Ophthalmic drug shortages more frequent, longer lasting than average

Ophthalmic drug shortages comprise approximately 15% of all active drug shortages in the US, according to a retrospective analysis of nationally representative data from the University of Utah.¹

Investigators led by Ian F. Pitha, MD, PhD, an ophthalmologist at the John A. Moran Eye Center, found that not only do ophthalmic drugs constitute a significant rate of the drug shortages reported in the US since 2001 — but their shortages generally last nearly a month longer than average.

Method

Pitha and colleagues reviewed drug shortage reports via the University of Utah Drug Information Service (UUDIS), a database that has gathered voluntary shortage reports from US healthcare professionals since 2001. The UUDIS verifies each shortage with manufacturers and compiles key information including the generic name and formulation of each affected drug, as well as the underlying cause and duration of the shortage.

The team assessed data logged between January 2001 – December 2024 to assess the frequency and duration of ophthalmic drug shortages. As they explained, the field of ophthalmology has experienced its own history of detrimental shortages including with erythromycin ointment, mitomycin C, and verteporfin. Additionally, the bankruptcy of Akorn Pharmaceuticals in 2023 resulted in drug shortages in the “relatively fragile generic market” of ophthalmic formulations.

“Aspects of ophthalmic drugs that potentially elevate their risk of shortage include the need for specialized facilities for drug production, a greater proportion of generic drugs that are associated with lower profit margins and therefore less incentive to avoid and fix shortages, and limited redundancy in drug production,” Pitha and colleagues noted.

Investigators excluded drug shortages due to discontinuations, business decisions, and those that did not exceed 1 day in duration. They identified ophthalmic drugs through expert review and a cross-reference of comprehensive medication lists. The causes of shortages were defined by 6 categories:

1. Manufacturing
2. Supply / demand imbalance
3. Materials
4. Regulatory
5. Unknown
6. Other

How common are ophthalmic drug shortages?

Among the 3086 valid shortage reports observed by the team during the select period, 379 (12.3%) involved ophthalmic medications. At the time of their assessment, 50 ophthalmic drug shortages remained ongoing. Among the 379 relevant shortages, 115 unique ophthalmic drugs comprised the list — with drugs like atropine appearing in up to 6 different shortages.

Ophthalmic drug shortages were nearly evenly split among systemic (n = 185 [49%]) and locally delivered (n = 194 [51%] medications. Most of the shortages occurred in anti-infective agents and steroids.

Pitha and colleagues observed a general correlation between patterns of ophthalmic medication and total drug shortage reports in the US. Though ophthalmic drug shortages accounted for 15% of all active shortages, the rate has ranged from 6% (in 2009) to 28% (in 2007).

What caused ophthalmic drug shortages?

According to the UUDIS database, nearly two-thirds (63%) of all reported ophthalmic shortages since 2001 have been due to unknown causes — consistent with the rate for all drugs in that period (56%). The next most common causes of ophthalmic drug shortages were manufacturing problems (20%) followed by supply / demand mismatch (10%).

The median duration for shortage reports was 326 days among ophthalmic medications (IQR, 145 – 695). This was 28 days longer than the median duration for all drug shortages (n = 298 [IQR, 111 – 619; P = .023). In assessing why ophthalmic drugs face longer shortages than average, investigators noted it was more likely due to the actual cause of the shortage than the drug type being impacted.

“Notably, there was an increased percentage of shortages that lasted for longer than 3 years due to manufacturing problems (18%) compared to unknown reasons (11%) and supply / demand mismatch (7%),” the team wrote. “The number of shortages due to regulatory (6) and raw material shortages (16) were relatively low, but 50% and 25% of shortages were longer than 3 years, respectively.”

Investigators additionally noted that the median shortage duration of patent-protected ophthalmic medications was nearly half that of off-patent medications (184 vs 359 days; P <.0001).

Takeaways

The team concluded that their findings evidence what has been a widely recognized trend in the field: ophthalmic drug access in the US has been notably impacted by frequent and lengthy shortages since 2001. Though the common causes of ophthalmic medication shortages parallel that of other drugs, the higher rate of cases and longer time to resolution is concerning for the field.

Pitha and colleagues described events such as inclement weather, the COVID-19 pandemic, and the Akorn bankruptcy as “failed stress tests” for a system already at odds with variable economic incentive for drug production, limited manufacturing due to industry consolidation, and complex regulatory and logical networks.

“However, incentives must exist to preserve drug production and create redundancies in the face of stressors,” they wrote. “Unfortunately, the high frequency of the unknown cause of ophthalmic drug shortages in this database and study does not inform whether the unique aspects of ophthalmic drugs lead to their shortages and whether specialized mitigation approaches are needed.”

Studies are currently underway to determine a finer list of ophthalmic medications impacted by shortages, to investigate a relationship between ophthalmic drug pricing and the frequency / duration of shortages, and to assess the clinical and societal impacts of such shortages.

References

1. Eakins RT, Lowrie LN, Stagg BC, Okudo A, Simpson R, Larochelle M, Fox ER, Pitha I. Ophthalmic Drug Shortages in the United States: Survey of the University of Utah Drug Information Service Drug Shortage Database. Ophthalmology. 2026 Feb 26:S0161-6420(26)00125-9. doi: 10.1016/j.ophtha.2026.02.025. Epub ahead of print. PMID: 41763579.

2. Hutton D. Théa’s ophthalmic products not impacted by Akorn recall. Ophthalmology Times. Published April 29, 2023. Updated May 1, 2023. https://www.ophthalmologytimes.com/view/th-a-s-ophthalmic-products-not-impacted-by-akorn-recall