STATE OF WISCONSIN
Controlled Substances Board
IN THE MATTER OF RULE-MAKING
PROCEEDINGS BEFORE THE
CONTROLLED SUBSTANCES BOARD
PROPOSED ORDER OF THE
CONTROLLED SUBSTANCES BOARD
ADOPTING RULES
(CLEARINGHOUSE RULE )
PROPOSED ORDER
An order of the
Controlled Substances Board
to
repeal 4.03 (3); to amend CSB
4.02 (4),
4.08
(
1), 4.10 (1) (c), 4.10 (2) (a), 4.11 (1), 4.11 (1) (b), 4.11 (2), 4.11 (2) (c), 4.11 (7), 4.11 (7) (c), 4.11 (8) and 4.11 (8) (c); to create 4. 15 relating to the operation of the prescription drug monitoring program.
Analysis prepared by the Department of
Safety and Professional Services
.
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ANALYSIS
Statutes interpreted:
s.
961.385
, Stats.
Explanation of agency authority:
The board
shall establish by rule a program for monitoring the dispensing of monitored prescription drugs. The section goes on to state
several
items the
board shall
do
,
including defin
ing
what constitutes suspicious or critically dangerous conduct or practices for purposes of the
rules
promulgated under
s.
961.385 (2) (c)
, Stats
.
Related statute or rule:
Plain language analysis:
Section 1 indicates Board means the Controlled Substances Board.
2015 Act 55
changed the
jurisdiction
of the prescription drug monitoring program from the Pharmacy Examining Board to the Controlled Substances Board.
Section 2 repeals Tramadol from the list of monitored
prescription
drugs
,
because Tramadol
is
now identified
as
a controlled
substance
by both federal and Wisconsin
law
.
Section 3 changes the “his or her” to its to be consistent with the language throughout this chapter.
Section
s
4 and 5 update dispenser and dispenser delegate to pharmacist and pharmacist delegate.
This change was done for clarity in
CR 14-003
,
and there were two instances of these words that were inadvertently missed.
Sections 6, 7, 8, 9, 10, 11, 12 and 13
replace
the references to PDMP information
with refer
e
nces to
dispensing data. This change is to create clarity between
the situations in which the Board may disclose
dispensing data and
when the Board may disclose other PDMP information
.
There are situations in which it may be inappropriate and contradictory to the purpose of the p
r
o
g
ram to disclose PDMP information when dispensing data would be more appropriate. The
change clearly
delineate
s when the Board may release
dispensing data
and
PDMP information.
Section 14 creates a section on disclosure of
PDMP
information
when the Board identifies
suspicious or critically dangerous conduct or practices
in PDMP data
.
2015
Act 55
directs the board to include
provisions in the rules governing the Board’s disclosure of PDMP information that allow the Board to
disclose information
to relevant state boards and agencies, agencies of other states and law enforcement agencies under circumstances
that
indicat
e
suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner or patient. This rule defines
the
factors
that the B
oa
rd will use to determine
whether the conduct or practices of a pharmacy, pharmacist, practitioner or patient are suspicious or
critically
dangerous.
When looking at the pharmacist’s or pharmacy’s practice, the factors will include: practice which deviates from accepted practice, unusual patterns in payment, history of actions taken against the pharmacist or pharmacy, type and number of monitored prescription drugs dispensed, forged prescription orders for a monitored prescription
that
have been dispensed, the distance patients travel to have monitored prescription drugs dispensed and the number of patients dispensed monitored prescription drugs who meet the criteria of patients engaging in suspicious or critically dangerous conduct.
When looking at the
practitioner’s
practice, the fac
tors will include: prescribing practices which deviate from accepted prescribing practices, prescribing potentially dangerous combinations of monitored prescription drugs to the same patient, the type and number of monitored prescription drugs prescribed by the practitioner, history of actions taken against the practitioner, the distance patients travel to obtain monitored prescription drug prescriptions and the number of patients
to whom
the practitioner prescribes monitored prescriptions who meet the criteria of patients
engaging
in suspicious or critically dangerous conduct.
When looking at a patient, the factors will include: the number of practitioners f
r
om whom the patient has obtained a prescription for a monitored prescription drug, number of pharmacies
from
where the patient was dispensed a monitored prescription drug, the number of prescriptions for monitored drug obtained by the patient, the number of monitored prescription drug doses dispensed to the patient, the monitored prescription drugs dispensed to a patient which include dangerous levels of any drug, the number of times the patient is prescribed or dispensed
a
monitored drug before the previously dispensed amount of the same or a similar monitored prescription drug would be expected to end and the payment methodology used by the patient to obtain controlled substances.
Upon determining that there are circumstances indicating suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner or patient, the Board may disclose
PDMP
information to
a
relevant patient, pharmacist, practitioner, state board or agency, agency of another state or law enforcement agency.
Summary of, and comparison with, existing or proposed federal regulation:
None
Comparison with rules in adjacent states:
Illinois
:
Illinois’ prescription monitoring program does not address proactive disclosure of suspicious or critically
dangerous conduct or practices.
Iowa
:
Iowa does not have rules which allow for disclosure to regulatory agencies or law enforcement without an order, subpoena or other means of legal compulsion relating to a specific investigation of a specific individual and supported by a determination of probable cause.
Michigan
:
Michigan’s prescription monitoring program does not address proactive disclosure of suspicious or critically dangerous conduct or practices to entities.
Minnesota:
The
Minnesota
Board
of Pharmacy is required by statute to
review the data submitted to the prescription monitoring program on at least a quarterly basis
to determine if a patient meets criteria defined by the
Board in
consultation with an advisory task force.
If the Board determines that a patient meets the criteria, the Board may disclose information about the patient to prescribers and pharmacists who have treated the patient.
The prescription monitoring program may be used by permissible users for the identification of individuals receiving prescriptions for controlled substances from
prescribers
who subsequently obtain controlled substances from dispensers in quantities or
with
a frequency
inconsistent
with generally recognized standards of use for those controlled
substances
and individuals presenting forged or otherwise false or altered prescriptions for controlled
substances
to
dispensers
.
Minnesota does not allow accessing the database for the sole purpose of identifying prescribers of controlled substances for unusual or excessive prescribing patterns without a valid search warrant or court order. No licensing board or agency may access the database for the purpose of obtaining information to be used to initiate or substantiate a disciplinary action against a prescriber.
Summary of factual data and analytical methodologies:
In order to define what factors to evaluate to determine what constitutes suspicious or critically dangerous conduct or practices the Board consulted the following sources:
Prescription Drug Monitoring Program Center of Excellence at Brandeis University,
Using PDMP Data to Guide Interventions with Possible At-Risk Prescribers
, Oct. 2014.
Prescription Drug Monitoring Program Center of Excellence at Brandeis University
, Guidance on PDMP Best Practices: Options for Unsolicited Reporting
, Jan. 2014.
Johns Hopkins Bloomberg School of Public Health,
The Prescription Opioid Epidemic: An Evidence-Based Approach
, Nov. 2015.
Haegerich, et al.,
What We Know, and Don’t Know, About the Impact of State Policy and Systems-Level Interventions on Prescriptions Drug Overdose
, Drug and Alcohol Dependence: An International Journal on Biomedical and Psychosocial Approaches, Oct. 2014.
WCMR 14-118-011 Rules Governing The Controlled Substances Prescription Monitoring Program.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact
analysis
:
This
rule was posted for economic comments and none were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business
:
These proposed rules
do
not
have
an economic impact on small businesses, as defined in s.
227.114 (1)
, Stats. The Department’s Regulatory Review Coordinator may be contacted by email at
Eric.Esser
@wisconsin.gov
, or by calling (608) 26
7-2435
.
Agency contact person
:
Sharon Henes, Administrative Rules Coordinator
, Department of
Safety and Professional Services
, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box
8366
, Madison, Wisconsin 53708; telephone 608-
261-2377
; email at
Sharon.Henes
@wisconsin.gov
.
Place where comments are to be submitted and deadline for submission
:
Comments may be submitted to
Sharon Henes, Administrative Rules Coordinator,
Department of
Safety and Professional Services
, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8
366
, Madison, WI 53708-
8366
, or by email to
Sharon.Henes
@wisco
ns
in.gov
. Comments must be received
at or before
the public hearing at 9:30 a.m. on February 5, 2016
to be included in the record of rule-making proceedings.
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TEXT OF RULE
Section
1
. CSB 4.02 (4) is
amended to read:
CSB 4.02 (4) “Board”
has the meaning given in s.
450.01
(2)
, Stats.
means Controlled Substances Board.
Section
2
. CSB 4.03 (3) is repealed.
Section
3
. CSB 4.08 (1) is amended to read:
CSB 4.08 (1) The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report as required under this chapter until the dispenser is required to renew
his or her
its
license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:
Section
4
. CSB 4.10 (1) (c) is amended to read:
CSB 4.10 (1) (c) The denial, suspension, revocation or other restriction or limitation imposed on the
dispenser’s
,
dispenser
pharmacist’s,
pharmacist
delegate
’s
, practitioner’s, or practitioner delegate’s account pursuant to s.
CSB 18.09 (3)
.
Section
5
. CSB
4.10
(2) (a) is amended to read:
CSB 4.10 (2) (a) The
dispenser’s
,
dispenser
pharmacist’s,
pharmacist
delegate’s
,
practitioner’s, or practitioner delegate’s name and address, including street address, city, state and ZIP code.
Section
6
. CSB
4.11 (1)
is amended to read:
CSB 4.11
(1)
The board shall disclose
PDMP information
dispensing data
about a patient to the patient if he or she does all of the following:
Section
7
. CSB
4.11 (1) (b) is amended to read:
CSB 4.11 (1)
(b) Makes a request for the
PDMP information
dispensing data
on a form provided by the board.
Section
8
. CSB
4.11 (2) is amended to read:
CSB 4.11 (2)
The board shall disclose
PDMP
information
dispensing
data
about a patient to a person authorized by the patient if the person authorized by the patient does all of the following:
Section
9
. CSB
4.11 (2) (c) is amended to read:
CSB 4.11 (2)
(c) Makes a request for the
PDMP information
dispensing data
on a form provided by the board.
Section
1
0
. CSB
4.11 (7) is amended to read:
CSB 4.11 (7)
The board shall disclose the minimum amount of
PDMP information
dispensing data
necessary to a prisoner’s health care provider, the medical staff of a prison or jail in which a prisoner is confined, the receiving institution intake staff at a prison or jail to which a prisoner is being transferred or a person designated by a jailer to maintain prisoner medical records or designated staff of the department of corrections in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss.
146.82
and
961.385
, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following:
Section
1
1
. CSB
4.11 (7) (c) is amended to read:
CSB 4.11 (7) (c) Makes a request for the
PDMP information
dispensing data
through its account with the board.
Section
1
2
. CSB
4.11 (8) is amended to read:
CSB 4.11 (8)
The board shall disclose the minimum amount of
PDMP information
dispensing data
necessary to a coroner, deputy coroner, medical examiner, or medical examiner’s assistant following the death of a patient in the same or similar manner, and for the same or similar purposes, as those persons are authorized to access similar confidential patient health care records under ss.
146.82
and
961.385
, Stats., this chapter, and other state or federal laws and regulations relating to the privacy of patient health care records if the person does all of the following:
Section
1
3
. CSB
4.11 (8) (c) is amended to read:
CSB 4.11 (8) (c) Makes a request for the
PDMP information
dispensing data
through its account with the board.
Section
1
4
. CSB
4.15 is created to read:
CSB 4.15
Disclosure of suspicious or critically
danger
ou
s
conduct or practices.
(1)
T
he board may review PDMP information to determine whether circumstances indicate suspicious or critically dangerous conduct or practices of a
pharmacist,
pharmacy, practitioner, or patient.
(a)
The board may
include
any of the following
factors
when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a
pharmacist or
pharmacy:
1.
The
pharmacist or
pharmacy’s monitored prescription drug dispensing practices deviate from accepted
pharmacist or
pharmacy practices.
2.
There
are unusual patterns in the payment methodology used by patients to
who
m
monitored prescription drugs are dispensed
by the pharmacist
or
pharmacy
.
3.
The history of actions taken against the
pharmacist or
pharmacy by other state agencies, agencies of another state, or law enforcement.
4.
The type and number of monitored prescription drugs dispensed
by the pharmacist or
at the pharmacy.
5
.
The
pharmacist or
pharmacy has dispensed forged prescription orders for a monitored prescription drug.
6.
The distance patients travel to have monitored prescription drugs dispensed at the pharmacy.
7.
The number of patients dispensed monitored prescription drugs at the pharmacy
or by the pharmacist
who satisfy any of the criteria identified in par. (c).
(b)
The board may
include
any of the following
factors
when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a practitioner:
1.
The
practitioner’s monitored prescription drug prescribing practices deviate from accepted prescribing practices.
2.
The
practitioner prescribes potentially dangerous combinations of monitored prescription drugs to the same patient.
3. The type and number of monitored prescription
drugs
prescribed by the practitioner.
4
.
The history of actions taken against the practitioner by other state agencies, agencies of another state, or law enforcement.
5
.
The distance patients travel to obtain monitored prescription drug prescriptions from the practitioner.
6
.
The number of patients to whom the practitioner prescribed a monitored prescription who satisfy any of the criteria identified in par. (c).
(c)
The board may
include
any of the following
factors
when determining whether circumstances indicate suspicious or critically dangerous conduct or practices of a patient:
1.
The number of practitioners from whom the patient has obtained a prescription for a monitored prescription drug.
2.
The number of pharmacies from where the patient was dispensed a monitored prescription drug.
3.
The number of prescriptions for a monitored prescription drug obtained by the patient.
4.
The number of monitored prescription drug doses dispensed to the patient.
5.
Whether the monitored prescription drugs dispensed to the patient include dangerous levels of any drug.
6.
The number of times the patient is prescribed or dispensed a monitored prescription drug before the previously dispensed amount of the same or a similar monitored prescription drug would be expected to end.
7.
The payment methodology used by the patient to obtain controlled substances at a pharmacy.
(d)
Upon determining that circumstances indicate suspicious or critically dangerous conduct or practices of a pharmacy, practitioner, or patient, the Board may disclose PDMP information to any of the following:
1.
A relevant patient.
2.
A relevant pharmacist or practitioner.
3.
A relevant state board or agency.
4.
A relevant agency of another state.
5.
A relevant law enforcement agency.
Section
15
. EFFECTIVE DATE.
The rules adopted in this order shall take effect on the first day of the month following publication in the
Wisconsin
administrative register, pursuant to s.
227.22 (2) (intro.)
, Stats.
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(END OF TEXT OF RULE)
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