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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 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]