Controlled Substance Monitoring Database
Prescription Drug Abuse Prevention Conference
September 19, 2014
Andrew Holt, PharmD.
Controlled Substance Monitoring Database
Disclosure Information- Andrew Holt, PharmD
• I have no financial relationships to disclose
• I will not discuss off label use and/or
investigational use in my presentation
Opioid Prescription Rates by County, TN 2007
Source: Tennessee Department of Health internal files, Baumblatt, et al
Opioid Prescription Rates by County, TN 2008
Source: Tennessee Department of Health internal files, Baumblatt, et al
Opioid Prescription Rates by County, TN 2009
Source: Tennessee Department of Health internal files, Baumblatt et al
Opioid Prescription Rates by County, TN 2010
Source: Department of Health internal files, Baumblatt et al
Opioid Prescription Rates by County, TN 2011
Source: Tennessee Department of Health internal files, Baumblatt et al
C-II Controlled Substance Utilization by State
Rank
State
Rx per Capita
1
Delaware
0.8127
2
3
4
5
Tennessee
District of Columbia
Massachusetts
Maine
0.6828
0.6329
0.6330
0.6231
Source: IMS Health
C-II Controlled Substance Growth by State
2013 vs. 2012
Rank
1
2
3
4
31
Source: IMS Health
State
Wyoming
South Dakota
Idaho
Louisiana
Tennessee
Change
7.1%
6.1%
5.1%
5.0%
0.3%
Oxycodone Utilization by State
Rank
1
2
3
4
5
Source: IMS Health
State
Delaware
District of Columbia
Tennessee
Massachusetts
Pennsylvania
Rx per Capita
0.36
0.32
0.31
0.29
0.29
Growth in Oxycodone Utilization by State
Rank
1
2
3
4
37
Source: IMS Health
State
Wyoming
Mississippi
South Dakota
Idaho
Tennessee
Change
5.1%
2.7%
2.5%
2.3%
-4.4%
C-III Controlled Substance Utilization by State
Rank
1
2
3
4
5
Source: IMS Health
State
Alabama
Tennessee
Mississippi
West Virginia
Kentucky
Rx per Capita
1.10
0.92
0.91
0.91
0.89
C-III Controlled Substance Growth by State
2013 vs. 2012
Rank
1
2
3
4
31
Source: IMS Health
State
Vermont
Arkansas
South Dakota
North Dakota
Tennessee
Change
-0.2%
-0.5%
-0.9%
-1.0%
-5.0%
Opioid Prescribing Analysis:
Analysis of Specialty/Profession Type in Tennessee
TTotal Dispensed Prescriptions (000's)
Tennessee Opioid Prescribing Volume by Specialty
Year ended August 2013
3,000
2,500
2,000
1,500
1,000
500
0
CSMD History
• Law Enacted in 2002
• Began collecting data in 2005
• Became searchable by practitioners in 2006
Controlled Substance Monitoring Database Committee
•
•
•
•
•
•
•
•
•
Board of Medical Examiners
Board of Nursing
Board of Pharmacy
Board of Osteopathic Examination
Committee on Physician Assistants
Board of Veterinary Medical Examiners
Board of Optometry
Board of Podiatric Medical Examiners
Board of Dentistry
Most Commonly Prescribed CS in TN
Table 3. Comparison of the 10 most frequently prescribed products in 2012 and 2013 in CSMD
Rank
2013
2012
1
Hydrocodone products
Hydrocodone products
2
Alprazolam
Alprazolam
3
Oxycodone products
Oxycodone products
4
Zolpidem
Zolpidem
5
Tramadol
Tramadol
6
Clonazepam
Clonazepam
7
Lorazepam
Lorazepam
8
Diazepam
Diazepam
9
Morphine products
Buprenorphine products
10
Buprenorphine products
Morphine products
Source: CSMD Annual Report to the 108th General Assembly, 2014
Prescription Safety Act of 2012
•
•
•
•
Mandatory PDMP registration
Mandatory PDMP usage
Shortened PDMP reporting window
Mandatory reporting of doctor shoppers to
law enforcement by practitioners
• Enabled interstate data sharing
• Established delegate accounts-”extenders”
• Increased administrative staffing
Prescriber CSMD Survey Results
• 71% changed a treatment plan after viewing a
CSMD report
• 73% are more likely to discuss substance
abuse issues or concerns with a patient
• 57% are more likely to refer a patient for
substance abuse treatment
• 79% feel that the CSMD is useful for
decreasing doctor shopping
Technological Innovations
• Color-coded risk
icons on patient
report for:
– Pharmacy Shopper
– Doctor Shopper
– High MME Dose
• Automated username and password retrieval
• Batch requests for high-volume clinics
CSMD Technology
CSMD Technology – Risk Indicators
Mandating CSMD Checking Resulted in More
Queries in Tennessee
1,200,000
1,000,000
Mandated checking
began April 1, 2013
800,000
600,000
Mandated registration
began April 1, 2013
400,000
200,000
0
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
2012 2012 2012 2012 2013 2013 2013 2013
Source: Tennessee Department of Health Internal Files, February 2014
CSMD Searches by
Delegates
CSMD Searches by
Prescibers
Number of High Utilization Patients* in PDMP 2012-2014
2500
2000
2012
1500
2013
1000
2014
500
0
1st quarter
2nd quarter
3rd quarter
4th quarter
*Individual who obtained controlled substance prescriptions from five or more prescribers and utilized
five or more pharmacies within the quarter
Source: Tennessee Department of Health Internal files, May 2014
5.0
10000
4.5
9000
4.0
8000
3.5
7000
3.0
6000
2.5
5000
2.0
4000
1.5
3000
1.0
2000
0.5
1000
0.0
0
2010
2011
2012
2013
High Utilization Patients
Patient Requests (in Millions)
More PDMP Queries, Fewer High Utilization Patients
Number of Searches
Made by Prescibers,
Dispensers, and
Delegates
High Utilization
Patients: Patients
filled 5 or more
prescriptions with
different DEA
Prescribers at 5 or
more different DEA
dispensers within 90
days.
Source: Tennessee Department of Health Internal Files, February 2014
Statistics
MME by Month for non-VA Dispensers
900,000,000
850,000,000
800,000,000
750,000,000
2013
700,000,000
2014
650,000,000
600,000,000
550,000,000
500,000,000
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Reducing Neonatal Abstinence Syndrome
• Pink NAS
reminder
messaging on all
females of
childbearing age
NAS Messaging in CSMD
• Pink cautionary statement on patient report
for females of childbearing age
– “Please remember that narcotic prescriptions for
women of child bearing age could result in
Neonatal Abstinence Syndrome (NAS) should
pregnancy occur; please discuss with your patient
methods to prevent unintended pregnancy.”
Future CSMD Activities
• Integrate into clinical workflow
• Enhanced analysis
– $1.4 million CDC grant awarded in 2014
• Increased interstate data sharing
Chronic Pain Management Guidelines
Prescription Drug Abuse Prevention Conference
S e p t e m b e r 1 9 , 20 1 4
Andrew Holt, PharmD.
Controlled Substance Monitoring Database
Public Chapter 430
• Chronic Pain Guidelines written by January 1,
2014
• All prescribers with DEA 2 hours CME every 2
years
• Prescribe 30 days at a time Schedule II-IV
Process Began on January 28, 2013
• Selected the Panel of Experts
• Selected the Steering Committee
• First Meeting Steering Committee Meeting July 1, 2013
Chronic Pain Guidelines Steering Committee
Worker’s Compensation
Abbie Hudgens
Board of Medical Examiners
Dr. Michael Baron
Office of General Counsel
Andrea Huddleston, J.D.
TN Department of Mental Health
Rodney Bragg, M.A., M.Div.
Controlled Substance Monitoring
Database
Andrew Holt, D.Ph.
Tennessee Medical Foundation
Dr. Roland Gray
Department of Health
Bruce Behringer, MPH
David Reagan, M.D.
Larry Arnold, M.D.
Mitchell Mutter, M.D.
Department of TennCare
Vaughn Frigon, M.D.
Special Thanks To:
Ben E. Simpson, J.D.
Tracy Bacchus
Chronic Pain Guideline Panel Members
Autry Parker, M.D.
Brett Snodgrass, APN
C. Allen Musil, M.D.
Carla Saunders, APN
Charles McBride, M.D.
James Choo, M.D.
Jason Carter, DPh
Jeffrey Hazlewood, M.D.
Jim Montag, PA-C
John Culclasure, M.D.
Katie Liveoak, D.Ph.
Michael O'Neil, D.Ph.
Paul Dassow, M.D.
Raymond McIntire, DPh
Rett Blake, M.D.
Stephen Loyd, M.D.
Ted Jones, PhD
Thomas Cable, M.D.
Tracy Jackson, M.D.
W. Clay Jackson, M.D.
William Turney, M.D.
Chapters of the TN Treatment Guidelines
•
•
•
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Introduction
Before initiating chronic opioid therapy
(over 90 days)
• Screening (including TN risk
model), non-opioid therapies,
referral to MH, others
• Informed consent
• Women's special considerations
Initiating chronic opioid therapy
• Standard therapy, combination
therapy
• Special considerations
• Methadone/buprenorphine
• UDS - qualitative &
quantitative
• CSMD
• Documentation in decision
making
Follow up therapy
• UDS - qualitative & quantitative
• CSMD
• ED visits for OD
• What constitutes a failure of
standard therapy?
• Referral to pain specialist
• Taper / discontinuation of opioids
• Documentation of decision
making
•
Appendices
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Pain Medicine Specialist
Risk Assessment Tools
Pregnant women
Use of Opioids in Worker's
Compensation Medical Claims
Tapering protocol
Sample Informed consent
Sample Patient Agreement
Controlled Substance Monitoring
Database
Medication Assisted Treatment
Program
Morphine equivalents dose
Psychological Assessment Tools
Prescription Drug Disposal
Safety Net
Definitions
Table of Frequently Prescribed Pain
Medications
Urine Drug Testing
Special Consideration: Women of
Child Bearing Age
Section I: Prior to Initiating Opioid Therapy
• Non Opioid Treatment if Possible
• All Newly Pregnant Women Should
• Complete evaluation: History and Physical
• Testing documented in medical record prior
• Chronic Pain shall not be treated via telemedicine
• Co-Morbid Mental Conditions
• There shall be the establishment of a current
diagnosis that justifies a need for opioid therapy
Section I: Prior to Initiating Opioid Therapy (cont.)
• Risk for Abuse
• Validated Risk Tools
• CSMD
• UDT
• Goals for Treatment
• Treatment plan for opioid and non-opioid
treatment
• Increase function, not to eliminate pain
• Documentation in medical record
Section II: Initiating Opioids
• Maximum four doses of short-acting opioids per
day
• Non pain medicine specialist should not prescribe
methadone
• Prescribers shall not prescribe buprenorphine in
oral or sublingual for chronic pain
• Avoid benzodiazepines
• Document reasons for deviation from guidelines
in record
Section II: Initiating Opioids (cont.)
• Therapeutic trial
• Lowest possible dose
• Opioid Naïve
• Informed Consent
• Treatment Agreement female patient
• Continually monitor for abuse, misuse, or
diversions
• CSMD and UDT
Section II: Initiating Opioids (cont.)
• Women’s Health
• Birth Control Plans
• Informed Consent
• Ask regarding pregnancy each visit
• Before starting opioids – in women shall have
pregnancy test
Section III: Treatment with Opioids
• Single provider and pharmacy
• Opioids used at lowest effective dose
• Ongoing Therapy
• Greater than 120 MEDD (Morphine Equivalent
Dose) should refer to Pain Specialists
• Greater than 120 MEDD shall refer
• UDT twice/year
• Continual assessment via 5A’s UDT, CSMD
• Emergency Physician, Primary Provider
Communication
• Discontinue when risk greater than benefits
ABPM
• Recognizes boards in the following
certification as qualified to sit for Board Exam
•
•
•
•
•
Anesthesia
Psychiatry
Neurology
Neurosurgery
Physical Medicine and Rehabilitation
• 50 hours CME in Pain Medicine past two (2)
years
• Substantial, recent and comprehensive
clinical practice experience
Pain Specialist
• Board of Medical Specialties (ABMS) primary
physician certification organization in US
• ABMS certifies pain medicine fellowship programs in
Anesthesia, Physical Medicine and Neurology
• American Board of Pain Medicine (ABPM) is not
ABMS and does not oversee fellowship training
programs.
• ABPM offers practice – related examinations to
qualified candidates. Diplomates of ABPM have
certification in Pain Medicine
• AOA Certification
Pain Specialist (cont.)
• Patients requiring less than 120 MEDD
a. Must have valid license by respective board
and DEA
b. CME pertinent to pain management directed
by regulatory board
c. Recommend (do not require) 3 year residency
and be ABMS eligible or certified
Pain Specialist (cont.)
• Patients requiring ≥ 120 MEDD
a. 11 times more likely to have adverse event such as
overdose death
b. Consultation with pain consultant who has additional
in pain medicine is recommended
1. Pain Consultant up to 7/1/2016 shall have
unencumbered license with no prior actions unless
an exception is approved by the respective board
2. Two year experience
3. Minimum 25 CME hours in pain management
every 12 months
4. Pain consultants after 7/1/2016 shall have ABPM
diplomate status or ABMS Boards
Websites
Prescription for Success
http://tn.gov/mental/prescriptionforsuccess/
Pain Clinic Website
http://health.state.tn.us/Boards/PainClinicRegistry.shtml
Pain Clinic Guidelines
http://health.state.tn.us/Downloads/ChronicPainGuidelines.pdf
2014 Legislative Report
http://health.state.tn.us/boards/Controlledsubstance/PDFs/CY%202013%20
CSMD%20Report%20to%20the%20General%20Assembly%20Post.PDF
Questions and Contact Information
Andrew Holt, PharmD
Controlled Substance Monitoring Database
Tennessee Department of Health
Andrew.Holt@tn.gov
615-253-1300