PHARMACOVIGILANCE

 

 

Pharmacovigilance is was defined by the World Health Organization as “Science and activities related to the identification, evaluation, understanding and prevention of adverse reactions or any other problem related to the use of medicines". For the benefit of all Group Companies, the I.B.N. Pharmacovigilance service Savio, made up of personnel with significant experience in the sectors of drugs, medical devices and nutraceutical products, has the final objective of constantly evaluating the tolerability profile of the product. of drugs throughout their period of use, collecting all reports of adverse events, including known ones, potentially associated with the use of a drug.

What is meant by adverse reaction?

An adverse reaction is a harmful and unwanted effect resulting from the use of a medicine:
• in accordance with the indications contained in the marketing authorisation, or

 

• not in accordance with the indications contained in the marketing authorization (including overdose, misuse, abuse, medication errors), or

• associated with the exhibition for professional reasons.

How to report an adverse drug reaction:

Spontaneous reporting by doctors, pharmacists, other healthcare professionals and by patients themselves is essential to allow the Authorities Healthcare departments responsible for health activities of Pharmacovigilance and the Pharmaceutical Companies themselves to define and keep updated the tolerability profile and drug safety (risk/benefit ratio).

Reports of suspected adverse reactions (ADR, Adverse Drug Reaction in English) from drugs and vaccines allow the detection of potential alarm signals relating to the use of medicines as to make them more safe, 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).
< strong>A suspected adverse reaction may be reported by healthcare professionals and/or citizens according to one of the following methods:

- directly online on the AIFA website at:

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

- by filling out the reporting form at the address:

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

and sending it to the Pharmacovigilance Manager of your facility membership registration via e-mail or fax

directly to the Marketing Authorization Holder (AIC) of the medicine 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 the Regulation (EU) 2016/679 for the activity of Pharmacovigilance.
The contact details for contacting the pharmacovigilance service are:

Tel: +39 3440226822
farmacovigilanza@ibnsavio.it