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Impact of Schedule IV Controlled Substance Classification On Drug and Alcohol Dependence 202 (2019) 172–177 Contents lists available at ScienceDirect Drug and Alcohol Dependence journal homepage: www.elsevier.com/locate/drugalcdep Impact of Schedule IV controlled substance classification on carisoprodol T utilization in the United States: An interrupted time series analysis ⁎ Yan Lia, , Chris Delcherb, Joshua D. Browna, Yu-Jung Weia, Gary M. Reisfieldc, Almut G. Wintersteina,d a Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, FL, USA b Institute for Pharmaceutical Outcomes and Policy, Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, KY, USA c Department of Psychiatry, College of Medicine, University of Florida, FL, USA d Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, FL, USA ARTICLE INFO ABSTRACT Keywords: Background: In January 2012, the Drug Enforcement Agency (DEA) classified carisoprodol as a Schedule IV Carisoprodol controlled substance at the US federal level. We aimed to examine the effect of this policy on the use ofcar- Controlled Substance Act isoprodol in a commercially-insured population. Controlled substance classification Methods: This interrupted time series study included individuals with musculoskeletal disorders in the IBM Drug schedules MarketScan Commercial Database between December 2009 and February 2014. We used comparative seg- Drug Enforcement Administration mented linear regression to assess changes in the proportions of patients who filled/newly filled carisoprodol Interrupted time series Skeletal muscle relaxants each month. United States Results: A total of 13.3 million patients were included. 29 states with no scheduling prior to the DEA classifi- cation had lower baseline prevalence of carisoprodol use compared to 17 states that had scheduled carisoprodol individually before 2010 (11.0 vs. 21.1 patients with fills per 1000 patients). The federal scheduling wasas- sociated with an immediate decline (–1.12 per 1000 patients, p < 0.01) and decreasing trend in prevalence (–0.07 per 1000 patients per month, p = 0.02). This effect was not modified by existing state-level scheduling status. During the first, second, third, and fourth 6-month periods after federal scheduling, the relative difference between observed and predicted prevalence was 7.8%, 10.5%, 13.4%, and 19.8%. Similar patterns were ob- served for carisoprodol initiation. Overall, declining use was more pronounced among younger age groups and patients with injury. Conclusions: Schedule IV controlled substance classification at the federal level was associated with a moderate reduction in the dispensing of carisoprodol regardless of whether scheduling was already present at the state level. 1. Introduction combined with other drugs such as opioids and benzodiazepines, con- tinues to this day (Horsfall and Sprague, 2017; Losby et al., 2017). Carisoprodol (Soma®, Meda Pharmaceuticals Inc.), a skeletal muscle The primary active metabolite of carisoprodol is meprobamate, a relaxant indicated for acute and painful musculoskeletal conditions, Schedule IV sedative-hypnotic (Olsen et al., 1994). In addition to the was initially approved as a non-controlled substance in the United recognized abuse potential of meprobamate, recent studies suggest that States (US) in 1959 (SOMA [package insert], 2009). While experiments carisoprodol itself can directly target the GABAA receptor and produce a in the early 1960s did not identify addictive properties of carisoprodol notable central nervous system depressant effect (Gonzalez et al., (Fraser et al., 1961), over time, reports have described cases of abuse in 2009a, b; Rho et al., 1997). At the population level, the significance of various settings. In these cases, individuals typically used carisoprodol carisoprodol abuse has been demonstrated by findings from public in much larger quantities than recommended to achieve mind-altering surveillance systems. Among all drug abuse or misuse related emer- effects, to substitute for other, less-available drugs, or to potentiate the gency department (ED) visits across the US collected by the Drug Abuse effects of co-ingested drugs (Reeves and Burke, 2010; Reeves et al., Warning Network, the number of cases involving carisoprodol nearly 2012). Concern about the abuse of carisoprodol, especially when doubled from 17,432 in 2004 to 29,864 in 2010 (Substance Abuse and ⁎ Corresponding author. E-mail address: [email protected] (Y. Li). https://doi.org/10.1016/j.drugalcdep.2019.05.025 Received 29 December 2018; Received in revised form 15 May 2019; Accepted 19 May 2019 Available online 19 July 2019 0376-8716/ © 2019 Elsevier B.V. All rights reserved. Y. Li, et al. Drug and Alcohol Dependence 202 (2019) 172–177 Mental Health Services Administration, 2013). According to the Na- January 11th, 2012; and (3) a 24-month post-intervention period tional Survey on Drug Use and Health, the number of Americans 12 (February 2012 through February 2014). Because most policy im- years and older using carisoprodol for non-medical purposes during plementations require some time until complete adoption, we omitted their lifetime has been estimated to be around 3.3 million from 2013 to the 3-month intervention period from statistical analyses (Wagner 2014 (Center for Behavioral Health Statistics and Quality, 2015). et al., 2002). Growing concerns over carisoprodol abuse have prompted reg- We grouped states by whether or not a state had scheduled car- ulatory actions. At the federal-level, a scheduling recommendation by isoprodol before the enactment of federal policy (Appendix Table S1*). the US Drug Enforcement Administration (DEA) in 1996 was un- Accordingly, 29 states with no scheduling prior to the 2012 federal successful because the Food and Drug Administration (FDA) Drug policy (no-state-policy group) were compared to 17 states with state Abuse Advisory Committee concluded there was insufficient evidence laws in place before 2010 (state-policy group). Most of these states had to support controlling carisoprodol (Drug Enforcement Administration, scheduled carisoprodol prior to 2004. We excluded four states 2009). At the state-level, where more restrictive pharmacy laws can be (Mississippi, Tennessee, Washington, and Wyoming) that had classified enacted, 21 states started to regulate carisoprodol as a controlled sub- carisoprodol as controlled substance between 2010 and 2011 because stance as early as 1994 (in New Mexico) (Fass, 2010; Reeves et al., the impact of these prior state-level legislative efforts may confound the 2012). A second attempt for federal action was made in 2009 when the evaluation of federal scheduling enacted shortly thereafter. DEA issued a Notice of Proposed Rulemaking to classify carisoprodol, which ultimately placed carisoprodol into Schedule IV, effective on 2.3. Outcomes January 11th, 2012 (Drug Enforcement Administration, 2011). In the US, substances with abuse liability or addiction potential are Our unit of time measurement was one month. For each month, the regulated by the Controlled Substances Act (CSA) and are divided into eligible population included beneficiaries with medical and pharmacy five categories (schedules), with Schedule I being the most restrictive benefits for the current and preceding 12 months. We then further re- and Schedule V being the least restrictive (Controlled Substances Act, stricted our study sample (denominators) to patients who had medical 1970; Rocha, 2013). Pursuant to the CSA, the intent of scheduling a encounters with diagnoses indicating potential clinical need for muscle prescription drug is to increase awareness of its abuse potential and relaxants during the current or the preceding one month. These diag- curb overprescribing, to heighten the scrutiny over its distribution, and noses included a broad range of musculoskeletal disorders: injury and to prevent related controlled substance violations and criminal activ- related conditions, arthritis and related conditions, bone and spinal ities with the ultimate goal to reduce abuse, addiction, and overdose conditions, or tension headache (see Appendix Table S2* for detailed (Controlled Substances Act, 1970; Drug Enforcement Administration, definitions). 2011). Paramount to this legislative intent are studies that empirically We estimated (1) the proportion of eligible patients who filled at test the policy’s effectiveness, yet it remains unclear in the current lit- least one prescription for carisoprodol and (2) the proportion of eligible erature how the clinical community and health systems have reacted to patients who newly filled (incident fill) carisoprodol each month. An the potentially stronger message imposed by federal action and how use incident fill was defined as having no carisoprodol fill in the preceding of carisoprodol was affected by the DEA Schedule IV classification. 12 months. The latter measure was introduced because patients with We aimed to examine the effect of controlled substance designation prescriptions that preceded federal scheduling could continue to fill on the dispensing of carisoprodol in a large commercially-insured po- these prescriptions. In contrast, carisoprodol initiation may be a mea- pulation in the US. sure more amenable to an immediate response by prescribers to the policy change. 2. Methods In a sensitivity analysis, we lifted the requirement for musculoske- letal disorder diagnoses and explored the use of carisoprodol
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