Drug Shortages for Prescription Amphetamine Derivatives.

Abstract

Objective: Amphetamine derivatives are first-line medications for attention-deficit/hyperactivity disorder (ADHD). Recently, there have been increasing reports of drug shortages involving amphetamine derivatives. The objective of this study is to describe trends in drug shortages impacting prescription amphetamine derivatives.

Methods: Drug shortage data were retrieved from the University of Utah Drug Information Service (UUDIS) from January 2001 to December 2023. Using UUDIS data, we analyzed all reported shortages of amphetamine derivatives, including amphetamine salts, dexmethylphenidate, dextroamphetamine, lisdexamfetamine, and methylphenidate. Specific dosage forms, including extended-release and immediate-release oral preparations and transdermal patch formulations were examined. Data were analyzed focusing on shortage trends over time, specific amphetamine product involved, product formulation, reason for shortage, shortage duration (for resolved shortages), and single source status (made by 1 manufacturer/facility).

Results: There were a total of 26 shortages impacting amphetamine derivatives verified by UUDIS from January 1, 2001 to December 31, 2023. The years with the greatest number of amphetamine shortages were 2012, 2013, 2015, and 2023, each with 7 total shortages. The mean shortage duration for resolved shortages was 20.7 months, with a range of 1.3 months to 61.6 months. The longest shortage (61.6 months) was for methylphenidate extended-release tablets. The majority of manufacturers (58%) did not disclose a reason for shortage.

Conclusions: Shortages for amphetamine derivatives have increased recently, limiting access to first-line therapy for ADHD. Inaccessibility of these agents can have negative implications for the cognitive development and functioning of children and adolescents, leading to comorbid mental health disorders.