Ophthalmic Drug Shortages in the United States

PURPOSE: To survey ophthalmic drug shortages in the United States from 2001 through 2024. DESIGN: Retrospective database review. SUBJECTS: Patient data were sourced from the University of Utah Drug Information Service (UUDIS) national database. MAIN OUTCOME MEASURES: The UUDIS drug shortage reports from 2001 through 2024 were reviewed, and shortages resulting from drug discontinuation, business decision, or duration of 1 day or less were excluded from analysis. The remaining 3086 drug shortage reports from 2001 through 2024 were reviewed by a panel of 4 ophthalmologists and 1 clinical pharmacist. METHODS: Drugs used in ophthalmology were highlighted, and their clinical applications were established. Drug delivery route (local vs. systemic), the cause of the shortage, the duration of the shortage, and whether the drug was patent protected during the shortage were assessed. RESULTS: Of 3086 shortage reports, 379 reports were of ophthalmic medications, of which 329 shortages had resolved and 50 remained active as of June 2024. On average, ophthalmic medications accounted for 15% of active shortages at any given time. Systemic and locally delivered medications were represented equally; most shortages were of anti-infective medications (35%) and steroids (26%). The leading causes of ophthalmic medication shortages were unknown (63%), manufacturing problems (20%), and supply and demand mismatch (10%). Median duration of ophthalmic medication shortage was 326 days (interquartile range [IQR], 145-695 days), nearly 30 days longer than the median duration for all drugs (298 days; IQR, 111-619; P = 0.023). Mean shortage duration of ophthalmic medications that were patent protected during each shortage was significantly less (184 days; IQR, 48-422 days) than medications that experienced a shortage while off-patent (359 days; IQR, 164-755 days; P < 0.0001). CONCLUSIONS: Ophthalmic drug shortages constitute a significant portion of total drug shortages, the median shortage length is greater than that for all medications, and shortage duration is influenced by patent status. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.