Brasão Governo de São Paulo

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Pharmacovigilance

Pharmacovigilance Pharmacovigilance monitor products manufactured by companies, in order to provide information to assess their safety, efficacy and quality
Credit: Butantan Communication

Pharmacovigilance is the set of activities related to the detection, evaluation, understanding, communication and prevention of Adverse Events and problems related to vaccines, antitoxin and antivenoms, and other medicines. Its objective is to monitor these products manufactured by companies, in order to provide information to assess their safety, efficacy and quality.

Here at Instituto Butantan, monitoring is done by receiving and analyzing contacts spontaneously made by users or health services, reporting the occurrence of Adverse Events and other issues related to the use of vaccines, antitoxins and antivenoms produced by Instituto Butantan and that are in use by the public health network.

Such assessment is carried out by Pharmacovigilance professionals and, therefore, it is important to report an Adverse Event.

Reporting must be made as soon as possible, that is, as soon as the adverse event is identified, containing as much information as possible, so that it can be investigated in a competent and timely manner (risk minimization).

All reported Adverse Events will be monitored and followed up by the Pharmacovigilance of Instituto Butantan, following the privacy and safety policy. With the authorization of the rapporteur, the Pharmacovigilance of Instituto Butantan may contact you to request more information.

For information regarding Adverse Events or questions about our products, please contact us.

What is an adverse event?

Any unfavorable medical situation that takes place after the person has received some medication, vaccine, antivenom or antitoxin and that may or may not have triggered the situation.

Other issues

Besides Adverse Events, what are the other main problems related to medications, vaccines, antivenoms and antitoxins?

I. Adverse events due to deviations in the quality of medicines;

II. Use in situations not approved in the package insert (off-label use).

III. Interactions with chemical substances, other medications, alcohol and food;

IV. Lack of efficacy (therapeutic ineffectiveness)

V. Drug-related intoxication;

VI. Prescription drug abuse;

VII. Errors in prescription, dispensing, storage, preparation and use.

Other assessments

  • Unexpected benefits;

  • Accidental exposures in the workplace;

  • Exposures during conception;

  • Exposures during pregnancy;

  • Exposures through breast milk.