The current state of U.S. drug shortages

Drug shortages in the United States have become increasingly prevalent and remain a critical issue. In the first quarter of 2024, the number of drugs in shortage reached 323, the highest figure since 2014. By September 2024, this number dropped slightly to 277. The most impacted drug categories include chemotherapy agents, central nervous system stimulants, antimicrobials, hormone therapies, and intravenous (IV) fluids. Additionally, some weight-loss medications have also experienced shortages.

According to the U.S. Pharmacopeia, the average duration of drug shortages has surpassed three years, up from approximately two years in 2020.

Behind the shortages

Several factors contribute to drug shortages, including regulatory changes, extreme weather events, pricing challenges, discontinuations, supply chain disruptions, increased demand, and geopolitical tensions.

The Food and Drug Administration (FDA) has increased its oversight of drug manufacturers, which has occasionally resulted in slowed or halted production. For instance, in 2023, issues at a chemotherapy supplier in India disrupted the availability of certain chemotherapy drugs in the U.S. Additionally, the Drug Enforcement Administration (DEA) revised quotas for controlled substances, further straining supplies of specific medications.

Extreme weather events have also had a significant impact. A pharmaceutical plant in North Carolina was damaged by a tornado in 2023, affecting the production of multiple drugs. Similarly, Hurricane Helene in September 2024 caused temporary closure of a facility responsible for producing 60% of the country’s IV fluids.

Affected drugs

Generic drugs are disproportionately affected by shortages due to their low prices, which discourage investments in redundancy or resilience-oriented manufacturing.

ADHD medications such as Adderall®, Ritalin®, Vyvanse®, and Focalin™ have faced persistent shortages since October 2022. These shortages result from increased diagnoses of ADHD and DEA-imposed production quotas.

The IV fluid shortage has been exacerbated by Hurricane Helene’s impact on a key North Carolina facility. Glucagon-like peptide-1 agonists (GLP-1s) like Zepbound®, Mounjaro®, and Wegovy® are also in short supply due to rising demand for their use in treating obesity and cardiovascular conditions, in addition to type 2 diabetes.

Two chemotherapy drugs, carboplatin and cisplatin, essential for treating breast and other cancers, are among the medications in short supply. Hormonal therapies for menopause and dronabinol, used to manage chemotherapy-induced nausea, have also been affected. Chantix®, an anti-smoking medication, remains scarce following a 2021 recall and is not expected to return until February 2025.

Impact of drug shortages

Drug shortages have profound consequences for patients. According to the Department of Health and Human Services (HHS), shortages can lead to higher costs, delayed care, and medication errors when substitutes are used. Patients may skip doses, underdose, or forego treatment altogether, with potentially dire outcomes, especially for those requiring life-saving cancer therapies.

Shortages also strain healthcare systems. A recent survey found that healthcare workers frequently encounter errors linked to drug shortages, while hospitals incur increased labor costs to manage substitutions. Patients often face higher out-of-pocket expenses for alternative medications and may experience worsened health outcomes, further escalating future healthcare costs.

Possible solutions

The American Society of Health-System Pharmacists has proposed several strategies to mitigate drug shortages:

1. Enforce existing shortage prevention requirements.
2. Increase transparency in manufacturer quality.
3. Encourage new manufacturers and production sites.
4. Implement long-term, guaranteed-volume contracts.
5. Diversify the manufacturing base.
6. Fund private-sector buffer supplies.

In November 2024, the American Medical Association adopted policies to address shortages. These include enhancing federal oversight of compounding pharmacies, providing incentives to boost drug manufacturing, and supporting measures to improve disaster resilience, stockpile medications, and promote reusable medical products.

Looking ahead

As 2025 begins, drug shortages persist. Addressing these challenges will require coordinated efforts to diversify manufacturing, streamline processes, strengthen oversight, and build stockpiles. By implementing these changes, stakeholders can work toward reducing the frequency and impact of drug shortages, ensuring better outcomes for patients and the healthcare system as a whole.

Read more

• A look forward: Five trends PBMs should expect in 2025
• Insights Hub
• Pharmacy deserts: A growing problem in the U.S.

References

• Robledo, Anthony. Drug shortages at highest since 2014: Chemo drugs, Wegovy, ADHD medications affected. USA Today. April 17, 2024.
• McCormick, Brooke. 5 Essential Drugs Currently Facing Shortages. American Journal of Managed Care. November 1, 2024.
• McPhillips, Deidre. Drug shortages reach record high in US. CNN. April 12, 2024.
• USP Annual Drug Shortages Report: Economic factors underpin 2023 shortages. U.S. Pharmacopeia. June 2024.
• Charted: Record-high drug shortages will ‘likely get worse.’ Advisory Board. April 12, 2024.
• Major Pfizer plant in North Carolina restarts production 10 weeks after tornado damage. CBS News. September 25, 2023.
• Kansteiner, Fraiser. Baxter offers recovery timeline after major IV fluid plan closure due to Hurricane Helene. FiercePharma. October 9, 2024.
• Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States. U.S. Department of Health and Human Services. April 2, 2024.
• Ault, Alicia. No End in Sight for National ADHD Drug Shortage. MedScape. March 12, 2024.
• Fortier, Jackie. Nationwide IV fluid shortage changing how hospitals manage patient hydration. NPR. November 19, 2024.
• McPhillips, Deidre. Some ER patients are half as likely to receive IV fluids since disruptions from Hurricane Helene. CNN. October 31, 2024.
• Uscher, Jen and Zack, Liz. How to Navigate a Chemo Drug Shortage. Breastcancer.org. October 3, 2024.
• Dronabinol Capsules Shortage. Drugs.com. October 18, 2024.
• Murdock, Joshua. Why Are There Drug Shortages, and How Can I Find Out Why My Medication Is on Shortage? GoodRx. August 13, 2024.
• Impact of Drug Shortages on Patients in the United States: A Case Study of Three Drugs. Office of the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services. April 26, 2024.
• Lupkin, Sydney. Chronic drug shortages stress hospital and patients. NPR. November 2, 2023.
• Lagasse, Jeff. Drug shortages lead to higher prices, trouble filling prescriptions. Healthcare Finance. July 12, 2023.
• Policy Solutions to Address the Drug Shortage Crisis. American Society of Health-System Pharmacists.
• AMA furthers policy to address nation’s growing drug supply shortages. American Medical Association. November 13, 2024.

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