G Hari Prakash, Sunil Kumar D, Vanishri Arun, Kiran Pk, Deepika Yadav, Arun Gopi, Rakesh M
{"title":"From needs to app: A user-centred design approach for developing mobile health interventions in oncology care.","authors":"G Hari Prakash, Sunil Kumar D, Vanishri Arun, Kiran Pk, Deepika Yadav, Arun Gopi, Rakesh M","doi":"10.1177/10781552261443469","DOIUrl":"https://doi.org/10.1177/10781552261443469","url":null,"abstract":"<p><p>BackgroundChemotherapy management presents multi-dimensional challenges, including severe side effects, treatment non-adherence, and psychological distress, particularly in low- and middle-income countries where healthcare access and digital literacy barriers compound these difficulties. Mobile health (mHealth) interventions offer promising solutions but require systematic, user-centred design approaches.ObjectiveTo employ user-centred design principles in developing a comprehensive mobile health application for chemotherapy patients through mixed-methods needs assessment and iterative co-design processes.MethodsAn exploratory sequential mixed-methods study was conducted at a tertiary cancer centre in South India. Phase 1 involved qualitative exploration using structured questionnaires with patients (n = 10), healthcare providers (n = 9), and caregivers (n = 5). Phase 2 employed a quantitative needs assessment using the validated Cancer Needs Assessment Tool for Chemotherapy Care (CNAT-CC) among 101 patients. Convergent analysis informed iterative co-design of the \"Onco Care\" mobile application.ResultsQualitative analysis revealed five major themes: physical symptom burden, psychological distress, information gaps, home-based management inadequacy, and treatment adherence challenges. Substantial physical symptom burden was observed, particularly related to appetite disturbance, pain, and nausea. The systematic integration resulted in a comprehensive application featuring treatment planning, symptom management, nutrition guidance, peer support, and a healthcare provider dashboard, with cultural adaptations including multilingual support and visual interfaces to address 33.7% illiteracy rates.ConclusionsUser-centred design effectively translated authentic stakeholder needs into evidence-based digital health solutions, providing a replicable methodology for developing comprehensive mHealth interventions that address multi-dimensional challenges in cancer care while ensuring cultural appropriateness and accessibility.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261443469"},"PeriodicalIF":0.9,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147729097","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}
Seda Jeral Evinç, Çağla Eyüpler Akmercan, Zeliha Birsin, Selin Cebeci, Emir Çerme, Vali Aliyev, Hamza Abbasov, Ebru Çiçek, Süheyla Atak, Nebi Serkan Demirci, Özkan Alan
{"title":"Co-reported respiratory adverse events in trastuzumab deruxtecan-associated interstitial lung disease: A pharmacovigilance analysis of the FAERS database.","authors":"Seda Jeral Evinç, Çağla Eyüpler Akmercan, Zeliha Birsin, Selin Cebeci, Emir Çerme, Vali Aliyev, Hamza Abbasov, Ebru Çiçek, Süheyla Atak, Nebi Serkan Demirci, Özkan Alan","doi":"10.1177/10781552261442891","DOIUrl":"https://doi.org/10.1177/10781552261442891","url":null,"abstract":"<p><p>BackgroundTrastuzumab deruxtecan (T-DXd) is an effective HER2-directed antibody-drug conjugate used across multiple solid tumors. Interstitial lung disease (ILD) and pneumonitis are well-recognized as clinically significant toxicities associated with T-DXd. However, most real-world studies have focused on signal detection rather than the clinical context in which ILD is reported. The patterns by which ILD co-occurs with other respiratory adverse events in routine clinical practice remain poorly characterized.MethodsWe analyzed adverse event reports submitted to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) between 2015 and 2025 in which T-DXd was listed as a suspect drug. ILD, pneumonitis, and respiratory adverse events were identified using MedDRA Preferred Terms. A binary case-event matrix was constructed, and hierarchical clustering was used to explore patterns of respiratory adverse event co-reporting. Subgroup analyses were conducted for breast, gastric/gastroesophageal junction (GEJ), and lung cancer. Cluster stability was assessed using bootstrap resampling.ResultsA total of 759 ILD cases and 289 pneumonitis cases associated with T-DXd were identified. In breast cancer reports, ILD consistently clustered with dyspnea and cough, forming a concentrated respiratory co-reporting phenotype. In gastric/GEJ cancer reports, ILD showed strong co-reporting with pneumonia, suggesting overlap between drug-related lung injury and infectious respiratory presentations. Lung cancer reports demonstrated more heterogeneous respiratory co-reporting patterns, with less consistent clustering of ILD with specific symptoms. Network analysis identified ILD as a central node within the respiratory adverse event network. Across all tumor types, respiratory clusters were reproducible in bootstrap analyses, indicating stable and non-random co-reporting structures.ConclusionsILD associated with T-DXd is reported alongside distinct respiratory adverse event patterns that differ across tumor types. Examining these co-reported respiratory events may help clinicians better interpret ILD reports in real-world practice, particularly in the setting of overlapping or non-specific pulmonary symptoms.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261442891"},"PeriodicalIF":0.9,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690727","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":"Practical management of antineoplastic-induced nausea and vomiting from antibody-drug conjugates: Insights from a Canadian expert panel.","authors":"Katarzyna J Jerzak, Stephanie Snow, Jan-Willem Henning, Nathaniel Bouganim, Lysanne Besse","doi":"10.1177/10781552261441533","DOIUrl":"https://doi.org/10.1177/10781552261441533","url":null,"abstract":"<p><p>ObjectiveTrastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) are antibody-drug conjugates (ADCs) that are associated with clinically significant antineoplastic-induced nausea and vomiting (AINV), for which prophylaxis and management strategies vary in clinical practice. Integration of available evidence, guideline recommendations, and expert clinical experience is required to develop practical, expert-informed strategies and approaches for the prevention and management of AINV in patients receiving these agents.Data SourcesA systematized literature review of PubMed publications from 2020 to 2024 was conducted to identify evidence regarding AINV management in patients receiving T-DXd or SG. Search terms were developed in consultation with a multidisciplinary Canadian expert panel, including medical oncologists and oncology pharmacists from academic and tertiary cancer centers, and included terms related to nausea, vomiting, emesis, and supportive care, as well as specific ADC agents and antiemetic therapies. Findings were contextualized using local and international guidelines. Expert clinical consensus was achieved through two virtual meetings and two rounds of structured group discussions using a modified Nominal Group Technique.Data SummaryThe search identified 1229 records, with 32 articles relevant to ADCs. The Canadian expert panel used this evidence, supplemented with non-ADC chemotherapy studies where ADC-specific data were limited, to inform practical clinical strategies. These included prophylactic, combination-based antiemetic strategies tailored to emetogenic risk; steroid-sparing and individualized approaches based on patient response and tolerability; early escalation or modification of therapy for persistent symptoms; structured patient education on symptom recognition, medication adherence and tools for symptom monitoring for acute and delayed AINV.ConclusionsWe provide expert consensus recommendations for practical approaches for the management of AINV in patients receiving T-DXd or SG, including an antiemetic algorithm and tools for structured symptom monitoring. These approaches are intended to support consistent implementation of AINV management strategies in diverse oncology settings.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261441533"},"PeriodicalIF":0.9,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690746","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":"Identifying the limitations of the 2015 NIOSH vapor containment performance protocol for assessing closed system transfer devices.","authors":"Lori T Armistead, Stephen F Eckel","doi":"10.1177/10781552261441766","DOIUrl":"https://doi.org/10.1177/10781552261441766","url":null,"abstract":"<p><p>IntroductionThe purpose of this series of three studies was to identify the limitations of the 2015 NIOSH Vapor Containment Performance Protocol for Assessing Closed System Transfer Devices (CSTDs) as well as the variables that may impact results when testing CSTDs.MethodsTwo different lots of Equashield<sup>®</sup> CSTDs were tested in accordance with Task 2 of the protocol, using 70% isopropyl alcohol (IPA) as a challenge agent and either a Gasmet™ DX5000 Terra multigas FTIR analyzer or MIRAN<sup>®</sup> SapphIRe XL Infrared analyzer to measure IPA vapor concentrations. All studies were conducted in NIOSH-designed, custom-built testing chambers. Variables assessed to determine impact on results included: user technique, brand of IV bag, brand of IV administration line, where (inside or outside the chamber) IV bags, IV lines, and y-site adapter CSTDs were assembled, CSTD manufacturing dates, and analyzer type.ResultsThe variables that impacted testing results included user technique and experience, use or non-use of bulky gloves during y-site adapter-to-IV-line assembly, and analyzer. Variations in the brands of IV bags and IV administration lines and manufacturing dates of CSTDs did not impact the results.ConclusionBased on the known limitations of the 2015 NIOSH protocol, an improved testing protocol - with a better hazardous drug (HD) surrogate than IPA - is needed for assessing the true effectiveness of CSTDs in containing HDs. In the meantime, this protocol can be used to help CSTD manufacturers and/or end users isolate and mitigate potential weaknesses in their CSTD products and/or the compounding techniques used.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261441766"},"PeriodicalIF":0.9,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690794","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}
Nesrine Mejri, Myriam Saadi, Saif Baklouti, Yessine Boujneh, Ahmed Anas Haouari, Haifa Rachdi, Yosra Berrazaga, Hamouda Boussen
{"title":"Immunotherapy \"stop and go\" and early discontinuation: A viable option in limited resources setting.","authors":"Nesrine Mejri, Myriam Saadi, Saif Baklouti, Yessine Boujneh, Ahmed Anas Haouari, Haifa Rachdi, Yosra Berrazaga, Hamouda Boussen","doi":"10.1177/10781552261439656","DOIUrl":"https://doi.org/10.1177/10781552261439656","url":null,"abstract":"<p><p>BackgroundImmunotherapy (IO) has transformed cancer treatment, improving survival across various malignancies. However, optimal treatment duration and dosing regimens remain unclear. In low- and middle-income countries like Tunisia, access to IO is hindered by financial and logistical constraints, often leading to treatment interruptions. Understanding the impact of these interruptions on patient outcomes is crucial for optimizing care in resource-limited settings.This study aimed to evaluate the clinical outcomes of cancer patients who experienced IO interruptions in Tunisia due to factors unrelated to disease progression or limiting toxicity. It explored the feasibility of \"stop and go\" and early discontinuation strategies as potential alternatives in such settings.MethodsThis retrospective study included 82 cancer patients who experienced IO interruptions for reasons other than disease progression or limiting toxicity between 2019-2023. Interruptions were defined as delays beyond the standard inter-cycle interval which is usually 21 dyas (Stop and go) or therapy cessation before the recommended 2-year duration. Data were collected from hospital records, and the study evaluated response, overall survival (OS) and time to progression (TTP) using the Kaplan-Meier method.ResultsThe study population consisted mostly of males (79%) with non-small cell lung cancer (NSCLC) in 67%. Treatment interruptions occurred in two patterns: early discontinuation (43.8%) and on-off schedules (56.3%). The main cause of interruption was drug unavailability (66%). The response to IO included 2.7% complete response and 38.4% partial response. Median OS was 31 months and median TTP was 7.72 months. Univariate analysis did not reveal any significant prognostic factors.ConclusionsIO interruptions, though often unavoidable in resource-constrained settings, can yield outcomes comparable to uninterrupted therapy when managed effectively. Optimizing dosing regimens and personalizing treatment strategies may enhance access and efficacy while reducing costs and toxicity. These findings support the feasibility of alternative IO approaches in limited-resource settings for selected patients.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261439656"},"PeriodicalIF":0.9,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690825","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}
Khadija Ben Chaabane, Oussema Slimani, Raafa Ben Saada, Zeïneb Zghal, Mohamed Ali Yousfi, Imen Limayem
{"title":"Pain and metastatic cancer: Opioid prescribing practices and perceptions of their effectiveness.","authors":"Khadija Ben Chaabane, Oussema Slimani, Raafa Ben Saada, Zeïneb Zghal, Mohamed Ali Yousfi, Imen Limayem","doi":"10.1177/10781552261440200","DOIUrl":"https://doi.org/10.1177/10781552261440200","url":null,"abstract":"<p><p>IntroductionPain management in patients with metastatic cancer is a major challenge. The aim of this study is to analyse opioid prescribing practices and evaluate their effectiveness as perceived by patients.MethodsA descriptive, prospective study was conducted at the hospital pharmacy over a period of six months. Data were collected through direct interviews with patients. The study included patients diagnosed with metastatic cancer who were treated with opioids. The data collected concerned the demographic and clinical characteristics of the patients, as well as the prescription modalities, perceived efficacy and adverse effects of opioids.ResultsA total of 144 patients were included, with a mean age of 49.5 years. The most frequent tumour site was the breast (25.9%). Metastases were predominantly bone metastases (52.4%). The intensity of perceived pain was high, with a score of ≥7 on the visual analogue scale in 94% of patients before the initiation of analgesic treatment. Morphine was the most commonly prescribed opioid (61.8%). Tramadol and the combination of paracetamol and codeine were also widely used. The perceived efficacy of opioids was positive for 78.5% of patients, with complete pain relief in 41.7%. However, 21.5% of patients reported persistent pain despite analgesic treatment. The leading adverse effect was constipation (39%).Discussion/ConclusionThis study highlights the importance of pain management, one of the four core components of supportive cancer care, with morphine remaining the opioid of choice for providing effective analgesia. However, the high frequency of adverse effects underscores the need for improved symptomatic management strategies. This study has several limitations. Nevertheless, it provides valuable real-world insights into opioid use in cancer pain management and emphasizes the need for larger, multicenter studies to validate and further expand these findings.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261440200"},"PeriodicalIF":0.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674284","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":"Comparative pharmacovigilance signals for PD-1, PD-L1, CTLA-4, and LAG-3 immune checkpoint inhibitor-associated hemophagocytic lymphohistiocytosis in the FAERS database.","authors":"Connor Frey","doi":"10.1177/10781552261443222","DOIUrl":"https://doi.org/10.1177/10781552261443222","url":null,"abstract":"<p><p>BackgroundHemophagocytic lymphohistiocytosis (HLH) is a fulminant, hyperinflammatory syndrome increasingly recognized as a rare but devastating immune checkpoint inhibitors (ICI) toxicity. Given the lack of robust epidemiological data, a large-scale pharmacovigilance analysis was performed to characterize HLH reporting patterns across distinct ICI classes.MethodsThe FDA Adverse Events Reporting System (FAERS) was queried to identify HLH cases associated with FDA-approved PD-1, PD-L1, CTLA-4, and LAG-3 inhibitors from Q4 2003 through Q3 2025. Disproportionality analysis was conducted to quantify safety signals relative to the full database.ResultsAll major ICI classes were associated with HLH, with PD-L1 inhibitors (particularly atezolizumab) and CTLA-4 inhibitors showing the strongest signals; no single agent class appeared to be spared. Among PD-1 inhibitors, pembrolizumab exhibited the highest burden (n = 120; ROR 9.51, 95% CI 7.93-11.40), while cemiplimab demonstrated a high point estimate (ROR 10.56). In the PD-L1 class, atezolizumab showed the strongest signal among widely used agents (n = 76; ROR 14.48, 95% CI 11.54-18.18). The CTLA-4 inhibitor ipilimumab yielded substantial disproportionality (n = 54; ROR 12.77, 95% CI 9.76-16.70), and the LAG-3 inhibitor relatlimab showed a comparable signal (ROR 12.64) despite limited case numbers.ConclusionsThis analysis confirms HLH as a significant class-wide toxicity of immune checkpoint blockade, with robust safety signals observed for pembrolizumab, atezolizumab, and ipilimumab. These findings underscore the critical need for heightened clinical vigilance and rapid diagnostic evaluation for HLH in patients presenting with hyperinflammatory symptoms during immunotherapy.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261443222"},"PeriodicalIF":0.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674297","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}
Miguel Escario Gómez, Macarena García-Trevijano Cabetas, Clara Herranz Muñoz, María Gema Casado Abad, Luis Sánchez Rubio-Ferrández, Alicia Herrero Ambrosio
{"title":"Effectiveness and safety of first-line nivolumab-ipilimumab in metastatic renal cell carcinoma.","authors":"Miguel Escario Gómez, Macarena García-Trevijano Cabetas, Clara Herranz Muñoz, María Gema Casado Abad, Luis Sánchez Rubio-Ferrández, Alicia Herrero Ambrosio","doi":"10.1177/10781552261441841","DOIUrl":"https://doi.org/10.1177/10781552261441841","url":null,"abstract":"<p><p>Background/AimThe combination of nivolumab and ipilimumab is the standard first-line treatment for patients with metastatic renal cell carcinoma (mRCC) of intermediate or poor IMDC risk. However, real-world data in unselected populations remain limited. We aimed to evaluate the effectiveness and safety of nivolumab-ipilimumab in a real-world cohort and to describe subsequent therapies after progression.Patients and MethodsWe conducted a retrospective, observational, real-world study at a Spanish tertiary hospital. All adults with intermediate- or poor-risk mRCC who received first-line nivolumab-ipilimumab between January 2018 and June 2025 were included. Overall survival (OS), progression-free survival (PFS), second progression-free survival (PFS2), overall response rate (ORR), disease control rate (DCR), duration of response (DOR) and immune-related adverse events (irAEs) were evaluated. Survival was estimated using the Kaplan-Meier method. Exploratory subgroup analyses were performed according to Eastern Cooperative Oncology Group performance status (ECOG PS), histology, metastatic sites and presence of irAEs.ResultsForty-three patients were included; median age was 64 years and 83.7% were male. Most patients had ECOG PS 0-1 (79%), clear-cell histology (86%) and 28% had sarcomatoid features. Brain metastases were present in 14%. After a median follow-up of 32.2 months, median OS was 18.4 months; the 12 and 36-month OS rates were 59.0% and 44.0%, respectively. Median PFS was 5.1 months; the 12 and 36-month PFS rates were 29.4% and 25.7%, respectively. ORR was 27.9% (4.7% complete responses, 23.2% partial responses) and DCR was 46.5%. Among responders, median DOR was not reached; 81.8% and 68.2% remained free of progression at 12 and 36 months, respectively. Any-grade irAEs occurred in 51.2% of patients, grade ≥3 irAEs in 34.8%, and 16.3% discontinued treatment due to toxicity. ECOG PS ≥2 was associated with significantly worse OS (HR 8.59; p = 0.0029), whereas the occurrence of irAEs was associated with improved OS (HR 0.14; p = 0.001).ConclusionIn this real-world cohort of intermediate/poor-risk mRCC, nivolumab-ipilimumab showed lower median OS and PFS than in pivotal trials and some real-world series, likely reflecting poorer baseline prognostic features. Nevertheless, a clinically relevant subgroup of long responders achieved durable benefit, and the safety profile was consistent with previous reports. Nivolumab-ipilimumab remains an effective first-line option in real-world practice, particularly in patients achieving early disease control.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261441841"},"PeriodicalIF":0.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674313","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}
Paolo Amari, Karen Campbell, Mark Henry, Martha Polovich, Paul Sessink
{"title":"Development of a unified approach to hazardous medicinal product management using closed system drug transfer devices.","authors":"Paolo Amari, Karen Campbell, Mark Henry, Martha Polovich, Paul Sessink","doi":"10.1177/10781552261434870","DOIUrl":"https://doi.org/10.1177/10781552261434870","url":null,"abstract":"<p><p>ObjectiveTo provide an overview of global directives, standards, guidelines, and best practices in the management of hazardous medicinal products (HMPs) with closed system drug transfer devices (CSTDs).Data sourcesA literature review was performed using PubMed on CSTD performance, use, and cost-effectiveness. The authors provided information on directives, standards, and guidelines. A roadmap was proposed, which is the expert opinion of the authors.Data summaryDespite evidence supporting CSTD use and their successful implementation in the United States, their usage remains inconsistent in Europe. Additionally, directives, standards, and guidelines on the safe management of HMPs vary in their recommendations. A unified approach to hazardous medicinal product management using CSTDs is therefore needed which includes training, action by professional societies, clear stances from professional bodies on which CSTDs are recommended, development and wider use of testing protocols, identification of current variables in directives and guidelines, and general alignment on these.ConclusionsThere is a need for global alignment on HMP management and when to use CSTDs. Implementation of the proposed roadmap will lead to improvements in the safety of healthcare practitioners exposed to HMPs.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261434870"},"PeriodicalIF":0.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674359","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":"Rethinking centralised oncology pharmacy practice in the era of flat-dose immunotherapy, subcutaneous formulations and visit-administration day separation: A conceptual analysis and reform proposal.","authors":"Mauro Iannopollo","doi":"10.1177/10781552261443223","DOIUrl":"https://doi.org/10.1177/10781552261443223","url":null,"abstract":"<p><p>ObjectiveTo examine whether the centralised Oncology Pharmacy Unit (OPU) model, established in the late 1990s for BSA-dependent cytotoxic compounding, remains fit for purpose in a contemporary oncology context dominated by flat-dose immunotherapy and subcutaneous checkpoint inhibitor formulations, and to propose a stratified hybrid model proportional to actual preparation complexity.Data SourcesPublished clinical trial data for subcutaneous checkpoint inhibitors (IMscin001, CheckMate-67 T, IMscin002); EMA and FDA regulatory documents (2024-2025); peer-reviewed literature on flat-dose immunotherapy, time toxicity and oncology pharmacy workflow; institutional reports from IOV IRCCS Padua, NHS England, French SFPO and the Veneto Region Pharmacy Working Group.Data SummaryFour structural inefficiencies are documented: (1) identical compounding workflows applied to pharmacologically non-equivalent preparations; (2) subcutaneous formulations with up to 80% administration time reduction routed through the full compounding circuit without clinical justification; (3) per-preparation process costs exceeding vial-sharing savings for off-patent generics; and (4) same-day compression of clinical assessment, prescribing, compounding and administration generating structural day-hospital congestion and measurable patient time toxicity. A four-level stratified hybrid model is proposed: robotic automation for high-complexity cytotoxics, simplified workflow for flat-dose IV immunotherapy, ward-based preparation for subcutaneous products, and D/D + 1 visit-to-administration day separation as an institutional standard.ConclusionThe 1999 OPU model has outlived its pharmacological context. A stratified approach to oncology pharmacy organisation - proportional to actual preparation complexity - is operationally feasible, clinically safe and necessary to restore pharmacy resources to where they generate genuine value.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552261443223"},"PeriodicalIF":0.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147674306","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}