• Gianluca Trifirò, Gianfranco Calogero, Francesca Menniti Ippolito, Mario Cosentino, Rodolfo Giuliani, Anita Conforti, Mauro Venegoni, Giampiero Mazzaglia, and Achille P Caputi.
• Department of Clinical and Experimental Medicine, Pharmacology Unit, University of Messina, Messina, Italy. gianluca.trifiro@unime.it
• Pharmacoepidemiol Drug Saf. 2005 May 1; 14 (5): 333-40.

PurposeThere is little evidence concerning adverse drug events (ADEs) in outpatients and related hospital admissions. In Italy, only one investigation was conducted on this important health issue. We therefore carried out a study to determine ADE incidence and ADE-related hospital admissions among emergency department (ED) visits, and to identify the risk factors for serious ADE leading to ED visit.MethodsDuring the year 2000, we performed a prospective study in two observational periods of 10 days each in 22 Italian EDs. Demographic, clinical and pharmacological data about all patients admitted to ED were collected by trained and qualified monitors. Records related to ADE were analysed and validated by a specific scientific committee.ResultsOn 18,854 enrolled patients, 629 (3.3%) were affected by ADE. Among these, 244 (38.8% of ADE patients) reported a serious event. Patients with ADE, accounting for 4.3% (193 cases) of total hospitalisations, were significantly more likely to be hospitalised (30.7% vs. 23.7%; p<0.0001), females (57.2% vs. 46.3%; p<0.0001) and elders, compared with the total sample. Serious ADE resulted significantly associated with male gender and old age. NSAIDs (16.5% of total ADE visits) and antibiotics (12.9%) were the drugs mostly involved in ADE occurrence. ADE affected mostly skin (213 ADE visits) and gastrointestinal system (211).ConclusionOld age and male gender resulted risk factors involved in the development of serious ADE. The high ADE-related hospitalisation incidence highlights the need for prevention strategies targeted to reduce the impact of ADE in the general population.Copyright (c) 2005 John Wiley & Sons, Ltd.

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