred and fifty doctors were sent questionnaires and 207 (59.1%) were returned completed. More than 77% of the responders stated to have noticed ADRs, which were mainly reported to the pharmaceutical manufacturers and, in a minority of cases, to the NHS. Fifty per cent did not report ADRs to anyone. Important factors for deciding to report were unusualness and severity of the reaction, and involvement of a new drug. The main reason for not reporting was the clinical negligibility of the reaction. There was little knowledge about the types of reactions to be preferentially reported and the purposes of ADR reporting systems. Nevertheless, nearly everyone asked for feed-back information about reported ADRs. NHS doctors in this district have little information concerning ADR reporting systems. Some effective measures to improve the situation could be: inclusion of pharmacovigilance into pre- and post-graduated continuing education programs, provision of guidelines for ADR spontaneous reporting and of feed-back information to reporters, implementation of regional pharmacovigilance units.
Cosentino
M
M
Department of Internal Medicine and Therapeutics, II Faculty of Medicine, University of Pavia, Varese VA, Italy.
Leoni
O
O
Banfi
F
F
Lecchini
S
S
Frigo
G
G
D016907:Adverse Drug Reaction Reporting Systems; D001291:Attitude of Health Personnel; D006801:Humans; D007558:Italy; D010821:Physicians, Family