Drug Shortages: Causes, Consequences, and Mitigation

Persistent, complex drug shortages plague US health care systems, with nearly all hospitals and pharmacies reporting shortages.¹ Many describe moderate to severe disruptions that affect patient care through treatment delays, medication substitutions, rationing, and, in some cases, procedure cancellation. Shortage frequency, duration, and clinical impact have prompted growing attention to system-level mitigation strategies.²

The Definition Dilemma

The FDA defines a shortage as a situation in which demand exceeds supply for a clinically important medication.³ In contrast, the American Society of Health-System Pharmacists and the University of Utah Drug Information Service define shortages as supply issues that disrupt dispensing or require therapeutic substitution.⁴ Definitional differences contribute to variation in reported prevalence across data sources.

Causes of local, national, and global drug shortages are multifactorial.^5,6 Local factors include inventory mismanagement, inaccurate demand forecasting, reliance on just-in-time supply chains, and unexpected surges in use during emergencies or outbreaks. These vulnerabilities reduce buffer capacity and amplify minor disruptions.

Nationally and globally, manufacturing and supply chain constraints often drive shortages.^5,6 A significant proportion of active pharmaceutical ingredients is produced outside the US, creating dependence on international manufacturing hubs and long, complex supply chains. Control failures, manufacturing shutdowns, limited production capacity for older sterile injectables, or regulatory delays may cause disruptions. Economic forces also contribute, particularly when single-source products dominate the market or manufacturers discontinue low-profit generics. Additional triggers include sudden changes in demand, drug diversion, geopolitical instability, and shifts in prescribing patterns influenced by media attention or public health emergencies.^5,6

Clinical, Economic, and Humanistic Consequences

Clinically, shortages force providers to delay therapy, substitute alternative agents, or ration medications.^7-9 These decisions can be especially challenging in high-acuity oncology, critical care, infectious diseases, and emergency settings, where treatment delays may affect outcomes significantly.¹⁰ Substituting unfamiliar medications also increases the risk of prescribing, dispensing, and administration errors.^5,11

Economically, higher prices for alternative therapies, increased labor required to manage shortages, and downstream costs associated with complications or suboptimal therapy shortages increase health care costs.⁵ Institutions frequently report measurably increased pharmacy budgets due to shortage management activities.¹² Humanistic impacts, including patient anxiety, dissatisfaction, and reduced trust in health care systems, are quantified less frequently but are important outcomes.¹³

Mitigation Information

Because shortages are likely to continue, mitigation strategies are essential. Coordinated, proactive, and system-level interventions are better than reactive management alone.

Multidisciplinary drug shortage management teams are a foundational mitigation strategy. They typically include pharmacy leadership, clinicians, nursing, supply chain personnel, and informatics specialists. These individuals must monitor supply status, anticipate disruptions, evaluate therapeutic alternatives, and coordinate institutional responses. Clear policies must permit rapid decision-making during critical shortages.²

Operational mitigation strategies must optimize inventory and distribution, as described in the Table.² Some institutions also use repackaging or allocation protocols to extend limited supplies equitably across patient populations. Conversion from intravenous to oral therapy, when clinically appropriate, can further reduce demand for scarce parenteral products.²

Clinical mitigation strategies emphasize safe, effective therapeutic substitution.² The care team must use clinical decision tools and standardized treatment pathways to identify alternative medications, dose conversions, and protocol adjustments quickly. Embedding shortage alerts and substitution guidance into electronic health records can reduce variability and prevent errors. Pharmacist-led review of medication orders is particularly important in high-risk areas (eg, oncology, anesthesia, and intensive care).^5,11

Clear communication is critical. Timely, transparent communication with clinicians, nurses, and patients helps reduce confusion, anxiety, and inappropriate prescribing. Many organizations stack communication with electronic alerts, institutional newsletters, and direct interdisciplinary updates that include the reason for the shortage (when known), the expected duration, and recommended alternatives.^2,5,11

Medication safety strategies can prevent errors associated with unfamiliar drug products. Standardized compounding procedures, updated order sets, and barcode verification systems help reduce risk during transitions to alternative therapies. Reporting and monitoring medication errors during shortages also supports continuous systemic quality improvement.^2,5,11

At the policy level, regulatory mechanisms also contribute to mitigation. The FDA maintains a public shortage list, facilitates expedited review of manufacturing changes, and may extend expiration dates for certain products based on stability data. These interventions can temporarily increase available supply and prevent unnecessary waste. In addition, legislative requirements for early manufacturer notification of potential shortages support earlier intervention.¹⁴

Technological solutions increasingly enhance mitigation. Integrating drug shortage databases into electronic health records allows real-time alerts at prescribing and dispensing points. Some systems also incorporate decision support tools that automatically suggest therapeutic alternatives based on current availability.²

Finally, long-term mitigation requires strong supply chain resilience. Proposed strategies include diversifying manufacturing sources, incentives for production of low-margin essential medications, and developing quality recognition programs for reliable manufacturers. Although these interventions require sustained regulatory and economic investment, they represent the most promising approach to reducing future shortages.¹²

Complex and interconnected factors spanning manufacturing, economics, regulation, and clinical demand drive drug shortages. Although their impact on patient care and health care costs is substantial, a range of mitigation strategies—particularly those that are proactive, multidisciplinary, and system-based—can reduce harm and improve resilience. Pharmacists must lead these efforts and ensure that patients continue to receive safe, effective, and timely therapy despite ongoing supply challenges.

About the Author

Jeannette Y. Wick, MBA, RPh, FASCP, is director of the Office of Pharmacy Professional Development at the University of Connecticut School of Pharmacy in Storrs.

REFERENCES

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3. Frequently asked questions about drug shortages. FDA. Updated December 18, 2024. Accessed May 19, 2026. https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages

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9. Lubell J. Drug shortages affect 88% of primary care physicians. American Medical Association. February 4, 2026. Accessed May 19, 2026. https://www.ama-assn.org/public-health/behavioral-health/drug-shortages-affect-88-primary-care-physicians

10. Drug, supply, and equipment shortages continue to compromise patient care. ISMP Medication Safety Alert! September 7, 2023. Accessed May 19, 2026. https://www.ismp.org/sites/default/files/newsletter-issues/20230907.pdf

11. Routsolias JC, Webb AN. Drug shortages negatively impact health systems and bedside patient care. J Med Toxicol. 2023;19(3):246-247. doi:10.1007/s13181-023-00950-6

12. Severity and Impact of Current Drug Shortages. American Society of Health-System Pharmacists. July 2023. Accessed May 19, 2026. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf

13. Phuong JM, Penm J, Chaar B, Oldfield LD, Moles R. The impacts of medication shortages on patient outcomes: a scoping review. PLoS One. 2019;14(5):e0215837. doi:10.1371/journal.pone.0215837

13. Pub L No. 112-144, 126 Stat 993 (2012). Accessed May 19, 2026. https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf