Details
The U.S. Food and Drug Administration (FDA) initiated this study to explore the Sentinel System’s ability to assess unmet medical need from drug shortages of certain central nervous system (CNS) stimulants by examining changes over time in the proportion of prescriptions written that were dispensed, using prescribing and dispensing data from several Sentinel Data Partners that were integrated healthcare delivery systems. A secondary analysis examined the proportion of amphetamine/dextroamphetamine dispensings that had a corresponding prescription documented, to assess whether patients who sought care outside of these integrated healthcare systems may have led to the prescribing data missing a substantial amount of the actual prescribing of CNS stimulants. This study was part of FDA’s efforts to understand the extent of the unmet medical need due to shortages in selected prescription stimulants labeled for treating attention-deficit/hyperactivity disorder (ADHD). All prescription stimulants examined were federally controlled substances, schedule II (C-II) of the Controlled Substances Act.
In the secondary analysis of drug prescribing and dispensing data, three-quarters of amphetamine/dextroamphetamine dispensings did not have a corresponding prescription documented in the past 15 days. This result indicated that the available prescribing data missed a majority of all amphetamine/dextroamphetamine prescriptions written for patients in the participating data partners.
Based on this finding, FDA determined that available prescribing data could not support reliable, interpretable estimates of changes over time in the proportion of prescriptions written that were dispensed, to understand unmet medical need associated with shortages of C-II prescription stimulants intended to have been dispensed through outpatient pharmacies. This exploratory study improved FDA’s understanding of the Sentinel Distributed Database’s (SDD) prescribing and dispensing data.