1. Department of Health and Vanderbilt University Chronic Pain Symposia
Mitchell Mutter, M.D.
Medical Director for Special Projects

2. Disclosure Information
I have no financial relationships to disclose I will not discuss off label use and/or investigational use in my presentation

3. Effectiveness of pain meds (from Cochrane reviews) (References 17,18,19,20)
It is also important to recognize that opioids are not very good pain relievers. A number of Cochran reviews have looked at postoperative pain relief. They measure adequate pain relief as a 50% reduction in pain.
They found that the combination of 10 mg of oxycodone mg of acetaminophen (roughly the equivalent to 5 mg Percocet pills) gave adequate pain relief to about 37% of the people who took it mg of ibuprofen alone resulted also in 37% with adequate pain relief18. Basically, the equivalent of 2 Percocet pills. Note that increasing to 400 mg of ibuprofen only gives adequate pain relief to an additional 3% of people. 600 or 800 mg of ibuprofen does not do much better but does significantly increase the risk of side-effects.
Oxycodone alone is not a very good pain reliever. 15 mg of oxycodone gave adequate pain relief to only 21% of people17. Taking 2 Tylenol #3 pills only gets adequate relief to 24% of people19.
However when we combine the over-the-counter dose of ibuprofen with an over-the-counter dose of acetaminophen taken together– a whopping 62% of people get adequate pain relief20. What’s more, studies have shown that over-the-counter doses of ibuprofen and over-the-counter doses of acetaminophen have side effect profiles similar to placebo when taken as directed5.

4. Overall Utilization of Pharmaceuticals by State

5. Growth in Utilization of Pharmaceuticals by State

6. C-II Controlled Substance Utilization by State
2013 USA total CII prescriptions = 257,450,331; TN total = 8,954,973
2014 USA total CII prescriptions = 249,953,231; TN total = 8,668,742

7. C-II Controlled Substance Growth by State

8. Opioid Utilization by State

9. Growth in Opioid Utilization by State

10. Drug Overdose Death, 2014
New overdose death chart based on handout- move to top with NAS, 2 slides

11. Drug Overdose Death, 2014

12. Neonatal Abstinence Syndrome (NAS)

13. Controlled Substance Monitoring Database
Prescription Safety Act 2012
Mandatory Sign-up
Pharmacy and Prescribers
Query Database
Pharmacies filled
Data – 7 days to near real time
Method of Payment
PC 898??

14. Number of Registrants in CSMD, 2010 - 2014
Year
Registrants
Change (%)
2010
13,182 -
2011
15,323
16.2
2012
22,192
44.8
2013
34,802
56.8
2014
38,871
11.7
2015
(as of July 31)
41,650
9.8
Update

15. Registrants in the CSMD by Role (as of July 31, 2015)
Practitioner
18,080
Practitioner Extenders
5,260
Residents/VA
2,746
Advance Practice Nurse
5,743
Physician Assistant
1,335
D.Ph.
7,306
D.Ph. Extenders
1,115
Update

16. Number of DEA Registrants in Tennessee (as of July 31, 2015)
Profession
Number of DEA in TN
Pharmacy
            1,784
Hospital / Clinic
                245
Practitioner
          24,584
APN
            7,522
Optometrist
                919 PA
            1,613
All other
                487
TOTAL
          37,154

17. Public Chapter 898
All APN’s and PA’s MUST add supervising physicians in their accounts for each practice location and must have their supervising physicians log into their accounts to approve them to complete the process, otherwise, those without supervising physicians will not be able to pull patient requests after June 15, 2015.
Add graphic about number of APN/PA without supervisors

18. Advanced Nurse Practitioners Across the State
Data as of 7/31/2015
Sources: TN License and Regularly System, Drug Enforcement Agency, Controlled Substance Monitoring Database

19. Supervisor will log into CSMD
Supervisor will log into CSMD. As soon as they enter correct username and password this screen appears directing them they have delegates waiting for approval. Click the box to go to “My Account” screen.

20. Once the Supervisor clicks “My Account” this screen opens
Once the Supervisor clicks “My Account” this screen opens. The supervisor will see any approved delegates and any delegates awaiting approval. As you can see this one is awaiting approval.

21. Once the Supervisor clicks “Approve” You can see the successful message at the top. Also when you look at the delegate area the Supervisor now has the ability to “Revoke” this user if the Supervisor no longer supervises this delegate.

22. APN or PA will now be notified of the approval and when they log into the CSMD their “My Account” show “Active” for the Supervisor (s). The APN or PA have the option to “Delete” this supervisor.

23. Ratio of Number of Prescription to Number of Request in CSMD, 2010-2015*
Mandatory CSMD check before prescribing opioid / benzodiazepine after 4/1/13
Year
* VA prescriptions and requests were included.

24. Law Enforcement Request
Update and move

25. Number of Prescriptions of Controlled Substances Dispensed and Reported to CSMD, 2010-2014
Show before DS, leave alone

26. Number of Prescriptions of Controlled Substances Reported to CSMD by Class, 2010-2014
Show before DS

27. 2010-2014 Morphine Milligram Equivalents Reported to CSMD *
*Note: Morphine Milligram Equivalents (MME) were converted based on CDC MME conversion tables . Above numbers were derived from CSMD data downloaded on January 5, data are subject to change due to database updating. VA pharmacies were excluded from above analysis.

28. Cumulative Morphine Milligram Equivalent for 1st and 2nd quarter of each year, 2010-2015*
Note: data used in this analysis were downloaded on July 3, 2015;
VA pharmacies were excluded from the analysis.
MME was derived based on CDC tables.

29. Comparison of Overall Prescriptions, Number of Opioid Prescriptions and MME Dispensed/Reported to CSMD,

30. Number of Methadone Products and Morphine Milligram Equivalents (MME) Dispensed/Reported to CSMD,

31. More PDMP Queries, Fewer High Utilization Patients

32. Result of Survey on Doctor Shopping
Move with other DS stats

33. Number of Doctor Shopper Identified in CSMD by Quarter, 2010-2014*
Year
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
Total
Change (%)
2010
1,695
2,005
2,127
1,830
7,657 -
2011
1,950
2,413
2,515
2,352
9,230
20.5
2012
2,246
2,218
2,261
1,940
8,665
-6.1
2013
1,785
1,533
1,335
6,186
-28.6
2014
1,374
1,404
1,278
1,307
5,363
-13.3
change
*Doctor and pharmacy shopper was defined as a person who got his/her prescriptions from 5 or more different DEA prescribers and filled the prescriptions at 5 or more different DEA pharmacies within 3 months.

34. 2010-2014 Number of “Doctor and Pharmacy Shoppers" in CSMD *
update
*If patients in CSMD had same date of birth and same result of soundex first name and last name, we took the patients as same person. Data used for above analysis were downloaded on Jan. 5, Data are subject to change due to database updating and the other reasons. VA pharmacies were excluded from the analysis. Doctor and pharmacy shopper was defined as a person who got his/her prescriptions from 5 or more different DEA prescribers and filled the prescriptions at 5 or more different DEA pharmacies within 3 months.

35. Annual Top 50 Prescribers
Public Chapter 396
Registered letter
Significant control substances
Number of patients
Morphine Equivalents prescribed
Department may withhold information if active case in BIV or OGC
Prescriber must respond with an explanation justifying the amounts of control substance prescribe within 15 business days.

36. Top 50 Prescribers Identified in 2015 (based on data from Jan – Dec 2014 using CDC MME Conversion Tables)
Update- Tracy

37. Morphine Milligram Equivalents Dispensed by Top 50 Prescribers in 2013, 2014, and 2015*
* Note: Time periods of prescriptions fill used for identification of top 50 were as below:
2013: from 4/1/2012 to 3/31/2013 ;
2014: 4/1/2013 to 3/31/2014
2015: 1/1/2014 to 12/31/2014

38. Top 50 Prescribers Identified in 2015 (based on data from Jan – Dec 2014)

39. Small County Prescribers Identified in 2015 (based on data from Jan – Dec 2014)
Top 10 prescribers in small counties
Small defined as <50,000 people
Total MMEs for Small Counties: 122,671,152

40. Why do you check the CSMD before prescribing?

41. How has checking the CSMD changed the way you practice medicine?
Move before top 50

42. Public Chapter 475
Effective July 1, 2016
New requirements for pain clinic
Medical Director must be a physician and pain specialist
Pain Specialists are board certified by ABMS, ABPM, ABIPP, or AOA
Expected Outcomes

43. Tennessee Pain Clinics per County

44. Public Chapter 623 “Naloxone”
Licensed Healthcare Practitioner
Patient, family member, friend of patient at risk for overdose death
Naloxone Education will be available on the Department of Health website on July 1, 2014
Instruction how to administer

45. 2015 Legislative Updates
PDMP reporting window reduced to daily by 2016
Immunity to those who prescribe or administer naloxone to patients
January 1, 2015: Prohibit dispensing of opioids and benzodiazepines directly from any clinic
Prescription Safety Act of 2012 set to sunset June 30, 2016
Public Chapter 475 will take effect

46. Chronic Pain Guidelines

47. Chronic Pain Guidelines Expert Panel

48. 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
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.

49. Process Began on January 28, 2013
Selected the Panel of Experts
Selected the Steering Committee
First Meeting Steering Committee Meeting July 1, 2013

50. 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 Michael Baron, M.D. TN Department of Mental Health Rodney Bragg, M.A., M.Div. Tennessee Medical Foundation Roland Gray, M.D. Special Thanks To: Ben E. Simpson, J.D. Tracy Bacchus Debora Sanford

51. 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, D.Ph.
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, D.Ph.
Rett Blake, M.D.
Stephen Loyd, M.D.
Ted Jones, Ph.D.
Thomas Cable, M.D.
Tracy Jackson, M.D.
W. Clay Jackson, M.D.
William Turney, M.D
John Standridge, M.D.
T. Scott Baker, M.D.

52. Chapters in the Chronic Pain 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 -
ED visits for OD
What constitutes a failure of standard therapy?
Referral to pain specialist
Taper / discontinuation of opioids
Documentation of decision making

53. Chronic Pain Guidelines 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

54. 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

55. 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

56. 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

57. 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

58. 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

59. 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

60. Section III: Treatment with Opioids (cont.)
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

61. 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

62. 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
ABIPP

63. Pain Specialist (cont.)
Patients requiring less than 120 MEDD
Must have valid license by respective board and DEA
CME pertinent to pain management directed by regulatory board
Recommend (do not require) 3 year residency and be ABMS eligible or certified

64. Pain Specialist (cont.)
Patients requiring > 120 MEDD
11 times more likely to have adverse event such as overdose death
Consultation with pain specialists
Pain Specialists up to 7/1/2016 shall have unencumbered license with no prior actions unless an exception is approved by the respective board
Two year experience
Minimum 25 CME hours in pain management every 12 months
Pain consultants after 7/1/2016 shall have ABPM diplomate status or ABMS Boards
Include that you will be meeting to evaluate the new CDC guidelines?

65. CDC Chronic Pain Prescribing Guidelines
Evaluate Tennessee against CDC recommendations
Morphine Milligram Equivalent (MME) at which risk of Overdose significantly increases
Long vs. Short Acting opioid treatment options
Relative efficacy?
Relative safety?

66. Websites:
Prescription for Success address for public comments Pain Clinic Website Pain Clinic Guidelines Legislative Report

67. Websites:
NSC white papers: Evidence on the efficacy of pain medications: nsc.org/painmedevidence The Psychological and Physical Side Effects of Pain Medications: safety.nsc.org/sideeffects Prescription Pain Medications: A fatal cure for injured workers:

68. Questions and Contact Information:
Mitchell Mutter, MD Medical Director for Special Projects Tennessee Department of Health