title: Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.
abstract: Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse.
authors.affiliation: Andrew W. Roberts (drewroberts1@creighton.edu) is an assistant professor in the Department of Pharmacy Sciences, School of Pharmacy and Health Professions, and a program faculty member in the Center for Health Services Research and Patient Safety, both at Creighton University, in Omaha, Nebraska.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Roberts
authors.affiliation: Joel F. Farley is a professor in the Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, at the University of North Carolina at Chapel Hill.
authors.forename: Joel F
authors.initials: JF
authors.lastname: Farley
authors.affiliation: G. Mark Holmes is an associate professor in the Department of Health Policy and Management, Gillings School of Global Public Health, and director of the the Cecil G. Sheps Center for Health Services Research, both at UNC-Chapel Hill.
authors.forename: G Mark
authors.initials: GM
authors.lastname: Holmes
authors.affiliation: Christine U. Oramasionwu is an assistant professor in the Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, at UNC-Chapel Hill.
authors.forename: Christine U
authors.initials: CU
authors.lastname: Oramasionwu
authors.affiliation: Chris Ringwalt is a senior research scientist at the Injury Prevention Research Center, UNC-Chapel Hill.
authors.forename: Chris
authors.initials: C
authors.lastname: Ringwalt
authors.affiliation: Betsy Sleath is the George H. Cocolas Distinguished Professor; chair of the Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy; and director of the Child and Adolescent Health Services Program at the Sheps Center, all at UNC-Chapel Hill.
authors.forename: Betsy
authors.initials: B
authors.lastname: Sleath
authors.affiliation: Asheley C. Skinner is an associate professor at the Duke Clinical Research Institute, Duke University, in Durham, North Carolina.
authors.forename: Asheley C
authors.initials: AC
authors.lastname: Skinner
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use; D061891:Controlled Substances / Q000009:adverse effects / Q000032:analysis / Q000600:supply & distribution*; D004335:Drug and Narcotic Control / Q000379:methods*; D058999:Drug-Seeking Behavior; D005102:Health Expenditures; D006801:Humans; D008484:Medicaid; D009293:Opioid-Related Disorders / Q000188:drug therapy / Q000517:prevention & control*; D057766:Policy; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D061891:Controlled Substances
keywords: Lock-in program; Medicaid; Opioids; Pharmaceutical policy; Prescription drug abuse