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1. Law
Enforcement
Track:
Rx
Drug
Inves9ga9ons
in
the
21st
Century
Presenter:
Joseph
T.
Rannazzisi,
JD,
RPh,
Deputy
Assistant
Administrator,
Office
of
Diversion
Control,
United
States
Drug
Enforcement
AdministraEon
(DEA)
Moderator:
Dan
Smoot,
CEO,
OperaEon
UNITE
2. I
have
no
financial
rela.onships
to
disclose
and
I
will
not
discuss
off-‐label
use
and/or
inves.ga.onal
drug
use
in
my
presenta.on
Disclosure Statement
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
3. Examine
reasons
for
the
increasing
rate
of
diversion
and
abuse
of
prescrip.on
narco.cs
Evaluate
effec.ve
strategies
for
drug
diversion
inves.ga.ons
Describe
the
opportuni.es
for
law
enforcement
agencies
to
collaborate
with
regulatory
agencies
during
drug
diversion
inves.ga.ons
Goals and Objectives
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
4. Responding to America’s
Prescription Drug Abuse Crisis
“When Two Addictions Collide”
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
6. In
2010,
approximately
38,329
uninten9onal
drug
overdose
deaths
occurred
in
the
United
States,
one
death
every
14
minutes.
Of
this
number,
22,134
of
these
deaths
were
aNributed
to
Prescrip9on
Drugs
(16,651
aNributed
to
opioid
overdoses/
75.2
%).
Prescrip9on
drug
abuse
is
the
fastest
growing
drug
problem
in
the
United
States.
Source: CDC Drug Overdose Deaths in the United States, 2010 (October 2012)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Consequences
7. U.S. Drug Overdose Deaths
by Major Drug Type, 1999-2010
Source: CDC/NCHS, NVSS
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
8. Drug-Induced Deaths vs.
Other Injury Deaths, 1999–2009
Source: National Center for Health Statistics, Centers for Disease Control and Prevention.
National Vital Statistics Reports Deaths: Final Data for the years 1999 to 2009 (January 2012).
Causes
of
death
aGributable
to
drugs
include
accidental
or
inten.onal
poisonings
by
drugs
and
deaths
from
medical
condi.ons
resul.ng
from
chronic
drug
use.
Drug-‐induced
causes
exclude
accidents,
homicides,
and
other
causes
indirectly
related
to
drug
use.
Not
all
injury
cause
categories
are
mutually
exclusive.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
10. Prescription Drug Abuse
More Americans abuse prescription drugs
than the number of:
Cocaine, Hallucinogen, Heroin, and Inhalant abusers
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
11. Scope and Extent of Problem:
Past Month Illicit Drug Use among Persons
Aged 12 or Older
Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012 National Survey on Drug Use and HealthU.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
12. Source: 2011 National Survey on
Drug Use and Health
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Percentage of Past Month Nonmedical Use
of Psychotherapeutics by Age, 2003-2011
13. SOURCE: 2012 National Survey on Drug Use and
Health (NSDUH) published September 2013 by the
Dept of HHS/ Substance Abuse and Mental Health
Services Administration (SAMHSA)
Past Year Initiates 2012 –
Ages 12 and Older
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
14. Emergency Room Data 2004-2010
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN)
Findings on Drug-Related Emergency Department Visits, December 28, 2010
15. SOURCE: 2012 National Survey on
Drug Use and Health (NSDUH)
published September 2013 by the
Dept of HHS/ Substance Abuse and
Mental Health Services Administration
(SAMHSA)
Substances for Which Most Recent
Treatment Was Received in the Past Year
among Persons Aged 12 or Older: 2012
16. SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published
September 03, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services
Administration (SAMHSA)
Substances for Which Most Recent
Treatment Was Received in the Past Year
among Persons Aged 12 or Older: 2002-2012
17. Number of Forensic Cases
2001-2011
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
240%
257%
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
322%
19. Drug Overdose Mortality Rates
per 100,000 People 1999
Source: Trust for America’s Health,
www.healthyamericans.org. “Prescription Drug Abuse:
Strategies to Stop the Epidemic (2013)”
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
20. Source: Trust for America’s Health,
www.healthyamericans.org. “Prescription Drug Abuse:
Strategies to Stop the Epidemic (2013)”
Drug Overdose Mortality Rates
per 100,000 People 2010
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
21. Most severe in Southwest and Appalachian
In 2010, the top three states were West Virginia,
New Mexico, and Kentucky;
West Virginia: 28.9 deaths per 100,000
New Mexico: 23.8 deaths per 100,000
Kentucky: 23.6 deaths per 100,000
Lowest-North Dakota: 3.4 deaths per 100,000
Minnesota ranked 47th 7.3 deaths per 100,000
Where Prescription Painkiller Overdose
Deaths Are The Highest
SOURCE: Trust for America’s Heath-Prescription Drug
Abuse: Strategies To Stop
The Epidemic; October 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
22. Naloxone
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
23. Source:
U.S.
Census
Bureau
Statistical Perspective
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
24. Why is the problem outpacing
population growth?
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
26. In Florida
two
Westchase
teachers
learn a
lesson:
Say 'no' to
mints in pill
bottles
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
The
drug
boGles
were
made
more
realis.c
with
labels
that
read
in
part:
“Watson’s
Whiz
Kid
Pharmacy.
Take
1
tablet
by
mouth
EVERY
5
MINUTES
to
cure
FCAT
jiGers.
Repeated
use
may
cause
crah
to
spontaneously
ooze
from
pores.
No
refills.
Ms.
Falcon’s
authoriza.on
required.”
28. Source: DEA Drug Theft & Loss Database as of 03/18/2014
Pharmacy Armed Robberies
Rankings by State
January 1 thru December 31, 2011 (691)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
29. Pharmacy Armed Robberies
Rankings by State
January 1 thru December 31, 2012 (780)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Source: DEA Drug Theft & Loss Database as of 03/18/2014
30. Source: DEA Drug Theft & Loss Database as of 03/18/2014
Pharmacy Armed Robberies
Rankings by State
January 1 thru December 31, 2013 (692)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
32. Violence Related to Controlled
Substance Pharmaceuticals
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
33. Eyewitness
News
MEDFORD
(WABC)
-‐-‐
The
suspect
in
the
Father's
Day
massacre
at
a
Long
Island
pharmacy
pleaded
guilty
to
murder
charges
Thursday.
David
Laffer
has
officially
withdrawn
his
not
guilty
pleas
to
charges
of
first-‐degree
murder
and
criminal
use
of
a
firearm
and
waived
his
right
to
appeal.
Laffer
killed
four
people
at
Haven
Drugs
in
Medford
before
robbing
the
place
of
10,000
hydrocodone
pills.
Laffer's
wife,
Melinda
Brady,
also
pleaded
guilty
to
robbery
charges.
The
judge
announced
his
inten.on
to
sentence
Laffer
to
the
maximum
of
four
life
sentences
with
no
parole,
to
be
served
consecu.vely,
and
Brady
to
21
to
25
years
in
state
prison.
Formal
sentencing
for
both
husband
and
wife
is
scheduled
for
October
17.
Laffer
and
Brady
were
arrested
June
22
in
their
suburban
home
a
mile
and
a
half
from
Haven
Drugs,
where
authori.es
say
he
opened
fire
on
the
vic.ms
before
jamming
the
backpack
full
of
prescrip.on
painkillers.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Couple pleads guilty in
pharmacy murders
35. 2 killed, 2 wounded in pharmacy shooting; ex-Bean Station officer to be
charged
By News Sentinel staff Knoxville News Sentinel
Posted May 23, 2013 at 12:28 p.m., updated May 23, 2013 at 9:52 p.m.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
46. Community
Coali.ons
and
Advocacy
Groups
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
47. Education
Pharmacists
Drug
Experts
in
the
health
care
delivery
system
Corresponding
responsibility
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
48. Scheduled
PDACs
16-‐Knoxville,
TN
March
22-‐23,
2014
17-‐St.
Louis,
MO
April
5-‐6,
2014
18-‐Phoenix,
AZ
June
28-‐29,
2014
19-‐Philadelphia,
PA
July
12-‐13,
2014
20-‐Denver,
CO
Aug
2-‐3,
2014
21-‐Salt
Lake
City,
UT
Aug
23-‐24,
2014
FL
2
WA
UT
OR
CA
NV
ID
MT
AZ
WY
CO
NM
ND
SD
TX
4
NE
KS
OK
MN
IA
MO
AR
LA
MI
WI
IL
IN
6
KY
TN
MS AL GA
3
OH
1
WV
VA
NC
SC
PA
NY
5
MA
ME
DC
MD
NJ
CT
RI
DE
NH
VT
12
B
12A
18
21 20
7
11
10
17
9
14
8
16 15
13
19
Completed PDACs
Scheduled PDACs
February
11,
2014
Completed
PDACs
AGendance
1-‐Cincinna.,
OH
9/17-‐18/11
75
2-‐WPB,
FL
3/17-‐18/12
1,192
3-‐Atlanta,
GA
6/2-‐3/12
328
4-‐Houston,
TX
9/8-‐9/12
518
5-‐Long
Island,
NY
9/15-‐16/12
391
6-‐Indianapolis,
IN
12/8-‐9/12
137
7-‐Albuquerque,
NM
3/2-‐3/13
284
8-‐Detroit,
MI
5/4-‐5/13
643
9-‐Chicago,
IL
6/22-‐23/13
321
10-‐Portland,
OR
7/13-‐14/13
242
11-‐Baton
Rouge,
LA
8/3-‐4/13
259
12A-‐San
Diego,
CA
8/16-‐17/13
353
12B-‐San
Jose,
CA
8/18-‐19/13
434
13-‐Boston,
MA
9/21-‐22/13
275
14-‐Louisville,
KY
11/16-‐17/13
149
15-‐CharloGe,
NC
2/8-‐9/14
513
Total
AGendance
6,114
50. Most Frequent Method of
Obtaining a Pharmaceutical
Controlled Substance for Non-
Medical Use
Friends and Family…For
Free!! U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
51. SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 3, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services
Administration (SAMHSA)
Source Where Pain Relievers Were Obtained
for Most Recent Nonmedical Use Among Past
Year Users Aged 12 or Older: 2011-2012
53. Medicine Cabinets: Easy Access
More than half of teens (56%) indicate that it’s easy to get
prescription drugs from their parent’s medicine cabinet
Half of parents (495) say anyone can access their medicine
cabinet
More than four in 10 teens (42%) who have misused or
abused a prescription drug obtained it from their parent’s
medicine cabinet
Almost half (49%) of teens who misuse or abuse prescription
medicines obtained them from a friend
Source: 2012 Partnership Attitude Tracking Study,
published 4/23/13
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
54. So Many Drugs in the
Household – Why?
Unreasonable quantities being
prescribed
Insurance rules
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
55. Law Enforcement
Law
enforcement
officers,
ac9ng
to
enforce
laws
regarding
the
abandonment
of
controlled
substances,
may
receive
controlled
substances
from
ul9mate
users.
Law
enforcement
must
safeguard
the
controlled
substances
and
ensure
that
they
are
destroyed
properly.
Law
enforcement
must
be
present
during
the
destruc9on
of
the
controlled
substances.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
56. April
26,
2014
National Take Back Initiative
April 26, 2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
10:00
AM
–
2:00
PM
57. On September 30, 2010, approximately 122 tons
On April 30, 2011, approximately188 tons
On October 29, 2011, approximately 189 tons
On April 28, 2012, approximately 276 tons
On September 29, 2012, approximately 244 tons
On April 27, 2013, approximately 376 tons
On October 26 , 2013, approximately 324 tons
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
58. National Take Back Day: October 26, 2013
Total Weight Collected (pounds): 647,211 (324 Tons)
8,153
10,880
5,527
10,030
17,077
MA
2,171
RI
4,603
CT
16,520
3,430
VT
5,343
NH
811
PR
&
VI
33,761
22,000
215
38,506
10,402
46,565
936
18,433
1,195
1,251
4,461
11,380
23,678
9,171
3,215
72,886
1,777
2,580
HI
&
GU
16,950
14,841
NJ
2,541
18,008
1,420
4,123
41,501
38,493
10,303
14,508
5,766
4,587
2,763
19,901
7,004
9,737
6,194
908
20,072
4,977
9,425
MD
974
DC
5,258
DE
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
67. Most commonly prescribed prescription
medicine?
Hydrocodone/acetaminophen
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
68. Top Five Prescription Drugs Sold in the U.S.
(2008-2011)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Source:
IMS
Health,
Na.onal
Prescrip.on
Audit,
Updated
02/24/14
Millions
of
Prescrip.ons
69. State Ranking* - Hydrocodone
January – September 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and Analysis Unit
Most current ARCOS information as of March 18, 2014
70. Approval of Single Entity
Extended Release Hydrocodone
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
71. Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and Analysis Unit
Most current ARCOS information as of March 18, 2014
State Ranking* - Oxycodone
January – December 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
75. Opana ER (Schedule II)
Opana
ER
-‐
(Schedule
II)
– Treats
constant,
around
the
clock,
moderate
to
severe
pain
– Becoming
popular
and
is
abused
in
similar
fashion
to
oxycodone
;
August
2010
(Los
Angeles
FD
TDS)
– Slang:
Blues,
Mrs.
O,
Octagons,
Stop
Signs,
Panda
Bears
– Street:
$10.00
–
$80.00
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
76. Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and Analysis Unit
Most current ARCOS information as of March 18, 2014
State Ranking* - Oxymorphone
January – December 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
78. Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and Analysis Unit
Most current ARCOS information as of March 18, 2014
State Ranking* - Hydromorphone
January – December 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
80. Circle of Addiction & the Next Generation
Hydrocodone
Lorcet®
$5-‐$7/tab
Oxycodone
Combina.ons
Percocet®
$7-‐$10/tab
OxyCon9n®
$80/tab
Heroin
$10/bag
Roxicodone®
Oxycodone
IR
15mg,
30mg
$30-‐$40/tab
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
81. HEROIN CASES and EXHIBITS
National Forensic Laboratory Information System
Year
#
Exhibits
#
Cases
2004
69,467
60,851
2005
73,569
64,471
2006
83,945
72,351
2007
82,408
69,850
2008
94,229
79,366
2009
107,272
87,249
2010
104,676
84,170
2011
109,049
86,513
2012
127,568
101,512
2013:
Jan
–
Jun
69,574
55,325
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
82. Heroin
trafficking
organiza.ons
reloca.ng
to
areas
where
prescrip.on
drug
abuse
is
on
the
rise
Heroin
traffickers
pave
the
way
for
increasing
crime
and
violence
Law
enforcement
and
prosecutors
eventually
figh.ng
the
problem
on
two
fronts
(prescrip.on
opiate
diversion
and
heroin
distribu.on)
further
deple.ng
resources
Communi.es
suffer
Community Impact?
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
83. Where are the
Pharmaceuticals Coming
From?
Friends
and
Family
for
Free
Medicine
Cabinet
Doctor
Shopping
Internet
Pain
Clinics
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
84. Methods of Diversion
Practitioners / Pharmacists
– Illegal distribution
– Self abuse
– Trading drugs for sex
Employee pilferage
– Hospitals
– Practitioners’ offices
– Nursing homes
– Retail pharmacies
– Manufacturing / distribution
facilities
Pharmacy / Other Theft
– Armed robbery
– Burglary (Night Break-ins)
– In Transit Loss (Hijacking)
– Smurfing
Patients / Drug Seekers
– Drug rings
– Doctor-shopping
– Forged / fraudulent / altered
prescriptions
The medicine cabinet / obituaries
The Internet
Pain Clinics
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
86. Questions to Discuss
What
combina.on
of
drugs
is
referred
to
as
the
“trinity”?
A)
Hydrocodone,
alprazolam,
and
carisoprodol
B)
Promethazine
with
codeine,
methylphenidate
and
carisoprodol
C)
Hydromorphone,
carisoprodol
and
buprenorphine
D)
Methadone,
diazepam
and
tramadol
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
95. WA
OR
ID
WY
ND
SD
MN
NE
WI
MI
CO
KS MO
IL IN
UT
NV
CA
AZ NM
OK
AR
LA
TN
KY
MS AL GA
SC
NC
OH
VA
PA
NY
ME
V
T N
H
CT
DE
WV
RI
MD
MA
Domestic ‘Rx’ Flow
MTMT
FL
TX TX
2. Request goes
through Website
Server in
San Antonio, TX
WS
FL
IAIA NJ
1. Consumer in Montana
orders hydrocodone
on the Internet
C
3. Web Company
(located in Miami, FL)
adds request to queue
for Physician approval
WC
4. Order is
approved by
Physician in
New Jersey
and returned
to Web
Company
Dr.
S
6. Pharmacy in Iowa
fills order and ships to
Consumer via Shipper
Rx
5. Approved
order
then sent by
Web
Company
to an
affiliated
Pharmacy
96. New Felony Offense Internet
Trafficking - 10/15/2008
21 USC 841(h)(1): It shall be unlawful for any
person to knowingly or intentionally:
(A) deliver, distribute, or dispense a controlled
substance by means of the Internet, except as
authorized by this title; or
(B) aid or abet any violation in (A)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
97. Per Se Violations
No in-person medical evaluation by
prescribing practitioner
Online pharmacy not properly registered
with modified registration.
Website fails to display required information
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
100. Explosion of South Florida
Pain Clinics
As
of
June
4,
2010,
Florida
has
received
1,118
applica.ons
and
has
approved
1026
*As
of
May
14,
2010,
Broward
142;
Miami-‐Dade
79;
Palm
Beach
111
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
101. Hydrocodone Oxycodone
2002 9,376 8,288
2003 12,130 9,715
2004 16,401 13,492
2005 21,190 14,643
2006 24,984 17,927
2007 30,637 22,425
2008 33,731 28,756
2009 38,084 38,332
2010 39,444 48,210
2011 37,483 46,906
2012 35,140 42,869
2013* 26,844 31,897
NFLIS – Federal, State, and local cases reported
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
NFLIS
Query
Date:
02/24/14
104. Medical Care ?
Many
of
these
clinics
are
prescrip.on/
dispensing
mills
Minimal
prac..oner/pa.ent
interac.on
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
116. Drugs Prescribed
A
‘cocktail’
of
oxycodone
and
alprazolam
(Xanax)
An
average
‘pa.ent’
receives
prescrip.ons
or
medica.ons
in
combina.on
Schedule
II
Schedule
III
Schedule
IV
Oxycodone
15mg,
30mg
Vicodin
(Hydrocodone)
Xanax
(Alprazolam)
Roxicodone
15mg,
30mg
Lorcet
Valium
(Diazepam)
Percocet
Lortab
Percodan
Tylenol
#3
(codeine)
Demerol
Tylenol
#4
(codeine)
Methadone
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
117. Average Charges for a Clinic Visit
Price varies if medication is dispensed or if customers
receive prescriptions
Some clinics advertise in alternative newspapers
citing discounts for new patients such as 'buy one get
one free‘ or “50% off with this ad”
Typically, initial office visit is $250 or more; each
subsequent visit may exceed $200
Prescriptions average 120-180 30mg oxycodone
tablets per visit
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
118. Cost of Drugs
According
to
medical
experts,
most
clinics
do
not
require
sufficient
medical
history
and
tests
for
proper
prescribing
of
Schedule
II
substances
Oxycodone
30mg
immediate
release
tablets
cost
approximately
$30.00
to
$40.00
per
tablet
on
the
street
depending
on
the
sale
loca.on
in
the
U.S.
($1
per
mg
or
more)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
148. Foreign Mfr
Importer Manufacturer
Distri-
butor
Practitioner
Pharmacy
Hospital
Clinic
Patient
?
Law:
21
USC
822
(a)
(1)
Persons
Required
to
Register:
“Every
person
who
manufactures
or
distributes
any
Controlled
Substance
or
List
I
Chemical
or
who
proposes
to
engage
in
..”
Law:
21
USC
822
(a)
(2)
Persons
Required
to
Register:
“Every
person
who
dispenses,
or
who
proposes
to
dispense
any
controlled
substance
...”
153. WA
OR
ID
WY
ND
SD
MN
NE
WI
MI
CO
KS MO
IL IN
UT
NV
CA
AZ NM
OK
AR
LA
TN
KY
MS AL GA
SC
NC
OH
VA
PA
NY
ME
V
T N
H
CT
DE
WV
RI
MD
MA
Domestic ‘Rx’ Flow
MTMT
FL
TX TX
2. Request goes
through Website
Server in
San Antonio, TX
WS
FL
IAIA NJ
1. Consumer in Montana
orders hydrocodone
on the Internet
C
3. Web Company
(located in Miami, FL)
adds request to queue
for Physician approval
WC
4. Order is
approved by
Physician in
New Jersey
and returned
to Web
Company
Dr.
S
6. Pharmacy in Iowa
fills order and ships to
Consumer via Shipper
Rx
5. Approved
order
then sent by
Web
Company
to an
affiliated
Pharmacy
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
154. Purchases of hydrocodone by Known and Suspected
Rogue Internet Pharmacies
January 1, 2006 – December 31, 2006
Date
Prepared:
03/07/2007
Source:
ARCOS
98,566,711
155. Checks and Balances of the CSA
and the Regulatory Scheme
Distributors of controlled substances
“The registrant shall design and operate a system to
disclose to the registrant suspicious orders of
controlled substances…Suspicious orders include
orders of unusual size, orders deviating
substantially from a normal pattern, and orders of
unusual frequency.” (21 CFR §1301.74)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
156. DEA
Distributor
Ini9a9ve
Purpose and format:
Educate and inform distributors/manufacturers of their due diligence
responsibilities under the CSA by discussing their Suspicious Order Monitoring
System, reviewing their ARCOS data for sales and purchases of Schedules II and
III controlled substances, and discussing national trends involving the abuse of
prescription controlled substances
August 2005 – Present:
Briefings to 83 firms with 276 locations
Examples of civil action against distributors:
Cardinal Health , $34 million civil fine
McKesson, $13.25 million civil fine
Harvard, $6 million civil fine
Examples of suspension, surrender or revocation of DEA registration
Keysource, loss of DEA registration
Sunrise, loss of DEA registration U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
157. Source:
www.kuow.org
,
01/30/2014
John Gray, president and CEO of
Healthcare Distribution
Management Association, said
suppliers used to have a more
cooperative and collaborative
relationship with the Drug
Enforcement Agency. But things
have changed, he said. “It’s all
been dumped in our laps as
wholesalers to make what I
would consider to be law
enforcement decisions as to
whether or not a particular
customer or account is or is not
over what the DEA, in their own
mind, thinks is a viable limit for
Schedule II drugs they ought to
be dispensing,” Gray said.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
158.
159. “At
the
.me
we
filled
these
orders,
the
pharmacies
held
valid
state
board
of
pharmacy
and
DEA
licenses,”
BarreG
said
in
a
call
to
investors
on
Friday.
“Pharmaceu.cal
distributors
do
not
influence
the
manufacture
of
controlled
medicines.
We
do
not
write
prescrip.ons.
We
do
not
dispense
controlled
medicines,
nor
do
we
license
pharmacies.
Our
role
is,
as
a
distributor,
a
cri.cal
link
in
the
supply
chain
between
pharmaceu.cal
manufacturers
and
pharmacies.
“
Cardinal
CEO
George
BarreG
The
Company
called
the
DEA
ac.on
“a
dras.c
overreac.on”
that
would
disrupt
delivery
of
cri.cal
medica.ons
to
hospitals
and
pharmacies.
160. Misleading
Title?
Sponsored
by
Reps
from
TN,
PA,
CO,
and
GA
This
bill
effec.vely
eliminates
the
DEA’s
administra.ve
powers
of
the
OTSC
and
ISO
op.ons,
and
instead
requires
DEA
to
give
no.ce
and
offer
the
registrant
an
opportunity
to
submit
a
correc.ve
ac.on
plan.
An
ISO
is
issued
to
protect
the
public
from
imminent
harm.
By
redefining
an
ISO
and
delaying
it’s
issuance,
the
bill
would
prevent
the
DEA
from
protec.ng
the
public
when
harm
is
imminent.
DEA
conducts
more
5,000
inspec.ons
on
registrants
yearly
and
takes
administra.ve
ac.on
on
a
very
small
percentage
of
those
registrants
inspected.
161. DEA Imposed Quotas on Wholesalers/
Distributors of Controlled Substances to
downstream customers?
NO!
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
162. Checks and Balances
Under the CSA
• Practitioners
“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 professional practice.” (21 CFR §1306.04
(a))
United States v Moore 423 US 122 (1975)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
163. The Controlled Substances Act
Illegal Distribution
21 U.S.C. § 841 (a) Unlawful acts:
Except as authorized by this subchapter, it shall be
unlawful for any person to knowingly or
intentionally
(1) to manufacture, distribute or dispense, or
possess with intent to manufacture, distribute or
dispense, a controlled substance; or
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
164. The Last Line of Defense
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
165. Checks and Balances
Under the CSA
Pharmacists – The Last Line of Defense
“The responsibility for the proper prescribing and
dispensing of controlled substances is upon the
practitioner, but a corresponding responsibility rests
with the pharmacist who fills the prescription.”
(21 CFR §1306.04(a))
U.S v. Hayes 595 F. 2d 258 (5th Cir 1979)
U.S. v. Leal 75 F. 3d 219 (6th Cir 1996)
U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010)
East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27,
2010)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
166. Checks and Balances Under the CSA
Pharmacists – The Last Line of Defense
“An order purporting to be a prescription issued not in the
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 USC 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.” (21
CFR §1306.04(a))
U.S v. Hayes 595 F. 2d 258 (5th Cir 1979)
U.S. v. Leal 75 F. 3d 219 (6th Cir 1996)
U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010)
East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
167. When
prescrip.ons
are
clearly
not
issued
for
legi.mate
medical
purposes,
a
pharmacist
may
not
inten.onally
close
his
eyes
and
thereby
avoid
[actual]
knowledge
of
the
real
purpose
of
the
prescrip.ons.
(Ralph
J.
Bertolino,
55
FR
4729,
4730
(1990)),
169. What
happens
next?
You
aGempt
to
resolve…
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
170. Resolution is comprised of many
factors
Verifica.on
of
a
valid
prac..oner
DEA
number
is
required!
It
is
not,
however,
the
end
of
the
pharmacists
duty.
Invalid
RX
Resolu.on
cannot
be
based
solely
on
pa.ent
ID
and
prescriber
verifica.on.
You
must
use
your
professional
judgment,
training
and
experience…we
all
make
mistakes
Knowledge
and
history
with
the
pa.ent
Circumstances
of
prescrip.on
presenta.on
Experience
with
the
prescribing
prac..oner
It
does
not
require
a
call
to
the
prac..oner
for
every
CS
RX
This
is
not
an
all-‐inclusive
list…
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
171. Many
customers
receiving
the
same
combina.on
of
prescrip.ons;
cocktail
Many
customers
receiving
the
same
strength
of
controlled
substances;
no
individualized
dosing:
mul.ple
prescrip.ons
for
the
strongest
dose
Many
customers
paying
cash
for
their
prescrip.ons
Early
refills
Many
customers
with
the
same
diagnosis
codes
wriGen
on
their
prescrip.ons;
Individuals
driving
long
distances
to
visit
physicians
and/or
to
fill
prescrip.ons;
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
172. Customers
coming
into
the
pharmacy
in
groups,
each
with
the
same
prescrip.ons
issued
by
the
same
physician;
and
Customers
with
prescrip.ons
for
controlled
substances
wriGen
by
physicians
not
associated
with
pain
management
(i.e.,
pediatricians,
gynecologists,
ophthalmologists,
etc.).
Overwhelming
propor.on
of
prescrip.ons
filled
by
pharmacy
are
controlled
substances
Pharmacist
did
not
reach
out
to
other
pharmacists
to
determine
why
they
were
not
filling
a
par.cular
doctors
prescrip.on
Verifica.on
of
legi.macy
not
sa.sfied
by
a
call
to
the
doctors
office
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
173. AMA View on Corresponding
Responsibility
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Inquiries
by
pharmacists
with
doctors
regarding
the
ra.onale
behind
prescrip.ons,
diagnoses
and
treatment
plans
are
inappropriate.
These
inquiries
are
“an
interference
with
the
prac.ce
of
medicine
and
unwarranted”.
175. Purchases of Oxycodone 30mg
In
2009,
44%
of
all
oxycodone
30mg
products
were
distributed
to
Florida
In
2010,
43%
of
all
oxycodone
30mg
products
were
distributed
to
Florida
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
176. Remaining
States
593,625,290
dosage
units
Florida
94,923,484
dosage
units
Source:
ARCOS
Date
Prepared:
01/30/2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
177. Florida
94,923,484
dosage
units
New
York
50,658,100
dosage
units
Remaining
States
486,977,390
dosage
units
California
55,989,800
dosage
units
Source:
ARCOS
Date
Prepared:
01/30/2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
179. DEA Legal Recourse
Administra.ve
Immediate
Suspension
Order
(ISO)
Memorandum
of
Agreement
(MOA)
Order
to
Show
Cause
(OTSC)
Civil
Fines
Criminal
Tac.cal
Diversion
Squads
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
180. How Do You Lose Your
Registration?
The
Order
to
Show
Cause
Process
21
USC
§
824
a) Grounds
–
1. Falsifica.on
of
Applica.on
2. Felony
Convic.on
3. State
License
or
Registra.on
suspended,
revoked
or
denied
–
no
longer
authorized
by
State
law
4. Inconsistent
with
Public
Interest
5. Excluded
from
par.cipa.on
in
Title
42
USC
§
1320a-‐7(a)
program
b)
AG
discre.on,
may
suspend
any
registra.on
simultaneously
with
Order
to
Show
Cause
upon
a
finding
of
Imminent
Danger
to
Public
Health
and
Safety
181. * FY2014 as of February 27, 2014
AdministrativeActions Initiated by DEA
FY2007thru2014*
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
183. ARCOS
PDMP
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
184. Inves9ga9ng
Physicians
• “Outside the Scope”
– CFR and Case Law: “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.”
– “In accordance with the standard of medical practice
generally recognized and accepted in the US.”
Once outside the scope => 21 USC 841
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Legal Basis
185. Standards
of
Care-‐State
Boards
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
186. Inves9ga9ng
Physicians
Targeting sources:
– Referrals from medical/pharmacy boards
– Law enforcement agency partners
– Confidential Sources
– Liaison:
• Hospitals (ER staff)
• Medical examiners
• Treatment /Rehab facilities
• Pharmacies (PICs and security staff)
– Choicepoint and other commercially available databases
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Targeting/Evaluation
187. Interviews of sources (patients, former employees)
– Look for Patterns and RED FLAGS:
• Relatively large quantities of controlled substances
• Little or no medical exam or diagnostic exams
• Cash-only practice
• No referrals to specialist for treatment or evaluation
• Pain “cocktails”
• Patients live long distances from practice
• Long lines of waiting patients
• Patients show indications of addiction
• Directed patients to specific pharmacies
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Evaluation/Red Flags
Inves9ga9ng
Physicians
188. Dr.
Bamdad,
Los
Angeles
Fugitive Pill Mill Doctor (Dr. Robert Ignasiak) Who Faked Suicide Found
and Arrested in South Florida
190. Perfunctory
ini.al
physical
exam…return
visits
no
exam
Physical
exam
included
needle
mark
checks…some
were
simulated
Pa.ent
received
quan.ty
of
drugs
requested…were
charged
based
on
quan.ty
Unsupervised
urinalysis
–
results
did
not
maGer
Accurate
records
not
kept
–
quan.ty
dispensed
not
recorded
Prac..oner
not
authorized
to
conduct
methadone
maintenance;
Pa.ent
directed
prescribing;
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
191. Rosen
was
a
68
yo
physician
who
had
a
prac.ce
that
was
focused
on
obesity.
He
dispensed
large
quan..es
of
s.mulants
to
undercover
officers
outside
the
scope
and
not
for
a
legi.mate
purpose.
The
5th
circuit
had
to
address
whether
the
medica.on
was
dispensed
“for
a
legi.mate
medical
purpose
and
in
the
course
of
the
doctors
professional
prac.ce.”
In
its
analysis,
the
court
stated,
“We
are
however,
able
to
glean
from
reported
cases,
certain
recurring
concomitance
of
condemned
behavior,
examples
of
which
include
the
following:
An
inordinately
large
quan.ty
of
controlled
substances
prescribed
Large
numbers
of
prescrip.on
were
issued
No
physical
exam
given
The
physician
warned
the
pa.ent
to
fill
prescrip.ons
at
different
drug
stores
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
192. Customers
coming
into
the
pharmacy
in
groups,
each
with
the
same
prescrip.ons
issued
by
the
same
physician;
and
Customers
with
prescrip.ons
for
controlled
substances
wriGen
by
physicians
not
associated
with
pain
management
(i.e.,
pediatricians,
gynecologists,
ophthalmologists,
etc.).
Overwhelming
propor.on
of
prescrip.ons
filled
by
pharmacy
are
controlled
substances
Pharmacist
did
not
reach
out
to
other
pharmacists
to
determine
why
they
were
not
filling
a
par.cular
doctors
prescrip.on
Verifica.on
of
legi.macy
not
sa.sfied
by
a
call
to
the
doctors
office
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
193. The
physician
issued
prescrip.ons
to
a
pa.ent
known
to
be
delivering
the
drugs
to
others
The
physician
prescribed
controlled
drugs
at
intervals
inconsistent
with
legi.mate
medical
treatment
The
physician
involved
used
street
slang
rather
than
medical
terminology
for
the
drugs
prescribed
There
was
no
logical
rela.onship
between
the
drug
prescribed
and
treatment
of
the
condi.on
allegedly
exis.ng
The
physician
wrote
more
than
one
prescrip.on
on
occasions
in
order
to
spread
them
out
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
194. Pa.ents
receiving
the
same
combina.on
of
prescrip.ons;
cocktail
Pa.ents
receiving
the
same
strength
of
controlled
substances;
no
individualized
dosing:
mul.ple
prescrip.ons
for
the
strongest
dose
Majority
of
pa.ents
paying
cash
for
their
prescrip.ons
Pa.ent
directed
prescribing;
pa.ent
asks
for
drugs
in
street
slang
Early
refills
No
specialized
training
in
pain
management;
Individuals
driving
long
distances
to
visit
physicians
and/or
to
fill
prescrip.ons
No
records/pa.ent
contracts/
urinalysis
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
195. Initial verification/corroboration
– Prescription Monitoring Programs-30 day look
– Look for legitimate explanations of activity
– Physical surveillance-Video
• Patient traffic inside/outside clinic
• Staff removing records/bags from office
• MD/staff visiting banks
– Database checks; prior/related investigations
– Crosscheck with other agencies for related information
• Professional state licensing boards-Discipline/on-going
investigations
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Initial Evaluation
Inves9ga9ng
Physicians
196. Inves9ga9ng
Physicians
Considerations
– DON’T TRICK THE DOCTOR
– Intent: evidence of “outside the scope”
– Video/Audio recording crucial
– Pain mention- not always a show stopper
– MRI/Medical records- creating/patterns of use
– Frequency of visits-multiple undercovers
– Street slang/prices/conversation
– Meet other patients in clinic
– Medication prescribed for others not present
– ASK: specific drugs/increase doses/multiple scripts
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Undercover Process
197. Inves9ga9ng
Physicians
Grand Jury Subpoenas
– Banks- Laundering and asset identification
Expert Review
– Establish Probable Cause for Search warrant/Administrative
action
– PMP records
– Reports: Undercover, Interviews of patients/employees
– UC video/audio
– Opinion: “Extreme departure” from standards
– Sources: Professional boards/associations, teaching universities.
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Investigative Process
198. Inves9ga9ng
Physicians
Timing of search and arrests-considerations
– Public safety
– Rush to Indictment following arrest-be prepared
– Loss of assets
– High profile defendant-Press/political interests
– Immediate suspension of DEA registration/state licensing action
Processing medical records
– Know what you’re looking for
Expert Review of seized medical records
Patient and employee interviews
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Search Warrants
199. Inves9ga9ng
Physicians
Search warrants/affidavits
– Get a go-by
– Include: type of drugs, case law/statute of legitimate prescribing,
medical standards, how target violated standard, expert opinion,
specific records to seize, how to conduct search
– Special masters not usually required in fed cases
– Plan how to process and store records
– Request computer forensic/doc exploitation teams
– Electronic scanning/prosecution preference
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Search Warrant Mechanics
200. Inves9ga9ng
Physicians
Appropriate Jurisdiction:
Federal/State (Attorney General)/District Attorney’s
Office
– Offenses/charging/burdens/sentences all vary
Death enhancements
– Medical examiner investigation
– Cause of death/documentation
– Multiple Expert opinions
Other enhancements - Distances/under age 21
Charging: UC counts/Relative conduct at sentencing
– Medical fraud considerations
Asset Forfeiture - Criminal/civil/administrative
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Prosecution
201. Inves9ga9ng
Pharmacies
• Corresponding Responsibility – Unlawful Distribution
Title 21 USC 841 (a)(1)/846
• Evidence exists that pharmacist/owner delivered drugs to (an)
individual (s) pursuant to (an) unlawful order(s) (prescription). A
“rogue” physician is typically involved.
• Pharmacist knew or should have known that the prescription was illegal
(issued outside the course of a professional practice.)
Examples: Prescription was issued in the course of an UC operation in
exchange for cash; rx has obvious inadequacies, excessive dosages or
quantities, refills at an uncommonly high rate or indications of customer
misuse of the drug.
• Use of Expert Witness – Pharmacists or Doctors are usually called
upon to examine prescriptions and pharmacy records to aid in
determining if the pharmacist exercised corresponding responsibility.
201
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Legal Basis
202. Inves9ga9ng
Pharmacies
• Unlawful Distribution –Unlawful Distribution
Title 21 USC 841 (a)(1)/846
• Evidence exists that pharmacist delivered a drug without a
lawful order (issued outside the course of a professional
practice).
• Atypical to this case is the lack of physician involvement.
For example, UC operation details the pharmacist delivering
drugs to CS/UC in exchange for cash, and solicits CS/UC
for fraudulent rxs to cover up the diversion of drugs from
the pharmacy. (See Tampa case S/S Pharmacy, Federal
register notice dated 9/19/2013).
202
Legal Basis
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
203. Inves9ga9ng
Pharmacies
• Health Care Fraud –
• 31 U.S.C. 3729(a)(1)(A)(B): When a person knowingly makes a
false claim to receive payment from the government.
• There must be evidence that the pharmacist filled a prescription
and billed medical insurance providers knowing the prescriptions
were not written for a legitimate medical purpose.
203
Legal Basis
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
204. Inves9ga9ng
Pharmacies
• Chain Pharmacies-
• Pharmacy which has national exposure: CVS; Rite Aid;
Walgreens, etc.
• Typically targeted for civil prosecution (fines).
• Must be coordinated with DEA HQS ODG prior field contact
with US Attorney.
• Targeted pharmacy has numerous CSA violations (21 CFR 1300
to end) which led to facilitation of drug diversion.
204
Legal Basis
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
205. Inves9ga9ng
Pharmacies
• Sources of Information - Supplier/Distributor, Suspicious Order
Reports, Pharmacy Boards, Medical Examiners, Police Departments,
Tips from citizens, ARCOS, PDMP
• Spin-off cases – Medical Doctor, distributor investigations
• Informants - Included in routine narcotics debriefings. Cooperating
defendants/individuals.
• Government Agencies - Joint investigations with agencies such as FBI,
HHS, FDA, Homeland Security, Medical/Pharmacy Boards, etc.
• Drug Overdose Investigation - Check of Police Report of OD
deaths in area to compare to pharmacy prescription history.
What Triggers a Pharmacy Investigation
205
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
206. Inves9ga9ng
Pharmacies
• Profiles - Check ARCOS, PDMP, NADDIS, NCIC, Pharmacy Board,
ChoicePoint, CLEAR, Police Department activity reports.
• Industry reports - DEA-106s, DEA-41s, Check distributor customer
report.
• Surveillance - Observation of pharmacy activity, focus on video
recordings of suspicious individuals, vehicles (out of state plates),
parking lot hand exchanges, volume of customers in parking lot
waiting to enter facility.
• Customer base – Review PMP data, identify primary source physicians and
patient profiles (age, types of drugs, distance from residence, etc)
206
Conduct Background Investigation
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
207. Ringleader Robin
Steinke
Pharmacist Jeff
Clawson
CVS Pharmacy, Inc. Agrees to $11 Million Settlement
for Violations of the Controlled Substances Act
Large National Chain Pharmacy First Ever
DEA Registration Revocation
TDS Dismantles Oxycodone Trafficking Group and Arrests Pharmacist
PlaNe
Valley
Pharmacy
in
Brighton,
Colorado
Sanford,
FL,
CVS
208.
209. Inves9ga9ng
Pharmacies
• Vehicle Stops - Stops of multiple customers may reveal drug prescription
information, doctor information, drug type, drug quantities, patient
information, develop confidential informants. Criminal checks based on
vehicle registrations. Travel from afar? Follow to storage sites.
Organized vehicle stops with Police.
• Undercover Operations - Undercover buys may reveal pharmacy illegal
procedures, CSA violations, pharmacy/tech/owner conspiratorial
members. Consensual phone calls by informant(s) to pharmacist.
• Trash searches - May produce evidence for search warrants. May also
identify information regarding additional warehouses, banking information,
additional addresses, discarded scripts, etc.
209
Evidence Gathering Techniques
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
210. Inves9ga9ng
Pharmacies
• Video - Review any available video from inside pharmacy, consider
obtaining court order to bug pharmacy.
• Financial Check - Conduct financial investigation on pharmacist to
uncover unusual large cash deposits, bank accounts, associated assets.
• Purpose of investigative methods will aid in establishing probable
cause for a search warrant and identify conspirators.
210
Evidence Gathering Techniques (cont’d.)
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
211. Inves9ga9ng
Pharmacies
• Criminal Actions - Determine if evidence exists to prove the following
statutes:
• 21 U.S.C. 841(a)(1) – Illegal Distribution
• 21 U.S. C. 843(a)(3) – To acquire or obtain possession of a controlled
substance by misrepresentation, fraud, forgery, deception or subterfuge
• Civil Actions - Determine if there is a preponderance of evidence indicating
a violation of the following statutes:
• 21 U.S.C. 842(a)(1) – Dispensing outside the course of normal practice
• 21 U.S. C. 842(a)(5) – Violation of CSA, recordkeeping and reporting
requirements (Title 21 CFR 1300 to end).
211
Review Case to determine applicable
Administration, Civil or Criminal Actions
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
212. Inves9ga9ng
Pharmacies
• Administrative - Immediate Suspension Order/Order to Show
Cause- Determine if grounds exists under the following factors:
• (1) The recommendation of the appropriate State licensing board or professional
disciplinary authority: license revocation/suspension; admin findings relating to drug
violations, etc.
• (2) The applicant's experience in dispensing, or conducting research with respect to
controlled substances: unlawful drug distribution; health care fraud conviction, etc.
• (3) The applicant's conviction record under Federal or State laws relating to the
manufacture, distribution, or dispensing of controlled substances.
• (4) Compliance with applicable State, Federal, or local laws relating to controlled
substances.
• (5) Such other conduct which may threaten the public health and safety.
• *Need one or more factor to recommend OTSC/ISO action.
212
Review Case to determine applicable
Administration, Civil or Criminal Actions (cont’d.)
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
213. • Other Administrative Actions - Determine if violations of Title 21 CFR
1300 to end:
• Memorandum of Agreement (MOA) – Specifies terms of registrant’s
future compliance. Violation of terms is grounds for an OTSC.
• Letter of Admonition (LOA) – Notifies the registrant in writing of CSA
violations and requires that he/she remedies same.
• Investigative Warning – Investigator advises registrant of CSA
violations and requires that he/she remedies same.
Note: Controlled Substance Act of 1970 outlines regulations for registrants
regarding the proper handling of controlled substances. Violations of this act
are usually remedied through civil/administrative actions
Inves9ga9ng
Pharmacies
213
Review Case to determine applicable Administration,
Civil or Criminal Actions (cont’d.)
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
214. Inves9ga9ng
Pharmacies
• Search Warrant - Handled the same as normal search warrants but are
usually executed without force.
• Administrative Inspection Warrant (AIW) -
• Issued by a Federal Magistrate.
• Limited to records required to be kept under 21 CFR 1300 to end.
Examples: Order Forms, Invoices, prescriptions, inventories, etc.
• Has to be conducted during business hours in a professional manner.
• Notice of Inspection (DEA Form – 82) –
• Issued by assigned Agent/Investigator/TFO (deputized)
• Limited to required records relating to 21 CFR 1300 to end.
• Only copies can be taken without consent.
214
Methods of obtaining pharmacy documentary evidence
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
215. Inves9ga9ng
Pharmacies
• Arrests/Indictments
• Seized Assets
• Civil Fines
• Civil fines are payable to the Department of Justice and are not subject
to asset sharing
• Registration Revocation/Suspension Orders
• Issued by Office of Chief Counsel (CCD)
• Other Administrative Actions
• Sentencing
• Sentencing is enhanced if wrongful death is proven and Schedule II
narcotics are involved and quantified.
215
Investigative Outcomes
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
