Epidemiologia & Prevenzione最新文献

Background: twenty years after the last review of the European Union (EU) pharmaceutical legislation, the pharmaceutical sector has significantly changed and become more globalised. Unmet medical needs and unequal access to innovative treatments persist. In addition, there is a growing awareness of the need for developing new antibiotics and a rational use of existing ones. In this context, in 2020 the European Commission proposed a new pharmaceutical strategy for Europe aiming to ensure equitable access to effective and safe medicines while strengthening the competitiveness of the sector globally. In line with this strategy, the Commission itself proposed a comprehensive reform of the pharmaceutical legislation in 2023, which was later amended by the European Parliament.

Objectives: to analyse some of the main proposals for changes to the current regulatory framework and discuss their impact on European pharmaceutical policies and public health.

Design: analysis of the current regulatory context on medicines and comparison with the main proposals of the European Commission and Parliament.

Results: among the most significant reform proposals are: 1. the changes to data and market protection with the creation of a system of incentives to support innovation, promoting the development of safe and effective medicines and their access to patients, and making the EU attractive to the pharmaceutical companies; 2. the set of measures to incentivise the development of new antimicrobials and control antimicrobial resistance; 3. the measures aimed at increasing the transparency of the European Medicines Agency.

Conclusions: this critical and independent analysis of the current draft reform of the pharmaceutical legislation shows important novelties that could deeply transform the current European regulatory framework of the pharmaceutical sector, highlighting some critical issues regarding the significance and effectiveness of some proposals. Once the entire legislative process has been completed, it will be possible to witness the implementation of the reform in its final version, which will require an assessment of its real impact.

The respiratory syncytial virus causes numerous respiratory infections in children, with particularly severe manifestations during the first months of life, especially in premature infants or those with pre-existing clinical conditions.In Italy, the introduction of nirsevimab, a monoclonal antibody that is more practical and potentially usable in a broader population compared to the previous palivizumab, has highlighted several critical issues in the management of the prevention system. Initially, the manufacturer proposed the drug under category C, making it fully paid by patients. Subsequently, the company began direct negotiations with regional authorities, which independently planned the administration of the drug at no cost to patients, adopting differing and inconsistent approaches to preventive immunoprophylaxis programmes.Difficulties worsened when a statement from the Italian Ministry of Health clarified that regions undergoing financial recovery plans could not guarantee the administration of nirsevimab, as the treatment was excluded from the essential levels of care. The public and media uproar surrounding this exclusion prompted institutions to find a rapid solution. A national agreement was reached, allocating funds for an immunization campaign covering approximately 75% of newborns, corresponding to the availability guaranteed by the manufacturer. Additionally, a solidarity distribution mechanism was introduced, allowing up to 20% of doses to be shared among regions to protect the most vulnerable individuals.Despite the campaign started with the onset of the epidemic season, challenges persist in organizing procurement processes and managing immunoprophylaxis operations, resulting in significant disparities in implementation across regions.The nirsevimab case underscores the urgency of a nationally coordinated and shared strategy among central institutions, regional authorities, and other stakeholders to ensure equity and effectiveness in prevention policies, especially in light of upcoming regional autonomies.

Background: although there is an overabundance of terms that over time have connoted the phenomenon usually defined as Alcoholism, or Alcohol Dependence, this has been universally considered a unitary disease by experts, the media and lay people.

Objectives: to investigate whether there is a variety of configurations of alcohol dependence and alcohol abuse corresponding to different countries.

Design: secondary analysis of a dataset from a European project conducted in 2013-2014. The analysis was carried out mainly based on both artificial intelligence and statistical tools: Self Organizing Map (SOM) Neural Network, Multidimensional Scaling Population Algorithm (MSPA), and K-Means clustering algorithm.

Setting and participants: 1,767 participants in a European project treated in specialist alcohol dependence units in 9 countries/regions of Europe.

Main outcome measures: patients were interviewed to ascertain their correspondence to the 11 DSM-4 symptoms used for the diagnosis of 'alcohol dependence' and 'alcohol abuse', following up on a previous study that used traditional statistical methodology.

Results: results confirm that the symptoms of 'alcohol dependence' and 'alcohol abuse' identified by the DSM-4 are distributed according to distinct European geographical macroareas: Central-Northern and Southern, with an intermediate macroarea. These could partly correspond to different typologies of drinking cultures in the different macroareas.

Conclusions: alcoholism does not appear to be a unitary disease, but varies according to different cultures and social contexts, and should be treated appropriately.

The course "Climactions-URBAN HEALTH", dedicated to all professions related to the national health service, aimed to raise awareness among healthcare professionals about the risks to human health associated with climate change through an online tool. The course was created to promote training as a means of implementing adaptation and mitigation strategies for climate change. It is an online Continuing Medical Education (CME) course developed on the e-learning platform of the Italian National Health Institute (Istituto Superiore di Sanità - ISS). This course was directed and scientifically coordinated by the Ecosystem and Health Unit (ISS), in collaboration with the Department of Epidemiology of the Latium Region, and technically coordinated by the Training Office (ISS).The course attracted 25,000 participants, reaching the maximum limit available on the platform.The high number of participants who completed the course, their positive feedback on the course, the different professional categories to which they belong, and their diverse origins across the country serve as indicators of the effectiveness of distance learning, demonstrating it as a valid tool for promoting climate change adaptation and mitigation strategies for professionals within the Italian National Health Service and the Italian National Health System for Prevention.

Objectives: to identify environmental, socioeconomic, and territorial characteristics in five urban areas (Turin, Bologna, Rome, Bari, Palermo) and to identify areas characterized by high environmental and socioeconomic vulnerability.

Design: geographical study.

Setting and participants: study domain on five Italian cities, each city was characterized at the urban-area level.

Main outcome measures: for each urban area or neighbourhood, multiple spatial indicators were constructed concerning the main environmental (air pollution, urbanisation, temperature, altitude and presence of rivers and watercourses, greenery, road and rail networks), and socioeconomic (deprivation index) aspects. These characteristics have been synthesised into a composite indicator with a geographically weighted principal component analysis in order to characterise environmental and socioeconomic vulnerability in a single measure that can be more easily interpreted compared to a set of individual indicators.

Results: the involved cities have numerous databases suitable for mapping the main environmental and socioeconomic characteristics. Turin is the most populous of these cities and the one which has the highest average daily PM10 value (29.7±1.4 µg/m3). Together with Palermo, it is the city with the highest density of local roads. Data on residential land cover show a South-North gradient, from 50% in Palermo and Bari to 24,5% in Rome. Low-density residential areas prevail in all cities. The synthetic value of the indicator captures the spatial variability of the territory, highlighting the areas of greatest urban vulnerability in each city under study. Bologna and Roma are the cities with the highest percentage of residents in the high environmental, climate, and socioeconomic vulnerability level, respectively 38% and 29%, while Bari and Palermo show the highest fraction of population living in low vulnerability areas.

Conclusions: in this study, five Italian cities were characterised from an environmental, socioeconomic, and spatial perspective. Furthermore, through the use of a synthetic indicator of socioeconomic environmental exposure, the most vulnerable areas were identified. This indicator provides immediate and effective information to support policies to protect health and combat environmental and social risk factors in the area.

Background: Lombardy Region (RL) is organized into 8 Health Protection Agencies (ATS) and 86 Districts, which are responsible for organizing and coordinating territorial health care for reference population ranging between 80,000 and 120,000 inhabitants. RL has implemented the Health Profiles Portal, an advanced system that integrates health care, socio-health, and social data to provide a clear and comparable view of the population's needs at different territorial levels. To develop the portal, it was necessary to construct denominators that would ensure the accuracy and comparability of the healthcare indicators.

Objectives: to compare three different methods for constructing population denominators: two based on Regional Registries (NAR) and one on the Italian National Institute of Statistics (Istat) data.

Methods: the first denominator (NAR_portale) used for the portal was constructed from all monthly extractions of NAR in 2023 collected by the ATSs; the second denominator (NAR_202401) was based on the assisted population as of January 2024, including those who died in 2023; the third denominator (ISTAT_202401) was based on Istat population data as of 01.01.2024. Comparisons, expressed as percentage variations (VP) relative to NAR_portale, were carried out at both the ATS and District levels, with separate analyses by gender, age, nationality, and residence in nursing homes (RSA).  Results: overall, NAR_portale identified a population of 10,111,769 residents, NAR_202401 recorded 10,106,191 subjects (VP 0.05%), and ISTAT_202401 recoded 10,012,054 (VP 0.99%). Greater variability was observed at the ATS level, whereas districts within the same ATS exhibited more homogeneous trends. The largest VPs were observed in the extreme age groups (0-1 and 85+ years), among foreign citizens, and among RSA residents.

Conclusions: the differences between denominators highlight the complexity of constructing reference populations for health monitoring. NAR_portale provides greater dynamism and completeness, but efforts are needed to standardise and ensure comparability with other sources. In the future, the integration of different data sources and the use of advanced methodologies could improve monitoring quality and support more effective healthcare planning.