1. Na#onal
Rx
Drug
Abuse
Summit
Pharmaceu)cal
Take-‐Back
and
the
Proposed
DEA
Regula)ons
Pharmacy
Track
–
April
3,
2013
Sco=
Cassel,
CEO
and
Founder
The
Product
Stewardship
Ins#tute
1
2. Disclosure
Statement
Sco=
Cassel
has
no
has
no
financial
rela#onships
with
proprietary
en##es
that
produce
health
care
goods
and
services.
Chris
Angel
has
no
financial
rela#onships
with
proprietary
en##es
that
produce
health
care
goods
and
services.
Phil
Burgess
has
no
financial
rela#onships
with
proprietary
en##es
that
produce
health
care
goods
and
services.
2
3. Session
Learning
Objec#ves
1. Iden#fy
the
basis
and
effects
of
the
proposed
DEA
regula#ons.
2.
Lay
out
the
impact
of
the
proposed
regula#ons.
3.
Construct
a
plan
of
ac#on
to
implement
the
DEA
regula#ons
and
pill
take-‐back
programs
in
the
a=endee’s
community.
3
4. Topics
I
will
cover
today
• The
Problem
–
Improper
Disposal
of
Pharmaceu)cals
• Safety
issues
• Environmental
concerns
•
The
Solu)on:
Pharmaceu)cal
Take-‐Back
programs
• Support
for
Take-‐Back
• Trends
-‐
U.S.
and
interna#onal
• Why
exis#ng
efforts
are
not
solving
the
problem
• Overview
of
Product
Stewardship
and
Extended
Producer
Responsibility
(EPR)
for
Managing
Waste
Pharmaceu)cals
• Legisla#ve
ac#vity
at
local,
state,
and
federal
levels
• Overview
of
DEA’s
Proposed
Regula)ons
Regarding
the
Disposal
of
Controlled
Substances
4
5. Who
is
the
Product
Stewardship
Ins#tute?
•
Non-‐profit
founded
in
2000
• Memberships
47
States
200+
Local
governments
• Partnerships
(95+)
Companies
Organiza#ons
Universi#es
Non-‐US
Governments
• Board
of
Directors:
7
states,
Global
Product
Stewardship
Council
4
local
agencies
(PSI
represented
on
Board
of
Directors)
• Advisory
Council:
Mul)-‐
stakeholder
(14
members)
5
6. The
Problem:
Drug-‐induced
deaths
second
only
to
motor
vehicle
fatali#es
(1999–2007)
Source:
Na#onal
Center
for
Health
Sta#s#cs,
Centers
for
Disease
Control
and
Preven#on.
Na#onal
Vital
Sta#s#cs
Reports
Deaths:
Final
Data
for
the
years
1999
to
2007
(2001
to
2010).
6
7. The
Problem:
Prescrip#on
Drug
Abuse
Classified
as
an
“epidemic”
by
the
Centers
for
Disease
Control
and
Preven#on
7
out
of
10
prescrip#on
drug
abusers
obtained
their
drugs
from
friends
or
rela#ves
7
8. The
Problem:
Accidental
Poisonings
• Startling
facts
from
the
Centers
for
Disease
Control
and
Preven)on:
• In
2009,
76%
of
poisoning
deaths
in
the
U.S.
were
uninten#onal
• In
2009,
91%
of
all
uninten#onal
poisoning
deaths
were
caused
by
drugs.
• Among
children,
emergency
room
visits
for
drug
poisonings
(excluding
misuse
or
abuse)
are
twice
as
common
as
poisonings
from
other
household
products
(e.g.,
cleaning
solu#ons)
1
• Between
2004
and
2005,
an
es#mated
71,000
children
(<18
years
of
age)
were
seen
in
emergency
rooms
due
to
drug
poisonings
(excluding
abuse
and
recrea#onal
drug
use).
• Over
80%
were
because
an
unsupervised
child
found
and
consumed
medica#ons.
1
1Schillie
SF,
Shehab,
N,
Thomas,
KE,
Budnitz
DS.
Medica#on
overdoses
leading
to
emergency
department
visits
among
children.
Am
J
Prev
Med
2009;37:181-‐187.
8
9. The
Problem:
Environmental
Concerns
• Medicines
enter
our
waterways
via
a
number
of
channels:
• Agricultural
run-‐off
• Human
excre#on
• Improper
disposal
• Effects
in
the
environment:
• Aqua#c
impacts
• Poten#al
contamina#on
of
drinking
water
• Current
wastewater
treatment
plants
not
designed
to
remove
pharmaceu#cal
compounds
9
10. Pharmaceu#cal
Take-‐Back
Programs
• One-‐day
“ Take-‐Back”
events
operated
by:
• Law
enforcement
(can
accept
controlled
substances)
• Local
governments/Household
Hazardous
Waste
collec#ons
• Community
organiza#ons
and
other
NGOs
• Permanent
collec)ons
located
at:
• Police
departments
(can
accept
controlled
substances)
• Retail
pharmacies
• Healthcare
facili#es,
community
centers,
etc.
• Mail-‐back
programs
• Law
enforcement
• Retail
pharmacies
(partnering
with
reverse
distributors)
–
for
a
fee
• University
pilots
(e.g.,
University
of
Maine,
University
of
Wisconsin
Extension)
10
11. Support
for
Drug
Take-‐Back
• Drug
Enforcement
Administra)on
(DEA)
• Held
5
Na#onal
Prescrip#on
Drug
Take-‐Back
Days
since
2010
next
event
scheduled
for
April
27,
2013
• Office
of
Na)onal
Drug
Control
Policy
(ONDCP)
• Supports
drug
take-‐back
as
part
of
its
Na#onal
Drug
Control
Strategy
• Food
and
Drug
Administra)on
(FDA)
• Worked
with
ONDCP
to
develop
guidelines
for
drug
disposal
recommends
disposal
via
drug
take-‐back
programs
• Environmental
Protec)on
Agency
(EPA)
• Encourages
the
public
to
take
advantage
of
drug
take-‐back
programs
• 43
states
directly
promote
drug
take-‐back
• Agency
websites
provide
informa#on
either
on
their
own
state
programs
and/
or
federal
DEA
Take-‐Back
Days
11
12. Status
of
Pharmaceu#cal
Take-‐Back
Programs
• Over
500
take-‐back
programs
currently
opera#ng
across
the
country,
but
the
majority
of
Americans
do
not
have
access
to
a
convenient
take-‐back
loca#on
Results
from
Community
Medical
Founda:on
for
Pa:ent
Safety’s
Survey
of
Drug
Take-‐Back
and
Disposal
Programs
(2009
,
2010)
Collec)on
Method
of
Drug
Take-‐Back
Primary
Funding
Mechanism
of
Drug
Take-‐
Programs
Back
Programs
3%
Drop-‐off
(Pharmacy),
53%
Self-‐funded,
43%
8%
Drop-‐off
(Police
9%
Sta#on),
19%
Sponsors,
26%
17%
22%
43%
One-‐Day
Events,
17%
53%
Grants,
22%
19%
Other,
8%
26%
Other,
9%
Direct
Mail
Back,
3%
N=
562
(some
respondents
N=
926
(some
respondents
selected
selected
mul:ple
methods)
mul:ple
sources)
12
13. Why
aren’t
exis#ng
efforts
solving
the
problem?
PSI
developed
Key
Elements
of
Pharmaceu)cal
Collec)on
and
Disposal
Programs:
A
Vision
for
the
Great
Lakes
Region
• In
order
to
protect
public
health
and
the
environment,
programs
should
be:
• On-‐going
• Free
at
the
point
of
delivery
for
disposal
• Convenient
• Secure
• Able
to
accept
all
drugs
from
• Widely
promoted
households
• Programs
should
minimize
impact
on
the
environment
by
ensuring
collected
medicines
are
properly
destroyed
according
to
exis#ng
regula#ons.
• Programs
must
be
sustainably
and
adequately
funded.
• Programs
should
iden#fy
and
address
the
underlying
drivers
that
contribute
to
pharmaceu#cal
waste.
13
14. What
is
Product
Stewardship?
A
policy
approach
that…
• Minimizes
health,
safety,
environmental,
and
social
impacts
• Maximizes
economic
benefits
of
a
product
and
its
packaging
• Considers
all
lifecycle
stages,
from
design
to
end-‐of-‐life
• Is
either
voluntary
or
required
by
law
14
15. What
is
Extended
Producer
Responsibility
(EPR)?
• Mandatory
product
stewardship
Product
Stewardship
• Producers
hold
financial
and
managerial
responsibility
for
post-‐
Extended
consumer
products
and
Producer
packaging
Responsibility
(EPR)
• Central
tenet
of
product
stewardship
15
16. What
might
EPR
for
Pharmaceu#cals
Really
Look
Like?
Extended
Producer
Responsibility
(EPR)
16
17. Federal
Pharmaceu#cal
Stewardship
Legisla#on
Pharmaceu)cal
Stewardship
Act
of
2011
• Introduced
by
Congresswoman
Louise
Slaughter
(NY)
• First
federal
EPR
bill
on
any
product
• Would
create
“Na#onal
Pharmaceu#cal
Stewardship
Organiza#on,”
with
Directors
appointed
by
EPA,
to
implement
a
na#onal
EPR
program
• Rep.
Slaughter
plans
to
re-‐introduce
in
2013
17
18. Pharmaceu#cal
Stewardship
Legisla#on
State
Level
Bills
introduced:
California
(2013)
Florida
(2009)
Maine
(2010)
Maryland
(2010)
Minnesota
(2010)
New
York
(2011;
2013)
Oregon
(2009)
Pennsylvania
(2012)
Washington
(2011)
18
19. Local
Approach
to
Pharmaceu#cal
Stewardship
• Na#on’s
first
local
EPR
law,
first
pharmaceu#cals
EPR
law
• Requires
pharmaceu#cal
manufacturers
to
finance
and
manage
a
take-‐back
program
for
unused
and
expired
medica#ons
• Industry
lawsuit
claiming
law
violates
the
Interstate
Commerce
Clause
pending
19
20. Secure
and
Responsible
Drug
Disposal
Act
• Passed
by
Congress
in
October
2010
to
provide
a
framework
for
allowing
the
public
(i.e.,
ul#mate
users)
to
dispose
of
their
lesover
and
expired
controlled
substances
safely
and
securely
(more
flexibility
&
less
costly)
• Amends
the
Controlled
Substances
Act
• Drug
Enforcement
Administra#on
(DEA)
to
develop
regula#ons
regarding
the
disposal
of
controlled
substances
• January
2011
–
public
hearing
held
in
Washington,
D.C.
• December
2012
–
DEA
issued
proposed
rule
[Docket
No.
DEA
-‐316];
comment
period
closed
February
19,
2013
20
21. DEA
Proposed
Rule
Disposal
of
Controlled
Substances
DEA
proposed
to
expand
collec#on
op#ons
for
the
disposal
of
controlled
substances
to
include:
1. Take-‐back
events
–
conducted
by
law
enforcement
agencies
only.
2. Permanent
collec)on
sites
–
operated
by
DEA-‐authorized
retail
pharmacies,
distributors,
reverse
distributors,
law
enforcement
agencies,
or
manufacturers.
Retail
pharmacies
may
also
operate
collec#on
receptacles
at
long–term
care
facili#es
(“LTCFs”).
3. Mail-‐back
programs
–
operated
by
DEA-‐authorized
manufacturers,
distributors,
reverse
distributors,
retail
pharmacies,
or
law
enforcement
agencies.
21
24. Topics
I
will
cover
today
1.
Understand
the
importance
of
drug
take-‐back
programs
and
the
poten#al
role
for
pharmaceu#cal
stewardship
in
addressing
drug
abuse.
2.
Iden#fy
the
basics
of
DEA’s
proposed
rule
and
the
implica#ons
for
retail
pharmacies.
3.
Construct
a
plan
of
ac#on
to
par#cipate
in
a
drug
take-‐back
program
in
the
a=endees’
community
following
requirements
proposed
by
the
DEA
25. The
Problem
• Flushing
unwanted/unused
medica#ons
• Associated
Press
Study
• US
Geological
Study
• DEQ
–
Michigan
Department
of
Environmental
Quality-‐Other
State
Regulatory
Agencies
• Prescrip#on
Drug
Abuse
• DEA
–Controlled
Substances
32. Clean
Water
Safe
Communi#es
Environmental
Reasons………
Substance
Abuse
Preven#on
Reasons……
Law
Enforcement
Reasons…..
33. Clean
Water
Safe
Communi#es
We
Agree
on
that!
Let’s
Work
Together!
What
will
you
do
when
you
get
home
from
the
Rx
Drug
Abuse
Summit?
Yellow
Jug
Old
Drugs
Program
working
in
many
communi#es
to
provide
clean
water
and
safe
communi#es
34. Yellow
Jug
Old
Drugs
Program
Overview
Non
Profit
Model
Pharmacy
based
Area
Served
Number
of
par#cipa#ng
Pharmacies
55,000
pounds
collected
35. Yellow
Jug
Old
Drugs
Advantages
• Pharmacy
based
and
easily
recognizable
• Well
thought
out,
strict
protocol
• Leverage
grant
funds-‐Sustainable
aser
grants
• Low
opera#onal
cost
/
Volunteers
•
Professional
Customer
Service
• Free
publicity
–
News
stories,
Radio
and
Video
public
service
announcements
(PSAs)
• More
a=en#on
on
collec#on
of
controlled
substances
in
communi#es
that
have
YJOD
• New
DEA
Regs
to
allow
retail
pharmacies
to
accept
controlled
substances
36. Proposed
DEA
Regs
allow
Retail
Pharmacies
to
collect
controlled
Substances
•
Page
8
of
the
proposed
regula#ons
“authorized
registrants
that
choose
to
maintain
collec:on
receptacles
may
be
enhanced
by
increased
consumer
presence
at
their
registered
loca:ons
and
the
goodwill
that
develops
from
providing
a
valuable
community
service””
Page
86
“A
pharmacy
may
derive
tangible
benefits
such
as
addi:onal
revenue
from
increased
retail
traffic
to
the
pharmacy”
37. Substance
Abuse
Preven#on
Partners
Michigan
Rx
Be
the
Solu#on
Campaign
NMSAS
www.drugfreenorthernmichigan.com/disposal.htmlaign
h=p://www.barrycountysa}.com
Royal
Oak
Community
Coali#on
The
Alliance
of
Coali#ons
for
Healthy
Communi#es
(ACHC)
39. Contact
Info
Chris
Angel
President,
Volunteer
Board
of
Directors
Great
Lakes
Clean
Water
Organiza#on
info@greatlakescleanwater.org
www.greatlakescleanwater.org
989-‐736-‐8179
40. Pharmaceu)cal
Take-‐Back
and
the
Proposed
DEA
Regula)ons
Philip
P.
Burgess,
RPh,
DPh,
MBA
Chairman,
Illinois
State
Board
of
Pharmacy
April
2
–
4,
2013
Omni
Orlando
Resort
at
ChampionsGate
41. Topics
I
will
cover
today
• 1.
Understand
the
importance
of
drug
take-‐
back
programs
and
the
poten#al
role
for
pharmaceu#cal
stewardship
in
addressing
drug
abuse.
• 2.
Iden#fy
the
basics
of
DEA’s
proposed
rule
and
the
implica#ons
for
retail
pharmacies.
• 3.
Construct
a
plan
of
ac#on
to
par#cipate
in
a
drug
take-‐back
program
in
the
a=endees’
community
following
requirements
proposed
by
the
DEA.
42. Role
of
State
Boards
of
Pharmacy
• Protect
the
health
and
welfare
of
the
ci#zens
of
their
respec#ve
state.
• Ac#ve
involvement
in
drug
disposal
programs
by
pharmacists
can
have
significant
posi#ve
impact
on
pa#ent
safety
and
improve
pa#ent
care
• Delicate
“balancing
act”
to
decrease
drug
diversion
while
improving
pa#ent
safety.
43. Unused patient medication in the
U.S.
• Approximately 4 billion prescriptions are filled in the
United States annually with an estimated 35%, or 200
million pounds go unused.
• Improper disposal of unused medications can
adversely effect the environment
• Improper disposal or diversion of unused medications
increases the risk of accidental poisoning and drug
abuse.
44. Societal Impacts
When Drugs Get Into the Wrong Hands
Easy access to prescription drugs has led to a growing
number of teens whom the Partnership for a Drug-Free
America refers to as Generation Rx.
Nationwide, 1.5 Million kids say they have abused
prescription drugs. The 2010 National Survey on Drug Use
and Health indicates that over 70 percent of Americans 12
and older who used pain relievers non-medically in the
previous year obtained the drugs from a friend or relative.
Emergency room visits are greater for prescription drugs
than marijuana and heroin COMBINED, according to the
Drug Abuse Warning Network.
45. Why Pharmacists Should be Involved
Pharmacists
are
posi#oned
to
play
a
huge
role
in
helping
properly
dispose
of
unused
medica#ons.
The
most
readily
available
health
care
professional
in
the
community.
It
makes
sense
to
return
the
drugs
from
where
they
were
ini#ally
purchased.
46. Disposal Options
The Prescription Pill & Drug Disposal
Program is a multi-state, collaborative effort
between communities, local pharmacies,
police departments, hospitals and city
officials. Locations such as pharmacies
and police stations can participate by
setting up drop-boxes for the public to drop
off their old or unused prescription drugs.
www.p2d2program.org
47. Disposal Options
Minnesota s Take it to The Box
program at participating police
stations.
Similar grassroots efforts are popping
up nation-wide.
48. NCPA Dispose My Meds
• In 2010, National Community Pharmacy Association developed a
program to promote pharmacists involvement with drug disposal.
• Pilot program in conjunction with the Iowa Pharmacy Association and
the Iowa Board of Pharmacy.
• Participating NCPA members listed on www.disposemymeds.org
• To date:
– 1,400 pharmacies participating
– 70,000 lbs of drugs collected for safe disposal
– The Secure and Responsible Drug Disposal Act (S. 3397),
legislation backed by NCPA will improve and encourage voluntary
prescription drug disposal programs like the Dispose My Meds
program.
50. Impact
of
Proposed
DEA
Regula#ons
“These
regula#ons
propose
to
allow
authorized
manufacturers,
distributors,
reverse
distributors
and
retail
pharmacies
to
voluntarily
administer
mail-‐back
programs
and
maintain
collec#on
receptacles.
In
addi#on,
this
proposed
rule
expands
the
authority
of
authorized
retail
pharmacies
to
voluntarily
maintain
collec#on
receptacles
at
long
term
care
facili#es.”
51. Impact
of
Proposed
DEA
Regula#ons
• Allows
pharmacies
to
par#cipate
in
taking
back
controlled
substance
prescrip#ons
from
pa#ents
without
the
requirement
of
direct
law
enforcement
involvement.
• Increased
access
to
pa#ents
for
the
proper
disposal
through
drop-‐off
kiosks
in
pharmacies
or
use
of
various
mail-‐back
programs.
• Extensive
record-‐keeping
requirements.
52. Impact
of
Proposed
DEA
Regula#ons
• Although
most
state
pharmacy
regula#ons
mirror
DEA,
there
will
be
selected
states
that
will
require
changes
to
either
their
Pharmacy
Prac#ce
Acts
or
their
Rules
to
allow
the
taking
back
of
medica#ons
in
the
pharmacies.
• Un#l
those
changes
are
enacted,
the
use
of
the
mail-‐back
provisions
will
be
the
only
op#on
in
those
states.
53. Impact
of
Proposed
DEA
Regula#ons
• Con#nues
to
allow
law
enforcement
agencies
to
voluntarily
conduct
take-‐back
events,
administer
mail-‐back
programs,
and
maintain
collec#on
receptacles.
• NOT
ADDRESSED
in
the
regula#ons
is
the
need
to
be=er
educate
the
prescribers
to
minimize
the
quan##es
that
are
prescribed.