Wpływ ograniczeń dotyczących substancji kontrolowanych na dostęp do leczenia padaczki w Stanach Zjednoczonych: badanie ankietowe lekarzy neurologów

RATIONALE: Access to anti-seizure medications (ASMs) is critically important to patients with epilepsy (PWE), given that missed doses can lead to breakthrough seizures, morbidity, or mortality. Numerous ASMs are subject to U.S. Drug Enforcement Administration (DEA) scheduling regulations. Controlled substance restrictions present barriers to timely medication access. Scheduling restricts ASM access in myriad ways: biometric data and/or physical signature requirements, refill-too-soon policies, and mail-order availability may be restricted. We hypothesized that ASM misuse is rare, but there is sparse literature available regarding real-world ASM use and clinical impact of restrictions. This survey study investigates whether ASM restrictions impact patient care and whether neurologists encounter patient misuse of ASMs in common practice. METHODS: An anonymous IRB-approved electronic survey was directly distributed to neurologists and neurology clinicians who treat adult patients with epilepsy via email as well as indirectly via national neurology organization platforms. RESULTS: 236 participants completed the survey. 82% of respondents reported treating primarily PWE. 99% of participants reported having patients experience delayed ASM refills due to restrictions, and 96% reported breakthrough seizures among patients due to scheduled ASM restrictions. Perceived patient misuse of ASMs was generally low. There was a stark difference in reported misuse rates comparing clobazam to traditional benzodiazepines, with 8% reporting rare or occasional misuse of clobazam versus 79% reporting rare or occasional misuse of traditional benzodiazepines. Perceived misuse of non-benzodiazepine, non-gabapentinoid ASMs was very rare; 1% of participants perceived any instances of misuse with brivaracetam or lacosamide, and 0% reported any misuse with perampanel or cenobamate. CONCLUSIONS: Respondents reported high rates of medication access issues related to controlled substance restrictions and low rates of ASM misuse. Controlled substance restrictions create practical barriers to reliably obtaining scheduled ASM prescriptions that can result in increased risk of morbidity and mortality. Controlled substance restrictions warrant reevaluation for PWE given the specific risk-benefit tradeoffs for this life-threatening neurologic condition.