Pharmacological Research, Vol. 35, No. 2, 1997 ATTITUDES TO ADVERSE DRUG REACTION REPORTING BY MEDICAL PRACTITIONERS IN A NORTHERN ITALIAN DISTRICT MARCO COSENTINO, OLIVIA LEONI, FABIO BANFI*, SERGIO LECCHINI and GIANMARIO FRIGO Department of Internal Medicine and Therapeutics, Clinical Pharmacology Unit, II Faculty of Medicine, University of Pavia, Varese, and *Area Health Authority n.1, Varese Accepted 27 September 1996 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. 1997 The Italian Pharmacological Society KEY WORDS: pharmacovigilance, adverse drug reaction spontaneous reporting, medical practitioners. INTRODUCTION per million inhabitants were sent from Italy to the World Health Organization Collaborating Center, in Adverse drug reaction (ADR) spontaneous reporting contrast to, e.g., 429 from Denmark or 407 from Ger- man Federal Republic [1]. systems are the basic components for the comprehen- sive post-marketing surveillance of drug-induced In Italy, the law states that doctors must notify by means of a report form any suspected ADR to the risks. They are primarily designed to rapidly detect new ADRs, creating hypotheses to be tested in sub- Area Health Authorities, which, in turn, send the reports to the Ministry of Health. Although such sequent studies. Spontaneous reporting systems offer many advantages (e.g., they are inexpensive and reporting system has been established in 1987, recently published data concerning regional reporting simple to operate, potentially cover all drugs and the whole patient population, including special sub- rates [3] indicate that its efficiency in the various dis- tricts is at least quite disomogeneous. Indeed, during groups, do not interfere with prescribing habits), how- ever their strength is tightly connected to the actual 1994, nearly 40% of the total number of ADRs reported to the Ministry of Health originated from the reporting rate by the physicians, under-reporting being the main intrinsic disadvantage [1]. It has been Veneto, Friuli-Venezia Giulia and Emilia Romagna regions, whose populations account for only about estimated that in the United Kingdom where, since 1964, the ‘yellow card’ spontaneous reporting system 17% of the total Italian population. In Lombardia, the Area Health Authority n.1 of works, only 10–15% of even severe reactions are reported [2]. In Italy, the situation is even worse, since Varese, in collaboration with the Clinical Pharma- cology Unit of the local Faculty of Medicine, is cur- a structured national reporting scheme has not yet been fully set up. For instance, in 1992 only 75 reports rently organizing an internal system for routinely col- lecting and monitoring spontaneous ADR reports. More than 300000 inhabitants live and 350 National Health Service (NHS) medical practitioners operate in Correspondence to: Marco Cosentino, Department of Internal Medicine and Therapeutics, Clinical Pharmacology Unit, II Faculty this district. Notwithstanding this, during 1994 only of Medicine, University of Pavia, Via Ottorino Rossi n.9, I-21100 three ADRs were reported. Since available evidence Varese VA, Italy. 1043–6618/97/020085–04/$25.00/0/fr960138 1997 The Italian Pharmacological Society