When regulation disrupts treatment: controlled-substance policies, continuity of chronic disease care, and health equity

Background Controlled-substance regulation is intended to reduce misuse and diversion, but its implementation can also create barriers to clinically appropriate treatment. This study examines that tension using patient-reported experiences from MINDSET 2.0, an epilepsy self-management trial, and contextualizes these findings within emerging epilepsy evidence and a targeted narrative review of analogous barriers affecting other chronic conditions. Methods A qualitative descriptive study was embedded within the larger MINDSET 2.0 randomized controlled trial. Fifty-three adults with epilepsy recruited from neurology clinics in Arizona and Texas completed semi-structured exit interviews at the conclusion of the trial. Interview transcripts were analyzed using thematic content analysis and NVivo 12, with independent coding, collaborative review, consensus resolution of discrepancies, constant comparison, and assessment of thematic saturation. For the present policy-focused analysis, coded data were examined for recurring experiences related to controlled anti-seizure medication (ASM) access and treatment continuity. A targeted narrative review contextualized these patient experiences within U.S. controlled-substance policy and evidence from epilepsy, chronic pain, attention-deficit/hyperactivity disorder (ADHD), and medication-access research. Results Participants described interacting barriers involving refill timing restrictions, pharmacy processing and verification requirements, medication availability and partial fills, insurance refill limitations, prescriber-pharmacy coordination, travel, and transportation. Patient accounts showed how these barriers could disrupt work and travel, require repeated pharmacy visits, create substantial stress and uncertainty, and interfere with established self-management routines. Some participants reported treatment interruptions; one described breakthrough seizures after running out of medication during a refill and pharmacy-stock delay, while another described considering medication discontinuation after repeated refill difficulties. Participants’ experiences also demonstrated that regulatory, payer, pharmacy, and supply-related barriers were not always perceived as distinct but could operate as a cumulative medication-access burden. Recent national epilepsy evidence converges with these findings: a 2026 survey of 236 U.S. neurology clinicians found that 99% had encountered refill difficulty or missed medication days related to controlled-substance restrictions and 96% had encountered breakthrough seizures after missed scheduled ASM doses. Evidence from chronic pain and ADHD identified analogous challenges to treatment continuity. Conclusion Controlled-substance policy should be evaluated using a dual public health standard: prevention of misuse and diversion and preservation of timely access to medically necessary treatment. The patient experiences identified in MINDSET 2.0 suggest that regulatory requirements can interact with insurance rules, pharmacy practices, medication availability, transportation, employment, and other structural factors to create cumulative barriers to treatment continuity. Medication- and condition-specific proportionality, safe refill flexibility, streamlined prescriber-pharmacy workflows, and incorporation of patient-reported access outcomes may help reduce unintended harms while maintaining appropriate safeguards.