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1. Today’s webinar will begin in a few minutes. Please press *6 to mute your line or use the “mute” button on your phone. If you have questions for the presenter or need to contact TCPS staff, type your comments into the chat box. Lines will be opened during the call, so attendees may ask questions. Please do not put the conference on hold. Thank you for your patience.

2. Monthly Medication Safety Webinar: Update on Prescription Drug Abuse in Tennessee All lines will be muted during the presentation and unmuted during questions. If you do not have a question to ask, please mute your phone. If you do not have a mute button on your phone you can press *6 to mute your line. Please do not put the conference on hold. If you would like to ask a question during the webinar please enter the question into the question box.

3. Medication Safety: Update on Prescription Drug Abuse in Tennessee “The abuse of prescription opioids has been identified as one of the most serious and costly issues facing Tennesseans and other Americans today.” - Prescription for Success

4. Disclosure InformationTennessee Center for Patient Safety Jason Carter, Pharm.D. • I have no financial relationships to disclose • I will not discuss off-label use and/or investigational use during my presentation

5. Prescription Drug Abuse: A New Problem? • “The passage of the Harrison Narcotic Act in 1914 removed a blot from the pages of Pharmacy, as the unlimited sale of narcotic drugs without being in conflict with any law had become appalling.  This act placed the responsibility jointly up to physicians and druggists, and it is safe to say the consumption of narcotic drugs had diminished by 75%.” From the History of the Tennessee Pharmacists Association

6. Weekend Articles on Prescription Drug Abuse • The dark reality of prescription drug abuse in Tennessee (Bristol Herald-Courier) • Health leaders gather in Johnson City to discuss prescription drug epidemic (T-N) • Bitter pills: State, local health pros talk reducing prescription abuse (JCP) • Growing problem of drug-addicted babies gets officials’ attention (Herald-Courier) • Prescription drug drop boxes part of Prescription For Success campaign (Cookeville Herald Citizen)

7. Epidemiology

9. Background • Prescription drug abuse is the intentional use of a medication: • without a prescription; • in a way other than as prescribed; OR • for the experience or feeling it causes. • Approximately 7.0 million persons were current users of psychotherapeutic drugs taken non-medically in the US in 2010 (2.7% of US population) • Pain relievers - 5.1 million • Tranquilizers - 2.2 million • Stimulants - 1.1 million • Sedatives - 0.4 million

10. National Statistics • Prescription painkiller overdoses killed nearly 15,000 people in the US in 2008. This is more than 3 times the 4,000 people killed by these drugs in 1999. • In 2010, about 12 million Americans (age 12 or older) reported nonmedical use of prescription painkillers in the past year. • Nearly half a million emergency department visits in 2009 were due to people misusing or abusing prescription painkillers. • It is estimated that 20 percent of people in the United States have used prescription drugs for nonmedical reasons • Nonmedical use of prescription painkillers costs health insurers up to $72.5 billion annually in direct health care costs.

11. Tennessee Statistics • Three times more likely to identify prescription opioids as their primary substance of abuse than the national average • The use rate of prescription opioids among young adults (18-25-year- olds) was 30% higher than the national average in 2011 • Almost 7% of the 12-17-year-old population have used prescription drugs for non-medical reasons

12. Tennessee Statistics Cont. • 10-fold increase in NAS infants from 2001-2011 • Tied Nevada for second only to Florida in 2010 in morphine equivalents per 10,000 people (11.8 kilograms)

13. Patients Receiving Treatment by TDMHSAS for Opioids are More Likely to be: • A. Single, Employed, 10th grade education • B. Married, Employed, > 12 years of education • C. Married, Unemployed, 8th grade education • D. Single, Unemployed, 10th grade education

14. TDMHSAS Funded Treatment • People addicted to opioids are more likely to be • Married • Employed • >12 years of education Individuals receiving treatment at state funded treatment programs

15. Treatment Programs • Originally designed to treat people with heroinaddiction • Now… TDMHSAS “Prescription for Success” Executive Summary Report. Summer 2014.

16. Pregnant Women Receiving Treatment TDMHSAS “Prescription for Success” Executive Summary Report. Summer 2014.

17. How are these statistics possible? • Doctor shopping • Shift in prescribing practices • Different ways to access

18. Doctor Shopping • “The practice of a patient requesting care from multiple physicians simultaneously.” • Stems from a patient's addiction to, or reliance on, certain prescription drugs or other medical treatment. • Most start as legitimate treatment

19. Doctor Shopping Convictions TDMHSAS “Prescription for Success” Executive Summary Report. Summer 2014.

20. Prescribing Practices • Shift in view of how to treat chronic pain. • Tennessee Intractable Pain Treatment Act enacted in 2001 • Under-prescribing  Over-prescribing

21. Extent of the Problem • In 2010, evidence showed that in Tennessee, there were enough prescriptions dispensed to represent: • 51 hydrocodone for EVERY Tennessean>12yo • 22 alprazolam for EVERY Tennessean>12yo • 21 oxycodone for EVERY Tennessean>12yo

22. Controlled Substance Prescriptions by Class Information provided by Andrew Holt , Director TN CSMD

23. Top 10 Controlled Substance Rxs Information provided by Andrew Holt , Director TN CSMD

24. Morphine Milligram Equivalents Controlled Substance Monitoring Database 2014 Report to the 108th Tennessee General Assembly

25. Number of High Utilization Patients

26. The number one way patients access medications for non-medical use is: • A. Doctor shopping • B. Bought on internet • C. Drug dealer • D. Free from friend or relative

27. Ways to Access

28. Abuse Trends

29. Increase in Opioid-Related ED Visits

30. Increase in ED Overdose Dollars Spent

31. Overdose Deaths • Number of drug-related deaths due to overdoses increased at a greater rate in Tennessee than in the United States. • Increase in overdose deaths of 250% from 2001-2011

32. Neonatal Abstinence Syndrome in TN TDMHSAS “Prescription for Success” Executive Summary Report. Summer 2014.

33. Treatment Costs in 2013 • 5,854 people addicted to opioids were served by the Department of Mental Health and Substance Abuse Services at a cost of $16,280,429.

34. Tennessee Prescription Safety Act Public Chapter No. 880 Signed by Governor Haslam on May 9th, 2012 Effective April 1, 2013

35. Tennessee Prescription Safety Act • Definitions • "Dispenser" means a pharmacist, a pharmacy, or any healthcare practitioner who is licensed and has current authority to dispense controlled substances • "Healthcare practitioner extender" means any registered or licensed healthcare professional, and up to two (2) unlicensed persons designated by the prescriber or dispenser, who act as agents of that prescriber or dispenser. The prescriber or dispenser shall be responsible for all actions taken by their agents pursuant to this act.

36. Tennessee Prescription Safety Act • Who MUST to be registered for the database? • All prescribers with DEA numbers who prescribe controlled substances and dispensers in practice providing direct care to patients in Tennessee for morethan fifteen (15) calendar days per year shall be registered in the controlled substance database.

37. Tennessee Prescription Safety Act • When are you allowed to check the database? • A dispenser or pharmacist not authorized to dispense controlled substances conducting drug utilization or medication history reviews who is actively involved in the care of the patient • A dispenser having authority to dispense controlled substances to the extent the information relates specifically to a current or a bona fide prospective patient to whom that dispenser has dispensed, is dispensing, or considering dispensing any controlled substance

38. Tennessee Prescription Safety Act • When MUST you check the database? • All prescribers or their extenders must check the database prior to prescribing any opioid or benzodiazepine to a human patient at the beginning of a new episode of treatment and at least annually thereafter as long as that drug remains part of their treatment • Before dispensing, a dispenser shall have the professional responsibility to check the database or have a health care practitioner extender check the database if the dispenser is aware or reasonably certain that a person is attempting to obtain a Schedule II-V controlled substance, identified by the committee as demonstrating a potential for abuse for fraudulent, illegal, or medically inappropriate purposes

39. Tennessee Prescription Safety Act • How often do you have to report? • At least once every seven (7) days for all the controlled substances dispensed during the preceding seven (7) day period • When do you NOT have to report to the CSMD? • Drugs administered directly to the patient • Drug samples • Drugs dispensed for a non-human by a veterinarian for a quantity of less than 48 hours supply • Registered narcotic treatment programs (21 CFR 1304.24) • Drugs dispensed by a licensed healthcare facility for a quantity of less than a 48 hour supply

40. Senate Bill No. 676 Addison Sharp Prescription Regulatory Act of 2013 Public Chapter No. 430 Signed by Governor Haslam on May 16, 2013 Became effective October 1, 2013

41. Addison Sharp Act • Required the commissioner of health to develop recommended treatment guidelines for prescribing of opioids, benzodiazepines, barbiturates, and carisoprodol • must be reviewed and updated annually • Guidelines submitted to/reviewed by • prescribing boards that license health professionals who can legally prescribe controlled substances • board of pharmacy

42. Addison Sharp Act • All prescribers who • hold a current DEA license (AND) • who prescribe controlled substances MUST {complete at least 2 (two) hours of continuing education (CE) related to controlled substance prescribing biennially to count toward the licensees' mandatory CE}

43. Addison Sharp Act • The bill was amended to specify that no prescription for a schedule II-IV controlled substance may be dispensed in quantities greater than a 30 day supply. • No opioids, benzodiazepines, barbiturates, or carisoprodol may be dispensed directly by a registered pain management clinic.

44. Addison Sharp Act • If a prescriber dispenses any opioids, benzodiazepines, barbiturates, or carisoprodol, then the prescriber must submit the transaction to the controlled substances monitoring database. • Generally, any prescriber of opioids, benzodiazepines, barbiturates or carisoprodol to patients who are chronic, long-term drug therapy for 90 days or longer must consider mandatory urine drug testing.

45. Chronic Pain Guidelines Tennessee Clinical Practice Guidelines for Outpatient Management of Chronic Pain

46. Morphine Equivalent Dose (MED) • “Equipotent dose of any opioid in terms of morphine” • As MED increases, the likelihood of any side effects increases, therefore identifying at-risk patients is a crucial first step towards improving patient safety. MED Conversion Formula: MED= (Drug Strength)(Drug Quantity)(Morphine Equivalent Multiplier)/(Day Supply)

47. Chronic Pain Guidelines • Treatment with Opioids: Key Principles • All chronic opioid therapy should be handled by a single provider or practice and all prescriptions should be filled in a single pharmacy, unless the provider is informed and agrees that the patient can go to another pharmacy for a specific reason. • Opioids should be used at the lowest effective dose • A provider should not use more than one short-acting opiate concurrently. If a provider deems it necessary to do so then the medical reason shall be clearly documented

48. Chronic Pain Guidelines • Pain Medicine Specialist: • “Medical specialty dedicated to the prevention, evaluation and treatment of people with chronic pain.” • Have fellowship training from American Board of Medical Specialists (ABMS) or additional training in pain medicine sufficient to obtain American Board of Pain Medicine (ABPM) diplomat status.

49. Chronic Pain Guidelines • Tiers for the treatment of pain management • Tier 1: Non-Pain Medicine Specialists • Tier 2: Pain Medicine Specialists

50. Chronic Pain Guidelines • Tier 1: Non-Pain Medicine Specialists • All providers who wish to treat patients requiring less than 120 milligram morphine equivalent daily dose (MEDD) shall • Hold a valid Tennessee license issued by their respective board through the Department of Health and a current DEA certification. • Attend Continuing Education pertinent to pain management as directed by their governing board. • Recommends, but does not require, that providers have completed three years of residency training and be ABMS board eligible of board certified.