Tennessee Controlled Substances Monitoring Database Program

D. Todd Bess, Pharm.D. Director Tennessee Controlled Substance Monitoring Database

2015 Tennessee Public Health Association Conference, September 10, 2015

Disclosure Information • I have no financial relationships to disclose • I will not discuss off label use and/or

investigational use in my presentation

Objectives

• Review recent outcomes from the use of the Tennessee Controlled Substances Monitoring Database (CSMD) Program

• Explain how clinicians value and respond to their assessment of the CSMD

• Evaluate ways practice sites can best partner with CSMD Program

Controlled Substances Monitoring Database Appriss Updates

• Appriss acquired Optimum Technology (OTECH)

• TN Department of Health notified by letter 4/29/2015

• Appriss is working to transition to new infrastructure by the end of the year

Drug Overdose Death, 2014

950

1000

1050

1100

1150

1200

1250

1300

2011 2012 2013 2014

1062 1094

1166

1263

Source: TN Department of Health

Total Numbers

Public Chapter 623 “Naloxone” • Licensed Healthcare Practitioner • Patient, family member, friend of patient at risk for

overdose death • Naloxone Education available on the Department of

Health website • Instruction how to administer

http://www.tn.gov/health/topic/information-for-naloxone

Number of Registrants of CSMD, 2010-2014*

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

2010 2011 2012 2013 2014

Num

ber

of R

egis

tran

ts

Year * VA registrants were included in 2013 and 2014.

As of June 2015 the CSMD has greater than 41,000 registrants

But I only prescribe controls a few times a year…

“If you provide direct care and prescribe controlled substances to patients in

Tennessee for more than 15 days per year or you are a dispenser in practice providing

direct care to patients in Tennessee for more than 15 days per year, you are required to

register with the CSMD.”

Number of CSMD Requests from Law Enforcement 2012-2014

0

500

1,000

1,500

2,000

2,500

3,000

2012 2013 2014

Year

Ratio of Number of Prescription to Number of Request in CSMD, 2010-2015*

13.8 : 1

12.2 : 1

9.9 : 1

4.2 : 1 3.7 : 1 2.8:1

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.02010 2011 2012 2013 2014 2015Ra

tio

( Num

ber

of P

resc

ript

ion

: Num

ber

of R

eque

st)

Prescription Safety Act of 2012 became PC 880

Prescribers / dispensers requirement to be registered in CSMD by 1/1/13

Mandatory CSMD check before prescribing opioid / benzodiazepine after 4/1/13

* VA prescriptions and requests were included.

Year

How has checking the CSMD changed the way you practice medicine?

37.5%

41.4%

0.7%

20.5%

No Change

Less likely to prescribecontrolled substances

More likley toprescribe controlledsubstances

Other

How has checking the CSMD changed the way you practice pharmacy?

Source: 2014 CSMD Prescriber and Dispenser Survey

26.6%

47.2%

2.5% 23.8%

Have not change theway I practicepharmacy

Less likely todispense ControlledSubstance

More likely todispense ControlledSubstances

Other

Number of Controlled Substances Dispensed/Reported to CSMD, 2010-2014

15,500,000

16,000,000

16,500,000

17,000,000

17,500,000

18,000,000

18,500,000

19,000,000

2010 2011 2012 2013 2014

Num

ber

of P

resc

ript

ions

Year

Top 5 Drugs Prescribed 2015 Tennessee CSMD Data 1. Hydrocodone products

2. Alprazolam 3. Oxycodone products 4. Zolpidem 5. Tramadol * Unchanged in last 3 years

Number of Controlled Substances Reported to CSMD by Class, 2010-2014

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

7,000,000

8,000,000

9,000,000

10,000,000

2010 2011 2012 2013 2014

Num

ber o

f Pre

scrip

tions

Year

Opioid

Benzodiazepines

Muscle Relaxant

Other

Comparison of Overall Prescriptions, Opioid Prescriptions and MME Dispensed/Reported to CSMD, 2010-2014

8,200,000,000

8,400,000,000

8,600,000,000

8,800,000,000

9,000,000,000

9,200,000,000

9,400,000,000

9,600,000,000

9,800,000,000

10,000,000,000

0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

16,000,000

18,000,000

20,000,000

2010 2011 2012 2013 2014

Amou

nt o

f Mor

phin

e M

illig

ram

Equ

ival

ent

Num

ber o

f Pre

scrip

tions

Year

Overall Prescriptions of Controlled SubstancesPrescription of OpioidMorphine Milligram Equivalent

County-Specific MME Per Capita Filled by TN Residents in 2013

GilesShelby

Dyer

Wayne

Scott

Knox

Polk

Henry

Maury

Sevier

Fayette

Obion

Carroll

Hardin

Blount

Wilson

Monroe

Gibson

Greene

Lincoln

Perr

y

Marion

Tipton

Franklin

Hickman Cock

e

Sumner

Morgan

Weakley

McNairy

White

CoffeeMadison

Stewart

Hamilto

n

Hardem

an Law

renc

e

Rhea

Dickson

Bent

on

Bedford

Roane

Warren

Hawkins

Rutherford

Clay

Fentre

ss

Smith

Haywood

Davidson

Cumberland

Carter

SullivanOverton

McMinn

Williamson

Campbell

Putnam

Bledsoe

Lewis

Grundy

Humphreys

Henderson

Robertson ClaiborneMacon

Lauderdale

DeKalb

Mar

shal

l

Montgomery

Dec

atur

Brad

ley

UnionJackson

Anderson

John

son

Grainger

Jefferson

Cann

onCrockett

Lake

ChesterMeigs

Loudon

Unicoi

Cheatham Washington

Van Buren

Pickett Hancock

Houston

SequatchieMoore

Hamblen

Trousdale

LegendTNCountiesMME_Per_Capita_2013

450 - 1,000

1,001 - 1,500

1,501 - 2,000

2,001 - 2,500

2,501 - 3,655

Change on County-Specific MME Per Capita Among TN Residents from 2013 to 2014

GilesShelby

Dyer

Wayne

Scott

Knox

Polk

Henry

Maury

Sevier

Fayette

Obion

Carroll

Hardin

Blount

Wilson

Monroe

GibsonGreene

Lincoln

Perry

Marion

Tipton

Franklin

Hickman Cock

e

Sumner

MorganWeakley

McNairy

White

CoffeeMadison

Stewart

Ham

ilton

Rhea

Bent

on

Bedford

Roane

Warren

Hawkins

Fentre

ss

Smith

SullivanOverton

Williamson

Putnam

Bledsoe

Lewis

ClaiborneMacon

Dec

atur

Hardeman Lawrence

Dickson

Rutherford

Clay

Haywood

Davidson

Cumberland

Carter

McMinn

Campbell

Grundy

Humphreys

Henderson

Robertson

Lauderdale

DeKalb

Marshall

Montgomery

Bradley

UnionLake Jackson

ChesterMeigs

Anderson

Johnson

Grainger

Jefferson

CannonLoudon

Crockett

UnicoiCheatham Washington

Van Buren

Pickett Hancock

Houston

Sequatchie

Moore

Hamblen

Tipton

LegendTNCountiesChange_County_MME/Capita(2014-2013)

-393 - -200

-199 - -55

-54 - 0

+1 - +100

+101 - +215

Interstate Prescriber & Dispenser Queries August – December**

0

20000

40000

60000

80000

100000

120000

140000

AR KY MI MS SC VA

0

120,326

7,032 3,034 1,833

27,405 19,691

75,214

24,335 22,251 29,042

65,045

2014 Total Incoming Request (request from other state to TN)**

2014 Total Outgoing Request (request from TN to other states)**

All states in production during this timeframe

** Data mid August through December. AR and MS data only November and December

The CSMD is useful for decreasing the incidence of doctor shopping.

61.6% 23.9%

9.3%

2.8% 2.4%

Strongly agree Agree Neutral

Disagree Strongly disagree

Strongly agree or agree = 85.5%

Source: 2014 CSMD Prescriber and Dispenser Survey

The CSMD is useful for decreasing the incidence of doctor shopping.

55.7% 28.9%

9.1% 4.7% 1.6%

Strongly Agree Somewhat AgreeNeutral Somewhat DisagreeStrongly disagree

Strongly agree or agree = 84.6%

Potential Doctor-Pharmacy Shoppers Identified in CSMD*

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2010 2011 2012 2013 2014

Num

ber o

f Doc

tor-

Phar

mac

y Sh

oppe

r

Year * ≥5 Prescribers & ≥ 5 Dispensers in 3 months

Recent Evaluation of How States Quantify Doctor Shopping by TN CSMD Program

AR

OR WY

KS

SD IA

TN

MI

FL

MA

OH

NY

VA

RI

WV 5-5-3

Other 5-5-3 5-5-12

15-15-12 3-3-2 4-4-6 4-4-12

6-6-3 6-6-6 7-7-3

10-10-6 10-10-12 15-15-6

6+ /12 mo.

10+/12 mo.

NM

Where does TN Stand?

Regulatory and Controlled Substance Update

• Recent changes related to the Tennessee CSMD Program or Tennessee Board of Pharmacy – Public Chapter 1011 – Public Chapter 983 – Public Chapter 396 – Public Chapter 872 – Public Chapter 476

Regulatory and Controlled Substance Update

• TN PUBLIC CHAPTER 1011: Controlled Substance Reporting –Changes the required timeframe for

reporting to the Controlled Substance Database to once per business day

(effective January 1, 2016)

Regulatory and Controlled Substance Update

TN PUBLIC CHAPTER 983 (Restriction on Prescriber Dispensing) • Except as provided in§ 63-1-313, a health care

prescriber licensed under this title may not dispense an opioid or benzodiazepine

• Dispensing related to surgical procedure performed at a licensed health care facility allowed, but may not exceed 7 day supply

• ARCOS data will be linked to CSMD for audit purposes

• See Public Chapter 983 for details if you are a dispenser that prescribes these medications

• Effective January 1, 2015

Regulatory and Controlled Substance Update

• TN PUBLIC CHAPTER 396: “Addiction Treatment Act of 2015” – Mandates that only M.D.’s or D.O.’s are permitted to prescribe

buprenorphine for opioid dependence – Buprenorphine may only be prescribed for uses recognized by the

FDA • Unless the patient has a documented opiate addiction, • Receives treatment from a DEA registered addiction treatment

practice, • and is counted as one of the total allowable number of

patients the provider is allowed to treat. – Only pregnant women, nursing mothers, or patients with a

hypersensitivity to naloxone may be prescribed buprenorphine mono

– Effective July 1, 2015

Regulatory and Controlled Substance Update

• TN PUBLIC CHAPTER 872: ID BILL – Applies to C II-IV opioids, benzodiazepines, zolpidem,

barbiturates, and carisoprodol in quantities greater than a 7 day supply

– Requires the person taking possession of the dispensed prescription to present a valid government issued identification or public/private insurance card, unless the person is personally known

– Does not require the person to be the same person for whom the prescription is written

– Effective July 1, 2014

Regulatory and Controlled Substance Update

• TN Public Chapter 476 • Currently, the top 50 prescribers of controlled substances

in the state are annually identified and sent a letter notifying them of their inclusion on this list and asked to respond with a justification for their prescribing patterns.

• Public Chapter 476 adds the top 10 prescribers from all of the combined counties having populations of fewer than 50,000 this process

• Effective/Signed May 18, 2015

Morphine Milligram Equivalents Dispensed by Top 50

Prescribers in 2013, 2014, and 2015*

0

200,000,000

400,000,000

600,000,000

800,000,000

1,000,000,000

1,200,000,000

1,400,000,000

1,600,000,000

2013 2014 2015

Mor

phin

e M

illig

ram

Equ

ival

ents

Year

12% decrease

8% decrease

* Note: Time periods of prescriptions fill used for identification of top 50 were as below: 2013: from 4/1/2012 to 3/31/2013 ; 2014: 4/1/2013 to 3/31/2014 2015: 1/1/2014 to 12/31/2014

Tennessee Board of Pharmacy Policy on Medication Take Back Program

• Allowed If DEA Regulations are “STRICTLY FOLLOWED” • Recent changes in federal regulations allow licensed retail

pharmacies, hospital pharmacies, manufacturers, wholesalers, distributors, and reverse distributors that have a valid DEA registration to accept returns of unused legend drugs from end-users. These registrants may do so by modifying their DEA registration to serve as collectors of unused legend drugs, and by further complying with all DEA regulations pertaining to this activity.

• Therefore, any retail pharmacy, hospital pharmacy, manufacturer, wholesaler, distributor, or reverse distributor that is licensed by the Board and complies with all applicable DEA regulations pertaining to drug disposal MAY accept returns of unused legend drugs pursuant to DEA rules.

Tennessee Board of Pharmacy Policy on Medication Take Back Program (cont.) • If DEA regulations are not strictly followed, Board of

Pharmacy Rule 1140-03-.04(8) will apply. Rule 1140-03-.04(8) prohibits pharmacy practice sites, pharmacists, pharmacist interns, technicians, or any other place involved in the compounding and dispensing of prescription drugs and devices (except institutional pharmacies pursuant to Rule 1140-04-.10) from accepting returns of any order that has been taken from the premises of that pharmacy practice site or any other place of business.

• DEA resources pertaining to drug disposal, including a complete text of the applicable DEA rules, are available at: http://www.deadiversion.usdoj.gov/drug_disposal/

• See TN Board of Pharmacy website or call board office for questions

Next DEA Take-Back Day

Potential RED FLAGS for Pharmacists

• Many patients receiving the same combination of prescriptions (cocktail)

• Many patients receiving the same strength of controlled substances

• Many patients paying cash for their prescriptions • Prescriptions resulting in therapeutic conflicts • Many patients with the same diagnosis https://www.nabp.net/

Potential RED FLAGS for Pharmacists

• Individuals driving long distances to visit physicians and/or to fill prescriptions

• Patients coming into the pharmacy in groups, each with the same prescriptions from the same physician

• Constant requests for early refills

• MULTIPLE RED FLAGS COULD BE A REASON TO DENY pending consultation with prescriber

https://www.nabp.net/

Regulatory and Controlled Substance Update

– CONTROLLED SUBSTANCE ISSUES • Title 21 Code of Federal Regulations • PART 1306 — PRESCRIPTIONS • GENERAL INFORMATION • §1306.04 Purpose of issue of prescription. • (a) A prescription for a controlled substance to be effective must be issued for a

legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances

Top 10 States for Pharmacy Robberies DEA 2013 Statistics • Arizona • Indiana • California • Pennsylvania • Tennessee • North Carolina • Massachusetts • Ohio • Texas • Washington

http://drugtopics.modernmedicine.com/drug-topics/content/tags/arizona/top-10-states-pharmacy-robberies?page=0,0

Armed Robbery Thoughts to supplement your practice site policies to aid surviving the robbery and assisting law enforcement

• Cooperate with robber • Be a good witness and study what is touched or moved • If a weapon is displayed, note the type and color • Keep the note if used to make robbery demands for police • Stay as calm as possible (Indicate you and your team will comply

with demands) • If possible, get the escape vehicle description, license number, and

escape direction for police • Lock the building down after the event and call police • Wait for police and cooperate fully

http://drugtopics.modernmedicine.com/drug-topics/news/7-tips-surviving-pharmacy-robbery?page=0,0

Considerations with Use of the Tennessee CSMD

Training User

Clinical Risk Indicators (high risk patients) on CSMD Reports

= 4 Practitioners in last 90 days

≥ 90 but < 120 Active Cumulative Morphine Equivalents per day

≥ 5 Practitioners in last 90 days

≥ 5 Pharmacies in last 90 days

≥ 120 Active Cumulative Morphine Equivalents per day

R

Y

Y

R

R

Y

= 4 Pharmacies in last 90 days

Clinical Risk Indicators (high risk patients) on CSMD Reports

Female and child bearing age (15-45 years of 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.”

Practitioner vs. Peer Report

Survey: Discuss CSMD Report with Patient

12% 10%

30% 18%

31%

Prescribers

79% Sometimes or more often

14%

20%

33%

17%

17%

Dispensers

Not Very Often Rarely or Never Sometimes Somewhat Often Very Often

67% Sometimes or more often

Has checking the CSMD changed your practice of referring patients for substance abuse treatment?

54.0%

1.2%

33.5%

11.3%

None Less likely to refer More likley to refer Other

Prescribers are more likely to refer patients for substance abuse treatment.

Source: 2014 CSMD Prescriber and Dispenser Survey

CSMD has changed my practice of communicating with the physician regarding a patient whom I believe needs referred for substance abuse treatment?

21.2%

30.9%

38.8%

5.4% 3.7%

Strongly Agree Somewhat AgreeNeutral Somewhat DisagreeStrongly Disagree

Comparison of Overall MME, MME of Buprenorphine, and MME not Including Buprenorphine Dispensed/Reported to CSMD, 2010-2014

0

2,000,000,000

4,000,000,000

6,000,000,000

8,000,000,000

10,000,000,000

12,000,000,000

2010 2011 2012 2013 2014

Amou

nt o

f Mor

phin

e M

illig

ram

Equ

ival

ents

Year Total MME MME from Buprenorphine MME not including Buprenorphine

Public Chapter 898

Since June 15, 2015 any APN or PA who fails to have a supervisor listed in the CSMD is blocked from running patient reports (includes any healthcare practitioner extenders).

The supervisor has the right to revoke Entering your supervisor in the CSMD does not relieve

you from notifying your regulatory board of their board specific requirements.

If you change your supervisor you have 30 days to make that change within the CSMD and your regulatory board (as directed).

Public Chapter 898

Requires PAs & APNs with a certificate of fitness and their extenders to identify the supervising provider in the CSMD by entering the provider’s

driver's license number

CSMD Demonstration of TN Public Chapter 898

For each work location, enter “Supervisor’s Driver License Number” and click “Add”

Check appropriate Work Location Click Add Selected Supervisor

Save

Entered but not confirmed

Supervisor Review Pending

Supervisory Relationship Pending

Contact your supervising physician to inform that

additional action in the CSMD is needed

Supervisor will log into CSMD. As soon as they enter correct username and password this screen appears directing them they have delegates waiting for approval. Click the box to go to “My Account” screen.

Once the Supervisor clicks “My Account” this screen opens. The supervisor will see any approved delegates and any delegates awaiting approval. As you can see this one is awaiting approval.

Once the Supervisor clicks “Approve” You can see the successful message at the top. Also when you look at the delegate area the Supervisor now has the ability to “Revoke” this user if the Supervisor no longer supervises this delegate.

APN or PA will now be notified of the approval and when they log into the CSMD their “My Account” show “Active” for the Supervisor (s). The APN or PA have the option to “Delete” this supervisor.

APN Prescriber with Two Supervisors

APN Smith supervised by Dr. Doe at Retail Clinic (no controlled substances prescribed) and

Dr. Deer at Pain Clinic (controlled substances prescribed)

File Notice and Formulary with BON, include both Drs. Doe & Deer

Enter Dr. Deer as

supervisor in CSMD Enter Dr. Deer’s d.l. # Supervisory relationship

in CSMD approved by Dr. Deer

PA Changes Supervisor

PA Paddington’s primary supervising physician Dr. Bird retires and is replaced by Dr. Bear

Paddington prescribes controlled substances at the Bear Orthopedic Clinic

PA Paddington notifies the PA Committee by letter of the change in primary supervisory physician (15 days)

PA Paddington deletes

retired Dr. Bird on CSMD, enters Dr. Bear and Bear’s d.l. #.

Dr. Bear approves PA

Paddington

Who’s responsible for the PA Supervisory Physician Form? By law: YOU ARE!

A physician assistant to whom the authority to prescribe legend drugs and controlled substances has been delegated by the supervising physician shall file a notice with the committee containing the name of the physician assistant, the name of the licensed physician having supervision, control and responsibility for prescriptive services rendered by the physician assistant and a copy of the formulary describing the categories of legend drugs and controlled substances to be prescribed and/or issued, by the physician assistant. The physician assistant shall be responsible for updating this information; T.C.A. § 63-19-107(2)(B)

PA/APN Your Formulary MATTERS

THOU SHALL NOT prescribe Schedules II, Ill and IV controlled substances unless such prescription is

specifically authorized by the formulary or expressly approved after consultation with the supervising

physician before the initial issuance of the prescription or dispensing of the medication;

Schedule II and III Opioids (Public Chapter 396 passed in 2013)

1 supply

Schedule II or III opioids listed on the formulary shall only be prescribed for a maximum of a non-refillable, thirty-day course of treatment, unless specifically approved after consultation with the supervising physician before the initial issuance of the prescription or dispensing of the medication.

Improve Practice Site Partnership with CSMD Program • Assure Supervisor Relationships are documented in the CSMD

(See Frequently Asked Questions on CSMD Website http://tn.gov/health/article/CSMD-faq)

• See Questions 36 – 39 • Best Process for correction of Wrong Prescriber name in CSMD

(Contact the pharmacy and discuss each prescription number in question with pharmacist to reconcile correct prescriber name)

• Protect you password and assure your extenders do the same • Support Dispensers with entering the correct patient names,

addresses, birthdates, and prescriber name

Conclusion • Recent outcomes from the use of the Tennessee

Controlled Substances Monitoring Database (CSMD) Program are encouraging

• Clinicians value and respond to their assessment of TN CSMD Patient Reports

• Prescribers, Dispensers and Practice Site partnership is needed and valued by the CSMD Program