Abstract:
The aim of this study is to characterize the patients and the ADR notified to a Pharmacovigilance Center at a university hospital in Brazil. The ADR rate in hospitalized patients is 10% to 20% and the frequency of hospitalization due to ADR is 0,5% to 6,5%. The ADRs contribute to the increase of length in hospitalization and costs. Patient’s exposures have an increase in the rate of mortality, although about 60% to 80% could be prevented. A descriptive study carried at a university hospital in
Northeast of Brazil, where all the spontaneous notifications were analyzed during two years. For the process of notification of ADR suspicions, WHO definition was used. After receiving the notification, ADR suspicions were analyzed and the causality assessment was done by CFV staff members, using three different algorithms, and classified according to severity and type. Seventy eight ADR suspicions were spontaneously notified. The female gender represented 55% of cases. Black and mulatto races represented 70%. The most frequent organ and system affected was the skin. Medicines most frequently involved in ADR were anti-infectious agents followed by anti-parasitic agents. The causality assessment shows that the frequency of
certain and probable ADRs were around 55%. ADRs severity was moderate in 41%, although more than 60% of all ADRs could be prevented. ADRs are a major problem and measures must be adopted to minimize them.
