Journal of Oncology Pharmacy Practice最新文献

{"title":"Quantitative analysis of vial surface and cross-contamination of widely used antineoplastic drugs in Türkiye: A critical assessment for manufacturing and occupational safety.","authors":"Orhan Ziya, Tuba Reçber, Emirhan Nemutlu, Merve Güdül Bacanlı","doi":"10.1177/10781552251381167","DOIUrl":"https://doi.org/10.1177/10781552251381167","url":null,"abstract":"<p><p>IntroductionThe global rise in cancer incidence has led to an increased demand for antineoplastic agents, intensifying occupational risks associated with drug handling.MethodsThis study aimed to quantitatively assess both surface contamination and cross-contamination on the vials of six frequently used cytotoxic drugs in Türkiye, 5-fluorouracil (5-FU), doxorubicin, etoposide, gemcitabine, ifosfamide, and cyclophosphamide, using a standardized wipe sampling method followed by LC-MS/MS analysis. This study quantitatively assess both surface contamination on 65 vials of six frequently used cytotoxic drugs and cross-contamination on an extended set of 75 vials (including oxaliplatin), using a standardized wipe sampling method followed by LC-MS/MS analysis.ResultsOut of 65 vials, 63.08% were contaminated with the active pharmaceutical ingredient (API), while 49.33% of 75 vials exhibited cross-contamination with other APIs. Notably, contamination was present in 100% of 5-FU and gemcitabine samples, with the highest recorded level reaching 2276.920 ng/cm² (133199.848 ng/vial).ConclusionsWe explicitly state that this is the first study in Türkiye to assess both surface and cross-contamination on cytotoxic drug vials at a national level. These findings underscore significant disparities in manufacturing hygiene practices and highlight an urgent need for regulatory oversight to mitigate healthcare worker exposure risks. The study advocates mandatory contamination reporting, stricter decontamination protocols, and enhanced batch control measures in drug production facilities.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251381167"},"PeriodicalIF":0.9,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145131089","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":"Risk Evaluation and Mitigation Strategies (REMS) for oral oncolytics: Increased safety or barrier to access?","authors":"Vincent Harris, Ming-Hei Tai","doi":"10.1177/10781552251377770","DOIUrl":"https://doi.org/10.1177/10781552251377770","url":null,"abstract":"<p><p>Many oral oncolytics inhibit rapidly dividing cells and are teratogenic. However, only a few agents are restricted under a Risk Evaluation and Mitigation Strategies (REMS) program due to embryo-fetal toxicity. The benefit of a REMS program for only select oral oncolytics is unclear.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251377770"},"PeriodicalIF":0.9,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075152","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":"Risk assessment of pneumatic tube systems for in-hospital transportation of biotherapeutics.","authors":"Michaela Cohrs, Paula E Borgonje, Nele Clottens, Pieter Ramaut, Kevin Braeckmans, Stefaan De Smedt, Hristo L Svilenov, Tiene Bauters","doi":"10.1177/10781552251378729","DOIUrl":"https://doi.org/10.1177/10781552251378729","url":null,"abstract":"<p><p>IntroductionUse of Pneumatic tube systems (PTS's) poses a risk to inherently unstable protein therapeutics. Mechanical stress caused by those systems can lead to aggregation, compromising product safety and quality. However, PTS's are widely used in hospitals, and contradictory effects on protein stability have been reported.MethodsWe studied whether mechanical stress levels differ between hospitals and routes, potentially leading to different findings regarding protein aggregation. By transporting a mechanical sensor on nine different PTS routes in seven different hospitals, we quantified the accelerations that protein therapeutics experience in a specific PTS setup.ResultsIt was found that the maximum acceleration within the different PTS setups was similar. However, transportation times differed up to 4-fold, leading to varying amounts of cumulative stress.ConclusionThe cumulative and maximum stress quantified can be compared to stress found in studies investigating protein stability, which justifies the usage of mechanical sensors for risk evaluation. The differences in stress found underscore the importance of evaluating handling practices individually in each hospital, for each therapeutic protein.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251378729"},"PeriodicalIF":0.9,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075462","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":"Estimation of financial burden of breast cancer and its effect on quality of life.","authors":"Fiza Ayub, Tahir Mehmood Khan","doi":"10.1177/10781552251376301","DOIUrl":"https://doi.org/10.1177/10781552251376301","url":null,"abstract":"<p><p>BackgroundCancer survivors (CS) skipping follow-up appointments, discontinuing their prescriptions, and prolonging or refusing medical care have all been connected to financial stress spurred on by the disease. The aim of the study is to estimate the direct and indirect cost of breast cancer with the quality of life of breast cancer patients receiving treatment in a public hospital setting in Lahore, Pakistan.MethodsA cross-sectional study was conducted on females with breast cancer, and the instrument used was: a FACIT-B Version 4 questionnaire, and a demographic/clinical characteristics section, and given to a random sample of 130 Pakistani women. Data analysis included descriptive analysis, independent sample t-test, and ANOVA test.ResultsAccording to the survey, the average cost of illness was $218.14 per month, varying from $40.82 to $1367.42 per month. A significant difference was observed in terms of Physical Well-being (PWB) among the cost of food. We had not found any significant difference in terms of any direct and indirect cost of breast cancer treatment. There was a statistically significant relationship between the stage of cancer and entitlement with the socioeconomic status of the patient.ConclusionThe study's findings offer detailed insight into the financial hardship faced by breast cancer patients' families and propose potential policy implications. Future studies should examine different subgroups' financial experiences in order to better identify people who are at risk and provide tailored solutions.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376301"},"PeriodicalIF":0.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069727","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 retrospective study on the prescription pattern of commonly prescribed drugs in the Department of Surgical Oncology in a Tertiary Care Teaching Hospital.","authors":"Lakshmipuram Bipin Chakravarthy, Goutham Yerrakula, Gaddam Narasimha Rao, Navakoti Kusuma Reddy, Kunkala Priyanka, Kunnur Yogeshwara Naidu, K Mounika, P Dharani Prasad, Jeevan Kumar B, K Rohith Chandra","doi":"10.1177/10781552251376521","DOIUrl":"https://doi.org/10.1177/10781552251376521","url":null,"abstract":"<p><p>BackgroundSurgical oncology plays a key role in cancer therapy, combining surgical techniques with oncological care. Rational drug prescribing is essential for optimal patient outcomes, particularly in complex cancer care settings.ObjectivesThis study aimed to assess prescribing patterns and adherence to WHO prescribing indicators among surgical oncology patients within a tertiary care hospital.MethodsThis retrospective observational study was executed over a ten-month period (June 2023-March 2024) in the Department of Surgical Oncology at Sri Venkateshwara Institute of Medical Sciences, Tirupati. A total of 158 biopsy-confirmed cancer patients aged above 18 years were enrolled. Prescription data were systematically evaluated to determine drug classes utilized, prescribing frequency, and adherence to World Health Organization (WHO) core prescribing indicators.ResultsPatients aged 40-60 years represented the largest proportion of the cohort (39.90%), and females accounted for the majority of cases (69.60%). Adenocarcinoma was identified as the most prevalent cancer subtype (20.90%). Among antibiotics, cephalosporins were predominantly prescribed (92.92%), with cefuroxime being the most frequently utilized agent (31%). Analgesics were administered in 89.87% of cases, although opioid prescriptions remained relatively low (5.70%). WHO prescribing indicator analysis revealed: average drugs per encounter (3.15), generic prescribing rate (75.35%), essential drug list adherence (73.74%), and antibiotic encounter rate (62.65%). Deviations from WHO standards, particularly in antibiotic overuse and EDL adherence, were noted.ConclusionThe study identifies key prescribing trends and deviations from recommended practices. The findings emphasize the need for standardized, evidence-based prescribing protocols to reduce irrational drug use, enhance patient safety, and improve treatment efficacy in surgical oncology.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376521"},"PeriodicalIF":0.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069571","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":"The surface contamination of hazardous drugs in different working places of healthcare facilities in shaanxi, China.","authors":"Changkun Li, Silu Wang, Meiwen Wang, Linlin Jing, Chengsen Pang, Ni Ma, Weihua Dong","doi":"10.1177/10781552251376292","DOIUrl":"https://doi.org/10.1177/10781552251376292","url":null,"abstract":"<p><p>IntroductionSurface contamination from chemotherapy drugs poses occupational risks to healthcare workers, yet data from China are limited. This study assessed such contamination in healthcare facilities in Shaanxi Province.MethodsA cross-sectional study was conducted in 16 institutions. Surface wipe samples were collected from Pharmacy Intravenous Admixture Services (PIVAS) and drug preparation rooms in wards (DPRWs) over three days, before and after cleaning. Concentrations of cyclophosphamide (CP) and gemcitabine (Gem) were measured using HPLC-MS/MS. Statistical analyses evaluated contamination differences across environments and cleaning effects.ResultsA total of 659 samples were analyzed. In PIVAS, median Gem and CP levels ranged from 0.00-1.44 ng/cm² and 0.0011-1.10 ng/cm², respectively. In DPRWs, levels ranged from 0.01-3.53 ng/cm² (Gem) and 0.47-36.61 ng/cm² (CP), with CP consistently higher. Contamination concentrated on biological safety cabinet (BSC) surfaces in PIVAS and cabinet windows or preparation tables in DPRWs. Cleaning significantly reduced contamination, which correlated with drug preparation volume. While DPRWs had higher median contamination, the overall difference with PIVAS was not significant. However, DPRWs equipped with BSC had notably lower contamination.ConclusionsHazardous drug contamination remains a concern, especially in DPRWs without BSC. Enhanced cleaning protocols and stricter safety regulations are needed to protect healthcare workers in Chinese medical settings.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376292"},"PeriodicalIF":0.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069719","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":"Epidemiology of chemotherapy-related adverse drug reactions among patients with cancer in Ethiopia: A systematic review and meta-analysis.","authors":"Woretaw Sisay Zewdu, Samuel Berihun Dagnew, Mulugeta Molla Zeleke, Yared Andargie Ferede, Achenef Bogale Kassie, Muluken Adela Alemu, Tilay Arega Moges","doi":"10.1177/10781552251372165","DOIUrl":"https://doi.org/10.1177/10781552251372165","url":null,"abstract":"<p><p>ObjectiveAdverse drug reaction (ADR) induces iatrogenic harm, costs a lot in cancer care continuum. However, there is a dearth of concrete evidence regarding its prevalence in a resource-limited setting. Thus, the present systematic review set out to cohere the available evidences.Designsystematic review and meta-analysis.Data sourcesPubMed, CINAHL, Web of Science, EMBASE, and Google Scholar databases were searched.Eligibility criteriaobservational studies focused on the magnitude of chemotherapy-related ADRs among patients with cancer were eligible.Data extraction and synthesisPrimary studies quality was appraised employing the Joanna Briggs Institute (JBI) Checklist. A random-effects meta-analysis employing the meta package for proportions (Metaprop) was conducted. Heterogeneity was assessed with Cochrane's Q test and <i>I</i>² statistic, and publication bias with Egger's test and a funnel plot. Protocol was registered at PROSPERO with a reference number - [CRD42024546390].ResultsOut of 1507 identified studies, 7 were met the inclusion criteria. The pooled prevalence of ADRs was 43% [95% CI: 35%, 50%, <i>I</i>² = 87.06%]. Age > 65 years (<i>p</i> = 0.001), standard anticancer dose (<i>p</i> = 0.015), concomitant medication (<i>p</i> < 0.000), etoposide (<i>p</i> < 0.002), mercaptopurine (<i>p</i> < 0.041), doxorubicin (<i>p</i> < 0.005) and polychemotherapy (<i>p</i> < 0.001) were the predictors of chemotherapy-related ADRs.ConclusionChemotherapy-related ADRs are quite common among patient with cancer in Ethiopia. Consequently, healthcare providers should pay closer attention to ADR assessment and monitoring by using tailored screening tools, with special emphasis on older adults, those receiving standard anticancer doses, concomitant medications, polychemotherapy, or regimens containing etoposide, mercaptopurine, or doxorubicin to improve safety and efficacy of chemotherapies.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251372165"},"PeriodicalIF":0.9,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069586","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":"Establishing the clinical IDS pharmacist role in a phase 1 clinic.","authors":"Felecity Estrella, Julia Lewin, Anneliese Schuessler","doi":"10.1177/10781552251376302","DOIUrl":"https://doi.org/10.1177/10781552251376302","url":null,"abstract":"<p><p>BackgroundPhase 1 oncology clinical trials are complex and prioritize patient safety. Clinical pharmacists-experts in pharmacotherapy and patient-centered care-can enhance these trials by managing drug regimens and interactions. Despite demonstrated benefits, their integration into trial teams remains inconsistent. To address this, the Fred Hutch Phase 1 Clinical Trials Program embedded a clinical Investigational Drug Services (IDS) pharmacist into the clinic. This study assessed pharmacist utilization, intervention types, time spent, and inquiry sources.MethodsA retrospective review compared a pilot phase (Apr 2021-Apr 2022) and a follow-up (Apr-Sept 2023). Intervention type, frequency, duration, and communication modality were descriptively analyzed.ResultsDuring the pilot phase, 311 interventions were documented, primarily related to concomitant medication reviews (77%) and drug information (16%). In the 6-month follow-up period, 302 interventions were recorded, demonstrating an increased reliance on pharmacist services. Concomitant medication reviews remained high at 83%, indicating the pharmacist's critical role in medication management. Total intervention time was 93 h (pilot) compared to 72 h (follow-up), with a consistent median time per intervention. Over 85% of inquiries originated from study coordinators and nurses. The adoption of digital communication tools supported streamlined workflows and timely responses, aligning with broader clinic operational enhancements.ConclusionsThe integration of clinical IDS pharmacists enhanced the management of phase 1 trials while maintaining high safety and compliance standards. This study demonstrates the important contributions of pharmacists in supporting early-phase clinical trial research and highlights opportunities for expanding their role to meet growing trial complexities.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251376302"},"PeriodicalIF":0.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145054275","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":"Description and outcomes of a hospital-based pharmacovigilance system at a comprehensive cancer centre in Jordan.","authors":"Razan Sawalha, Abeer Al Rabayah","doi":"10.1177/10781552251370552","DOIUrl":"https://doi.org/10.1177/10781552251370552","url":null,"abstract":"<p><p>BackgroundThe fast emergence of new therapies requires monitoring their adverse drug reactions (ADRs) in real world oncology setting to mitigate negative health impacts. A functional Pharmacovigilance (PV) system is essential for detecting, assessing, and preventing ADRs. This study aims to describe the PV system at King Hussein Cancer Centre (KHCC), a comprehensive cancer center, and evaluate its functionality in terms of structure, processes, and outcomes.MethodsThis was a longitudinal descriptive study at KHCC. We used the Indicator Pharmacovigilance Assessment Tool (IPAT) to evaluate the functionality of the PV system in 2013, 2016, and 2020. The IPAT includes 29 adapted indicators, categorized into core and supplementary based on their importance to the PV system. Each indicator is scored based on predefined criteria with a 78.7% threshold defining PV system functionality. Required data were extracted from KHCC policies and procedures, Pharmacy and Therapeutic Committee meeting minutes, official medication safety correspondence, the ADRs documentation database, and drug use evaluation reports.ResultsThe overall functionality score was 74.5% in 2013, rising to 80.8% in 2016, exceeding the minimum IPAT threshold and becoming fully functional. By 2020, the score increased to 87.2%. The study highlights strengths in structural and process indicators, as all were met in 2020, except for two, while also identifying gaps in supplementary outcome indicators.ConclusionThe PV system at KHCC is functional and meets the IPAT minimum threshold for overall indicators. Continued efforts are essential to address the identified gaps, improve performance in outcome indicators and ensure the sustainability of pharmacovigilance activities within oncology practice.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251370552"},"PeriodicalIF":0.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145054211","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":"Tolerability of a Tunisian generic Docetaxel in early breast cancer: A prospective study.","authors":"Wala Ben Kridis, Rim Sahnoun, Chadha Maalej, Rim Atheymen, Serria Hammami, Nabil Toumi, Khaled Zeghal, Afef Khanfir","doi":"10.1177/10781552251377766","DOIUrl":"https://doi.org/10.1177/10781552251377766","url":null,"abstract":"<p><p>BackgroundDocetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere^®, a local produced generic formulation of Docetaxel, has been used since 2017. Concerns have been raised regarding the safety of certain generic of taxanes, but prospective data on Cytotere^® remain lacking. We aimed to evaluate the safety profile of Cytotere^® in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.MethodsWe conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere^® (100 mg/m² every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French Bégaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.Results60 patients were included. Asthenia (90%), arthralgia/myalgia (71.7%), mucositis (50%), and hand-foot syndrome (36.7%) were the most frequent adverse events. Grade 3 toxicities were rare, occurring in 16.7% of patients, most commonly hand foot syndrome and neutropenia. Febrile neutropenia was reported in 8.3% of cases. One hypersensitivity reaction (1.7%) was observed despite standardized premedication. Dose reduction was required in 23.3% of patients, and significantly associated with the occurrence of grade 3 toxicities (p < 0.001) and HFS (p = 0.008).ConclusionCytotere^® was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere^® in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251377766"},"PeriodicalIF":0.9,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145054241","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}