What is Pharmacovigilance?
The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other problems related to drugs.
What is an adverse reaction?
"An adverse reaction is a harmful and unwanted effect resulting from the use of a medicinal product. In accordance with the directions
- contained in the marketing authorization, medication errors, uses outside the indications
- contained in the marketing authorization, including overdose, misuse, abuse of the product,
- as well as associated with occupational exposure;
What to do if you think you have had an adverse reaction to a drug?
First, contact your doctor, informing him of what happened. In case you want to also report what happened, please follow the instructions below.
In order to increase safety it is extremely important to gather all information about adverse drug reactions and on their inadequate use.
Immediate reporting of suspected adverse reactions can be carried out both by citizens and health workers, through the ministerial forms. Also, for healthcare professionals, the Italian law establishes timings and ways for filing a report with the adequate Pharmacovigilance personnel of Hospitals or of Local Health Authorities.
All these reports will then be inserted by the various health facilities in the national database of adverse reactions to drugs called "National Network of Pharmacovigilance”.
For more insights on Pharmacovigilance:
Communications must be made through a special "Form template for communication of side effects from the citizens" that can be downloaded from the website of the Italian Drug Agency (AIFA) to this address:
The completed and signed form must then be submitted to the Head of Pharmacovigilance of the healthcare facility attended by the signaler. The list updated by the Pharmacovigilance personnel of the various health facilities divided by region can be found at this address:
For more information on Pharmacovigilance
Health Care Professionals
Communications must be made through a special “Reporting Form for suspected adverse reaction" which can be downloaded from the website of the Italian Drug Agency (AIFA) to this address:
The completed and signed form must then be forwarded to the Head of Pharmacovigilance of the healthcare structure attended by the signaler. Pharmacovigilance of different health facilities divided by region can be found at this address:
Tel. +39 06.77209020
Fax +39 06.70474067
Pharmacovigilance activities carried out by Di Renzo S.R.L