Ph 5 michel ward_warren

Liabilities for
Pharmacists
April
23,
2014

Atlanta
Marrio2
Marquis

Troubles
Along
The
Way

Disclosure Statements
•  Alix
C.
Michel

•  David
J.
Ward

•  Michael
L.
Warren

The three faculty for this activity have disclosed no relevant, real or
apparent personal or professional financial relationships.

Learning Objectives
1.  IdenGfy
current
liabiliGes
facing
pharmacists.

2.  Evaluate
cases
brought
against
a
pharmacist

to
show
best
pracGces.

3.  Establish
methods
for
improving
a

pharmacist’s
pracGce.

Overview of Pharmacist Liabilities
•  Pharmacy
Robberies

•  Criminal
Liability

•  Civil
Liability

•  CMS
Issues

•  Board
InvesGgaGons

Troubles That Break Down Your Door
Pharmacy Robberies
•  Chain
Pharmacies
reported
517
armed

robberies
January
‘12-‐January
’13

•  Retail
Pharmacies
reported
214
armed

robberies
January
‘12-‐January
’13

How Robberies Impact Pharmacies
•  Psychological
impact

•  Loss
of
employees

•  Loss
of
business

•  Time
and
expense

– DEA,
police
and
insurance
invesGgaGon
and

reporGng

What keeps pharmacists up at night
Police Arrest Second Suspect In Pharmacy Robbery, Murder
Sep 22, 2013 - myfoxphili.com
Prosecutors to seek death penalty against ex-lawman in pharmacy
slayings, robbery
Sep 17, 2013 - Knoxnews.com
Pharmacy Shooting: 2 people dead, 2 injured in shooting at East
Tennessee pharmacy
May 24, 2013 - WBIR-TV
NY Pharmacy Robbery Leaves Suspect, ATF Agent Dead in Confused
Shootout
Jan. 1, 2012 - WACB-TV

Suspect Arrested in New York Pharmacy Killings
June 22, 2011 - ABC News

“Hardening the Target” –
Making the store less attractive
•  Employees
trained
on
suspicious
persons
and

behaviors
and
what
to
do
if
a
robbery
occurs

•  Front
counter
easily
visible
from
the
outside

•  Video
surveillance
prominent

•  High
pharmacy
counter

•  Bullet
resistant
glass

•  Time
delay
safe

“2nd level” Protection
•  Tracking
devices

•  DNA
and
other
marking
technologies

•  Veriﬁed
alarms

•  Community
policing
–

– Know
the
police

– Share
informaGon

– Suspicious
person
alerts

What to Do If Robber Enters Building
•  Remain
as
calm
as
possible

•  Comply
but
don’t
volunteer

•  Make
sure
the
robber
understands
what
you

are
about
to
do

•  Observe

•  Do
not
a2empt
to
chase
or
apprehend
the

robber

What to do after Robber has left
•  Immediately
lock
all
doors

•  Call
police

•  Take
notes
on
what
happened

•  Preserve
evidence

Other Pharmacist’s Responses

Problems that Knock at Your Door
Why pharmacist liability is so high
•  Pharmacists
are
consistently
viewed
as
the
“last

line
of
defense”
in
making
sure
a
prescripGon
is

right
–
that
it
is
the
correct
drug,
that
dosage
is

correct
and
that
the
person
should
be
receiving

the
prescripGon

How
that
applies
to
prescrip/on
narco/cs

Problems that Knock at Your Door
The Corresponding Responsibility
Doctrine
•  The
United
States
Controlled
Substances
Act

(CSA)
is
the
statutory
basis
for
federal
oversight

of
controlled
substance
regulaGon
in
the
United

States.

•  The
CSA
provides
the
pharmacist
an
aﬃrmaGve

obligaGon
to
only
ﬁll
prescripGons
that
are

“issued
in
the
usual
course
of
professional

treatment,”
and
prescripGons
that
do
not
meet

this
requirement
are
considered
improper.

•  The
pharmacist
must
exercise
sound

professional
judgment
regarding
the

validity
of
a
prescripGon
prior
to

dispensing.
The
pharmacist
should
not

assume
that
every
controlled
substance

prescripGon
is
improper,
but
rather
take

aﬃrma8ve
steps
to
ensure
the

prescrip8on’s
validity

Source of Pharmacists’ Corresponding
Responsibility
•  (A)n
order
purporGng
to
be
a
Rx
issued
not
in
the

usual
course
of
professional
treatment
or
in

legiGmate
and
authorized
research
is
not
a
Rx
within

the
meaning
and
intent
of
secGon
309
of
the
Act
(21

U.S.C.
§
829)
and
the
person
knowingly
ﬁlling
such
a

purported
Rx,
as
well
as
the
person
issuing
it,
shall

be
subject
to
the
penal8es
provided
for
violaGons
of

the
provisions
of
law
relaGng
to
controlled

substances.

21
C.F.R.
§
1306.04(a)

Corresponding Responsibility
Doctrine
U.S. v. Hayes 1979 (Texas)
•  Pharmacist
ﬁlled
34
prescripGons
for
Dilaudid
for

paGent
(3400
pills)
and
75
prescripGons
for

Preludin
in
month
1

•  101
prescripGons
for
Dilaudid
and
137

prescripGons
for
Preludin
in
month
2

•  Prescribing
Doctor
was
transient
alcoholic
that

lived
part-‐Gme
with
pharmacist

Doctrine
U.S. v. Hayes 1979 (Texas)
•  Pharmacist:
Cannot
have
a
"corresponding

responsibility"
to
that
of
a
pracGGoner

because
he
cannot
prescribe
at
all
but
only

dispense;
an
a2empt
by
regulaGon
to
impose

on
him
the
obligaGons
of
a
prescriber
must,

therefore,
be
ineﬀectual.

•  Court:
Pharmacist
may
not
ﬁll
a
wri2en

order
from
a
pracGGoner,
appearing
on
its

face
to
be
a
prescripGon,
if
he
knows
the

pracGGoner
issued
it
in
other
than
the

usual
course
of
medical
treatment.
The

regulaGon
gives
"fair
noGce
that
certain

conduct
is
proscribed.“
We
aﬃrm
the

Convic8on.

Doctrine
U.S. v. Irwin 1981 (Texas)
•  Delivery
of
Controlled
Substance

•  Delivery
of
controlled
substance
was
other

than
for
a
legiGmate
medical
purpose
and
in

the
usual
course
of
professional
pracGce

•  Conduct
was
knowing
and
intenGonal

Doctrine
Med. Shoppe-Jonesborough v. DEA 2008
The
regulaGon
requires
pharmacists
to
use

common
sense
and
professional
judgment,

which
includes
paying
a2enGon
to
the
number

of
prescrip8ons
issued,
the
number
of
dosage

units
prescribed,
the
dura8on
and
paNern
of

the
alleged
treatment,
the
number
of
doctors

wri8ng
prescrip8ons
and
whether
the
drugs

prescribed
have
a

high
rate
of
abuse.
When
pharmacists'

suspicions
are
aroused
as
reasonable

professionals,
they
must
at
least
verify
the

prescrip8on's
propriety,
and
if
not
saGsﬁed

by
the
answer
they
must
refuse
to

dispense.

Doctrine
Holiday CVS 2012 FL
ViolaGon
of
“corresponding
responsibility”
in

administraGve
cases
required

•  Delivery
of
controlled
substance

•  Red
ﬂag
that
was
or
should
had
been

recognized

•  QuesGon
raised
by
the
red
ﬂag
not
resolved

conclusively
prior
to
dispensing

Doctrine
Holiday CVS 2012 FL
The
“irresolvable”
red
flags:

•  Prescriber
in
Fort
Lauderdale,
paGent
had
out

of
state
address,
and
paGent
paid
cash
for

oxycodone

•  Same
red
flags
+
prescripGon
filled
in
close

sequence
for
individuals
from
out
of
state

Doctrine
Holiday CVS 2012 FL
The
“irresolvable”
red
ﬂags:

•  Dispensing
oxycodone
30
mg
and
15
mg

products
to
the
same
paGent

•  Prescribers
whose
prescribing
pa2ern

suggests
a
one
size
ﬁts
all
concept

Doctrine
Holiday CVS 2012 FL

Doctrine
Top Rx Pharmacy (2013)
ViolaGon
of
“corresponding
responsibility”
in

administraGve
case
required

•  Delivery
of
controlled
substance

•  A
red
ﬂag
that
was
or
should
have
been

recognized

•  The
quesGon
raised
by
the
red
ﬂag
is
not

resolved
conclusively

prior
to
dispensing

Doctrine
Red
ﬂags
based
on
state
law

•  Dispensing
is
unlawful
if
pharmacist
knows
or
should
know

that
the
prescripGon
was
issued
outside
a
valid
physician-‐
paGent
relaGonship

•  Can
judge
validity
of
physician-‐paGent
relaGonship
on

1.  Manner
in
which
prescripGons
are
received

2.  Number
of
prescripGons
for
controlled
substances
issued

by
the
pracGGoner

3.  Number
of
paGents
receiving
controlled
substances

Doctrine
Red
ﬂags
based
on
statements
made
by

pharmacy
employees:

“To
the
extent
[the]
statements
consGtuted
a
red
ﬂag,

[the
pharmacy]
should
have
stopped
all
controlled

substances
dispensing
unGl
resolved.”

Doctrine
Conclusively
resolving
red
flags

•  Judged
using
“reasonable
pharmacist

standard”

•  Steps
necessary
to
resolve
red
flags
are

influenced
by
circumstances
giving
rise
to
the

red
flags.

What are “Red Flags”?
•  PrescripGons
for
controlled
substances
from

mulGple
doctors

•  PaGent
receives
more
than
one
controlled

substance
to
treat
the
same
indicaGon

•  PaGent
has
prescripGons
for
large
quanGGes/
doses
of
controlled
substances

•  PaGent
seeks
early
reﬁlls

•  PaGent
travels
long
distance

•  Prescribing
physician
located
at
great
distance

•  PaGent
receives
opiate,
benzodiazepine
and

carisopridol
(cocktail)

•  Filling
mulGple
prescripGons
for
strongest

formulaGon

•  PaGents
travelling
in
groups

•  Large
porGons
of
prescripGons
for
controlled

substances
issued
by
one
prescriber

•  Large
percentage
of
prescripGons
paid
for
in

cash.

•  Failing
to
call
other
pharmacists
to
inquire
as

to
why
they
refuse
to
fill
prescripGons
filled
by

a
parGcular
prescriber

•  Cash
payments
in
combinaGon
with
other
red

flags

•  Drug
is
inconsistent
with
prescriber
area
of

pracGce

•  PaGent
refers
to
drug
in
street
slang

•  MulGple
people
from
same
address
receive

controlled
substances

•  Family
members
receive
controlled
substances

from
same
prescriber

•  State
board
or
law
enforcement
acGon
against

prescriber

•  Lack
of
valid
doctor-‐paGent
relaGonship

How to Resolve Red Flags
•  Use
PDMP

•  Talk
to
paGents
you
know

•  Extensively
talk
to
paGents
you
don’t
know

•  Contact
the
Prescriber

•  Document
all
communicaGon
with
Prescriber

•  Verify
Prescriber
DEA
number

How to Resolve Red Flags
•  Talk
with
other
pharmacists

•  Use
your
insGncts

•  If
not
comfortable,
refuse
to
ﬁll
the

prescripGon

Inadequate Supply of Pain Meds
to Meet the Medical Needs of the
Community
Pharmacies Wholesalers

DEA

blame

blame

Possible
“red
ﬂags”
that
could
lead
to
the

prescripGon
being
denied
include:

• A
pain
medicaGon
not
previously
ﬁlled
at

Walgreens

• A
new
doctor
wriGng
a
prescripGon
for
the
same

pain
medicaGon

• A
doctor
wriGng
a
prescripGon
who
is
not
in
a

“reasonable
geographic
locaGon”
near
the

pharmacy.

• A
paGent
paying
for
a
prescripGon
in
cash

• A
paGent
seeking
an
early
reﬁll
of
a

prescripGon

• A
paGent
seeking
an
“excessive”
number
of

pills

• A
paGent
taking
the
same
pain
medicaGon
for

more
than
6
months

Viscous
cycle
Prescribers
fearful of
liability
Wholesalers
fearful of DEA
Pharmacies
fearful of
being cut-off

What’s old is new again…
1914
1940
1970
2001
2010
?
The Harrison Act and
Restricted Access
Death bed
or Combat
The pendulum
shifts
The 5th Vital sign,
“non-addictive”
Oxycontin
CDC declares
an epidemic
History
doesn’t
repeat
itself, but it
rhymes
- Mark Twain
Congress declares a
pain free decade.

But Wait…What a Generation of
Doctors Learned Was Wrong.
PBS
special,
5/2/13

Troubles With Your License
Board Investigations

TRENTON — The licenses of three New Jersey pharmacists have been
suspended following their arrests last month and allegations that they
participated in an illegal prescription drug ring, state authorities said today.
The suspensions — handed down against Daniel Podell, 87, of Clark;
Howard Hirsh, 61, of Cranbury; and Lawrence Zaslow, 59, of Cherry Hill —
will remain in effect until further action by the state Board of Pharmacy
and the resolution of the criminal charges.
Authorities allege several pain management clinics in Florida provided
prescriptions for painkillers such as oxycodone, hydromorphone and
morphine sulfate to patients who had no medical need for them.

Huntington Beach Pharmacy Shutdown,
connected to Dr. Tseng

Emerging Trends
Walgreens Loses $1.4M for Sharing Patient’s
Private Medical Info
Walgreens
pharmacist
whose
husband
was
the

ex-‐boyfriend
of
customer
at
the
pharmacy

suspected
ex
of
giving
her
husband
a
sexually

transmi2ed
disease,
so
she
used
her
authority
at

the
pharmacy
to
access
ex’s
medical
records.

She
shared
ex’s
sensiGve
medical
details
with

her
husband,
who
later
sent
ex
a
text
message

indicaGng
he
knew
the
records’
contents.

Even
though
ex
called
the
pharmacy
to

complain,
pharmacist
was
allowed
to
access

the
informa8on
a
second
8me.
The
suit

accused
Walgreens
of
negligence
in
its

supervision
of
pharmacist,
though
the

company
fought
back
by
arguing
that

pharmacist’s
illegal
acts
weren’t
associated

with
her
employer-‐authorized
conduct.
A

judge
disagreed
and
sent
the
quesGon
to
a

jury,
which
found
the
company
liable
for
80%

of
the
damages
owed
to
ex.
Walgreens

indicated
it
would
appeal
the
decision.

(Indiana)

Prescriber Education
•  In
April
2011,
FDA
announced
the
elements
of
a

Risk
EvaluaGon
and
MiGgaGon
Strategy
(REMS)

to
ensure
that
the
beneﬁts
of
extended-‐release

and
long-‐acGng
(ER/LA)
opioid
analgesics

outweigh
the
risks.

•  As
part
of
the
REMS,
all
ER/LA
opioid
analgesic

companies
must
provide:

• 
EducaGon
for
prescribers
of
these

medicaGons,
which
will
be
provided

through
accredited
conGnuing
educaGon

(CE)
acGviGes
supported
by
independent

educaGonal
grants
from
ER/LA
opioid

analgesic
companies.

• 
InformaGon
that
prescribers
can
use

when
counseling
paGents
about
the
risks

and
beneﬁts
of
ER/LA
opioid
analgesic

use.

TIRF REMS Access Program
•  The
Transmucosal
Immediate
Release
Fentanyl
(TIRF)

Risk
EvaluaGon
and
MiGgaGon
Strategy
(REMS)
program

is
an
FDA-‐required
program
designed
to
ensure

informed
risk-‐beneﬁt
decisions
before
and
during

treatment,
to
ensure
appropriate
use
of
TIRF
medicines.

•  The
purpose
of
the
TIRF
REMS
Access
program
is
to

miGgate
the
risk
of
misuse,
abuse,
addicGon,
overdose

and
serious
complicaGons
due
to
medicaGon
errors
with

the
use
of
TIRF
medicines.

•  You
must
enroll
in
the
TIRF
REMS
Access
program
to

prescribe,
dispense,
or
distribute
TIRF
medicines

http://healthyamericans.org/health-issues/rx-drug-abuse-report-app

Questions?
Alix
C.
Michel

Alix@MichelandWard.com

(423)
602-‐9522

David
J.
Ward

David@MichelandWard.com

(423)
602-‐9523

Michael
L.
Warren,
ARM,
OHST,
CCLS Risk

Manager,
Pharmacists
Mutual
Insurance

(800)
247-‐5930
ext.
7229

Disclaimer
This
presenta8on
is
provided
with
the

understanding
that
the
presenters
are
not

rendering
legal
advice
or
services.

Laws
are

constantly
changing,
and
each
federal
law,
state

law,
and
regula8on
should
be
checked
by
legal

counsel
for
the
most
current
version.

We
make
no

claims,
promises,
or
guarantees
about
the

accuracy,
completeness,
or
adequacy
of
the

informa8on
contained
in
this
presenta8on.

Do

not
act
upon
this
informa8on
without
seeking
the

advice
of
an
aNorney.

This
outline
is
intended
to
be

informa8onal.

It
does
not
provide
legal

advice.

Neither
your
aNendance
nor
the

presenters
answering
a
speciﬁc
audience

member
ques8on
creates
an
aNorney-‐
client
rela8onship.

Ph 5 michel ward_warren

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