The document summarises the data from the Registers and the activities conducted during the pandemic.

During the pandemic emergency, AIFA conducted national and regional monitoring of the use of antiviral drugs and monoclonal antibodies used for COVID-19. The data and monitoring activities covering a time interval of 964 days (i.e. 2.6 years) are described in the report published on the Agency's website.

During this period, over 100 periodic videoconferences were coordinated with the Regions, and 157 statistical analyses were produced from the data collected in the AIFA register platform through 11 monitoring registers implemented during the pandemic (each register is given by the drug-therapeutic indication combination; in chronological order of online release: remdesivir, bamlanivimab, bamlanivimab+etesevimab, casirivimab+imdevimab both in the early and hospital setting, sotrovimab, remdesivir in the early setting, molnupiravir, nirmatrelvir+ritonavir, tixagemivab+cilgavimab and tixagemivab+cilgavimab in prophylaxis) . At the same time, during the pandemic, 114 reports on the trend in the use of medicines for COVID-19 were published on the AIFA portal.

The monitoring data were used to inform the Ministry of Health and the Commissioner's Structure for the COVID-19 emergency on the trend in the use of these medicines in relation to the evolution of the pandemic situation at national level and in the individual Regions. The data and analyses were also used in order to optimise the stocks reported by the various Regions, displacing them towards those Regions with the greatest consumption, i.e. minimising any conditions of localised shortage of products.

Lastly, on the basis of the data from the AIFA monitoring register platform, four articles were published in prestigious international scientific journals on the impact of the COVID-19 pandemic and the outcomes of the use of antiviral drugs in clinical practice.

The summary report describes: 

• the regulatory reference framework for medicines, which lists the AIFA provisions issued during the pandemic and the related links to the press releases, which concerned the establishment or modification of the mandatory monitoring required for these medicines, as well as any suspension or withdrawal;
• the historical series of the number of patients started for treatment with each active ingredient during the COVID-19 pandemic, displayed in conjunction with the data relating to the number of positive cases recorded by the National Health Institute;
• the summary picture on a regional basis of the total number of treatments initiated over the entire monitoring period;
• the summary picture of the number of treatments per capita referring to the resident population in each Region, initiated over the entire monitoring period;
• the summary picture of the number of treatments per capita referring to the total number of positive cases for each Region, initiated over the entire monitoring period.

It should be noted that the management of medicines for COVID-19 in the various Regions has had to adapt according to the regulatory decisions adopted over time, the organisational factors of healthcare in the individual Regions, the availability of products, the methods of distribution and dispensing of medicines to patients and the evolution of the SARS-Cov-2 variants over time. Therefore, the report could combine different management methods that could have arisen in the individual Regions during the pandemic and for which reference should be made to the weekly reports published periodically on the AIFA website.

Published on: 28 July 2023