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4. Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

Author

Manellari, Sara, Leone, Maria Grazia, Casiraghi, Antonella, Gennari, Chiara Grazia Milena, and Minghetti, Paola

Subjects
MEDICAL equipment, MEDICAL supplies, MEDICAL laws, SPIROMETRY equipment, SPIROMETRY
Abstract

European legislation provides that each product used for healthcare purposes be regulated according to specific directives and regulations based on its intended use and mechanism of action. However, qualification issues may arise for medical devices, their accessories, and medicinal products. This is the case with gases for spirometry, which support spirometers in measuring patients' pulmonary capacities. This article discusses criticisms connected to their proper regulatory qualification, detailing why they should be more properly qualified as accessories of medical devices instead of as medicinal products or medical devices. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

Author

Scaglione, Francesco, Minghetti, Paola, Ambrosio, Francesco, Ernst, Beat, Ficarra, Vincenzo, Gobbi, Marco, Naber, Kurt, Schellekens, Huub, Scaglione, Francesco, Minghetti, Paola, Ambrosio, Francesco, Ernst, Beat, Ficarra, Vincenzo, Gobbi, Marco, Naber, Kurt, and Schellekens, Huub

Abstract

The nature of alpha-D-mannose—natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections—in the interaction with E. coli is addressed in order to drive the issue of its regulatory classification as a medicinal product or medical device. PRISMA systematic review approach was applied; Delphi Panel method was used to target consensus on statements retrieved from evidence. Based on regulatory definitions and research evidence, the mechanism of D-mannose does not involve a metabolic or immunological action while there is uncertainty regarding the pharmacological action. Specific interaction between the product and the bacteria within the body occurs, but its nature is inert: it does not induce a direct response activating or inhibiting body processes. Moreover, the action of D-mannose takes place, even if inside the bladder, outside the epithelium on bacteria that have not yet invaded the urothelial tissue. Therefore, its mechanism of action is not directed to host structures but to structures (bacteria) external to the host's tissues. On the basis of current regulation, the uncertainty as regard a pharmacological action of alpha-D-mannose makes possible its medical device classification: new regulations and legal judgments can add further considerations. From a pharmacological perspective, research is driven versus synthetic mannosides: no further considerations are expected on alpha-D-mannose.

Published
2023

7. Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

Author

Afd Pharmaceutics, Pharmaceutics, Scaglione, Francesco, Minghetti, Paola, Ambrosio, Francesco, Ernst, Beat, Ficarra, Vincenzo, Gobbi, Marco, Naber, Kurt, Schellekens, Huub, Afd Pharmaceutics, Pharmaceutics, Scaglione, Francesco, Minghetti, Paola, Ambrosio, Francesco, Ernst, Beat, Ficarra, Vincenzo, Gobbi, Marco, Naber, Kurt, and Schellekens, Huub

Published
2023

14. Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability

Author

Selmin, Francesca, Musazzi, Umberto M., Franzè, Silvia, Scarpa, Edoardo, Rizzello, Loris, Procacci, Patrizia, and Minghetti, Paola

Subjects
RS1-441, gel electrophoresis, Pharmacy and materia medica, mass vaccination, DLS, NTA, aggregates, TEM, COVID-19, compatibility, Article, in-use stability
Abstract

Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (&lt, 0.2). Samples were stable independently of syringe materials and storage conditions. Only strong mechanical stress (e.g., shaking) caused massive aggregation of lipid nanoparticles and mRNA degradation. These proof-of-concept experiments support the hypothesis that vaccine doses can be safely prepared in a dedicated area using an aseptic technique and transferred without affecting their stability.

Published
2021
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15. Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities

Author

Dimitri, Paul, primary, Pignataro, Valeria, additional, Lupo, Mariangela, additional, Bonifazi, Donato, additional, Henke, Maria, additional, Musazzi, Umberto M., additional, Ernst, Floris, additional, Minghetti, Paola, additional, Redaelli, Davide F., additional, Antimisiaris, Sophia G., additional, Migliaccio, Giovanni, additional, Bonifazi, Fedele, additional, Marciani, Luca, additional, Courtenay, Aaron J., additional, Denora, Nunzio, additional, and Lopedota, Angela, additional

Published
2021
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22. Considerations on D-mannose Mechanism of Action and Consequent Classification of Marketed Healthcare Products

Author

Scaglione, Francesco, Musazzi, Umberto M., and Minghetti, Paola

Subjects
Pharmacology, medical device, Mini Review, FimH adhesin, Pharmacology (medical), product administrative classification, urologic and male genital diseases, urinary tract infection, female genital diseases and pregnancy complications, D-mannose
Abstract

Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20–40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenic Escherichia coli that invades urothelial cells and forms quiescent bacterial reservoirs. Recurrences of UTIs are often treated with non-prescribed antibiotics by the patients, with increased issues connected to antibiotics resistance. D-mannose, a monosaccharide that is absorbed but not metabolized by the human body, has been proposed as an alternative approach for managing UTIs since it can inhibit the bacterial adhesion to the urothelium. This manuscript discusses the mechanisms through which D-mannose acts to highlight the regulatory aspects relevant for determining the administrative category of healthcare products placed on the market. The existing literature permits to conclude that the anti-adhesive effect of D-mannose cannot be considered as a pharmacological effect and, therefore, D-mannose-based products should be classified as medical devices composed of substances.

Published
2021

28. Lessons learned from COVID-19 for clinical research operations in Italy: what have we learned and what can we apply in the future?

Author

Cagnazzo, Celeste, primary, Besse, Marie-Georges, additional, Manfellotto, Dario, additional, Minghetti, Paola, additional, Cazzaniga, Sara, additional, Cottini, Lorenzo, additional, Fontanella, Andrea, additional, Maruti, Ilaria, additional, Stabile, Stefano, additional, Testoni, Sara, additional, Trogu, Paola, additional, Sinno, Valentina, additional, and Gussoni, Gualberto, additional

Published
2020
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33. Fixed Versus Free Combinations Of Antihypertensive Drugs: Analyses Of Real-World Data Of Persistence With Therapy In Italy

Author

Putignano,Daria, Orlando,Valentina, Monetti,Valeria Marina, Piccinocchi,Gaetano, Musazzi,Umberto Maria, Piccinocchi,Roberto, Minghetti,Paola, and Menditto,Enrica

Subjects
Patient Preference and Adherence
Abstract

Daria Putignano,1 Valentina Orlando,1 Valeria Marina Monetti,1 Gaetano Piccinocchi,2 Umberto Maria Musazzi,3 Roberto Piccinocchi,4 Paola Minghetti,3 Enrica Menditto1 1CIRFF, Center of Pharmacoeconomics, University of Naples Federico II, Naples, Italy; 2SIMG, Società Italiana di Medicina Generale, Florence, Italy; 3Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Milan, Italy; 4University of Naples Federico II, Naples, ItalyCorrespondence: Valentina OrlandoCIRFF, Center of Pharmacoeconomics, University of Naples Federico II, Via Domenico Montesano 49, Naples 80131, ItalyTel +39 081 678657Fax +39 081 678303Email valentina.orlando@unina.itPurpose: To analyse the pattern of use and cost of antihypertensive drugs in new users in an Italian population, and explore the patient/treatment factors associated with the risk of therapy discontinuation.Patients and methods: In this retrospective study, information was collected from a population-based electronic primary-care database. Persistence with medication use 1 year from therapy initiation was evaluated for each user using the gap method. Each new user was classified according to his/her pattern of use as: “continuer”, “discontinuer” “switching” or “add-on”. A Cox regression model was used to analyse the factors influencing therapy discontinuation. Primary-care costs comprised specialists’ visits, diagnostic procedures and pharmacologic therapies.Results: Among 14,999 subjects included in persistence analyses, 55.1% of cases initially started on monotherapy were classified as discontinuers vs 36.5% of cases taking combination therapy (42.3% vs 32.7%, respectively, for free and fixed combinations, P < 0.01). Old age, high cardiovascular risk and being in receipt of fixed-combination therapy were associated with greater persistence. Overall, the primary-care cost/person/year of hypertension management was ∼€95.3 (IQR, 144.9). The monotherapy cost was €88 per patient (IQR, 132.9), and that for combination therapy was €151±148.3. The median cost/patient with a fixed combination was lower than that for a free combination (€98.4 (IQR, 155.3) and €154.9 (IQR, 182.6), respectively).Conclusion: The initial type of therapy prescribed influences persistence. Prescribing fixed combinations might be a good choice as initial therapy.Keywords: drug-utilization, adherence, fixed combination, hypertension

Published
2019

42. Do laws impact opioids consumption? A breakpoint analysis based on Italian sales data

Author

Musazzi,Umberto Maria, Rocco,Paolo, Brunelli,Cinzia, Bisaglia,Luisa, Caraceni,Augusto, Minghetti,Paola, Musazzi,Umberto Maria, Rocco,Paolo, Brunelli,Cinzia, Bisaglia,Luisa, Caraceni,Augusto, and Minghetti,Paola

Abstract

Umberto Maria Musazzi,1 Paolo Rocco,1 Cinzia Brunelli,2,3 Luisa Bisaglia,4 Augusto Caraceni,2,3 Paola Minghetti1 1Department of Pharmaceutical Sciences, University of Milan, Milan, Italy; 2Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy; 3European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; 4Department of Statistical Sciences, University of Padua, Padua, Italy Purpose: In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors – such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies – on opioids sales to community pharmacies in Italy, focusing on the time period 2000–2010. Materials and methods: Five opioids were considered: codeine, tramadol, buprenorphine, morphine, and fentanyl. The analysis is based on sales data collected at wholesale distributors. For each one of the five drugs, time series of the number of Defined Daily Doses per thousand inhabitants per day in the period 2000–2010 were analyzed, and an estimation of breakpoints was performed using segmented linear regression. Results: Drug sales underwent a sharp increase in 2000–2010, although on different scales. Segmented regression analysis highlighted different potential breakpoints, corresponding to either a significant change in value and/or in slope. Sales of the five opioids were affected by at least one relevant event, often due to a synergy of regulatory, marketing, and technological factors. The effect of reimbur

Published
2018

46. Lessons learned from COVID-19 for clinical research operations in Italy: what have we learned and what can we apply in the future?

Author

Cagnazzo, Celeste, Besse, Marie-Georges, Manfellotto, Dario, Minghetti, Paola, Cazzaniga, Sara, Cottini, Lorenzo, Fontanella, Andrea, Maruti, Ilaria, Stabile, Stefano, Testoni, Sara, Trogu, Paola, Sinno, Valentina, and Gussoni, Gualberto

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has stressed the importance of health research as never before. In the specific domain of clinical research, the effort to rapidly find responses to health challenges and therapeutic hypotheses has highlighted the need for efficient, timely, ethically correct research. The guidelines published by the Agenzia Italiana del Farmaco have shown that some useful changes are feasible: simple and rapid methods have been implemented to conduct clinical research in the emergency conditions of the pandemic, maintaining high levels of quality. In this perspective, four Italian scientific associations operating in clinical research have worked together to evaluate which measures, among the ones implemented during the pandemic, have been particularly significant and potentially effective under normal conditions or in case of emergencies, and that therefore will be useful in the future as well.

Published
2021
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47. The constrained prescription, interchangeability and substitution of biosimilars

Author

Minghetti, Paola, Rocco, Paolo, Schellekens, Huub, Pharmaceutics, Sub Biotechnological drugs, Pharmaceutics, and Sub Biotechnological drugs

Subjects
Medicine(all), Mathematical optimization, Drug Industry, Drug Substitution, United States Food and Drug Administration, business.industry, Substitution (logic), Biomedical Engineering, Biosimilar, Bioengineering, Drug Prescriptions, Interchangeability, Applied Microbiology and Biotechnology, United States, Biotechnology, Europe, Biosimilar Pharmaceuticals, Humans, Molecular Medicine, Medical prescription, business, Drug industry
Published
2015

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