Causes and Characteristics of Drug Shortages in the United States

OBJECTIVES: Drug shortages increase costs, expose patients to risks, and may deny access to critical therapies. The US Food and Drug Administration (FDA) recognizes shortages when total product demand exceeds total supply. The FDA Safety and Innovation Act (FDASIA 2012) has the FDA provide reasons for ongoing and resolved shortages of “medically necessary” drugs. The present study characterizes active drug shortages reported by the FDA and identifies the primary causes by drug form and therapeutic category (TC).

METHODS: Ongoing shortage data were downloaded from FDA’s website on January 10, 2024. Analyses were performed in Microsoft Excel.

RESULTS: The 124 shortages had a median of 7 (IQR 3-16) presentations and 102 (82.25%) had at least one presentation available. By TC, 21 (16.9%) products were in gastroenterology; 18 (14.5%) in endocrinology/metabolism; 17 (13.7%) in cardiovascular; 16 (12.9%) in oncology; and 15 (12.1%) inanesthesia. Increased demand impacted 70 (62.9%) shortages; 49 (39.5%) experienced shipment delays; and 18 (14.5%) were affected by the discontinuation of at least one presentation. Active ingredient shortages and requirements for good manufacturing practices each impacted 10 (8.1%) shortages. Only 9 (7.3%) experienced regulatory delays. Shortages included 80 (64.5%) injectables, 16 (12.9%) tablets, and 28 (22.5) in other forms. Injectables were most impacted by manufacturing delays (39; 48.75%) and increased demand (53; 62.25%). There were 21 (16.9%) gastroenterology shortages; 18 (14.5%) endocrinology/metabolism; 17 (13.7%) cardiovascular; 16 (12.9%) oncology; and 15 (12.1%) anesthesia. Shipment delays impacted 8 (38.1%) gastroenterology products; 8 (44.4%) endocrinology/metabolism; 8 (47.1%) cardiovascular; 4 (25.0%) oncology; and 9 (60.0%) anesthesia. Demand increase impacted 15 (71.4%) gastroenterology products; 12 (66.7%) endocrinology/metabolism; 7 (41.2%) cardiovascular; 12 (75.0%) oncology; and 13 (86.7%) anesthesia.

CONCLUSIONS: Demand increases and shipping delays were the two most common reasons for shortages, overall and for each evaluated TC. Remaining causes impacted few shortages.