Senate
Study
Bill
3071
-
Introduced
SENATE/HOUSE
FILE
_____
BY
(PROPOSED
BOARD
OF
PHARMACY
BILL)
A
BILL
FOR
An
Act
relating
to
the
Iowa
prescription
monitoring
program,
1
including
by
establishing
an
advisory
committee,
authorizing
2
a
registration
surcharge,
expanding
information
collection
3
and
reporting
requirements,
and
making
penalties
applicable.
4
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
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Section
1.
Section
124.550,
Code
2018,
is
amended
by
adding
1
the
following
new
subsection:
2
NEW
SUBSECTION
.
3.
“Proactive
notification”
means
3
a
notification
by
the
board,
generated
based
on
factors
4
determined
by
the
board
and
issued
to
a
specific
prescribing
5
practitioner
or
pharmacist,
indicating
that
a
patient
may
6
be
practitioner
shopping
or
pharmacy
shopping
or
at
risk
of
7
abusing
or
misusing
a
controlled
substance.
8
Sec.
2.
Section
124.551,
subsection
1,
Code
2018,
is
amended
9
to
read
as
follows:
10
1.
Contingent
upon
the
receipt
of
funds
pursuant
to
11
section
124.557
sufficient
to
carry
out
the
purposes
of
12
this
subchapter
,
the
board,
in
conjunction
with
the
advisory
13
council
committee
created
in
section
124.555
,
shall
establish
14
and
maintain
an
information
program
for
drug
prescribing
and
15
dispensing.
16
Sec.
3.
Section
124.552,
Code
2018,
is
amended
to
read
as
17
follows:
18
124.552
Information
reporting.
19
1.
Each
Unless
otherwise
prohibited
by
federal
or
state
law,
20
each
licensed
pharmacy
that
dispenses
controlled
substances
21
identified
pursuant
to
section
124.554,
subsection
1
,
paragraph
22
“g”
,
to
patients
in
the
state,
and
each
licensed
pharmacy
23
located
in
the
state
that
dispenses
such
controlled
substances
24
identified
pursuant
to
section
124.554,
subsection
1
,
25
paragraph
“g”
,
to
patients
inside
or
outside
the
state,
unless
26
specifically
excepted
in
this
section
or
by
rule,
and
each
27
prescribing
practitioner
furnishing,
dispensing,
or
supplying
28
controlled
substances
to
the
prescribing
practitioner’s
29
patient,
shall
submit
the
following
prescription
information
30
to
the
program:
31
a.
Pharmacy
identification.
32
b.
Patient
identification.
33
c.
Prescribing
practitioner
identification.
34
d.
The
date
the
prescription
was
issued
by
the
prescribing
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practitioner.
1
e.
The
date
the
prescription
was
dispensed.
2
f.
An
indication
of
whether
the
prescription
dispensed
is
3
new
or
a
refill.
4
g.
Identification
of
the
drug
dispensed.
5
h.
Quantity
of
the
drug
dispensed.
6
i.
The
number
of
days’
supply
of
the
drug
dispensed.
7
j.
Serial
or
prescription
number
assigned
by
the
pharmacy.
8
k.
Type
of
payment
for
the
prescription.
9
l.
Other
information
identified
by
the
board
and
advisory
10
council
by
rule.
11
2.
Information
shall
be
submitted
electronically
in
a
12
secure
format
specified
by
the
board
unless
the
board
has
13
granted
a
waiver
and
approved
an
alternate
secure
format.
14
3.
Information
shall
be
timely
transmitted
as
designated
by
15
the
board
and
advisory
council
by
rule,
unless
the
board
grants
16
an
extension.
The
board
may
grant
an
extension
if
either
of
17
the
following
occurs:
18
a.
The
pharmacy
or
prescribing
practitioner
suffers
19
a
mechanical
or
electronic
failure,
or
cannot
meet
the
20
deadline
established
by
the
board
for
other
reasons
beyond
the
21
pharmacy’s
or
practitioner’s
control.
22
b.
The
board
is
unable
to
receive
electronic
submissions.
23
4.
This
section
shall
not
apply
to
a
prescribing
24
practitioner
furnishing,
dispensing,
supplying,
or
25
administering
drugs
to
the
prescribing
practitioner’s
patient,
26
or
to
dispensing
by
a
licensed
pharmacy
for
the
purposes
of
27
inpatient
hospital
care,
inpatient
hospice
care,
or
long-term
28
residential
facility
patient
care.
29
Sec.
4.
Section
124.553,
subsection
1,
paragraph
b,
Code
30
2018,
is
amended
to
read
as
follows:
31
b.
An
individual
who
requests
the
individual’s
own
program
32
information
in
accordance
with
the
procedure
established
in
33
rules
of
the
board
and
advisory
council
adopted
under
section
34
124.554.
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Sec.
5.
Section
124.553,
subsection
1,
Code
2018,
is
amended
1
by
adding
the
following
new
paragraph:
2
NEW
PARAGRAPH
.
g.
A
prescribing
practitioner
or
pharmacist
3
through
the
use
of
a
targeted
distribution
of
proactive
4
notifications.
5
Sec.
6.
Section
124.553,
subsections
2,
3,
and
7,
Code
2018,
6
are
amended
to
read
as
follows:
7
2.
The
board
shall
maintain
a
record
of
each
person
that
8
requests
information
from
the
program
and
of
all
proactive
9
notifications
distributed
to
prescribing
practitioners
and
10
dispensing
pharmacists
as
provided
in
subsection
1,
paragraph
11
“g”
.
Pursuant
to
rules
adopted
by
the
board
and
advisory
12
council
under
section
124.554
,
the
board
may
use
the
records
13
to
document
and
report
statistical
information,
and
may
14
provide
program
information
for
statistical,
public
research,
15
public
policy,
or
educational
purposes,
after
removing
16
personal
identifying
information
of
a
patient,
prescribing
17
practitioner,
dispenser,
or
other
person
who
is
identified
in
18
the
information.
19
3.
Information
contained
in
the
program
and
any
information
20
obtained
from
it,
and
information
contained
in
the
records
21
of
requests
for
information
from
the
program
and
information
22
distributed
to
prescribing
practitioners
and
dispensing
23
pharmacists
as
provided
in
subsection
1,
paragraph
“g”
,
24
is
privileged
and
strictly
confidential
information.
Such
25
information
is
a
confidential
public
record
pursuant
to
section
26
22.7
,
and
is
not
subject
to
discovery,
subpoena,
or
other
27
means
of
legal
compulsion
for
release
except
as
provided
in
28
this
subchapter
.
Information
from
the
program
shall
not
be
29
released,
shared
with
an
agency
or
institution,
or
made
public
30
except
as
provided
in
this
subchapter
.
31
7.
The
Except
as
allowed
in
section
124.557,
the
32
board
shall
not
charge
a
fee
to
a
pharmacy,
pharmacist,
or
33
prescribing
practitioner
for
the
establishment,
maintenance,
34
or
administration
of
the
program,
including
costs
for
forms
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required
to
submit
information
to
or
access
information
from
1
the
program
,
except
that
the
.
The
board
may
charge
a
fee
2
to
an
individual
who
requests
the
individual’s
own
program
3
information.
A
fee
charged
to
an
individual
pursuant
to
this
4
subsection
shall
not
exceed
the
actual
cost
of
providing
the
5
requested
information
and
shall
be
considered
a
repayment
6
receipt
as
defined
in
section
8.2
.
7
Sec.
7.
Section
124.554,
Code
2018,
is
amended
to
read
as
8
follows:
9
124.554
Rules
and
reporting.
10
1.
The
board
and
advisory
council
,
in
consultation
with
the
11
advisory
committee,
shall
jointly
adopt
rules
in
accordance
12
with
chapter
17A
to
carry
out
the
purposes
of,
and
to
enforce
13
the
provisions
of,
this
subchapter
.
The
rules
shall
include
14
but
not
be
limited
to
the
development
of
procedures
relating
15
to:
16
a.
Identifying
each
patient
about
whom
information
is
17
entered
into
the
program.
18
b.
An
electronic
format
for
the
submission
of
information
19
from
pharmacies
and
prescribing
practitioners
.
20
c.
A
waiver
to
submit
information
in
another
format
for
21
a
pharmacy
or
prescribing
practitioner
unable
to
submit
22
information
electronically.
23
d.
An
application
by
a
pharmacy
or
prescribing
practitioner
24
for
an
extension
of
time
for
transmitting
information
to
the
25
program.
26
e.
The
submission
by
an
authorized
requestor
of
a
request
27
for
information
and
a
procedure
for
the
verification
of
the
28
identity
of
the
requestor.
29
f.
Use
by
the
board
or
advisory
council
committee
of
the
30
program
request
records
required
by
section
124.553,
subsection
31
2
,
to
document
and
report
statistical
information.
32
g.
Including
all
schedule
II
,
schedule
III,
schedule
IV,
33
controlled
substances
and
those
substances
in
schedules
III
34
and
IV
that
the
advisory
council
and
board
determine
can
be
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addictive
or
fatal
if
not
taken
under
the
proper
care
and
1
direction
of
a
prescribing
practitioner
schedule
V
controlled
2
substances
except
when
dispensed
by
a
pharmacist
without
a
3
prescription
.
4
h.
Access
by
a
pharmacist
or
prescribing
practitioner
to
5
information
in
the
program
pursuant
to
a
written
agreement
with
6
the
board
and
advisory
council
.
7
i.
The
correction
or
deletion
of
erroneous
information
in
8
the
program.
9
j.
The
establishment
of
thresholds
or
other
criteria
or
10
measures
to
be
used
in
identifying
an
at-risk
patient
as
11
provided
in
section
124.553,
subsection
1,
paragraph
“g”
,
and
12
the
targeted
distribution
of
proactive
notifications
suggesting
13
review
of
the
patient’s
prescription
history.
14
k.
User
registration
processes
and
requirements.
15
2.
Beginning
January
1,
2007
15,
2019
,
and
annually
by
16
January
1
15
thereafter,
the
board
and
advisory
council
17
committee
shall
present
to
the
general
assembly
and
the
18
governor
a
report
prepared
consistent
with
section
124.555,
19
subsection
3
,
paragraph
“d”
,
which
shall
include
but
not
be
20
limited
to
the
following:
21
a.
The
cost
to
the
state
of
implementing
and
maintaining
the
22
program.
23
b.
Information
from
pharmacies,
prescribing
practitioners,
24
the
board,
the
advisory
council
committee
,
and
others
regarding
25
the
benefits
or
detriments
of
the
program.
26
c.
Information
from
pharmacies,
prescribing
practitioners,
27
the
board,
the
advisory
council
committee
,
and
others
regarding
28
the
board’s
effectiveness
in
providing
information
from
the
29
program.
30
Sec.
8.
Section
124.555,
Code
2018,
is
amended
to
read
as
31
follows:
32
124.555
Advisory
council
committee
established.
33
An
advisory
council
committee
shall
be
established
to
34
provide
oversight
to
the
board
and
the
program
and
to
comanage
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program
activities.
The
board
and
,
in
consultation
with
1
the
advisory
council
committee,
shall
jointly
adopt
rules
2
specifying
the
duties
and
activities
of
the
advisory
council
3
committee
and
related
matters.
4
1.
The
council
committee
shall
consist
of
eight
a
minimum
5
of
four
members
appointed
by
the
governor
board
.
The
members
6
shall
include
but
not
be
limited
to
at
least
one
member
from
7
each
of
the
following
categories:
three
licensed
pharmacists,
8
four
physicians
licensed
under
chapter
148
,
and
one
licensed
9
prescribing
practitioner
practitioners
who
is
are
not
a
10
physician
physicians,
and
public
members
who
are
not
health
11
care
professionals
.
The
governor
shall
board
may
solicit
12
recommendations
for
council
committee
members
from
Iowa
health
13
professional
licensing
boards,
associations,
and
societies
,
14
and
other
interested
groups
.
The
license
of
each
health
care
15
professional
member
appointed
to
and
serving
on
the
advisory
16
council
committee
shall
be
current
and
in
good
standing
with
17
the
professional’s
licensing
board.
18
2.
The
council
committee
shall
advance
the
goals
of
the
19
program,
which
include
identification
of
misuse
and
diversion
20
of
controlled
substances
identified
pursuant
to
section
21
124.554,
subsection
1
,
paragraph
“g”
,
reduction
of
overdoses
22
and
deaths
as
a
result
of
prescription
controlled
substance
23
use
and
abuse,
and
enhancement
of
the
quality
of
health
care
24
delivery
in
this
state.
25
3.
Duties
of
the
council
committee
shall
include
but
not
be
26
limited
to
the
following:
27
a.
Ensuring
the
confidentiality
of
the
patient,
prescribing
28
practitioner,
and
dispensing
pharmacist
and
pharmacy.
29
b.
Respecting
and
preserving
the
integrity
of
the
patient’s
30
treatment
relationship
with
the
patient’s
health
care
31
providers.
32
c.
Encouraging
and
facilitating
cooperative
efforts
33
among
health
care
practitioners
and
other
interested
and
34
knowledgeable
persons
in
developing
best
practices
for
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prescribing
and
dispensing
controlled
substances
and
in
1
educating
health
care
practitioners
and
patients
regarding
2
controlled
substance
use
and
abuse.
3
d.
Making
recommendations
regarding
the
continued
benefits
4
of
maintaining
the
program
in
relationship
to
cost
and
other
5
burdens
to
the
patient,
prescribing
practitioner,
pharmacist,
6
and
the
board.
The
council’s
committee’s
recommendations
shall
7
be
included
in
reports
required
by
section
124.554,
subsection
8
2
.
9
e.
One
physician
and
one
pharmacist
member
of
the
council
10
shall
include
in
their
duties
the
responsibility
for
monitoring
11
and
ensuring
that
patient
confidentiality,
best
interests,
and
12
civil
liberties
are
at
all
times
protected
and
preserved
during
13
the
existence
of
the
program.
14
4.
Members
of
the
advisory
council
committee
shall
15
be
eligible
to
request
and
receive
actual
expenses
for
16
their
duties
as
members
of
the
advisory
council
committee
,
17
subject
to
reimbursement
limits
imposed
by
the
department
of
18
administrative
services,
and
shall
also
be
eligible
to
receive
19
a
per
diem
compensation
as
provided
in
section
7E.6,
subsection
20
1
.
21
Sec.
9.
Section
124.556,
Code
2018,
is
amended
to
read
as
22
follows:
23
124.556
Education
and
treatment.
24
The
program
for
drug
prescribing
and
dispensing
shall
25
include
education
initiatives
and
outreach
to
consumers,
26
prescribing
practitioners,
and
pharmacists,
and
shall
also
27
include
assistance
for
identifying
substance
abuse
treatment
28
programs
and
providers.
The
board
and
advisory
council
29
committee
shall
adopt
rules,
as
provided
under
section
124.554
,
30
to
implement
this
section
.
31
Sec.
10.
Section
124.557,
Code
2018,
is
amended
to
read
as
32
follows:
33
124.557
Drug
information
program
fund.
34
The
drug
information
program
fund
is
established
to
be
used
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by
the
board
to
fund
or
assist
in
funding
the
program.
The
1
board
may
make
deposits
into
the
fund
from
any
source,
public
2
or
private,
including
grants
or
contributions
of
money
or
other
3
items
of
value,
which
it
determines
necessary
to
carry
out
the
4
purposes
of
this
subchapter
.
The
board
may
add
a
surcharge
5
of
not
more
than
twenty-five
percent
to
the
applicable
fee
6
for
a
registration
issued
pursuant
to
section
124.302
and
the
7
surcharge
shall
be
deposited
into
the
fund.
Moneys
received
8
by
the
board
to
establish
and
maintain
the
program
must
9
be
used
for
the
expenses
of
administering
this
subchapter
.
10
Notwithstanding
section
8.33
,
amounts
contained
in
the
fund
11
that
remain
unencumbered
or
unobligated
at
the
close
of
the
12
fiscal
year
shall
not
revert
but
shall
remain
available
for
13
expenditure
for
the
purposes
designated
in
future
years.
14
Sec.
11.
Section
124.558,
subsection
1,
Code
2018,
is
15
amended
to
read
as
follows:
16
1.
Failure
to
comply
with
requirements.
A
pharmacist,
17
pharmacy,
prescribing
practitioner,
or
agent
of
a
pharmacist
18
or
prescribing
practitioner
who
knowingly
fails
to
comply
19
with
the
confidentiality
requirements
of
this
subchapter
20
or
who
delegates
program
information
access
to
another
21
individual
except
as
provided
in
section
124.553
,
is
subject
to
22
disciplinary
action
by
the
appropriate
professional
licensing
23
board.
A
pharmacist
,
or
pharmacy
,
or
prescribing
practitioner
24
that
knowingly
fails
to
comply
with
other
requirements
of
this
25
subchapter
is
subject
to
disciplinary
action
by
the
board.
26
Each
licensing
board
may
adopt
rules
in
accordance
with
chapter
27
17A
to
implement
the
provisions
of
this
section
.
28
Sec.
12.
TRANSITION
——
APPOINTMENT
AND
TERMS
OF
ADVISORY
29
COMMITTEE
MEMBERS.
This
Act’s
amendments
changing
the
name
of
30
the
“advisory
council”
to
the
“advisory
committee”
shall
not
31
affect
the
appointment
of
a
member
who
served
on
the
advisory
32
council
immediately
prior
to
the
effective
date
of
this
Act.
33
That
member
shall
continue
to
serve
on
the
advisory
committee
34
at
the
pleasure
of
the
governor.
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Sec.
13.
TRANSITION
——
ADMINISTRATIVE
RULES
AND
OTHER
1
ACTIONS
AND
DOCUMENTS.
Any
rule,
form,
order,
or
directive
2
promulgated
by
the
advisory
council
created
in
section
124.550,
3
in
force
and
effect
immediately
prior
to
the
effective
date
of
4
this
Act,
shall
continue
in
full
force
and
effect
until
the
5
earlier
of
the
following:
6
1.
It
is
amended,
rescinded,
or
supplemented
by
the
7
affirmative
actions
of
the
board
of
pharmacy.
8
2.
It
expires
by
its
own
terms.
9
EXPLANATION
10
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
11
the
explanation’s
substance
by
the
members
of
the
general
assembly.
12
This
bill
alters
the
Iowa
prescription
monitoring
program
13
(PMP)
by
establishing
an
advisory
committee,
authorizing
a
14
registration
surcharge,
expanding
information
collection
and
15
reporting
requirements,
and
making
penalties
applicable
to
16
dispensing
practitioners.
17
The
bill
adds
dispensing
prescribers
to
the
list
of
persons
18
required
to
report
to
the
PMP
the
dispensation
of
reportable
19
controlled
substances
to
patients
in
Iowa,
subject
to
the
20
same
exceptions
provided
to
pharmacies,
unless
otherwise
21
prohibited
by
state
or
federal
law.
The
bill
also
eliminates
22
the
PMP
advisory
council
and
creates
an
advisory
committee
to
23
assume
the
duties
of
the
advisory
council,
with
members
to
be
24
appointed
from
among
health
care
professionals
and
the
general
25
public
by
the
board
in
numbers
to
be
determined
by
the
board,
26
provided
the
committee
consists
of
at
least
four
members.
27
The
bill
provides
that
members
of
the
advisory
council
shall
28
continue
to
serve
on
the
advisory
committee
and
that
any
29
rule,
form,
order,
or
directive
promulgated
by
the
advisory
30
council
shall
continue
to
be
in
force
and
effect
until
they
are
31
amended,
rescinded,
or
supplemented
by
the
board
of
pharmacy
32
or
expire
by
their
own
terms.
33
The
bill
also
allows
the
board,
in
consultation
with
34
the
PMP
advisory
committee,
to
establish
criteria
for
the
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identification
of
patients
who
are
potentially
misusing
or
1
abusing
prescription
controlled
substances
and
authorizes
the
2
board
to
proactively
notify
the
pharmacists
and
prescribing
3
practitioner
involved
in
the
patient’s
care
of
its
concerns.
4
The
bill
authorizes
the
collection
of
dispensing
records
for
5
all
schedule
II,
III,
IV,
and
V
controlled
substances
except
6
when
the
schedule
V
controlled
substance
is
dispensed
by
a
7
pharmacist
without
a
prescription.
The
bill
also
authorizes,
8
but
does
not
require,
the
board
to
impose
a
surcharge
to
9
be
deposited
into
the
drug
information
program
fund
on
10
controlled
substances
Act
registrations,
which
any
person
who
11
manufactures,
distributes,
or
dispenses
a
controlled
substance
12
must
obtain
and
maintain,
to
be
used
for
the
expenses
of
13
administering
the
PMP.
14
The
bill
adds
to
the
goals
of
the
program
the
reduction
of
15
overdoses
and
deaths
as
a
result
of
prescription
controlled
16
substance
use
and
abuse.
The
bill
also
changes
the
due
17
date
for
annual
reports
to
the
governor
and
the
legislature
18
regarding
the
program
from
January
1
to
January
15.
19
The
bill
makes
prescribing
practitioners
subject
to
20
disciplinary
action
by
the
board
under
Code
section
124.558
for
21
failure
to
comply
with
the
reporting
requirement.
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