Pharmacovigilance

Pharmacovigilance is a science and a set of activities related to the identification, evaluation, understanding, and prevention of adverse effects or problems associated with the use of medications. It aims to ensure that the benefits of medications outweigh the risks by monitoring adverse events after registration, when the medication begins to be used in the real-life population. An adverse event is an undesirable, unintended medical occurrence temporally related to the use of a medication, which may include signs, symptoms, or diseases. Pharmacovigilance addresses adverse reactions, quality problems, therapeutic ineffectiveness, medication errors, off-label use, abuse, poisoning, and drug interactions.

The main work processes of pharmacovigilance area at Anvisa include:

- Analysis of Risk Management Plans (RMP)

- Analysis of Periodic Benefit-Risk Evaluation Reports (PBRER)

- Receipt and analysis of notifications of suspected adverse events related to medications and vaccines

- Risk communication

- Inspection of good pharmacovigilance practices

The reporting of adverse events related to medications and vaccines must be done through VigiMed. Adverse events related to medications and vaccines must be reported, that is, any undesirable medical occurrence in which a medication or vaccine has been administered, even without certainty that the occurrence was caused by the treatment.

The National Center for Drug Monitoring (CNMM), established in May 2001 by Ordinance No. 696 of the Ministry of Health, is based at Anvisa, specifically in the Pharmacovigilance Management, and represents Brazil in the International Drug Monitoring Program (PIMM) of the World Health Organization (WHO).

The PIMM was established by WHO in 1968 to enable the rapid dissemination of information about adverse drug events, especially events related to new or less-studied medications. The goal of the CNMM in Brazil is to early identify a new adverse event or expand the knowledge of a poorly described adverse event that may have a causal relationship with the medications and vaccines marketed in the country.

The notifications received through VigiMed are evaluated by Anvisa, and the anonymized data (without the identification of the reporters) are forwarded to WHO. Therefore, by sending a notification to the Agency, citizens, healthcare professionals, or holders of medication registration contribute to the detection of signals worldwide.

The legislation related to pharmacovigilance can be found at this page.