1. Indiana’s New Law on Controlled Substance Prescribing: What’s the Impact? Indiana Rural Health Conference 2014 Indianapolis, IN June 10, 2014 Dan Degnan, PharmD, MS, CPPS John Hertig, PharmD, MS, CPPS Katelyn Brown, PharmD Center for Medication Safety Advancement Purdue University, College of Pharmacy

2. Objectives Describe the history of Senate Enrolled Act 246 (Public Law 185, 2013) that will be enacted through emergency rule by the Indiana Medical Licensing Board on December 15, 2013 Review the impact that similar prescribing laws and regulatory requirements in other states have had on rural health, patient pain management and opioid drug abuse Contrast the need for enforcement of new Indiana opioid regulatory requirements with the need for chronic pain management through the use of opioids

3. Some Definitions A physician or clinic, and occasionally a pharmacy, that is prescribing or dispensing controlled substance narcotics inappropriately for non-medical reasons. What is a Pill Mill? Florida Attorney General. Pill Mill Initiative. Available at: http://myfloridalegal.com/pages.nsf/main/aa7aaf5caa22638d8525791b006a30c8. Accessed February 2, 2014

4. Some Definitions Characteristics of Pill Mills Accept cash only Patient may or may not be seen by a physician No physical exam No prior medical records or X-rays needed Patients are directed to in-house pharmacy Treat pain with medication only Line of patients in parking lot or waiting room Clinic accepts out of town or out of state patients

6. More Definitions Derived from the opium poppy Drug that affects specific receptors Legal and illegal substances Opioid (or opiate) is often medical term, narcotic is often a legal term What is an opioid? What is a narcotic? Legal system classification of substance – State and Federal Based on potential for abuse C I through C V What is a controlled substance?

7. Examples of Specific Medications MedicationClassificationIndiana Status Hydrocodone and Acetaminophen (Norco™, Vicodin™) Opioid with other substance Schedule III or CIII MorphineOpioidSchedule II or CII Diazepam (Valium™)BenzodiazepineSchedule IV or C IV CocaineCoca plant derivativeSchedule II or CII Oxycodone (Oxycontin™)OpioidSchedule II or CII Alprazolam (Xanax™)BenzodiazepineSchedule IV or CIV CodeineOpioidSchedule II or CII HeroinOpioid/Illegal substanceSchedule I or C I Methylphenidate (Ritalin™)StimulantSchedule II or CII Indiana Government Website. Available at: http://www.in.gov/legislative/ic/code/title35/ar48/ch2.pdf Accessed April 18, 2014

8. Significant problem in the US CDC declared prescription drug abuse to be a “national” epidemic Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/rxbrief/ Accessed April 18, 2014

9. Significant problem in the US 14,800 prescription painkiller deaths in 2008 CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60: 1-6

10. In Florida alone.... Formerly known as “National Pill Mill Capital” 90 of the top 100 oxycodone-purchasing doctors 53 of the top 100 oxycodone-purchasing pharmacies Interstate 75 became known as the “Oxy Express” More than 7 people died everyday due to prescription drug overdose Visitors came from all over the US to get “roxies” http://usatoday30.usatoday.com/news/nation/story/2011- 10-13/pill-mill-drug-trafficking/50896242/1

11. http://www.chron.com/news/houston-texas/article/Dangers-of-prescription- drug-abuse-hit-home-1607219.php Las Vegas Cocktail Soma Coma Party Pack Dance Holy Trinity hillbilly heroin Soma™, Vicodin™, Xanax™

12. In Florida.... Lack of regulation around opioid prescribing and pain clinics No legislation and No appropriation – No enforcement Florida passed legislation in 2011 – Purdue Pharma offered $1 million to fund the bill – State collected grants and donations to fund the program In 2012, DEA declared that Florida no longer “Pill Mill Capital”

13. After Florida.... Pill Mills spread

14. Indiana Pill Mills Clark County Wellness Clinic in Jeffersonville, IN Came from Georgetown, KY – Following new legislation in Kentucky Few legal options to shut the clinic down – Indiana’s new legislative oversight for controlled substances – Senator Grooms sponsored bill

15. In Indiana... News spread of the “pill mills” Indiana ranks as one of the highest states in the nation for prescription painkiller abuse Surrounding states passing legislation Indiana AG investigations of physicians for over prescribing controlled substances Between 1999 and 2009, prescription overdose in Indiana increased 502% In 2012, 5.7% of Hoosiers reported using prescription painkiller for nonmedical reasons

16. What does new law require? Senate Act 246 Allows Attorney General’s office to get an injunction to stop a pill mill Requires Medical Licensing Board to contribute to the effort Requires Health Finance Commission to conduct research on the issue Requires Division of Mental Health and Addiction to give Health Finance data on opioid treatment

17. Medical Licensing Board Prescribing Rules apply – Long term prescribing of opioid containing substances for chronic pain – If a patient has been prescribed for more than 3 consecutive months >60 opioid containing pills per month or a morphine equivalent dose of >15 mg/day Exclusions – Patients who are terminally ill – Residents of an Indiana licensed health facility – Patients enrolled in an Indiana licensed hospice program – Patients enrolled in a palliative care program that is part of an Indiana licensed hospital or hospice

18. Medical Licensing Board Physicians must personally perform initial patient evaluations Use non-opioid medications when appropriate Patient must be informed of risks Patient visits should be scheduled INSPECT report must be run initially and then annually Drug monitoring test initially and annually (postponed until Jan 1, 2015) Treatment agreement

19. What are the results in Indiana? No official reports to date – Report from the Health Finance Commission is not available – Report from the Division of Mental Health and Addiction is not available

20. What do other states do to address the problem? Variety of options to prevent prescription drug abuse – Prescription Drug Monitoring Programs – Regulate Pain Clinics – Require Physical exams – Implement tamper resistant prescription forms – Institute drug limit laws – Enact doctor shopping laws – Requiring patient ID

21. National Alliance for Model State Drug Laws (NAMSDL) website. Available at: http://www.namsdl.org/library/1E4808C8-1372-636C-DD0293F829471A7E/ Accessed April 21, 2014

22. Center for Disease Control Website. Available at: http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/pain_clinic.html Accessed April 21, 2014 Regulation of Pain Clinics

23. Center for Disease Control Website. Available at: http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/exam.html Accessed April 21, 2014 Physical Exam Required

24. Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html Accessed April 23, 2014 Tamper Resistant Rx Forms

25. Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html Accessed April 23, 2014 Drug Limit Requirements

26. Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html Accessed April 23, 2014 “Doctor Shopping”

27. Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html Accessed April 23, 2014 Require Picture ID

28. Legislation – What is the effect? Kentucky House Bill 217 Very similar to Indiana What are the differences? – No drug screening in Kentucky – Restrictions on emergency department physicians IV control substances Lost or stolen prescriptions Replacing methadone or suboxone No more than 7 days of controlled substances – Regulation of pain clinics Cohron PP. The Commonwealth’s Response to Kentucky’s Pill Mill Problem. Kentucky Law Journal Online. Available at: http://www.kentuckylawjournal.org/online-originals-2/the-commonwealths-response-to-kentuckys-pill-mill-problem/ Accessed April 23, 2014.

29. Legislation – What is the effect? Kentucky House Bill 217 Cohron PP. The Commonwealth’s Response to Kentucky’s Pill Mill Problem. Kentucky Law Journal Online. Available at: http://www.kentuckylawjournal.org/online-originals-2/the-commonwealths-response-to-kentuckys-pill-mill-problem/ Accessed April 23, 2014. 10 pain management clinics were closed in 3 months Closure of Pill Mills Prescriptions written for pill mill cocktails dropped dramatically “Cocktail” prescriptions Tripling of subscribers to the system KASPER handling more than 18,000 requests per day KASPER Subscribers

30. Legislation – What is the effect? Florida House Bill 7095 Very similar to Indiana What are the differences? – No drug screening in Florida – Regulation of pain clinics Limits dispensing activities Eliminates prescribers outside of the clinic – Restrictions on pharmacies Policies and procedures to prevent fraud – New provisions for drug wholesalers Health Regulation Committee. Prescription Drugs. Available at: http://www.flsenate.gov/Committees/BillSummaries/2011/html/7095HR Accessed April 23, 2014.

31. Legislation – What is the effect? Florida House Bill 7095 17% reduction in deaths attributed to prescription drug abuse 4.1% reduction in number of prescriptions written for strongest, most highly addictive opioids Reduction Painkiller deaths 400 clinics either shut down or closed their doors More addicts seeking qualified treatment Pain Clinics Chronic pain patients find it more difficult to fill prescriptions Increase in the use of heroin Unintended Consequences Health Regulation Committee. Prescription Drugs. Available at: http://www.flsenate.gov/Committees/BillSummaries/2011/html/7095HR Accessed April 23, 2014.

32. Legislation – What is the effect? Benefit weighed against Consequence Decreased prescription drug abuse Addicts seeking qualified treatment Fewer deaths due to Rx overdose Less access to vulnerable populations (teens) Decreased prescription drug abuse Addicts seeking qualified treatment Fewer deaths due to Rx overdose Less access to vulnerable populations (teens) Increase in pharmacy robberies Less access to opioid medications Additional difficulties for legitimate chronic pain patients Potential increase in illicit drug use Increase in pharmacy robberies Less access to opioid medications Additional difficulties for legitimate chronic pain patients Potential increase in illicit drug use

33. Legislation – What is the effect? What will the effect be in Indiana? 0.2 to 1.2% physicians are pain specialists in IN IN has traditionally had very little regulation for prescribing opioids for chronic pain – Federation of State Medical Boards – Fewer pill mills more primary care physician In 2010, 654 Hoosiers died from accidental drug overdoses More Hoosiers abuse prescription drugs than cocaine, heroin, hallucinogens and inhalants combined 1 in 5 teenagers in IN have used prescription drugs for a nonmedical reason Indiana Pain Society. Indiana Pain Society Legislative Report on Pain Clinics & Opioid Prescribing in Indiana 2012. Available at http://www.naddi.org/aws/NADDI/asset_manager/get_file/50875/in-ips_final_legislative_report.pdf. Accessed April 24, 2014.

34. Legislation – What is the effect? What will the effect be in Indiana? Indiana Pain Society. Indiana Pain Society Legislative Report on Pain Clinics & Opioid Prescribing in Indiana 2012. Available at http://www.naddi.org/aws/NADDI/asset_manager/get_file/50875/in-ips_final_legislative_report.pdf. Accessed April 24, 2014.

35. Legislation – What is the effect? What will the effect be in rural communities? Indiana Pain Society. Indiana Pain Society Legislative Report on Pain Clinics & Opioid Prescribing in Indiana 2012. Available at http://www.naddi.org/aws/NADDI/asset_manager/get_file/50875/in-ips_final_legislative_report.pdf. Accessed April 24, 2014. Reports of physicians not prescribing opioids because regulation too burdensome Florida Physicians in rural communities stopped prescribing opioids Changes made in subsequent bill to alleviate issue Kentucky Cause for complaints in Florida and Kentucky not in Indiana law Drug screening likely will be an issue for review Indiana

36. Legislation – What is the effect? What’s the effect on chronic pain patients? 76 million sufferers in this country Nearly 60% of older adults have had it for more than a year Social isolation based on condition Question remains: How to treat patients with chronic pain without misuse, abuse and diversion of prescription medication? Arnstein P, St. Marie B. Managing Chronic Pain with Opioids: A Call for Change. NPHF 2010. Braden JB, Russo J, Ran M, et al. Long-term Opioid treatment of Nonmalignant Pain. JCOM 201-;17:538-540.

37. Legislation – What is the effect? What are some solutions outside of legislation? Arnstein P, St. Marie B. Managing Chronic Pain with Opioids: A Call for Change. NPHF 2010. Solutions for better opioid control AND chronic pain management Education of healthcare practitioners Use of pain management screening tools Opioid management and dosing tools Perform urine drug toxicology screening Adherence monitoring for overall treatment plan – including medications Patient and healthcare practitioner awareness of need to balance treatment and harm prevention

38. Legislation in IN – Is it working?

40. Senate Act 246 was enacted to prevent “pill mill” spread and increasing number of Hoosiers abusing prescription drugs – Two reports on the effectiveness of the bill have yet to be released – Further rule making will take place in December of 2014 Similar laws in other states have had a dramatic effects at reducing abuse of prescription medications – Unintended consequences have been reported in other states – Kentucky modified its law following initial implementation Rural health impact should be accounted for with follow up reports Conclusions

41. Thanks! Are there any questions?