| 1. National Pharmacovigilance Center |
National Drug Monitoring Center (CNMM), hosted in Anvisa. |
| SINAF legal framework, structure, and functions |
Federal provision: institutes the CNMM and defines its attributions. Spontaneous reporting is the traditional method; Legally mandatory reporting: DRM and health services. |
| Reporting forms for DRM. Guidelines for risk management in pharmacovigilance for state, municipal, and Federal District health surveillance agencies. |
| Periodic Safety Report: mandatory under federal law. |
| Difficulties linking federal and state regulation of pharmacovigilance, e.g., much information from São Paulo State is not recorded in Notivisa-medicamento (KI). |
| Surveillance network, featuring Sentinel. |
| A national pharmacovigilance system to coordinate the surveillance needs to be defined in legal terms. |
| SINAF financing |
No budget source was identified, earmarked for CNMM or the pharmacovigilance technical unit. |
| In 2014, the total budget of Anvisa was BRL 792,499,510.00 * (BRL 3.96 per capita) to cover 130 organizational units, including divisions, departments, advisory bodies, etc. **. |
| SINAF staff |
Anvisa had 2,125 employees in 2014 6262. Agência Nacional de Vigilância Sanitária. Relatório de atividades 2014. Brasília: Agência Nacional de Vigilância Sanitária; 2015.. In 2012, the pharmacovigilance technical unit had a staff of 12 5656. Agência Nacional de Vigilância Sanitária. Boletim de Farmacovigilância 2012; 1(1).. The team’s responsibilities include: assessment of causality between drug and adverse reaction, data analysis for signal detection, activities in communications, inspection in pharmacovigilance, and technical and administrative work (KI). No mention of the staff size working fulltime in the CNMM. |
| Access to professional training in Brazil and abroad. |
| WHO Program for International Drug Monitoring |
Brazil has been a member of the Program since 2001, collaborating with information on reporting of adverse drug reactions. |
| 2. National spontaneous reporting system with form for adverse drug reactions |
Notivisa-medicamento: main repository of spontaneous reporting data. |
| Nationwide coverage. |
| Uses standard online form for reporting suspected ADEs, especially adverse reactions, therapeutic ineffectiveness, and medication error. The form is too long. Drug poisoning has a specific form, integrated with Notivisa. Lay persons, patients, and family members report ADEs in a single form not integrated electronically with Notivisa. Many reports from the state of São Paulo reach Anvisa via electronic spreadsheets. |
| 3. National database for recording and monitoring ADEs |
Arrangement of the database prioritizes detection of safety signals by focusing on the drug-adverse event pair. This means that the presence of multiple pairs in the database may reflect the experience of only one patient. |
| Mean annual reporting rate (2008 to 2013): 25 per million inhabitants ***. |
| 4. Advisory committee on pharmacovigilance activities in the country |
No exclusive advisory committee to support pharmacovigilance activities. CATEME focuses mainly on efficacy and safety issues in drug registration phase. Detection of post-marketing safety signals is relegated to lower priority. |
| 5. Communications strategy for pharmacovigilance activities |
The review identified risk communication strategies, mainly targeting health and health surveillance activities, such as bulletins, reports, and safety alerts and letters to health professionals. Effective direct communication with citizens is still a challenge. |
| Innovative initiatives have encouraged reporting of ADEs in public health programs such as for TB and viral hepatitis. |
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