世界银行-巴西的药物警戒：在多样化的国家建立有效的系统（英）-2023.8-26页_635kb

报告摘要

Pharmacovigilance in Brazil: Creating an Effective System in a Diverse Country

Core Content

Pharmacovigilance (PV) in Brazil is a critical component of ensuring the safety and effectiveness of medicines and vaccines. Given Brazil's large and diverse population, as well as its federal structure, developing a unified PV system has been a complex process. The report outlines the historical development, challenges, and key initiatives in establishing a national PV framework.

Main Points

Importance of PV: PV is essential for monitoring the safety of medicines and vaccines, especially in ensuring that their benefits outweigh risks in daily clinical use. It is a recognized method to improve patient safety and strengthen health systems.
Challenges in Brazil: Due to its vast size, population diversity, and federal structure, Brazil has faced significant challenges in implementing a consistent PV system across its 26 states. Each state has historically operated independently, leading to disparities in PV activities and reporting.
Key Milestones:
- 1976: Law 6360 established the need for health surveillance of medicines, drugs, and related products.
- 1980: Sinitox, the National System for Toxico-Pharmacological Information, was created, marking the first step in structured health surveillance.
- 1990s: PV activities started in universities, drug centers, and health professionals' associations. São Paulo was among the first to develop PV initiatives.
- 2001: Brazil joined the WHO Program for International Drug Monitoring (PMID), and the creation of the National Medicines Monitoring Center (CNMM) under ANVISA followed.
- 2009: The establishment of NOTIVISA and VIGIPOS marked a significant step in centralizing PV reporting and monitoring.

Key Laws and Regulations

Law/Regulation	Key Topic / Sentence
Law no. 6.360 (1976)	Mandated reporting of adverse drug events (ADEs) to health authorities.
Directive no. 577 (1978)	Encouraged the development of a national pharmacological surveillance system.
Directive MS/SVS no. 40 (1995)	Introduced the National System of Pharmacoepidemiology.
Directive no. 3.916 (1998)	Approved a National Medicines Policy emphasizing safety, efficacy, and quality.
Directive no. 6 (1999)	Required local health authorities to establish PV mechanisms for high-risk substances.
Law no. 9.782 (1999)	Created ANVISA to coordinate and monitor national PV systems.
Directive no. 696 (2001)	Established the CNMM to strengthen PV actions and promote rational drug use.
Resolution RDC no. 136 (2003)	Required marketing authorization holders to submit periodic safety update reports.
Directive no. 354 (2006)	Approved ANVISA's internal PV rules.
Resolution RDC no. 04 (2009)	Detailed PV regulations for all medicinal product manufacturers.
Directive no. 1.660 (2009)	Established VIGIPOS, a national system for monitoring and researching ADEs.
Resolution RDC no. 55 (2010)	Set the registry of new biological products.
Resolution RDC no. 36 (2013)	Mandated compulsory reporting of adverse events by the Patient Safety Nucleus.
Resolution RDC no. 51 (2014)	Created the Sentinel Network (Rede Sentinela) for national health surveillance.
Directive no. 1.856 (2017)	Established the Pharmacovigilance Technical Board.
Resolution RDC no. 406 (2020)	Enumerated Good Pharmacovigilance Practices for marketing authorization holders.
Regulatory Instruction IN no. 63 (2020)	Introduced the Periodic Benefit-Risk Evaluation Report (PBRER) for submission to ANVISA.
Resolution RDC no. 585 (2021)	Approved updated internal PV rules for ANVISA.

Key Institutions and Systems

ANVISA (Agência Nacional de Vigilância Sanitária): Established in 1999, ANVISA is responsible for coordinating and monitoring the National Health Surveillance System (SNVS). It oversees the regulation of medicines, medical devices, food, cosmetics, and sanitizers.
GFARM (Gerência de Farmacovigilância): Part of ANVISA's 5th Directorate, GFARM is responsible for PV activities.
CNMM (Centro Nacional de Monitorização de Medicamentos): Hosted by GFARM, CNMM was created in 2001 to strengthen PV actions and promote rational drug use.
NOTIVISA (Sistema Nacional de Notificações para a Vigilança Sanitária): A national, web-based reporting system launched in 2006 for ADEs and technical complaints.
VIGIPOS (Sistema de Notificação e Investigação em Vigilância Sanitária): A system established in 2009 to monitor, analyze, and research ADEs and technical complaints.
Rede Sentinela (Sentinel Network): A network of sentinel sites created in 2002 and expanded in 2014 to enhance active PV.

Key Contributions and Activities

São Paulo: As the wealthiest state, São Paulo was a pioneer in PV. The CVS-SP (Centro de Vigilância Sanitária) initiated PV programs in the 1990s, including the PERIWEB database and the establishment of the PERI program to promote ADE research and reporting.
GPUIM (Group for the Prevention of Improper Use of Pharmaceuticals): Based in Ceará, this group played a key role in identifying ADEs and contributed to international discussions on PV.
Reporting Efforts: Initiatives like the Sentinel Network and reporting pharmacies were introduced to increase ADE reporting rates. The report highlights the importance of these efforts in addressing underreporting.

Take-Home Messages

Brazil's PV system has evolved over decades, driven by both national and international initiatives.
The establishment of ANVISA in 1999 was a pivotal moment, leading to the creation of a national PV database (VigiMed) in 2018.
Harmonization of PV activities across states is necessary to ensure consistency and effectiveness.
Active PV programs, such as the Sentinel Network, are crucial for detecting and addressing ADEs.
Legal frameworks and institutional support have been key to the development and consolidation of PV in Brazil.

Conclusion

The development of an effective PV system in Brazil reflects the country's commitment to improving public health safety. Despite challenges related to its size and federal structure, Brazil has made significant progress in establishing a centralized, standardized, and comprehensive PV system. Continued efforts to reduce underreporting, enhance training, and integrate PV into national health policies will be essential for sustaining and improving this system.

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