PHARMACOVIGILANCE

 

 

What is Pharmacovigilance?

Pharmacovigilance is the set of activities aimed at continuously evaluating all information relating to the safety of medicines in order to ensure that, for all medicines, there is a favorable benefit/risk ratio for the population. 

In line with this general definition, the main objectives of Pharmacovigilance are:

• Promote and protect public health by improving the use of medicines through the detection, evaluation, understanding and prevention of side effects or any other problems related to the medicine.
• Promote the safe and effective use of medicines through timely communication of medicine safety information to healthcare professionals, patients and the public.

What is an adverse reaction?

An Adverse Reaction is a harmful and unintentional response following the use of a medicine.
Adverse Reactions may arise from authorized or unauthorized use of the medicine.

Particular situations are also of interest for pharmacovigilance

such as professional exposure, exposure during pregnancy and breastfeeding, lack of efficacy, overdose, off-label use (use of the medicine for unauthorized indications), abuse, improper use and therapeutic errors, falsified medicines, elderly and pediatric populations.

What to do in case of suspected adverse reactions or side effect to medicine?

Spontaneous reporting by doctors, pharmacists, other healthcare workers and by the patients themselves is essential to allow the Health Authorities responsible for Pharmacovigilance activities and the Pharmaceutical Companies themselves to define and keep the tolerability and safety profile of drugs updated ( risk/benefit ratio).
Reports of suspected adverse drug reactions (ADR) allow us to detect potential warning signs relating to the use of medicines so as to make them safer, for the benefit of all patients.
European legislation on pharmacovigilance requires all healthcare professionals and citizens to report any suspected adverse reaction (serious and non-serious, known and unknown) and any particular situation of exposure to the medicine.
A suspected adverse reaction can be reported by healthcare professionals and/or citizens in one of the following ways:
- directly online on the AIFA website at the address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

- by filling out the reporting form at the address:
https://www.aifa.gov.it/web/guest/moduli-segnalazione-reazioni-avverse
and sending it to the Pharmacovigilance Manager of your institution via e-mail or fax
- directly to the Marketing Authorization Holder (AIC) of the medicinal product suspected of having caused the adverse reaction.
Before reporting an adverse reaction, we invite you to read the information on the processing of personal data pursuant to Regulation (EU) 2016/679 for Pharmacovigilance activities.
The contact details to contact the pharmacovigilance service and make a report are:

Tel: +39 3289215572

farmacovigilanza@ibnsavio.it