Administrative Rules on Prescribing Opioids for Chronic Non-Terminal Patients

1. Administrative Rules on Prescribing Opioids for Chronic Non-Terminal Patients John P. McGoff, MD, FACEP Member, Indiana Medical Licensing Board Trustee, Indiana State Medical Association

2. Indiana Medical Licensing Board • Appointed by the Governor for four year terms • Five MDs and one DO • One consumer member, who cannot be involved in the practice of medicine • Oversight on all MDs, Dos, as well as Genetic Counselors and Acupuncture practices

3. Duties of the Board • Establish administrative rules to supplement the minimum requirements for licensure and standards of practice that are set by statute • Review licensure and renewal application to assure required competency for practice • Conduct hearings and impose disciplinary sanctions on practitioners who violate the standards of practice

4. Disciplinary cases 90% of board’s functions involve disciplinary matters • Majority are drugs/alcohol abuse or diversion • Sexual misconduct • Overprescribing or internet prescribing • Fraud in obtaining or renewing a license • Action from other jurisdictions/states

5. Types of Hearings • Emergency Suspensions • Final Disciplinary Hearings • Notice of Proposed Default • Order to Show Cause • Request to Reinstate/Modify Probation • Appeal Hearings • Personal Appearances

6. Types of Sanctions • Revocation • Suspensions • Emergency Suspensions • Probation • Reprimand/Censure • Fines • Non-disciplinary Citations • Personal Appearances

7. History of Indiana’s Pain Management Rules • SB 246 required MLB to adopt emergency rules on opioid prescribing – effective Dec 15, 2013 • Aggressive Timetable set by General Assembly • Hearings held throughout the summer with input from various stakeholders • Significant changes were made after hearing concerns and there was intense deliberation • Personal Appearances

8. Overview of MLB Pain Management Emergency Rules Those excluded from these rules are: • Residents in health care facility • Residents in hospice • Residents in palliative care • Terminal* patients * - Terminal is defined as a condition caused by illness, disease or injury from which, to a reasonable degree of medical certainty, death can be anticipated (no specific time reference)

9. Overview of MLB Pain Management Emergency Rules Those subject to these rules are those patients that have been prescribed: • more than 60 opioid- containing pills a month for 3 consecutive month; OR • a morphine equivalent dose of more than 15 milligrams per day for more than 3 consecutive months

10. Overview of MLB Pain Management Emergency Rules If the aforementioned occur the physician shall do the following: • Perform detailed history/physical • Review records from previous providers • Have the patient complete objective pain assessment tool • Assess mental health status • Tailor a diagnosis and treatment plan • When appropriate – use non-opioid options • Counsel women on Neonatal abstinence syndrome

11. Overview of MLB Pain Management Emergency Rules The physician and patient shall review and sign a “Treatment Agreement” which shall include: • Goals of the treatment • Consent to toxicology • Patient prescribing policies • Permission to conduct random pill counts • Information on pain meds prescribed by other physicians

12. Overview of MLB Pain Management Emergency Rules MD/DO shall also do the following: • Conduct face to face visits with patient every 4 months • Conduct an initial INSPECT query (effective Dec 2013) on patient and then annually thereafter (effective Nov 2014) • Perform drug screens annually (effective Jan 2015) • If the patient’s opioid dose reaches a morphine equiv of 60 milligrams/day, face to face review of the treatment plan is required

13. Summary of Rules • All stakeholders have been heard, including OAG Drug Task Force, ISMA, IPS, IHA, IAFP, etc. • These rules ensure patient safety • Goal was to maintain doctor-patient relationship and minimize burdensome paperwork • It is required that MLB adopt permanent rules by November 1, 2014.

14. Prescriber’s Compliance Guide “First Do No Harm” Prescription Drug Symposium Deborah A. McMahan, MD November 1, 2013

15. Agenda • Process for Development • Toolkit • Ten Key Prescribing Recommendations • Resources • Next Steps

16. Education Subcommittee Shelly Symmes Natalie Robinson Michelle Sybesma Cynthia Stone Michael Whitworth Cindy Vaught Tamara Weaver Sharon Blair Dr. Joan Duwve Dr. Deb McMahan Dr. Palmer Mackie Abby Kuzma Dr. Amy LaHood Pam Pontones Jim Mowry, PharmD Dr. Mark Gentry

17. Goal Raise awareness of the dangers of prescription drug abuse and misuse through the education of parents, youth, patients, and healthcare providers. Wanted to start with two groups of folks: • Healthcare Providers • General Public

18. Subcommittees • Healthcare Provider Educational Subcommittee • General Education Subcommittee • Data and Outcomes Subcommittee • Legislative Subcommittee

19. Process for Development

20. Community Education Working Group Tamara Weaver Natalie Robinson John Silcox Michelle Sybesma Abby Kuzma Lori Croasdell Sharon Blair Phil Zahm

21. Community Education Subcommittee Objective is to develop a state wide public awareness campaign to increase awareness and prevention of prescription drug abuse among specific populations. • Specific populations include parents, youth. Teachers, pregnant women and the elderly. • Considering a Teacher’s Toolkit for student education. We have to change the paradigm with which we view chronic pain as a community, state and nation.

22. Data and Outcomes Working Group Providing and researching recent and current data to evaluate the overall goal of reducing prescription drug abuse and the death and illness associated with that abuse  Pam Pontones Dr. Joan Duwve Dr. Deb McMahan Dr. Todd Rumsey Jim Mowry, PharmD Marion Greene Cynthia Stone, DrPH

23. Data and Outcomes Subcommittee Objective: to support the educational subcommittee and it’s working groups in identifying relevant data and statistics to both describe the issue as well as to evaluate the impact of the interventions recommended. • This subcommittee is charged with identifying relevant available data sets in Indiana • Developing and implementing a healthcare provider survey to assess current provide prescribing practices • Identify variables to monitor for new aberrant behaviors (e.g. heroin use) • Obtain a data set to describe current prescription drug use among vulnerable populations including youth, elderly, pregnant women, etc.

24. Education Toolbox Working Group Developing user friendly guidelines and tools for primary care providers to use in the management of noncancerous pain. Dr. Joan Duwve Dr. Deb McMahan Dr. Palmer Mackie Abby Kuzma Dr. Amy LaHood Jim Mowry, PharmD Dr. Mark Gentry Dr. Eric Schrier Tracy Brooks, PharmD Cynthia Stone Dr. Greg Eigner Dr. Dan Roth Natalie Robinson Michelle Sybesma Michael Whitworth Dr. Kalyan Rao Alicia Elliot Pat Weicher, RN Ersin H. Özlem, PhD Dr. Tim King

25. Healthcare Provider Educational Subcommittee Objective is to ensure adequate training to prescribers regarding appropriate prescribing and dispensing of controlled substances. • This subcommittee is developing an educational toolbox for providers: First Do No Harm: The Indiana Healthcare Providers Guide to the Safe, Effective Management of Non-Terminal Pain.

26. Healthcare Provider Working Group • Our goal was to have geographic, professional and specialty diversity represented in our group. • Formed a “working group” with folks that were already working with this issue in the private sector as well as in academics. • We have met a number of times with all day work meetings to discuss issues. • All recommendations have been vetted through this group.

27. Compared our Recommendations with Other Respected Guidelines

28. Healthcare Provider Toolkit

29. Format • Not a dissertation “designed for the busy doc” • Designed to be easy to read • Provide links to resources/tools • Provide templates for various forms • Links to websites with more in-depth information for you and your patients • Talking points for difficult conversations

30. A number of topics to choose from to assist you in coming into compliance with recommendations and rules

31. Key Stat To engage Overview Has a bit more depth than the recommendations and includes links to forms, additional info, etc Specific Recommendations Just the facts ma’am

32. Include Talking Points Conversation starters with patients In the margins will be testimonials and other info

33. Ten Key Prescribing Recommendations

34. Recommendations 1.Do your own evaluation. • Perform a detailed history/physical exam and obtain appropriate tests, as indicated. • Obtain and review records from previous caregivers • Ask your patient to complete a Brief Pain Inventory (BPI) survey to document and better understand their specific pain concerns. • After completing your initial evaluation, attempt to establish a working diagnosis and tailor a treatment plan to functional goals that your patient identifies with you, reviewing them from time to time.

36. Recommendations 2.Risk Stratification for all. • Assess both the mental health status and risk for substance abuse in each patient with a diagnosis of chronic pain. • Mental health metrics such as PHQ-2 or PHQ-9 (for depression) and GAD-7 (for anxiety), are useful screening tools. • Ask patients about any past or current history of substance abuse (alcohol, prescription medications or illicit drugs) prior to initiating treatment for chronic pain. • A risk assessment survey (e.g. Opioid Risk Tool, SOAPP or COMM) should be completed at intake for every patient seeking treatment for chronic pain. Since risk levels may vary over time, repeat these assessments accordingly at follow-up visits. The use of chronic opioids in “high risk” individuals is strongly discouraged.

39. Recommendations 3.Set functional goals with your patients that include achievable targets for pain management. • In general, it is unrealistic for patients to expect complete resolution of their chronic pain with any specific treatment or combination of therapies. • Work together towards improving pain control and achieving specific functional goals, as both are key outcomes. • Functional goals might include increasing physical activity level, resuming a job/hobby or improving the quality of sleep.

41. Recommendations 4.Utilize evidence based treatments, including non-opioid options initially, where possible. • Give strong consideration to non-pharmacologic therapies, in addition to the various medications available. • Also utilize available first-line pharmacologic options before prescribing opioids. • When you believe that an opioid trial is warranted, use the lowest dose of medication required to reduce pain and improve functioning. • Don’t begin a treatment that you are not prepared to stop.

42. Recommendations 5.Discuss the potential risks and benefits of opioid treatment for chronic pain, as well as expectations related to prescription requests and proper medication use. • Provide a simple and clear explanation to help patients understand the key elements of their treatment plan. • Together, review and sign a “Treatment Agreement”, which includes the details of this discussion for all patients that are prescribed controlled substances (opioids, benzodiazepines, stimulants) on an ongoing basis. Refer to the sample “Opioid Consent Form and Treatment Agreement” included in the Tool Box.

43. Recommendations 6.Avoid prescribing for patients without periodic scheduled visits. • Evaluate patient progress and compliance with their treatment plan regularly and set clear expectations along the way (e.g. attending PT, counseling or other treatment options).  • Follow-up visits should probably occur at least once every 3-4 months.  • For patients working with you to achieve optimal management, more frequent visits would be appropriate.

44. Recommendations 7. Remember the 5 A’s when managing your chronic pain patients with opioids: • Assess Affect (and screen for mental illness in general), ask about Activities of Daily Living (ADL’s), provide Analgesia to assist patients in meeting their functional goals, minimize Adverse effects of treatment, and monitor for Aberrant drug use behaviors.

45. Recommendations 8. INSPECT: Indiana’s prescription drug monitoring program, helps us all.  • Use INSPECT regularly for both new and established patients.  This system tracks all controlled substance prescriptions filled by patients state-wide. • Links have been established with neighboring states as well. INSPECT is easy to use and there is no cost, so please register with the state at  www.in.gov/inspect • INSPECT reports should be run at least once every 3-6 months; or more often as desired or appropriate. 

46. Recommendations 9. Urine drug monitoring (UDM) protects you and your patients.  • Urine drug monitoring has evolved to become a standard of care when prescribing opioids for chronic pain.  • UDM should be used at the initiation of an opioid trial and also periodically thereafter. 

47. Recommendations 10.Action is required when a patient’s opioid dose reaches high levels (Morphine Equivalent Dose, or MED 60mg/day) and the patient is still reporting intolerable pain and/or no functional improvement.  See your patient for a complete review.  Then based on your assessment, consider these possible actions:  • a) Institute a slow, compassionate therapeutic wean of the opioid or rotate to another opioid, if appropriate. • b) Refer patients to an addiction specialist for evaluation when a substance use disorder is suspected. • c) Enhance mental health support and physical well-being with a modified treatment plan that you monitor. • d) Refer to a pain management specialist for consultation and/or ongoing care.

48. Toolkit Resources • Resources • Screening tools • Sample informed consent • Sample treatment agreement • Follow-up tools • Great articles • Great websites

49. Bitter Pill Website

50. Bitter Pill Website • Toolkit will be housed here • Additional videos for providers to view • Links for patients to other resources