Abstract

ABSTRACT Introduction Symptoms of testosterone deficiency are increasingly prevalent in the aging male population. Oftentimes, this is managed medically with exogenous testosterone supplementation. Pharmacologic testosterone is classified as a schedule III controlled substance by the Food and Drug Administration. In recent years, many states have implemented prescription drug monitoring programs (PDMP) to help track the prescribing and dispensing of controlled substances in an effort to curb the opioid epidemic. Many states also require a provider query of an online system prior to prescribing controlled medications, which has led to a reduction in opioid prescriptions. Objectives We sought to determine if the implementation of a state mandated query of PDMP prior to prescribing testosterone impacted provider prescribing behavior. Methods State PDMP requirements were determined by examining state regulatory websites. Only states who had recently implemented PDMP query mandates (since 2016) for testosterone were included. Using an insurance claims database, we evaluated all men aged 40-70 in each state who were enrolled for at least 1 year and did not move to another state during follow up. From this, a sub-cohort of men who enrolled within 3 and 6 months before and after the start date of their respective state's mandate in attempt to identify any immediate effect. Men were also stratified by race/ethnicity (White, Black, Hispanic, Asian) to observe any demographic trend. In a similar fashion, the total number of men who ever or never filled prescriptions for testosterone were identified. Rates before and after mandate implementation were compared using the generalized estimating equations test. Results 11 states (AK, CA, FL, HI, MI, NM, NV, PA, SC, WI, WY) were identified has having recent PDMP mandates for testosterone. A total of 2,297,290 men who met enrollment criteria were identified. Rates of testosterone prescriptions varied around the country (from 5.02 to 32.80 per 1000 person years). Moreover, there were no consistent changes in the rates of testosterone prescriptions after mandate implementation, regardless of the timeframe evaluated. Testosterone prescriptions increased in a majority of the states after implementation of a PDMP mandate (6 of 11 states, p<0.05) or showed no change (3 states). South Carolina and Wisconsin showed a decrease in the number of prescriptions after mandate implementation (p<0.05). While differences in the rates of testosterone prescriptions existed between races, the association with PDMP mandates were similar to the statewide analyses. Conclusion The implementation of state mandated PDMP query prior to prescribing testosterone does not appear to have a reliable effect on testosterone prescription patterns. Men with symptomatic hypogonadism do not appear to be negatively affected by new regulatory controls largely meant to curb opioid prescriptions. Disclosure No

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