{"title":"Efficacy and safety of capecitabine therapy in patients with Biliary tract cancer: A systematic review and meta-analysis.","authors":"Syed Kashif Ali, Christy Thomas, Mahesh Rathod, Krishna Undela","doi":"10.1177/10781552251372874","DOIUrl":"10.1177/10781552251372874","url":null,"abstract":"<p><p>BackgroundCapecitabine, an oral fluoropyrimidine prodrug, has demonstrated promising activity in Biliary tract cancers (BTC), but its role in combination chemotherapy is still debated.ObjectiveTo evaluate the efficacy and safety of capecitabine, both alone and in combination, for treating BTC.MethodologyA systematic search was performed in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar from the inception to 25<sup>th</sup> June 2024 to identify the RCTs on capecitabine therapy among BTC patients. Fixed or Random-effects model was used based on heterogeneity identified by using the I² statistic and Cochran's Q test. Quality of the RCTs was evaluated by the modified JADAD scale and RoB-2.ResultsA total of six RCTs comprising 613 patients were included in the study. Pooled results showed no statistically significant differences in progression-free survival (PFS) (Mean Difference [MD]: 0.07, 95% CI: -1.32 to 1.46; P = 0.92) or overall survival (OS) (MD: -0.22, 95% CI: -1.97 to 1.53; P = 0.80) between capecitabine therapy and the control group. No significant differences in adverse events (AEs), including hand-foot syndrome, neutropenia, and thrombocytopenia.ConclusionCapecitabine did not demonstrate a statistically significant benefit in PFS or OS for patients with BTC. The AEs from the capecitabine combination therapy were well-tolerated.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251372874"},"PeriodicalIF":0.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145054265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of ambulatory use of daratumumab hyaluronidase injection.","authors":"Noah Vannarat, David J Hermel, Anne M Spengler","doi":"10.1177/10781552251374914","DOIUrl":"https://doi.org/10.1177/10781552251374914","url":null,"abstract":"<p><p>IntroductionDaratumumab is a therapeutic cornerstone of the management of multiple myeloma, exerting its anti-myeloma activity through targeting of the cell surface glycoprotein CD38 on plasma cells. While originally given intravenously, the subcutaneous formulation, daratumumab hyaluronidase injection (Dara SC), has been associated with non-inferior efficacy and lower infusion-related reaction rates (IRRs) in the treatment of multiple myeloma and light chain amyloidosis. A noted benefit of Dara SC is a short administration time; however, the optimal observation time post injection to ensure patient safety is unclear from the drug labeling. Our institutional monitoring protocol states to monitor for 6 h after the first dose, 2 h after the second dose, and no monitoring required for the third and subsequent doses.MethodsWe conducted a retrospective analysis of all adult patients with multiple myeloma and light chain amyloidosis who initiated Dara SC treatment in the outpatient setting at our Scripps Clinic infusion rooms. The primary outcome was the cumulative incidence of any-grade infusion-related and injection-site reactions within the first three doses of Dara SC. Secondary outcomes included severity and time to onset of reactions, incidence of reaction in relation to dose number, and reaction rates in Dara-naïve versus Dara-experienced patients.ResultsA total of 97 patients were identified for inclusion in the study. The incidence of infusion- and injection-related reactions in the first three doses were 7 (7.2%) and 2 (2.1%), respectively. The severity grade of reactions were mostly Grade 1 with a single Grade 2 reaction, and time to onset of reaction for infusion-related reactions was 6 h (0-48) and 22.5 h (1-44) for injection-related reactions. All infusion-related reactions were associated with Dose 1 and the injection-related reactions were associated with Dose 2 and 3. No reactions were identified in the Dara-experienced population.ConclusionDara SC infusion- and injection-related reactions were mild and reversible with limited use of additional supportive care medications to alleviate symptoms. Thus given its safety profile and our clinical experience, a robust monitoring protocol similar to clinical trials may not be warranted when administered in the outpatient infusion setting.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251374914"},"PeriodicalIF":0.9,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145030100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of hepatotoxicity due to conditioning regimens in beta thalassemia major and aplastic anemia patients undergoing bone marrow transplantation.","authors":"Sadia Parveen, Muhammad Liaquat Raza, Saqib Hussain Ansari, Bushra Kaleem, Uzma Zaidi, Tahir Shamsi","doi":"10.1177/10781552251376972","DOIUrl":"https://doi.org/10.1177/10781552251376972","url":null,"abstract":"<p><p>IntroductionConditioning regimen-related hepatotoxicity is one of the frequent causes of morbidity and mortality in hematological disorder patients undergoing bone marrow transplantation-the current study aimed to evaluate the effects of conditioning regimens on liver enzymes.MethodsThis observational analytical study was conducted for one year and recruited patients who received conditioning regimens before undergoing Bone Marrow Transplantation for benign hematological disorder [aplastic anemia (AA) and beta-thalassemia major (BTM)]. Pre-and post-transplant assessment particularly liver function test was done. End point was abnormality in biochemical parameters due to conditioning regimens.ResultsA total of 53 patients (aplastic anemia = 23 and beta thalassemia major = 30), 58% were males and 85% were <16 years of age. Significant differences in serum glutamic pyruvic transaminase (SGPT) and alanine aminotransferase (ALT) were observed before and during treatment. Overall survival in AA and BTM patients was 100% and 90% respectively. Liver injury (total bilirubin ≥2 Grade) was observed in 9.4% [<i>n</i> = 5 (AA = 2 and BTM = 3)] patients. VOD was observed in one BTM patient. All of them had received a Cyclophosphamide (Cy) based conditioning regimen. Of the 49 patients receiving a Cy-based conditioning regimen, 10.2% of which one patient expired.ConclusionDespite being significant, hepatotoxicity due to the rise in SGPT and ALT was transient in BTM and AA patients taking the Cy-based conditioning regimen in our cohort. This evidence needs to be further evaluated by conducting studies over a larger scale and conducting liver profiles as regular biochemical profiles of transplant patients in both pre- and post-transplant periods.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376972"},"PeriodicalIF":0.9,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145029483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A new frontier in oncology: Understanding the landscape of cancer vaccines.","authors":"Tarun Kumar Suvvari, Keshavi Killi, Shreya Veggalam, Venkataramana Kandi","doi":"10.1177/10781552251375363","DOIUrl":"https://doi.org/10.1177/10781552251375363","url":null,"abstract":"<p><p>Cancer vaccines represent a transformative shift in oncology, aiming to prevent malignancies or treat established cancers by training the immune system to recognize tumor-specific or tumor-associated antigens. This review explores the diverse platforms and mechanisms supporting cancer vaccines, ranging from prophylactic vaccines such as HPV and hepatitis B vaccines that have significantly reduced virus-related cancers to therapeutic vaccines like Sipuleucel-T and T-VEC that extend survival in prostate cancer and melanoma. Vaccine types are classified, and delivery platforms including mRNA, peptide, dendritic cell and viral vector-based approaches are examined alongside pivotal clinical trial outcomes. Key barriers to vaccine efficacy include tumor immune evasion, heterogeneity and the suppressive tumor microenvironment; combination therapies with checkpoint inhibitors or chemotherapy are evaluated for their potential to overcome these challenges. Despite promising trials, challenges persist in neoantigen selection, biomarker development, regulatory approval and scalable vaccine manufacturing. Data on current global utilization, approved indications and coverage disparities particularly in low and middle-income countries are presented. Furthermore, the cancer vaccine market is segmented by disease type, platform technology and region, with rising investments in personalized mRNA platforms and combined immunotherapies driving growth. In conclusion, cancer vaccines offer a less toxic, more precise approach to cancer prevention and treatment. Continued innovation, global collaboration, and infrastructure development are essential to realizing their full potential in improving patient outcomes and reducing the global cancer burden.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251375363"},"PeriodicalIF":0.9,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145015680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Usefulness of hydrocortisone prophylaxis for oxaliplatin-induced hypersensitivity reactions: A retrospective study.","authors":"Maho Tanaka, Masato Komuro, Yasushi Kojima, Takahiro Nishimura, Satoshi Numazawa","doi":"10.1177/10781552251372177","DOIUrl":"https://doi.org/10.1177/10781552251372177","url":null,"abstract":"<p><p>IntroductionOxaliplatin is a platinum-based drug widely used for treating colorectal cancer. However, its use is often complicated by hypersensitivity reactions and other adverse effects, including peripheral neuropathy and myelosuppression. We evaluated the efficacy of prophylactic hydrocortisone administration in preventing hypersensitivity reactions during oxaliplatin therapy in patients with colorectal cancer.MethodsPatients who received oxaliplatin between January 2017 and December 2023 were retrospectively analyzed. Among them, 53 received 100 mg of hydrocortisone as a preventive measure when the cumulative oxaliplatin dose exceeded 400 mg/m<sup>2</sup> or if they experienced a treatment interruption of >8 weeks. We compared the incidence and severity of hypersensitivity reactions, as well as cumulative oxaliplatin dose, between patients who received routine premedication only (the Routine group) and those who received additional hydrocortisone prophylaxis (the Prophylaxis group).ResultsOverall, 370 patients were included in the study. Hypersensitivity reactions occurred in 23 patients (18 in the Routine group and 5 in the Prophylaxis group), with a significantly higher cumulative dose of oxaliplatin in the Prophylaxis group (644 vs. 1383 mg/m<sup>2</sup>, <i>p</i> = 0.0032). Severe reactions were observed only in the Routine group. Treatment discontinuation owing to hypersensitivity reactions was more common in the Routine group (five patients) than in the Prophylaxis group (one patient).ConclusionsProphylactic administration of hydrocortisone may promote oxaliplatin treatment continuation. This approach is proposed as a potential strategy for preventing oxaliplatin-induced hypersensitivity reactions.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251372177"},"PeriodicalIF":0.9,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"PrOACT-URL and MCDA for benefit-risk assessment in multiple myeloma: A case study.","authors":"Sidney Marcel Domingues, Erica Aranha Suzumura, Alessandro Gonçalves Campolina, Patrícia Coelho de Soarez","doi":"10.1177/10781552251374555","DOIUrl":"https://doi.org/10.1177/10781552251374555","url":null,"abstract":"<p><p>IntroductionThe objective of this study was to present the use of the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk, and Linked decisions (PrOACT-URL) and multi-criteria decision analysis (MCDA) frameworks as a methodological innovation with the potential to support decision-making in the process of incorporating and monitoring technologies in the Brazilian Unified Health System (SUS).MethodsThe present is a case study that used these frameworks as a basis for the benefit-risk assessment (BRA) of chemotherapy treatment options for multiple myeloma (MM) in the context of a Brazilian public hospital.ResultsThe application of the PrOACT-URL was not sufficient to guide stakeholders in making decisions about the best treatment alternative for MM, making it necessary to complement the qualitative analysis with the MCDA. In general, comparing the average scores for the five treatment options, the overall survival result was higher in four of the five treatments available for MM. The results that presented the lowest score were the risk of thrombosis and the risk of neuropathy. The sensitivity analysis showed that, for most stakeholder groups (managers, academia and clinicians), the treatment with the highest total value in the ranking was treatment with cyclophosphamide, thalidomide and dexamethasone (CTD).ConclusionsThe present case study showed that cyclophosphamide, thalidomide and dexamethasone presented the best benefit-risk balance for the treatment of MM and highlights the importance of the complementarity of these two structured approaches for more transparent decision-making, with an expansion of the deliberative process and the incorporation of preferences from different stakeholders.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251374555"},"PeriodicalIF":0.9,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A novel closed-system drug-transfer device for oral dosage forms: Enhancing safety and administration of hazardous oral therapies in patients with dysphagia.","authors":"Salim Hadad, Iyad Khamaysi, Eyas Haddad","doi":"10.1177/10781552251371292","DOIUrl":"https://doi.org/10.1177/10781552251371292","url":null,"abstract":"<p><p>BackgroundMany oral medications are manufactured as solid dosage forms, posing challenges for patients with dysphagia-including older adults and children-and creating occupational hazards for healthcare workers who must crush or manipulate hazardous drugs. Existing methods for preparing such medications often involve open systems, exposing staff to cytotoxic agents and risking cross-contamination.ObjectiveTo develop and evaluate a novel, single-use closed-system drug-transfer device (CSTD) designed to crush and dissolve or suspend solid oral medications within a sealed environment, enhancing safety for healthcare workers and improving medication access for patients with swallowing difficulties.MethodsWe developed a prototype CSTD comprising a 20 mL transparent barrel, a mechanical crushing piston with an integrated mesh, one-way fluid inlet, and a sealed outlet port for administration. Device sealing integrity was evaluated using vacuum methylene blue ingress testing, while drug extraction efficiency was quantified using high-performance liquid chromatography (HPLC) analysis of paracetamol solutions prepared with the device.ResultsSealing integrity tests demonstrated no dye ingress under vacuum conditions, confirming a robust closed system. HPLC analysis of paracetamol solutions showed recoveries exceeding 98%, indicating effective crushing and dissolution. The device offers a practical closed-system approach for handling hazardous oral medications and enables safe administration via oral or enteral routes.ConclusionThis novel CSTD represents a promising innovation to improve occupational safety during hazardous drug handling and to enhance treatment accessibility for patients with dysphagia. Further clinical evaluation and regulatory review are underway.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251371292"},"PeriodicalIF":0.9,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144992863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marie Kroemer, Guillaume Galy, Severine Tarun-Coquoz, Camille Stampfli, Pauline Thomann, Antoine Pierrot, Laurent Carrez, Farshid Sadeghipour
{"title":"Excess volume addition method improves human resource efficiency and environmental sustainability of cytotoxic drug preparations.","authors":"Marie Kroemer, Guillaume Galy, Severine Tarun-Coquoz, Camille Stampfli, Pauline Thomann, Antoine Pierrot, Laurent Carrez, Farshid Sadeghipour","doi":"10.1177/10781552251369431","DOIUrl":"10.1177/10781552251369431","url":null,"abstract":"<p><p>IntroductionThe increasing incidence of cancer entails a rising burden of cytotoxic drugs preparation. To improve the preparation process of cytotoxic drugs, specially designed half-filled bags with overfill capacity were manufactured and used in clinical routine. The aim of this study was to investigate the impact of using such bags on the duration of preparation, human resources, costs and environmental sustainability.Methods and MaterialsA retrospective study comparing two methods, volume substitution and excess volume addition, for cytotoxic drug preparations was conducted over two periods of 6 months, within a University Hospital chemotherapy production unit. Volume substitution method (period 1; 5527 preparations) corresponded to the use of filled-bags. Excess volume addition method (period 2; 5108 preparations) corresponded to the use of half-filled bags. Preparation time included drug reconstitution and gravimetric controls. Data were extracted from the BD Cato<sup>TM</sup> database.ResultsMedian duration of preparation using the excess volume addition method (2.4 min; IQR: 1.9-3.2) was significantly shorter than the volume substitution method (3.2 min; IQR: 2.6-4.1; <i>p</i> < 0.0001). It allowed saving 67 h during period 2, corresponding to 9.8% of a full-time equivalent technician. However, mean cost per preparation was significantly increased by 58% when using the excess volume addition method (p < 0.0001), due to higher costs of the newly designed bags. Broken down over the course of a year, the excess volume addition method would decrease the weight of cytotoxic waste for the entire hospital by 2.21%.ConclusionUsing the excess volume addition method with half-filled bags decreases time preparation, consumables and waste related to cytotoxic drug preparation.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251369431"},"PeriodicalIF":0.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144958110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Chemotherapy Orders Team: A non-traditional operational and clinical support team enhancing order set development and implementation.","authors":"Thomas J Vassas, Emily Fenner, Vishnuprabha Vogel","doi":"10.1177/10781552251369434","DOIUrl":"10.1177/10781552251369434","url":null,"abstract":"<p><p>ObjectiveOncology treatment regimens require increasing information technology (IT) integration in health systems to enhance delivery and safety, however, this creates a burden on medical teams and clinical pharmacists to manage. This primer introduces the University of Michigan Health Academic Medical Center's (UMH-AMC) response to this need with the Chemotherapy Orders Team (COT).SummaryThe COT includes five clinical oncology pharmacy generalists with a split full-time equivalent (FTE) appointment in COT-based activities and staffing in infusion. They manage the clinical content of oncology and non-oncology treatment and therapy plans at UMH-AMC, including over 1330 commercial plans and over 260 investigational plans. The COT ensure compliance with national and regulatory guidelines for order sets. This involves leaning on order group standardization to improve the efficiency of treatments across multiple disease states. The COT has been instrumental in managing the compounding standards for all infusion agents, including support to the electronic health record (EHR) team.ConclusionThe COT is an innovative team of clinical pharmacist infusion generalists, providing non-traditional clinical and operations support. They work alongside medical teams, pharmacy operations, and health informatics to provide robust management of EHR pathways for oncology and non-oncology related therapies. Importantly, they act as a translational liaison between the clinical teams and the EHR. Their efforts to modernize and improve the treatment and therapy plan experience at UMH-AMC has been an ongoing exercise, with many improvements in order set standardization and communication.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251369434"},"PeriodicalIF":0.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144958144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Soumaya El Baraka, Oualid Ziraoui, Zineb Lachhab, Omar El Hamdaoui, Said Zouhair
{"title":"Risk-based analytical quality control of chemotherapy preparations: A simulation and FMECA approach.","authors":"Soumaya El Baraka, Oualid Ziraoui, Zineb Lachhab, Omar El Hamdaoui, Said Zouhair","doi":"10.1177/10781552251374565","DOIUrl":"10.1177/10781552251374565","url":null,"abstract":"<p><p>IntroductionEnsuring the analytical quality control of chemotherapy preparations is essential to patient safety and treatment efficacy. However, the risk of preparation errors remains a critical concern in hospital pharmacy. Failure Mode, Effects, and Criticality Analysis (FMECA) is a structured risk assessment tool that can help identify, evaluate, and mitigate potential failures. This study integrates FMECA within a simulation-based training approach to enhance the safety and reliability of chemotherapy preparation quality control.Materials and MethodsA simulation-based learning program was implemented at the Faculty of Medicine and Pharmacy of Marrakech. Pharmacy students performed quality control steps, including limpidity testing, sterility testing, dosage uniformity, content verification, ingredient identification, and labeling accuracy. Analytical techniques such as UV-visible spectrophotometry, microbiological culture, and barcode verification were used. FMECA was applied at each critical step to assess failure risks. Statistical analysis measured pre- and post-training performance improvements.Results and DiscussionSimulation-based training significantly improved quality control performance across all parameters (p < 0.05). Notably, labeling errors decreased (p = 0.005), sterility compliance improved (p = 0.02), and dosage accuracy increased (p = 0.01). FMECA identified high-risk failure modes, reinforcing the need for standardized protocols and advanced analytical techniques.ConclusionIntegrating FMECA with simulation-based training enhances analytical quality control, reduces human errors, and strengthens adherence to Good Preparation Practices (GPP). These findings highlight the importance of proactive risk management in hospital pharmacy.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251374565"},"PeriodicalIF":0.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144958158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}