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Optimizing medication therapy in elderly patients: The impact of medication review using STOPP and START criteria version 2. 优化老年患者的药物治疗:使用 STOPP 和 START 标准 2 版进行药物审查的影响。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-18 DOI: 10.1177/10781552241296882
Silpa Murali, Aswin Damodaran, Namita Maria Jacob, Anjaly Venugopal, Joveena Johnson, Meenu Vijayan, K Pavithran, M Sonal Sekhar

Background: Higher prevalence of inappropriate medication use among cancer patients increases risk of drug-related problems(DRP) like drug-drug interactions, ADR, and non-adherence. Potentially inappropriate medication (PIM) and Potential Prescription Omission (PPO) were identified using Screening Tool of Older Person's Prescriptions (STOPP) and Screening Tool to Alert Doctors to the Right Treatment (START) criteria. Objectives: The study objective was to optimize prescriptions for the elderly by analyzing the impact of medication review. Methods: An observational study in which PIM and/or PPO were identified and the prescriptions were optimized by a physician. Results: Out of 150 patients, a total of 35 drugs were stopped and 12 drugs were started. Medication omissions were identified in 12 patients (8%). There were no DRPs associated with medication adjustments. Conclusion: Based on a pharmacist-led comprehensive medication review of the elderly, the STOPP and START criteria allow the optimization of prescriptions.

背景:癌症患者用药不当的发生率较高,这增加了药物相关问题(DRP)的风险,如药物相互作用、药物不良反应和不依从性。我们使用老年人处方筛查工具(STOPP)和提醒医生正确治疗的筛查工具(START)标准来确定潜在的用药不当(PIM)和潜在的处方遗漏(PPO)。研究目标研究目的是通过分析药物审查的影响来优化老年人的处方。方法:一项观察性研究,其中确定了 PIM 和/或 PPO,并由一名医生对处方进行优化。结果在 150 名患者中,共有 35 种药物被停用,12 种药物被启用。发现有 12 名患者(8%)漏服药物。没有与药物调整相关的 DRP。结论基于药剂师主导的老年人综合用药检查,STOPP 和 START 标准可优化处方。
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引用次数: 0
Enteral tube administration of extemporaneously compounded suspensions of venetoclax according to an institutional medication use process. 根据机构用药流程,对临时配制的 venetoclax 悬浮液进行肠内管给药。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-18 DOI: 10.1177/10781552241299690
Sakib T Haque, Joseph S Bubalo

Introduction: Venetoclax is a potent oral oncology drug (OOD) frequently used to treat hematologic cancers due to its convenience and high efficacy. However, some patients cannot tolerate solid oral formulations, requiring a reformulated version of venetoclax for effective administration. Currently, there is limited information in the literature regarding the extemporaneous compounding of venetoclax.

Methods: We present our institution's medication use process (MUP) for preparing compounded suspensions of venetoclax for patients with dysphagia who cannot tolerate solid oral formulations. This report has two main aims: to review our MUP from design to implementation, illustrated with real patient cases, and to present it as a strategy for administering venetoclax-based therapies to patients with dysphagia or feeding tubes. From February 2020 to January 2024, 17 patients received venetoclax through the standard MUP, with four developing tumor lysis syndrome (TLS). This study describes their clinical courses and evaluates their responses to the compounded suspensions, considering the uncertain effects of venetoclax prepared through this method.

Results: The four patients received venetoclax suspensions during hospitalization due to swallowing difficulties or nutritional support needs. We prepared extemporaneous venetoclax suspensions to ensure continuous therapy, thus avoiding treatment interruptions. TLS was managed using rasburicase and prophylactic allopurinol.

Conclusions: The clinical outcomes indicate that the current MUP provides a practical approach to administering venetoclax for dysphagic patients. However, additional research is needed to determine if there are pharmacokinetic differences in the bioavailability of venetoclax between oral and enterally delivered formulations. Further studies will help inform best practices for patient care.

简介Venetoclax 是一种强效口服肿瘤药物(OOD),因其服用方便、疗效显著而常用于治疗血液肿瘤。然而,有些患者不能耐受固体口服制剂,因此需要重新配制 Venetoclax 才能有效给药。目前,有关 venetoclax 即用复方制剂的文献资料十分有限:我们介绍了本机构为无法耐受固体口服制剂的吞咽困难患者配制复方 venetoclax 悬浮液的用药流程 (MUP)。本报告有两个主要目的:回顾我们的 MUP 从设计到实施的整个过程,并以真实的患者病例加以说明;将其作为一种策略,用于为吞咽困难或插管喂养的患者提供基于 Venetoclax 的疗法。从2020年2月到2024年1月,17名患者通过标准MUP接受了venetoclax治疗,其中4人出现了肿瘤溶解综合征(TLS)。本研究描述了他们的临床过程,并评估了他们对复方混悬液的反应,同时考虑到通过这种方法制备的 venetoclax 的不确定性影响:四名患者因吞咽困难或营养支持需要而在住院期间接受了 Venetoclax 悬浮液治疗。我们临时配制了 Venetoclax 悬浮液,以确保持续治疗,从而避免治疗中断。使用拉布替卡酶和预防性别嘌呤醇治疗了TLS:临床结果表明,目前的 MUP 为呼吸困难患者提供了一种实用的 Venetoclax 施用方法。然而,还需要进行更多的研究,以确定口服制剂和肠道给药制剂的生物利用度是否存在药代动力学差异。进一步的研究将有助于为患者护理的最佳实践提供依据。
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引用次数: 0
Qualitative analysis of clinical pharmacy interventions in an inpatient leukemia service. 对白血病住院服务中临床药学干预措施的定性分析。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-11 DOI: 10.1177/10781552241296407
Rand Al-Hadaddin, Nour Mustafa, Ahmad Alyamani, Nour Faqeer

Introduction: Leukemia, a complex hematological malignancy, requires a multidisciplinary treatment approach, with clinical pharmacists playing a crucial role. However, their involvement in clinical practice is not well-documented in the literature. This study aimed to examine the characteristics of clinical pharmacy interventions (CPIs) reported by clinical pharmacists.

Method: This retrospective study involved extraction of CPIs entered into a pharmacy documentation database "Quantifi®" between January 2019 and June 2023. These CPIs included direct clinical pharmacist interventions (DCPIs), detected medication errors (MEs) and adverse drug reactions (ADRs).

Results: A total of 6286 CPIs were extracted, of which DCPIs, MEs and ADRs accounted for 5701 (90.7%), 357 (5.7%) and 228 (3.6%) reports, respectively. The most prevalent DCPIs were drug therapy discontinuation (n = 1080, 18.9%). Antimicrobials were the most common medications associated with DCPIs (n = 1991, 34.9%). Physicians accepted 99.4% of DCPIs and 64.1% (n = 3656) of direct interventions were considered significant. Among detected MEs, antimicrobials were the most reported medications (n = 158, 44.3%), with pharmacy internal errors being the most prevalent cause of the events (n = 172, 48.2%). Among the reported ADRs, hematological reactions were the most common (n = 81, 35.5%), and antineoplastic agents were the most frequently associated medications with ADRs (n = 164, 71.9%).

Conclusion: This study highlights the crucial role of clinical pharmacists in managing leukemia patients, emphasizing their key interventions and ability to identify MEs and ADRs. Further research is needed to explore the clinical outcomes and financial impact of their involvement.

简介:白血病是一种复杂的血液恶性肿瘤,需要采用多学科治疗方法,临床药剂师在其中发挥着至关重要的作用。然而,他们在临床实践中的参与并没有在文献中得到充分记录。本研究旨在探讨临床药师报告的临床药学干预(CPIs)的特点:这项回顾性研究涉及提取 2019 年 1 月至 2023 年 6 月期间输入药学文档数据库 "Quantifi®"的 CPI。这些 CPI 包括临床药师直接干预 (DCPI)、检测到的用药错误 (ME) 和药物不良反应 (ADR):共提取了 6286 份 CPI,其中 DCPI、ME 和 ADR 报告分别占 5701 份(90.7%)、357 份(5.7%)和 228 份(3.6%)。最常见的 DCPIs 是药物治疗中断(1080 例,18.9%)。抗菌药物是与 DCPIs 相关的最常见药物(n = 1991,34.9%)。医生接受了 99.4% 的 DCPIs,64.1%(n = 3656)的直接干预被认为是有意义的。在检测到的 MEs 中,抗菌药物是报告最多的药物(n = 158,44.3%),药房内部错误是最常见的事件原因(n = 172,48.2%)。在报告的不良反应中,血液学反应最为常见(n = 81,35.5%),抗肿瘤药物是最常发生不良反应的药物(n = 164,71.9%):本研究强调了临床药剂师在管理白血病患者中的关键作用,强调了他们的关键干预措施以及识别 ME 和 ADR 的能力。需要进一步开展研究,探讨药剂师参与的临床结果和经济影响。
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引用次数: 0
Systemic therapy for non-clear cell renal cell carcinomas: A systematic review. 非透明细胞肾细胞癌的系统治疗:系统综述。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-11 DOI: 10.1177/10781552241289920
Balqees Ara, Anum Babar, Durkho Atif, Bushra Ghafoor, Mustafa Shah, Syed Maaz Abdullah, Danish Safi, Amir Kamran

Objective: Renal cell carcinoma (RCC) is the most common kidney cancer, with clear cell RCC being the predominant subtype. However, non-clear cell RCC constitutes a significant proportion of cases, presenting distinct challenges in treatment due to its varied histological subtypes. Despite recent advancements, the optimal therapeutic approach for non-clear cell RCC remains uncertain due to limited high-quality evidence. This systematic review aims to evaluate the efficacy of systemic therapies in nccRCC subgroups.

Data source: A comprehensive literature search identified studies from 2010 to 2024, using PubMed and Clinicaltrials.gov databases focusing on clinical trials and treatment outcomes.

Data summary: Results highlight the evolving therapeutic landscape, with targeted agents and immunotherapy demonstrating promising anti-tumor effects. Notably, tyrosine kinase inhibitors (TKIs) such as sunitinib and mTOR inhibitors like temsirolimus have shown efficacy across different subtypes. Combination therapies, including immunotherapy-based regimens, have also shown favorable outcomes. immune checkpoint inhibitors such as nivolumab and pembrolizumab demonstrated encouraging antitumor activity. Furthermore, specific targeting of signaling pathways, such as the c-MET pathway, has demonstrated efficacy in certain PapillaryRCC.

Conclusion: While combination therapies, including immunotherapies, have shown positive outcomes, immune checkpoint inhibitors like nivolumab and pembrolizumab have demonstrated encouraging antitumor activity. Additionally, targeting the c-MET pathway has proven effective in certain papillary RCC. Further research is warranted to establish optimal treatment strategies and improve outcomes for patients with non-clear cell RCC. Systemic therapy for non-clear cell RCC is complex and evolving. Further research is needed to delineate optimal treatment strategies for different histological subtypes and improve patient outcomes.

目的:肾细胞癌(RCC)是最常见的肾癌,其中透明细胞癌是最主要的亚型。然而,非透明细胞 RCC 占了相当大的比例,由于其组织学亚型各不相同,给治疗带来了独特的挑战。尽管最近取得了一些进展,但由于高质量证据有限,非透明细胞 RCC 的最佳治疗方法仍不确定。本系统综述旨在评估系统疗法在非透明细胞RCC亚组中的疗效:数据来源:利用PubMed和Clinicaltrials.gov数据库对2010年至2024年的研究进行了全面的文献检索,重点关注临床试验和治疗结果:研究结果凸显了不断发展的治疗前景,靶向药物和免疫疗法显示出良好的抗肿瘤效果。值得注意的是,舒尼替尼等酪氨酸激酶抑制剂(TKIs)和temsirolimus等mTOR抑制剂已在不同亚型中显示出疗效。免疫检查点抑制剂(如 nivolumab 和 pembrolizumab)显示出令人鼓舞的抗肿瘤活性。此外,针对信号通路(如 c-MET 通路)的特异性靶向治疗已在某些乳头状 RCC 中显示出疗效:结论:包括免疫疗法在内的综合疗法已显示出积极的疗效,nivolumab 和 pembrolizumab 等免疫检查点抑制剂已显示出令人鼓舞的抗肿瘤活性。此外,靶向 c-MET 通路已被证明对某些乳头状 RCC 有效。为确立最佳治疗策略并改善非透明细胞 RCC 患者的预后,还需要进一步的研究。非透明细胞 RCC 的系统治疗非常复杂且不断发展。需要开展进一步研究,为不同组织学亚型确定最佳治疗策略,改善患者预后。
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引用次数: 0
Barriers to opioid use in the Arab world. 阿拉伯世界使用阿片类药物的障碍。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-11 DOI: 10.1177/10781552241292497
Sewar Salmany, Suzan Hammoudeh, Asma Al-Khrabsheh, Saad Jaddoua, Omar Shamieh, Imad Treish

Background: The Arab world consists of 22 countries, representing 5.5% of the world's population. Morphine consumption accounts for less than 1% of the world's consumption. This is the first study to identify barriers to opioid use in the Arab world.

Aim: This study aimed to investigate the barriers to opioid use in pain management in the Arab world.

Method: Online survey was developed to investigate barriers to governance, prescribing, distributing, dispensing and administering, as well as educational barriers in the Arab world. The questionnaire was sent via email and a mobile app to one expert physician in pain management and one licensed pharmacist from each Arab country.

Results: With the exception of Tunisia, Djibouti and Comoros, 34(77%) participants from 19 Arab countries answered the survey. Most countries lack local opioid production, necessitate special licenses for physicians, and restrict opioid prescribing to medical specialists. Special prescription forms are mandated, and pharmacists lack the authority to correct prescription errors or accept refill or verbal orders on opioids. Storage requirements for empty ampoules and prescriptions are enforced. Nurses are not allowed to carry opioids during home visits, and only first degree relatives can collect opioids for patients. Furthermore, the integration of palliative care and pain management curricula into pharmacies and medical schools is lacking.

Conclusion: There is a wide range of regulatory and other barriers to opioid use in the Arab world. There is a substantial need for regulatory review and reform, as well as for educational initiatives, in most Arab countries.

背景:阿拉伯世界由 22 个国家组成,占世界人口的 5.5%:阿拉伯世界由 22 个国家组成,占世界人口的 5.5%。吗啡的消费量不到世界消费量的 1%。本研究旨在调查阿拉伯世界在疼痛治疗中使用阿片类药物的障碍:制定了在线调查问卷,以调查阿拉伯世界在治理、处方、分发、配药和用药方面的障碍以及教育障碍。调查问卷通过电子邮件和移动应用程序发送给每个阿拉伯国家的一名疼痛管理专家医师和一名执业药剂师:除突尼斯、吉布提和科摩罗外,来自 19 个阿拉伯国家的 34 名参与者(77%)回答了调查问卷。大多数国家缺乏阿片类药物的本地生产,医生必须持有特殊执照,阿片类药物的处方仅限于医疗专家。规定必须使用特殊的处方表格,药剂师无权纠正处方错误或接受阿片类药物的补货或口头订单。空安瓿和处方的储存要求得到强制执行。护士在家访时不得携带阿片类药物,只有一级亲属才能为病人领取阿片类药物。此外,药房和医学院缺乏姑息治疗和疼痛管理课程的整合:结论:在阿拉伯世界,阿片类药物的使用存在广泛的监管障碍和其他障碍。大多数阿拉伯国家亟需进行监管审查和改革,并采取教育措施。
{"title":"Barriers to opioid use in the Arab world.","authors":"Sewar Salmany, Suzan Hammoudeh, Asma Al-Khrabsheh, Saad Jaddoua, Omar Shamieh, Imad Treish","doi":"10.1177/10781552241292497","DOIUrl":"https://doi.org/10.1177/10781552241292497","url":null,"abstract":"<p><strong>Background: </strong>The Arab world consists of 22 countries, representing 5.5% of the world's population. Morphine consumption accounts for less than 1% of the world's consumption. This is the first study to identify barriers to opioid use in the Arab world.</p><p><strong>Aim: </strong>This study aimed to investigate the barriers to opioid use in pain management in the Arab world.</p><p><strong>Method: </strong>Online survey was developed to investigate barriers to governance, prescribing, distributing, dispensing and administering, as well as educational barriers in the Arab world. The questionnaire was sent via email and a mobile app to one expert physician in pain management and one licensed pharmacist from each Arab country.</p><p><strong>Results: </strong>With the exception of Tunisia, Djibouti and Comoros, 34(77%) participants from 19 Arab countries answered the survey. Most countries lack local opioid production, necessitate special licenses for physicians, and restrict opioid prescribing to medical specialists. Special prescription forms are mandated, and pharmacists lack the authority to correct prescription errors or accept refill or verbal orders on opioids. Storage requirements for empty ampoules and prescriptions are enforced. Nurses are not allowed to carry opioids during home visits, and only first degree relatives can collect opioids for patients. Furthermore, the integration of palliative care and pain management curricula into pharmacies and medical schools is lacking.</p><p><strong>Conclusion: </strong>There is a wide range of regulatory and other barriers to opioid use in the Arab world. There is a substantial need for regulatory review and reform, as well as for educational initiatives, in most Arab countries.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241292497"},"PeriodicalIF":1.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142622356","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}
引用次数: 0
Carboplatin dosing in obese patients. 肥胖患者的卡铂剂量。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-11-04 DOI: 10.1177/10781552241292503
Cristina Ramírez-Roig, Alberto Espuny-Miró, Raquel Olmos-Jiménez, María Sacramento Díaz-Carrasco

Objectives: The study aimed to: 1) Describe the carboplatin dosing criteria in obese patients in routine clinical practicein a general university hospital. 2) Evaluate toxicity based on the dosing criterion used. 3) Assess effectiveness in major diagnoses according to the dosing criterion employed.

Methodology: An observational, retrospective, descriptive study, including all obese patients (BMI ≥ 30 kg/m2) who started carboplatin treatment between 1st January 2012 and 31st January 2015. Data on patient characteristics, disease and treatment were collected. As a result variables were collected: carboplatin dosing methods, dosage criteria, alternative dosing approaches, treatment delays, dose reductions, relative dose intensity, adverse reactions and severity (CTCAE v. 4.0) as well as overall survival and progressive free survival for major diagnoses.

Conclusions: 1) Carboplatin dosing at the centre used Calvert's formula for calculating AUC and Cockcroft-Gault's formula for estimating glomerular filtration rate. 2) Cockcroft-Gault's formula employed actual body weight and ideal adjusted body weight in similar proportions. 3) The ideal adjusted body weight was more commonly used in patients with higher obesity and diabetes. 4) In the general population, the developmental trend of toxicity during treatment was greater in the group dosed by actual body weight, reaching significant differences in thrombopenia, neutropenia, GOT elevation, hyporexia and myalgias. 5) Major diagnoses in the present study were ovarian cancer and non-small cell lung cancer. The effectiveness in terms of overall survival and progression-free survival, comparing the groups dosed by actual body weight and ideal adjusted body weight within each pathology did not show statistically significant differences.

目标:本研究旨在1) 描述一家综合性大学医院在常规临床实践中对肥胖患者使用卡铂的剂量标准。2)根据使用的剂量标准评估毒性。3)根据采用的剂量标准评估主要诊断的有效性:观察性、回顾性、描述性研究,包括2012年1月1日至2015年1月31日期间开始卡铂治疗的所有肥胖患者(体重指数≥30 kg/m2)。研究收集了有关患者特征、疾病和治疗的数据。收集的变量包括:卡铂给药方法、剂量标准、替代给药方法、治疗延迟、剂量减少、相对剂量强度、不良反应和严重程度(CTCAE v.4.0)以及主要诊断的总生存期和无进展生存期:1)该中心的卡铂剂量使用卡尔弗特公式计算AUC,使用Cockcroft-Gault公式估算肾小球滤过率。2)Cockcroft-Gault 公式中实际体重和理想调整体重的比例相似。3)理想调整体重更常用于肥胖和糖尿病患者。4)在普通人群中,按实际体重用药组在治疗期间的毒性发展趋势更大,在血栓性血小板减少症、中性粒细胞减少症、GOT 升高、厌食症和肌痛等方面差异显著。5)本研究的主要诊断为卵巢癌和非小细胞肺癌。在总生存期和无进展生存期方面,比较每种病理类型中按实际体重和理想调整体重用药的组别,其疗效未显示出统计学上的显著差异。
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引用次数: 0
Deprescribing in hospitalized patients with cancer: A clinical pharmacist-initiated multidisciplinary intervention. 住院癌症患者的去处方化:临床药剂师发起的多学科干预。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-10-29 DOI: 10.1177/10781552241294016
Razan Sakran, Michael Litvak, Nissim Haim, Daniel Kurnik

Purpose: To examine the feasibility and utility of a clinical pharmacist-led multidisciplinary deprescribing intervention in hospitalized cancer patients.

Methods: We performed a retrospective cohort study among cancer patients hospitalized in oncology department who underwent a medication review by a clinical pharmacist. The pharmacist's recommendations were evaluated by a multidisciplinary team. We collected demographic and clinical information, including information on medication burden before and after intervention and number and types of deprescribing recommendations and their acceptance, and compared them among patients with different estimated life expectancies.

Results: During a 2-year study period, 392 patients evaluated by the clinical pharmacist received 2808 prescriptions (median, 7 per patient). The clinical pharmacist recommended deprescribing of 559 medications (19.9%; 95 CI, 18.4-21.4%), at least 1 medication in 321 patients (82%). The multidisciplinary team accepted 89.6% of deprescribing recommendations, resulting in a reduction of the medication burden by 501 medications (P < 0.001). 12.8% of deprescriptions addressed clinically manifested adverse drug effects in 15.1% of patients. The estimation of life expectancy by the senior oncologist was reasonably accurate, but did not affect deprescribing rate.

Conclusions: A clinical pharmacist-led deprescribing intervention within a multidisciplinary team effectively reduces medication burden and addresses adverse drug effects in cancer patients. Deprescribing interventions should be incorporated in cancer patients at any stage of the disease.

目的:研究以临床药师为主导的多学科处方干预对住院癌症患者的可行性和实用性:我们对在肿瘤科住院的癌症患者进行了一项回顾性队列研究,这些患者接受了临床药剂师的用药审查。药剂师的建议由一个多学科团队进行评估。我们收集了人口统计学和临床信息,包括干预前后的用药负担、停药建议的数量和类型及其接受程度,并对不同预期寿命的患者进行了比较:在为期两年的研究期间,接受临床药剂师评估的 392 名患者共收到 2808 份处方(中位数为每名患者 7 份)。临床药剂师建议停用 559 种药物(19.9%;95 CI,18.4-21.4%),其中 321 名患者(82%)至少停用 1 种药物。多学科团队接受了 89.6% 的减药建议,从而减少了 501 种药物的用药负担(P 结论:临床药师主导的减药治疗可减少患者的用药负担:在多学科团队中由临床药师主导的去处方干预措施可有效减轻癌症患者的用药负担,并解决药物不良反应问题。在癌症患者的任何疾病阶段都应采取减药干预措施。
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引用次数: 0
Real world comparison of filgrastim to filgrastim-sndz in patients with chemotherapy-induced neutropenia. 在化疗引起的中性粒细胞减少症患者中,菲格列汀与菲格列汀-ndz的实际效果比较。
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-10-23 DOI: 10.1177/10781552241290437
Manal Saad, Kelsey Shadick, Sapna Prasad, Kejal Amin, Randa Chaar, Osama Abdelghany

Introduction: There exists some apprehension by prescribers, healthcare providers, and other stakeholders regarding the real-world safety and effectiveness of biosimilars. While some of the apprehension is likely due to clinician knowledge gaps in the biosimilarity exercise, additional data (including those generated from the real-world) regarding safety and efficacy could reduce a clinician's perception of biosimilar uncertainty and can potentially increase biosimilar acceptance and uptake. The published literature is lacking regarding the real-world impact on healthcare costs and clinical outcomes when a single healthcare institution converts from filgrastim to filgrastim-sndz as its short-acting Granulocyte Colony Stimulating Factor (GCSF), especially within diverse populations and indications not explicitly studied through the registration trials. Specifically, both filgrastim and filgrastim-sndz possess FDA-approved indications within patients with hematologic malignancies receiving high-dose chemotherapy and in those undergoing bone marrow transplantation. As a biosimilar to filgrastim, the FDA did not require prospective, randomized controlled trials to obtain these indications for filgrastim-sndz. The purpose of this study is to describe real-world healthcare resource costs, utilization patterns, and clinical outcomes in patients with hematologic malignancies who received filgrastim-sndz or filgrastim to support neutrophil recovery following chemotherapy (i.e., induction or consolidation) or a bone marrow transplant (BMT) at Yale New Haven Hospital (YNHH).

Methods: A total of 148 patients were identified and met the following criteria: at least 18 years old, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, absence of fever or infection, newly diagnosed acute myeloid leukemia or newly post-bone marrow transplant and received filgrastim-sndz (Zarxio®) or reference filgrastim (Neupogen®).

Results: Healthcare resource utilization outcomes were compared between biosimilar and reference filgrastim using descriptive statistics. There were no major differences between either cohort, including duration of hospitalization, the number of overall emergency room visits and additional hospital admissions with a primary diagnosis of febrile neutropenia or neutropenia within 30 days post-discharge from initial hospital admission, time to neutrophil recovery following GCSF support, and the incidence and duration of both fever and febrile neutropenia. The total cost based on treatment of all patients in each arm differed significantly with filgrastim-sndz being the most cost-effective choice.

Conclusion: filgrastim-sndz significantly reduced healthcare utilization costs compared to reference filgrastim with similar effect on absolute neutrophil count, incidence of fever, and febrile neutropenia.

导言:处方者、医疗服务提供者和其他利益相关者对生物类似药在真实世界中的安全性和有效性存在一些疑虑。虽然部分忧虑可能是由于临床医生对生物类似药的认识存在差距,但有关安全性和有效性的更多数据(包括从真实世界中获得的数据)可以减少临床医生对生物类似药不确定性的看法,并有可能提高生物类似药的接受度和吸收率。目前尚缺乏已发表的文献,说明当单一医疗机构从使用菲格司汀转为使用菲格司汀-ndz 作为其短效粒细胞集落刺激因子(GCSF)时,尤其是在注册试验未明确研究的不同人群和适应症中,对医疗成本和临床结果的实际影响。具体来说,filgrastim 和 filgrastim-sndz 都拥有 FDA 批准的适应症,适用于接受大剂量化疗的血液恶性肿瘤患者和接受骨髓移植的患者。作为 filgrastim 的生物仿制药,FDA 并不要求进行前瞻性随机对照试验来获得 filgrastim-sndz 的这些适应症。本研究旨在描述耶鲁大学纽黑文医院(YNHH)血液恶性肿瘤患者在化疗(即诱导或巩固治疗)或骨髓移植(BMT)后接受非格司亭-ndz或非格司亭治疗以支持中性粒细胞恢复的实际医疗资源成本、使用模式和临床结果:共有148名患者符合以下标准:至少18岁,东部合作肿瘤学组(ECOG)表现为0至2级,无发热或感染,新诊断为急性髓性白血病或新进行骨髓移植,并接受了filgrastim-ndz(Zarxio®)或参考filgrastim(Neupogen®)治疗:采用描述性统计方法比较了生物仿制药和参考药菲格拉司汀的医疗资源利用结果。两组患者的住院时间、急诊就诊总次数、以发热性中性粒细胞减少症或出院后30天内中性粒细胞减少症为主要诊断的额外住院次数、GCSF支持后中性粒细胞恢复时间、发热和发热性中性粒细胞减少症的发生率和持续时间等方面均无重大差异。结论:菲格拉司汀-桑德斯与参考菲格拉司汀相比显著降低了医疗费用,对绝对中性粒细胞计数、发热发生率和发热性中性粒细胞减少症的影响相似。
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引用次数: 0
Falls and fractures in men with prostate cancer taking second-generation androgen receptor antagonists: A retrospective chart review. 服用第二代雄激素受体拮抗剂的前列腺癌男性患者的跌倒和骨折情况:回顾性病历
IF 1 4区 医学 Q4 ONCOLOGY Pub Date : 2024-10-22 DOI: 10.1177/10781552241291837
Morgan Dennison, Lisa Holle

Introduction: Second-generation androgen receptor antagonists, including enzalutamide, apalutamide, and darolutamide, are commonly used to treat metastatic and non-metastatic prostate cancer. Although these medications are typically well-tolerated, falls were reported in 4.2-15.6% of patients and fractures in 4.2-11.7% of patients enrolled in the phase III clinical trials evaluating these drugs in prostate cancer. However, post-marketing studies have reported a lower incidence than reported in clinical trials. The objective of this study is to determine the prevalence of falls and fractures in patients with prostate cancer receiving second-generation androgen receptor antagonists at UConn Health and identify potential risk factors associated with falls and fractures in these patients.

Methods: A retrospective chart review involving patients with prostate cancer treated with darolutamide, enzalutamide, or apalutamide from March 1, 2022, to March 31, 2023, at UConn Health Carole & Ray Neag Comprehensive Cancer Center. Data recorded includes basic demographics, history of fall or fracture, presence of metastases, fall risk, history of osteoporosis, prescribed second-generation androgen receptor antagonist, and other comorbidities. Data was evaluated using descriptive statistics.

Results: Twenty-six men were included, all of whom were receiving enzalutamide. At baseline, 96.1% of patients had bone metastases, 15.4% had osteoporosis, 15.4% had osteopenia, and 34.6% had neuropathy. The incidence of falls was 19.2% and the incidence of fractures was 26.9%. The mean length of therapy at time of a fall was 19.44 months (range, 6-31 months). The mean length of therapy at time of a fracture was 19 months (range, 1-33 months). In patients experiencing fall, 100% had arthralgia, 60% had neuropathy, 40% had a gait problem, 40% had hypertension, and 80% of them were at risk of fall. In patients experiencing fracture, 28.6% had osteoporosis, 42.9% had osteopenia, 100% had bone metastases, and 57.1% were on denosumab at time of fracture.

Conclusion: The prevalence of falls and fractures in patients receiving enzalutamide were higher in this retrospective chart review than reported in clinical trials and post-marketing studies. This could be due to the small patient population or the patient's comorbidities such as osteoporosis, bone metastases, or neuropathy. Fall/fracture risk with enzalutamide and other risk factors for fall and fracture should be considered when discussing treatment and developing a monitoring plan.

导言:第二代雄激素受体拮抗剂,包括恩扎鲁胺、阿帕鲁胺和达罗鲁胺,常用于治疗转移性和非转移性前列腺癌。虽然这些药物通常耐受性良好,但在评估这些药物治疗前列腺癌的III期临床试验中,有4.2-15.6%的患者出现跌倒,4.2-11.7%的患者出现骨折。不过,上市后研究报告的发生率低于临床试验报告的发生率。本研究旨在确定在康涅狄格大学健康中心接受第二代雄激素受体拮抗剂治疗的前列腺癌患者中跌倒和骨折的发生率,并确定与这些患者跌倒和骨折相关的潜在风险因素:一项回顾性病历审查,涉及2022年3月1日至2023年3月31日期间在康涅狄格大学Carole & Ray Neag综合癌症中心接受达罗鲁胺、恩扎鲁胺或阿帕鲁胺治疗的前列腺癌患者。记录的数据包括基本人口统计学特征、跌倒或骨折史、是否存在转移灶、跌倒风险、骨质疏松症史、处方第二代雄激素受体拮抗剂以及其他合并症。数据采用描述性统计进行评估:共纳入26名男性患者,他们都在接受恩杂鲁胺治疗。基线时,96.1%的患者有骨转移,15.4%有骨质疏松症,15.4%有骨质增生,34.6%有神经病变。跌倒发生率为 19.2%,骨折发生率为 26.9%。跌倒时的平均治疗时间为 19.44 个月(6-31 个月)。骨折时的平均治疗时间为 19 个月(1-33 个月)。在跌倒患者中,100%有关节痛,60%有神经病变,40%有步态问题,40%有高血压,80%有跌倒风险。在发生骨折的患者中,28.6%患有骨质疏松症,42.9%患有骨质疏松症,100%患有骨转移,57.1%在骨折时正在服用地诺单抗:结论:在这一回顾性病历审查中,接受恩杂鲁胺治疗的患者跌倒和骨折的发生率高于临床试验和上市后研究中的报告。这可能是由于患者人数较少或患者患有骨质疏松症、骨转移或神经病变等合并症。在讨论治疗和制定监测计划时,应考虑恩杂鲁胺的跌倒/骨折风险以及其他跌倒和骨折风险因素。
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引用次数: 0
Decreasing IV magnesium infusion time to improve delivery of patient care. 缩短静脉注射镁剂的时间,改善病人护理服务。
IF 16.4 4区 医学 Q4 ONCOLOGY Pub Date : 2024-10-21 DOI: 10.1177/10781552241291221
Molly Lofy, Cameron Ninos, Elizabeth Dow-Hillgartner

Introduction: Hypomagnesemia is a common issue in patients with cancer due to magnesium wasting drugs like calcineurin inhibitors, chemotherapy sides effects such as diarrhea, and poor oral intake. Historically, magnesium has been given over prolonged infusions due to concern for rapid elimination of magnesium when large doses are administered. At UW Health, magnesium was given at a rate of 1g/60 min. A prolonged infusion rate often creates logistical issues including limited IV access, incompatibility concerns and increased chair time. The purpose of this project is to increase the infusion rate of IV magnesium without compromising therapeutic repletion, benefit, and safety.

Methods: The magnesium infusion rate was increased to the following rates: 4g/60 min, 2g/30 min, 1g/15 min. The primary outcome is the grams of IV magnesium replaced per outpatient visit between the pre-intervention (prolonged) and post-intervention (rapid) groups. Secondary outcomes include assessment of differences in chair time between groups and total incidence of critical magnesium lab values.

Results: There was no statistically significant difference in magnesium requirements per outpatient visit between a prolonged and rapid magnesium infusion rate (2.18g vs 2.15g; p = 0.49). Additionally, there was no difference in number of outpatient visits (3 vs 3; p = 1). The average chair time was decreased by 110 min per outpatient encounter between the prolonged and rapid magnesium infusion rate, which was determined to be clinically and statistically significant.

Conclusion: This study suggests that there is no difference in magnesium requirements between a rapid or prolonged magnesium infusion in both solid and liquid tumor patients.

简介低镁血症是癌症患者常见的问题,原因包括钙神经蛋白抑制剂等消耗镁的药物、化疗副作用(如腹泻)以及口服摄入量不足。一直以来,由于担心大剂量给药后镁会被快速排出体外,镁都是通过长时间输液来补充的。在华大健康中心,镁的输注速度为 1 克/60 分钟。延长输注时间往往会造成后勤问题,包括静脉注射通道受限、不相容问题和增加坐椅时间。本项目旨在提高静脉输注镁的速度,同时不影响治疗补给、益处和安全性:方法:将镁的输注速度提高到以下水平:方法:将镁输注速度提高到以下速度:4 克/60 分钟、2 克/30 分钟、1 克/15 分钟。主要结果是干预前(长时间)组与干预后(快速)组每次门诊补充静脉注射镁的克数。次要结果包括评估各组间坐椅时间的差异以及关键镁化验值的总发生率:结果:延长镁输注时间组和快速镁输注时间组每次门诊的镁需求量差异无统计学意义(2.18 克 vs 2.15 克;P = 0.49)。此外,门诊次数也没有差异(3 vs 3;p = 1)。延长镁输注时间与快速镁输注时间相比,每次门诊的平均椅子时间减少了 110 分钟,这在临床和统计学上都具有显著意义:这项研究表明,无论是实体瘤还是液体瘤患者,快速还是长时间输注镁元素对镁元素的需求量并无差异。
{"title":"Decreasing IV magnesium infusion time to improve delivery of patient care.","authors":"Molly Lofy, Cameron Ninos, Elizabeth Dow-Hillgartner","doi":"10.1177/10781552241291221","DOIUrl":"10.1177/10781552241291221","url":null,"abstract":"<p><strong>Introduction: </strong>Hypomagnesemia is a common issue in patients with cancer due to magnesium wasting drugs like calcineurin inhibitors, chemotherapy sides effects such as diarrhea, and poor oral intake. Historically, magnesium has been given over prolonged infusions due to concern for rapid elimination of magnesium when large doses are administered. At UW Health, magnesium was given at a rate of 1g/60 min. A prolonged infusion rate often creates logistical issues including limited IV access, incompatibility concerns and increased chair time. The purpose of this project is to increase the infusion rate of IV magnesium without compromising therapeutic repletion, benefit, and safety.</p><p><strong>Methods: </strong>The magnesium infusion rate was increased to the following rates: 4g/60 min, 2g/30 min, 1g/15 min. The primary outcome is the grams of IV magnesium replaced per outpatient visit between the pre-intervention (prolonged) and post-intervention (rapid) groups. Secondary outcomes include assessment of differences in chair time between groups and total incidence of critical magnesium lab values.</p><p><strong>Results: </strong>There was no statistically significant difference in magnesium requirements per outpatient visit between a prolonged and rapid magnesium infusion rate (2.18g vs 2.15g; <i>p</i> = 0.49). Additionally, there was no difference in number of outpatient visits (3 vs 3; <i>p</i> = 1). The average chair time was decreased by 110 min per outpatient encounter between the prolonged and rapid magnesium infusion rate, which was determined to be clinically and statistically significant.</p><p><strong>Conclusion: </strong>This study suggests that there is no difference in magnesium requirements between a rapid or prolonged magnesium infusion in both solid and liquid tumor patients.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552241291221"},"PeriodicalIF":16.4,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468143","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}
引用次数: 0
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Journal of Oncology Pharmacy Practice
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