The Italian Medicines Agency (Agenzia Italiana del Farmaco in Italian, NdT) has recently updated the ways to report suspicious adverse reactions to medicines (ADR). In order to do this, healthcare professionals and citizens can visit this website (www.vigifarmaco.it) and send a report.
Before being placed on the market, a medicine undergoes a series of preclinical and clinical tests in order to get its own efficacy and safety certified. However, these studies involve a small number of patients (that are often neither children nor elderly people) and last for a relatively short amount of time, that is to say less than two years. In addition to this, they don’t take into consideration those patients who suffer from underlying diseases and use more than one medication. New medicines may be taken off the market after the discovery of adverse reactions to them.
How does the report work?
If you notice side effects after having taken a medication, you should go to your physician or pharmacist. On this website (www.vigifarmaco.it) you may report the adverse reaction, be it severe or not, be it known (and so printed on the package leaflet) or not.
Voluntary reports by healthcare professionals, patients and pharmaceutical companies alike are paramount to pinpoint adverse reactions to medicines. In fact, the package leaflet gathers the known side effects, but some adverse reactions may still be unknown. The issues reported by users are analyzed by regulatory agencies, such as AIFA (Italian Medicines Agency) in Italy. If necessary, further warnings will be added to the package leaflet, updating and completing the information about the medication.
Reports are important because they make medications safer and help other patients. However, in order to issue a report you have to observe the time limits required by the Health Ministry decree of April 30, 2015: within two days for medications and within 36 hours for biological medicinal products and vaccines.
