Indiana’s New Law on Controlled Substance Prescribing: What’s the Impact? Indiana Rural Health Conference 2014 Indianapolis, IN June 10, 2014 Dan Degnan,

Indiana’s New Law on Controlled Substance Prescribing: What’s the Impact?

Indiana Rural Health Conference 2014Indianapolis, INJune 10, 2014

Dan Degnan, PharmD, MS, CPPSJohn Hertig, PharmD, MS, CPPS

Katelyn Brown, PharmDCenter for Medication Safety Advancement

Purdue University, College of Pharmacy

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

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

Some DefinitionsCharacteristics 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

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?

Examples of Specific MedicationsMedication Classification Indiana Status

Hydrocodone and Acetaminophen (Norco™, Vicodin™)

Opioid with other substance

Schedule III or CIII

Morphine Opioid Schedule II or CII

Diazepam (Valium™) Benzodiazepine Schedule IV or C IV

Cocaine Coca plant derivative Schedule II or CII

Oxycodone (Oxycontin™) Opioid Schedule II or CII

Alprazolam (Xanax™) Benzodiazepine Schedule IV or CIV

Codeine Opioid Schedule II or CII

Heroin Opioid/Illegal substance Schedule I or C I

Methylphenidate (Ritalin™) Stimulant Schedule II or CII

Indiana Government Website. Available at: http://www.in.gov/legislative/ic/code/title35/ar48/ch2.pdfAccessed April 18, 2014

Significant problem in the USCDC 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

Significant problem in the US14,800 prescription painkiller deaths in 2008

CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60: 1-6

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

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™

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”

After Florida . . . . Pill Mills spread

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

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

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

Medical Licensing BoardPrescribing 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

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

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

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

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

Center for Disease Control Website. Available at: http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/pain_clinic.htmlAccessed April 21, 2014

Regulation of Pain Clinics

Center for Disease Control Website. Available at: http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/exam.htmlAccessed April 21, 2014

Physical Exam Required

Center for Disease Control Website. Available at: http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.htmlAccessed April 23, 2014

Tamper Resistant Rx Forms


Drug Limit Requirements


“Doctor Shopping”


Require Picture ID

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 clinicsCohron 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.

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.

Closure of Pill Mills

• 10 pain management clinics were closed in 3 months

“Cocktail” prescriptions

• Prescriptions written for pill mill cocktails dropped dramatically

KASPER Subscribers

• Tripling of subscribers to the system• KASPER handling more than 18,000 requests per day

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.

Legislation – What is the effect?Florida House Bill 7095

Reduction Painkiller deaths

• 17% reduction in deaths attributed to prescription drug abuse• 4.1% reduction in number of prescriptions written for strongest, most highly addictive opioids

Pain Clinics

• 400 clinics either shut down or closed their doors• More addicts seeking qualified treatment

Unintended Consequences

• Chronic pain patients find it more difficult to fill prescriptions• Increase in the use of heroin

Health Regulation Committee. Prescription Drugs.Available at: http://www.flsenate.gov/Committees/BillSummaries/2011/html/7095HR Accessed April 23, 2014.

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)

• Increase in pharmacy robberies• Less access to opioid medications• Additional difficulties for legitimate

chronic pain patients• Potential increase in illicit drug use

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.

Legislation – What is the effect?What will the effect be in Indiana?


Legislation – What is the effect?What will the effect be in rural communities?


Florida

• Reports of physicians not prescribing opioids because regulation too burdensome

Kentucky

• Physicians in rural communities stopped prescribing opioids• Changes made in subsequent bill to alleviate issue

Indiana

• Cause for complaints in Florida and Kentucky not in Indiana law• Drug screening likely will be an issue for review

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.

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

Legislation in IN – Is it working?



• 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

Thanks!

Are there any questions?

Documents

Indiana’s New Law on Controlled Substance Prescribing: What’s the Impact? Indiana Rural Health Conference 2014 Indianapolis, IN June 10, 2014 Dan Degnan,