Use of antibacterials and acute renal injury: pharmacovigilance analysis

Abstract

Antibacterials are part of one of the most relevant therapeutic classes in the population and play an important role in the treatment of infections. Among the adverse reactions that are potentially related to the use of these drugs, acute renal injury is included. One way to carry out analyzes of possible adverse events caused by these substances, which is a practice commonly used in other countries, but is not available in Brazil, is through reporting systems. Making use of a national reporting system to monitor the incidence of these cases would make it possible to know the degree to which this reaction is reported. This project aims to investigate reports of acute renal injury potentially caused by the use of antibacterials in Brazil. A case/non-case study will be carried out through analysis of disproportionality based on the analysis of the records available in the notification system database of the AgênciaNacional de VigilânciaSanitária (Anvisa), the Sistema de Notificação de ReaçõesInesperadas a Medicamentos e Vacinas (VigiMed), adopted by Anvisa in 2018. Reports in VigMedof renal insufficiency caused by antibacterialsbelonging to the Anatomical Therapeutic Chemical Classification System J01AA, J01BA, J01C, J01D, J01E, J01F, J01G, J01M, and J01X will be eligible. After descriptive statistics, the measure of association for adverse reactions related to acute renal injury will be estimated by the reported odds ratio. Partnership in the Infections and Antimicrobial Resistance Group, Division of Population Medicine, Cardiff University, was envisioned for research collaboration.