Medicine In Italy Research Articles

Early Access for Medicines in ITALY: The Case of Ruxolitinib for Patients with Graft-Versus-Host Disease.

After European Medicines Agency (EMA) approval, national pricing and reimbursement procedures are necessary to guarantee access to drugs, based on the willingness to pay and the recognition of therapeutic value. These can result in delays in drug availability for patients, even for those with important unfmet needs for whom it may be necessary and ethical to ensure access. The objective of this study was to evaluate the use of ruxolitinib for patients with graft-versus-host disease (GvHD) after EMA approval at the University Hospital of Catania. We analysed data about the use of ruxolitinib in patients with GvHD, describing their basic characteristics, their outcomes and the cost of the treatment. In the reference period, 24 ruxolitinib treatments were started according to the Summary of Product Characteristic. The average treatment duration was 10 months. Twenty patients showed a response, maintained over time, with no adverse reactions. The total expenditure amounts to EUR 963,424. The use of ruxolitinib in a real population confirms its role in an important therapeutic need. The quantification of costs requires a reflection on the sustainability of early access to medicines authorised by the EMA for serious diseases and in the absence of therapeutic alternatives.

Medicine, Life, and Transformations of Matter

This Ambix special issue explores premodern alchemical ideas and practices in their entanglements with medicine. It employs diverse methods, from traditional close reading to the new distant-reading framework of computational humanities, to investigate alchemical thought over a timespan of several centuries. In medieval times, everyday practices could offer heuristic models of material transformation – such as the fermentation of bread as a model for metallic transmutation (Schmechel). Paracelsus relied on “fire” to link his natural philosophy with his medical alchemy; new computational methods show how his ideas evolved over time (Hedesan). Early modern medical pluralism favoured the thriving of chemical medicine in Italy; diplomatic efforts introduced chemical remedies into acknowledged pharmacopoeias (Clericuzio). An English physician offers William Cavendish both practical distillation recipes and the hope of learning more about the principles of chemistry (Begley). In eighteenth-century France, Diderot draws on chemical ideas to blur the conceptual boundary between living and non-living matter (Wolfe). The papers largely adhere to integrated history and philosophy of science (iHPS) and to a pragmatist “operational ideal of knowledge” (Chang). They showcase the interdisciplinarity of premodern scientific thought and examine how medicine and alchemy, but also theory and (everyday) practice informed each other fruitfully across the ages.

The economic impact of 14 compassionate use programs for medicines in Italy, in the perspective of the National Health Service

Background: Compassionate use programs (CUP) for medicines allow patients, not recruited in trials, accessing medicines before marketing approval. The evidence on the economic impact of CUP is limited to one paper that did not include the possible long-term economic impact of medicines used in CUP compared to alternative treatments, like avoided hospitalization costs. This paper aims at covering this information gap, updating and integrating the existing evidence, with a cost analysis in the perspective of the Italian National Health Service (SSN). Methods: Data were retrieved from the Roche CUP Database, the peer-reviewed literature (e.g. published cost-effectiveness studies, if any), the gray literature (e.g. regional documents for the alternative treatment cost) and unpublished data (e.g. cost-effectiveness analysis provided for price and reimbursement negotiation for medicines in CUP). Results: We retrieved data from 14 CUPs and 3,485 patients (70% affected by tumors) (Jan 2015-August 2022). The alternative treatment mean cost per patient ranged from € 11.1 k to € 18.8 k. The net economic benefit ranged from € 47 million to € 75 million (€ 13.5 k-€ 21.5 k per patient). Avoiding alternative treatments mostly contributes to the economic benefit. The long-term economic impact accounted for 20/30% of the net economic impact. The net economic benefit for cancer drugs ranged from € 12.6 million to € 40.0 million. Conclusions: Despite research limitations, this paper provides additional evidence on the economic impact of CUP in Italy. This could represent the first step of a broader analysis of the economic impact of early access schemes for drugs.

Translating Forbidden Authors: New Evidence on the Alchemical Library of Don Antonio de’ Medici

Research into the history of alchemy and Paracelsianism in Italy has highlighted the role of Italian courts in the sixteenth and seventeenth centuries as centres of elaboration and diffusion of alchemical knowledge. Among these, one of the best known is the Medici court which already dedicated spaces in the ducal foundry to the alchemical arts in the time of Cosimo I. This interest would remain alive with Francesco I and his son, Don Antonio de' Medici, one of the greatest supporters of Paracelsian medicine in Italy. This contribution presents previously unpublished sources, now preserved in the Archivio di Stato di Firenze and in the collection of the Biblioteca degli Intronati in Siena, that can help us reconstruct in greater detail some significant aspects of Medici alchemical engagement and can, above all, help further determine Paracelsus’s influence in seventeenth century Florence.

Making change: the new principles of the World organization of general medicine (Wonca 2022) and territorial medicine in Italy.

The new european declaration "Core values and principles of general practice and family medicine" (Wonca Europe 2022) has been recently issued: which contributions can it provide to the discussion on the future of primary health medicine? And what challenges and changes would it impose in its application to the contexts of medical training, care services and clinical research in Italy? We analyse here the seven principles and values of the new declaration: 1) person-centred care; 2) continuity of care; 3) cooperation in care; 4) community-oriented care; 5) equity in care; 6) science-oriented care; 7) professionalism in care; and through them we reflect on the announced reforms of primary health care (Phc) policy. Indeed, these provide an important basis for a critical discussion regarding the reform of the primary care model, the evolution of the medical training pathway (pre- and post-graduate and therefore towards an adjustment of the specialty pathway of future general practitioners) and research Phc. Considering that the Phc health policies are experiencing a condition of permanent and apparently uncontrollable change, it is well to ask ourselves how and if these values-principles, which are considered fundamental at an international level, will be able to come to life in order to build a new therapeutic trust, specific to general practice and family medicine, both in the professional and disciplinary sphere.

Access and use of WHO essential medicines in Italy.

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. 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. In 2021, approximately 85.2% (n = 414) of medicines included in the WHO EML were commonly marketed in Italy. Of these, 396 EMs were fully reimbursed by the Italian National Healthcare Service (INHS), corresponding to 81.5% (396/486) of the WHO EML, while the remaining 18.5% (90/486) were neither authorised (n = 72) nor reimbursed (n = 18). The study found a low coverage for anti-parasitic, insecticides, and repellent products (ATC P) in addition to medicines for the genitourinary system and sex hormones (ATC G). Even though medicines on the WHO EML, including therapeutic alternatives, accounted for ~48.5% of the expenditure for medicines reimbursed by INHS, the list covered 74% of all national drug consumed. Novel high-cost therapies indicated in high-prevalence diseases and rare conditions, mostly antineoplastic and immune-modulating agents (ATC L) not included in the WHO EML, were also guaranteed. 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.

Women in the medical profession in 1900 from extended maternity to social equity. The life of Lucia Servadio.

The history of social medicine in Italy between the late nineteenth and early twentieth centuries was characterised by a marked presence of gender and the consequent commitment of women of Jewish origin to the issues of early childhood education, as well as safeguarding of work and motherhood and health prevention with regard to social and cultural fragility. Some of the roles of women engaged in social medicine campaigns have been widely studied in the historiography of medicine, having recognized their roles and commitment to attempting to create a fair society through their expertise in medicine and health. However, there are some biographies and professional lives that are still unpublished and worthy of attention by historical medical research. Lucia Servadio, who was of Jewish origin (1900-2006), was the youngest Italian doctor of the first twenty years of the twentieth century. She successfully worked, despite the degrading identification of women at the time, in the field of medicine and welfare, thanks to her qualified professional, cultural and social commitment. Dr Servadio's professionalism was constantly defined by a vision of health as a right that the doctor must protect by pursuing the goal of social equity. Precisely on the basis of these principles, solidified by the practical and social activism of women's groups of the time, Dr Servadio's professional and private life was continuously shaped between medicine and social activism. However, her story is also pervaded by the ambiguity of the role played by women, often highly educated and with considerable professional standing, engaged in forms of scientific intellectual collaboration of a conjugal nature.

Training in Honey Bee Veterinary Medicine in Italy: An Observational Study and Practical Proposals to Face Professional Challenges.

Honey bees, like other livestock, may be affected by infectious, parasitic, and abiotic diseases that need proper sanitary monitoring and control. Currently, there are limited opportunities for undergraduate students to receive education in Honey Bee Veterinary Medicine (HBVM) as part of their regular degree program, despite the professional requirements for veterinarians to carry out the increasing tasks related to honey bee health and production. Additionally, postgraduate training and specialization in HBVM is also underdeveloped. This study was an observational survey that evaluated the educational opportunities available in HBVM for current and future veterinarians in Italy. The survey analyzed both undergraduate and postgraduate programs, including Undergraduate Degree Programs in Veterinary Medicine (UDPVM), "Scuole di Specializzazione", Masters, and other postgraduate courses. The results indicate that the current training available for veterinarians in the field of apiculture, both before and after graduation, is also insufficient in Italy, as already reported in other EU- and extra-EU countries. Finally, a roadmap for veterinary training in HBVM is developed here describing objectives and teachings aimed at fulfilling the needs of the profession in the field of beekeeping, considering the existing rules and regulations governing public health and possible evolution of this legal framework in the future.

P-086 Oestrus ovis: A survey on its presence and relative disease awareness in human medicine in Italy

P-086 Oestrus ovis: A survey on its presence and relative disease awareness in human medicine in Italy

Walking around the Autonomous Province of Trento (Italy): An Ethnobotanical Investigation.

The Trentino-South Tyrol region is a special statute region of northeastern Italy. This territory is of particular interest for its morphology, flourishing vegetation, and history, having been a meeting area among different civilizations. Hence, Trentino is characterized by an ethnic plurality and a rich ethnobotanical knowledge, even if the available information is fragmentary, widely dispersed, and often guarded in oral popular culture. To fill this gap, in the present work 200 subjects were interviewed using an ethnobotanical survey. The resulting 817 citations referred to 64 native species, used either for human or animal health or for domestic purposes. As a second step, for each plant exploited for medicinal purposes, local importance was evaluated by calculating their relative frequency of citation. Moreover, the main traditional preparations were discussed. Among them, the most cited and exploited ones are Achillea millefolium, Arnica montana, Hypericum perforatum, Malva sylvestris, Pinus mugo, and Satureja montana, for which a deeper analysis has been performed. Lastly, the ethnobotanical knowledge of the plants growing in this territory will add a piece to the mosaic of traditional medicine in Italy and may lay the foundation for a nature-aided drug discovery process.

Biomaterials for Regenerative Medicine in Italy: Brief State of the Art of the Principal Research Centers.

Regenerative medicine is the branch of medicine that effectively uses stem cell therapy and tissue engineering strategies to guide the healing or replacement of damaged tissues or organs. A crucial element is undoubtedly the biomaterial that guides biological events to restore tissue continuity. The polymers, natural or synthetic, find wide application thanks to their great adaptability. In fact, they can be used as principal components, coatings or vehicles to functionalize several biomaterials. There are many leading centers for the research and development of biomaterials in Italy. The aim of this review is to provide an overview of the current state of the art on polymer research for regenerative medicine purposes. The last five years of scientific production of the main Italian research centers has been screened to analyze the current advancement in tissue engineering in order to highlight inputs for the development of novel biomaterials and strategies.

Knowledge of University Students in Health Care Settings on Vaccines and Vaccinations Strategies: Impact Evaluation of a Specific Educational Training Course during the COVID-19 Pandemic Period in Italy.

Background: Training future healthcare professionals on vaccination through specific courses is important to properly promote active immunization among the general population and to fight fake news and false beliefs on vaccinations. The aim of the study was to assess the impact of an elective course about vaccinations on the knowledge of medical students, pharmacy students, and medical resident in Hygiene and Preventive Medicine in Italy. Methods: The participants were asked to complete an anonymous questionnaire before and after an elective teaching activity (ETA) on vaccination. The two questionnaires contained the same 30 questions and focused on different aspects of vaccines and vaccination. The students who had attended the seminar were allowed to fulfil the post-lecture questionnaire. Both descriptive and inferential analysis were performed on the results; in particular, Student’s t-test for independent samples was used to compare the total score obtained before and after attending the ETA. Results: A total of 449 students participated in the ETA. Overall, the participation in the ETA allowed them to significantly improve their final score (+27.28%, p < 0.001). Good results were obtained even when comparing the three groups (medical students, pharmacy students and medical residents) separately. Females improved more than males, especially among pharmacy students. Discussion: The present study highlights the importance and the impact that extracurricular activities can have in improving knowledge about vaccinations. With vaccination and vaccine hesitancy and acceptance topics with increasing attention paid by the population, especially after the COVID-19 pandemic, it is fundamental to develop new strategies to increase future healthcare professionals’ knowledge about vaccinations.

The Assessment of the Innovativeness of a New Medicine in Italy.

Objectives: Starting from April 2017, the Italian Medicine Agency (AIFA) has approved new criteria for defining any new medicinal product with an innovative indication. The purpose of the study is to analyze the activity of innovativeness evaluation according to the new approach, to estimate the weight of each criterion considered for innovativeness definition, and to evaluate how the new approach works in terms of consistency and reproducibility.Methods: A retrospective analysis was performed on the final reports evaluating the drug innovativeness assessment published on the AIFA's website between April 2017 and January 2021. Descriptive statistics, chi-square test, whether the conditions were respected, or Fisher's exact test was used to explore the association between characteristics of drugs and the innovativeness status and the association between the three criteria. Profiles of the decision process and their relationship with innovativeness response were described. In order to evaluate the weight of each criterion in predicting the innovativeness status, a Classification Tree (CT) algorithm was applied.Results: Overall, of the 109 published drugs reports, 37 (33.9%) were recognized as fully innovative, 29 (26.6%) were considered conditionally innovative, while for 43 (39.4%) reports innovativeness was not recognized. Considering the three criteria of the decision process, the added therapeutic value was the only criterion statistically associated with a drug's degree of innovation (p < 0.001). The therapeutic need and the quality of clinical evidence were statistically associated (p = 0.008) even if only a mild association was observed. The added therapeutic value was the most important variable in predicting the innovativeness status according to the classification tree (CT) model applied, achieving an accuracy of 89.4%. No difference was found between orphans and non-orphan drugs or oncological and non-oncological drugs.Discussion: The added therapeutic value is the most important criterion of the multidimensional approach for the innovativeness status definition of a new medical product. A mild association was found between the therapeutic need and the quality of evidence. Overall, similar decision profiles bring the same evaluation of innovativeness status, indicating a good consistency and reproducibility between decisions.

Health in Prison: Does Penitentiary Medicine in Italy Still Exist?

Despite the detailed legislative developments that have occurred within the context of prison medicine in Italy, problems of a management nature continue to affect prisoner health and management, which in turn impact the prison system’s ability to offer prisoners a real opportunity for rehabilitation. Certain behavioral aspects reported in prisons may alter and negatively impact the normal doctor-patient relationship, including elements that hinder the therapeutic alliance and impede proper clinical risk prevention and management. However, practical steps may be taken in connection with the analysis of flows and healthcare services that may enable prison administrations to bring about a true, modern restructure of the prison system.

Early access programs and managed entry agreements for medicines in Italy: results of a Focus Group (Early Access Programs and Managed Entry Agreement).

Early access of medicines occurs with an uncertainty in the evidence even higher than the one experienced when price and reimbursement status is negotiated. Our aim is discussing the role of managed entry agreements (MEA) within early access programs (EAP) in Italy. The discussion relied on a Focus Group, participated by twelve experts, including clinicians and representatives of regulatory authorities, regional and local pharmaceutical departments, pharmaceutical companies, and an association advocating for active citizenship. The Focus Group emphasised that the topic under discussion should be embedded into a more general reform of EAP in Italy. The 648 List mostly includes mature products and indications that are rarely launched into the market afterwards. The 5% Fund is affected by an important administrative burden uncertainty of the timing of reimbursement. Starting from the discussion on MEA and EAP, the Focus Group recommended a new legislation better regulating EAP, that early access concerns specific classes of medicines selected on the grounds of the need to guarantee a rapid access and to collect real world data, that early access can be accompanied by outcome-based and population-based MEA, and that MEA are embedded into the subsequent price and reimbursement negotiation.

New drug pricing criteria in Italy: considerations and proposals to support value and innovation

The definition of criteria and processes for the submission of price and reimbursement requests (P&amp;R) of a drug in Italy cannot be separated from the definition of an overall “Pharmaceutical Policy” that includes, in an organic vision: (i) the governance related to the research, marketing and monitoring of drugs in the Italian market; (ii) the availability of drugs on the national territory as an element included in the essential levels of care (LEA) and the related conditions in terms of timing and equity of access between different regions, as well as towards other European countries; (iii) the assessment criteria used. The decree published in the Italian Official Journal in the summer of 2020, which defines the new criteria for the regulation of P&amp;R of medicines in Italy, focuses on the final part of the process, i.e. the price negotiation. It would be necessary to frame this last step within a broader and more organic structure of drug policies aimed at: 1. optimising healthcare funding by encouraging competition between healthcare technologies; 2. reducing assessment time by simplifying processes; 3. improving early access to drugs for unmet need; 4. increasing the quality of P&amp;R dossiers by improving interaction with the companies; 5. encouraging innovative agreements and complementary elements to the price; 6. encouraging the reproducibility of assessment methodologies in a value-based pricing system; 7. considering cost-benefit analyses as tools for the definition of price and conditions of reimbursability; 8. creating a place for discussion on drug policies.

Price and reimbursement for orphan medicines and managed entry agreements: does Italy need a framework?

This article illustrates a consensus opinion of an expert panel on the need and usefulness of a framework for price and reimbursement (P&R) process and managed entry agreements (MEAs) for orphan medicines in Italy. This opinion was gathered in three rounds: an introductory document was sent to the panel and discussed during a recorded online meeting. A second document was sent to the panel for their review. In the third step the final document was validated. Members of the expert panel are the authors of the article. The panel agreed that Italy does not need a specific value framework for orphan medicines, driving the P&R process. Rather, a more structured value framework for all medicines tailored to the specific drugs can be useful. For orphan drugs, the panel advocated for a multidisciplinary approach and the contribution of different stakeholders to value assessment, and acknowledged the importance of addressing, more than for other drugs, unmet needs, equity issues and societal value. The panel raised the need of increasing the importance of patient-reported outcomes. Experts, acknowledging the growing criticisms in implementation of outcome-based agreements in Italy, expressed their position against their abandonment in favour of discounts only and supported orphan medicines as natural candidates for these agreements. Finally, the panel made some recommendations on the appraisal process for orphan medicines, including an early discussion on the uncertainty of the evidence generated and the adoption of a structured approach to identify the agreement, which better responds to the uncertainty.

New trajectories for emergency medicine in Italy.

New trajectories for emergency medicine in Italy.

Focus on Social Security and Social Assistance Medicine in Italy: synthetical comparison of the Social Security in European and non-European countries

article: Focus on Social Security and Social Assistance Medicine in Italy: synthetical comparison of the Social Security in European and non-European countries - Minerva Forensic Medicine 2021 March;141(1):19-23 - Minerva Medica - Journals

The teaching of the History of Medicine in Italy: a path in progress.

Background:The increasing attention to the potential application of technology in medicine represents a dangerous warning in the direction of a reductionist approach. The academic system should therefore be strongly engaged to ensure even in medical practice the greatest enhancement of the human dimension.Targets:How much space is offered to the teaching of History of Medicine (HM) in Italian Universities? This work aims to answer this question through an in-depth analysis of the teaching plans of the Master’s Degree courses in Medicine and Surgery (MD) activated in Italy.Materials and Methods:The survey was carried out through the consultation of information, relating to the year 2019-2020, contained in the UniversItaly portal of the Italian Ministry of Education, University and Research, created to accompany students in their studies, as well as through the information published in the web portals of the various universities.Results and Discussion:In Italy in 43 out of 97 Universities there is the Degree Course in Medicine and Surgery for a total of 66 degree courses; some Universities have activated more degree courses depending on the number of learners or on issues of territorial distribution. The teaching of HM is present in the curricula of 54 MD) (82%) and in these is mandatory. In 93% of the cases, it is included in Integrated Courses (IC) and for only 4 MD) it results as autonomous teaching. For the most part (86%) it is included in the first year’s educational plan. The typology of the different ICs is extremely varied, both in terms of denomination, year, and content, as well as in the overall CFUs assigned (university credits). The current teaching staff is divided as follows: 6 full professors; 12 associate professors; 13 Researchers (RU/RD); 20 contract professors. 19 are the researchers/professors engaged in the scientific field of the HM (MED/02).Conclusion:Those findings indicate that the HM subject in the Italian medical education programs is not yet universally recognized as able to stimulate medical students to a holistic view of the person and illness and therefore not sufficiently valued. (www.actabiomedica.it)