Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil
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LEADING ARTICLE
Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil Marcelo Vogler1 · Heloísa Ricci Conesa2 · Karla de Araújo Ferreira1 · Flávia Moreira Cruz1 · Fernanda Simioni Gasparotto1 · Karen Fleck1 · Fernanda Maciel Rebelo1 · Bianca Kollross1 · Yannie Silveira Gonçalves1
© The Author(s) 2020
Abstract Pharmacovigilance is defined by the World Health Organization as the science and practice related to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs). In a well-functioning pharmacovigilance system, information on possible ADRs is collected from patients, health professionals and marketing authorisation holders. Of all data sources for drug safety monitoring, spontaneous reporting systems provide the highest volume of information at the lowest maintenance cost and have proven their value in the early detection of product-related safety issues. At the beginning of 2018, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária—Anvisa) decided to replace the national electronic reporting system in Brazil (Notivisa) with the system provided by Uppsala Monitoring Centre (VigiFlow) for ADR reporting. This paper describes that process and reports on the progress made by Anvisa in terms of making Brazil compliant with international pharmacovigilance standards as well as significantly increasing the number of individual case safety reports collected.
Key Points
1 Introduction
Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - Anvisa) implemented VigiFlow in 2018 as an initiative to improve the national pharmacovigilance system.
Before medicines are approved for sale they must be tested for quality, safety and efficacy. Clinical trials in particular provide regulatory agencies with the evidence they need on safety and efficacy for market approval. However, such studies have limitations, and the information collected during the pre-marketing phase is incomplete when it comes to possible adverse drug reactions (ADRs). This is because the patients in clinical trials are selected and few in number, and studies are limited in duration. The conditions of use also differ from clinical practice and information about rare adverse reactions, chronic toxicity, use in special groups (children, elderly, pregnant women) or drug interactions are usually incomplete or unavailable [1]. Consequently, it has been necessary to establish drug monitoring mechanisms related to the detection, assessment, understanding and prevention of adverse events or any other problems related to medicines [2]. Pharmacovigilance, or medicine safety, implies a constant state of watchfulness to recognise when things are going wrong, to take action to solve immediate problems, and to share information about the causes of harm to influence future policy and practice [3]. Among the different methods of reporting suspected
Individual case study reports (ICSRs) rates increased after the implementation of Vigiflow in Brazil. Fro
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