rx16 pdmp wed_330_1_hoppe_2sun_3baumgartner-leichting
TRANSCRIPT
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Linking and MappingPDMP Data
Presenters:• Jason Hoppe, DO, Emergency Physician and Medical Toxiocologist,
University of Colorado and Rocky Mountain Poison and Drug Center• Benjamin Sun, MD, MS, Emergency Medicine Physician, Oregon Health
and Science University• Christopher Baumgartner, Drug Systems Director, Washington State
Department of Health• Gillian Leichtling, Senior Research Associate, Acumentra Health
PDMP Track
Moderator: Christopher M. Jones, PharmD, MPH, Director, Division of Science Policy, Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and Member, Rx and Heroin Summit National Advisory Board
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Disclosures
Christopher Baumgartner; Jason Hoppe, DO; Gillian Leichtling; Benjamin Sun, MD, MS; and Christopher M. Jones, PharmD, MPH, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.
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Disclosures
• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
• The following planners/managers have the following to disclose:– John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest:
Starfish Health (spouse)– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
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Learning Objectives
1. Explain the benefits, challenges and opportunities of linking PDMP data to clinical data.
2. Identify the benefits of mapping data to target treatment expansion and overdose prevention efforts.
3. Describe a state GIS mapping tool that integrates PDMP data with existing databases and displays community-level results.
4. Provide accurate and appropriate counsel as part of the treatment team.
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Linking PDMP Data
Jason Hoppe, DODepartment of Emergency Medicine
University of Colorado SOM
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Disclosures
• Dr. Hoppe has no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services
• Dr. Hoppe is supported by a Harold Rogers BJA grant for PDMP research partnership via the Colorado Division of Regulatory Agencies but this presentation does not reflect the opinions of either entity
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Benefits of linking data
• Maximize possible benefit to public health by translating research findings to clinical practice– Enhance patient safety and individual
healthcare experiences– Expand knowledge about diseases and
treatments – Strengthen healthcare system efficiency and
effectiveness – Help businesses meet customer needs
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Benefits continued
• Evaluate the true value of PDMPs and the impact of PDMP interventions
• Help evaluate causation/cause-effect relationship identify modifiable causes
• Evaluate prescribing decisions across multiple providers, settings and care organizations
• Improve interpretation of PDMP data, risk factors improve decision-making
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Investigator data needs• No identifiable data!• Clinical data– Diagnosis, visits/discharges, meds, risk factors,
imaging, past med/social history, drug screens • PDMP data– Patient: Past/future medication use, overlaps, co-
prescribing, MME, # of providers/pharm/Rx/$$$ – Prescriber: # Rx, doses/trends in dosing, co-
prescribing, comparison to peer group• Time periods (not dates)• Outcomes (clinical and/or PDMP)
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Barriers for PDMP studies
• Informed consent not realistic or efficient• Impractical/impossible to re-contact research
subjects• Even if possible, final group may not represent
intended group• Need to have reliable, de-identified data sets– Data sets in separate places, correct matching– Waiver of informed consent
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Barriers continued
• Statutory authority of governing body– Interpretation of law
• Hospital and state are legally separate entities– PDMP vendor may be third entity
• Multiple data use agreements (DUA)• Payment mechanism
• Resources– Little incentive to invest in infrastructure to support
research, not the mission of state or PDMP vendor
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Current mechanisms to link data
• PDMP pulls data• Vendor pulls data• Researcher pulls data• Department of public health
• Considerations: DUAs, resources, cost, time, PHI protection, data transfer, data accuracy
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Ideal mechanism for linkage
• Collaborative relationships• Within confines of state laws– Legal and regulatory safeguards in place
• Timely• Cost effective• Reproducible• Reasonably assures de-identification• Automated data transfer
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Ideal mechanism “A”
• Approved investigator requests clinical data for IRB approved study
• Verified suitability• Identifies pts and obtains pt info• Accuracy assessed• De-identifies data set• De-identified data set back to investigator
Choi et al. (2015), Establishing the role of honest broker: bridging the gap between protecting personal health data and clinical research efficiency. PeerJ 3:e1506; DOI 10.7717/peerj.1506
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Ideal mechanism “B”
• Request clinical or public health data for IRB approved study
• Verified suitability• Identifies pts and obtains pt info• Public health data linked to appropriate pt• Accuracy assessed• De-identifies data set• Merged, de-identified data set back to investigator
Choi et al. (2015), Establishing the role of honest broker: bridging the gap between protecting personal health data and clinical research efficiency. PeerJ 3:e1506; DOI 10.7717/peerj.1506
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Honest broker
• Layer of protection; HIPAA safe harbor• Individual, organization or system acting as a
neutral intermediary to collect/supply data to approved requestors in a way in which it is not reasonably possible to identify participants
• Firewall between investigator and identifiable information
• Independent of the research team
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Linking PDMP Data
Benjamin Sun, MD, MPPOregon Health & Science University
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Disclosures
• Dr. Sun is supported by NIH grant R01DA03652• Dr. Sun has disclosed no relevant, real, or
apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
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Learning Objective
• Explain the benefits, challenges and opportunities of linking PDMP data to clinical data.
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The Plan
• NIH supported study to assess the impact of PDMP use of emergency physicians on opioid prescribing and patient outcomes
• Collaboration with WA State Department of Health (PDMP) and Health Care Authority (Medicaid)
• Beneficiary and physician level linkage of PDMP and beneficiary level data
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The Plan
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Challenges
• Getting Permission
• Getting the Data
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Getting Permission- State IRB
• State IRB– Concerns about patient and provider identifiable
information– Proposed complex linkage strategy• PDMP vendor will create encrypted patient and
provider identifiers• All files released to research team will have encrypted
identifiers, no direct patient identifiers
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Getting Permission- State IRB
• Ambiguity in legislative language– RCW 70.225.040 (4): “The department may
provide data to public or private entities for … research…
– IRB questioned whether data release by PDMP vendor violates legislation
– Department of Health issued memo clarifying PDMP vendor is agent of DOH
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Getting Permission- State IRB
• Limited Resources– Very lengthy turnaround times– Initial review and approval: 9 months– Minimum risk amendment to add additional
variables: 6 months
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Getting Permission- Data Use Agreements
• Separate DUA required with Department of Health
• Requires contracts and legal review on both sides
• Very slow: 6 months
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Getting Permission- Lessons Learned
• START EARLY– We initiated IRB application 9 months prior to
study start; still had ~6 month delays• ACTIVE MANAGEMENT– Get on phone immediately to understand
potential barriers– Conference calls when multiple parties involved
• USE (AND THANK) YOUR ALLIES
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Getting the Data
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Getting the Data- PDMP
• Vendor manages PDMP on behalf of state• PDMP vendor saturated with PDMP core
tasks, non-core requests are delayed (2 years)• Other possible solutions– Contract directly with state• Pay existing staff• Hire new staff
– Varying ability of state partners to do this
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Getting the Data- PDMP
• We are obtaining de-identified, non-linkable PDMP files so that research team can understand data structure
• We hope to obtain linkable PDMP files by late summer 2016
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Overall Project Management
• Research staff fully occupied preparing Medicaid files for analysis (~500 million lines of data)
• Plan to complete 4 analyses that only require data we already have (detour from core questions about PDMP use)
• Close contact with sponsor
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Summary
• Getting permission– Begin IRB/ DUA process as soon as possible– Actively manage the process
• Getting data– Explore all options, including having state
personnel prepare data• Treat your collaborators well!
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PDMP Track: Linking and Mapping PDMP Data
Gillian Leichtling – Acumentra HealthChris Baumgartner, WA State Dept. of Health
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Disclosure Statement
• Gillian Leichtling and Chris Baumgartner have disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
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Learning Objectives
1. Explain the benefits, challenges and opportunities of linking PDMP data to clinical data.
2. Identify the benefits of mapping data to target treatment expansion and overdose prevention efforts.
3. Describe a state GIS mapping tool that integrates PDMP data with existing databases and displays community-level results.
4. Provide accurate and appropriate counsel as part of the treatment team.
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MAPPING OPIOID AND OTHER DRUG ISSUES (MOODI) TOOL
Washington State
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WA State Unintentional Poisonings Workgroup (UPWG)
• Began quarterly meetings in June 2008• Representatives from public & private organizations:
• State/local health agencies, tribal authorities, insurers, law enforcement, substance abuse prevention/treatment, poison control, health professional associations, academic institutions, etc…
• Developed short-term actions• Increase provider and public education• Identify methods to reduce diversion through emergency departments• Increase surveillance• Support evaluation of practice guidelines for providers treating chronic,
non-cancer pain • Support prescription monitoring program
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2016 Washington State Interagency Opioid Working Plan
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Goal 1: Prevent opioid misuse and abuse• Improve prescribing practices
Goal 2: Treat opioid dependence• Expand access to treatment
Goal 3: Prevent deaths from overdose• Distribute naloxone to people who use heroin
Goal 4: Use data to monitor and evaluate• Optimize and expand data sources
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Opioid Plan - Goal 4 Strategies1. Improve PDMP functionality to document and
summarize patient and prescriber patterns to inform clinical decision making
2. Utilize the PDMP for public health surveillance and evaluation
3. Continue and enhance efforts to monitor opioid use and opioid-related morbidity and mortality
4. Monitor progress towards goals and strategies and evaluate the effectiveness of our interventions
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Bureau of Justice Assistance (BJA)
Previous• Category 1:
Implementation• FY 2010• FY 2011• Both closed
Recent• Category 2:
Enhancement• FY 2012• Ends March
2016
Current• Category 3:
Data-Driven Approaches
• FY 2014• Jan 2015 – June
2016
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Harold Rogers Prescription Drug Monitoring Grants to the Washington State Department of Health
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Category 3 Harold Rogers Grant
• Data-Driven Multidisciplinary Approaches to Reducing Rx AbuseProgram goals:
• Pilot innovative approach
• Form multidisciplinary action group
• Examine multiple data sources
• Identify target areas and create data-driven response strategies
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Project Implementation Partners
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Washington Dept. of Health - PDMP• Oversight, dataset prep
Acumentra Health• Project management
University of Washington• Analytic guidance
Looking Glass Analytics• Mapping tool development
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MOODI Purpose: Local Visualization
• E.g., risky Rx patterns, Rx opioid or heroin overdose hospitalizations and deaths
Identify Needs
• E.g., buprenorphine access, methadone/OTP, naloxone, PDMP registration, prescription drug disposal sites
Identify Resources
• E.g., medication-assisted treatment (MAT) “service deserts” with high treatment need and low availability
Identify Gaps
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Datasets Currently Included• Dispensing records• Prescriber registrationsPDMP
• Opioid OD hospitalizations• Opioid OD deathsOverdose• Buprenorphine-waivered physicians• Opioid Treatment Program list• State treatment admissions data
MAT
• Naloxone sites• Safe Rx drug disposal sitesOther
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Supporting Documents
Guidance manual to aid stakeholders in interpretation and prioritizing interventions
Technical document with analytic detail
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SAMPLE SCREENSHOTSOpioid Mapping Tool
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MOODI Functionality
Users can: Click to see technical details and definitions Zoom in or out Display up to 4 maps simultaneously View results using various denominators (e.g.,
counts, rates per 1,000 prescriptions, rates per 1,000 population)
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Multiple Prescriber Episodes
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High Dosage
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Side-by-Side: Prescribing Risks
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Overdose Hospitalizations
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Travel Time to Buprenorphine Prescriber
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Availability of Opioid Treatment Programs
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Additional Maps
• Other maps look at bup maintenance/long-term treatment, patients in OTP services, PDMP registration, and dot maps for naloxone and Rx drug disposal sites
• Maps in progress: – Buprenorphine service availability: considers
active/inactive prescribers and caseload– MAT service deserts: shows index score across needs
and resources related to MAT
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USING, SUSTAINING, AND EXPANDING MOODI
Stakeholder Examples and Next Steps
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State Stakeholder Examples
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Medicaid OfficialIdentifies areas with
high opioid issues, few bup prescribers
Targets outreach efforts to providers to seek bup
waivers
Health OfficerIDs areas with high
rates of high dosage and overlapping
benzos
Targets prescriber education efforts
Behavioral Health Official
IDs areas where bup prescribers are
providing short-term prescriptions
Works to ID barriers to maintenance bup treatment
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Local Stakeholder Examples
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County Health OfficerIDs areas with high
rates of overdose and no naloxone
Targets pharmacies for naloxone distribution
Prevention CoalitionLow rates of PDMP
registration, high rates of multiple prescriber
episodes
Implements PDMP registration campaign
Police Chief High rates of opioid overdose
Seeks funding for first responder naloxone trainings
Medical Provider High rates of overdose and Rx risk
Convenes local prescriber workgroup with county health officer
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Sustaining/Expanding MOODI
Working on funding to sustain and expand, for example: Show trends over time Add additional opioid-related data
Administrative: crime lab, arrests, ER, EMS Survey: BRFSS, statewide student survey
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Expanding Stakeholder Groups
MOODI infrastructure now in place and may be useful for others, for example: Add marijuana-related data for state groups
working on this issue Make platform available to other states
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Contact
Chris Baumgartner, PMP [email protected]
Gillian Leichtling, Mapping Project [email protected]
Project PartnersWA Department of HealthAcumentra HealthUniversity of Washington (Caleb Banta-Green, Ryan Hansen)Looking Glass Analytics
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Thanks!
• Questions?
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Linking and MappingPDMP Data
Presenters:• Jason Hoppe, DO, Emergency Physician and Medical Toxicologist,
University of Colorado and Rocky Mountain Poison and Drug Center• Benjamin Sun, MD, MS, Emergency Medicine Physician, Oregon Health
and Science University• Christopher Baumgartner, Drug Systems Director, Washington State
Department of Health• Gillian Leichtling, Senior Research Associate, Acumentra Health
PDMP Track
Moderator: Christopher M. Jones, PharmD, MPH, Director, Division of Science Policy, Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and Member, Rx and Heroin Summit National Advisory Board