Presentation (CTI)

OBJECTIVES: The US Food and Drug Administration (FDA) monitors and addresses “medically necessary” drug shortages which may deprive patients of treatment and expose them to elevated risk of harm. FDA aims to reduce the duration of shortages to minimize these impacts. The present study evaluates the duration of recently resolved shortages of medically necessary drugs.
METHODS: Resolved shortage data were downloaded from FDA’s website on January 7, 2025. Analyses were performed in Microsoft Excel.
RESULTS: Fourteen products were reported resolved between June 27 and December 31, 2024. Products had 1 to 26 presentations with a median of 6; and 1 to 4 manufacturers, with a median of 2; Five products had a single manufacturer. These products included 9 distinct therapeutic categories (TC), which are not mutually exclusive. Of these 5 (35.7%) products were Endocrinology/Metabolism and 4 (28.6%) were listed for Gastroenterology. Injectables included 11 (78.6%) of the 14 products. Additionally, 5 (35.7%) products were marked for pediatric use. The median duration for all shortages was 878.5 days (IQR 423.5-1089.25) with a minimum of 28 days and maximum of 4,563 days. The mean duration was notably higher at 1,222.5 days. Injectables had a mean duration of 1,477 days versus 436.6 days average for the three non-injectables. Pediatric product shortages lasted a mean of 1,131.2 days versus 1,233.75 days for non-pediatric. Endocrinology/Metabolism shortages had a mean of 997 days versus 1,300.85 for other products. Gastroenterology shortages averaged 1,172.25 days versus 1,209.5 for non-gastroenterology. Three (21.4%) oncology products averaged 640.67 days versus 1,339.29 for non-oncology.
CONCLUSIONS: Overall, mean shortage length was considerably longer than the median, indicating that a smaller number of shortages are skewing the mean. Injectables were most represented and lasted considerably longer than non-injectables. The top two TCs were Endocrinology/Metabolism and Gastroenterology, each of which resolved faster than their corresponding counterparts.