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Chronic Pain Guidelines
Symposium 2014
How did TN get
to 2014 Laws?
C‐II Controlled Substance Utilization by State
Distribution of Number the Top 10 Products Reported to CSMD, 2013
Diazepam,
4.1%
Lorazepam, 5.0%
Morphine products, 3.5%
Buprenorphine products,
3.2%
Hydrocodone products, 34.6%
Clonazepam,
6.1%
Tramadol, 6.7%
Zolpidem,
9.2%
Oxycodone products, 13.1%
Alprazolam, 14.5%
Deaths Due to Drug Overdose by Intent Tennessee, 1999‐2011
Deaths Due to Drug Overdose by Intent
Tennessee, 1999‐2011
1000
900
Number of Deaths
800
Accidental
Intentional
Undetermined
700
600
500
400
300
200
100
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Year
Drug Overdose Deaths*
Traffic Fatalities Due to Substance Abuse
Emergency Department Visits 2010
Nearly 1.2 million
Drug
ED Visits
Oxycodone
146,535
Hydrocodone
95,972
Methadone
65,945
Fentanyl
21,196
Hydromorphone
17,666
Buprenorphine
15,778
Note: Figures include cases in which medications were combined with other drugs.
Source: “Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Add Dispensing Restrictions for Buprenorphine Combination as used Medications,” Department of Health and Human Services , Federal Register, December 6, 2012.
Incidence of NAS among TennCare recipients, CY 2012
Hospitalizations for NAS
Tennessee, 2012
NAS Cases
2013 Cases
Estimated 2011
900
855
800
700
Number of Cases
600
500
400
300
200
100
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
Week
CSMD
Prescription Safety Act 2012
A. Mandatory Sign‐up Pharmacy and Prescribers
B. Query Database C. Pharmacies filled
D. Data – 7 days to near real time E. Method of Payment
CSMD Committee Board of Medical Examiners
Board of Nursing
Board of Pharmacy
Board of Osteopathic Examination
Board of Medical Examiners’ Committee on Physician
Assistants
Board of Veterinary Medical Examiners
Board of Optometry
Board of Podiatric Medical Examiners
Board of Dentistry
Number of Registrants in CSMD, 2010 ‐ 2013
Year
Registrants
Change (%)
2010
13,182
‐
2011
15,323
16.2
2012
22,192
44.8
2013
34,802
56.8
CSMD Clinical Notifications
CSMD Report
CSMD Report (cont.)
CSMD Pharmacy for Prescribers
Public Chapter 430
Jane Doe
39
Definitions of High Risk Patients
Provider shoppers
 >4 providers in a year
Pharmacy shoppers
 >4 pharmacies in a year
High-dosage patients
 >100 morphine milligram equivalents (MME) per day
average for year
Number of Controlled Substances Prescriptions (by class) Reported to CSMD, 2010 ‐ 2013*
Year
Opioids
% Change
Benzodiazepines
% Change
Other
% Change
2010
8,150,946
‐
3,951,144
‐
4,423,662
‐
2011
9,018,139
10.6
4,152,587
5.1
5,001,445
13.1
2012
9,265,450
2.7
4,061,418
‐2.2
5,125,142
2.5
2013
9,227,456
‐0.4
3,913,356
‐3.6
5,433,347
6
* Classes of controlled substances were defined based on CDC guidance document.
Overall Morphine Milligram Equivalent (MME) Dispensed and Reported to CSMD, 2010 ‐2013
9,884
10,000
9,800
9,898
9,618
Amount of MME ( in millions)
9,600
9,400
9,200
8,782
9,000
8,800
8,600
8,400
8,200
2010
2011
2012
2013
Year
Number of High Utilization Patients by Quarter in CSMD, 2010‐2013*
Year
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
2010
1,668
1,971
2,096
1,811
2011
1,922
2,373
2,465
2,322
2012
2,224
2,185
2,229
1,908
2013
1,776
1,540
1,518
1,228
*Patients filled prescriptions from 5 or more prescribers at 5 or more dispensers within 90 days.
Trend of Number of High Utilization Patients by Quarter in CSMD, 2010‐2013
Number of Patient Requests from CSMD, 2010 ‐ 2013
Year
Healthcare Providers
Law Enforcement 2010
1,200,435
N/A 2011
1,486,932
551
2012
1,861,485
2,565
2013
4,497,866
1,938
Number of Patient Requests from CSMD, 2010 ‐ 2013
Year
Healthcare Providers
Law Enforcement 2010
1,200,435
N/A 2011
1,486,932
551
2012
1,861,485
2,565
2013
4,497,866
1,938
Patient Alerts ‐ Prescribers
Year
2013
2013
Time Period
April – May June – July
>4 Dispensers >4 Prescribers
(%)
(%)
6,798
15,925
(0.51)
(1.21)
6,047
15,117
(0.48)
(1.21)
Number of Prescription by Class of Controlled Substances Reported to CSMD, 2010‐2013
Distribution of Number of Prescriptions by Products Reported to CSMD, 2013 Hydrocodone products,
23.8%
Other, 31.4%
Alprazolam, 10.0%
Buprenorphine products, 2.2%
Morphine products,
2.4%
Oxycodone products, 9.0%
Diazepam,
2.8%
Lorazepam, 3.4%
Clonazepam, 4.2%
Tramadol,
4.6%
Zolpidem, 6.3%
Overall Morphine Milligram Equivalent (MME) Dispensed and Reported to CSMD, 2010‐2013
Year
MME
Change (%)
2010
8,782,383,683
‐
2011
9,618,319,622
9.5
2012
9,883,615,759
2.8
2013
9,898,069,236
0.1
Rate of Prescriptions Dispensed (per capita) Among Tennessee Residents Reported to CSMD, 2013
CSMD Clinical Notifications
(Time Period 60 days)
90 MME/day - yellow = medium risk
120 MME/day - red = high risk
3 Prescribers - yellow = medium risk
4 Prescribers - red = high risk
3 Dispensers - yellow = medium risk
4 Dispensers - red = high risk
CSMD Clinical Notifications
CSMD Clinical Notifications (cont.)
CSMD Clinical Notifications (cont.)
Summary MME increased by .1 percent
Benzodiazepine declined
Future Plans
Improve CSMD Workflow
Interstate data sharing Unsolicited Reports
Risk of Unintentional Opioid‐related Overdose Death by Patient Risk Factors
Risk factor
Cases
N=592
Controls
N=11,840
No. (%)
No. (%)
Provider
shopping
227 (38)
Pharmacy
shopping
High dosage
use
AORs
95%
Confidence
Interval
513 ( 4 )
5.1
3.2–8.1
145 (24)
196 ( 2 )
4.5
2.5–8.1
140 (24)
172 ( 1 )
13.2
8.6–20.8
Tennessee Pain Clinics per County
Pain Clinic Owner
 >90 days








II-IV Control Substances
Agreement Patient and Provider (No Restrictions)
Substance Abuse Risk
Urine Screens
2 year cycle renewal
Owner no criminal record or disciplinary actions related to controlled substances
Medical Director (Onsite 25% over all protocols have a substitute)
Policy and Procedure
 Documentation TRG, Licensure
 Certified Staff
 Drug screen policy
 Substance abuse Risk Tool
 Q&A
 Medicine Count
 Patient Agreements
Pain Clinics /Owner (cont.)


Policy and Procedure (continued)
 CSMD
 Documents of request other providers
 Infection Control
 Policy Health and Safety
 Safety STD
 Records must be kept for 7 years
 Payment
Must be check or credit card
Cash only for co-payment with
insurance
Policy for Continue of Care
 Medical Records and Patient Billing
 H & P Testing
 Evaluations and Consults
 Prescriptions objective and options
 Risks vs Benefits
 Log of Meds Rx
 Instruction and Agreements
Periodic Reviews
 Reason for Rx >72h of non malignant pain
 CSMD
 Records of other providers
 Urine Q6 months and PRN
Chronic Pain
Guidelines
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
Public Chapter 430 (cont.)
By January 1, 2014 the commissioner shall develop recommended treatment guidelines for prescribing opioids, benzodiazepines, barbiturates, and carisoprodol. That can be used in the state as guide for caring for patients.
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
Office of General Counsel
Andrea Huddleston, J.D.
Controlled Substance Monitoring Database
Andrew Holt, D.Ph.
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.
Board of Medical Examiner
Dr. Michael Baron
TN Department of Mental Health
Rodney Bragg, M.A., M.Div.
Tennessee Medical Foundation
Dr. Roland Gray
Special Thanks To:
Ben E. Simpson, J.D.
Tracy Bacchus
Chronic Pain Guidelines 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
–
–
–
–
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/suboxone
– UDS ‐ qualitative & quantitative
– CSMD
– Documentation in decision making
Follow up of 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

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
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



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
• 5 A’s •
•
•
•
•
Analgesia
Activities
Adverse side effects
Aberrant
Affect
Section III: Treatment with Opioids
• Ongoing Therapy
• Greater than 100 MEDD (Morphine Equivalent Dose) should refer to Pain Specialists
• Greater than 200 MEDD shall refer
• UDT twice/year
• Continual assessment via 5A’s UDT, CSMD
• Emergency Physician, Primary Provider Communication
• Discontinue when risk greater than benefits
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. Diplomats of ABPM have certification in Pain Medicine
Pain Specialist (cont.)
• Patients Requiring less than 100 MEDD
a. Must have valid license by respective board and DEA
b. CMF 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 100‐199 MEDD
a. 13 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.
2.
3.
4.
Pain Consultant up to 7/1/2016 shall have unencumbered license with no prior actions unless an exception is approved by the respective board
Two years experience
Minimum 25 CME hours in pain management every 12 months
Pain consultants after 7/1/2016 shall have ABPM diplomat status
Public Chapter 396
Annual top 50 prescribers
•
•
•
•
•
Registered letter
Significant control substances
Number of patients
Morphine Equivalents prescribed
Department may withhold information if active case in BIV or OGC
Public Chapter 396 (cont.)
Prescriber must respond with an explanation justifying the amounts of control substance prescribe within 15 business days.
Questions and Contact Information:
Mitchell Mutter, MD
Medical Director for Special Projects
Tennessee Department of Health
[email protected]
615-532-3541
[email protected]