PHARMACOVIGILANCE

 

 

The Pharmacovigilance has been defined by the World Health Organisation as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.

What is meant by adverse reaction?

An adverse reaction is a noxious and unintended response to a drug product:
• used according to the directions contained in the marketing authorisation, or

 

• not used according to the directions contained in the marketing authorisation (including overdosage, misuse, abuse, therapeutical mistakes), or

• associated to the exposition due to professional reasons.

How to report an adverse reaction

The spontaneous reporting made by physicians, pharmacists, other healthcare operators and patients is essential to allow the Health Authorities operating on Pharmacovigilance and the Pharmaceutical Companies to define the tolerability and safety profile of medicinal product (benefit/risk ratio) and keep it updated.

The reports of suspected adverse reactions (Adverse Drug Reactions, ADRs) to drugs and vaccines allow the detection of potential alert signals relating to the use of medicines, to make them safer for the benefit of all patients.
The EU pharmacovigilance legislation requires all healthcare professionals and patientsto report any suspected adverse reactions (serious and not serious, known and not known).

You can report a suspected adverse reaction in one of the following ways:

- Online on the AIFA website:

https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse

- filling the reporting form available on the AIFA website:

https://www.aifa.gov.it/en/moduli-segnalazione-reazioni-avverse

and by sending it to the Responsible of Pharmacovigilance of your own facility by e-mail or fax;

- directly to the Marketing Authorization Holder (MAH) of the drug suspected to have caused the adverse reaction.

Please read the information on personal data processing according to EU Regulation 2016/679 for Pharmacovigilance activities before making a report of an adverse reaction.


The contact details for contacting the pharmacovigilance service are:

- Tel: +39 3440226822

- farmacovigilanza@ibnsavio.it