[Somatropin therapy in Italy during 2019-2022: prevalence and incidence rates estimated by data from the national register and regional health sources.].

Introduction: The availability of epidemiological data relating to the therapy with somatropin (recombinant Growth Hormone, rGH) is scarce and mostly limited to specific clinical conditions. In Italy, the National Register of rGH users (Registro nazionale degli assuntori dell'ormone della crescita - Rnaoc) has been established since 2004 as recommended by the Italian medicine agency (Aifa). However, prevalence (P) and incidence (I) estimates in the Italian population are lacking.

Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study.

Background And Objective: Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from coronavirus disease 2019 (COVID-19) vaccine pharmacovigilance systems. Three cohort studies and two self-controlled case series (SCCS) studies evaluating the association between mRNA vaccines and appendicitis reported discordant results. To address this uncertainty, the present study examines in a large population, with a SCCS design, the association between mRNA (BNT162b2 and mRNA-1273) and, for the first time, viral vector (ChAdOx1-S and Ad26.

An algorithm to generate 2D bathymetry of an Alpine river for habitat suitability assessment.

Here we present an original approach to generate 2D high detail riverbed based on a drone photogrammetric survey, and RTK bathymetry measurements for Mera river in the Italian Alps. The aim is to better represent macro-roughness and riverbed structure of the river, also extending it to an ungauged area. Specifically, we apply a step-by-step approach.

Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy.

Background: The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population.

Methods: In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included.

[Protect the experts' work.].

During the most worrying months of the Covid-19 pandemic, Italy's Regions and Autonomous Provinces were classified into four areas distinguished by different colours - red, orange, yellow and white - corresponding to three risk scenarios, thus leading to restrictive measures of varying degrees. The Public Prosecutor's Office of the Court of Bergamo - one of the cities hardest hit by the health emergency - has closed an initial investigation claiming that the failure to establish the red zone caused the epidemic to spread to a valley in Lombardy with a significant increase in avoidable mortality if the restrictive measures had been put in place in time. The accusation is an opportunity to consider the role of experts and the risks of error in the decision-making process.

The timelines for the price and reimbursement authorization in Italy 2018-2020.

Objective: This investigation aimed to guarantee the principles of transparency in public administration; to inform citizens about the time to patient access to reimbursed medicines; to assess the duration of the P&R process for the first time in the period 2018-2020; and to evaluate whether and how the SARS-CoV-2 (COVID-19) pandemic affected the P&R activity. This study analyzed the timelines of pricing and reimbursement procedures submitted in Italy by the pharmaceutical marketing authorization holder (MAH) from 2018 to 2020.

Methods: The analysis was run through an AIFA web-based platform that collects data about P&R procedures for each step of the Italian Price and Reimbursement (P&R) procedure, including dates of the Technical Scientific Committee (CTS) and Price and Reimbursement Committee (CPR) meetings from January 2018 to December 2020.

Dynamics of price competition in Italian pharmaceutical off-patent market.

Introduction: The aim of the study was to evaluate, in a regulated generics market, the effect of the number of manufacturers of generic drugs on the amplitude of off-patent products price reduction and the price evolution of originators and generics after the patent expiry of pharmaceuticals dispensed by community pharmacies and reimbursed by the Italian National Health Service (INHS).

Methods: The AIFA "transparency list" was utilized to select unbranded and branded off-patent drug dispensed by community pharmacies and reimbursed by the Italian National Health Service between 2012 and 2018. The unbranded drug entry in the transparency list database was considered as a proxy of its patent expiry.

Effect of Fluoroquinolone Use in Primary Care on the Development and Gradual Decay of Resistance to Fluoroquinolones: A Matched Case-Control Study.

The reversibility of bacterial resistance to antibiotics is poorly understood. Therefore, the aim of this study was to determine, over a period of five years, the effect of fluoroquinolone (FQ) use in primary care on the development and gradual decay of Escherichia coli resistance to FQ. In this matched case−control study, we linked three sources of secondary data of the Health Service of the Autonomous Province of Bolzano, Italy.

[Scientific rigor and attention to values. Memory of Alessandro Liberati.].

The author describes the personality of Alessandro Liberati - an Italian doctor and researcher - ten years after his death: a competent, kind person with a good sense of humor. The take-home message is that it is worth engaging in the institutions in which we work throughout our lives and that the improvement of individual health conditions and public health go through daily work capable of combining values and the best scientific evidence available.

[Medicines use in Italy. 2020 OsMed National Report.].

The 2020 National Report "Medicines use in Italy", produced by the National Observatory on the Use of Medicines (OsMed) of the Italian Medicines Agency (AIFA), describes the Italian pharmaceutical assistance through different available information flows that allow to recompose pharmaceutical territorial and hospital assistance, concerning both the national health service and private citizens. In the Report the results of numerous analyzes, both general and focused on specific therapeutic categories and classes, relating to pharmaceutical expenditure and consumption, are reported, but it is also present an in-depth analysis about monitoring registries and conditional reimbursement agreements, and a comparison between the most relevant Italian data and those of nine other European countries.

Impact of Prior Antibiotic Use in Primary Care on Resistance to Third Generation Cephalosporins: A Case-Control Study.

Research is lacking on the reversibility of antimicrobial resistance (AMR). Thus, we aimed to determine the influence of previous antibiotic use on the development and decay over time of third generation cephalosporin (3GC)-resistance of . Using the database of hospital laboratories of the Autonomous Province of Bolzano/Bozen (Italy), anonymously linked to the database of outpatient pharmaceutical prescriptions and the hospital discharge record database, this matched case-control study was conducted including as cases all those who have had a positive culture from any site for 3GC resistant (3GCREC) during a 2016 hospital stay.

Safety of switching between rituximab biosimilars in onco-hematology.

Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy).

Comparison of Demand for Drugs Used for COVID-19 Treatment and Other Drugs During the Early Phase of the COVID-19 Pandemic in Italy.

This cross-sectional study compares demand for drugs for treatment of coronavirus disease 2019 (COVID-19) between the period directly before the COVID-19 outbreak in Italy and the early period of the outbreak.

Turmeric (Curcuma longa L.) food supplements and hepatotoxicity: an integrated evaluation approach.

Introduction: Turmeric is the common name for the rhizome of Curcuma longa L. In the recent years, food supplements containing turmeric have been marketed and widely used by an increasing number of consumers. Spontaneous reports of suspected adverse reactions to food supplements are collected within the Phytovigilance system.

Involvement of the exocrine pancreas during COVID-19 infection and possible pathogenetic hypothesis: a concise review.

The gastrointestinal system may be affected by COVID-19 infection with an incidence variable from 3% up to 79%. Several works show that the pancreas, both in its exocrine and endocrine function, can be affected by this viral infection, although this organ has been poorly analyzed in this current epidemic context. This mini-review aims to provide a summary of available studies on exocrine pancreas involvement during COVID-19 infection.

Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy.

Objective: To investigate whether the prices of new anticancer drugs correlated with their relative benefit despite negotiation.

Design: Retrospective cross-sectional study correlating new anticancer drugs prices with clinical outcomes.

Setting: We did a retrospective cross-sectional study including all new anticancer drugs approved by the European Medicines Agency (EMA) (2010-2016) and reimbursed in Italy.

In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study.

Background And Objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15-20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009-2015.

Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009-2015.

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

Introduction: Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients.

Objective: The objective of this study was to evaluate the effectiveness and safety of switching versus non-switching and of switching from originator/biosimilar epoetin alpha (ESA α) to any other epoetin in CKD patients.

Comparative Effectiveness of Two Tiotropium Formulations: A Retrospective Cohort Study.

The effectiveness of the tiotropium Respimat formulation in routine clinical practice is still an open issue due to concern about the generalizability of the Tiotropium Safety and Performance in Respimat (TIOSPIR) trial findings. Our aim was to compare the incidence of acute respiratory events between new users of tiotropium Respimat and HandiHaler. The study population comprised patients aged ≥45 years resident in two Italian regions who received a first tiotropium prescription (HandiHaler or Respimat) between 1 July 2011 and 30 November 2013.