1. 1 Indiana Medical Licensing Board Emergency Pain Management Prescribing Rule

2. 2 SPEAKERS NameCommercial InterestWhat I receivedMy RoleConflict/Resolved Julie Reed JDI do not have any relevant financial relationships with any commercial interests.N/A None Mike RineboldI do not have any relevant financial relationships with any commercial interests.N/A None PLANNING CMTE. NameCommercial InterestWhat I receivedMy RoleConflict/Resolved Jill BruceI do not have any relevant financial relationships with any commercial interests.N/A None Sandy MillerI do not have any relevant financial relationships with any commercial interests.N/A None Julie Reed JDI do not have any relevant financial relationships with any commercial interests.N/A None Mike RineboldI do not have any relevant financial relationships with any commercial interests.N/A None OBJECTIVES At the end of live activity, participants should be able to: (1) List Indiana’s new prescribing laws (2) Identify patient compliance tools appropriate for controlled substance prescribing (3) Discuss ways to comply with Indiana’s new prescribing laws. CME CREDIT INFORMATION Credit Designation Information: The Indiana State Medical Association (ISMA) designates this live seminar for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Accreditation Information: The ISMA is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Disclosure Information: To comply with ACCME accreditation requirements, the ISMA is including the Speaker and Committee Financial Relationship Disclosure Grid for this program (see following pages for grid). In accordance with the ACCME Standards for Commercial Support, educational programs sponsored by the ISMA must demonstrate balance, independence, objectivity and scientific rigor. Financial disclosure or relationships with a commercial product or manufacturer of commercial services that might be discussed or referred to in the educational activity must be made to the audience prior to the activity. To receive CME credit, you must complete the evaluation at the close of this seminar, providing name and attestation of hours. The CME certificate will be e-mailed. FINANCIAL DISCLOSURE CONFLICT OF INTEREST GRID The ISMA has implemented a process where everyone who is in a position to control the content of an education activity has disclosed to us all relevant financial relationships with any commercial interest. In addition, should it be determined that a conflict of interest exists as a result of a financial relationship this will need to be resolved prior to the activity.

3. 3 Background and Context Every 25 minutes someone dies from a prescription drug overdose. 1:20 people in the United States have used prescription painkillers for non-medical reasons. Approx. 560 to 700 Hoosiers die every year from overdoses from prescribed narcotics (rank: 16 th per capita). (Source: http://www.in.gov/bitterpill/)

4. 4 Physician Disciplinary Cases Since January 2012, the Office of the Indiana Attorney General has taken action against more than 15 doctors for their controlled substance prescribing habits.

5. 5 Physician Disciplinary Cases Multiple Patient Deaths Due to Multiple Drug Toxicity Pre-signing Prescription Pads High Pill Counts & Dangerous Pharmacological Mixes: – opiates/benzodiazepines + muscle relaxers – opiates/benzodiazepines + stimulants – butrans + hydrocodone

6. 6 National Landscape Rise of the pain management clinics – Florida Kentucky and Ohio - comprehensive “pill mill” laws Kentucky clinic  Jeffersonville, IN – Regulators immediately frustrated by their inability to take prompt action against the clinic/physician. – Senator Ron Grooms

7. 7 SEA 246 1. Clinic owners (who are not otherwise already licensed/registered) must register pain management clinics. 2. MLB adopt emergency rules by November 1, 2013 creating an investigation authorization procedure for AG’s office to examine a physician’s records and controlled substances inventory and materials relating to controlled substance prescribing practices. 3. MLB adopt emergency rules by Nov. 1, 2013, to establish standards and protocols for the prescribing of controlled substances for pain management.

8. 8 Lots of Existing Prescribing Laws!

9. 9 The Federal Standard A prescription that is issued for a legitimate medical purpose in the usual course of professional practice by: (i) a practitioner who has conducted at least one in-person medical evaluation of the patient; or (ii) a covering practitioner. (21 U.S.C. § 829(e)(2)(A))

10. 10 Indiana Law: Prescribing to Patients Not Seen Except in limited circumstances,* a physician cannot prescribe, dispense, or otherwise provide any prescription medication to a person the physician has never personally physically examined and diagnosed. *Limited circumstances: – Inpatients/residents of Institutional facilities – On-call coverage – Cross-coverage – Advanced practice nurses with prescriptive authority under collaborative arrangement (844 IAC 5-4-1)

11. 11 Indiana Law: Assisting an Addict A physician is subject to disciplinary sanctions if the physician “knowingly prescribed, sold, or administered any drug classified as a narcotic, addicting, or dangerous drug to a habitue or addict.” (Ind. Code § 25-1-9-4(a)(9))

12. 12 Indiana Law: Prescription Formalities Must be dated as of the day when issued. Must be signed the day when issued. Non-electronically prescribed prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. (856 IAC 2-6-4)

13. 13 Drug Refills Prohibited for Schedule II’s DEA – Revised regulations (2007) A prescribing practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the mandatory conditions are met.

14. 14 Federal Law: Multiple Prescriptions 1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; 2. The individual practitioner provides written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription; 3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; 4. The issuance of multiple prescriptions is permissible under state laws (Indiana law defers to federal regulations regarding this issue); 5. The individual practitioner complies fully with all other applicable requirements under state and federal laws.

15. 15 Indiana Law: Diet Drugs Physicians may not prescribe any amphetamine, sympathomimetic amine drug or a schedule II controlled substance for weight reduction or control. Only a physician may treat a patient for weight reduction or control with a schedule III or IV controlled substance. In those circumstances, it is permissible only if the physician: Determines through review of either the physician's records of prior treatment or records of prior treatment from a previous treating physician or weight-loss program that the patient made a reasonable effort to lose weight using a weight- reduction regimen based on caloric restriction, nutritional counseling, behavior modification and exercise – without controlled substances. And the physician must determine the treatment described in those records was ineffective, documenting thoroughly. Obtains a thorough history and performs a thorough physical examination of the patient before initiating a treatment plan using a schedule III or schedule IV controlled substance for weight reduction or to control obesity. Again, document thoroughly.

16. 16 Diet Drugs (cont.) A physician may not begin and shall discontinue using a schedule III or schedule IV controlled substance for weight reduction or obesity control after determining by professional judgment: The patient failed to lose weight using a treatment plan involving the controlled substance; The controlled substance has offered decreasing contributions toward further weight loss for the patient, unless continuing to take the controlled substance is medically necessary or appropriate as maintenance therapy; The patient has a history of or shows a propensity for alcohol or drug abuse, or has consumed or disposed of a controlled substance in a manner not strictly in compliance with a treating physician's direction.” (Ind. Code 35-48-3-11)

17. 17 Federal Guidance Use of Staff Agent may not make medical determinations for the prescribing physician (i.e., medical need determination may not be delegated). Physician must personally sign (e- or manual) (i.e., signature authority cannot be delegated). (U.S. Dept. of Justice, Drug Enforcement Administration, 21 CFR Part 1306, “Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies,” Policy Statement, 75 Fed. Reg. 193, p. 61613, Oct. 6, 2010)

18. 18 Indiana Law Staff – Nurse Practitioners NPs can prescribe once granted prescriptive authority, consistent with the terms of a physician collaborative agreement. NPs must submit prescribing practices to physician within 7 days and physician must review 5% random sampling of charts and medications.

19. 19 Indiana Law Staff – Physician Assistants Can prescribe under a supervision agreement with a physician (limit 2 at any moment). Can prescribe a controlled substance, in an aggregate amount, that does not exceed a thirty (30) day supply. Any refills or subsequent prescriptions beyond the thirty (30) day supply must be authorized by the supervising physician and recorded in the medical record. If the supervising physician/designee is not present in the same facility as the PA, the supervising physician/designee must be within reasonable travel distance from the facility.

20. 20 Indiana Law Staff – Physician Assistants Review of patient encounters within 72 hours for the following: o 100% for the 1 st year of employment o 50% for the 2 nd year of employment o 25% for the 3 rd year of employment PAs are now required to submit a list of all locations where the PA and the supervising physician may practice.

21. 21 The Three Rules of Responsible Prescribing 1. Consider whether it is responsible to prescribe - i.e., consider alternatives 2. If you do prescribe, do it responsibly - i.e., monitor your patients 3. If your patient is noncompliant or the treatment isn’t working, take action.

22. 22 Indiana’s New Pain Management Prescribing Emergency Rule Adopted by the MLB on October 24, 2013

23. 23 The Rulemaking Process (2013) May 31MLB solicited stakeholder proposals (IN RULE FORMAT) by June 20, 2013. June 17ISMA and AG Task Force met to discuss rule language. June 27MLB discussed process at monthly meeting. July 16 Rule stakeholder meeting including ISMA and AG Task Force. July 24MLB special public forum for input on rules. Aug. 22MLB discussed proposals at monthly meeting. Sept. 25MLB held 2 nd public forum for input on rules. Sept. 26MLB discussed rule at monthly mtg. Oct. 24MLB adopted Rule

24. 24 Applicability Only applies to the use of opioid- containing controlled substances for chronic pain management.

25. 25 Definition – Chronic Pain “Chronic Pain” – A state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.

26. 26 Exclusions The rule does not apply to: 1. Patients who are terminal. 2. Residents of a licensed* health facility. 3. Patients enrolled in a licensed* hospice program. 4. Patients enrolled in inpatient or outpatient palliative care program of a licensed* hospital or licensed* hospice. (*Indiana licensed)

27. 27 Definition - Terminal “Terminal” – A condition caused by injury, disease or illness from which, to a reasonable degree of medical certainty: 1) there can be no recovery; and 2) progression to death can be anticipated as an eventual consequence of that condition.

28. 28 Dosing Thresholds The rules only apply if the patient has been prescribed, for more than 3 consecutive months: 1) >60 opioid-containing pills per month; OR 2) morphine equivalent dose >15 mg/day

29. 29 Patient Assessment Physician must perform own evaluation and risk stratification of the patient in initial evaluation: 1) Appropriately focused H&P exam & appropriate tests, as indicated 2) Documented attempt to obtain and review records from prior providers 3) Patient complete pain assessment tool

30. 30 Patient Assessment 4) Assess patient’s MH status and risk for substance abuse w/ valid screening tools 5) After initial evaluation, establish working DX and tailor treatment plan to meaningful and functional goals (review w/ patient occasionally)

31. 31 Consider Alternatives Where medically appropriate, the physician shall utilize non-opioid options instead of prescribing opioids.

32. 32 Patient Informed Consent Discuss with the patient: – Potential risks and benefits of opioid treatment for chronic pain – Expectations related to prescription requests – Proper medication use

33. 33 Patient Informed Consent Discuss with patient: – Alternative modalities to opioids for managing pain – Provide a simple and clear explanation to help patients understand the key elements of their treatment plan – Counsel women 14-55, of child bearing potential, about risk to fetus when mother has taken chronic opioids during pregnancy (including risk of fetal opioid dependency and neonatal abstinence syndrome)

34. 34 Face-to-Face Patient Visits No prescribing without periodic scheduled face-to-face visits. – Stable meds & treatment plan  every 4 months – More frequent if still optimizing. – Changes to meds & treatment plan  every 2 months until stabilized

35. 35 Patient Visits During visits, evaluate progress and compliance with treatment plan regularly and set clear expectations along the way (e.g., PT, counseling, other treatment).

36. 36 INSPECT Reports At outset of treatment plan, and at least annually thereafter, prescribing physician must run an INSPECT report and document in patient’s chart whether it is consistent with the physician’s knowledge of the patient’s controlled substance use history. *Initial report – grandfathering as of 12/15/13 *Annual report – postponing to 11/1/14

37. 37 Drug Monitoring Tests At outset, and at least annually thereafter, prescribing physician must perform a drug monitoring test, which must include confirmatory test. If test is inconsistent with medication use patterns or shows illicits, review treatment plan. Document the discussion and any changes in patient chart.

38. 38 Drug Monitoring Tests Initial test – Grandfathering as of 1/1/15 Annual test – Postponing to 1/1/15

39. 39 The Prescribing Rule “Think Twice” When opioid dose reaches morphine equivalent dose of >60mg/day: 1. Schedule a face-to-face review of treatment plan and patient evaluation 2. Consider referral to a specialist Think twice…and then…

40. 40 After Thinking Twice…. If physician elects to continue treating at that level, physician must: – Develop a revised assessment and plan for ongoing treatment. – Document in chart, including assessment of increased risk for adverse outcomes, including death.

41. 41 Treatment Agreements Together with patient, review and sign a “Treatment Agreement,” which must include (minimum): 1) Goals of the treatment 2) Patient’s consent to drug monitoring testing 3) Your prescribing policies, including a) Rule that patient take meds as prescribed b) Prohibition on sharing meds

42. 42 Treatment Agreements 4) Requirement that the patient inform the physician about any other controlled substances prescribed or taken. 5) Reasons the opioid therapy may be changed or discontinued by the physician. 6) Grant physician permission to conduct random pill counts. *A copy of the agreement stays in patient’s chart*

43. 43 Supervising PAs - A Reminder The prescribing of opioids for chronic pain management falls within the requirements on supervising physicians (or their designees), including appropriate delegating of duties and responsibilities and appropriate supervision.

44. 44 Collaborating with NPs – A Reminder The prescribing of opioids for chronic pain management falls within the requirements on collaborating physicians regarding the prescriptive authority for advanced practice nurses.

45. 45 Rule Enforcement Date December 15, 2013

46. 46 ISMA Prescribing Resources Newsletter articles Website (www.ismanet.org)www.ismanet.org – New prescribing resources webpage – Pain Management Rule Webinar (30 min.) – 2-page rule summary CME programs (December, May, September, November) Hospital talks around the state Phone and email inquiries

47. 47 Additional Resources www.bitterpill.in.gov – Prescribers Toolkit www.bitterpill.in.gov Book, Responsible Opioid Prescribing (2 nd ed.), Scott Fishman, MD Drug Disposal - www.in.gov/idem/recycle/2343.htm www.in.gov/idem/recycle/2343.htm

48. 48 We want to hear from you!! Questions about the rule? Concerns about implementation? What changes should be made to the rule?