Questions and answers

– I have an adverse reaction to a medicine, what should I do?

You can report this reaction to your doctor or pharmacist who will report it to the Agency’s National Center for Monitoring Adverse Drug Reactions (pharmacovigilance)

– What is pharmacovigilance?

Pharmacovigilance is the process of monitoring, reporting, evaluating, and responding to adverse drug reactions.

– Why are adverse drug reactions monitored?

At the end of a clinical trial of a medicine, frequent adverse reactions are known. After registration, the medicine is marketed when it begins to be used in routine clinical practice on a large number of patients, under far less strict conditions. At that time, we still do not know the overall safety profile of the medicine, that is, information is incomplete or not available at all regarding rare adverse reactions and reactions after long-term exposure, interactions, resistance, potential for medical errors, unapproved use of the medicine, abuse and misuse, use of the medicine in specific categories of patients (children, the elderly, pregnant women, nursing mothers, patients with accompanying diseases: liver, kidney, heart failure, etc.). For the above reasons and as there is a difference between a very precise and organized way of conducting clinical trials and everyday routine clinical practice, knowledge about the safety profile of the medicine is limited and must be expanded. That is why it is of great importance to monitor the safety of all medicines from the moment they are marketed – or pharmacovigilance.