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
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
What is a Pill Mill?
• A physician or clinic, and
occasionally a pharmacy, that is
prescribing or dispensing controlled
substance narcotics inappropriately
for non-medical reasons.
Florida Attorney General. Pill Mill Initiative. Available at:
http://myfloridalegal.com/pages.nsf/main/aa7aaf5caa22638d8525791b006a30c8.
Accessed February 2, 2014
Some Definitions
Characteristics of Pill Mills
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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
What is an opioid? What is a narcotic?
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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 a controlled substance?
• Legal system classification of substance – State and Federal
• Based on potential for abuse
• C I through C V
Examples of Specific Medications
Medication
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
Indiana Government Website. Available at:
http://www.in.gov/legislative/ic/code/title35/ar48/ch2.pdf
Accessed April 18, 2014
Schedule II or CII
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
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
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/201110-13/pill-mill-drug-trafficking/50896242/1
Dance
hillbilly heroin
Las Vegas Cocktail
Holy Trinity
Soma Coma
Party Pack
Soma™, Vicodin™, Xanax™
http://www.chron.com/news/houston-texas/article/Dangers-of-prescriptiondrug-abuse-hit-home-1607219.php
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 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
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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
Regulation of Pain Clinics
Center for Disease Control Website. Available at:
http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/pain_clinic.html
Accessed April 21, 2014
Physical Exam Required
Center for Disease Control Website. Available at:
http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/exam.html
Accessed April 21, 2014
Tamper Resistant Rx Forms
Center for Disease Control Website. Available at:
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html
Accessed April 23, 2014
Drug Limit Requirements
Center for Disease Control Website. Available at:
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html
Accessed April 23, 2014
“Doctor Shopping”
Center for Disease Control Website. Available at:
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html
Accessed April 23, 2014
Require Picture ID
Center for Disease Control Website. Available at:
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/forms.html
Accessed April 23, 2014
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
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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.
Legislation – What is the effect?
Kentucky House Bill 217
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
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.
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
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Decreased prescription drug abuse
Addicts seeking qualified treatment
Fewer deaths due to Rx overdose
Less access to vulnerable
populations (teens)
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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?
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 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
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’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?
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
Arnstein P, St. Marie B. Managing Chronic Pain with Opioids: A Call for Change. NPHF 2010.
Legislation in IN – Is it working?
Legislation in IN – Is it working?
Legislation in IN – Is it working?
Conclusions
• 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
Thanks!
Are there any questions?