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 by detecting, evaluating, understanding and preventing 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 such as professional exposure, exposure
WHAT TO DO IN CASE OF A SUSPECTED ADVERSE REACTION OR SIDE EFFECT TO MEDICINES?
Reporting suspected adverse reactions that occur after authorization of the medicinal product is important to allow continuous monitoring of its benefit/risk balance. If you experience any adverse reactions or side effects with the use of any of our products, please contact your doctor/pharmacist, local health authority or pharmaceutical company to report your experience.
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).
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 to contact the pharmacovigilance service and make a report are:
Tel: +39 3440226822
farmacovigilanza@ibnsavio.it