Former FDA officials on prescription stimulant shortages

Abstract

Sortages of prescription stimulants, used to treat attention deficit-hyperactivity disorder (ADHD), are mainly due to a dramatic increase in adults prescribed the medications, according to a Viewpoint published online March 26 in JAMA Psychiatry. There is also a problem with nonmedical use of prescription stimulants, the article stated. The warning signs come from the opioid overdose epidemic, which began with prescribed opioids, according to the article. “Given the association between increased prescribing of opioids with the overdose crisis, it is reasonable to examine whether the observed increase in stimulant prescribing is associated with increased misuse of these medications and associated harms,” the authors write, citing in particular “potential inappropriate prescribing by telemedicine companies that may increase the likelihood of subsequent nonmedical use.” However, despite increased prescribing, there is no documented increase in nonmedical use, the article stated, adding that in general “nonmedical use tends to be sporadic for the specific intended purpose of improving performance.” Still, the overall public health effects of the growing use of prescription stimulants by adults are not known, the authors write. “The Department of Health and Human Services is working to address many of these knowledge gaps,” with the Food and Drug Administration (FDA) analyzing data from emergency department encounters, poison centers, treatment center admissions, and more. However, studies that measure the journal of patients with ADHD from diagnosis to treatment, including sharing of medications with others, are needed, according to the authors. The FDA has a Drug Shortages Staff what works to understand the risk of shortages and to respond, partly by working with manufacturers to overcome production hurdles. “For example, to support production increases, the Drug Shortages Staff can help manufacturers get expedited reviews and inquire about current manufacturing capabilities and possible manufacturing site additions.” The article, “Prescription Stimulant Prescribing, Nonmedical Use, and Shortages: US FDA Research and Response” is by Joshua P. Rising, M.D., and Robert M. Califf, M.D. Until January 2025, Califf was FDA commissioner and Rising was senior clinical advisor to the FDA.