Pharmacovigilance

THE SAFETY OF DRUGS FOR GUIDOTTI

Guidotti monitors the safety of a drug even after it’s marketed, from the time a drug is prescribed by the physicians up to the time it’s used by the patient (and even later).

This monitoring is done through an essential instrument, Pharmacovigilance, which takes care of identifying, evaluating, understanding and preventing any type of any safety problem related to a drug.

In the Menarini Group, the Pharmacovigilance Department consists of more than 200 people, graduated in scientific disciplines in the majority of cases, often physicians.

Pharmacovigilance collects (through reports, literature etc.), all possible information about any problem related to a drug, identified as possible adverse reactions. This is done for all the drugs marketed by Menarini worldwide.

These reports can be made, in addition to the competent Health Authority, also to the Company, both by healthcare operators (physicians, nurses, pharmacists) or by the patients themselves (or those acting on their behalf). Healthcare professionals and patients are, in fact, an integral part of this monitoring system.

To give an example

1 - The patient has a problem related to a drug.

2 - The patient, in addition to the competent Health Authority and/or the Company, may report it to their treating physician, who in turn must forward the issue to the competent Health Authority and, if necessary, also directly contact the Company.

3 - Every report that arrives in Guidotti is promptly handled by the Pharmacovigilance Department and entered in company database, directly connected with the database of the European Medicines Agency (EMA).

4 - All the information contained in this database is constantly analysed in order to identify and prevent any problems that may occur related to a drug.

We do all this to safeguard the patient’s health and safety.