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. 1. Iden.fy
the
pharmacological
proper.es
of
Zohydro™
ER.
2. Outline
approaches
law
enforcement
should
consider
to
reduce
the
poten.al
effects
of
abuse
and
diversion.
3. Describe
poten.al
methods
of
abuse
and
diversion
of
Zohydro™
ER.
Learning Objectives
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
4. Background
of
opioid
use
and
abuse
–Scope
of
the
problem
Describe
the
hydrocodone
situa.on
pre
Zohydro™
(hydrocodone
bitartrate
ER)
Discuss
pharmacology
of
Zohydro™
(hydrocodone
bitartrate
ER)
Iden.fy
methods
of
pharmaceu.cal
diversion
and
discuss
how
the
pharmacist
can
prevent
diversion
in
the
retail
seQng
Discuss
law
enforcement
role
in
preven.ng
abuse
and
trafficking
Goals and Objectives
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
5. Outline
Hydrocodone
historical
perspec.ve
Background
on
Zohydro™
ER
Pharmacology
Indicated
Use
Poten.al
for
Abuse
Toxicity
Law
Enforcement
Involvement
Methods
of
Abuse
and
Diversion
Risk
Management
Plan
for
Zohydro™
ER
What
The
Future
Holds
Review
/
Ques.ons
/
Comments
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
6. INCB: Availability of opioids* for pain management (2010-2012 average)
(Consumption in defined daily doses for statistical purposes (S-DDD)
per million inhabitants per day)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Date
Prepared/
Source:
4/14/14,
h^p://www.incb.org/incb/en/narco.c-‐drugs/Availability/availability.html
7. Drug Overdose Mortality Rates
per 100,000 People 1999
Source:
Trust
for
America’s
Health,
www.healthyamericans.org.
“Prescrip.on
Drug
Abuse:
Strategies
to
Stop
the
Epidemic
(2013)”
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
8. Source:
Trust
for
America’s
Health,
www.healthyamericans.org.
“Prescrip.on
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
9. U.S. Rates of Opioid Overdose Deaths, Sales,
and Treatment Admissions, 1999-2010
Source:
Na.onal
Vital
Sta.s.cs
System
(NVSS),
DEA’s
Automa.on
of
Reports
and
Consolidated
Orders
System,
SAMHSA’s
Treatment
Episode
Data
Set
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
10. Hydrocodone
Aggregate Production Quota History
16,314
20,208
21,417
23,825
25,702
30,622
34,000
37,604
42,000
46,000
55,000
55,500
55,000
59,000
79,700
99,652
99,625
0
20,000
40,000
60,000
80,000
100,000
120,000
(in
kilograms)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Date
Prepared/
Source:
04/14/2014,
ODQ
Revised
APQ
11. Worldwide Hydrocodone Use
SOURCE:
UN
Interna.onal
Narco.cs
Control
Board
website.
Es.mated
World
Requirements
of
Narco.c
Drugs
in
grams
for
2014.
h^p://
www.incb.org
.
Accessed
April
14,
2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
12. Worldwide Hydrocodone Use
Of the 20 Countries that reported an estimated needs
requirement for hydrocodone at one kilogram or more
8 countries reported an estimated need of 1 kilogram to 5
kilograms
4 countries reported an estimated need over 5 kilograms
to 10 kilograms
8 countries reported an estimated need over 10 kilograms
SOURCE:
UN
Interna.onal
Narco.cs
Control
Board
website.
Es.mated
World
Requirements
of
Narco.c
Drugs
in
grams
for
2014.
h^p://www.incb.org
.
Accessed
April
14,
2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
13. Top 10 List
SOURCE:
UN
Interna.onal
Narco.cs
Control
Board
website.
Es.mated
World
Requirements
of
Narco.c
Drugs
in
grams
for
2014.
h^p://www.incb.org
.
Accessed
April
14,
2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
14. Most commonly prescribed
prescription medicine?
Hydrocodone/acetaminophen
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
15. Current FDA-approved hydrocodone-containing
products on the U.S. market (as of January, 2014)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Date
Prepared/
Source:
Drug Name and Brand
Name
HYDROCODONE BITARTRATE and ACETAMINOPHEN;
ANEXSIA; LORTAB; NORCET; NORCO; ZYDONE
Active Ingredient(s) • ACETAMINOPHEN; HYDROCODONE BITARTRATE
Form(s) and
Strength(s) Available
CAPSULE; ORAL: 500MG; 5MG
SOLUTION; ORAL:
TABLET; ORAL:
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
16. 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
0
20
40
60
80
100
120
140
160
2008
2009
2010
2011
2012
Hydrocodone/
Paracetamol
Levothyroxine
Sodium
Lisinopril
Simvasta.n
Metoprolol
Millions
of
Prescrip.ons
17. 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
18. U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
State Ranking* - Hydrocodone
January – September 2013
Source:
Drug
Enforcement
Administra.on,
Office
of
Diversion
Control,
Pharmaceu.cal
Inves.ga.ons
Sec.on,
Targe.ng
and
Analysis
Unit
Most
current
ARCOS
informa.on
as
of
March
18,
2014
19. State Ranking* - Hydrocodone
January – September 2013
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
Source:
Drug
Enforcement
Administra.on,
Office
of
Diversion
Control,
Pharmaceu.cal
Inves.ga.ons
Sec.on,
Targe.ng
and
Analysis
Unit
Most
current
ARCOS
informa.on
as
of
March
18,
2014
20. 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
21. 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
Procedures to control a substance
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
22. 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
23. NFLIS Cases
(Federal, State, and Local)
*2012
data
is
s.ll
being
submi^ed,
data
queried
on
1/22/2013
-‐
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
2006
2007
2008
2009
2010
2011
2012
2013*
Number
of
Cases
MEPERIDINE
OXYMORPHONE
CODEINE
HYDROMORPHONE
METHADONE
MORPHINE
HYDROCODONE
OXYCODONE
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
34. How Supplied
Strength
Image
Capsule
color(s)
Capsule
Text
NDC
Number
10
mg
White
opaque
“Zogenix
10
mg”
in
black
ink
43376-‐210-‐10
100
ct
bo^les
15
mg
Light
green
and
white
opaque
“Zogenix
15
mg”
in
black
ink
43376-‐215-‐10
100
ct
bo^les
20
mg
Light
green
opaque
“Zogenix
20
mg”
in
black
ink
43376-‐220-‐10
100
ct
bo^les
30
mg
Dark
blue
and
white
opaque
“Zogenix
30
mg”
in
black
ink
43376-‐230-‐10
100
ct
bo^les
40
mg
Dark
brown
and
white
opaque
“Zogenix
40
mg”
in
black
ink
43376-‐240-‐10
100
ct
bo^les
50
mg
Dark
brown
opaque
“Zogenix
50
mg”
in
black
ink
43376-‐250-‐10
100
ct
bo^les
35. ZohydroTM ER Formulation
Mul.-‐par.culate
formula.on
of
coated
carrier
beads
in
hard
gela.n
capsules
– Single-‐en.ty
Hydrocodone
bitartrate
– Rate-‐controlling
polymers
– Drug
release
by
diffusion
Extended
release
delivered
by
SODAS®
technology
– Example
of
SODAS®
technology
used
in
Ritalin®
LA
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
36. Alkermes SODAS® (Spheroidal Oral
Drug Absorption System) Technology
A
schema.c
representa.on
of
SODAS®
mul.layer
drug
delivery
technology
(adapted
from
Elan
drug
technologies)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
37. Background
OxyConIn®
(oxycodone)
vs.
Zohydro™
ER
(hydrocodone)
– SimilariIes:
• High-‐dose,
extended
release
(delivery
system)
• Schedule
II
opioids
(developed
from
opium)
• High
abuse
and
dependence
poten.al
• Indicated
for
the
management
of
pain
severe
enough
to
require
daily,
around-‐the-‐clock,
long
term
opioid
treatment
and
for
which
alterna.ve
treatment
op.ons
(e.g.
non-‐
opioid
analgesics
or
immediate-‐release
opioids)
are
inadequate
• Used
in
condi.ons
requiring
extended
period
of
pain
relief
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
38. Dosing Data for Clinically
Employed Opioid Analgesics
Source: Goodman and Gilman’s The
Pharmacological Basis of Therapeutics, 12th edition
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
39. Currently Marketed
Hydrocodone Products, U.S. only
Tabletscapsulesolu.on
(hydrocodone
+
acetaminophen
ibuprofen)
– Hydrocodone
dosage:
2.5
mg,
5
mg,
7.5
mg,
and
10
mg
– Product
Names:
Anexsia,
Lortab,
Norcet,
Norco,
Reprexain,
Vicoprofen,
Zydone
Solu.oncapsule
(hydrocodone
+
chloropheniramine
pseudoephedrine)
– Hydrocodone
dosage:
4
mg,
5
mg,
8
mg,
10
mg,
60
mg
– Product
Names:
Renzira,
Tussi
Caps,
Tussinox,
Vituz,
Zutripro
Syrup
(hydrocodone
+
homatropine)
– Hydrocodone
dosage:
1.5
mg/5
mL,
5
mg/5
mL
– Product
Names:
Hycodan,
Tussigen
As
of
January
2014
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
41. Meeting of the Anesthetic and Analgesic
Drug Products Advisory Committee
(AADPAC)
Date:
Dec.
7,
2012
Commi^ee
was
asked
to
determine
whether
the
benefit-‐risk
assessment
of
this
product
favors
its
approval
for
marke.ng.
The
commi^ee
is
comprised
of
authori.es
knowledgeable
in
the
fields
of
anesthesiology,
surgery,
epidemiology
or
sta.s.cs
and
related
special.es.
AADPAC
voted
2-‐11
[with
1
absten.on]
against
the
approval
of
ZohydroTM
ER
(hydrocodone
bitartrate
extended-‐release
capsules)
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
42. Zohydro™ ER Pharmacology
Zohydro™
ER,
extended
release
capsules
contain
a
higher
amount
of
pure
hydrocodone
dosages
compared
to
other
hydrocodone-‐containing
products
as
immediate
release
tablets
(e.g.,
50
mg
vs.
10
mg)
Zohydro™
ER
is
a
Schedule
II
opioid
– Other
Schedule
II
opioids
include
Fentanyl,
Oxycodone,
Methadone,
Morphine
Hydrocodone
is
approximately:
– 1
.mes
as
potent
as
oxycodone
– 1.5
.mes
as
potent
as
morphine
– 10
.mes
as
potent
as
codeine
The
principal
therapeu.c
ac.on
of
hydrocodone
is
analgesia.
As
with
other
opioids,
hydrocodone
causes
respiratory
depression.
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
43. Indicated Use
Zohydro™
ER
is
indicated
for
the
management
of
pain,
severe
enough
to
require
daily,
around-‐the-‐clock,
long-‐term
opioid
treatment
for
which
alterna.ve
treatment
op.ons
(e.g.
non-‐
opioid
analgesics
or
immediate-‐release
opioids)
are
inadequate
Dosage
strengths
and
administra.on
– 10,
15,
20,
30,
40,
50
mg
– Twice-‐daily
(q12h)
administra.on
Not
indicated
– Acute
pain
– PRN
analgesia
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
44. Potential for Abuse
Like
other
opioids,
hydrocodone
has
high
abuse
and
dependence
poten.al
Can
be
abused
in
a
manner
similar
to
other
opioids,
legal
or
illicit
Pa.ents
at
increased
risk
of
opioid
abuse
will
require
intensive
monitoring
for
signs
of
abuse
or
addic.on
DEA
was
able
to
extract
95%
or
more
of
the
ac.ve
drug
ingredient
by
grinding
the
capsule
contents,
and
dissolving
the
powder
in
water
or
common
solvents
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
45. Toxicity
Zohydro™
ER
contains
high
amounts
of
hydrocodone
Use
in
opioid
non-‐tolerant
pa.ents
may
lead
to
overdose,
par.cularly
acute
and
fatal
respiratory
depression
– Capsules
are
indicated
to
be
swallowed
whole
– Breaking
of
capsules
and
crushing
beads
Co-‐inges.on
of
alcoholic
beverages
may
result
in
fatal
plasma
hydrocodone
levels
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
46. What is a Risk Evaluation and
Mitigation Strategy (REMS)?
REMS
is
a
strategy
to
manage
known
or
poten.al
serious
risks
associated
with
a
drug
product.
FDA
requires
a
REMS
for
extended-‐release
and
long-‐ac.ng
opioid
analgesics.
The
goal
of
the
REMS
is
to
reduce
serious
adverse
outcomes
resul.ng
from
inappropriate
prescribing,
misuse,
and
abuse
of
these
products.
Developed
by
the
manufacturer
and
approved
by
FDA
A
REMS
is
an
a^empt
to
balance
the
need
for
access
to
the
drug
with
the
risks
associated
with
its
use
and
is
product
specific
Typically
implemented
prior
to
the
drug’s
approval
and
as
a
condi.on
of
approval
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
47. Risk Mitigation Elements of the ER/LA Opioid
REMS and the ZohydroTM ER Safe Use Initiative
ER/LA
Opioid
REMS
ZohydroTM
ER
Safe
Use
IniIaIve
Pa.ent
Ini.a.ves
• Medica.on
guide
• Counseling
• Pa.ent
Treatment
Kit
• Web-‐based
and
print
educa.on
• Opioid
disposal
program
• Locking
bo^le
cap/lock
box
Prescriber
Ini.a.ves
• REMS
educa.on
• Safe
use
training
• Risk
training
• Targeted
prescriber
marke.ng
• Prescriber
training
and
educa.on,
including
mentoring
• Prescriber
took
kit
• Pa.ent
selec.on
tools
• Urine
drug
screening
• Web-‐based
and
print
educa.on
• Clinical
tools
Pharmacist
Ini.a.ves
• Pharmacist
brochure
• Web-‐based
and
print
educa.on
Distributor
Ini.a.ves
• Distributor
starter
kit
Assessments
• Prescriber
training
• Quality
of
materials
• HCP
awareness
• Pa.ent
risk
understanding
• Misuse,
abuse,
overdose,
addic.on,
death
rates
• U.liza.on
pa^erns
• Prescribing
behaviors
• Prescribing
pa^erns
• Surveillance
for
medical
and
non-‐medical
use
• Teenager
surveillance
• Internet
and
media
surveillance
• Safe
Use
Advisory
Board
• Cash
claim
data
• Pharmacovigilance
review
Reproduced
from:
Advisory
CommiXee
Briefing
Document
NDA
20-‐2880
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
48. Prescriber Components of ER/LA
Opioid Analgesic REMS
Train
(Educate
Yourself)
-‐
Comple.on
of
a
REMS-‐compliant
educa.on
program
offered
by
an
accredited
provider
of
con.nuing
educa.on
(CE)
for
your
discipline
Counsel
Your
Pa.ents
-‐
Discuss
the
safe
use,
serious
risks,
storage,
and
disposal
of
ER/LA
opioid
analgesics
with
pa.ents
and
caregivers
every
.me
you
prescribe
these
medica.ons
Emphasize
Pa.ent
and
Caregiver
Understanding
of
Medica.on
Guide
-‐
Stress
pa.ents
and
their
caregivers
the
importance
of
reading
the
Medica.on
Guide
that
they
will
receive
from
their
pharmacist
every
.me
an
ER/LA
opioid
is
dispensed
to
them
Consider
Using
Other
Tools
–
In
addi.on
to
pa.ent
counseling,
there
are
publicly
available
tools
to
improve
pa.ent,
household
and
community
safety,
as
well
as
compliance
with
condi.ons
of
treatment,
including
pa.ent-‐
prescriber
agreement
(PPA)
and
risk
assessment
instruments
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
49. Zohydro™ ER Safe Use
Initiative
PaIent
IniIaIves
Pa.ent
Treatment
Kit
Web-‐based
and
print
educa.on
Opioid
disposal
program
Locking
bo^le
cap/lock
box
Prescriber
IniIaIves
Targeted
prescriber
marke.ng
Prescriber
training
and
educa.on,
including
mentoring
Prescriber
tool
kit
Pa.ent
selec.on
tools
Urine
drug
screening
Web-‐based
and
print
educa.on
Clinical
tools
Pharmacist
IniIaIves
Pharmacist
brochure
Web-‐based
and
print
educa.on
Distributor
IniIaIves
Distributor
Starter
Kit
Assessments
Surveillance
for
medical
and
non-‐
medical
use
Teenager
surveillance
Internet
and
media
surveillance
Safe
Use
Advisory
Board
Cash
claim
data
Pharmacovigilance
review
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
50. Concerns
A^orney
Generals
from
28
States
sent
a
le^er
to
FDA
Commissioner
regarding
the
approval
of
ZohydroTM
ER
The
le^er
requests
FDA
reconsider
its
approval
or
set
a
.meline
for
ZohydroTM
ER
to
be
reformulated
to
be
abuse-‐deterrent
while
working
with
other
federal
agencies
to
impose
restric.ons
on
how
ZohydroTM
ER
can
be
marketed
and
prescribed
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
51. Concerns
Recently
a
coali.on
of
more
than
40
healthcare,
consumer
and
addic.on
treatment
groups
urged
FDA
to
revoke
approval
of
ZohydroTM
ER
In
a
le^er
to
the
Secretary
of
Health
and
Human
Services,
eight
members
of
the
United
States
Congress
requested
HHS
to
reconsider
approval
of
ZohydroTM
ER
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
52. Potential methods of Diversion
Medicine
Cabinet
Friends
Street
sales
Prescrip.on
Fraud
Doctor
Shopping
Burglary/Robbery
Rogue
pain
clinic
–
Rogue
prac..oner
Rogue
pharmacy
Hospital/medical
staff
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
53. Law Enforcement Action Plan
for Zohydro™ (hydrocodone bitartrate ER)
Learn
from
our
previous
mistakes
-‐
OxyCon.n™
(oxycodone
ER)
Contact
MEs
and
emergency
room
physicians
to
ensure
they
are
educated
on
this
product.
Ensure
that
first
responders
are
educated
as
well.
Liaison
with
poison
control
centers
Educate
students,
teachers
,
guidance
counselors
,
civic
and
community
groups
Introduce
yourself
to
local
addic.on
treatment
providers
and
ask
them
to
report
recent
trends
they
are
observing
Request
ARCOS
and
PDMP
informa.on
as
appropriate.
Follow
up
all
leads
as
quickly
as
possible
concerning
inappropriate
health
prac..oner
prescribing
Work
with
DEA,
pharmacy/medical
boards
and
other
LE
agencies
at
the
first
hint
of
diversion
and
abuse
in
your
area.
Our
ability
to
network
and
share
resources
will
greatly
assist
in
quickly
iden.fying
and
shuQng
down
a
threat
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
54. Review
Questions / Comments
Background
on
Zohydro™
ER
– Pharmacology
– Indicated
Use
– Poten.al
for
Abuse
– Toxicity
DEA’s
Zohydro™
ER
Ac.on
Plan
Risk
Evalua.on
and
Mi.ga.on
Strategy
(REMS)
What
The
Future
Holds
U.S.
Drug
Enforcement
Administra.on
Office
of
Diversion
Control
