Challenges of Pharmacovigilance in Brazil

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

doi:10.5539/gjhs.v13n2p1

Abstract

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.

Highlights

Medicines are indispensable instruments in the therapeutic scheme of various diseases and can prevent, treat and hinder their progression
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 objective of this study is to present the challenges of pharmacovigilance in Brazil

Summary

Introduction

Medicines are indispensable instruments in the therapeutic scheme of various diseases and can prevent, treat and hinder their progression. In Brazil, an initiative to broaden and systematize surveillance of products used in health services was taken by the National Health Surveillance Agency in partnership with Brazilian hospitals, developed the Sentinela Network. The aims of this network were to expand the reporting base, to implement notification schemes, and to emphasize pharmacovigilance-related themes in the education of health professionals Increased resources available to regulators and public research networks in the US and Canada allow more independent research to shape their decisions These differentiated policy and governance approaches contribute to divergence in international pharmacovigilance strategies (Wiktorowicz, Lexchin, & Moscou, 2012). The objective of this study is to present the challenges of pharmacovigilance in Brazil

Issues in Notification

Notifying Professionals

Findings

Conclusion