PHARMACOVIGILANCE

PHARMACOVIGILANCE

Patients are at the center of everything we do at BIRM, we work to provide excellence in medicines. Pharmacovigilance is a system that takes care of the safety information of marketed medicines. It aims to detect, evaluate, understand and prevent adverse drug events.

What are adverse effects?

These are undesirable and unintended responses to the use of a product, i.e., a clinical episode that may manifest with the use of a drug but does NOT necessarily have a causal relationship with this treatment.

Importance of Pharmacovigilance

Before a product is marketed, safety and efficacy evaluations are limited to our experiences in clinical studies. The conditions under which clinical studies are conducted are carefully controlled. These ideal conditions often do not reflect how the product is used in clinical practice after it is marketed. In addition, there are adverse reactions considered rare, which may not appear during studies. For this reason, it is very important that the company maintains a well-structured Pharmacovigilance system.

Who Can Notify?

• Consumer
• Treating physician
• Nurse
• Pharmacist
• Biomedical
• Physiotherapist
• Internal and external customers

What is the Adverse Reaction?

According to the World Health Organization, an adverse reaction is any response to a drug that is harmful, unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or treatment of disease, or for modification of a physiological function.

What to Notify?

Adverse event: any untoward medical occurrence that may be related to the drug.

Adverse reaction: Any harmful or undesirable response, which is necessarily related to a drug/product.

Therapeutic Inefficacy: The absence or reduction of the expected therapeutic response of a drug/product under the conditions shown in prescribed use or package insert (lack of efficacy).

Medication errors:

Any preventable event that may cause or lead to inappropriate medication/product use or cause harm to a patient, e.g. illegible handwriting on prescription, similar medication/product names, distraction, misuse, etc.

How to Notify?

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.