Pharmacovigilance
Drug Safety
Pharmacovigilance collects and studies adverse reactions (harmful and unwanted effects resulting from the use of a drug) that may be associated with drug treatment, in order to:
assess their incidence
identify the causal relationship with drug use
identify possible risk factors for the onset of such adverse events
identify possible means of preventing adverse events themselves
When a drug is placed on the market, only the adverse reactions recorded during pre-registration clinical trials are known: such studies are generally conducted on a limited number of patients, belonging to selected categories. Only after its marketing, the drug is administered to a large number of various categories of patients and it is therefore possible to know more thoroughly the benefit/risk ratio related to the use of the drug itself. This is achieved through the systematic collection of adverse events and reactions. Spontaneous reporting by doctors, pharmacists, other healthcare professionals and by patients themselves is, therefore, essential to allow the Health Authorities responsible for Pharmacovigilance activities and Pharmaceutical Companies to define and keep updated the tolerability and safety profile of drugs (benefits versus risks) in real conditions of use.
Adverse Event Report
To report suspected adverse reactions (adverse drug reaction - ADR) by healthcare professionals or citizens, you can connect to the AIFA website (Italian Medicines Agency).
D.M.G. Italia provides the following channels to report an adverse event related to the use of one of our drugs:
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