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Article ; Online: The use of medications approved for alcohol use disorders in Italy.

Fortinguerra, Filomena / Pierantozzi, Andrea / Trotta, Francesco

2023 Volume 11, Page(s) 1110435

Abstract: Background: Italy has the highest per capita alcohol consumption among European countries. Several pharmacological treatments for alcohol use disorders (AUDs) are currently available in Italy, but no consumption data are available. A first analysis of ... ...

Abstract	Background: Italy has the highest per capita alcohol consumption among European countries. Several pharmacological treatments for alcohol use disorders (AUDs) are currently available in Italy, but no consumption data are available. A first analysis of national drug consumption, comprising the whole Italian population over a long-term period covering the COVID-19 pandemic, was performed. Methods: To analyze the consumption of medications indicated for therapy of alcohol dependence, different national data sources were used. Consumption was measured as a defined daily dose (DDD) per 1,000,000 inhabitants per day. Results: In 2020, the total consumption of medicines used in the treatment of AUDs amounted to 310.3 DDD per 1 million inhabitants per day (0.018% of the overall drug consumption in Italy) with a decreasing gradient from the north (373.9 DDD) to the south (250.7 DDD). 53.2% of the overall doses were dispensed by public healthcare facilities and 23.5% by community pharmacies, while the remaining 23.3% were purchased privately. The temporal trend of consumption seemed to be stable across the last few years, although an impact of the COVID-19 pandemic was observed. Disulfiram was the most consumed medicine over years. Conclusion: All Italian regions offer pharmacological treatments to patients with AUDs, but differences in the number of dispensed doses suggest a different local organization of patient care, which can be partly explained by the different severity of the clinical condition of residing patients. Pharmacotherapy of alcoholism should be deeply investigated to describe the clinical characteristics of treated patients (i.e., comorbidities) and evaluate the appropriateness of prescribed medications.
MeSH term(s)	Humans ; Alcoholism ; Pandemics ; COVID-19 ; Italy ; Europe
Language	English
Publishing date	2023-02-15
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2711781-9
ISSN	2296-2565 ; 2296-2565
ISSN (online)	2296-2565
ISSN	2296-2565
DOI	10.3389/fpubh.2023.1110435
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Article: L’organizzazione dell’assistenza farmaceutica sul territorio non ha effetto sulla compliance del paziente: il caso della distribuzione diretta o per conto degli antidiabetici.

Di Filippo, Aurora / Trotta, Francesco / Perna, Serena

Epidemiologia e prevenzione

2023 Volume 47, Issue 4-5, Page(s) 281–287

Abstract: Objectives: the objective of the study is to assess the effect of the delivery channel on adherence, persistence and potential wastage of new antidiabetic drugs.: Design: longitudinal descriptive observational study. New users were defined as ... ...

Title translation	The organization of pharmaceutical care in the territory has no effect on patient compliance: the case of direct or account distribution of antidiabetics.
Abstract	Objectives: the objective of the study is to assess the effect of the delivery channel on adherence, persistence and potential wastage of new antidiabetic drugs. Design: longitudinal descriptive observational study. New users were defined as subjects who received a first prescription of drugs belonging to the antidiabetic category in the period between 01.01.2021 and 31.03.2021 (index date) and who did not receive prescriptions for drugs belonging to the same category in the previous 6 months, as of 01.07.2020. Each subject was followed for a follow-up period of 9 months. Setting and participants: the study examined adherence and persistence to treatment with antidiabetic drugs in Italy for patients aged>=45 years (information flow of pharmaceutical services performed in direct distribution and on behalf established by Ministerial Decree Health 31 July, 2007). Main outcome measures: adherence to treatment measured by the Medication Possession Rate (MPR) indicator, defined as the ratio of the number of days of therapy dispensed (calculated from DDDs) to the number of days covered by drug therapy; persistence to treatment defined as "time elapsed between the initiation and discontinuation of a prescribed drug therapy" estimated by as "time elapsed between the initiation and discontinuation of a drug therapy" estimated by Cox semi-parametric model; difference in terms of waste understood as the number of packs not fully used by non-persistent subjects. Results: the analysis showed that there were no significant differences between the dispensing channels in adherence, persistence, and medication wastage (defined as the distribution of packages to non-persistent patients). Specifically, it turns out that the percentage of highly adherent subjects at 9 months is 62.2 for those on treatment in the direct distribution channel and 64.6 for those on treatment with account distribution; with regard to persistence at 9 months, however, a difference of less than one percentage point was observed between the two channels. Although this study focused on a specific therapeutic class, the results can be generalised to other high-prevalence chronic diseases. However, some limitations of the study were pointed out, such as the difficulty of replicating the results due to the variability of data depending on the drug category and the time period considered. Conclusions: the choice of distribution channel for antidiabetic drugs should not be based on adherence or persistence to treatment, but on other determinants such as cost of service and logistical complications.
MeSH term(s)	Humans ; Hypoglycemic Agents/therapeutic use ; Medication Adherence ; Retrospective Studies ; Italy/epidemiology ; Patient Compliance ; Pharmaceutical Preparations ; Pharmaceutical Services
Chemical Substances	Hypoglycemic Agents ; Pharmaceutical Preparations
Language	Italian
Publishing date	2023-10-17
Publishing country	Italy
Document type	Observational Study ; English Abstract ; Journal Article
ZDB-ID	1038112-0
ISSN	1120-9763
ISSN	1120-9763
DOI	10.19191/EP23.4-5.A614.068
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Zs.A 2748: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Materials for Infectious Diseases.

Zarrabi, Ali / Caldera, Fabrizio / Trotta, Francesco

International journal of molecular sciences

2023 Volume 24, Issue 4

Abstract: The COVID-19 pandemic showed the crucial significance of investing in and conducting research on infectious diseases [ ... ]. ...

Abstract	The COVID-19 pandemic showed the crucial significance of investing in and conducting research on infectious diseases [...].
MeSH term(s)	Humans ; COVID-19 ; SARS-CoV-2 ; Pandemics ; Communicable Diseases
Language	English
Publishing date	2023-02-07
Publishing country	Switzerland
Document type	Editorial
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms24043295
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Article ; Online: Blind Spots in Development of Nanomedicines.

Salvi, Bhagyashree V / Kantak, Maithali / Kharangate, Kalyani / Trotta, Francesco / Maher, Timothy / Shende, Pravin

Technology in cancer research & treatment

2024 Volume 23, Page(s) 15330338241245342

Abstract: The field of nanomedicine demonstrates immense advantages and noteworthy expansion compared to conventional drug delivery systems like tablet, capsules, etc. Despite the innumerable advantages, it holds certain shortcomings in the form of blind spots ... ...

Abstract	The field of nanomedicine demonstrates immense advantages and noteworthy expansion compared to conventional drug delivery systems like tablet, capsules, etc. Despite the innumerable advantages, it holds certain shortcomings in the form of blind spots that need to be assessed before the successful clinical translation. This perspective highlights the foremost blind spots in nanomedicine and emphasizes the challenges faced before the entry into the market, including the need for provision of safety and efficacy data by the regulatory agencies like FDA. The significant revolution of nanomedicine in the human life, particularly in patient well-being, necessitates to identify the blind spots and overcome them for effective management and treatment of ailments.
MeSH term(s)	Humans ; Nanomedicine ; Drug Delivery Systems ; Nanoparticles
Language	English
Publishing date	2024-04-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2146365-7
ISSN	1533-0338 ; 1533-0346
ISSN (online)	1533-0338
ISSN	1533-0346
DOI	10.1177/15330338241245342
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Zs.A 5871: Show issues

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Article ; Online: Preliminary assessment of environmental safety (ecosafety) of dextrin-based nanosponges for environmental applications.

Bellingeri, Arianna / Palmaccio, Gian Marco / Cecone, Claudio / Trotta, Francesco / Corsi, Ilaria

Ecotoxicology and environmental safety

2024 Volume 273, Page(s) 116120

Abstract: The ability to employ waste products, such as vegetable scraps, as raw materials for the synthesis of new promising adsorbing materials is at the base of the circular economy and end of waste concepts. Dextrin-based nanosponges (D_NS), both cyclodextrin ( ...

Abstract	The ability to employ waste products, such as vegetable scraps, as raw materials for the synthesis of new promising adsorbing materials is at the base of the circular economy and end of waste concepts. Dextrin-based nanosponges (D_NS), both cyclodextrin (CD) and maltodextrin (MD), have shown remarkable adsorption abilities in the removal of toxic compounds from water and wastewater, thus representing a bio-based low-cost solution which is establishing itself in the market. Nevertheless, their environmental safety for either aquatic or terrestrial organisms has been overlooked, raising concern in terms of potential hazards to natural ecosystems. Here, the environmental safety (ecosafety) of six newly synthesized batches of D_NS was determined along with their full characterization by means of dynamic light scattering (DLS), thermogravimetric analysis (TGA), Fourier transformed infrared spectroscopy with attenuated total reflection (FTIR-ATR) and transmission electron microscopy (SEM). Ecotoxicity evaluation was performed using a battery of model organisms and ecotoxicity assays, such as the microalgae growth inhibition test using the freshwater Raphidocelis subcapitata and the marine diatom Dunaliella tertiolecta, regeneration assay using the freshwater cnidarian Hydra vulgaris and immobilization assay with the marine brine shrimp Artemia franciscana. Impact on seedling germination of a terrestrial plant of commercial interest, Cucurbita pepo was also investigated. Ecotoxicity data showed mild to low toxicity of the six batches, up to 1 mg/mL, in the following order: R. subcapitata > H. vulgaris > D. tertiolecta > A. franciscana > C. pepo. The only exception was represented by one batch (NS-Q+_BDE_(GLU2) which resulted highly toxic for both freshwater species, R. subcapitata and H. vulgaris. Those criticalities were solved with the synthesis of a fresh new batch and were hence attributed to the single synthesis and not to the specific D_NS formulation. No effect on germination of pumpkin but rather more a stimulative effect was observed. To our knowledge this is the first evaluation of the environmental safety of D_ NS. As such we emphasize that current formulations and exposure levels in the range of mg/mL do not harm aquatic and terrestrial species thus representing an ecosafe solution also for environmental applications.
MeSH term(s)	Animals ; Water Pollutants, Chemical/toxicity ; Water Pollutants, Chemical/chemistry ; Dextrins ; Ecosystem ; Plants ; Wastewater/toxicity ; Artemia
Chemical Substances	Water Pollutants, Chemical ; Dextrins ; Wastewater
Language	English
Publishing date	2024-02-23
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	436536-7
ISSN	1090-2414 ; 0147-6513
ISSN (online)	1090-2414
ISSN	0147-6513
DOI	10.1016/j.ecoenv.2024.116120
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Zs.A 1418: Show issues

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Article ; Online: Evaluation of the Swelling Properties and Sorption Capacity of Maltodextrin-Based Cross-Linked Polymers.

Cecone, Claudio / Hoti, Gjylije / Caldera, Fabrizio / Ginepro, Marco / Matencio, Adrián / Trotta, Francesco

Gels (Basel, Switzerland)

2024 Volume 10, Issue 4

Abstract: The development of polymers obtained from renewable sources such as polysaccharides has gained scientific and industrial attention. Cross-linked bio-derived cationic polymers were synthesized via a sustainable approach exploiting a commercial ... ...

Abstract	The development of polymers obtained from renewable sources such as polysaccharides has gained scientific and industrial attention. Cross-linked bio-derived cationic polymers were synthesized via a sustainable approach exploiting a commercial maltodextrin product, namely, Glucidex 2
Language	English
Publishing date	2024-03-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2813982-3
ISSN	2310-2861 ; 2310-2861
ISSN (online)	2310-2861
ISSN	2310-2861
DOI	10.3390/gels10040232
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Article ; Online: Access and use of WHO essential medicines in Italy.

Petrella, Alessandro / Fortinguerra, Filomena / Cangini, Agnese / Pierantozzi, Andrea / Trotta, Francesco

Frontiers in public health

2023 Volume 11, Page(s) 1211208

Abstract: Background: Many countries use the WHO Essential Medicines List (EML) as a guide for health policy choices to promote the efficient use of healthcare resources or adopt the concept of essential medicines (EMs) to develop their own national list of ... ...

Abstract	Background: Many countries use the WHO Essential Medicines List (EML) as a guide for health policy choices to promote the efficient use of healthcare resources or adopt the concept of essential medicines (EMs) to develop their own national list of essential medicines. The aim of this study is to analyse the availability and use of medicines included in the 22nd WHO EML in Italy. Methods: Using the ATC code (5th level), a comparison was made between the medicines included in the WHO EML and those retrieved from the Italian Medicines Agency (AIFA) database. The availability (regulatory and reimbursement status) of EMs, as well as the market share in expenditure (million euros) and consumption [measured in WHO-defined daily doses (DDDs)], compared to all reimbursed medicines in 2021, were analysed. Results: In 2021, approximately 85.2% ( Conclusions: In Italy, high coverage of EMs was found. It was largely reimbursed by the INHS, even when compared to other European countries. Essential medicines represented a high percentage of the overall expenditure and consumption in Italy. The WHO EML could be an important tool to guide the health policy choices of high-income countries, although a more frequent update and easier access to information on rejected medicines are needed.
MeSH term(s)	World Health Organization ; Antineoplastic Agents ; Health Expenditures ; Europe ; Italy ; Drugs, Essential/therapeutic use
Chemical Substances	Antineoplastic Agents ; Drugs, Essential
Language	English
Publishing date	2023-10-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2711781-9
ISSN	2296-2565 ; 2296-2565
ISSN (online)	2296-2565
ISSN	2296-2565
DOI	10.3389/fpubh.2023.1211208
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Article ; Online: Financial Outcomes of Managed Entry Agreements for Pharmaceuticals in Italy.

Trotta, Francesco / Guerrizio, Maria Alessandra / Di Filippo, Aurora / Cangini, Agnese

JAMA health forum

2023 Volume 4, Issue 12, Page(s) e234611

Abstract: Importance: Most countries in the Organisation for Economic Co-operation and Development apply managed entry agreements (MEAs), reimbursement arrangements between manufacturers and payers, to pharmaceuticals. Few data exist regarding their ability to ... ...

Abstract	Importance: Most countries in the Organisation for Economic Co-operation and Development apply managed entry agreements (MEAs), reimbursement arrangements between manufacturers and payers, to pharmaceuticals. Few data exist regarding their ability to lower expenditures. Objective: To analyze the financial outcomes of MEAs for pharmaceuticals from 2019 to 2021 in Italy. Design, setting, and participants: In this observational study of MEAs and pharmaceutical spending in Italy, medications that were monitored through individually collected data and generated paybacks from manufacturers during the 2019 to 2021 study period were included in the analysis. Payback data were collected through pharmaceutical spending monitoring activities conducted by the Agenzia Italiana del Farmaco (Italian Medicines Agency). Expenditure data were collected through the Italian Drug Traceability System. Products were categorized by type of MEA: financial-based, outcome-based, or mixed. Main outcomes and measures: The main outcome was median payback as a proportion of expenditure by category of MEA. Results were also provided by subtype: cost sharing or capping models for financial-based MEAs and risk-sharing or payment-by-result models for outcome-based MEAs. Mixed MEAs were considered when medications had multiple indications with different MEA types. Results: A total of 73 medications with MEAs generated a payback by manufacturers during the study period. Six were either not reimbursable or delivered within the Italian National Health Service, and 5 had incomplete data. Of the 62 medications analyzed, 24 (38.7%) had financial-based MEAs, 30 (48.4%) had outcome-based MEAs, and 8 (12.9%) had mixed MEAs. A total payback amount of €327.5 million was calculated during the 3 years, corresponding to 0.9% of the €41.1 billion of total expenditures for medications purchased by public health facilities in Italy. Financial-based MEAs returned the highest payback revenues, €158.1 million; the outcome-based MEAs and mixed MEAs generated smaller paybacks of €74.5 million and €94.9 million, respectively. Overall, the median proportion of payback to expenditure on the medications analyzed was 3.8%. For mixed MEAs, the payback-to-expenditure proportion was 6.7%; for outcome-based MEAs, 3.3%; and for financial-based MEAs, 3.7%. Conclusions and relevance: This observational study found limited evidence that MEAs lower pharmaceutical expenditures. Determining criteria for prioritizing MEA use, identifying potential design changes, and improving implementation may be needed in the future.
MeSH term(s)	State Medicine ; Italy ; Health Expenditures ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2023-12-01
Publishing country	United States
Document type	Observational Study ; Journal Article
ISSN	2689-0186
ISSN (online)	2689-0186
DOI	10.1001/jamahealthforum.2023.4611
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Article ; Online: Environmental safety of nanotechnologies: The eco-design of manufactured nanomaterials for environmental remediation.

Corsi, Ilaria / Venditti, Iole / Trotta, Francesco / Punta, Carlo

The Science of the total environment

2022 Volume 864, Page(s) 161181

Abstract: Nanosafety is paramount considering the risks associated with manufactured nanomaterials (MNMs) whose implications could outweigh their advantages for environmental applications. Although nanotechnology-based solutions to implement pollution control, ... ...

Abstract	Nanosafety is paramount considering the risks associated with manufactured nanomaterials (MNMs) whose implications could outweigh their advantages for environmental applications. Although nanotechnology-based solutions to implement pollution control, remediation and prevention are incremental with clear benefits for public health and Earth' natural ecosystems, nanoremediation is having a setback due to the risks associated with the safety of MNMs for humans and the environment. MNMs are diverse, work differently and bionano-interactions occurring upon environmental exposure will guide their fate and hazardous outcomes. Here we propose a new ecologically-based design strategy (eco-design) having its roots in green nanoscience and LCA that will ground on an Ecological Risk Assessment approach, which introduces the evaluation of MNMs' ecotoxicity along with their performances and efficacies at the design stage. As such, the proposed eco-design strategy will allow recognition and design-out since the very beginning of material synthesis, those hazardous peculiar features that can be hazardous to living beings and the natural environment. A more ecologically sound eco-design strategy in which nanosafety is conceptually included in MNMs design will sustain safer nanotechnologies including those for the environment as remediation by leveraging any risks for humans and natural ecosystems.
MeSH term(s)	Humans ; Ecosystem ; Nanostructures/toxicity ; Nanotechnology ; Environmental Restoration and Remediation ; Environmental Pollution
Language	English
Publishing date	2022-12-26
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	121506-1
ISSN	1879-1026 ; 0048-9697
ISSN (online)	1879-1026
ISSN	0048-9697
DOI	10.1016/j.scitotenv.2022.161181
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Zs.A 949: Show issues

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Article ; Online: Distribuzione dei medicinali diretta e per conto: opportunità e criticità.

Di Filippo, Aurora / Cangini, Agnese / Trotta, Francesco

Recenti progressi in medicina

2022 Volume 113, Issue 9, Page(s) 475–483

Abstract: The direct delivery of medicines by public healthcare facilities (Local health authorities, hospitals) is being discussed in Italy: the article considers opportunities and drawbacks of the different options (delivery through health facilities or through ... ...

Title translation	Direct and on behalf delivery of drugs for human use: opportunities and problems.
Abstract	The direct delivery of medicines by public healthcare facilities (Local health authorities, hospitals) is being discussed in Italy: the article considers opportunities and drawbacks of the different options (delivery through health facilities or through specific agreements with public and private community pharmacies) with respect to the characteristics of medicinal products and the needs of patients. The authors of the Italian Medicines Agency (AIFA) identify the main issues to be considered for a possible shift of some drugs from direct delivery to that on behalf, and which mainly concern drugs that must in any case be administered in hospital (see drugs for intravenous use or usable only in hospitals); drugs whose dispensing requires special precautions regarding confidentiality or for which dispensing by the staff of a health facility can improve patient adherence to therapy; innovative drugs monitored through registers.
MeSH term(s)	Humans ; Italy ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	Italian
Publishing date	2022-08-08
Publishing country	Italy
Document type	Journal Article
ZDB-ID	138266-4
ISSN	2038-1840 ; 0034-1193
ISSN (online)	2038-1840
ISSN	0034-1193
DOI	10.1701/3865.38514
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