International Harmonization of Good Pharmacovigilance Practices: Impact on Brazil

• Published in: Drug safety Vol. 45; no. 10; pp. 1291 - 1292
• Main Authors: Palmeira, J F, Cruz, F M, Carvalho, A C S C, Vidal, J S, Jube, T A, Araujo, A C F D O G D, Capucho, H
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.10.2022
• Subjects: COVID-19; Decision making; Demand; Pandemics; Pharmacology; Pharmacovigilance; Reduction; Regulations; Risk communication; Technical information; Brazil
• ISSN: 0114-5916; 1179-1942

Introduction: As in other areas of health management, in Pharmacovigilance it is essential to know the results of interventions carried out and evaluate their impact on decision-making. In this regard, the World Health Organization (WHO) has published references to key performance indicators (KPIs) for Pharmacovigilance systems [1,2]. In Brazil, the Pharmacovigilance Office (GFARM) of the Brazilian Health Regulatory Agency (Anvisa) published, in 2020, a Brazilian standard on good pharmacovigilance practices (GVP) that are in line with the world's leading regulatory agencies. Objective: To evaluate the impact of the change in Brazilian Pharmacovigilance regulations on the demand for post-marketing monitoring of drugs at the Anvisa. Methods: This is a before-and-after descriptive, retrospective, documentary analysis study. In it, the impact of Resolution RDC 406/20, a new standard for GVP published in July 2020, was evaluated using a set of seven KPIs focused on the internal demands of GFARM/ Anvisa. The analyzed period was divided into a before (from July 2019 to June 2020-nb) and an after (from August 2020 to July 2021na). Results: In the comparison, it was possible to observe an increase in all the KPIs analyzed: 10.0% for the number of risk communications made (nb = 20; na = 22), 85.5% for the number of Adverse Drug Reaction (ADR) received (nb = 30035; na = 55723), 38.0% for the number of non-serious ADR (nb = 24257; na = 33476), 285.0% for the number of severe ADR (nb = 5778; na = 22247), 84.1% for the number of notifications of ADR per million inhabitants (nb = 142.4; na = 262.2), 26.0% for the number of technical processes (nb = 998; na = 1257), and 9.5% for the number of technical documents generated (nb = 483; na = 529). Furthermore, when analyzing the number of professionals involved in the demands in each period, a reduction of 10.3% in the average number of GFARM professionals was confirmed (nb = 14.5; na = 13). Conclusion: Although there was a reduction in the team, there was an increase in the demand from GFARM/Anvisa with the change in Pharmacovigilance regulations. This may have occurred because of rules in line with the world's leading standards, but also because of the demand of the Covid-19 pandemic. Once implemented, management through KPIs must be ongoing to qualify the management process and the area's decision-making.