Issue link: https://beckershealthcare.uberflip.com/i/1546376
9 PATIENT SAFETY & OUTCOMES reimbursement a generic wouldn't get — even though, clinically, Dr. Quesenberry said there's no real difference from the generic; sometimes it's simply a different concentration or a pre-mixed suspension rather than a powder. e remaining friction is getting clinicians and patients to switch, since some insurers still require step therapy first, though most are waiving that given the shortage, he said. Baptist Health, based in Louisville, Ky., has started using Kyxata as well. Brandon McLain, PharmD, chief pharmacy officer, said the system has directed new patients starting treatments to the drug while reserving conventional carboplatin supply for patients already established on therapy. Dr. McLain said he has also pointed patients to manufacturer-sponsored assistance programs to offset the cost difference. Sara Moran Smith, PharmD, oncology pharmacy program manager at Minneapolis-based Allina Health, said that while supply for carboplatin, cisplatin and oxaliplatin has been sufficient enough to avoid widespread treatment modifications or delays, ifosfamide is in critical shortage. Dr. Moran Smith and her team are currently prioritizing use of ifosfamide for select patients and identifying clinically appropriate alternative treatment regimens. "Rationing oncology drugs is one of the most challenging situations health systems face," she said. "Organizations must evaluate disease state, treatment intent, available alternatives and anticipated outcomes while ensuring decisions are applied consistently and fairly. is requires a transparent ethical framework, multidisciplinary review and strong support for clinicians who may experience significant moral distress when scarce resources limit treatment options." St. Luke's has combined direct manufacturer allocations, internal inventory redistribution and vetted secondary sourcing with centralized purchasing and weekly demand forecasting, Dr. Curtis said. Miami has relied on secondary wholesalers, its GPO and select third-party wholesalers rather than therapeutic substitutions, backed by close systemwide coordination, according to Mr. Desai. City of Hope swapped in an alternative carboplatin product without restricting use by indication, and is using a different ifosfamide formulation while reserving the on-shortage version for patients at higher risk of neurotoxicity, Dr. Samara said. Community Health Network's cancer centers added new NDCs of ifosfamide to supplement supply, and leans on its multi-site buying power to purchase full allocations from distributors before reallocating internally to meet patient needs, according to Day Giles, an oncology pharmacy buyer for the Indianapolis-based system's cancer centers. Karen McConnell, PharmD, chief pharmacy officer at Ann Arbor, Mich.-based Michigan Medicine, said U-M Health has implemented clinical criteria to allocate ifosfamide supply for critical indications, though it hasn't made changes for oxaliplatin, carboplatin or cisplatin. To minimize waste, the system has started scheduling ifosfamide patients on the same day so vials are fully used, and compounding doses just in time. However, none of it has been as severe as 2023, not because the underlying supply fragility has been fixed, but because health systems have built more muscle for it. Broader access to multiple manufacturers for direct allocations has helped at St. Luke's, Dr. Curtis said, though she's still watching ifosfamide closely, echoing the uncertainty European regulators have flagged regarding when the ifosfamide supplier's German facility returns to full capacity. e 2023 crisis pushed Miami to build reserve inventory targets and start regular systemwide shortage meetings, Mr. Desai said. Having alternative products already in place has given City of Hope more flexibility and faster response than it had in 2023, Dr. Samara said. However, not everyone has felt that same improvement. Dr. McConnell said the current shortage is similar in severity to 2023, and Michigan Medicine still doesn't know how long it will last. Mr. Giles said Community Health Network's cancer centers convened a multidisciplinary Critical Drug Shortage Team in 2023 — including clinical, ethics and supply chain representatives — that revised utilization criteria as oen as weekly. e system hasn't needed to reconvene that team this time, though he said it's reassuring to know the infrastructure exists if it's needed again. What would help most Transparency is the fix many in the industry support. Dr. Huang and Dr. Samara both want earlier, clearer communication from manufacturers about disruptions before they hit. Dr. Huang said FDA mandates may be necessary to make that stick, and flagged 340B implications for safety-net and academic centers already running on thin margins. Mr. Desai's policy list goes furthest: government incentives to stand up temporary domestic manufacturing lines, expanded FDA authorization for science- backed expiration date extensions, mandatory early FDA notification of manufacturing interruptions, and tighter regulatory monitoring to prevent price gouging — asks that track closely with the FDA's own playbook from 2023, when the agency authorized temporary cisplatin imports from a Chinese manufacturer to ease that shortage. "e recurring shortages of older generic oncology drugs highlight a fundamental lack of resiliency in the supply chain," Dr. Moran Smith said. "ese products oen have very thin profit margins, leaving few manufacturers in the market and little capacity to rapidly increase production when disruptions occur. Hospitals can manage the consequences of shortages, but they cannot solve the root cause. Meaningful long-term solutions will likely require national policy interventions that incentivize domestic manufacturing, increase supply redundancy and create greater resilience across the generic drug market." Dr. Curtis shared similar sentiments and wants more equitable allocation practices from manufacturers, GPOs and wholesalers earlier in the process, calling the four drugs "the backbone of many oncology treatment regimens." Dr. Quesenberry's version is more granular. Manufacturers being upfront about the scale of a shortage, and giving front-line staff running timelines and updates, makes the biggest difference, he said. n "e recurring shortages of older generic oncology drugs highlight a fundamental lack of resiliency in the supply chain." — Dr. Sara Moran Smith, oncology pharmacy program manager, Allina Health