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Policies and laws_for_pharmacists_final_rev
1. Policies
and
Laws
for
Pharmacists
Dr.
Lynn
Rafferty,
Pharm.
D,
MBA,
N.D.,
CNC,
CNHP.
Assistant
Professor
at
The
College
of
Medicine,
Nova
Southeaster
University
Joel
Thornbury
President,
Kentucky
Board
of
Pharmacy
2. Learning
ObjecKves
1. Describe
the
relaKonship
between
federal
law,
state
law
and
other
regulatory
requirements
pertaining
to
diversion.
2. Outline
the
variables
to
consider
when
construcKng
a
strategy
for
diversion
prevenKon,
detecKon
and
remediaKon.
3. Formulate
an
effecKve
plan
of
acKon
when
diversion
is
discovered
or
suspected.
3. Disclosure
Statement
• Lynn
Lafferty
has
no
financial
relaKonships
with
proprietary
enKKes
that
produces
health
care
goods
and
services.
• Joel
Thornbury
has
no
financial
relaKonships
with
proprietary
enKKes
that
produces
health
care
goods
and
services.
4. Florida
Law
and
the
PracKce
of
Pharmacy
Lynn
Lafferty,
Pharm.D.,
N.D.
Assistant
Professor
College
of
Osteopathic
Medicine
Nova
Southeastern
University
*SPECIAL
THANKS
Dr.
James
Hall,
Broward
Task
Force
5. Federal
Laws
• Title
21
United
States
Code
(21
U.S.C.)
801-‐971
and
the
DEA
regulaKons,
Title
21,
Code
of
Federal
RegulaKons
(21
C.F.R.),
Parts
1300
to
End.
– On
line
Pharmacists
Manuel
– Sec$on
1306.06
Persons
en$tled
to
fill
prescrip$ons
“A
prescripKon
for
a
controlled
substance
may
only
be
filled
by
a
pharmacist,
acKng
in
the
usual
course
of
his
professional
pracKce
and
either
registered
individually
or
employed
in
a
registered
pharmacy,
a
registered
central
fill
pharmacy,
or
registered
insKtuKonal
pracKKoner.”
–
6. Florida
State
Law
• Title
XLVI,
Chapter
893
• A
pharmacist,
in
good
faith
and
in
the
course
of
professional
pracKce
only,
may
dispense
controlled
substances
upon
a
wriaen
or
oral
prescripKon
of
a
pracKKoner,
under
the
following
condiKons:
7. Prescription Drug-Related Deaths
in Florida: 2011
5,489 individuals died with one
or more prescription drugs in their
system. The drugs were at both
lethal and non-lethal levels.
Source:
Florida
Department
of
Law
Enforcement:
Florida
Medical
Examiners
Commission
Report
2011
8. Physician
Dispensing
• Physicians
ordering
and
dispensing
prescripKon
medicaKons
– Used
to
be
limited
to
emergency
supply
and
samples
– Large
problems
with
limited
benefits
to
paKents.
9. Physician
Dispensing
Pros
• Improved
paKent
access
to
medicaKons
• PaKent
convenience
• Generic
and
therapeuKc
subsKtuKons
due
to
the
physician’s
enhanced
awareness
of
medicaKon
costs
• Possible
improved
paKent
adherence
with
medicaKon
regimens
10. Physician
Dispensing
Cons
• Conflict
of
Interest
– Large
Problem
with
narcoKc
dispensing
• Serious
medicaKon
safety
concerns
– loss
of
a
crucial
second
check
by
a
pharmacist
and
use
of
sofware
to
detect
prescribing
errors
and
,
– lack
of
regulatory
oversight
•
lax
procedures
for
medicaKon
labeling
• record-‐keeping
• storage
• supervision
of
the
dispenser
11. Top 25 Dispensing Practitioners of
Oxycodone in the U.S.
(All in Florida)
October2008 – March 2009
ARCOS
17. Number
of
Oxycodone
Reports
Detected
among
Decedents
in
Broward
County:
2007-‐2011
250
225
236
200
NUMBER
of
171
Oxycodone
174
OCCURRENCES
150
Including
“Present”
&
“Cause
of
Death”
Broward
100
119
50
0
2007
2008
2009
2010
2011
SOURCE:
Florida
Medical
Examiners
Commission
Report
2011
18. Number
of
Alprazolam
Reports
Detected
among
Decedents
in
Broward
County:
2007-‐
2011
300
245
235
250
NUMBER
of
203
Alprazolam
200
OCCURRENCES
Including
199
“Present”
&
150
133
“Cause
of
Death”
100
Broward
50
0
2007
2008
2009
2010
2011
SOURCE:
Florida
Medical
Examiners
Commission
Report
2011
19. Number
of
Emergency
Departments
Reports
by
Drug
in
Broward
&
Palm
Beach
Coun$es,
FL:
2008,,2009
and
2010
6,000
# of ED Report Estimates
5,560
5,500
5,000
Cocaine
4,479
4,500
4,081
4,000
3,500 3,299
3,000 2,913
3,110
2,351 2,900
2,500
2,274
NMU
Benzodiazepines
2,000
2008 2009 2010
Note:
Cocaine
visits
had
sta$s$cally
significant
decreases
from
2008
to
2009.
Prescrip$on
Opioid
nonmedical
use
visits
had
sta$s$cally
significant
increases
from
2008
to
2010.
No
sta$s$cally
significant
changes
were
noted
for
2008
or
2009
compared
with
2010
for
Benzodiazepines.
SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
20. Number
of
Emergency
Departments
Reports
by
Drug
in
Broward
&
Palm
Beach
Coun$es,
FL:
2008,,2009
and
2010
6,000
# of ED Report Estimates
5,560
5,500
5,000
Cocaine
4,479
4,500
4,081
4,000
3,500 3,299
2,928 2,913 3,249
3,000
2,500
2,351 2,870 Marijuana
2,000
2008 2009 2010
Note:
Cocaine
visits
had
sta$s$cally
significant
decreases
from
2008
to
2009.
Prescrip$on
Opioid
nonmedical
use
visits
had
sta$s$cally
significant
increases
from
2008
to
2010.
No
sta$s$cally
significant
changes
were
noted
for
2008
or
2009
compared
with
2010
for
Marijuana.
SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
21. Number
of
Heroin-‐related
Deaths
in
Florida:
2000
–2011
400
12
??
20 Florida
#
Lethal
Heroin
Deaths
350 Miami-Dade
300
Broward
250
200
150
100
62
50 15
0 3
SOURCE: Florida Medical Examiners Commission Reports 2000-2011
22. Sun
SenKnel
February
19,
2013
• “Heroin
taking
oxy's
place
for
more
addicts”
– Heroin
increasing
– Lost
opportunity
to
get
people
into
treatment
23. Number
of
Primary
Heroin
Treatment
Admissions
Miami-‐Dade
and
Broward
Coun$es,
FL:
2009-‐2012
350
Broward
316
#
of
primary
Treatment
Admissions
Miami-‐Dade
308
300
250
227
200
183
150
156
169
150
105
100
50
0
2009
2010
2011
2012*
2009
2010
2011
2012*
1
2
3
4
5
6
7
8
*
2012
Admissions
based
on
2
x‘s
1st
Half
2012
SOURCE:
Florida
Department
of
Children
and
Families
24. FL
House
Bill
7095
EffecKve
July
1,
2011
• PracKoners
no
longer
authorized
to
dispense
Schedule
II
or
III
controlled
substances.
– Except:
Emergency
72
hr.
supply,
correcKons,
hospice,
clinical
trials,
surgical
procedures,
and
methadone
clinics
• Standards
Made
Clear
– Complete
medical
history
– Wriaen
individualized
RX
plan
– Wriaen
controlled
substance
agreement
– Reg.
follow-‐up
plan
• Must
designate
themselves
as
a
controlled
substance
prescribing
pracKKoner
• Counterfeit-‐proof
Rx
pad
25. Pharmacist
• Number
one
most
respected
professional
• Most
Accessible
– More
paKent
contacts
than
any
other
health
care
professional
• Has
access
to
paKent,
doctor
and
informaKon
• CriKcized
not
taking
a
strong
role
in
addicKon
medicine
26. Knowledge,
Aktudes
and
PracKces
of
Pharmacists
Concerning
PrescripKon
Drug
Abuse,
Lafferty,
Hunter
and
Marsh
• 454
Pharmacists
QuesKoned
• 65%
Retail,
16.5%
Hospital,
9%
Mail
order
• 68%
B.S.,
25%
Pharm.D.
• 65%
Male
and
35%
Female
• 65%
over
45
years
old
27. Results
• Knowledge
– Most
did
not
answer
the
addicKon
quesKons
correctly
• Only
28%
knew
the
standard
of
care
• Less
than
half
said
they
knew
about
intervenKon
and
treatment
• EducaKon
– Almost
30%
had
no
substance
abuse
educaKon
– 67.5%
had
less
than
2
hours
28. Treatment
and
IntervenKon
• Although
most
had
not
intervened,
the
more
educaKon
they
had
the
more
confident
they
were
to
do
intervenKon
• They
were
also
more
likely
to
call
the
physician
to
speak
about
a
problem.
29. EducaKon
Needed
• Pharmacists
can
help
by:
– Calling
doctors
when
they
believe
there
is
a
problem
– Speaking
to
alternaKves
to
paKent
– Checking
and
making
sure
they
are
not
using
mulKple
pharmacies
and
doctors
– Intervening
30. Discussion
• Pharmacists
Role
– CerKficaKon
program
– EducaKon
needed
to
have
a
greater
role
– Pain
pharmacy
• Society
at
Large
– Oxycodone
vs.
Heroin
31. Abuse…a
problem….Hello?
Yes,
Kentucky
Pharmacy
is
Here!!
April
2
–
4,
2013
Omni
Orlando
Resort
at
ChampionsGate
32.
33. Topics
for
Discussion
• 1.
Describe
what
SS-‐HB1
has
done
to
affect
the
Profession
and
help
reduce
diversion.
• 2.
Provide
an
update
on
issues
we
faced
and
what
Bill
has
just
passed
and
signed
to
correct
issues.
• 3.
Formulate
an
effecKve
plan
of
acKon
when
diversion
is
discovered
or
suspected.