What's pharmacovigilance

Pharmacovigilance is a set of activities aimed to continuously assess all information relating to the safety of drugs and to ensure a favorable risk/benefit profile for the population, concerning all medicinal products authorized for marketing. For this reason, the main pharmacovigilance objective is the identification of the adverse drug reactions (ADR) to drugs.

The safety use of drugs is ensured especially through continuous monitoring of the suspected adverse drug reactions coming from different sources: reports from healthcare professionals or patients, from the scientific literature, from clinical studies.

Pharmacovigilance, therefore, involves whole community at different levels (patients, prescribers, health professionals, pharmaceutical companies, institutions) and reporting of ADRs can be performed by the health care professionals as well as directly by the citizens.

In the Italian Pharmacovigilance System any unexpected event and any side effect occurring during a therapy, whether or not described in the Package Information Leaflet of the drug being used, should be reported promptly to the physician or pharmacist, or directly to the pharmacovigilance responsible of the Local Health Authority unit of pertinence.

If you are not able to consult your doctor or pharmacist, you can fill the report form “Scheda di segnalzione per I cittadini, wether paper or electronic (https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse) and send it to the pharmacovigilance responsible of your Local Health Authority of pertinence.

The list of contact details and e-mail of pharmacovigilance responsibles of Local Health Authorities is available at the following address: https://www.aifa.gov.it/responsabili-farmacovigilanza

Reporting of adverse drug reactions in European countries other than Italy or in non-EU countries may be subject to other law provisions. For this reason, we advise contacting local health professionals in order to follow the correct reporting procedure.