Italian Medicines Agency Agenzia Italiana del Farmaco

Antibiotic medicinal products


Antibiotics are a group of medicines that can, with different mechanisms of action, prevent the development of bacteria. They are therefore essential for the treatment of bacterial infections. Since their introduction, antibiotics have contributed significantly to population health improvement. These medicines should be used only under prescription of a physicians and it is essential that they are taken for as long as necessary and at prescribed doses exclusively for the treatment of bacterial infections. Conversely, their use is inappropriate for the treatment of diseases caused by other infectious agents (viruses, fungi, protozoa), unless there is a risk identified by a specialist of complications due to overlapping bacterial infections.

Unfortunately, their excessive and inappropriate use in humans and animals is contributing dramatically to accelerating the phenomenon of antibiotic resistance, the natural process by which bacteria become resistant to those antibiotics that were once able to defeat them. These bacteria many humans and the infections they cause are harder to treat.

Bacterial resistance and in particular multi-resistance (resistance of a bacterium to 4 or more medicines belonging to different classes of antibiotics) is a global public health concern, as it results in increased mortality, prolonged hospital stays and high healthcare costs.

A recent study by the European Centre for Disease Prevention and Control (ECDC) reports that in 2015, in the European Union and the European Economic Area, there were 671,689 cases of infection due to antibiotic-resistant bacteria, estimated to cause 33,110 deaths, one third of which occurred in Italy, highlighting the seriousness of the problem in our country.

The study also revelas that antibiotic-resistant infections are widespread across all population groups, but mostly affect extreme age groups. These antibiotic-resistant infections were associated in 75 % of with healthcare, confirming the need to intervene through law enforcement especially in treatment environments.

Data compiled by ECDC networks, the European Antimicrobial Resistance Surveillance Network (EARS-Net) and the European Surveillance of Antimicrobial Consumption Network (ESAC-Net), which provide reference data on antimicrobial resistance and consumption in the European Union, also confirm the seriousness of the threat of antibiotic resistance in Europe, calling for urgent and effective measures.

Italy is among the European countries with the highest consumption (although the tremd has been decreasing in recent years) and with the highest rates of resistance and multi-resistance.

The increase in resistance, encouraged by misuse and abuse of antibiotics, can only be effectively tackled through a global approach – one health – promoting interventions aimed at responsible use of these medicines in all areas.

Strategies for control and prevention of antibiotic resistance require coordination at European and global level, but also national plans adapted to local conditions. For this reason, Italy has adopted a first National Action Plan on Antimicrobial Resistance (PNCAR) 2017-2020 which, in line with WHO’s indications, provides for, among others, the implementation of a surveillance system of antibiotic consumption both in human and in veterinary fields.

The “National report on antibiotic use in Italy 2017”, which provides data on consumption and expenditure of this category of medicine at national and regional level, is made available in this Section, as a contribution to monitoring activities provided for in the PNCAR.

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