Governance and pharmacovigilance in Brazil: a scoping review

Abstract

BackgroundThis scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance.MethodsSixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated.ResultsBrazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information.ConclusionsPharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0053-y) contains supplementary material, which is available to authorized users.

Evolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância Sanitária

“…Some state-level health surveillance agencies have State Pharmacovigilance Centers, notably the states of São Paulo, Rio de Janeiro, Paraná, Santa Catarina, and Bahia 2,31 . Several other states, like Ceará, implemented the Pharmacovigilance Center housed in Universidade Federal do Ceará since 1996, one of the most active in pharmacovigilance work in Brasil 32 .…”

“…In 2005, the spontaneous reporting method incorporated two forms of data collection in addition to the ADE reporting forms targeted to health professionals, namely: (i) reporting of adverse events by users of medications (Sisfarmaco) 23 ; and (ii) Reporting System for Adverse Events and Technical Complaints Related to Health Products (SINEPS), for sentinel hospitals 22 . That same year, Anvisa established the pilot project entitled Reporting by Pharmacies in the state of São Paulo, with initial participation by 43 pharmacies (out of a total of 14,000), aimed at increasing the number of qualified spontaneous reports of adverse events and quality deviations in medications 2,22 . This was later expanded to other states of Brazil, with at least three changes: (i) the project's name was changed to Reporting by Pharmacies Program; (ii) an advisory committee was created to support Anvisa in the Program's development; and (iii) promotion of safe and rational drug use in the Community Pharmacy context 35 .…”

“…A pharmacovigilance system is an essential part of drug regulatory policies 1 and pharmacogovernance, defined as government structures, policy instruments, regulations, standards, and institutional authority, administered in such a way as to safeguard society's interests in relation to patient safety, and to protect against adverse drug events (ADEs) 2 . The purpose is to identify, evaluate, analyze, and prevent ADEs 3 , which are relevant causes of morbidity and mortality 4,5,6 .…”

Regulation of Tissue Engineered Devices in some Latin American Countries: Development and External Influences

“…ANVISA was stablished in 1999 as an independent regulatory entity associated to the Ministry of Health. ANVISA regulates a broad spectrum of products and services in both health sectors (i.e., medical devices, and pharmaceuticals) and nonhealth sectors (e.g., agricultural and food)(20). In the area of pharmaceuticals, ANVISA received influences from the World Health Organization (WHO) and the Pan American Health Organization (PAHO)(20).…”

“…ANVISA regulates a broad spectrum of products and services in both health sectors (i.e., medical devices, and pharmaceuticals) and nonhealth sectors (e.g., agricultural and food)(20). In the area of pharmaceuticals, ANVISA received influences from the World Health Organization (WHO) and the Pan American Health Organization (PAHO)(20). In the context of medical devices, the selection of ANVISA as a regulatory institution was established under the Resolution RDC No.…”