Medication Meltdown: Unpacking Drug Shortages

INTRODUCTION

Shortages occur when supply and demand become unbalanced, and a drug shortage happens when the demand for a medication exceeds the available supply.¹ However, drug products do not follow supply and demand rules. Consumers rarely have control over product selection, and health care providers may prescribe first-line medications regardless of the price. Lastly, manufacturers are not required to disclose product quantity, leaving buyers unable to base purchasing decisions on this information.²

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At the start of 2024, researchers recorded 323 drug shortages. At the end of 2024, active drug shortages had decreased to 271. Notably, 48% of these shortages started in or before 2022 and continued into 2024.³ In 2024, the top drug classes experiencing active shortages included chemotherapies, antimicrobial drugs, central nervous system medications, fluids/electrolytes, and hormones.³

IMPACTS OF DRUG SHORTAGES

Drug shortages impact how medications are prepared or dispensed, affect patient care, and may require using alternative treatments.^2,4 They may cause delays in medical procedures, medication errors, and patient harm.^2,4,5 During a shortage, medication errors are more likely to occur due to changes in ordering, preparing, or dispensing processes. Furthermore, prescribing unfamiliar alternatives may result in reduced effectiveness, elevated risk of adverse events, more complex monitoring, or challenging dosing regimens.²

Drug shortages also create significant financial burdens. For instance, researchers have estimated that shortages in 2013 cost $209 million.² During drug shortages, health care providers must allocate resources toward purchasing expensive alternatives and paying personnel to manage pharmacy automation systems and update electronic medical records.²

CAUSES OF DRUG SHORTAGES

The reasons for drug shortages vary and can include manufacturing capacity limitations, delays, natural disasters, business decisions, supply and demand issues, and raw material issues.^2,5 Manufacturing sites may also fail FDA quality management inspections. Because the FDA has a pass-fail system, consumers are unable to evaluate the quality metrics of drug products.²

Generic products are particularly susceptible to shortages. With tight profit margins, manufacturers often prepare these medications on shared manufacturing lines, and the facilities typically operate at full capacity, making even small interruptions potentially significant.^1,2,6

THE COVID-19 PANDEMIC AND DRUG SHORTAGES

The COVID-19 pandemic underscored challenges related to supply chains and drug shortages, highlighting the need for action. Demand for medical resources surged unevenly across the United States, while lockdowns created obstacles to exporting and distributing supplies.¹ The nation struggled to assess the composition of the Strategic National Stockpile (SNS), a repository of supplies and medications available upon request from US agencies.^5,7

Researchers have studied and compared drug shortages before and during the COVID-19 pandemic. Findings demonstrated that drugs with supply chain issues are more likely to experience declines in sales compared with those without such issues (13.7% vs 4.1%). Furthermore, supply shortages occurred more frequently at the onset of the COVID-19 pandemic, regardless of supply chain issues (34.2% of drugs with issues vs 9.5% without).^1,6

HURRICANE HELENE AND DRUG SHORTAGES

In September 2024, Hurricane Helene swept across southeastern states, impacting Baxter’s North Carolina manufacturing site and intravenous (IV) fluid production.^8-10 A survey assessing the effects of the IV fluid shortage revealed that 53.9% of respondents had a 10-day supply, 20% had to postpone elective surgeries, and 58% considered doing so.¹¹

MANAGEMENT OF DRUG SHORTAGES

The pharmacy department is crucial in managing drug shortages. The American Society of Health-System Pharmacists (ASHP) has outlined guidelines for managing drug shortages. Researchers recommend forming a drug shortage team, a resource allocation committee, and a process to identify alternative therapies while addressing ethical concerns. Pharmacists should serve as members of these committees.^2,4

By selecting committee members ahead of a drug shortage, health systems and pharmacies can allocate tasks efficiently and create a comprehensive plan once a shortage arises. Once the committee develops and agrees on the plan, committee members must communicate it clearly to the impacted individuals through multiple methods.^2,4 Effective communication to all affected parties is key for ensuring success. Importantly, drug shortages constantly evolve, but 2 primary organizations keep health care providers and the public informed about these issues. The FDA provides updates on drug shortages, whereas the CDC focuses on vaccinations.^2,12,13

However, the FDA drug shortage list does not cover all medications, focusing only on market-wide shortages and those considered important for public notification.¹ Health care providers may also rely on ASHP’s Current Drug Shortages catalog to stay informed.¹⁴

PREVENTING FUTURE DRUG SHORTAGES

Health care organizations nationwide work to address drug shortages. One common recommendation is to improve the functionality, composition, and accessibility of the SNS by finalizing a list of its contents and increasing transparency regarding products and quantities.⁵ The Table¹⁵ provides a summary from the FDA highlighting common causes and proposed solutions for drug shortages.

CONCLUSION

Drug shortages continue to create challenges for health care systems and the public. To address the issue, US agencies must focus on identifying early warning signs of potential shortages, conducting further surveillance, and ensuring timely public dissemination of information for all medications.

REFERENCES

1. Socal MP, Sharfstein JM. Drug shortages – a study in complexity. JAMA Netw Open. 2024;7(4):e244168. doi:10.1001/jamanetworkopen.2024.4168

2. Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018;75(21):1742-1750. doi:10.2146/ajhp180441

3. Improving the quality and resilience of the United States healthcare supply chain. American Society of Health-System Pharmacists. Accessed March 26, 2025. https://www.ashp.org/-/media/assets/news-and-media/docs/Healthcare-Supply-Chain-Recommendations

4. Drug shortages statistics. American Society of Health-System Pharmacists. Accessed March 26, 2025. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics

5. University health care hospitals and clinics policy manual: drug shortage. American Society of Health-System Pharmacists. Updated April 21, 2010. Accessed March 26, 2025. https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-resources-sample-drug-shortages-policy.pdf

6. Callaway Kim K, Rothenberger SD, Tadrous M, et al. Drug shortages prior to and during the COVID-19 pandemic. JAMA Netw Open. 2024;7(4):e244246. doi:10.1001/jamanetworkopen.2024.4246

7. Yasgur BS. Hospitals reeling from IV fluid shortages in the aftermath of Hurricane Helene. Medscape. October 16, 2024. Accessed March 26, 2025. https://www.medscape.com/viewarticle/hospitals-reeling-iv-fluid-shortages-aftermath-hurricane-2024a1000iwa

8. O’Reilly KB. Fixing IV fluid shortage only a start in addressing drug supply. American Medical Association. October 30, 2024. Accessed March 26, 2025. https://www.ama-assn.org/delivering-care/public-health/fixing-iv-fluid-shortage-only-start-addressing-drug-supply#

9. FDA drug shortages. FDA. Accessed March 26, 2025. https://dps.fda.gov/drugshortages

10. Current vaccine shortages & delays. CDC. September 27, 2024. Accessed March 26, 2025. https://www.cdc.gov/vaccines/hcp/vaccines-us/shortages-delays.html

11. Drug shortages: root causes and potential solutions. FDA. Updated February 21, 2020. Accessed March 26, 2025. https://www.fda.gov/media/131130/download

12. Strategic National Stockpile (SNS). Radiation Emergency Medical Management. Updated March 14, 2025. Accessed March 26, 2025. https://remm.hhs.gov/sns.htm

13. Hurricane Helene updates. News release. Baxter. February 17, 2025. Accessed March 26, 2025. https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

14. Navigating IV fluid shortages post-Hurricane Helene: insights from USP on compounding and conservation strategies. Pharmacy Times. October 24, 2024. Accessed March 26, 2025. https://www.pharmacytimes.com/view/navigating-iv-fluid-shortages-post-hurricane-helene-insights-from-usp-on-compounding-and-conservation-strategies

15. Current drug shortages. American Society of Health-System Pharmacists. Accessed March 26, 2025. https://www.ashp.org/drug-shortages/current-shortages?loginreturnUrl=SSOCheckOnly