Controlled Substance Monitoring Database

Prescr ipt ion Drug Abuse Prevent ion ConferenceSeptember 19, 2014

Andrew Holt, PharmD.Controlled Substance Monitoring

Database

Disclosure Information- Andrew Holt, PharmD

• I have no financial relationships to disclose

• I will not discuss off label use and/or investigational use in my presentation

Opioid Prescription Rates by County, TN 2007

Source: Tennessee Department of Health internal files, Baumblatt, et al

Opioid Prescription Rates by County, TN 2008

Source: Tennessee Department of Health internal files, Baumblatt, et al

Opioid Prescription Rates by County, TN 2009

Source: Tennessee Department of Health internal files, Baumblatt et al

Opioid Prescription Rates by County, TN 2010

Source: Department of Health internal files, Baumblatt et al

Opioid Prescription Rates by County, TN 2011

Source: Tennessee Department of Health internal files, Baumblatt et al

C-II Controlled Substance Utilization by State

Rank State Rx per Capita

1 Delaware 0.8127

2 Tennessee 0.6828 3 District of Columbia 0.6329 4 Massachusetts 0.6330 5 Maine 0.6231

Source: IMS Health

C-II Controlled Substance Growth by State2013 vs. 2012

Rank State Change 1 Wyoming 7.1% 2 South Dakota 6.1% 3 Idaho 5.1% 4 Louisiana 5.0% 31 Tennessee 0.3%

Source: IMS Health

Oxycodone Utilization by State

Rank State Rx per Capita 1 Delaware 0.36 2 District of Columbia 0.32 3 Tennessee 0.31 4 Massachusetts 0.29 5 Pennsylvania 0.29

Source: IMS Health

Growth in Oxycodone Utilization by State

Rank State Change 1 Wyoming 5.1% 2 Mississippi 2.7% 3 South Dakota 2.5% 4 Idaho 2.3% 37 Tennessee -4.4%

Source: IMS Health

C-III Controlled Substance Utilization by State

Rank State Rx per Capita 1 Alabama 1.10 2 Tennessee 0.92 3 Mississippi 0.91 4 West Virginia 0.91 5 Kentucky 0.89

Source: IMS Health

C-III Controlled Substance Growth by State2013 vs. 2012

Rank State Change 1 Vermont -0.2% 2 Arkansas -0.5% 3 South Dakota -0.9% 4 North Dakota -1.0% 31 Tennessee -5.0%

Source: IMS Health

Opioid Prescribing Analysis:Analysis of Specialty/Profession Type in Tennessee

0

500

1,000

1,500

2,000

2,500

3,000

TTot

al Di

spen

sed

Pres

crip

tions

(000

's)

Tennessee Opioid Prescribing Volume by SpecialtyYear ended August 2013

CSMD History

• Law Enacted in 2002• Began collecting data in 2005• Became searchable by practitioners

in 2006

Controlled Substance Monitoring Database Committee

• Board of Medical Examiners• Board of Nursing • Board of Pharmacy • Board of Osteopathic Examination• Committee on Physician Assistants • Board of Veterinary Medical Examiners• Board of Optometry • Board of Podiatric Medical Examiners • Board of Dentistry

Most Commonly Prescribed CS in TN

Table 3. Comparison of the 10 most frequently prescribed products in 2012 and 2013 in CSMD

Rank 2013 2012

1 Hydrocodone products Hydrocodone products

2 Alprazolam Alprazolam

3 Oxycodone products Oxycodone products

4 Zolpidem Zolpidem

5 Tramadol Tramadol

6 Clonazepam Clonazepam

7 Lorazepam Lorazepam

8 Diazepam Diazepam

9 Morphine products Buprenorphine products

10 Buprenorphine products Morphine products

Source: CSMD Annual Report to the 108th General Assembly, 2014

Prescription Safety Act of 2012

• Mandatory PDMP registration• Mandatory PDMP usage• Shortened PDMP reporting window• Mandatory reporting of doctor shoppers

to law enforcement by practitioners• Enabled interstate data sharing• Established delegate

accounts-”extenders”• Increased administrative staffing

Prescriber CSMD Survey Results

• 71% changed a treatment plan after viewing a CSMD report

• 73% are more likely to discuss substance abuse issues or concerns with a patient

• 57% are more likely to refer a patient for substance abuse treatment

• 79% feel that the CSMD is useful for decreasing doctor shopping

Technological Innovations

• Color-coded risk icons on patient report for:

– Pharmacy Shopper– Doctor Shopper– High MME Dose

• Automated username and password retrieval

• Batch requests for high-volume clinics

CSMD Technology

CSMD Technology – Risk Indicators

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

CSMD Searches by DelegatesCSMD Searches by Prescibers

Mandating CSMD Checking Resulted in More Queries in Tennessee

Source: Tennessee Department of Health Internal Files, February 2014

Mandated checking began April 1, 2013

Mandated registration began April 1, 2013

Number of High Utilization Patients* in PDMP 2012-2014

1st quarter 2nd quarter 3rd quarter 4th quarter0

500

1000

1500

2000

2500

2012

2013

2014

*Individual who obtained controlled substance prescriptions from five or more pre -scribers and utilized five or more pharmacies within the quarter

Source: Tennessee Department of Health Internal files, May 2014

More PDMP Queries, Fewer High Utilization Patients

2010 2011 2012 20130.0

500,000.0

1,000,000.0

1,500,000.0

2,000,000.0

2,500,000.0

3,000,000.0

3,500,000.0

4,000,000.0

4,500,000.0

5,000,000.0

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

Number of Searches Made by Prescibers, Dispensers, and Delegates

High Utilization Patients: Pa-tients filled 5 or more prescrip-tions with dif-ferent DEA Pre-scribers at 5 or more different DEA dispensers within 90 days.

Source: Tennessee Department of Health Internal Files, Feb-ruary 2014

Pati

en

t R

eq

uest

s (i

n M

illion

s)

Hig

h U

tiliza

tion

Pati

en

ts

Statistics

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec500,000,000

550,000,000

600,000,000

650,000,000

700,000,000

750,000,000

800,000,000

850,000,000

900,000,000

MME by Month for non-VA Dispensers

20132014

Reducing Neonatal Abstinence Syndrome

• Pink NAS reminder messaging on all females of childbearing age

NAS Messaging in CSMD

• Pink cautionary statement on patient report for females of childbearing 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.”

Future CSMD Activities

• Integrate into clinical workflow• Enhanced analysis– $1.4 million CDC grant awarded in 2014

• Increased interstate data sharing

Chronic Pain Management Guidelines

Prescr ipt ion Drug Abuse Prevent ion ConferenceSeptember 19, 2014

Andrew Holt, PharmD.Controlled Substance Monitoring

Database

Public Chapter 430

• Chronic Pain Guidelines written by January 1, 2014

• All prescribers with DEA 2 hours CME every 2 years

• Prescribe 30 days at a time Schedule II-IV

Process Began on January 28, 2013

• Selected the Panel of Experts

• Selected the Steering Committee

• First Meeting Steering Committee Meeting July 1, 2013

Chronic Pain Guidelines Steering Committee

Worker’s CompensationAbbie Hudgens

Office of General CounselAndrea Huddleston, J.D.

Controlled Substance Monitoring Database

Andrew Holt, D.Ph.

Department of HealthBruce Behringer, MPHDavid Reagan, M.D.Larry Arnold, M.D.

Mitchell Mutter, M.D.

Department of TennCareVaughn Frigon, M.D.

Board of Medical ExaminersDr. Michael Baron

TN Department of Mental HealthRodney Bragg, M.A., M.Div.

Tennessee Medical Foundation

Dr. Roland Gray

Special Thanks To:Ben E. Simpson, J.D.

Tracy Bacchus

Chronic Pain Guideline Panel Members

Autry Parker, M.D.Brett Snodgrass,

APNC. Allen Musil, M.D.Carla Saunders, APNCharles McBride,

M.D.James Choo, M.D.Jason Carter, DPhJeffrey Hazlewood,

M.D.Jim Montag, PA-CJohn Culclasure,

M.D.Katie Liveoak, D.Ph.

Michael O'Neil, D.Ph.Paul Dassow, M.D.Raymond McIntire,

DPhRett Blake, M.D.Stephen Loyd, M.D.Ted Jones, PhDThomas Cable, M.D.Tracy Jackson, M.D.W. Clay Jackson,

M.D.William Turney, M.D.

Chapters of the TN Treatment Guidelines

• Introduction • Before initiating chronic opioid

therapy (over 90 days) • Screening (including TN risk

model), non-opioid therapies, referral to MH, others

• Informed consent• Women's special considerations

• Initiating chronic opioid therapy • Standard therapy, combination

therapy• Special considerations

• Methadone/buprenorphine • UDS - qualitative &

quantitative• CSMD• Documentation in decision

making• Follow up therapy

• UDS - qualitative & quantitative• CSMD• ED visits for OD• What constitutes a failure of

standard therapy?• Referral to pain specialist• Taper / discontinuation of opioids• Documentation of decision

making

• Appendices• Pain Medicine Specialist• Risk Assessment Tools• Pregnant women • Use of Opioids in Worker's

Compensation Medical Claims• Tapering protocol• Sample Informed consent• Sample Patient Agreement• Controlled Substance

Monitoring Database• Medication Assisted Treatment

Program• Morphine equivalents dose• Psychological Assessment

Tools• Prescription Drug Disposal• Safety Net• Definitions• Table of Frequently Prescribed

Pain Medications• Urine Drug Testing • Special Consideration: Women

of Child Bearing Age

Section I: Prior to Initiating Opioid Therapy

• Non Opioid Treatment if Possible• All Newly Pregnant Women Should• Complete evaluation: History and

Physical• Testing documented in medical record

prior• Chronic Pain shall not be treated via

telemedicine• Co-Morbid Mental Conditions• There shall be the establishment of a current diagnosis that justifies a need for opioid therapy

Section I: Prior to Initiating Opioid Therapy (cont.)

• Risk for Abuse• Validated Risk Tools• CSMD• UDT• Goals for Treatment• Treatment plan for opioid and non-opioid

treatment• Increase function, not to eliminate pain• Documentation in medical record

Section II: Initiating Opioids

• Maximum four doses of short-acting opioids per day• Non pain medicine specialist should not

prescribe methadone• Prescribers shall not prescribe

buprenorphine in oral or sublingual for chronic pain • Avoid benzodiazepines• Document reasons for deviation from

guidelines in record

Section II: Initiating Opioids (cont.)• Therapeutic trial• Lowest possible dose• Opioid Naïve• Informed Consent• Treatment Agreement female patient• Continually monitor for abuse, misuse,

or diversions• CSMD and UDT

Section II: Initiating Opioids (cont.)

• Women’s Health• Birth Control Plans• Informed Consent• Ask regarding pregnancy each visit• Before starting opioids – in women

shall have pregnancy test

Section III: Treatment with Opioids

• Single provider and pharmacy • Opioids used at lowest effective dose

• Ongoing Therapy• Greater than 120 MEDD (Morphine

Equivalent Dose) should refer to Pain Specialists• Greater than 120 MEDD shall refer• UDT twice/year• Continual assessment via 5A’s UDT, CSMD• Emergency Physician, Primary Provider

Communication• Discontinue when risk greater than benefits

ABPM

• Recognizes boards in the following certification as qualified to sit for Board Exam

• Anesthesia• Psychiatry• Neurology• Neurosurgery • Physical Medicine and Rehabilitation

• 50 hours CME in Pain Medicine past two (2) years

• Substantial, recent and comprehensive clinical practice experience

Pain Specialist

• Board of Medical Specialties (ABMS) primary physician certification organization in US

• ABMS certifies pain medicine fellowship programs in Anesthesia, Physical Medicine and Neurology

• American Board of Pain Medicine (ABPM) is not ABMS and does not oversee fellowship training programs.

• ABPM offers practice – related examinations to qualified candidates. Diplomates of ABPM have certification in Pain Medicine

• AOA Certification

Pain Specialist (cont.)

• Patients requiring less than 120 MEDD

a. Must have valid license by respective board and DEA

b. CME pertinent to pain management directed by regulatory board

c. Recommend (do not require) 3 year residency and be ABMS eligible or certified

Pain Specialist (cont.)

• Patients requiring ≥ 120 MEDDa. 11 times more likely to have adverse event such

as overdose deathb. Consultation with pain consultant who has

additional in pain medicine is recommended1. Pain Consultant up to 7/1/2016 shall have

unencumbered license with no prior actions unless an exception is approved by the respective board

2. Two year experience3. Minimum 25 CME hours in pain management

every 12 months4. Pain consultants after 7/1/2016 shall have ABPM

diplomate status or ABMS Boards

Websites

Prescription for Success http://tn.gov/mental/prescriptionforsuccess/

Pain Clinic Websitehttp://health.state.tn.us/Boards/PainClinicRegistry.shtml

Pain Clinic Guidelines http://health.state.tn.us/Downloads/ChronicPainGuidelines.pdf

2014 Legislative Reporthttp://health.state.tn.us/boards/Controlledsubstance/PDFs/CY%202013%20CSMD%20Report%20to%20the%20General%20Assembly%20Post.PDF

Andrew Holt, PharmDControlled Substance Monitoring Database

Tennessee Department of HealthAndrew.Holt@tn.gov

615-253-1300

Questions and Contact Information