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 Tennessee 0.6828 3 District of Columbia 0.6329 4 Massachusetts 0.6330 5 Maine 0.6231 Source: IMS Health

C-II Controlled Substance Growth by State 2013 vs. 2012 Rank State Change 1 Wyoming 7.1% 2 South Dakota 6.1% 3 Idaho 5.1% 4 Louisiana 5.0% 31 Tennessee 0.3% Source: IMS Health

Oxycodone Utilization by State Rank State Rx per Capita 1 Delaware 0.36 2 District of Columbia 0.32 3 Tennessee 0.31 4 Massachusetts 0.29 5 Pennsylvania 0.29 Source: IMS Health

Growth in Oxycodone Utilization by State Rank State Change 1 Wyoming 5.1% 2 Mississippi 2.7% 3 South Dakota 2.5% 4 Idaho 2.3% 37 Tennessee -4.4% Source: IMS Health

C-III Controlled Substance Utilization by State Rank State Rx per Capita 1 Alabama 1.10 2 Tennessee 0.92 3 Mississippi 0.91 4 West Virginia 0.91 5 Kentucky 0.89 Source: IMS Health

C-III Controlled Substance Growth by State 2013 vs. 2012 Rank State Change 1 Vermont -0.2% 2 Arkansas -0.5% 3 South Dakota -0.9% 4 North Dakota -1.0% 31 Tennessee -5.0% Source: IMS Health

Opioid Prescribing Analysis: Analysis of Specialty/Profession Type in Tennessee

Began collecting data in 2005 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 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 Mandated checking began April 1, 2013 Mandated registration began April 1, 2013 Source: Tennessee Department of Health Internal Files, February 2014

Number of High Utilization Patients* in PDMP 2012-2014

More PDMP Queries, Fewer High Utilization Patients

Statistics

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 September 19, 2014 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 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 Examiners 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 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 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 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 ED visits for OD What constitutes a failure of standard therapy? Referral to pain specialist Taper / discontinuation of opioids Documentation of decision making

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 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

Pain Specialist (cont.) Patients requiring ≥ 120 MEDD 11 times more likely to have adverse event such as overdose death Consultation with pain consultant who has additional in pain medicine is recommended 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 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

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