Pharmacovigilance

What is Pharmacovigilance?

Pharmacovigilance is the set of activities aimed at collecting, processing, and providing information on the safety of drugs, with the aim of protecting the patient from potential risks related to the use of a medicine.

Pharmacovigilance continuously evaluates the risk-benefit ratio of drugs in order to provide the Competent Authorities, doctors, pharmacists, and patients with complete and up-to-date information on the safety profile of drugs. 

Reporting Adverse Reactions/Side Effects in Italy

Information for pharmacovigilance activities, as they allow for the detection of potential signals of attention and/or alarm.

In compliance with current legislation, Pharmacovigilance collects and analyzes reports of adverse events and adverse reactions. 

Adverse Event: Any unfavorable and unintended medical event (sign, symptom, or disease) that may occur during treatment with a medicine, but which does not necessarily have a causal relationship with the medicine itself.

Adverse Reaction: A harmful and unintended response to a medicine, for which it is reasonable to hypothesize a causal relationship between medicine and adverse event. 

Adverse reactions may result from the use of the product in accordance with or in violation of the terms of the marketing authorization (MA), or from occupational exposure. Improper use includes the use of the drug in all conditions not provided for in the MA, overdose, misuse, abuse, and therapeutic errors. Other conditions that require specific reporting are the transmission of infectious agents through the drug, use during pregnancy and breastfeeding, lack of efficacy, drug interactions, addiction.

In Italy, the authority responsible for Pharmacovigilance is the Italian Medicines Agency (AIFA), which offers services and constant updates on its website https://www.aifa.gov.it/.

Reports of adverse reactions can be made by doctors, healthcare workers, and citizens, according to the methods reported on the AIFA website, while the forms for reporting adverse reactions (for healthcare workers or citizens) are available in the "Forms" section at the following link: https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse. 

The report can be communicated to the Marketing Authorization Holder of the medicine suspected of having caused the adverse reaction. Doctors, healthcare workers, or citizens who wish to report an adverse reaction to S&R Farmaceutici can do so through the pharmacovigilance agency Di Renzo Regulatory Affairs, at +39 06.77209020 or at pharmacovigilance@direnzo.biz.

Please remember that any health problems should be reported first and foremost by patients to their doctor or the nearest healthcare facility.