Drug Shortages—There are Drivers We Can Address

Drug pricing, access, contracting, availability, and shortages are driven by many external influences that can directly affect the ability of physicians to acquire or prescribe drugs for patients, or even for patients to access prescribed drugs.

What can physicians and cancer centers do to prepare themselves, their staff, and patients for how these entities and barriers may affect medical decision-making, treatment access, and affordability?

Basics of Drug Shortages and Management

There is no standard definition for what constitutes a drug shortage. The Federal Food, Drug, and Cosmetic Act is used by the FDA to define a drug shortage as a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.¹ The American Society of Health-System Pharmacists (ASHP), another key resource, states that “a drug product shortage is defined as a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”²

How Can Drug Shortages and Supplies
Be Tracked?

Both the FDA³ and the ASHP⁴ provide free and searchable databases related to drug shortages. The searchable terms vary slightly between the 2 data bases, but practices and even patients can explore the status of current or resolved shortages, discontinued drugs, and other categories. One proactive step would be for every cancer practice to assign a lead within their organization to periodically track the top drugs (or even supplies) on which they rely, so as to not get caught off-guard.

• In 2023, the FDA reported that sterile injectables accounted for 61% of drug shortages, and 15% of new drug shortages were for oncologic agents. The January 2025 ASHP National Drug Shortage report noted that chemotherapeutic agents totaled 18% of the top 5 active drug class shortages as of December 2024. In total, there are 29 oncology drugs listed in shortage as of January 25, 2025, on either the FDA, the ASHP list, or both.⁵
• Some of these drugs in shortage include backbone generic chemotherapies, such as cisplatin, carboplatin, docetaxel, methotrexate, and vinblastine. Potentially a half million patients were threatened by a US cisplatin/carboplatin shortage. Once a drug goes into shortage status, it may take a long time, even years, to reverse the situation that caused the shortage.⁶

Adverse Consequences for Cancer Patients

Cancer patients are particularly vulnerable to drug shortages, since their treatment options are time sensitive and limited. Shortages may lead to drug substitutions, downward alterations in dosing, or delays in treatment. There could be an increased risk of medication errors due to lower familiarity with substituted products. Automation systems (pumps, order sets, etc) may need to be adjusted to avoid errors in medication. Use of alternates, such as second-line and third-line chemotherapeutic agents, may not only increase the risk of adverse drug events but also increase labor and drug acquisition costs for the alternative drugs (affecting both providers and patients).

Shortages of Staple Treatment Components Can Also Disrupt Cancer Care

The shortage of a key staple—IV fluids—related to hurricane Helene affected a wide range of cancer treatments. Just 1 Baxter manufacturing facility in North Cove, NC, manufactured about 60% of IV fluid, peritoneal dialysis, and IV solutions used by hospitals in the United States. Hurricane Helene rains caused massive flooding of that Baxter plant in late September 2024. Site remediation was required to be able to resume safe sterile production.

Hospitals postponed elective surgeries and instituted other drug shortage management protocols, including prioritizing IV fluids for the most acute patients and using hydration alternatives like hydration tablets and Gatorade. FDA involvement and assessment led to temporary importation of 23 different IV and peritoneal fluid from 5 international Baxter facilities; first flights began October 2024, and each carried over 100,000 units of product. On May 13, 2025, Baxter announced that all remediation was completed, and inventory and allocation levels were restored to pre-hurricane levels.^7,8

Importance of Active Product Ingredients

Shortages can be driven by the building components of drugs as well as by the fully finished drug itself. Active product ingredients (APIs), as well as other component aspects of an FDA-approved drug, may often be sourced from various locations. There is limited worldwide access to APIs.

China produces from two-thirds to almost all the APIs needed to manufacture medications, including chemotherapeutic agents. India (the biggest provider of generic finish-drug-form products to the United States, obtains more than 70% of its APIs from China. Likely disruptions to API sourcing and the resultant end product can include geopolitical issues, natural disasters, and import tariffs.⁵

Common Causes of Drug Shortages

Most commonly recognized causes of drug shortages may seem to be out of the control of the cancer practice: demand surge, emergencies, manufacturing capacity reduction, disruptions in transportation and delivery, manufacturing supply and quality issues, and regulatory and legislative challenges affecting the market supply and demand. However, cancer practices can influence some of the current and looming drivers of drug shortages through action, advocacy, awareness, and involvement.

Political Intervention May Now Escalate
Drug Shortages

Rising activity on the national and the state level are increasing the risk of future shortages of drugs and key APIs.

At the national level, Presidential Chief Executive Orders and a letter to 17 pharmaceutical companies address plans for tariffs on pharmaceuticals, expectations for reduced most-favored-nation pricing for new drugs in the United States, creation of manufacturer direct-to-consumer pricing models that cut out middlemen, and reinvestment of manufacturing facilities and resources in the United States, rather than overseas.⁹ Pharmaceutical tariffs may start small, then in 12 to 18 months maximum, rise to 150%, and then 250%.¹⁰ Considering the high percentages of APIs made in countries that could likely be tariffed, this could impact both component cost and final finished drug form costs for most drugs, including oncology drugs.

States are equally active with numerous initiatives that could add pricing limits, cost controls, oversight of a nonmedical nature, risky importation, medical tourism, and even state-based compounding. We have addressed several of these legislative initiatives in previous OPM issues. Prescription Drug Advisory Boards (PDABs), reference-based pricing, and upper pricing limits all seek to use pricing and cost limitations on drugs without regard for individual patient medical necessity or needs. Both active drug importation and international medical tourism lead to US patients being subjected to drugs not approved for use in the United States and circumventing FDA safety guidelines and regulations. More than 750 bills targeting prescription drug pricing and health system costs were tracked in 2024 by the National Academy for State Health Policy.¹¹

What Can Practices Do?

We cannot stop hurricanes, flooding, or geopolitical disruptions that lead to drug shortages. We can and should develop internal plans for managing drug shortages, and speak up in our states and nationally on policies that could harm our patients. Driving down prices/reimbursement of drugs below normal manufacturing costs or provider acquisition costs leads to reduced access for those drugs. Generic drugs are particularly vulnerable. As generic prices drop, fewer manufacturers can afford to produce them. Limited production capacity leaves even cornerstone items like cisplatin and sterile IV fluid bags vulnerable to a facility closure and can quickly lead to a national drug shortage. If providers are unable to acquire drugs below a state mandated pricing limit, they will not be able to order that drug for their patients. Patients will experience delays or worse, substitutions of nonpreferred treatments, and potentially adverse outcomes.

Internal Practice Management Guidance for Drug Shortages

ASCO has created significant resources for the practice management of oncology drug shortages. These may be found at the following locations:

• ASCO Drug Shortages Advisory Group. Ethical Principles and Implementation Strategies. www.asco.org/practice-patients/practice-support/drug-shortages/ethics-principles-implementation-strategies
• ASCO Ethical Guidance for the Practical Management of Oncology Drug Shortages. https://ascopubs.org/doi/abs/10.1200/JCO.23.01941
• ASCO Clinical Guidance. www.asco.org/practice-patients/practice-support/drug-shortages/clinical-guidance
• Crisis of Cancer Drug Shortages: Understand the Causes and Proposing Sustainable Solutions https://ascopubs.org/doi/10.1200/OP-25-00381

Most states have at least 1 looming or even already passed bill related to PDABs, drug pricing control, drug importation, reference pricing, and even international medical tourism. Many states have insurance and healthcare commissions in their state legislature and governance structure. We need the voice of the medical community in the offices of those commissions, in front of the legislators, state departments, and their staff. We need to bring the voice of reason and practicality to these conversations. I myself testified on most of these topics this legislative season in Connecticut and would be happy to share talking points with anyone considering raising these issues in their own state.

Next Steps for Cancer Practices

• Designate a drug shortage lead in your group to track, design a drug shortage plan, network, and learn from others
• Collaborate, inform, and join forces with others facing similar challenges, as well as local, state, and federal leadership
• Address federal and state legislation and policy that may have a positive or adverse impact on drug shortage triggers

Share your thoughts and experiences with me at This email address is being protected from spambots. You need JavaScript enabled to view it.. I would be interested to hear what you have found, or what more you want to know. I can provide additional resources on this topic if you wish.

References

1. US Food and Drug Administration. Frequently Asked Questions about Drug Shortages. www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages
2. American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages. Am J Health-Syst Pharm. 2018; 75:1742-1750.
3. US Food and Drug Administration. FDA Drug Shortages. www.Accessdata.Fda.Gov/scripts/drugshortages/default.Cfm
4. American Society of Health-System Pharmacists. Current Drug Shortages. www.ashp.org/drug-shortages/current-shortages?loginreturnUrl=SSOCheckOnly
5. Lisi DM. Oncology Drug Shortages. US Pharmacist. April 15, 2025, www.uspharmacist.com/article/oncology-drug-shortages
6. Westin J, Sherwood S, Hagerty K, Gralow J. Crisis of cancer drug shortages: understanding the causes and proposing sustainable solutions. JCO Oncol Pract. July 1, 2025. https://ascopubs.org/doi/10.1200/OP-25-00381
7. Baxter. Hurricane Helene Updates. May 13, 2025. www.baxter.com/baxter-newsroom/hurricane-helene-updates
8. American Medical Association. IV shortage update: Baxter facility damage after hurricane in North Carolina 2024. www.ama-assn.org/public-health/behavioral-health/iv-shortage-update-baxter-facility-damage-after-hurricane-north
9. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs. July 31, 2025. www.whitehouse.gov/fact-sheets/2025/07/fact-sheet-president-donald-j-trump-announces-actions-to-get-americans-the-best-prices-in-the-world-for-prescription-drugs/
10. Constantino AK. Trump says pharma tariffs could eventually reach up to 250%. CNBC. August 5, 2025. www.cnbc.com/2025/08/05/trump-says-pharma-tariffs-could-eventually-reach-up-to-250percent.html
11. Hensley-Quinn M, Torrey Z. State Legislatures Pursue Policies to Address High Health Care Prices. National Academy for State Health Policy. January 27, 2025. nashp.org/state-legislatures-pursue-policies-to-address-high-health-care-prices/