Analysis of Drug Shortages, 2018-2023

The report, "Analysis of Drug Shortages, 2018-2023" provides additional information on the data, methods, and findings. Below are the key findings.

KEY POINTS

• Between 2018 and 2023, a total of 258 unique active ingredients (i.e., molecules) went into national shortage per the FDA’s report to Congress. Using historical archives of the FDA Drug Shortages resources and the FDA NDC Directory, the authors found that these 258 molecules are represented by 1,961 unique CDER-regulated prescription drug products (identifiable by their 9-digit NDC numbers).
• According to the authors' analysis of publicly available FDA data sources, over twice as many generic drug shortages began (n = 1,391) as brand drug shortages (n = 600), which is partly due to generic drug products being more common in the market. An additional 47 drug product shortages involved unapproved drugs with market authorization.
• Injectable drug products made up half (n = 1,018) of all drug shortages, compared to 42.3 percent (n = 863) for oral drug products and 7.7 percent (n = 157) for topical drug products. This is highly disproportionate, as oral medications are by far the most common type of drug marketed in the United States.
• Using the data from 2018 to 2023, the authors found that drug shortages last roughly twice as long for injectable products (median = 4.6 years) as for oral products (median = 1.6 years) or topical products (median = 2.2 years).
• Shortages of essential products last much longer (median = 4.0 years) than those medicines that are not on the essential medicines lists used in this analysis (median = 2.3 years). Essential medicines also accounted for roughly one-third (n = 599 or 29.4 percent) of the drug products that went into shortage.
• The number of generic drug products with an ongoing shortage decreased from 2020 to 2023, while the number of brand drug products increased slightly. There was a spike in drug shortages in the middle of 2020, possibly due to the COVID-19 pandemic, but this decreased over the next two years before starting to rise again in 2023. Since the creation of the Executive Order Essential Medicines List in October 2020 (which also coincided with the COVID-19 pandemic), there has been a substantial decrease in the number of generic essential medicines with an ongoing shortage.

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