Pharmacovigilance: VigiMed: Contribution with reports of suspected adverse drug-related events in Rio Grande do Sul.

Abstract

Pharmacovigilance: VigiMed: Contribution with reports of suspected adverse drug-related events in Rio Grande do Sul.

Abstract

Objective: To analyze data on suspected adverse events related to drugs and vaccines reported on the VigiMed platform during the post-marketing phase of the State of Rio Grande do Sul.

Methods: Cross-sectional study with a quantitative approach using the Anvisa notification system database - VigiMed, which is based on voluntary reporting of suspected adverse events by health professionals, patients and pharmaceutical companies, publicly available and without identification of the subjects, on the Pharmacovigilance Notifications Panel in the period between January 1, 2019 and December 31, 2021.

Results: 1,740 notifications were analyzed, with pharmacists being the main notifiers. It was found that 17.5% (n=314) of the notifications presented severity criteria. Among the reported outcomes, 5 resulted in death, with Paclitaxel being one of the medications involved in the suspicion. Skin and subcutaneous tissue disorders were the most prevalent among adverse drug reactions, mainly related to the use of antineoplastic agents.

Conclusions: Knowledge of the profile of notifications in the state of Rio Grande do Sul can contribute to the development of strategies to prevent AMR in our state. In this way, pharmacovigilance can contribute to decision making on pharmacotherapy, in addition to complementing information not contained in the package inserts.

Keywords: Pharmacovigilance, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions.