Patients are at the center of everything we do at BIRM. We work to provide excellence in medicines. Pharmacovigilance is a system that monitors the safety of marketed medicines. Its objective is to detect, evaluate, understand and prevent adverse drug-related events.
These are undesirable and unintended responses to the use of a product. That is, a clinical episode that may manifest with the use of a drug, but does NOT necessarily have a causal relationship with this treatment.
Before a product is marketed, safety and efficacy evaluations are limited to our experiences in clinical studies, which are conducted under controlled conditions. These ideal conditions do not necessarily reflect the use of the product in actual clinical practice. In addition, there are rare adverse reactions that may not manifest themselves during studies. Therefore, it is essential that the company maintains a well-structured Pharmacovigilance system.
According to the World Health Organization (WHO), an adverse reaction is any response to a drug that is harmful and unintended, and that occurs at doses normally used in humans for prophylaxis, diagnosis, treatment of disease or modification of physiological functions.
Any preventable event that may cause or lead to the inappropriate use of a drug or product, or that may cause harm to a patient. Examples include: illegible handwriting on the prescription, similar drug or product names, distraction, misuse, among others.
BIRM guarantees the safety of its products and receives spontaneous reports of adverse events from consumers and health professionals. This information is confidential and of great importance to the company.
Notification can be made through:
