Ph 4 rannizzisi

Joseph Rannazzisi
Deputy Assistant
Administrator
Office of Diversion Control

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

1.  Iden.fy
the
legal
standard
for
dispensing

medica.ons
pursuant
to
a
valid
prescrip.on.

2.  Iden.fy
the
basis
and
eﬀects
of
the
proposed

DEA
regula.ons.

3.  List
the
factors
the
pharmacist
should

consider
in
determining
whether
to
dispense

medica.on.

Learning Objectives
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

  Iden.fy
the
legal
standard
for
dispensing

medica.ons
pursuant
to
a
valid
prescrip.on

  Iden.fy
regula.ons
that
establish
prac..oners

legal
requirements
under
21
USC

  List
the
factors
the
pharmacist
should
consider

prior
to
dispensing

  Review
status
of
drug
disposal
legisla.on
and

regula.ons

Goals and Objectives
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

In
2010,
approximately
38,329
uninten7onal
drug

overdose
deaths
occurred
in
the
United
States,
one

death
every
14
minutes.

Of
this
number,
22,134
of
these
deaths
were

aFributed
to
Prescrip7on
Drugs
(16,651
aFributed

to
opioid
overdoses/
75.2
%).

Prescrip7on
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

Although
more
men
die
from
drug
overdoses
than
woman,

the
percentage
increase
in
deaths
since
1999
is
greater

among

woman.

More
woman
have
died
each
year

from
drug
overdoses
than
from
motor
vehicle–related

injuries
since
2007.

Deaths
and
ED
visits
related
to
OPR

con.nue
to
increase
among
woman.

U.S. Drug Overdose Deaths
by Major Drug Type, 1999-2010
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source: CDC/NCHS, NVSS

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
aTributable
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

2011 Current Users (Past Month) 2012

Source:
2011
&
2012
NSDUH

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

Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012
National Survey on Drug Use and Health U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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

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

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

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

Questions to Discuss
 

According
to
the
Na.onal
Survey
on
Drug
Use
and

Health
(NSDUH),
in
2012
there
were
6.8
million

persons
aged
12
and
older
who
used
prescrip.on-‐
type

psychotherapeu.c
drugs
non-‐medically
in
the

last

month.
Which
class
of
pharmaceu.cal
had
the

highest

level
of
non-‐medical
use?

A)
S.mulants

B)
Seda.ves

C)
Pain
relievers

D)
Tranquilizers

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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%

Poisoning Deaths: Opioid Analgesics
*2009
data
approximated

*

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

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

 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

Naloxone

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source:
U.S.
Census
Bureau

Statistical Perspective
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Why is the problem outpacing
population growth?
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Violence
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Prescription drug
epidemic?
How did we get to this
point?
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

70s
Public
Service
Announcement
–
The
Magician

The 1960s/70s/80s
Downers
-‐
Barbiturates

Uppers
-‐
Amphetamines

Meprobamate

Hydromorphone

“Ts
and
Blues”

“Fours
and
Doors”

Oxycodone/APAP

Methaqualone

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The
1990s

Hydrocodone
AlprazolamOxycodone 30 mg
Carisoprodol

OxyCon.n®
80mg

(Oxycodone
controlled-‐release)

Commonly Abused Controlled Pharmaceuticals
Oxymorphone

C-‐IV
as
of
1/11/2012

The Trinity
C-‐IV
as
of
1/11/2012

Hydrocodone

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The HolyTrinity

Inadequate Pain Control
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

We
conclude
that
despite
widespread
use
of

narco.c
drugs
in
hospitals,
the
development
of

addic.on
is
rare
in
medical
pa.ents
with
no

history
of
addic.on.

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

1.Temperature

2.Heart
Rate

3.Blood
Pressure

4.Respira.on

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The Fifth Vital Sign?
5.Pain?

U.S.
Drug
Enforcement
Administra.on

Office
of
Diversion
Control

Now,
Dr.
Portenoy
and
other
pain
doctors
who
promoted

the
drugs
say
they
erred
by
oversta.ng
the
drugs’

benefits
and
glossing
over
risks.

“Did
I
teach
about
pain

management,
specifically
about
opioid
therapy,
in
a
way

that
reflects
misinforma.on?

We,
against
the
standards

of
2012,
I
guess
I
did,”
Dr.
Portenoy
said
in
an
interview

with
The
Wall
Street
Journal.
“We
didn’t
know
then

what
we
know
now.”

Source:
The
Wall
Street
Journal,
December
15-‐16,
2012

Direct to Consumer Advertising
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

We will not arrest our way
out of this problem!!!!!
Enforcement
is
just
as
important
as….

Preven.on/Educa.on

Treatment

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Drug Education
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Education
 
Children/Teens

Informa.on
from
the
Internet

or
their
peers

Following
parents

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Parents & Their Attitudes
Parents are not discussing the risks of abusing prescription drugs
Source: 2011 Partnership Attitude Tracking Study
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source of Concerns
 1 in 5 parents (20 percent) report that they have given
their teen a prescription drug that was not prescribed to
them.
 17 percent of parents do not throw away expired
medications.
 14 percent of parents say they themselves have misused
or abused prescription drugs within the past year.
 49 percent of parents say anyone can access their
medicine cabinet.
SOURCE: 2012 Partnership Attitude
Tracking Study Report; Partnership for a
Drug-Free America and MetLife
Foundation, published April 23, 2013.
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Where do kids get their
information from?

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

www.EROWID.org

Community
Coali.ons
and

Advocacy
Groups

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Education
 

Physicians/Den.sts/Prac..oners

Prescribing
habits

Mandatory
opiate
prescribing

con.nuing
educa.on?

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Education
 Pharmacists

Drug
Experts
in
the
health
care

delivery
system

Corresponding
responsibility

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Scheduled
PDACs

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
April
8,
2014

Completed
PDACs

ATendance

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-‐CharloTe,
NC
2/8-‐9/14
513

16-‐Knoxville,TN
3/22-‐23/14
246

17-‐St.
Louis,
MO
4/5-‐6/14
224

Total
ATendance

6,584

The Controlled Substances Act
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

CSA Registrant Population
March
20,
2014

Provisional
registra7ons

in
eﬀect
at
the

7me
CSA

was
passed
(rela7ve
to
the

Harrison
Narco7cs
Act
of
1914)

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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 ...”

Cyclic
Investigations
Security
Requirements
Recordkeeping
Requirements
ARCOS Reporting
Established
Quotas
Registration
Established
Schedules
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Closed System of Distribution

The Flow of Pharmaceuticals
PATIENTS
Hospitals NTPs
21 CFR 1306.04
Physicians
(Rx and drugs)
Pharmacies
QUOTASRaw Material
Importers Imp - Manufacturers
21 USC 823(c)(1)
21 USC 823(d)(1)
21 CFR 1301.71
Dosage Form
Manufacturers
Manufacturers
Dosage Form
Manufacturers
21 USC 823(b)(1)
21 USC 823(e)(1)
21 CFR 1301.71
21 CFR 1301.74
(Suspicious Orders)
Wholesalers - DistributorsSmaller Distributors
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Diversion via the
Internet
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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

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

DEA
Distributor
Ini7a7ve

  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

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

“At
the
.me
we
ﬁlled
these
orders,
the
pharmacies
held
valid
state

board
of
pharmacy
and
DEA
licenses,”
BarreT
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
BarreT

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.

H.R.
4069:
Ensuring
Pa.ent
Access
and

Effec.ve
Drug
Enforcement
Act
of
2013

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.

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

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
maTer

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

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

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
wriTen
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

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

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
asking
for
drugs
in
street
slang

Pa.ent
directed
prescribing

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

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

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

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

The Last Line of Defense
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Pharmacists

  The $80 million settlement is the
largest fine related to DEA’s
strategy of cracking down on
rampant prescription drug abuse
by targeting large corporations
  Walgreen “negligently allowed”
prescription painkillers to be
diverted for illegal black market
sales
  The license of a Florida facility
used by Walgreen to distributed
controlled substances was revoked
for two years
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The $80 million
settlement is the
largest fine paid by a
pharmacy chain as
related to DEA’s
strategy of cracking
down on rampant
prescription drug
abuse
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,

according
to
a
new
resolu.on
by
the
American
Medical
Associa.on.

The
AMA
adopted
the
resolu.on
at
its
2013
annual
mee.ng,
calling

such
inquiries
“an
interference
with
the
prac.ce
of
medicine
and

unwarranted”.

Red Flag?
What
happens
next?

You
aTempt
to
resolve…

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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
wriTen
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

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
wriTen
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
doctor’s
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

Large-Scale Diversion
 In
2009,
the
average
purchase
for
all
oxycodone
products
for

all
pharmacies
in
US
–
63,294
d.u.

 In
2010,
the
average
was
–
69,449
d.u.

 In
2009,
the
average
purchase
for
all
oxycodone
products
for

the
top
100
pharmacies
in
Florida
–
1,226,460
d.u.

 In
2010,
the
average
was
–
1,261,908
d.u.

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source:
DEA
Automated
Reports
and
Consolidated
Orders
System
(ARCOS)

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

Source:
DEA
Automated
Reports
and
Consolidated
Orders
System
(ARCOS)

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

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

Paul
Volkman,
Chicago
Doctor,
Gets
4
Life
Terms

In
Drug
Overdose
Case

ANDREW
WELSH-‐HUGGINS

02/14/12
06:45
PM
ET
Associated
Press

COLUMBUS,
Ohio
—
A
Chicago
doctor
who
prosecutors
say
dispensed
more
of
the
powerful
painkiller
oxycodone
from
2003

to
2005
than
any
other
physician
in
the
country
was
sentenced
Tuesday
to
four
life
terms
in
the
overdose
deaths
of
four

pa.ents.

Dr.
Paul
Volkman
made
weekly
trips
from
Chicago
to
three
loca.ons
in
Portsmouth
in
southern
Ohio
and
one
in
Chillicothe
in

central
Ohio
before
federal
inves.gators
shut
down
the
opera.ons
in
2006,
prosecutors
said.
He
was
sentenced
in
federal

court
in
Cincinna..

"This
criminal
conduct
had
devasta.ng
consequences
to
the
community
Volkman
was
supposed
to
serve,"
Assistant
U.S.

ATorneys
Adam
Wright
and
Tim
Oakley
said
in
a
court
filing
ahead
of
Tuesday's
hearing.

"Volkman's
ac.ons
created
and
prolonged
debilita.ng
addic.ons;
distributed
countless
drugs
to
be
sold
on
the
street;
and

took
the
lives
of
numerous
individuals
who
died
just
days
azer
visi.ng
him,"
they
said.

The
64-‐year-‐old
Volkman
fired
his
aTorneys
earlier
this
month
and
said
he
acted
at
all
.mes
as
a
doctor,
not
a
drug
dealer.

"The
typical
drug
dealer
does
not
care
how
much
drugs
a
client
buys,
how
ozen
he
buys,
or
what
he
does
with
his
drugs,"

Volkman
said
in
a
28-‐page
handwriTen
court
filing
Monday,
maintaining
that
he
did
all
those
things
and
more
for
his

pa.ents.

U.S.
Drug
Enforcement
Administra.on

Office
of
Diversion
Control

Violations?
What
happens
next…..

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The DEA Inspection
 Investigators will identify themselves
and produce their official credentials
 Investigators will produce, either a
– Notice of Inspection
– Administrative Inspection Warrant
– Search Warrant
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Notice of Inspection
 You may refuse the Notice of Inspection and
require an Administrative Inspection Warrant or
Search Warrant:
Explain the NOI and provide a copy
Explain the purpose of the visit
Request to inspect the registered location
and the controlled substance records
Receipt provided for records obtained
Conducted between normal business
hours

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Administrative Inspection Warrant
 Reviewed by an Assistant United States
Attorney
 Executed by a United States Magistrate
Judge
 Served with a copy of the AIW
 Controlled substances records obtained
and a receipt provided
 Conducted between normal business
hours
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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

* FY2014 as of April 10, 2014
AdministrativeActions Initiated by DEA
FY2007thru2014*
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control


True
or
False…

For
a
controlled
substance
prescrip.on
to
be

eﬀec.ve,
it
must
be,
“issued
for
a
legi.mate

medical
purpose
by
an
individual
prac..oner
ac.ng

in
the
usual
course
of
professional
prac.ce.”

 A)
True

 B)
False

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

 The
ATorney
General
can
immediately
suspend
a

DEA
registra.on
based
on
the
determina.on
that

the
con.nued
registra.on
poses
an
imminent

danger
to
public
health
or
safety;

 A)
True

 B)
False

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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)
First Specific Drug Associated with Initiation
of Illicit Drug Use Among Past Year Illicit
Drug Initiates Aged 12 or Older: 2012

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

 
According
to
the
Na.onal
Survey
on
Drug
Use
and
Health

(NSDUH),
in
2012,
par.cipants
iden.ﬁed
the
most
frequent

method
of
obtaining
a
prescrip.on-‐type
psychotherapeu.c

drug
that
they
most
recently
non-‐medically
used
as:

A)

Internet

B)

From
a
friend
or
rela.ve
for
free

C)

Purchased
from
a
friend
or
rela.ve

D)

Purchased
from
stranger/drug
dealer

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The Problem – Easy Access
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Medicine Cabinets: Easy Access
 More
than
half
of
teens
(56%)
indicate
that
it’s
easy
to
get

prescrip.on
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
prescrip.on
drug
obtained
it
from
their
parent’s
medicine

cabinet

 Almost
half
(49%)
of
teens
who
misuse
or
abuse
prescrip.on

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

So Many Drugs in the
Household – Why?

 Unreasonable
quan..es
being
prescribed

 Insurance
rules

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

So
Why
is
this
important
to
me

(Pharmacist, Physician, Dentist, Nurse etc.)
 Under
the
current
law,
receiving
a
controlled

substance
from
a
ul.mate
user
is
a
viola.on
of
the

CSA

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Ultimate User Disposal of Medicines
National Take-Back Events: Take-back events are a good way
to remove expired, unwanted, or unused medicines from
the home.
Law Enforcement Collection Bins: Collection bins installed by our
Law Enforcement Partners are a good way to remove expired, unwanted,
or unused medicines from the home.
Disposal in Household Trash: Mix medicines (do not crush tablets or
capsules) with substances such as kitty litter or used coffee grounds and
place the mixture in a container such as a sealed plastic bag and throw the
container in your household trash.
Disposal by Flushing: Some medicines have specific disposal
instructions that indicate they should be flushed down the sink
or toilet when they are no longer needed.
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

ONDCP Guidelines
 ONDCP
guidelines
for
the
disposal
of
ul.mate
user

medica.ons,
including
dispensed
controlled
substances

(2/20/07).

 Advise
public
to
flush
medica.ons
only
if
the

prescrip.on
label
or
accompanying
pa.ent
informa.on

specifically
states
to
do
so.

 ONDCP
recommends
a
minimal
deac.va.on
procedure,

and
disposal
in
common
household
trash.

U.S.
Drug
Enforcement
Administra.on

Office
of
Diversion
Control

Law Enforcement
Law
enforcement
oﬃcers,
ac7ng
to
enforce
laws
regarding
the

abandonment
of
controlled
substances,
may
receive
controlled

substances
from
ul7mate
users.

Law
enforcement
must
safeguard
the
controlled
substances
and

ensure
that
they
are
destroyed
properly.

Law
enforcement
must
be
present
during
the
destruc7on
of
the

controlled
substances.

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

 Prior
to
passage
of
the
Secure
and
Drug
Disposal
Act
of

2010
and
its
implemen.ng
regula.ons,
ul.mate
users
could

dispose
of
controlled
substances
in
the
following
manner:

A)

Wrap
in
coﬀee
grinds
and
dispose
in
trash

B)

Give
to
a
pharmacist
for
disposal

C)

Give
to
a
law
enforcement
agency
for
disposal

D)

a
and
c

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

 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

National Take Back Day
October 26, 2013
4,114 Agencies; 5,683 Sites
647,211 Pounds Collected (324 Tons)
DRUG
ENFORCEMENT

ADMINISTRATION

DIVERSION
CONTROL
PROGRAM

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

National Take Back Day: October 26, 2013
Total Law Enforcement Participation: 4,114
78

77

51

68

152
MA

32

RI

46

CT

135

29
VT

79

NH

14

PR
&
VI

204
70

6

135

29

191

12

98

17

21

53

128

143

62

38

258

15

1
HI
115

222

NJ

38

140

22
65

199

246

63

20

31

134

33

71

65

18

140
68

46

MD

7

DC

28

DE

36

65

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Total Collection Sites: 5,683
97

134

79

95

157
MA

39

RI

78
CT

165

60

VT
85

NH

19

PR
&
VI

243
88

6

158

37

284

17

134

21

24

59

168

234

77

69

425

22

12

HI

164

232

NJ

57

185

20
84

293

368

91

86

36

24

35

190

51

99

84

23

200
132

101

MD

11

DC

31

DE

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

Secure
and
Responsible
Drug

Disposal
Act
of
2010

 Enacted
in
October
2010
(Pub.
L.
111-‐273,
codiﬁed
at
21
U.S.C.
822(g)
and
823(b)(3))

 Act
allows
an
ul.mate
user
to
“deliver”
a
controlled
substance
“to
another
person

for
the
purpose
of
disposal”
in
accordance
with
regula.ons
issued
by
DEA

 If
the
ul.mate
user
dies
while
in
lawful
possession
of
the
controlled
substance,
then

any
person
lawfully
en.tled
to
dispose
of
the
decedent’s
property
may
deliver
the

controlled
substance
to
another
person
for
the
purpose
of
disposal.

 DEA
may
also,
by
regula.on,
authorize
long
term
care
facili.es
(LTCFs)
to
dispose
of

controlled
substances
on
behalf
of
ul.mate
users
who
reside
or
have
resided
at
the

LTCF.

 DEA
is
working
to
promulgate
regula.ons
to
implement
this
Act.

DEA
must
consider:

–  Public
health
and
safety

–  Ease
and
cost
of
program
implementa.on

–  Par.cipa.on
by
various
communi.es

–  Diversion
Control

 Par.cipa.on
is
voluntary.

DEA
may
not
require
any
person
to
establish
or
operate
a

delivery
or
disposal
program.

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

No.ce
of
Proposed
Rulemaking

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Pharmaceuticals
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

* Must be reduced in writing, and followed by sign, hard copy of the prescription.
** A signed, hard copy of the prescription must be presented before the medication is dispensed.
*** 72 hour time limitation.
# With medical authorization, up to 5 in 6 months. U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Opioids
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

U.S.
Rates
of
Opioid
Overdose
Deaths,
Sales,

and
Treatment
Admissions,
1999-‐2010

Source: National Vital Statistics System (NVSS),
DEA’s Automation of Reports and
Consolidated Orders System, SAMHSA’s
Treatment Episode Data Set U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Most commonly prescribed prescription
medicine?
Hydrocodone/acetaminophen
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source:
IMS
Health,
Na.onal
Prescrip.on
Audit

Updated
March
22,
2013

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

Top 25 U.S. Pharmaceuticals by Dispensed Prescriptions*
Source:
IMS
Health,
Na.onal

Prescrip.on
Audit
Updated
March

22,
2013

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

Hydrocodone Combinations
CSA
defines
hydrocodone
substance
as
Schedule
II,
while

its
combina.on
products
as
Schedule
III.

DEA
has
received
a
pe..on
to
reschedule
CIII

hydrocodone
combina.on
products
to
CII.

In
2004,
DEA
completed
an
ini.al
review
forwarded
the

data
to
DHHS
with
a
request
for
scien.fic
and
medical

evalua.on
and
scheduling
recommenda.on.

In
2008,
HHS
provided
a
scien.fic
and
medical
evalua.on

In
2009,
DEA
sent
addi.onal
data
to
FDA/HHS
and

requested
a
scien.fic
and
medical
evalua.on.

U.S.
Drug
Enforcement
Administra.on

Office
of
Diversion
Control

  DEA
receives
a
pe..on
from
an
interested
party
(proceedings
may

also
be
ini.ated
at
the
request
of
the
AG
or
Secretary
of
HHS)

  Pe..on
is
reviewed
and
accepted

  DEA
conducts
ini.al
8-‐factor
analysis
review

  Documents
and
material
gathered
during
the
ini.al
review
and

analysis
of
pe..on
is
sent
to
HHS/FDA
with
a
request
for
a
scien.ﬁc

and
medical

evalua.on
and
a
recommenda.on
as
to
whether
the

drug
should
be
controlled

  The
recommenda.on
and
review
document
is
received
back
from

HHS/FDA

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Schedule II
  The
drug
or
other
substance
has
a
high
poten.al
for
abuse

  The
drug
or
other
substance
has
a
currently
accepted
medical
use

in
treatment
in
the
United
States

or
a
currently
accepted
medical

use
with
severe
restric.ons

  Abuse
of
the
drug
or
other
substance
may
lead
to
severe

psychological
or
physical
dependence

Schedule III
  The
drug
or
other
substance
has
a
poten.al
for
abuse
less
than

the
drugs
or
other
substances
in
schedules
I
or
II

  The
drug
or
other
substance
has
a
currently
accepted
medical
use

in
treatment
in
the
United
States

  Abuse
of
the
drug
or
other
substance
may
lead
to
moderate
or

low
physical
dependence
or
high
psychological
dependence

21
USC
812(b)(2),(3)
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Approval of Single Entity
Extended Release Hydrocodone
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

State Ranking* - Oxycodone
January – December 2012
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

State Ranking* - Oxycodone
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

OxyContin® (Schedule II)
(Oxycodone controlled-release)
 Controlled- release formulation of Schedule II oxycodone
–  The controlled release method of delivery allows for a longer duration of
drug action so it contains much larger doses of oxycodone
–  Abusers easily compromise the controlled release formulation by
crushing the tablets for a powerful morphine-like high
–  Street Slang: “Hillbilly Heroin”
–  10, 15, 20, 30, 40, 60, 80mg available
 Effects:
–  Similar to morphine in effects and potential for abuse/ dependence
 Street price: Approx. $80 per 80mg tablet
 New formulation: Introduced into the marketplace in 2010 that is
more difficult to circumvent for insufflation (snorting) or injection. Does
nothing to prevent oral abuse.
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

OxyContin® Change
(Oxycodone controlled-release)

New OxyContin® OP
(oxycodone-controlled release)
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Oxycodone 15mg/30mg
Immediate Release
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Opana ER (Schedule II)
(Oxymorphone extended release)
 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

State Ranking* - Oxymorphone
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Hydromorphone
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

State Ranking* - Hydromorphone
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Opiates v. Heroin
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Poppy

Codeine

Hydrocodone

Morphine

Hydromorphone

Thebaine

Oxycodone

Hydrocodone

Somniferum

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

U.S. Rates of Opioid Overdose Deaths, Sales,
and Treatment Admissions, 1999-2010
Source: National Vital Statistics System (NVSS),
DEA’s Automation of Reports and
Consolidated Orders System, SAMHSA’s
Treatment Episode Data Set
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Hydrocodone

Lorcet®

$5-‐$7/tab

Oxycodone

Combina.ons

Percocet®

$7-‐$10/tab

OxyCon7n®

$80/tab

Heroin

$10/bag

Roxicodone®

Oxycodone
IR

15mg,
30mg

$30-‐$40/tab

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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)
Past Month and Past Year Heroin Use
Among Persons Aged 12 or Older: 2002-2012
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

Percent

Source: SAMSHA Treatment Episode Data Set,
1998-2008 released July 15, 2010
Substance Abuse Treatment Admissions
within Specific Age Groups That Reported
Any Pain Reliever Abuse: 1998-2008
Up
more
than
fourfold

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

Methods of Diversion
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Source:
DEA

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

Prescription Fraud
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

 
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

Doctor Shopping
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Prescription Drug Monitoring
Programs
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Mandatory PDMP review before
prescribing CS?
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Standard of Care
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

National Association of
Boards of Pharmacy
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

What has been the reaction????

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

Current CSA Registrant Population
Total Population: 1,523,995
  Practitioner 1,177,455
  Mid-Level Practitioner 246,543
  Pharmacy 69,807
  Hospital/Clinic 16,047
  Teaching Institution 312
  Manufacturer 543
  Distributor 839
  Researcher 7,346
  Analytical Labs 1,524
  NTP 1,365
  Importer/Exporter 476
  ADS Machine 755
  Chemicals 1,005
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

As
of
03/21/14

Pain Clinics
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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

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

Increased Law Enforcement
Pressure
 Clinics
migra.ng
north
and
west

 Funded
by
owners
in
Florida

U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNESOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.
ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.
IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

‘The Florida Migration’
 Vast majority of ‘patients’ visiting Florida “pain
clinics”come from out-of-state:
–  Georgia
–  Kentucky
–  Tennessee
–  Ohio
–  Massachusetts
–  New Jersey
–  North and South Carolina
–  Virginia
–  West Virginia
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNESOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.
ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.
IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT..
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNESOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.
ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.
IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
(MIAMI)
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

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

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

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

What’s the Profit?
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

The Last Line of Defense
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Pharmacist

Thank You!
U.S.
Drug
Enforcement
Administra.on

Oﬃce
of
Diversion
Control

Ph 4 rannizzisi

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