Journal of Oncology Pharmacy Practice最新文献

Introduction/Rationale for Study: This retrospective, observational analysis evaluated real-world hazardous drug (HD) surface wipe test data collected from U.S. healthcare facilities following implementation of a closed-system transfer device (CSTD). Methods: Wipe test submissions collected between 2018 and 2022 were analyzed to characterize the frequency, magnitude, and distribution of HD contamination across hospital systems, care locations, and drug analytes under routine clinical practice conditions. Although pre-implementation (baseline) wipe data were not available, this analysis reflects real-world effectiveness of CSTD use in minimizing detectable HD surface contamination within participating facilities. Results: Among 5531 wipe samples analyzed, 4.45% demonstrated measurable contamination, with the majority originating from two hospital systems. Higher contamination frequencies were observed in patient administration rooms and infusion areas compared with other locations, with 5-fluorouracil demonstrating higher contamination frequency relative to other analytes. Conclusion: An independent statistical analysis corroborated the initial Sponsor findings, confirming that using the CSTD significantly minimizes contamination and the potential for HD exposure risks. Variability in contamination across facilities and locations highlights the need for standardized cleaning protocols and clear standards for acceptable limits in hazardous drug handling. Overall, these data provide insight into HD contamination patterns observed during routine clinical use of a CSTD and support continued optimization of handling practices, along with prospective studies employing standardized wipe protocols and pre/post implementation designs.

IntroductionImmune checkpoint inhibitors (ICIs) are used across many solid tumor malignancies. The mechanism varies depending on the agent but ultimately leads to immune system activation by targeting key regulators of immune tolerance. Toxicities occur due to persistent activation of the immune system that can manifest in nearly all organs, including endocrinopathies. Although recognition has improved, the incidence of endocrinopathies should be evaluated in the real-world setting. The primary objective was to evaluate the incidence of select endocrine toxicities secondary to curative-intent ICI therapy in patients with solid tumor malignancies.MethodsThis was an observational, retrospective, single-center, cohort study of patients with solid tumor malignancies who received ICIs for curative intent at our institution. Patients had to be ≥ 18 years old and received ICI therapy between May 1, 2022 and March 30, 2023.ResultsFive hundred ten patients were included. Majority of patients received pembrolizumab or nivolumab, and the most common malignancies were breast (28%), melanoma (24%), and non-small cell lung cancer (16%). Twenty-five patients (4.9%) developed an endocrine toxicity with a median onset of 103 days. Hypothyroidism was the most common endocrine toxicity (52%). Nearly all endocrine toxicities were of Grade 2 severity (92%) with no Grade ≥ 4 events.ConclusionWe observed an incidence of endocrine toxicities of 4.9% with a median onset of 103 days in patients with solid tumor malignancies receiving curative intent ICI therapy. Generalizability of these results may be impacted by the exclusion of documented stage IV disease and palliative intent treatment.

IntroductionCancer services within the independent sector often operate with limited oncology pharmacists on site. This causes operational issues when leave occurs and can also limit overall capacity. While locum cover is a potential option, this often causes service disruption and negative patient experience due to lack of local knowledge. To tackle this issue, an enhanced pharmacy technician role was piloted.MethodsAn appropriate site and pharmacy technician were chosen based on key selection criteria. The selected pharmacy technician was then trained and accredited to manage all aspects of the oncology pharmacy service with the proviso that clinical tasks would be managed by a remote supporting oncology pharmacist. Feedback on the service from key stakeholders was collated and reviewed.ResultsThe response to the pilot study was extremely positive, with pharmacy management reporting elimination of locum requirement, the pharmacy technician reporting significant improvement in job satisfaction, and nursing colleagues reporting significant improvement in workflow and patient experience when comparing the enhanced pharmacy technician role to prior experiences with locum cover. The new role also improved overall capacity during normal working hours when the incumbent oncology pharmacist was on site.ConclusionThis study confirms the feasibility of the enhanced pharmacy technician role in enabling remote cover for a specialist service. It also provides a valuable professional development pathway for pharmacy technicians and has implications both internationally within oncology, and within other clinical specialty areas. Further research across multiple sites and specialties is warranted.

PurposeChildren with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and allogeneic haemopoietic stem cell transplantation (HSCT) are at high risk of invasive fungal infection (IFI), which contributes to morbidity and mortality. The purpose of this study was to describe fungal prophylaxis and IFI for children at our hospital.MethodsThe primary objective was to describe fungal prophylaxis for children with AML, relapsed ALL, and HSCT. Secondary objectives included describing prevalence of proven, probable, or possible fungal infections; type of fungal infection; and prevalence and type of adverse effects of fungal prophylaxis. This was a retrospective cohort study of children admitted to our hospital with AML, relapsed ALL, and HSCT between January 2015 and June 2019.ResultsWe included 105 patients with 263 inpatient visits. Eighty-three patients (79%) had fungal prophylaxis at all visits. Fungal prophylaxis was present at 91 (95%) inpatient visits for AML, 15 (21%) for relapsed ALL, and 87 (99%) for HSCT. Caspofungin was the most prescribed antifungal (86%). There were 4 patients each with proven and possible IFI and 11 patients with probable IFI, representing a prevalence of 18.1%. There were 10 patients with fungal infection in the lungs, 2 patients each in the liver and spleen, and 1 patient with disseminated fungal infection. There was a total of 283 adverse events in 79 (40.1%) patients.ConclusionThe prevalence of IFI in this population is within range of what is reported from other countries. Choice of fungal prophylaxis was consistent with published guideline recommendations.

BackgroundObservational studies increasingly inform treatment decisions for CDK4/6 inhibitors in metastatic breast cancer, yet their validity is compromised by immortal time bias, a mechanistic bias that inflates treatment benefits when follow-up begins at treatment initiation rather than at diagnosis. However, whether historical bias estimates generalise to contemporary CDK4/6 research with rapid treatment initiation remains unknown.MethodsWe conducted a simulation-based study comparing naive observational analysis (time-zero at treatment) with target trial emulation (time-zero at diagnosis) across three synthetic cohorts reconstructed from published CDK4/6 inhibitor studies: a Danish population registry (N equals 1196), the Rugo et al. Flatiron database (N equals 9146), and a germline BRCA subgroup analysis (N equals 4050). We quantified bias magnitude and examined associations with treatment delay, patient characteristics, and healthcare system factors.ResultsContrary to expectations, we observed minimal immortal time bias across all comparisons (mean absolute bias of 0.55 months, range 0.2 to 0.9 months; per cent bias of 0.5 to 2.1 per cent). Remarkably, all estimates showed underestimation by naive analysis, indicating that prevalent user bias (the exclusion of early deaths) dominated immortal time inflation. The duration of treatment delay accounted for only 25% of the variability in bias, indicating that context-dependent factors beyond delay duration determine bias magnitude.ConclusionsModern CDK4/6 inhibitor observational studies avoid historical immortal-time bias due to rapid treatment initiation and high event rates. These findings clarify that immortal time bias may be a smaller threat than historical cancer literature suggests in contemporary settings, though explicit time-zero specification remains a methodological best practice.

BackgroundOutpatient oncology pharmacies manage increasingly complex antineoplastic, hormonal, and supportive therapies that require precise and consistent patient counselling to ensure safe and effective use. Oral anticancer agents, hormonal therapies, biologics, and opioid analgesics pose particular challenges due to narrow therapeutic windows, long treatment durations, and specific administration and safety requirements. Inconsistent counselling may increase the risk of medication errors, non-adherence, and delayed recognition of adverse effects in cancer patients.ObjectiveTo develop a comprehensive and standardized oncology drug data resource to support pharmacists in delivering consistent, accurate, and patient-centered counselling in outpatient oncology care.MethodsThis study employed a cross-sectional tool development and descriptive evaluation design focused on the development and structured evaluation of a counselling support tool. A total of 63 active pharmaceutical ingredients (APIs) commonly used in outpatient oncology units were included. These APIs were selected to represent the most frequently dispensed and clinically high-risk medications encountered in routine outpatient oncology practice, while rarely used agents and therapies limited to inpatient or day-hospital settings were excluded to ensure practical relevance. Key counselling domains - administration instructions, safety precautions, red-flag symptoms, reproductive considerations, and storage requirements - were systematically compiled from validated references and expert pharmacist input. High-priority medications requiring enhanced counselling were identified based on treatment complexity and patient risk.ResultsEach medication required an average of 5-10 counselling points, reflecting the heterogeneity and complexity of outpatient oncology therapies. The finalized tool provides structured counselling guidance for all included APIs and is designed for integration into the hospital electronic system, allowing multilingual printing for inclusion in patient documentation. This dual-format approach may facilitate consistent access to reliable counselling information for healthcare professionals and patients.ConclusionThis structured oncology drug data resource offers a validated, accessible, and standardized reference intended to support patient counselling in outpatient oncology practice. This study provides a descriptive evaluation of the developed tool rather than an assessment of clinical effectiveness or patient-level outcomes. Its integration into hospital information systems has the potential to contribute to safe medication use, improved adherence, and high-quality patient education, but these effects remain to be evaluated in future studies. Future studies should assess its impact on patient comprehension, adherence, and clinical outcomes in cancer care.

BackgroundMultidisciplinary care programs are developed to secure oral anticancer treatments and ensure continuity of care. The aim of this study is to assess the impact of this educational pathway on patients' knowledge of oral anticancer drugs and other medicines, 6 months after the start of anticancer drug.MethodA single-center prospective study was conducted between January 2019 and 2020 on adult patients starting oral anticancer drugs and followed up in the Oncoral outpatient pathway. A 4 domains questionnaire was developed to assess patients' knowledge of: 1/ anticancer drug, 2/adverse effects, 3/symptomatic medications and 4/ the risk of interaction with medicinal plants. The assessment was carried out 1 month and 6 months after starting the anticancer drug.Results96 patients answered the questionnaire. Oral anticancer drugs were prescribed for malignant hemopathy (n = 55, 57%) or solid tumor (n = 41, 43%). Patients knowledge on self-administration of oral anticancer drugs and associated treatments, adverse effects and symptomatic medication and the risk of interaction with complementary medicines significantly improved over time (p < 0001). Discontinuous oral anticancer drugs schedules were associated with lower knowledge score than continuous. Health literacy was reported for 41% of patients and 56% had satisfactory level.ConclusionOncoral is the first multidisciplinary community-hospital follow-up program to demonstrate improved patient knowledge of self-administration of oral anticancer drugs and associated treatments, adverse effects and symptomatic medication and the risk of herb-drug interactions. Vulnerability factors associated with level of knowledge have not been identified and investigations should be extended to larger populations.

IntroductionImmune checkpoint inhibitors (ICIs), such as anti-PD-1/PD-L1 antibodies, improve survival in patients with advanced malignancies. However, their combination with chemotherapy may increase the incidence of severe immune-related adverse events (irAEs), including rare but life-threatening dermatologic toxicities.Case reportWe report the case of a 69-year-old male diagnosed with stage IV squamous cell lung cancer who received first-line treatment with carboplatin, paclitaxel, and pembrolizumab. Two days after the third cycle, he developed non-itching macular lesions which progressively extended to over 90% of the body surface area (BSA) and evolved into large bullous lesions with exudation. Antineoplastic treatment was discontinued and the patient was hospitalized.Management and outcomeSystemic corticosteroids, antihistamines, and analgesics were initiated, along with topical wound care with steroids and zinc sulphate. Due to the limited response to treatment, etanercept was administered and the patient was transferred to a specialized burn unit, where corticosteroid therapy and topical wound care were continued until re-epithelialization. Eventually, after 16 days of admission, the patient was discharged with a diagnosis of toxic epidermal necrolysis (TEN) secondary to immunotherapy.DiscussionSJS/TEN are rare, life-threatening cutaneous adverse reactions potentially triggered by ICIs. Management involves prompt identification and discontinuation of the offending drug, initiation of supportive measures, and meticulous skin care. The use of systemic corticosteroids remains controversial. TNF-α inhibitors, such as etanercept, have shown efficacy in different studies, but additional trials are needed to confirm these findings. This case highlights the importance of early recognition and multidisciplinary management of severe ICI-induced dermatologic toxicity.

İntroductionThe standard treatment for hormone receptor-positive and HER2-negative metastatic breast cancer is a combination of CDK4/6 inhibitors and endocrine therapy.Case reportIn this case, our aim was to demonstrate the safety and effectiveness of ribociclib in a patient with metastatic breast cancer undergoing hemodialysis three days a week.Management & OutcomeA 59-year-old female patient with end-stage kidney disease who undergoes hemodialysis was diagnosed with metastatic breast cancer. The tumour is hormone receptor positive and HER2 negative. She received ribociclib with a reduced dose due to haematological toxicity, as well as letrozole and denosumab due to bone metastasis. PET/CT scans revealed that the primary tumour had regressed by 50%, with partial regression of the metabolic activity of the bone metastases. Ribociclib was administered safely and effectively for nine months.DiscussionWe presented our experience of using ribociclib in a patient with metastatic breast cancer who was receiving hemodialysis. Ribociclib was administered safely, and a response to the treatment was achieved.

IntroductionThe most important cause of cervical cancer is Human Papilloma Virus (HPV). The most important method of protection against HPV infection is vaccination. As pharmacy students will be the pharmacists of the future, they need to have sufficient knowledge about HPV infection, HPV testing, and HPV vaccines. This study aimed to measure the knowledge level of students about HPV infection, testing and vaccines at a pharmacy faculty in Türkiye.MethodsThis online survey was conducted among students at the Süleyman Demirel University Faculty of Pharmacy in Isparta between November and December 2024. The Turkish version of the HPV Knowledge Scale was used.ResultsA total of 255 students (63.75%) participated in this study. The mean HPV Knowledge Scale score was 15.25 ± 6. 67. The vaccination rate of students was 7.1%. Students' sources of information about HPV vaccines were mostly social media (30.3%) and pharmacists (23.5%). Gender and grade year were found to have a significant effect on HPV test and vaccine scores (p < 0.05).ConclusionIn this study, the overall HPV scale score was found to be average. Although students had an acceptable level of knowledge about HPV infection, they lacked sufficient knowledge about HPV testing and HPV vaccines. To raise awareness about HPV in Türkiye, topics such as HPV awareness can be incorporated into university curricula. Social campaigns and informative videos can be organized with health experts on social media platforms where young people are active.