When a person takes a drug, such as a vaccine, and has an unwanted reaction, this consequence is called “adverse events” in medicine and by health authorities. In these cases, the orientation is to communicate the episode to the National Health Surveillance Agency (Anvisa).
Notification needs to be made even if there is no suspicion that the discomfort was caused by the medication. According to Anvisa, underreporting can delay the identification of signs of risk and underestimate the magnitude of a problem.
According to the Pharmacovigilance manager, Helaine Capucho, the monitoring carried out by Anvisa is important to assess if the reaction to a product is increasing and if there are problems associated with it. Underreporting can delay the identification of signs of risk and underestimate the scale of a problem.
“Notification is important for us to know the benefit and risk profile of the products, because every product has a risk in its use. so we need [da notificação] when the product is on the market and the benefits continue to outweigh the risks,” explains Helaine.
Communication can be done through the site from Anvisa, by the Vigimed and Notivisa system. There, it is possible to report problems in several products, including medicines and vaccines.
Notifications can be made by physicians and other healthcare professionals, as well as pharmacists and drug users.
Anvisa also provides a telephone number in case it is difficult to send the notification through the website: 0800 642 9782.
On this page, a channel was also created for submitting technical complaints about vaccines against covid-19. The term is used to designate suspected alteration or irregularity in the product in technical and legal aspects, which may or may not cause harm to health.
Examples are changes in color or appearance, a foreign body inside the vaccine vial, suspicion of contamination by microbes, problems with the vial sealing or ampoule breakage, or forgeries.
Unlike the adverse event, the technical complaint is directed to the product, and not to an unwanted effect that has occurred to the patient, in addition to serving as a form of inspection of the quality of vaccines.