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Pharmacovigilance
What pharmacovigilance is
Pharmacovigilance comprises various activities aimed at continuously assessing any relevant information concerning the safety of drugs and to ensure, for all medicinal products authorised for marketing, a favourable risk-benefit ratio for the population. To do this, the main objective of pharmacovigilance consists of identifying adverse drug reactions (ADR).
What is an adverse drug reaction?
An adverse reaction is a harmful and unwanted effect following the use of a medicinal product:
- in accordance with the indications contained in the marketing authorisation,
- with therapeutic errors,
- for uses not in line with the indications contained in the marketing authorisation, including overdose, misuse or abuse,
- associated with exposure for professional reasons.
The safety of use of the drugs is ensured mainly through the continuous monitoring of reports of suspected adverse reactions from different sources: reports from health professionals or patients, scientific literature and clinical studies. Pharmacovigilance therefore involves the whole community at different levels (patients, prescribers, healthcare providers, pharmaceutical companies and institutions) and reporting can be done not only by the healthcare provider but also, directly, by citizens.
Reporting suspected adverse reactions in Italy
In the Italian Pharmacovigilance System, any incident and any side effect which arises in the course of treatment, indicated or not in the package leaflet of the drug in use, must be reported immediately to your doctor or pharmacist or directly to the person responsible for pharmacovigilance at the competent Local Health Authority (ASL).
If you are not in a condition to directly consult health personnel, please complete the reporting form for citizens, in paper or electronic format that can be found at the following address:
and send it to the person responsible for pharmacovigilance at the competent ASL.
The list with references and email contacts of those responsible for pharmacovigilance at the ASLs is available at the following address:
