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Clemente Ponzetti,1 Monica Canciani,2 Massimo Farina,2 Sara Era,3 Stefan Walzer4,5 1Gruppo Policlinico di Monza, Alessandria, ANMDO National Association of Hospital Physicians, Bologna, 2Studio EmmEffe Srl, Milan, 3Roche Spa, Monza, Italy; 4MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, 5State University Baden-Wuerttemberg, Health Care Management, Loerrach, Germany Background: In oncology, an important parameter of safety is the potential treatment error in hospitals. The analyzed hypothesis is that of subcutaneous therapies would provide a superior safety benefit over intravenous therapies through fixed-dose administrations, when analyzed with trastuzumab and rituximab.Methods: For the calculation of risk levels, the Failure Mode and Effect Analysis approach was applied. Within this approach, the critical treatment path is followed and risk classification for each individual step is estimated. For oncology and hematology administration, 35 different risk steps were assessed. The study was executed in 17 hematology and 16 breast cancer centers in Italy. As intravenous and subcutaneous were the only injection routes in medical available for trastuzumab and rituximab in oncology at the time of the study, these two therapies were chosen.Results: When the risk classes were calculated, eight high-risk areas were identified for the administration of an intravenous therapy in hematology or oncology; 13 areas would be defined as having a median-risk classification and 14 areas as having a low-risk classification (total risk areas: n=35). When the new subcutaneous formulation would be applied, 23 different risk levels could be completely eliminated (65% reduction). Important high-risk classes such as dose calculation, preparation and package labeling, preparation of the access to the vein, pump infusion preparation, and infusion monitoring were included in the eliminations. The overall risk level for the intravenous administration was estimated to be 756 (ex-ante) and could be reduced by 70% (ex-post). The potential harm compensation for errors related to pharmacy would be decreased from eight risk classes to only three risk classes. Conclusion: The subcutaneous administration of trastuzumab (breast cancer) and rituximab (hematology) might lower the risk of administration and treatment errors for patients and could hence indirectly have a positive financial impact for hospitals. Keywords: health economics, safety, insurance premium, oncology, intravenous therapy, subcutaneous therapy

Clemente Ponzetti,1 Monica Canciani,2 Massimo Farina,2 Sara Era,3 Stefan Walzer4,5 1Group Policlinic Monza, Alessandria, National Scientific Associazione Nazionale dei Medici delle Direzioni Ospedaliere (National Association of Hospital Physicians), Bologna, 2Studio EmmEffe S.r.l, Milan, 3Roche S.p.a., Monza, Italy; 4MArS Market Access and Pricing Strategy GmbH, Weil am Rhein, 5Health Care Management, State University Baden-Wuerttemberg, Loerrach, Germany Introduction: Subcutaneous versions of different oncology therapies have been available for patients for a few years, yet patient-relevant and hospital benefits have not been assessed in real life. Methods: In order to analyze the impact of subcutaneous administrations for rituximab or trastuzumab in comparison to the respective intravenous mode a primary research in Italy was executed. The study’s primary objectives were to analyze the resource and cost implications from different perspectives (patient, medical staff) in the real world. The route of administration was discussed and aligned with the participating centers in order to capture all relevant therapy parts. After the successful execution of a pilot study 19 centers in six regions in Italy were recruited to participate. Results: Significant time savings might be achieved with the subcutaneous mode through significantly lower patient preparation time including less time preparing the actual dosing for each individual patient. The total time difference is 3.3 hours with rituximab in hematology (non-Hodgkin’s lymphoma), which adds up to 23.55 hours for a full course of treatment per patient (overall preparation time: 40.1 hours intravenous [95% confidence interval (CI): ±0.47] vs 16.6 hours subcutaneous [95% CI: ±0.2]). In early breast cancer (trastuzumab), the time saving might be 3.3 hours for the first cycle and the total time saving for patient preparation might be 17.2 hours (overall preparation time: 38.8 hours intravenous [95% CI: ±9.42] vs 21.6 hours subcutaneous [95% CI: ±9.9]). Furthermore, in both settings, the time of medical staff was reduced and could hence be used elsewhere. Finally, in case wastage was experienced with intravenous therapies, there were potential significant reductions in wastage through the subcutaneous administration (93%–100%) with cost savings of €6,057 with rituximab subcutaneous and €28,399 with trastuzumab subcutaneous administration for the full treatment course. Conclusion: There are significant resource and cost savings due to subcutaneous administration with rituximab and trastuzumab in Italy based on a systematic survey. With the availability of a subcutaneous use of rituximab and trastuzumab, hospitals, patients and payers in general still have the current standard of care therapies available in the approved indications for a more efficient use of time and resources. Keywords: health economics, cost savings, oncology, intravenous therapy, subcutaneous therapy

Ponzetti C, Canciani M, Farina M, Era S, Walzer S. ClinicoEconomics and Outcomes Research. 2016;8:227–233.On page 230, Table 3, first column: The last time component should be: “Patient preparation time for eighteen cycles of therapy in oncology (breast cancer)”. On page 231, Table 4, first column: The second rituximab preparation item should be: “Median time to prepare rituximab (for median number of patients per day)”. On page 231, Table 4, first column: The third item should be: “Median time to prepare trastuzumab (for each patient with eighteen therapeutic administrations)”. On page 231, Table 4, first column: The last trastuzumab preparation item should be: “Median time to prepare trastuzumab (for median number of patients per day)”. On page 232, Table 5, first column: Wording of the last outcome for each therapy should be: “Annual economic impact” rather than “Annual economic impact per patient”. On page 232, Table 5, second column: “In breast cancer (trastuzumab)”, the mean annual economic impact for the intravenous administration should be: €29,872. On page 232, Table 5, second column: The public price (hospital price) for subcutaneous administration should be: €2.89/mg. Read the original article.

Background. The International Standardization Organization operates the world's most widely recognized quality management system standard, the ISO 9001:2015. In the healthcare sector, the adoption of this standard within an organization helps to improve the overall performance and provides a foundation for development and continuous progress. Our study aims to describe the implementation process of a quality management system according to the ISO 9001:2015 standards in an Angiology Unit of an Italian University hospital. Methods. The project was structured in 5 operational phases, which were carried out during a time frame of 14 months (March 2018-May 2019) and entailed several improvement actions associated with quality and safety outputs such as clinical management, clinical practice, safety, and patient-centeredness. Results. Implementation of the quality management system led to the improvement of many aspects of the processes performed in the Angiology Unit, both in the outpatient and day hospital setting. Overall, the project positively impacted on systems for patient safety, particularly in communication and data transmission, and clinical leadership. Conclusions. The implementation of the ISO 9001 certification is a process that apparently may seem expensive in terms of resources used, commitment, work, comparison, but it leads to substantial and always progressive improvements in the offer of Services to the user, safety both for the users and for the healthcare personnel involved, in addition to the care processes that translate into significant benefits in terms of quality of care for patients, as well as management savings for the organization. [ABSTRACT FROM AUTHOR]

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Copyright of Thiasos Monografie is the property of Edizioni Quasar di Severino Tognon s.r.l. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)