The Italian Medicines Agency recently updated the reporting of suspected adverse reactions to medicinal products (ADR). To do this, healthcare professionals and citizens can connect to and report online.

Before being placed on the market, a drug undergoes preclinical and clinical trials, with the aim of assessing its efficacy and safety. However, these studies involve a small number of patients (and often children and the elderly are excluded) and have a relatively short duration of less than two years. Patients with concomitant pathologies and/or multiple drug therapies are not considered. Therefore, new medicines may be withdrawn from the market following subsequent identification of adverse reactions.


How does the report work?

If you notice side effects after taking a medication, talk to your doctor or pharmacist. Through the website it is possible to report the adverse reaction, whether serious or not, whether recognized (and therefore present on the package leaflet) or not.

Spontaneous reporting by healthcare professionals, patients and pharmaceutical industries is essential to detect adverse reactions. The leaflet contains known side effects, but some reactions may not yet be recognized. The various reports are taken into account and analyzed by the regulatory agencies; in Italy, AIFA, the Italian Medicines Agency, takes care of them, and if necessary further warnings will be included in the package leaflet, thus making the information on the drug complete and updated.

Reporting is therefore important because it makes medicines safer and helps other patients. For reporting, however, it is necessary to comply with the time limits set forth in the Ministry of Health Decree of 30 April 2015: within two days for drugs and within 36 hours for biological medicinal products and vaccines.