Challenges of Pharmacovigilance in Brazil

  •  Vanessa M. de Oliveira    
  •  Vanessa T. Gubert-Matos    
  •  Alexandre A. Tutes    
  •  Cristiane M. Ferreira    
  •  Erica F. Vasconcelos-Pereira    
  •  Monica C. Toffoli-Kadri    
  •  Maria T. F. D. Monreal    


Pharmacovigilance encompasses the detection, evaluation, understanding, and prevention of adverse effects or any other drug-related problems. Knowledge of real and independent pharmacovigilance data is essential because clinical trials with medicinal products are limited and do not reveal all adverse effects of a product. The spontaneous notification system is one of the main tools used in pharmacovigilance. However, important remaining challenges for health professionals are the accurate recognition of adverse drug reactions and reporting routinely and systematically during their work. Once low notification rates make it harder to detect and monitor potential safety issues, it is needed risk assessment, and regulatory actions to safeguard patient safety. The objective of this study is to present the challenges of pharmacovigilance in Brazil. The implementation of computerized active search tools significantly improves the identification of possible adverse drug effects. Effective pharmacovigilance is crucial to ensure the safety and integrity of healthcare systems, to avoid lengthy hospital stays and to optimize healthcare spending. However, pharmacovigilance tools remain underused, undervalued, or even unknown in Brazil.

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