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transcript
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