1. 2015 Tennessee Controlled Substances Monitoring Database Program D. Todd Bess, Pharm.D. Director Tennessee Controlled Substance Monitoring Database

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. Objectives Review recent outcomes from the use of the Tennessee Controlled Substances Monitoring Database (CSMD) Program Explain how clinicians value and respond to their assessment of the CSMD Evaluate ways practice sites can best partner with CSMD Program

4. Controlled Substances Monitoring Database Appriss Updates Appriss acquired Optimum Technology (OTECH) TN Department of Health notified by letter 4/29/2015 Appriss is working to transition to new infrastructure by the end of the year

5. Number of Registrants of CSMD, 2010-2014* As of June 2015 the CSMD has greater than 41,000 registrants

6. Number of CSMD Requests from Law Enforcement 2012-2014

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

8. How has checking the CSMD changed the way you practice medicine? How has checking the CSMD changed the way you practice pharmacy? Source: 2014 CSMD Prescriber and Dispenser Survey

9. Number of Controlled Substances Dispensed/Reported to CSMD, 2010-2014

10. Top 5 Drugs Prescribed 2015 Tennessee CSMD Data 1.Hydrocodone products 2.Alprazolam 3.Oxycodone products 4.Zolpidem 5.Tramadol * Unchanged in last 3 years

11. Number of Controlled Substances Reported to CSMD by Class, 2010-2014

12. Comparison of Overall Prescriptions, Opioid Prescriptions and MME Dispensed/Reported to CSMD, 2010-2014

13. Interstate Prescriber & Dispenser Queries August – December**

14. The CSMD is useful for decreasing the incidence of doctor shopping. Strongly agree or agree = 85.5% Source: 2014 CSMD Prescriber and Dispenser Survey The CSMD is useful for decreasing the incidence of doctor shopping.

15. Potential Doctor-Pharmacy Shoppers Identified in CSMD* * ≥5 Prescribers & ≥ 5 Dispensers in 3 months

16. Regulatory and Controlled Substance Update Recent changes related to the CSMD Program or Tennessee Board of Pharmacy –Public Chapter 1011 –Public Chapter 983 –Public Chapter 396 –Public Chapter 872 –Public Chapter 476

17. Regulatory and Controlled Substance Update PUBLIC CHAPTER 1011: Controlled Substance Reporting –Changes the required timeframe for reporting to the Controlled Substance Database to once per business day (effective January 1, 2016)

18. Regulatory and Controlled Substance Update PUBLIC CHAPTER 983 (Restriction on Prescriber Dispensing) Except as provided in§ 63-1-313, a health care prescriber licensed under this title may not dispense an opioid or benzodiazepine Dispensing related to surgical procedure performed at a licensed health care facility allowed, but may not exceed 7 day supply ARCOS data will be linked to CSMD for audit purposes See Public Chapter 983 for details if you are a dispenser that prescribes these medications Effective January 1, 2015

19. Regulatory and Controlled Substance Update PUBLIC CHAPTER 396: “Addiction Treatment Act of 2015” –Mandates that only M.D.’s or D.O.’s are permitted to prescribe buprenorphine for opioid dependence –Buprenorphine may only be prescribed for uses recognized by the FDA Unless the patient has a documented opiate addiction, Receives treatment from a DEA registered addiction treatment practice, and is counted as one of the total allowable number of patients the provider is allowed to treat. –Only pregnant women, nursing mothers, or patients with a hypersensitivity to naloxone may be prescribed buprenorphine mono –Effective July 1, 2015

20. Regulatory and Controlled Substance Update PUBLIC CHAPTER 872: ID BILL –Applies to C II-IV opioids, benzodiazepines, zolpidem, barbiturates, and carisoprodol in quantities greater than a 7 day supply –Requires the person taking possession of the dispensed prescription to present a valid government issued identification or public/private insurance card, unless the person is personally known –Does not require the person to be the same person for whom the prescription is written –Effective July 1, 2014

21. Regulatory and Controlled Substance Update Public Chapter 476 Currently, the top 50 prescribers of controlled substances in the state are annually identified and sent a letter notifying them of their inclusion on this list and asked to respond with a justification for their prescribing patterns. Public Chapter 476 adds the top 10 prescribers from all of the combined counties having populations of fewer than 50,000 this process Effective/Signed May 18, 2015

22. Tennessee Board of Pharmacy Policy on Medication Take Back Program Allowed If DEA Regulations are “STRICTLY FOLLOWED” Recent changes in federal regulations allow licensed retail pharmacies, hospital pharmacies, manufacturers, wholesalers, distributors, and reverse distributors that have a valid DEA registration to accept returns of unused legend drugs from end- users. These registrants may do so by modifying their DEA registration to serve as collectors of unused legend drugs, and by further complying with all DEA regulations pertaining to this activity. Therefore, any retail pharmacy, hospital pharmacy, manufacturer, wholesaler, distributor, or reverse distributor that is licensed by the Board and complies with all applicable DEA regulations pertaining to drug disposal MAY accept returns of unused legend drugs pursuant to DEA rules.

23. Tennessee Board Policy on Medication Take Back Program (cont.) If DEA regulations are not strictly followed, Board of Pharmacy Rule 1140-03-.04(8) will apply. Rule 1140-03-.04(8) prohibits pharmacy practice sites, pharmacists, pharmacist interns, technicians, or any other place involved in the compounding and dispensing of prescription drugs and devices (except institutional pharmacies pursuant to Rule 1140-04-.10) from accepting returns of any order that has been taken from the premises of that pharmacy practice site or any other place of business. DEA resources pertaining to drug disposal, including a complete text of the applicable DEA rules, are available at: http://www.deadiversion.usdoj.gov/drug_disposal/ See TN Board of Pharmacy website or call board office for questions

24. Next DEA Take-Back Day

25. Potential RED FLAGS for Pharmacists Many patients receiving the same combination of prescriptions (cocktail) Many patients receiving the same strength of controlled substances Many patients paying cash for their prescriptions Prescriptions resulting in therapeutic conflicts Many patients with the same diagnosis https://www.nabp.net/

26. Potential RED FLAGS for Pharmacists Individuals driving long distances to visit physicians and/or to fill prescriptions Patients coming into the pharmacy in groups, each with the same prescriptions from the same physician Constant requests for early refills MULTIPLE RED FLAGS COULD BE A REASON TO DENY pending consultation with prescriber https://www.nabp.net/

27. Regulatory and Controlled Substance Update –CONTROLLED SUBSTANCE ISSUES Title 21 Code of Federal Regulations PART 1306 — PRESCRIPTIONS GENERAL INFORMATION §1306.04 Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances21 U.S.C. 829

28. Top 10 States for Pharmacy Robberies DEA 2013 Statistics Arizona Indiana California Pennsylvania Tennessee North Carolina Massachusetts Ohio Texas Washington

29. Armed Robbery Thoughts to supplement your practice site policies to aid surviving the robbery and assisting law enforcement Cooperate with robber Be a good witness and study what is touched or moved If a weapon is displayed, note the type and color Keep the note if used to make robbery demands for police Stay as calm as possible (Indicate you and your team will comply with demands) If possible, get the escape vehicle description, license number, and escape direction for police Lock the building down after the event and call police Wait for police and cooperate fully

30. Clinical Risk Indicators (high risk patients) on CSMD Reports = 4 Practitioners in last 90 days ≥ 90 but < 120 Active Cumulative Morphine Equivalents per day ≥ 5 Practitioners in last 90 days ≥ 5 Pharmacies in last 90 days ≥ 120 Active Cumulative Morphine Equivalents per day R Y Y R R Y = 4 Pharmacies in last 90 days

32. Clinical Risk Indicators (high risk patients) on CSMD Reports Female and child bearing age (15-45 years of 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.”

34. Survey: Discuss CSMD Report with Patient 67% Sometimes or more often

35. Has checking the CSMD changed your practice of referring patients for substance abuse treatment? Prescribers are more likely to refer patients for substance abuse treatment. Source: 2014 CSMD Prescriber and Dispenser Survey CSMD has changed my practice of communicating with the physician regarding a patient whom I believe needs referred for substance abuse treatment?

38. Public Chapter 898  Since June 15, 2015 any APN or PA who fails to have a supervisor listed in the CSMD is blocked from running patient reports (includes any healthcare practitioner extenders).  The supervisor has the right to revoke  Entering your supervisor in the CSMD does not relieve you from notifying your regulatory board of their board specific requirements.  If you change your supervisor you have 30 days to make that change within the CSMD and your regulatory board (as directed).

39. Improve Practice Site Partnership with CSMD Program Assure Supervisor Relationships are documented in the CSMD (See Frequently Asked Questions on CSMD Website http://tn.gov/health/article/CSMD-faq) http://tn.gov/health/article/CSMD-faq See Questions 36 – 39 Best Process for correction of Wrong Prescriber name in CSMD (Contact the pharmacy and discuss each prescription number in question with pharmacist to reconcile correct prescriber name) Protect you password and assure your extenders do the same Support Dispensers with entering the correct patient names, addresses, birthdates, and prescriber name

40. Conclusion Recent outcomes from the use of the Tennessee Controlled Substances Monitoring Database (CSMD) Program are encouraging Clinicians value and respond to their assessment of TN CSMD Patient Reports Prescribers, Dispensers and Practice Sites partnership is needed and valued by the CSMD Program