Antineoplastic adverse drug reactions spontaneous notifications profile sent to the Pharmacovigilance Program of a university hospital in Porto Alegre

Abstract

Introduction: Pharmacovigilance encompasses a range of crucial activities aimed at detecting, evaluating, comprehending and preventing adverse events, or any other drug-related problems. It is an essential component of health systems, contributing to the evaluation and monitoring of the safety of medication use. Among the relevant activities of Pharmacovigilance, the notifications of adverse drug reactions (ADR) stand out. Due to their narrow therapeutic index, antineoplastic drugs have a high potential for the occurrence of adverse events. Objective: The aim of this study was to globally quantify the antineoplastic ADR spontaneous notifications profile sent to the Pharmacovigilance Program of a university hospital in Porto Alegre. Material and Methods: This is a cross-sectional, descriptive and retrospective study, carried out between 2020 and 2021. This study was approved by the Research Ethics Committee of the aforementioned institution. Results: The hospital's Pharmacovigilance Program spontaneously received 119 and 105 ADR notifications in the years 2020 and 2021, respectively, of which 71 (60%) and 49 (47%), respectively, were related to antineoplastic therapy. A total of 14 different antineoplastic drugs involved in the 2020 and 11 in the 2021 notifications were identified, with emphasis on Oxaliplatin and Paclitaxel. Conclusions: This work highlighted the importance of the Pharmacovigilance Program around antineoplastic chemotherapy, adding safety to the use of drugs in the hospital environment.