2015 Tennessee Controlled Substances Monitoring Database Program

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

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

Number of Registrants of CSMD, 2010-2014*

2010 2011 2012 2013 20140

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

Year* VA registrants were included in 2013 and 2014.

Nu

mb

er o

f R

egis

tran

ts

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

Number of CSMD Requests from Law Enforcement 2012-2014

2012 2013 20140

500

1,000

1,500

2,000

2,500

3,000

Year

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

2010 2011 2012 2013 2014 2015

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

13.8 : 1

12.2 : 1

9.9 : 1

4.2 : 13.7 : 1 2.8:1

Rati

o (

Nu

mb

er

of

Pre

scri

pti

on

: N

um

ber

of

Req

uest)

Prescription Safety Act of 2012 be-came PC 880

Prescribers / dispensers re-quirement 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 prescribe controlled substances

More likley to pre-scribe controlled substances

Other

Prescribers are less likely to prescribe after using the CSMD.

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 the way I practice pharmacy

Less likely to dispense Controlled Substance

More likely to dispense Con-trolled Sub-stances

Other

Pharmacies are less likely to dispense after checking the CSMD.

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

2010 2011 2012 2013 201415,500,000

16,000,000

16,500,000

17,000,000

17,500,000

18,000,000

18,500,000

19,000,000

Year

Nu

mb

er

of

Pre

scri

pti

on

s

Top 5 Drugs Prescribed 2015 Tennessee CSMD Data

1. Hydrocodone products2. Alprazolam3. Oxycodone products4. Zolpidem5. Tramadol

* Unchanged in last 3 years

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

2010 2011 2012 2013 20140

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

Opioid

Benzodiazepines

Muscle Relaxant

Other

Year

Num

ber o

f Pre

scri

ption

s

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

2010 2011 2012 2013 20140

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

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

Overall Prescriptions of Controlled SubstancesPrescription of OpioidMorphine Milligram Equivalent

Year

Num

ber o

f Pre

scrip

tions

Amou

nt o

f Mor

phin

e M

illig

ram

Equ

ival

ent

Interstate Prescriber & Dispenser Queries August – December**

AR KY MI MS SC VA0

20000

40000

60000

80000

100000

120000

140000

0

120,326

7,032 3,034 1,833

27,40519,691

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%

Prescribers think the CSMD helps them decrease doctor shoppers.

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 Agree Neutral

Somewhat Disagree Strongly disagree

Strongly agree or agree = 84.6%

Pharmacies think the CSMD helps them decrease doctor shoppers.

Potential Doctor-Pharmacy Shoppers Identified in CSMD*

2010 2011 2012 2013 20140

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

Year

Num

ber o

f Doc

tor-

Phar

mac

y Sh

oppe

r

* ≥5 Prescribers & ≥ 5 Dispensers in 3 months

Regulatory and Controlled Substance Update

• Recent changes related to the 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

• 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

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

• 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

• 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

• 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

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 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 RobberiesDEA 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

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.”

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 Agree Neutral

Somewhat Disagree Strongly Disagree

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).

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 Sites partnership is needed and valued by the CSMD Program