Cancer
Jen Hand
What will it take to overcome the persistent shortages of vital oncology medications in the United States? There is no single easy button to push for solutions, but rather several, as researchers noted in a series of research articles published in the September/October 2025 issue of The Cancer Journal.
Three-quarters of oncology pharmacists report delays, dose reductions, or regimen changes due to shortages, often leading to inferior outcomes, according to one of the recent studies.
“Shortages may place added burden on clinicians, pharmacists, and hospitals because providers may need to spend extra time identifying and implementing therapeutic substitution protocols,” said Mariana Socal, MD, lead author of an article investigating key drivers and mitigation strategies of oncology drug shortages.
“[They] may contribute to higher health care costs, due to the extra time required from staff and the higher cost of therapeutic substitutes,” said Socal, who is director of the PhD program in Health Services Research at Johns Hopkins Bloomberg School of Public Health.
The researchers detailed several risk factors and causes, impacts, mitigation strategies, and actionable policy reforms for advocacy concerning the ongoing cancer drug shortages in two of the review articles.
Causes and impacts
Using the FDA Drug Shortage Database and other publicly available sources, the research team identified 15 oncology drugs with shortages between 2023 and 2025. Fourteen of the medications were injectables, and 12 were in shortage for longer than 2 years.
Key themes that contributed to the shortages included:
- Manufacturing quality issues
- Limited source dependency
- Regulatory bottlenecks
- Global over-reliance
- Absence of buffer stocks
- Demand surges
- Low economic incentives
- Active pharmaceutical ingredient shortages
- Shelf-life constraints
Manufacturing quality problems and dependency on limited sources were the two causes that affected all 15 drugs in the study. The findings were in line with most of FDA’s list of root causes for shortages; however, the authors noted that those not part of FDA’s official lists could provide additional insight and help inform new policies aiming to prevent shortages.
Another research article by a group of authors from the USP Quality Institute analyzed the impacts, policy reforms, and advocacy imperatives of oncology drug shortages.
Using the USP Medicine Supply Map, Amy Cadwallader, PhD, and colleagues found four factors that increase the risk of drug shortages: low prices, geographic concentration, manufacturing complexity, and quality concerns. The authors noted that for cancer therapies, the combination of factors is common.
The USP team pointed to organizations that have developed clinical and ethical guidance and hospitals and professional societies that have developed evidence-based prioritization protocols during shortages, including therapeutic substitutions and clinical trial drug reallocation.
“Pharmacists continue to face patient frustration when their medicines are unavailable and remain important advocates for patients—[by] understanding the reasons for shortage, answering difficult questions about where medicines come from and why alternatives are so hard to find and [helping] patients access their medicines or alternatives,” said Cadwallader.
Mitigation strategies, focused advocacy
The Johns Hopkins researchers found eight mitigation strategies that were used to address drug shortages and organized them across four operational levels: regulatory level (expedited regulatory action, importation, expiration extension), manufacturer level (capacity expansion), provider level (dose sparing regimens, therapeutic alternative protocols, and allocation prioritization), and procurement-distribution level (supply collaboration).
Both reviews reinforced the importance of collaborator engagement at multiple levels. To create a focused advocacy message, USP partnered with the American Cancer Society Cancer Action Network to establish the Drug Shortage Task Force, which works to educate policymakers and provide data-informed solutions to drug shortage issues. Cadwallader noted that pharmacists and their professional organizations play an essential role in advocacy-focused interventions.
“Shortages leave patients in poorer health and overburden providers. Improved monitoring of supply chain vulnerabilities, promoting preventative infrastructure, and engaging stakeholders across regulatory, manufacturing, clinical, and distribution domains are essential to strengthening the resilience of the U.S. oncology pharmaceutical supply,” the Johns Hopkins researchers concluded. ■