Notificações espontâneas de eventos adversos a medicamentos hospitalares: estudo piloto

Introduction: Post-marketing surveillance of drugs aims to detect problems related to safety, effectiveness and quality. The identification of adverse drug events (ADE) is made, mainly, by health professionals´ spontaneous reporting. This method allows risk communication in pharmacovigilance and contributes for market regulation. Objective: To estimate the prevalence of adverse drug reaction (ADR) and the suspicions of therapeutic failure (TF) reported by health professionals; to verify the active principle and type of drugs related to ADE, seriousness, causality, production mechanism and clinical manifestation of the events identified. METHODS: A cross-sectional study was performed in a teaching and public hospital which integrates the Sentinel Hospital Network, in 2008. ADR seriousness was classified according to intensity (mild, moderate, serious and lethal); drugs associated with ADE were categorized according to type (brand name drugs and non-brand name drugs); causality was imputed with Naranjo algorithm and the mechanism of occurrence was analyzed according to Rawlins e Thompson definitions (A or B). Results: There were 103 ADE reports in the period, of which 39 comprised TF and 64 ADR. Nurses reported the most ADE (53.4%). The majority of ADR were classified as type A (82.8%), mild (81.3%), possible (57.8%), according to causality assessment, and related to brand name drugs (20/35). Human immunoglobulin, docetaxel and paclitaxel were the drugs frequently associated with ADR. TF arising from no-brand name drugs (26/29), regarding, mainly, midazolam and ganciclovir. Conclusion: The results of the ADE report contribute for proposition of trigger tools for intensive monitoring of drug safety, as well as for the supplier qualification and for the improvement of quality products.