S T A T E O F N E W Y O R K
________________________________________________________________________
5805
2015-2016 Regular Sessions
I N A S S E M B L Y
March 5, 2015
___________
Introduced by M. of A. McDONALD -- read once and referred to the Commit-
tee on Higher Education
AN ACT to amend the education law, in relation to authorizing pharma-
cists to perform collaborative drug therapy management, and to amend
chapter 21 of the laws of 2011 amending the education law relating to
authorizing pharmacists to perform collaborative drug therapy manage-
ment with physicians in certain settings, in relation to making such
provisions permanent
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 6801-a of the education law, as added by chapter 21
of the laws of 2011, is amended to read as follows:
S 6801-a. Collaborative drug therapy management [demonstration
program]. 1. As used in this section, the following terms shall have
the following meanings:
a. "CLINICAL SERVICES" SHALL MEAN THE COLLECTION AND INTERPRETATION
OF PATIENT DATA FOR THE PURPOSE OF INITIATING, MODIFYING AND MONITORING
DRUG THERAPY WITH ASSOCIATED ACCOUNTABILITY AND RESPONSIBILITY FOR
OUTCOMES IN A DIRECT PATIENT CARE SETTING.
B. "Collaborative drug therapy management" shall mean the performance
of CLINICAL services by [a pharmacist] PHARMACISTS relating to the
review, evaluation and management of drug therapy to a patient, who is
being treated by a physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER
for a specific disease or disease [state] STATES, in accordance with a
written agreement or protocol with a voluntarily participating
physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER and in accordance
with the policies, procedures, and protocols of [the] A facility OR
MEDICAL PRACTICE. Such agreement or protocol as entered into by the
physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER and [a pharmacist]
PHARMACISTS, may include[, and shall be limited to]:
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD06620-05-5
A. 5805 2
(i) [adjusting or managing] PRESCRIBING IN ORDER TO ADJUST OR MANAGE a
drug regimen of a patient, pursuant to a patient specific [written]
order, or NON-PATIENT-SPECIFIC protocol made by the patient's physician,
PHYSICIAN ASSISTANT OR NURSE PRACTITIONER, which may include adjusting
drug strength, frequency of administration or route of administration[.
Adjusting the drug regimen shall not include substituting or selecting a
different] OR SELECTING A drug which differs from that initially
prescribed by the patient's physician [unless such substitution is
expressly], PHYSICIAN ASSISTANT OR NURSE PRACTITIONER AS authorized in
the written order or protocol. [The pharmacist] PHARMACISTS shall be
required to [immediately enter into] DOCUMENT IN the patient record [any
change or] changes made to the patient's drug therapy and shall use any
reasonable means or method established by the facility or [the depart-
ment] MEDICAL PRACTICE to notify [any of] the patient's other treating
physicians [with whom he or she does not have a written agreement or
protocol regarding such changes. The patient's physician may prohibit,
by written instruction, any adjustment or change in the patient's drug
regimen by the pharmacist], PHYSICIAN ASSISTANTS, NURSE PRACTITIONERS
AND OTHER PROFESSIONALS AS REQUIRED BY THE WRITTEN AGREEMENT OR
PROTOCOL;
(ii) evaluating and, [only if specifically] AS authorized by the NEW
WRITTEN AGREEMENT OR protocol and only to the extent necessary to
discharge the responsibilities set forth in this section, ordering
[clinical] DISEASE STATE laboratory tests related to the drug therapy
management for the specific disease or disease [state] STATES specified
within the WRITTEN AGREEMENT OR protocol; and
(iii) [only if specifically] AS authorized by the WRITTEN AGREEMENT OR
protocol and only to the extent necessary to discharge the responsibil-
ities set forth in this section, ordering or performing routine patient
monitoring functions as may be necessary in the drug therapy manage-
ment[, including the collecting and reviewing of patient histories, and
ordering or checking patient vital signs, including pulse, temperature,
blood pressure and respiration].
[b. "Written agreement or protocol" shall mean a written document,
pursuant to and consistent with any applicable state or federal require-
ments, that addresses a specific disease or disease state and that
describes the nature and scope of collaborative drug therapy management
to be undertaken by the pharmacist, in collaboration with the partic-
ipating physician, in accordance with the provisions of this section.
c. "Physician" shall mean the physician, selected by or assigned to a
patient, who has primary responsibility for the treatment and care of
the patient for the disease or disease state that is the subject of the
collaborative drug therapy management.
d.] C. "Facility" shall mean a [teaching] hospital, [including any]
diagnostic center, treatment center, or hospital-based outpatient
department, [however, for the purposes of this section,] residential
health care facilities [and] OR nursing [homes shall be excluded] HOME
OR ANY FACILITY AS DEFINED IN SECTION TWENTY-EIGHT HUNDRED ONE OF THE
PUBLIC HEALTH LAW OR OTHER ENTITY THAT PROVIDES DIRECT PATIENT CARE
UNDER THE AUSPICES OF A MEDICAL DIRECTOR.
D. "MEDICAL PRACTICE" SHALL MEAN A PLACE OR SITUATION IN WHICH PHYSI-
CIANS, PHYSICIAN ASSISTANTS AND NURSE PRACTITIONERS EITHER ALONE OR IN
GROUP PRACTICES PROVIDE DIAGNOSTIC AND TREATMENT CARE FOR PATIENTS. [For
the purposes of this section, a "teaching hospital" shall mean a hospi-
tal licensed pursuant to article twenty-eight of the public health law
that is eligible to receive direct or indirect graduate medical educa-
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tion payments pursuant to article twenty-eight of the public health
law.]
E. "PHYSICIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER" SHALL MEAN
THE PHYSICIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER SELECTED BY OR
ASSIGNED TO A PATIENT, WHO HAS PRIMARY RESPONSIBILITY FOR THE TREATMENT
AND CARE OF THE PATIENT FOR THE DISEASE OR DISEASE STATE THAT IS THE
SUBJECT OF THE COLLABORATIVE DRUG THERAPY MANAGEMENT.
F. "WRITTEN AGREEMENT OR PROTOCOL" SHALL MEAN A WRITTEN DOCUMENT,
PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE OR FEDERAL REQUIRE-
MENTS, THAT ADDRESSES A SPECIFIC DISEASE OR DISEASE STATES AND THAT
DESCRIBES THE NATURE AND SCOPE OF COLLABORATIVE DRUG THERAPY MANAGEMENT
TO BE UNDERTAKEN BY THE PHARMACISTS, IN COLLABORATION WITH THE PARTIC-
IPATING PHYSICIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY,
IN ACCORDANCE WITH THE PROVISIONS OF THIS SECTION.
2. a. [A pharmacist who meets the experience requirements of paragraph
b of this subdivision and who is employed by or otherwise affiliated
with a facility shall be permitted to enter into a written agreement or
protocol with a physician authorizing collaborative drug therapy manage-
ment, subject to the limitations set forth in this section, within the
scope of such employment or affiliation.
b. A participating pharmacist] PARTICIPATING PHARMACISTS must:
[(i)(A) have been awarded either a master of science in clinical phar-
macy or a doctor of pharmacy degree;
(B)] (I) maintain a current unrestricted license; and
[(C) have a minimum of two years experience, of which at least one
year of such experience shall include clinical experience in a health
facility, which involves consultation with physicians with respect to
drug therapy and may include a residency at a facility involving such
consultation; or
(ii)(A) have been awarded a bachelor of science in pharmacy;
(B) maintain a current unrestricted license; and
(C) within the last seven years, have a minimum of three years experi-
ence, of which at least one year of such experience shall include clin-
ical experience in a health facility, which involves consultation with
physicians with respect to drug therapy and may include a residency at a
facility involving such consultation.
c.] (II) SATISFY ANY TWO OF THE FOLLOWING CRITERIA:
(A) BOARD CERTIFICATION FROM A NATIONAL ACCREDITING BODY AS APPROVED
BY THE DEPARTMENT IN CONSULTATION WITH THE STATE BOARD OF PHARMACY OR
OTHER CREDENTIAL OR PROGRAM IN PHARMACY CLINICAL SERVICES AS APPROVED BY
THE DEPARTMENT, IN CONSULTATION WITH THE STATE BOARD OF PHARMACY;
(B) POSTGRADUATE RESIDENCY THROUGH AN ACCREDITED POSTGRADUATE PROGRAM
REQUIRING AT LEAST FIFTY PERCENT OF THE EXPERIENCE BE IN DIRECT PATIENT
CARE SERVICES WITH INTERDISCIPLINARY TERMS; OR
(C) HAVE PROVIDED CLINICAL SERVICES TO PATIENTS FOR AT LEAST ONE YEAR
EITHER:
(1) UNDER A COLLABORATIVE PRACTICE AGREEMENT OR PROTOCOL WITH A PHYSI-
CIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY; OR
(2) HAS DOCUMENTED EXPERIENCE IN THE PROVISION OF CLINICAL SERVICES TO
PATIENTS FOR AT LEAST ONE YEAR OR ONE THOUSAND HOURS, OR AS APPROVED BY
THE DEPARTMENT, IN CONSULTATION WITH THE STATE BOARD OF PHARMACY.
B. NOTWITHSTANDING ANY PROVISION OF LAW, NOTHING IN THIS SECTION SHALL
PROHIBIT A LICENSED PHARMACIST FROM ENGAGING IN CLINICAL SERVICES ASSO-
CIATED WITH COLLABORATIVE DRUG THERAPY MANAGEMENT, IN ORDER TO GAIN
EXPERIENCE NECESSARY TO QUALIFY UNDER ITEM TWO OF CLAUSE (C) OF SUBPARA-
GRAPH (II) OF PARAGRAPH A OF THIS SUBDIVISION, PROVIDED THAT SUCH PRAC-
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TICE IS UNDER THE SUPERVISION OF A PHARMACIST THAT CURRENTLY MEETS THE
REFERENCED REQUIREMENT, AND THAT SUCH PRACTICE IS AUTHORIZED UNDER THE
COLLABORATIVE DRUG THERAPY MANAGEMENT PROTOCOL WITH THE INVOLVED PHYSI-
CIAN, PHYSICIAN ASSISTANT, NURSE PRACTITIONER OR FACILITY.
3. Notwithstanding any provision of this section, nothing herein shall
authorize [the pharmacist] PHARMACISTS to diagnose disease. In the event
that a treating physician, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER may
disagree with the exercise of professional judgment by [the] A pharma-
cist, the judgment of the treating physician, PHYSICIAN ASSISTANT OR
NURSE PRACTITIONER shall prevail.
[3. The physician who is a party to a written agreement or protocol
authorizing collaborative drug therapy management shall be employed by
or otherwise affiliated with the same facility with which the pharmacist
is also employed or affiliated.
4. The existence of a written agreement or protocol on collaborative
drug therapy management and the patient's right to choose to not partic-
ipate in collaborative drug therapy management shall be disclosed to any
patient who is eligible to receive collaborative drug therapy manage-
ment. Collaborative drug therapy management shall not be utilized unless
the patient or the patient's authorized representative consents, in
writing, to such management. If the patient or the patient's authorized
representative consents, it shall be noted on the patient's medical
record. If the patient or the patient's authorized representative who
consented to collaborative drug therapy management chooses to no longer
participate in such management, at any time, it shall be noted on the
patient's medical record. In addition, the existence of the written
agreement or protocol and the patient's consent to such management shall
be disclosed to the patient's primary physician and any other treating
physician or healthcare provider.]
4. PHARMACISTS WHO ARE CERTIFIED BY THE DEPARTMENT TO ENGAGE IN COLLA-
BORATIVE DRUG THERAPY MANAGEMENT MAY ENTER INTO A WRITTEN AGREEMENT OR
PROTOCOL WITH A PHYSICIAN, PHYSICIAN ASSISTANT OR NURSE PRACTITIONER AS
AN INDEPENDENT HEALTH CARE PROVIDER OR AS AN EMPLOYEE OF A PHARMACY OR
OTHER HEALTH CARE PROVIDER. IN A FACILITY, THE PHYSICIAN, PHYSICIAN
ASSISTANT OR NURSE PRACTITIONER AND THE PHARMACIST WHO ARE PARTIES TO A
WRITTEN AGREEMENT OR PROTOCOL AUTHORIZING COLLABORATIVE DRUG THERAPY
MANAGEMENT SHALL BE EMPLOYED BY OR BE OTHERWISE AFFILIATED WITH THE
FACILITY.
5. Participation in a written agreement or protocol authorizing colla-
borative drug therapy management shall be voluntary, and no patient,
physician, [pharmacist, or facility] PHYSICIAN ASSISTANT, NURSE PRACTI-
TIONER OR PHARMACIST shall be required to participate.
[6. Nothing in this section shall be deemed to limit the scope of
practice of pharmacy nor be deemed to limit the authority of pharmacists
and physicians to engage in medication management prior to the effective
date of this section and to the extent authorized by law.]
S 2. Section 5 of chapter 21 of the laws of 2011, amending the educa-
tion law relating to authorizing pharmacists to perform collaborative
drug therapy management with physicians in certain settings, as amended
by chapter 125 of the laws of 2014, is amended to read as follows:
S 5. This act shall take effect on the one hundred twentieth day after
it shall have become a law [and shall expire 4 years after such effec-
tive date when upon such date the provisions of this act shall be deemed
repealed]; provided, however, that the amendments to subdivision 1 of
section 6801 of the education law made by section one of this act shall
be subject to the expiration and reversion of such subdivision pursuant
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to section 8 of chapter 563 of the laws of 2008, when upon such date the
provisions of section one-a of this act shall take effect; provided,
further, that effective immediately, the addition, amendment and/or
repeal of any rule or regulation necessary for the implementation of
this act on its effective date is authorized and directed to be made and
completed on or before such effective date.
S 3. This act shall take effect immediately, provided that section one
of this act shall take effect on the one hundred twentieth day after it
shall have become a law; provided, further, that, effective immediately,
the addition, amendment and/or repeal of any rule or regulation neces-
sary for the implementation of this act on its effective date is author-
ized and directed to be made and completed on or before such effective
date.