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Mitigating the Impact of Drug Shortages in Oncology: Lessons Learned From the 2023 Shortages of Carboplatin and Cisplatin. 缓解肿瘤药物短缺的影响:从2023年卡铂和顺铂短缺中吸取的教训
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000786
Maxwell L Izen, June M McKoy, Linda Martin, Chadi Nabhan, Gretchen LeFever Watson, Joseph Magagnoli, Kenneth R Carson, Kevin Knopf, Edward Smith, Edward Zyszkowski, Mia Lynch, Demir Uslu, Peter Georgantopoulos, David Aboulafia, Charles L Bennett

Purpose/background: Cancer drug shortages adversely affect cancer patient care and ultimately cancer patient lives. Shortages of cancer drugs used for pediatric cancer patients are well described.

Methods: Review of published literature, news reports, and grey literature on cisplatin and carboplatin shortages.

Results: The shortages were multifactorial-reflecting supply chain disruption, limited redundancy in manufacturing, and dependence on out-of-country sources for injectable generic oncology drugs.

Discussion: This report of carboplatin and cisplatin shortages extends concerns noted earlier with pediatric oncology drug shortages. Improvements in supply chain and consideration of on-shoring manufacturing is needed.

目的/背景:癌症药物短缺对癌症患者的治疗产生不利影响,最终影响癌症患者的生活。用于儿童癌症患者的抗癌药物的短缺得到了很好的描述。方法:回顾有关顺铂和卡铂短缺的已发表文献、新闻报道和灰色文献。结果:短缺是多因素的,反映了供应链中断,有限的生产冗余,以及对注射用非专利肿瘤药物的国外来源的依赖。讨论:这篇关于卡铂和顺铂短缺的报告扩展了先前对儿科肿瘤药物短缺的关注。需要改进供应链,并考虑生产在岸。
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引用次数: 0
The Oncology Drug Shortage: ASCO's Vision and Proposals for Resolving This Public Health Emergency. 肿瘤药物短缺:ASCO解决这一突发公共卫生事件的愿景和建议。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000788
Jason Westin, Dominic Sawaya, Shimere Williams Sherwood, Julie R Gralow

The issue of drug shortages is a persistent and complex one. There is an urgent need for a wide-ranging, multifaceted strategy to address drug shortages and bold, comprehensive solutions. Professional societies, such as the American Society of Clinical Oncology (ASCO), have a crucial role to play in advocating for governmental action and raising awareness to combat these critical shortages of lifesaving and life-prolonging medications. ASCO's proposed solutions focus on reforming economic incentives related to generic drug pricing to foster market sustainability and encourage investment in high-quality manufacturing. This will require significant collaboration, including government intervention and public-private partnerships.

药品短缺问题是一个长期而复杂的问题。迫切需要制定一项广泛、多方面的战略来解决药品短缺问题,并提出大胆、全面的解决办法。专业协会,如美国临床肿瘤学会(ASCO),在倡导政府行动和提高认识方面发挥着至关重要的作用,以应对这些挽救生命和延长生命的药物的严重短缺。ASCO提出的解决方案侧重于改革与仿制药定价相关的经济激励措施,以促进市场可持续性,并鼓励对高质量制造业的投资。这将需要大量合作,包括政府干预和公私伙伴关系。
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引用次数: 0
What an Oncology Drug Shortage Looks and Feels Like to Patients and What Can Be Done About It. 肿瘤药物短缺对患者的影响以及如何应对。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000790
Laura Bray

Drug shortages continue to pose a serious threat to health care systems worldwide, often depriving patients of essential, life-saving medications. This article presents the patient perspective on drug shortages through the work of Laura Bray, founder of Angels for Change-a nonprofit committed to ending drug shortages through advocacy, awareness, and supply chain resilience. Inspired by her personal journey when her daughter's cancer treatment was nearly derailed by a shortage, and informed by her professional background in supply chain management, Bray launched a grassroots movement that now connects patients, providers, manufacturers, supply chain leaders, and policymakers. The article explores Bray's belief in a patient-centered supply chain, her creation of the Drug Shortage Hotline, and her collaborative, multi-stakeholder approach to systemic change. It also highlights the industry and policy reforms she champions to prevent future shortages and create a more reliable pharmaceutical system. Through the lens of Angels for Change, the piece illustrates the transformative power of patient advocacy and cross-sector cooperation in addressing one of health care's most urgent challenges.

药物短缺继续对世界各地的卫生保健系统构成严重威胁,常常使患者无法获得基本的救命药物。这篇文章通过Laura Bray的工作展示了患者对药物短缺的看法。Laura Bray是“改变天使”的创始人,这是一个致力于通过宣传、意识和供应链弹性来结束药物短缺的非营利组织。Bray的女儿的癌症治疗几乎因药物短缺而中断,她的亲身经历和她在供应链管理方面的专业背景启发了她,她发起了一项草根运动,现在将患者、供应商、制造商、供应链领导者和政策制定者联系起来。本文探讨了Bray对以患者为中心的供应链的信念,她创建的药品短缺热线,以及她对系统性变革的合作,多方利益相关者的方法。这也凸显了她所倡导的行业和政策改革,以防止未来出现药品短缺,并创建一个更可靠的制药体系。通过“变革天使”的视角,这篇文章说明了患者倡导和跨部门合作在解决医疗保健领域最紧迫挑战之一方面的变革力量。
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引用次数: 0
Oncology Drug Shortages: Impacts, Policy Reforms, and Advocacy Imperatives. 肿瘤药物短缺:影响,政策改革和倡导的必要性。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000784
Marissa Malta, Matthew Christian, Amy B Cadwallader

Oncology drug shortages have reached unprecedented levels and have had a substantial impact on the treatment of cancer patients, which can include medication rationing, delayed treatments, and inferior therapeutic substitutions. This manuscript outlines systemic drivers of supply chain vulnerabilities that lead to drug shortages, presents medicines supply chain data analyses of ongoing shortages, and proposes actionable policy reforms for advocacy to address patient needs and build resilience and sustainable change in the pharmaceutical supply chain.

肿瘤药物短缺已达到前所未有的水平,并对癌症患者的治疗产生了重大影响,其中包括药物配给,延迟治疗和劣质治疗替代。本文概述了导致药品短缺的供应链脆弱性的系统性驱动因素,提出了持续短缺的药品供应链数据分析,并提出了可操作的政策改革,以倡导解决患者需求,并在药品供应链中建立弹性和可持续变革。
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引用次数: 0
Impact of a Drug Shortage at a Comprehensive Cancer Center: It Is Time to End Drug Shortages. 综合癌症中心药物短缺的影响:是结束药物短缺的时候了。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000792
Kenneth Komorny

Shortages of oncology medications have unique complications for dedicated cancer centers and comprehensive cancer centers. Mitigation solutions for medication shortages at these types of health systems can help extend supply and decrease existing demand run rates, but these shortages can eventually lead to suboptimal patient outcomes. Health care's collective focus should be on ending drug shortages, not mitigating them.

肿瘤药物的短缺对专门的癌症中心和综合癌症中心具有独特的并发症。在这些类型的卫生系统中,缓解药物短缺的解决方案可以帮助扩大供应并降低现有的需求运行率,但这些短缺最终可能导致患者的结果不理想。医疗保健的共同重点应该是结束药品短缺,而不是减轻短缺。
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引用次数: 0
Key Drivers and Mitigation Strategies of Oncology Drug Shortages 2023 to 2025. 2023 - 2025年肿瘤药物短缺的关键驱动因素和缓解策略。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000791
Mariana P Socal, Joy Acha, Chia-Yu Yang, Yunxiang Sun, Maqbool Dada, Tinglong Dai, Gerard Anderson, Jeromie Ballreich

Drug shortages remain a problem in the United States, jeopardizing patient care. To help inform solutions, this study reviewed recent oncology drug shortages for causes and mitigation strategies. Using the FDA's Drug Shortage Database, 15 oncology drugs with shortages between 2023 and 2025 were identified. Twelve drugs had shortages lasting >2 years (maximum: >13 y). Searches of PubMed and Google Scholar, online media sources, and FDA documents uncovered 9 main causes: manufacturing quality problems, limited-source dependency, regulatory bottlenecks, global over-reliance, absence of buffer stocks, demand surges, low economic incentives, active pharmaceutical ingredient shortages, and shelf-life constraints. Mitigation strategies involved 4 stakeholders: regulators (expedited regulatory action, importation, expiration extensions), manufacturers (capacity expansion), providers (dose-sparing regimens, therapeutic alternative protocols, allocation prioritization), and purchasers-distributors including GPOs (supply collaboration). Policies to mitigate drug shortages should include new approaches to identify vulnerable markets and involve multiple stakeholders. Factors identified in this study also offer pathways for shortage prevention.

药物短缺仍然是美国的一个问题,危及病人的护理。为了帮助提供解决方案,本研究回顾了近期肿瘤药物短缺的原因和缓解策略。使用FDA的药物短缺数据库,确定了2023年至2025年间短缺的15种肿瘤药物。12种药物的短缺持续时间为50 - 2年(最长为50 - 13年)。对PubMed和谷歌Scholar、在线媒体资源和FDA文件的搜索发现了9个主要原因:制造质量问题、有限来源依赖、监管瓶颈、全球过度依赖、缺乏缓冲库存、需求激增、低经济激励、有效药物成分短缺和保质期限制。缓解战略涉及4个利益攸关方:监管机构(加速监管行动、进口、有效期延长)、制造商(产能扩张)、供应商(剂量节约方案、替代治疗方案、分配优先次序)以及包括gpo在内的采购-分销商(供应协作)。缓解药品短缺的政策应包括确定脆弱市场并让多个利益攸关方参与的新方法。本研究确定的因素也为预防短缺提供了途径。
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引用次数: 0
National Stockpiling of Pediatric Cancer Medications in the United States: An Alternative Approach to Hospital-Based Storage for Essential Oncology Drugs. 美国儿童癌症药物的国家储备:基本肿瘤药物在医院储存的另一种方法。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000795
Maxwell L Izen, Mia Lynch, Charles L Bennett

Despite continued efforts, pediatric oncology patients face, at times, insurmountable barriers to cancer medication access, creating an ongoing public health crisis with potentially tragic consequences. These shortages adversely impact pediatric patients in the United States and their ability to complete pivotal drug regimens. Resource availability and accessibility are exacerbated by a lack of oversight and predictability in the practices of manufacturers, distributors, and hospitals. In this review, we specifically examined the impact of current drug inventory practices within hospitals and subsequently developed recommendations for implementing pediatric cancer drugs into Strategic National Stockpiles for a more regulated approach to drug distribution.

尽管持续努力,儿科肿瘤患者有时在获得癌症药物方面面临不可逾越的障碍,造成持续的公共卫生危机,可能带来悲剧性后果。这些短缺对美国儿科患者及其完成关键药物治疗方案的能力产生不利影响。由于制造商、分销商和医院的实践缺乏监督和可预测性,资源的可用性和可获得性恶化。在这篇综述中,我们特别研究了目前医院内药物库存实践的影响,并随后提出了将儿童癌症药物纳入国家战略库存的建议,以更规范的方式进行药物分配。
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引用次数: 0
Cancer Drugs and United States Tariffs: Attention Must Be Paid. 抗癌药物和美国关税:必须引起注意。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-09-01 Epub Date: 2025-09-25 DOI: 10.1097/PPO.0000000000000785
Maxwell L Izen, June M McKoy, Linda Martin, Chadi Nabhan, Gretchen LeFever Watson, Joseph Magagnoli, Kenneth R Carson, Kevin Knopf, Edward Smith, Edward Zyszkowski, Mia Lynch, Demir Uslu, Peter Georgantopoulos, David Aboulafia, Charles L Bennett

The Trump Administration has signaled its intent to impose tariffs on pharmaceuticals worldwide, raising uncertainty about the potential impact on cancer treatments in the United States. Increasing concern surrounds the possibility that these tariffs may compromise the quality of care and adversely affect the survival outcomes of cancer patients across the country. The proposed tariffs on pharmaceuticals threaten to worsen already high drug costs and disrupt access to essential cancer treatments. As Martha Basey of Patients for Affordable Drugs points out, "We know that already one in three people in the United States can not fill their prescriptions because of high costs. We expect the pharmaceutical companies not to let this chaos over trade go to waste Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation and try to raise prices while pointing the finger at tariffs." Given the complex global supply chain and existing drug shortages, tariffs risk increasing prices without encouraging more domestic production or improving patient care. For these reasons, policy experts strongly caution against imposing broad tariffs on cancer medicines and advocate for alternative solutions to protect access to and affordability of these medications.

特朗普政府已表示有意在全球范围内对药品征收关税,这增加了对美国癌症治疗潜在影响的不确定性。越来越多的人担心,这些关税可能会损害护理质量,并对全国癌症患者的生存结果产生不利影响。拟议中的药品关税可能会加剧本已高昂的药品成本,并扰乱人们获得基本癌症治疗的途径。正如“负担得起的药物患者”组织的玛莎·贝西指出的那样,“我们知道,在美国,已经有三分之一的人因为高昂的费用而无法按处方服药。我们希望制药公司不要让这种混乱的贸易浪费,并试图提高价格,同时指责关税。”鉴于复杂的全球供应链和现有的药品短缺,关税可能会提高价格,而不会鼓励更多的国内生产或改善患者护理。由于这些原因,政策专家强烈警告不要对癌症药物征收广泛的关税,并主张采取替代解决方案,以保护这些药物的可及性和可负担性。
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引用次数: 0
Tumor Evolution Driving Genome Instability, Immune Interactions, and Response to Radiotherapy. 肿瘤进化驱动基因组不稳定性、免疫相互作用和对放疗的反应。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-07-01 Epub Date: 2025-08-11 DOI: 10.1097/PPO.0000000000000777
George Seed, France Truong, Rahma Riahi, Ben O'Leary

This review article explores the role of immuno-radiotherapy in the context of genome instability and tumor evolution. Genomic changes in tumors exist in a delicate balance with the immune system, offering evolutionary pathways to adapt and grow but risking provoking an immune response. Rapid developments across both immunotherapy and radiotherapy have raised questions about the potential benefits combination therapy, and how best to identify ideal treatment populations. Here we discuss foundational studies of genomic instability and tumor evolution, how these paradigms translate into immune surveillance and evasion, and subsequently go on to explore recent preclinical and clinical studies of both treatment modalities. Understanding how cancers evolve in the context of the immune system could provide a key insight in delivering better therapies that could overcome treatment resistance.

这篇综述文章探讨了免疫放疗在基因组不稳定和肿瘤进化的背景下的作用。肿瘤的基因组变化与免疫系统保持着微妙的平衡,提供了适应和生长的进化途径,但也有引发免疫反应的风险。免疫治疗和放射治疗的快速发展提出了关于联合治疗的潜在益处以及如何最好地确定理想治疗人群的问题。在这里,我们讨论基因组不稳定性和肿瘤进化的基础研究,这些范式如何转化为免疫监视和逃避,并随后继续探索这两种治疗方式的临床前和临床研究。了解癌症是如何在免疫系统的背景下进化的,可以为提供更好的治疗方法提供关键的见解,从而克服治疗耐药性。
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引用次数: 0
Are we Only Doing Good? Long-term Psychosocial Effects of Fertility Preservation (or Lack Thereof) on Survivors of Cancer During Adolescence and Young Adulthood. 我们只是在做好事吗?保留生育能力(或缺乏生育能力)对青春期和青年期癌症幸存者的长期心理社会影响。
IF 2.2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-07-01 Epub Date: 2025-08-11 DOI: 10.1097/PPO.0000000000000774
Vicky Lehmann, Niels van Poecke, Leah Waterman, Christianne A R Lok, Catharina C M Beerendonk, Ellen M A Smets
<p><strong>Purpose/background: </strong>Patients diagnosed with cancer at reproductive age can be offered fertility preservation, which includes options of freezing sperm (male patients), oocytes, embryos, or ovarian tissue (female patients). This is intended to provide survivors with a chance to have biological children later in life (e.g., through utilizing assisted reproductive technologies, ART). However, psychosocial effects of no or completed fertility preservation remain largely unknown.</p><p><strong>Methods: </strong>A total of 48 survivors completed semi-structured interviews (Mage = 34 y). They had been diagnosed with cancer during adolescence and young adulthood (AYA; between age 12 and 39 y), were <1 to 18 years (M = 5 y) from diagnosis, and had completed active cancer treatment. Survivors were asked about perceived consequences of having or not having completed fertility preservation. Answers were qualitatively analyzed with template analysis.</p><p><strong>Results: </strong>Almost half of the survivors had completed fertility preservation at diagnosis. During interviews, all survivors described an emotional impact of no or completed fertility preservation, which caused positive or negative feelings, or was described as minor/absent. These feelings can change over time, as they were determined by past, present, or possibly future events. Such events clustered into a disruption in family building, followed by a phase of exploration of reproductive health posttreatment. This phase included much uncertainty, which triggered the exploration of survivors' fertility status, reproduction/pregnancies, and options of ART. Hope for natural conception prevailed irrespective of completed fertility preservation and was still abstract for various survivors. Utilization of ART was scarce and physically and emotionally burdensome. Alternatives to biological parenthood were deemed unfeasible. Uncertainty and phases of exploration, together with learning more about their fertility status (e.g., uncovering infertility/having problems conceiving, unexpected pregnancies) changed survivors' outlook on life and affected their romantic relationships, partner communication, and dating profoundly.</p><p><strong>Discussion: </strong>Uncertainty about fertility and reproductive options is universal, irrespective of whether survivors had completed fertility preservation or not. If completed, fertility preservation can provide survivors with positive feelings (e.g., hope/reassurance), but uncertainties and worries surrounding reproduction/ART can add substantial burden throughout survivorship. Survivors' perception of no/completed fertility preservation can change over time and largely depends on whether ART is needed and its outcome. Thus, fertility preservation cannot always buffer negative effects, and if survivors remain without (additional) children unintentionally, emotional burden and grief can be significant. Health care providers should address any conc
目的/背景:在育龄诊断为癌症的患者可以提供生育能力保存,包括冷冻精子(男性患者)、卵母细胞、胚胎或卵巢组织(女性患者)的选择。这是为了让幸存者有机会在以后的生活中拥有亲生孩子(例如,通过利用辅助生殖技术,ART)。然而,没有或完全保留生育能力的社会心理影响在很大程度上仍然未知。方法:共有48名幸存者完成了半结构化访谈(Mage = 34 y)。他们在青春期和青年时期被诊断出患有癌症(AYA;结果:几乎一半的幸存者在诊断时完成了生育保存。在访谈中,所有幸存者都描述了没有或完全保留生育能力的情感影响,造成了积极或消极的感受,或被描述为轻微/缺席。这些感觉会随着时间的推移而改变,因为它们是由过去、现在或可能的未来事件决定的。这些事件聚集在一起导致家庭建设中断,随后是对治疗后生殖健康的探索阶段。这一阶段包含很多不确定性,这引发了对幸存者生育状况、生育/怀孕以及抗逆转录病毒治疗选择的探索。自然受孕的希望占了上风,而不考虑完整的生育保存,对各种幸存者来说仍然是抽象的。抗逆转录病毒治疗的利用是稀缺的,身体和精神上都是负担。除了亲生父母之外的其他选择被认为是不可行的。不确定性和探索阶段,以及更多地了解自己的生育状况(例如,发现不孕/怀孕有问题,意外怀孕)改变了幸存者的人生观,深刻地影响了他们的浪漫关系,伴侣沟通和约会。讨论:生育能力和生殖选择的不确定性是普遍存在的,无论幸存者是否完成了生育能力保存。如果完成,生育能力保存可以为幸存者提供积极的感觉(例如,希望/安心),但围绕生殖/ART的不确定性和担忧可能会在整个幸存者期间增加实质性负担。幸存者对没有或完全保留生育能力的看法可能随着时间的推移而改变,这在很大程度上取决于是否需要抗逆转录病毒治疗及其结果。因此,保留生育能力不能总是缓冲负面影响,如果幸存者无意中没有(额外的)孩子,情感负担和悲伤可能是重大的。卫生保健提供者应解决AYA患者/幸存者的任何关切,并就家庭建设选择向他们提供现实的建议;如有需要,将患者和幸存者转介给心理健康专家。
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引用次数: 0
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