Prescription Drug Monitoring Programs and Other State-Level Strategies Interventions to Reduce Opioid-Related Harms: Misuse, Abuse, Addiction, and Overdose Tamara M. Haegerich, PhD Acting Associate Director for Science Presentation at the National Academies of Sciences September 22, 2016 National Center for Injury Prevention and Control Division of Unintentional Injury Prevention
Evidence-Based State-Level Strategies 1 Prescription Drug Monitoring Programs Real time, mandated, and actively managed controlled substance centralized database accessible to providers 2 Public and Private Insurance Strategies Drug utilization review, lock-in programs, and prior authorization 3 Clinical Guidelines Recommendations based on the most recent scientific evidence and national guidelines 4 Legislation Pain clinic regulation, Good Samaritan laws * Naloxone distribution and access to Medication-Assisted Treatment are covered within other panel presentations and not considered herein
Summary of Available Research Evidence Few rigorous evaluations Assess knowledge/behavior rather than health outcomes Methodological limitations e.g., no comparison group, small samples, short-term Low quality of evidence Strategies identified are promising
Prescription Drug Monitoring Programs
PDMP System Overview
PDMP adoption Status of PDMPS September 2013 States with no PDMP Adapted from NAMSDL, Annual review of prescription drug monitoring programs. March 2015. http://www.namsdl.org/library/3449ddcf-bb94-288b-049eb9a92bad73df/.
How can PDMPs be used? Surveillance and evaluation tool Clinical decision-making Law enforcement Regulation (state medical board)
Selected PDMP Best/Promising Practices Real time/reductions in data collection interval Universal registration and use Active management (proactive prescriber outreach; unsolicited reporting to regulatory boards) Collection of data on all controlled substances schedules Delegated access (e.g., NPs, PAs) Enabled access by appropriate users (e.g., public health, regulatory boards, law enforcement) Epidemiological analysis Integration with EHRs and HIEs Interstate data sharing Clark et al. (2012). Prescription Drug Monitoring Programs: An assessment of the evidence for best practices. PDMP Center of Excellence, Brandeis University. http://www.pdmpexcellence.org/sites/all/pdfs/brandeis_pdmp_report.pdf
Evidence for Effectiveness PDMPs Descriptive before-after and time series Mixed findings for prescribing prescribing schedule II; prescribing of schedule III Decrease in multiple prescribers and pharmacies Mixed findings for morbidity (e.g., ED visits) and mortality Patrick et al (2016): ITS 1.12 opioid-related overdose deaths per 100,000 population in year of implementation; greater reductions with higher numbers of drugs included and data updates at least weekly
Public and Private Insurance Strategies
Prior authorization Insurance Strategies Coverage requires review to ensure criteria met Drug utilization review Retrospective claims review to identify inappropriate prescribing Patient review and restriction Require patients to use one prescriber and/or pharmacy for controlled substance prescriptions
Evidence for Effectiveness Insurance Strategies Descriptive/before-after, time series, RCT Decrease in ED visits No changes in mortality Decrease in poly-pharmacy, high dosage, number of prescribers and pharmacies Gonzalez & Kolbasovsky (2012): RCT Comparing provider letter provision based on drug utilization review to resource provision; 24% in prescribers, 16% in pharmacies, 15% in filled prescriptions
Clinical Guidelines
Clinical Guideline Strategy Issued by federal, state, and national organizations CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016 Prescribing recommendations Initiation Dosing Monitoring (e.g., PDMP, UDT) Discontinuation Typically accompanied by implementation efforts Education (e.g., CME) Academic detailing
Evidence of Effectiveness Clinical Guidelines Descriptive before-after, time series, RCT Moderate knowledge improvements for providers Limited use of recommended practices, particularly without training and education efforts to support Some effects on dosing limits, ER/LA opioids, urine drug testing Decreases in ED visits and deaths Cochella & Bateman (2011): Pretest-posttest; after academic detailing with clinic presentations and translation materials, selfreported lowering initial dosages and slowing dose escalations and increased PDMP use; 14% overdose deaths Paone et al (2015): 29% opioid overdose deaths in Staten Island after comprehensive strategy with guideline at core
Legislation
Pain clinic regulation State Legislation Requires state oversight and contains requirements concerning ownership and operation (e.g., personnel requirements, inspection, license procedures) Good Samaritan laws Criminal immunity for help seeking; immunity for possession or administration of naloxone
Evidence of Effectiveness State Legislation Descriptive/before-after, time series Greater comfort calling 911 and greater likelihood of reporting behavior with immunity Reduction in pain clinics, opioid supply, overdose death rates after implementation of pain clinic law Johnson et al (2014) After regulation, overdose death rate 27%; prescribing declined for drugs where overdose death rate declined
Research Gaps How can PDMP data be best leveraged for surveillance and etiologic investigation? How could PDMP data be used for post-marketing surveillance of opioid medications? What systems-level translation and improvement strategies can enhance adoption and use of recommended clinical strategies, including PDMP use? Could inclusion of education on PDMP checks and CDC guideline recommendations more broadly in REMS improve use and utility? Which insurance/pbm interventions and state policies change prescribing behaviors most effectively while supporting effective pain management?
For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888- 232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.