Education Track, National Rx Drug Abuse Summit, April 2-4, 2013. Trends in Rx Drug Abuse presentation by Dr. Andrew Kolodny, Tess Benham and Sherry Green

1. Trends
in
Rx
Drug
Abuse
Dr.
Andrew
Kolodny
Chairman,
Department
of
Psychiatry,
Maimonides
Medical
Center
Tess
Benham
Program
Manager,
Na?onal
Safety
Council
Hon.
Sherry
L.
Green,
JD
Chief
Execu?ve
Officer,
Na?onal
Alliance
for
Model
State
Drug
Laws

2. Learning
Objec?ves
1. Iden?fy
recent
increasing
trends
in
the
misuse
and
abuse
of
prescrip?on
drugs.
2. Evaluate
the
state
laws
and
regula?ons
that
exist
on
a
state
level
across
the
country.
3. Outline
ini?a?ves
that
can
be
taken
back
and
implemented
in
your
state.

3. Disclosure
Statement
• Andrew
Kolodny
has
no
financial
rela?onships
with
proprietary
en??es
that
produce
health
care
goods
and
services.
• Tess
Benham
has
no
financial
rela?onships
with
proprietary
en??es
that
produce
health
care
goods
and
services.
• Sherry
Green
has
no
financial
rela?onships
with
proprietary
en??es
that
produce
health
care
goods
and
services.

4. Overview
of
the
Opioid
AddicAon
Epidemic
April
2
–
4,
2013
Omni
Orlando
Resort
at
ChampionsGate

5. Presenta?on
Outline
I. Past
opioid
epidemics
II. Current
epidemic
III. Reasons
for
the
current
epidemic
IV. The
chronic
pain
controversy
V. Strategies
to
control
the
epidemic

6. The Opium Poppy
Papaver Somniferum
6

7. Crude Opium Latex on Poppy Head
7

8. Opioids
• Morphine
• Codeine
• Heroin
• Hydrocodone (Vicodin, Lortab)
• Methadone
• Oxycodone (Percocet, Oxycontin)
• Hydromorphone (Dilaudid)
• Meperidine (Demerol)

9. Winslow's Soothing Syrup for infants
Active Ingredient: Morphine

11. Source: The New York Times Magazine, June 5, 1977

12. 12

13. Rates of ED visits for nonmedical use of selected
opioid analgesics increased significantly in the US
40
35
2004 2005 2006 2007 2008
ED visits per 100,000 population
30
25
20
*
15 *
*
* *
10 *
5
*
*
0 * *
Fentanyl Hydrocodone Hydromorphone Methadone Morphine Oxycodone
* Indicates a rate that was significantly less than the rate in 2008.
Note: Drug types include combination products , e.g, combinations of oxycodone and aspirin. 13

14. Opioid-­‐Dependent
Infants
in
Tennessee

15. Unintentional Drug Overdose Deaths
United States, 1970–2007
38,329 drug overdose deaths in 2010
Cocaine
Heroin
Year
National Vital Statistics System, http://wonder.cdc.gov

16. Drug Overdose Deaths by Major Drug Type,
United States, 1999–2010
Opioids Heroin Cocaine Benzodiazepines
18,000
16,000
14,000
12,000
Number of Deaths
10,000
8,000
6,000
4,000
2,000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
CDC, National Center for Health Statistics, National Vital Statistics System, CDC Wonder. Updated with 2010 mortality data.

17. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
17

18. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
18

19. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
19

20. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
20

21. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
21

22. Primary
non-­‐heroin
opiates/syntheAcs
admission
rates,
by
State
(per
100,000
populaAon
aged
12
and
over)
22

23. UnintenAonal
overdose
deaths
involving
opioid
analgesics
parallel
per
capita
sales
of
opioid
analgesics
in
morphine
equivalents
by
year,
U.S.,
1997-­‐2007
*
Number
of
Opioid
sales
(mg/
Deaths
person)
Source:
Na?onal
Vital
Sta?s?cs
System,
mul?ple
cause
of
death
dataset,
and
DEA
ARCOS
*
2007
opioid
sales
figure
is
preliminary.

24. Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010
8
Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000
7
6
5
Rate
4
3
2
1
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
CDC. MMWR 2011

25. 25

26. 26

27. Dollars Spent Marketing OxyContin (1996-2001)
Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and
Efforts to Address the Problem.”
27

28. Industry-funded organizations
campaigned for greater use of opioids
• Pain Patient Groups
• Professional Societies
• The Joint Commission
• The Federation of State Medical Boards
28

29. Industry-funded “education” emphasizes:
• Opioid addiction is rare in pain patients.
• Physicians are needlessly allowing patients to
suffer because of “opiophobia.”
• Opioids are safe and effective for chronic pain.
• Opioid therapy can be easily discontinued.
29

30. “Only four cases of addiction among
11,882 patients treated with opioids”
Porter J, Jick H. Addiction rare in patients treated
with narcotics. N Engl J Med. 1980 Jan 10;302(2):
123
Cited 677 times (Google Scholar)
30

31. N Engl J Med. 1980 Jan 10;302(2):123.
31

33. I think that after 20 years of a failed
experiment that there are not many people
supporting this except for the die-hards and
the pharmaceutical industry.
Jane C. Ballantyne, MD FRCA
Professor, Univ. of Washington
Source: New York Times, April 9, 2012. Tightening the Lid on Pain
Prescriptions .

34. The Emperor’s New Paradigm:
Patient Selection, Risk Stratification & Monitoring
34

35. Urine
Tox
Results
in
Chronic
Pain
PaAents
on
Opioid
Therapy
Source:
Couto
JE,
Goldfarb
NI,
Leider
HL,
Romney
MC,
Sharma
S.
High
rates
of
inappropriate
drug
use
in
the
chronic
pain
popula?on.
Popul
Health
Manag.
2009;12(4):185–190.
35

36. Controlling
the
epidemic:
A
Three-­‐pronged
Approach
• Primary
Preven?on-­‐
prevent
new
cases
of
opioid
addic?on.
• Secondary
Preven?on-­‐
provide
people
who
are
addicted
with
effec?ve
treatment.
• Supply
control-­‐
collaborate
with
law
enforcement,
DEA
and
OPMC
to
over-­‐prescribing
and
black-­‐market
availability.
36

37. Opioid manufacturers continue to advertise opioids as
safe and effective for chronic pain.

38. Controlling the Epidemic:
Potential Interventions
• Opioid Label Changes
• Hydrocodone Up-scheduling
• Prescription Drug Monitoring Programs
• Tamper-Resistant Formulations

39. This is a false dichotomy
Aberrant drug use behaviors are common in pain patients
63% admitted to using opioids for
purposes other than pain1
92% of opioid OD decedents
were Pain Patients
prescribed opioids for Drug Abusers
chronic pain.
35% met DSM V criteria for
addiction2
1. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving
Daily Opioid Therapy. J Pain 2007;8:573-582.
2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:
comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.
3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of
Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.

40. Please
visit
www.supportPROP.org
Follow
us
on
Twi[er
@supportPROP
40

41. Trends
in
Prescrip?on
Drug
Abuse
April
2
–
4,
2013
Omni
Orlando
Resort
at
ChampionsGate

42. Who
is
NSC?
Our
Mission:
The
Na?onal
Safety
Council
saves
lives
by
preven?ng
injuries
and
deaths
at
work,
in
homes
and
communi?es,
and
on
the
roads
through
leadership,
research,
educa?on
and
advocacy.

43. • Na?onal
Governors
Associa?on
Policy
Academy
• Report
Release
(April
2012)

44. Opportuni?es
for
Ac?on
• Build
State
Capacity
to
Address
Rx
Drug
Overdoses
• Increase
Access
and
U?liza?on
of
Prescrip?on
Monitoring
Programs
(PMPs)
• Support
Responsible
Opioid
Prescribing
• Advocate
for
Overdose
Educa?on
Programs

46. Increase
Access
and
U?liza?on
of
(PMPs)
• Allow
authorized
delegates
• Move
to
real-­‐?me
data
collec?on
intervals
• Share
PMP
data
with
other
states
• Proac?ve
alerts

47. Support
Responsible
Prescribing
• Deter
forma?on
of
pill
mills
• Provide
guidance
and
educa?on
on
responsible
prescribing
of
controlled
substances
• Increase
u?liza?on
of
PMPs
by
prescribers
and
dispensers

48. Overdose
Educa?on
Programs
• Provide
overdose
educa?on
• Naloxone
distribu?on
• Good
Samaritan
laws

49. Ques?ons
Tess
Benham
Na?onal
Safety
Council
tess.benham@nsc.org

50. Snapshot
of
Laws,
RegulaAons
and
Policies
on:
State
PrescripAon
Drug
Monitoring
Programs
(PMPS)
State
RegulaAon
of
Pain
Clinics
State
Prescribing
PracAces
for
the
Treatment
of
Non-­‐Cancer
Pain
April
2
–
4,
2013
Omni
Orlando
Resort
at
ChampionsGate

51. Who
is
NAMSDL?
• 501
(c)(3)
nonprofit
corpora?on
• Successor
to
the
President’s
Commission
on
Model
State
Drug
Laws
• 19
½
years
• Funded
by
Congress
• Provides
legisla?ve
and
policy
services
on
drug
and
alcohol
laws
to
a
variety
of
stakeholders
at
the
state
and
local
level

52. State
PrescripAon
Drug
Monitoring
Programs
(PMPS)
–
InformaAon
Tools
• PMP-­‐
statewide
electronic
database
that
collects
designated
data
on
prescrip?on
controlled
substances
and
some?mes
drugs
of
concern
 49
states
with
PMP
laws
 44
states
with
opera?onal
programs

53. InformaAon
Tools
Cont…
• 12
common
categories
of
recommenda?ons
by
6
en??es
 PMP
Center
of
Excellence
at
Brandeis
University
 School
of
Medicine
and
Public
Health
at
University
of
Wisconsin-­‐Madison
 Mitre
Corpora?on,
Office
of
Na?onal
Coordinator
for
Health
Informa?on
Technology
and
the
Substance
Abuse
and
Mental
Health
Services
Administra?on
 NAMSDL
 Alliance
of
States
with
PMPS
 American
Cancer
Society

54. InformaAon
Tools
Cont…
• Increase
use
of
PMP
as
health
care
tool
• Frequency
of
dispenser
repor?ng
 Real
?me
–
OK
 Daily/24
hours
–
5
states:
DE,
KS,
MN,
ND,
WV
 Weekly/7
Days
–
31
states:
AL,
AZ,
AR,
CA,
FL,
GA,
HI,
ID,
IL,
IN,
IA,
KY,
LA,
ME,
MA,
MS,
MT,
NV,
NH,
NM,
NC,
OH,
OR,
SD,
TN,
TX,
UT,
VT,
VA,
WA,
WY
 Twice
monthly
–
4
states:
CO,
CT,
MI,
NJ
 Monthly
–
5
states:
AK,
NY,
PA,
RI,
SC

55. InformaAon
Tools
Cont…
• Expand
categories
of
authorized
users
 Delegates
or
authorized
agents
of
prescribers/dispensers
–
21
states:
DE,
ID,
IN,
IA,
KS,
KY,
ME,
MD,
MA,
MN,
MT,
NM,
NY,
ND,
OH,
SD,
TN,
UT,
VA,
WA,
WV
 Mental
health/substance
abuse
professionals,
peer
review/
quality
improvement
commirees
–
7
states:
IN,
KS,
MD,
ND,
SD,
TN,
UT

56. InformaAon
Tools
Cont…
• Mandatory
use
of
PMP
by
prescribers
 13
states

4
-­‐
Limited
circumstances:
CO,
LA,
OK,
NC

2
-­‐
If
prescriber
believes
pa?ent
wants
prescrip?on
for
non-­‐medical
purpose:
NV,
DE

6
-­‐
Upon
the
ini?a?on
of
designated
circumstances,
such
as
ini?al
prescribing
or
dispensing
of
specified
substances,
and
periodically
thereaser:
KY,
NM,
NY,
OH,
TN,
WV

1
-­‐
Department
of
Health
to
promulgate
regula?ons
outlining
when
prescribers
have
to
use
the
PMP
prior
to
seeing
a
new
pa?ent:
MA

57. InformaAon
Tools
Cont…
• Proac?ve
or
unsolicited
alerts/reports
 42
states:
AL,
AK,
AZ,
AR,
CA,
CT,
DE,
FL,
HI,
ID,
IL,
IN,
KS,
KY,
LA,
ME,
MA,
MI,
MS,
MT,
NV,
NH,
NJ,
NM,
NY,
NC,
ND,
OH,
OK,
PA,
RI,
SC,
SD,
TN,
TX,
UT,
VT,
VA,
WA,
WV,
WI,
WY
• Interstate
sharing
 Other
state
PMPs
–
20
states:
AL,
AR,
DE,
HI,
IL,
KS,
ME,
MD,
MA,
MS,
MT,
NV,
NH,
NC,
OR,
RI,
SD,
UT,
VA,
WI
 Authorized
users
in
other
states
–
8
states:
AK,
CA,
CO,
ID,
IA,
MN,
TX,
WY
 Both
–
15
states:
AZ,
CT,
IN,
KY,
LA,
MI,
NJ,
NM,
NY,
ND,
OH,
SC,
TN,
WA,
WV

58. State
RegulaAon
of
Pain
Clinics
• 8
states
as
of
12/31/2012
have
adopted
pain
clinic
regula?on
acts:
FL,
KY,
LA,
MS,
OH,
TN,
TX,
WV
• 14
common
components
• Defini?on
of
“pain
clinic”
 Publically
or
privately
owned
facility
 Majority
of
pa?ents
on
a
monthly
basis
prescribed
or
dispensed
specified
substances
as
part
of
treatment
for
pain

59. State
RegulaAon
Cont…
• Registra?on,
cer?fica?on
or
licensure
 Exemp?ons:
long-­‐term
care,
nursing
homes,
hospice
facili?es,
state
operated
facili?es
• Clinic
owners
must
hold
certain
licenses/board
cer?fica?ons
 Physician
with
unrestricted
license
to
prac?ce
 Board
cer?fica?on
by
American
Board
of
Pain
Medicine
or
American
Board
of
Interven?onal
Pain
Physicians
 Subspecialty
in
pain
management,
hospice
or
pallia?ve
care
 Comple?on
of
residency
or
fellowship
in
pain
medicine

60. State
RegulaAon
Cont…
• Restric?ons
on
prescribing
or
dispensing
controlled
substances
 Louisiana
–
limits
prescrip?ons
to
non-­‐refillable
30
day
supply
 Florida
–
document
reason
for
prescribing
more
than
72
hour
dose
of
controlled
substances
for
treatment
of
pain
 West
Virginia
–
limits
dispensing
of
controlled
substances
to
72
hour
supply

61. State
RegulaAon
Cont…
• Requirement
to
access
a
state’s
PMP
• Enforcement
experience
 Reduc?on
of
“pill
mills”
 Unintended
consequences
–
some
claims
that
legi?mate
pa?ents
having
difficulty
accessing
pain
medica?ons
 Some
“pill
mill”
operators
re-­‐labeled
themselves
as
wellness
clinics
or
weight
loss
centers

62. Prescribing
of
Controlled
Substances
for
the
Treatment
of
Non-­‐Cancer
Pain
• Policies,
guidelines,
rules,
strategies,
and
guides
 Federa?on
of
State
Medical
Boards
 Utah
Department
of
Health
 Journal
of
Pain
 Washington
State
 American
Society
of
Interven?onal
Pain
Physicians
 U.S.
Food
and
Drug
Administra?on
(FDA)
 Dr.
Scor
Fishman
–
“Responsible
Opioid
Prescribing:
A
Physician’s
Guide”

63. Prescribing
Cont…
• 7
commonly
recommended
prescribing
prac?ces
• Educa?on
on
designated
topics:
pain
management,
prescribing
of
controlled
substances,
addic?on
and
addic?on
treatment,
use
of
the
state’s
PMP
 Statute
or
regula?on
-­‐
14
states:
AR,
CA,
FL,
GA,
KY,
MA,
MI,
NM,
OH,
OR,
TN,
TX,
UT,
WA
 Medical
board
policy
-­‐
4
states:
MI,
MN,
MT,
VA

64. Prescribing
Cont…
• Physical
exam
and/or
screening
for
substance
abuse
and
addic?on
 Statute
or
regula?on
-­‐
25
states
+
D.C.:
AL,
AR,
DE,
DC,
FL,
GA,
IA,
KY,
LA,
ME,
MN,
MS,
NV,
NH,
NJ,
NM,
OH,
OK,
OR,
RI,
TN,
TX,
UT,
VA,
WA,
WV
 Medical
board
policy
-­‐
39
states:
AL,
AZ,
CA,
CO,
CT,
DE,
FL,
GA,
HI,
ID,
IA,
KS,
KY,
ME,
MD,
MA,
MI,
MN,
MS,
MO,
MT,
NE,
NV,
NH,
NM,
NC,
OH,
OK,
OR,
PA,
RI,
SC,
SD,
UT,
VA,
WA,
WV,
WI,
WY

65. Prescribing
Cont…
• Treatment
plan,
including
informed
consent,
with
periodic
review;
treatment
agreement
with
provider/
pa?ent
responsibili?es
 Statute
or
regula?on
-­‐
25
states
+
D.C.:
AL,
AR,
DE,
DC,
FL,
GA,
IA,
KY,
LA,
ME,
MN,
MS,
NV,
NH,
NJ,
NM,
OH,
OK,
OR,
RI,
TN,
TX,
UT,
VA,
WA,
WV
 Medical
board
policy
-­‐
41
states:
AL,
AZ,
AR,
CA,
CO,
CT,
DE,
FL,
GA,
HI,
ID,
IA,
KS,
KY,
ME,
MD,
MA,
MI,
MN,
MS,
MO,
MT,
NE,
NV,
NH,
NM,
NY,
NC,
OH,
OK,
OR,
PA,
RI,
SC,
SD,
UT,
VA,
WA,
WV,
WI,
WY

66. Prescribing
Cont…
• Use
of
the
state
PMP
 Statute
or
regula?on
-­‐
5
states:
KY,
LA,
NM,
TN,
WV
 Medical
board
policy
-­‐
2
states:
NC,
WA
• Referral
to
specialists
for
addi?onal
evalua?on
and
treatment,
or
steps
to
take
for
suspected
abuse
or
diversion
 Statute
or
regula?on
-­‐
22
states
+
D.C.:
AL,
CA,
DE,
DC,
FL,
GA,
IA,
KY,
LA,
ME,
MS,
NE,
NH,
NJ,
NM,
OH,
OK,
OR,
TN,
TX,
UT,
VA,
WA
 Medical
board
policy
-­‐
38
states:
AL,
AZ,
CA,
CO,
CT,
DE,
FL,
HI,
ID,
IA,
KS,
KY,
ME,
MD,
MA,
MI,
MN,
MS,
MO,
MT,
NE,
NV,
NH,
NM,
NC,
OH,
OK,
OR,
PA,
RI,
SC,
SD,
UT,
VA,
WA,
WV,
WI,
WY

67. Prescribing
Cont…
• Restric?ons
on
Schedule
II
controlled
substances,
including
opioids
 Statute
or
regula?on
-­‐
45
states
+
D.C.:
AL,
AZ,
AR,
CA,
DE,
DC,
FL,
GA,
ID,
IL,
IN,
IA,
KS,
KY,
LA,
MD,
MA,
MI,
MN,
MS,
MO,
MT,
NE,
NV,
NH,
NJ,
NM,
NY,
NC,
ND,
OH,
OK,
OR,
PA,
RI,
SC,
SD,
TN,
TX,
UT,
VT,
VA,
WA,
WV,
WI,
WY
 Medical
board
policy:
2
states
–
UT,
WA

68. Prescribing
Cont…
• Complete
and
accurate
medical
records
 Statute
or
regula?on
-­‐
27
states
+
D.C.:
AL,
AR,
CA,
DE,
DC,
FL,
GA,
IA,
KY,
LA,
ME,
MS,
MO,
NV,
NH,
NJ,
NM,
ND,
OH,
OK,
OR,
RI,
TN,
TX,
UT,
VA,
WA,
WV
 Medical
board
policy
-­‐
41
states:
AL,
AZ,
AR,
CA,
CO,
CT,
DE,
FL,
GA,
HI,
ID,
IA,
KS,
KY,
ME,
MD,
MA,
MI,
MN,
MS,
MO,
MT,
NE,
NV,
NH,
NM,
NY,
NC,
OH,
OK,
OR,
PA,
RI,
SC,
SD,
UT,
VA,
WA,
WV,
WI,
WY

69. Prescribing
Cont…
• Implementa?on
of
recommended
prac?ces
–
facilita?on
of
the
use
of
legi?mate
pain
management
prac?ces
 Integrated,
interdisciplinary
approach
that
promotes
referrals
to
specialists
and
the
use
of
alterna?ves
and
adjuncts
to
controlled
substances
 Use
of
opioids
for
chronic
pain
must
be
associated
with
documented
func?onal
outcomes

70. Prescribing
Cont…
 Restric?ons
on
dispensing
by
prescribers
 Support
in
payment
systems
for
referrals
to
specialists,
including
qualified
pain
management
and
addic?on
treatment
professionals.
e.g.,
reimbursement
for
psychological/psychiatric
evalua?ons
for
high
risk
pa?ents
 Mandated
referral
to
a
pain
management
specialist
if
the
pa?ent
is
receiving
a
certain
dosage
of
opioids

71. NAMSDL
CONTACT
INFORMATION
Sherry
L.
Green
WEBSITE:
www.namsdl.org
Chief
Execu?ve
Officer
Sarah
Kelsey
NAMSDL
Headquarters
Office
Legisla?ve
Arorney
215
Lincoln
Ave.,
Suite
201
NAMSDL
Santa
Fe,
NM
87501
1598
Gray
Fox
Trail
Phone:
703-­‐836-­‐7496
Charloresville,
VA
22901
Cell:
703-­‐801-­‐8350
Phone:
703-­‐836-­‐6100,
Fax:
505-­‐820-­‐1750
Ext.
119
Email:
sgreen@namsdl.org
Email:
skelsey@namsdl.org
Heather
Gray
Research
Arorney
Kevin
Smith
NAMSDL
Government
Affairs
Coordinator
9841
Cedar
Glade
NAMSDL
Memphis,
TN
38016
113
Manchester
Ave.
Phone:
703-­‐836-­‐6100,
Earlville,
IA
52041
ext.
114
Phone:
703-­‐836-­‐6100,
Email:
hgray@namsdl.org
Ext.
118
Cell:
563-­‐929-­‐0519
Email:
ksmith@namsdl.org