Pharmacovigilance

What is pharmacovigilance?
Pharmacovigilance is the set of activities aimed at collecting, processing and providing information on the safety of medicines, with the aim of protecting the patient from potential risks related to the use of a medicine.
Pharmacovigilance continuously assesses the risk/benefit ratio of medicines in order to provide Competent Authorities, doctors, pharmacists and patients with complete and up-to-date information on the safety profile of medicines.

Adverse reaction/side effect reporting in Italy
Reports of suspected adverse reactions/side effects are an important source of information for pharmacovigilance activities, as they allow the detection of potential signals of attention and/or alarm.
In accordance with current legislation, Pharmacovigilance collects and analyses reports of adverse reactions/side effects.
Adverse reactions/side effects may result from a correct or inappropriate use of the product compared to the terms of the marketing authorisation (MA), or from occupational exposure. Inappropriate use includes the use of the drug in any condition not covered by the MA, that are overdose, misuse, abuse and medication errors. Other conditions requiring specific reporting are transmission of infectious agents via the drug, use during pregnancy and lactation, lack of efficacy, drug interactions, drug dependence.
In Italy, the authority responsible for pharmacovigilance is the Agenzia Italiana del Farmaco (AIFA), which offers constant services and updates on its website (www.agenziafarmaco.gov.it).
Reports of adverse reactions can be made by doctors, healthcare professionals and citizens, according to the procedures reported on the AIFA website www.aifa.gov.it/content/segnalazioni-reazioni-avverse, otherwise it is possible to report directly online at www.vigifarmaco.it following the appropriate procedure.
Alternatively, the report can be communicated to the owner of the medicine suspected of causing the adverse reaction. Physicians, healthcare professionals or members of the public who wish to report an adverse reaction to Laboratori Baldacci SpA can do so by emailing infoeu@baldaccilab.com.
We remind you that any health problem should be reported in the first instance by patients to their own physician or to the nearest local Health Authority.