Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.

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.

Reducing Opioid Misuse: Evaluation of a Medicaid Controlled Substance Lock-In Program.

Opioid misuse, abuse, and overdose are a rapidly growing public health epidemic. Medicaid Lock-In Programs (MLIPs) are designed to prevent overutilization of controlled substances by Medicaid patients. However, despite widespread use, there is little information on their effect. Using North Carolina (NC) Medicaid claims data from October 2008 through June 2013, we examined changes in Medicaid-reimbursed opioid prescriptions by patients enrolled in NC's MLIP. We used mixed effects models to examine the effect of MLIP enrollment on monthly opioid claims, number of pharmacies, total days' supply, total units (ie, pills), and total Medicaid payments for opioids. In our sample of 6,148 MLIP patients, the odds of having any opioid claim in a given month was 84% lower during MLIP enrollment relative to the period before enrollment (odds ratio = .16). MLIP enrollment also corresponded with a reduction in monthly number of opioid prescriptions by 1.13, monthly number of pharmacies by .61, and monthly Medicaid expenditures by $22.78. Although MLIPs may constitute a successful component of comprehensive efforts to reduce the potential overutilization of opioids, care should be taken to ensure that programs such as MLIPs do not constrain patients' legitimate needs for analgesic medications. PERSPECTIVE: Enrollment in NC's MLIP reduced the likelihood that patients would present a claim for an opioid prescription, and the number of opioid prescriptions patients secured each month. MLIPs may constitute a successful strategy for reducing the misuse, abuse, and diversion of prescription opioids. However, further research is needed to examine the program's potential unintended consequences.

A Randomized Controlled Trial of an Emergency Department Intervention for Patients with Chronic Noncancer Pain.

BACKGROUND: Emergency Departments (EDs) are beginning to notify their physicians of patients reporting chronic noncancer pain (CNCP) who frequent EDs, and are suggesting that the physicians not prescribe opioids to these patients. OBJECTIVES: We hypothesized that this intervention would reduce both the number of opioids prescribed to these patients by their ED physicians and the number of these patients' return visits to the ED. METHODS: We conducted a randomized controlled trial of this intervention in 13 electronically linked EDs. Patients eligible for the study were characterized by CNCP, lacked evidence of sickle cell anemia and suicide ideation, and made frequent (>10) visits to the EDs over a 12-month period. We randomly assigned 411 of these patients to either an intervention group or a control group. Our intervention comprised both an alert placed in eligible patients' medical files and letters sent to the patients and their community-based providers. The alert suggested that physicians decline requests for opioid analgesic prescriptions and instead refer these patients to community-based providers to manage their ongoing pain. RESULTS: During the 12 months after randomization, patients in the intervention and control groups averaged 11.9 and 16.6 return visits, and received prescriptions for opioids on 16% and 26% of those visits, respectively. Altogether, patients in the intervention group made 1033 fewer return visits to the EDs in the follow-up year than those in the control group. CONCLUSION: This intervention constitutes a promising practice that EDs should consider to reduce the number of visits made by frequent visitors with CNCP.

The effects of North Carolina's prescription drug monitoring program on the prescribing behaviors of the state's providers.

State-level prescription drug monitoring programs (PDMPs) show promise as a key strategy to respond to the epidemic of the misuse and abuse of controlled substances (CS), particularly opioid analgesics, in the United States. Undocumented concerns have been expressed that these PDMPs may have a "chilling effect" on providers' willingness to prescribe these substances to their patients. Using data from North Carolina's PDMP for the 3-year period from 2009 through 2011, we examined whether rapid increases in (1) the number of providers who queried the system, and (2) the number of days on which they queried it, would be related to their prescribing practices in regards to CS. We hypothesized that neither marker of PDMP utilization would be associated with a decrease in either patients receiving CS prescriptions or CS prescriptions filled. We found no association between either of these variables and the number of patients who filled prescriptions for CS or the number of prescriptions for CS filled. However, we did find a slight positive relationship between the growth in the utilization of the PDMP and the number of prescriptions filled for opioid analgesics. Concerns that PDMPs may constrain prescribing behavior with regards to CS are not supported.

Racial disparities across provider specialties in opioid prescriptions dispensed to medicaid beneficiaries with chronic noncancer pain.

OBJECTIVE: Chronic pain affects both psychological and physical functioning, and is responsible for more than $60 billion in lost productivity annually in the United States. Although previous studies have demonstrated racial disparities in opioid treatment, there is little evidence regarding disparities in treatment of chronic noncancer pain (CNCP) and the role played by physician specialty in these disparities. DESIGN: A retrospective cohort study. SETTING: We analyzed North Carolina Medicaid claims data, from July 1, 2009 to May 31, 2010, to examine disparities by different provider specialties in beneficiaries' dispensed prescriptions for opioids. SUBJECTS: The population included white and black North Carolina Medicaid beneficiaries with CNCP (N = 75,458). METHODS: We used bivariate statistics and logistic regression analysis to examine race-based discrepancies in opioid prescribing by physician specialty. RESULTS: Compared with white beneficiaries with CNCP (N = 49,197), black beneficiaries (N = 26,261) were less likely (odds ratio [OR] 0.91 [confidence interval {CI}: 0.88-0.94]) to fill an opioid prescription. Our hypothesis was partially supported: we found that race-based differences in beneficiaries' dispensed opioid prescriptions were more prominent in certain specialties. In particular, these differences were most salient among patients of specialists in obstetrics and gynecology (OR 0.78 [CI: 0.67-0.89]) and internal medicine (OR 0.86 [CI: 0.79-0.92]), as well as general practitioners/family medicine physicians (OR 0.91 [CI: 0.85-0.97]). CONCLUSIONS: Our findings suggest that, in our study population, black beneficiaries with CNCP are less likely than whites to fill prescriptions for opioid analgesics as a function of their provider's specialty. Although race-based differences in patients filling opioid prescriptions have been noted in previous studies, this is the first study that clearly demonstrates these disparities by provider specialty.

North Carolina Medicaid recipient management lock-in program: the pharmacist's perspective.

BACKGROUND: The misuse and abuse of prescription opioids have become an urgent health issue in North Carolina (NC), particularly among Medicaid patients who suffer high rates of morbidity and mortality due to abuse and overdose. The NC Division of Medical Assistance (DMA) implemented a recipient management lock-in program, which limits identified patients for a 12-month period to 1 prescriber and 1 pharmacy for benzodiazepine, opiate, and certain anxiolytic prescriptions in order to prevent misuse and reduce overutilization of Medicaid benefits.  OBJECTIVES: To (a) evaluate pharmacists' perceptions of the implementation of the NC recipient management lock-in program (MLIP) and (b) determine how the beliefs and attitudes of pharmacists could promote or inhibit its success.  METHODS: We conducted 12 structured phone interviews with NC pharmacists serving lock-in patients. Interview responses were analyzed through construct analysis, which identified themes organized into 3 domains: organization and implementation, perceived effectiveness, and acceptability.  RESULTS: Most respondents reported a positive experience with the program but expressed doubt concerning its impact on prescription drug abuse. The program successfully utilized the pharmacist role as a gatekeeper of controlled substances, and the procedures of the program required no active effort on pharmacists' part. However, respondents suggested that the DMA improve communication and outreach to address pharmacists' lack of knowledge about the program's purpose and confusion over remediating problems that arise with lock-in patients. The DMA should also address the ways in which the program can interfere with access to health care and treatment, allow patients to see multiple physicians within the same clinic, and clarify procedures for patients whose complex health issues require multiple specialists.  CONCLUSIONS: Although possible improvements were identified, the NC MLIP has strong potential for success as it utilizes pharmacists' medication gate-keeping role, while minimizing the effort required for successful implementation.

Differential prescribing of opioid analgesics according to physician specialty for Medicaid patients with chronic noncancer pain diagnoses.

BACKGROUND: Despite >20 years of studies investigating the characteristics of patients seeking or receiving opioid analgesics, research characterizing factors associated with physicians' opioid prescribing practices has been inconclusive, and the role of practitioner specialty in opioid prescribing practices remains largely unknown. OBJECTIVE: To examine the relationships between physicians' and other providers' primary specialties and their opioid prescribing practices among patients with chronic noncancer pain (CNCP). METHODS: Prescriptions for opioids filled by 81,459 Medicaid patients with CNCP in North Carolina (USA), 18 to 64 years of age, enrolled at any point during a one-year study period were examined. χ2 statistics were used to examine bivariate differences in prescribing practices according to specialty. For multivariable analyses, maximum-likelihood logistic regression models were used to examine the effect of specialty on prescribing practices, controlling for patients' pain diagnoses and demographic characteristics. RESULTS: Of prescriptions filled by patients with CNCP, who constituted 6.4% of the total sample of 1.28 million individuals, 12.0% were for opioids. General practitioner/family medicine specialists and internists were least likely to prescribe opioids, and orthopedists were most likely. Across specialties, men were more likely to receive opioids than women, as were white individuals relative to other races/ethnicities. In multivariate analyses, all specialties except internal medicine had higher odds of prescribing an opioid than general practitioners: orthopedists, OR 7.1 (95% CI 6.7 to 7.5); dentists, OR 3.5 (95% CI 3.3 to 3.6); and emergency medicine physicians, OR 2.7 (95% CI 2.6 to 2.8). CONCLUSIONS: Significant differences in opioid prescribing practices across prescriber specialties may be reflective of differing norms concerning the appropriateness of opioids for the control of chronic pain. If so, sharing these norms across specialties may improve the care of patients with CNCP.

Effects of an online alcohol education course among college freshmen: an investigation of potential mediators.

The authors investigated possible mediating effects of psychosocial variables (perceived drinking norms, positive and negative alcohol expectancies, personal approval of alcohol use, protective behavioral strategies) targeted by an online alcohol education course (AlcoholEdu for College) as part of a 30-campus randomized trial with 2,400 first-year students. Previous multilevel analyses have found significant effects of the AlcoholEdu course on the frequency of past-30-day alcohol use and binge drinking during the fall semester, and the most common types of alcohol-related problems. Exposure to the online AlcoholEdu course was inversely related to perceived drinking norms but was not related to any of the other psychosocial variables. Multilevel analyses indicated at least partial mediating effects of perceived drinking norms on behavioral outcomes. Findings of this study suggest that AlcoholEdu for College affects alcohol use and related consequences indirectly through its effect on student perceptions of drinking norms. Further research is needed to better understand why this online course did not appear to affect other targeted psychosocial variables.

Statistical methods for designing and assessing the effectiveness of community-based interventions with small numbers.

Community-based interventions are, by their nature, tailored to the particular needs of the members and stakeholders of the community. In the area of safety promotion, the multifaceted aspects of violence and unintentional injuries necessitate complex intertwining of strategies and approaches. The evaluation of the effectiveness of any 'intervention' programme, either as a whole or of its discrete components, is thus challenging. In addition, standard experimental research designs involving controlled comparisons and the use of randomisation are often not practical. The evaluation is complicated further when the numbers of events in the community that constitute outcomes to be measured, before and after the interventions, are small. This manuscript reviews some of the statistical considerations that impact the evaluation of the effectiveness of such intervention approaches, and proposes a meta-regression methodology to address this complex issue. The application of the proposed methodology to the 'Safe Community' Model is provided as an example.

Predicting high risk adolescents' substance use over time: the role of parental monitoring.

We examined whether parental monitoring at baseline predicted subsequent substance use in a high-risk youth population. Students in 14 alternative high schools in Washington State completed self-report surveys at three time points over the course of 2 years. Primary analyses included 1,423 students aged 14-20 who lived with at least one parent or step-parent at baseline. Using hierarchical linear modeling, we found that high parental monitoring at baseline predicted significantly less use of alcohol, marijuana, downers, cocaine, PCP, LSD, and prescription drugs and drinking to intoxication at the first posttest. Approximately 1 year later, high parental monitoring at baseline predicted significantly less use of alcohol, cocaine, prescription drugs, uppers, and ecstasy and drinking to intoxication. Study results suggest that parental monitoring serves as a protective factor, even for high-risk alternative high school students. Including a parental monitoring component may increase the effectiveness of traditional drug prevention programs.

The role of teacher communicator style in the delivery of a middle school substance use prevention program.

We examine whether teachers' communicator style relates to student engagement, teacher-student relationships, student perceptions of teacher immediacy, as well as observer ratings of delivery skills during the implementation of All Stars, a middle school-based substance use prevention program. Data from 48 teachers who taught All Stars up to 3 consecutive years and their respective seventh-grade students (n = 2,240) indicate that having an authoritative communication style is negatively related to student engagement with the curriculum and the quality of the student-teacher relationship, while having an expressive communicator style improves teachers' immediacy to student needs. Adaptations made by a subsample of teachers (n = 27) reveal that those who were more expressive asked students more questions, used more motivational techniques, and introduced more new concepts than authoritarian teachers.

Is there an association between adolescent bullying victimization and substance abuse?

Bullying is endemic in the nation's schools and takes a substantial toll on its victims' physical and social-emotional well-being. We assessed the association between specific reasons for which adolescents believe that they are targeted for bullying and their rates of various types of substance use by analyzing the association between self-reported past 30-day substance use and past 30-day bullying victimization among 53,750 middle and high school students in Oregon. Our results confirm previous estimates of prevalence rates for bullying as well as modest (r < 0.20) associations between bullying victimization and substance use. However, study findings did not reveal a particular reason for bullying victimization that would place adolescents at a relatively high risk of substance use.

Are substance use prevention programs more effective in schools making adequate yearly progress? A study of Project ALERT.

This exploratory study sought to determine if a popular school-based drug prevention program might be effective in schools that are making adequate yearly progress (AYP). Thirty-four schools with grades 6 through 8 in 11 states were randomly assigned either to receive Project ALERT (n = 17) or to a control group (n = 17); of these, 10 intervention and nine control schools failed to make AYP. Students completed three self-report surveys. For lifetime cigarette use and 30-day alcohol use, Project ALERT was more effective in schools that made AYP. However, in these schools, Project ALERT negatively affected students' lifetime marijuana use. This study provided some preliminary evidence that prevention programming may not work as well in poorer performing schools; however, further exploration is needed.

Project success' effects on substance use-related attitudes and behaviors: a randomized controlled trial in alternative high schools.

Using a randomized controlled effectiveness trial, we examined the effects of Project SUCCESS on a range of secondary outcomes, including the program's mediating variables. Project SUCCESS, which is based both on the Theory of Reasoned Action and on Cognitive Behavior Theory, is a school-based substance use prevention program that targets high-risk students. We recruited two groups of alternative high schools in successive academic years, and randomly assigned schools in each group to either receive the intervention (n = 7) or serve as a control (n = 7). Students completed surveys prior to and following the administration of the program, and again 1 year later. Although participation in Project SUCCESS significantly increased students' perceptions of harm resulting from alcohol and marijuana use, students in the control group reported greater increases in peer support. We also found conflicting evidence in two opposing trends related to students' perceptions of the prevalence and acceptability of substance use. Therefore, the effects of Project SUCCESS on substance use-related beliefs and behaviors must be considered mixed.

The effects of No Child Left Behind on the prevalence of evidence-based drug prevention curricula in the nation's middle schools.

BACKGROUND: Concerns have been expressed that No Child Left Behind (NCLB) may be reducing the amount of classroom time devoted to subjects other than those for which students are tested. The purpose of this article is to explore whether NCLB legislation has affected the provision of evidence-based drug prevention curricula (EBC) in the nation's middle schools, a subject area that is not assessed by standardized tests. METHODS: Data were collected in spring 2005 and spring 2008 from a nationally representative sample of middle schools. Respondents completed a survey regarding their provision of EBC (2005 response rate: 78.1%). We also collected data on schools' adequate yearly progress (AYP) status as of 2005 as a measure of their compliance with NCLB targets. We restricted our sample to schools that responded to our survey in both waves (n = 1324, or 76.9% of those schools responding in 2005) and conducted logistic regression analyses to determine whether those schools not making AYP in 2005 were less likely to be using an EBC in 2008. RESULTS: Our results revealed no relationship between AYP status in 2005 and EBC use in 2008. Analyses of demographic characteristics showed that schools making AYP were more likely to be small and rural, and to serve majority White student populations whose families were characterized by lower levels of poverty. CONCLUSIONS: Our failure to find any relationship between AYP status and the provision of EBC suggests that concerns about the potential adverse effects of NCLB on drug use prevention have yet to be validated. Implications of our results are discussed.

Predicting adolescent substance use: the effects of depressed mood and positive expectancies.

This study examined whether sixth-graders' depressed mood and positive substance use expectancies predicted increases over the next two years in students' lifetime and 30-day cigarette, alcohol, and marijuana use, and whether sixth graders' positive substance use expectancies moderated the relationship between baseline depressed mood and changes over the next two years in the use of these substances. Study data came from a randomized controlled trial of Project ALERT, a school-based substance use prevention program, in which students from 34 schools completed self-report surveys as sixth (n=5782), seventh (n=5065), and eighth graders (n=4940). Primary analyses were performed using Hierarchical Nonlinear Modeling. Over time, there were significant effects of baseline positive expectancies on each of the six measures of substance use. Baseline depressed mood predicted increases over time only for lifetime use of cigarettes and alcohol, and for 30-day alcohol use. Positive expectancies significantly moderated the effects of adolescent depressed mood only on lifetime marijuana use. Although depressed mood predicted substance use for half of our variables, our results suggest that positive expectancies are a more consistent predictor of adolescent substance use, and that they may moderate the effects of depressed mood on marijuana, but not cigarette or alcohol, use. Substance use prevention programs may benefit from addressing adolescents' perceptions about the positive consequences of drug use.

Outlet density as a predictor of alcohol use in early adolescence.

INTRODUCTION: Recent national youth surveys suggest that alcohol availability plays a role in determining use. One measure of availability receiving recent attention is outlet density; however, few studies have examined the effects of outlet density in younger populations. METHODS: Data were collected from a national sample of the United States (N = 5,903) followed between 6th and 8th grades, as part of a study funded by the Office of Juvenile Justice and Delinquency Prevention (OJJDP). Measures of outlet density were also acquired. RESULTS: Students in high off-site density communities increased their alcohol use; however, students attending schools in low outlet density communities had higher initial levels of alcohol use that remained relatively stable. DISCUSSION: The implications and limitations of these findings are discussed.

The use of one- versus two-tailed tests to evaluate prevention programs.

Investigators have used both one- and two-tailed tests to determine the significance of findings yielded by program evaluations. While the literature that addresses the appropriate use of each type of significance test should be used is historically inconsistent, almost all authorities now agree that one-tailed tests are rarely (if ever) appropriate. A review of 85 published evaluations of school-based drug prevention curricula specified on the National Registry of Effective Programs and Practices revealed that 20% employed one-tailed tests and, within this subgroup, an additional 4% also employed two-tailed tests. The majority of publications either did not specify the type of statistical test employed or used some other criterion such as effect sizes or confidence intervals. Evaluators reported that they used one-tailed tests either because they stipulated the direction of expected findings in advance, or because prior evaluations of similar programs had yielded no negative results. The authors conclude that one-tailed tests should never be used because they introduce greater potential for Type I errors and create an uneven playing field when outcomes are compared across programs. The authors also conclude that the traditional threshold of significance that places α at .05 is arbitrary and obsolete, and that evaluators should consistently report the exact p values they find.

The prevalence of evidence-based drug use prevention curricula in U.S. middle schools in 2008.

The No Child Left Behind Act mandates the implementation of evidence-based drug prevention curricula in the nation's schools. The purpose of this paper is to estimate changes in the prevalence of such curricula from 2005 to 2008. We surveyed school staff in a nationally representative sample of schools with middle school grades. Using a web-based approach to data collection that we supplemented by telephone calls, we secured data from 1892 schools for a response rate of 78.2%. We estimate that the prevalence of evidence-based drug prevention curricula rose from 42.6% in 2005 to 46.9% in 2008, and that the prevalence of schools that used these curricula most frequently increased from 22.7% to 25.9% over this period. In addition, the proportion of schools using locally developed curricula also rose, from 17.6% to 28.1%. This study suggests the success of efforts by the Office of Safe and Drug-Free Schools to increase the prevalence of evidence-based curricula, as well as the need to continue to track the prevalence of these curricula in response to any reductions in the Office's fiscal support for evidence-based drug prevention curricula in the nation's schools.