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 Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária-Anvisa) implemented VigiFlow in 2018 as an initiative to improve the national pharmacovigilance system. Individual case study reports (ICSRs) rates increased after the implementation of Vigiflow in Brazil. From 2020, all pharmacovigilance stakeholders will be able to report ICSRs to VigiFlow, which will expand and reinforce the national use of VigiFlow in the years to come.

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Background: Adverse Drug Events represent a public health problem with high morbidity and mortality rates around the world. Knowledge, attitudes and practices of health professionals toward pharmacovigilance and reporting these events are important factors to promote safe drug therapy use. Objectives: The aim of this study was to evaluate Knowledge, attitudes and practices of health professionals and reporting of Adverse Drug Events by health professionals in Brazil. Methods: across-sectional study with a pretested questionnaire available online on the website of the Brazilian drug regulatory agency. Pharmacovigilance related Knowledge, attitudes and practices and Adverse Drug Events reporting were evaluated and correlations were estimated. Results: In total, 761health professionals responded to the survey. The overall knowledge, attitudes and practices was of 57.7% for pharmacists, 56.9% for nurses and 40% for physicians 40% (considered to be a poor level). When evaluating performance by region, one physician (100%) from the South region and one nurse from the Central-West (83.3%) performed well on this indicator. Professionals in the age group older than 45 years and those with postgraduate degrees had the best performance in knowledge, attitudes and practices. The statistical analysis was performed with the software State version 15. Conclusion: The study identified knowledge, attitudes and practices deficiencies in pharmacovigilance and mapped its main weaknesses, which makes it possible to better delineate measures to address these challenges and improve the Brazilian national pharmacovigilance system.

Amphotericin B is most widely used antifungal drug of choice. We report a case of a 56-year-old man developed pain and skin swelling over right forearm at the intravenous access site during amphotericin B administration treatment given for mucormycosis, the post-operative of sinuses. After 4 hours of affected period, amphotericin B was administration. A well revealed thrombophlebitis of the right forearm was noted. The systemic reaction was assessed based on the naranjo algorithm and was found to be probable. The safety profile of amphotericin B and its adverse effects must be monitored on long term treatment usage.