Prescription opioid pain reliever utilization has been increasing since the 1990s, due in part to changes in recommendations for the treatment of chronic pain, but also to abuse and diversion. One innovative policy solution to the abuse and diversion of prescription opioids is state prescription drug monitoring programs (PDMPs), which provide prescribers and other selected parties with patient controlled substance dispensation history; thereby, correcting an information asymmetry problem between prescribers and patients. The widespread implementation of state PDMPs, which vary in program design and requirements, has resulted in a variety of intended and unintended consequences. Previous PDMP evaluations have suggested such outcomes as the reduction of consumer access to opioids, the influencing of healthcare provider prescribing behaviors for opioids, and the re-shaping of the United States market for prescription opioids. PDMPs may also be associated with unintended outcomes: namely, the restriction of pharmaceutical opioids could be associated with an increase in heroin use, as evidenced by increases in heroin substance abuse treatment facility discharges. The analyses in this project examine the influence of PDMPs on healthcare providers and the market for prescription drugs by comparing trends in opioid utilization in states with varying PDMP features using Medicaid prescription utilization data and commercial insurance claims. The effect of PDMPs on consumers is explored with an analysis comparing substance abuse treatment facility discharge data for heroin abuse with pharmaceutical opioid prescriptions before and after PDMP regulatory change. Finally, the impact of other related opioid policy interventions, opioid overdose medication access laws, are analyzed by comparing opioid overdose mortality across states with differing overdose medication access policies over time. Contributions to the understanding about the impacts of these state-level opioid abuse and diversion policies can be used to improve or amplify intended outcomes and ameliorate unintended consequences.

OBJECTIVE: To review existing PDMP statutes, and to provide recommendations for good legislative drafting that will create effective statutory components that will enhance the function and increase the use of PDMPs. METHODS: This policy review was conducted from July 2014 to December 2014, using articles dated January 01, 2004 to July 01, 2014. All PubMed searches were artificially limited to peer reviewed articles that were available as “free full text.” To ensure a comprehensive review of the policies, statutes from all fifty states were surveyed using the legal database, Westlaw Next. The search used terms associated with PDMPs. Each statute was reviewed by title and content to determine applicability to the study. The list of statutes compiled from Westlaw Next was compared with existing publications that survey PDMP statutes. The recommendations are based on the investigator’s experience and training in law and public health in consultation with a legislative expert, and supported by peer reviewed articles and legislative drafting guides. RESULTS: There are twelve main topical components that are addressed in existing state PDMP statutes. The policy brief’s primary three recommendations are to implement an advisory committee with an outlined membership, impose a duty for the committee to routinely review database information and to report on the findings, mandate practitioners to consult the database prior to administering controlled substances, and enact a PDMP educational component for practitioners. Appendix A of this policy review (attached) provides a full list of the recommendations for effective legislation on all twelve topical components.

The United States is in the midst of an opioid epidemic. In addition to other system level interventions, almost all states have responded to the crisis by implementing prescription drug monitoring programs (PDMPs). PDMPs are state-level interventions that track the dispensing of Controlled Substances. Data generated at the time of medication dispensing is uploaded to a central data server that may be used to assist in identifying drug diversion, medication misuse, or potentially aberrant prescribing practices. Prior studies assessing the impact of PDMPs on trends in opioid-related morbidity have often failed to take into account the wide heterogeneity of program features and how the effectiveness of these features may be mitigated by insurance status. Previous research has also failed to differentiate the effects of these programs on prescription vs. illicit opioid-related morbidity. The studies in this dissertation attempt to address these gaps using epidemiological techniques to examine the associations between specific PDMP features and trends in prescription and illicit opioid-related poisonings in populations of different insurance beneficiaries. Results of these studies demonstrate that implementation of specific PDMP features is significantly associated with differential trends in prescription and illicit-opioid related poisonings and that the effectiveness of these features vary depending on the insurance status of the population studied. These results suggest that PDMPs offer a valuable tool in addressing the United States’ opioid epidemic, and may be used as empirical evidence to support PDMP best practices in the future.

Increased opioid analgesic (OA) prescribing has been associated with increased risk of prescription opioid diversion, misuse, and abuse. States established prescription drug monitoring programs (PDMPs) to collect and analyze electronic records for dispensed controlled substances to reduce prescription drug abuse and diversion. PDMP data can be used by prescribers for tracking patient’s history of controlled substance prescribing to inform clinical decisions. The studies in this dissertation are focused on the less utilized potential of the PDMP data to enhance public health surveillance to monitor OA prescribing and co-prescribing and association with opioid overdose mortality and morbidity. Longitudinal analysis of OA prescribing and evaluation of the effect of recent policies and opioid prescribing guidelines require consensus measures for OA utilization and computational tools for uniform operationalization by researchers and agencies. Statistical macros and computational tools for OA utilization measures were developed and tested with Kentucky PDMP data. A set of covariate measures using mortality and morbidity surveillance data were also developed as proxy measures for prevalence of painful conditions justifying OA utilization, and availability of heroin and medication treatment for opioid use disorder. A series of epidemiological studies used the developed OA measures as outcomes, and adjusted for time-varying socio-demographic and health care utilization covariates in population-averaged statistical models to assess longitudinal trend and pattern changes in OA utilization in Kentucky in recent years. The first study, “Trends and Patterns of OA Prescribing: Regional and Rural-Urban Variations in Kentucky from 2012 to 2015,” shows significant downward trends in rates of residents with OA prescriptions. Despite the significant decline over time, and after accounting for prevalence of injuries and cancer, the rate of dispensed OA prescriptions among residents in Kentucky Appalachian counties remained significantly higher than the rest of the state. The second study, “Population-Level Measures for High-Risk OA Prescribing: Longitudinal Trends and Relationships with Pain-Associated Conditions,” shows significant reduction in high-risk OA prescribing (e.g., high daily dosage, long-term use, concurrent prescriptions for OA and benzodiazepines) from 2012 to 2016, significantly positive associations between high-risk OA prescribing and cancer mortality rates with no substantial change in the association magnitude over time, and declining strengths of positive associations between high-risk OA prescribing and acute traumatic injuries or chronic non-cancer pain over the study period. The third study, “A Reciprocal Association between Longitudinal Trends of Buprenorphine/Naloxone Prescribing and High-Dose OA Prescribing,” indicates a significant reciprocal relationship between high-dose OA prescribing and buprenorphine/ naloxone prescribing, and a clinically meaningful effect of buprenorphine/naloxone prescribing on reducing OA utilization. The results from the studies advanced the understanding of the epidemiology of opioid use and misuse in Kentucky, and identified actionable risk and protective factors that can inform policy, education, and drug overdose prevention interventions. The developed operational definition inventory and computational tools could stimulate further research in Kentucky and comparative studies in other states.