NY State Senate Bill 2013-S5400

Senate Bill S5400

2013-2014 Legislative Session

Includes nurse practitioners as a provider of services for purposes of collaborative drug therapy management and makes the authorization for pharmacists to perform such management permanent

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Archive: Last Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2014	referred to higher education
May 16, 2013	referred to higher education

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2013-S5400 (ACTIVE) - Details

Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6801-a, Ed L; amd §5, Chap 21 of 2011
Versions Introduced in Other Legislative Sessions:: 2015-2016: S280
2017-2018: S4296
2021-2022: S4689
2023-2024: S4043

2013-S5400 (ACTIVE) - Summary

Includes nurse practioners as a provider of services for purposes of collaborative drug therapy management and makes the authorization for pharmacists to perform such management permanent.

2013-S5400 (ACTIVE) - Sponsor Memo

                                BILL NUMBER:S5400

TITLE OF BILL:
An act
to amend the education law, in relation to including nurse
practitioners as a provider of services for purposes of 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 management with physicians in certain
settings, in relation to making the authorization for pharmacists to
perform collaborative drug therapy management permanent

PURPOSE:
To extend and expand provisions enacted in 2011 that permit
pharmacists to collaborate with physicians in the provision of
collaborative drug therapy

SUMMARY OF PROVISIONS:
The bill would extend and make permanent the Collaborative Drug
Therapy Demonstration Project and expand the scope of the
authorization for collaborative drug therapy management (CDTM) as
follows:

Section one of the bill would amend section 6801-a of the Education
Law as follows:

* Deletes reference to a "demonstration program" in the title of the
section;

* Adds nurse practitioners (NPs) to the legislation to allow NPs to
enter into collaborative agreements with pharmacists by which drug
therapies would be reviewed, evaluated and managed;

* Authorizes CDTM to occur in all hospitals and other Article 28
facilities, such as nursing homes and clinics; and

* Permits the State Education Department in consultation with the
Department of Health, to include up to fifteen community practice
sites as authorized locations for the provision of CDTM.

Section two of the bill would repeal the expiration date of the prior
statute and make the provisions permanent.

EXISTING LAW:

Section 6801-a established the CDTM Demonstration Program and
authorized physicians and pharmacists in teaching hospitals
(including clinics associated with them) to engage in collaborative
drug therapy management. The existing law authorizes pharmacists and
physicians, pursuant to protocols entered into between them, to
adjust and manage a drug regimen of a patient, including adjusting
drug strength, frequency of administration and route of
administration. If authorized by the protocol, the substitution of a
different drug may also be permitted In addition, requirements
relating to follow up with the patient's treating physicians, the
qualifications of the pharmacists and various other requirements and
limitations exist in the current law.


JUSTIFICATION:
Legislation was enacted in 2011 to establish the Collaborative Drug
Therapy Management Demonstration Program, by which pharmacists,
working in collaborative agreements with physicians, could adjust,
manage, evaluate and implement drug therapies for patients in certain
settings. The current law only applies to teaching hospitals and
their affiliated outpatient and freestanding clinics. A report on the
results of the current statute will be issued in late 2013 or early
2014 but all preliminary reports have indicated that the legislation
has been successfully implemented by eligible facilities and the
collaboration between pharmacists and physicians has been very much
in the interest of promoting the best interests of their patients,
This bill would extend the current program to all Article 28 licensed
health care facilities (hospitals, clinics and residential health
care facilities) as well as permit the practice on a more limited
basis in certain community based settings. The bill would also permit
nurse practitioners to engage in the collaborative agreements with
pharmacists

Adverse drug reactions or adverse drug events (ADRs or ADEs) are
reported to be among the leading causes of death in the United
States, behind only heart disease, cancer and stroke The most updated
information on ADRs suggests that these earlier estimates may
actually understate the problem. A recent comprehensive study of
medication errors, estimated that as many as 2.7 million medication
errors occur each year in hospitals in the United States, adversely
affecting 130,000 patients. Studies have shown that at least 28% of
these errors were preventable. Nearly half of the errors made were
the result of errors in the prescribing process. These errors are
not only potentially dangerous to patients, they are extremely costly
to the health care system, resulting in additional and unnecessary
expenditures of as much as $177 billion per year. Of this amount,
seventy percent was attributed to unnecessary hospital admissions or
prolonged hospital stays due to medication errors.

Virtually every other state permits CDTM, most of which authorize the
practice in many more settings than permitted under the current New
York State law and the results have been uniformly positive: CDTM
along with pharmacist provided drug information services, adverse
drug reaction monitoring, drug protocol management and medial rounds
participation by pharmacists,have all shown to make a statistically
significant contribution to the reduction of medication errors. The
expansion of the statute to additional settings and the authorizing
of Nurse Practitioners as collaborating practitioners is warranted
not only by the success of the New York State initiative, but based
on the records of other states.

LEGISLATIVE HISTORY: Chapter 21 of the Laws of 2011.

FISCAL IMPLICATIONS: None.

EFFECTIVE DATE: Immediately

2013-S5400 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  5400

                       2013-2014 Regular Sessions

                            I N  S E N A T E

                              May 16, 2013
                               ___________

Introduced  by  Sen. LAVALLE -- read twice and ordered printed, and when
  printed to be committed to the Committee on Higher Education

AN ACT to amend the education law, in relation to including nurse  prac-
  titioners as a provider of services for purposes of collaborative drug
  therapy management; and to amend chapter 21 of the laws of 2011 amend-
  ing  the  education law relating to authorizing pharmacists to perform
  collaborative drug  therapy  management  with  physicians  in  certain
  settings,  in  relation to making the authorization for pharmacists to
  perform collaborative drug therapy management 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. "Collaborative drug therapy management" shall mean the  performance
of  services  by  a  pharmacist  relating  to the review, evaluation and
management of drug therapy to a patient,  who  is  being  treated  by  a
physician OR NURSE PRACTITIONER for a specific disease or disease state,
in  accordance  with  a written agreement or protocol with a voluntarily
participating physician OR NURSE PRACTITIONER and in accordance with the
policies, procedures, and protocols of the facility. Such  agreement  or
protocol  as  entered  into by the physician OR NURSE PRACTITIONER and a
pharmacist, may include, and shall be limited to:
  (i) adjusting or managing a drug regimen of a patient, pursuant  to  a
patient  specific written order or protocol made by the patient's physi-
cian 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
drug  which  differs  from  that  initially  prescribed by the patient's

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11076-01-3

S. 5400                             2

physician OR NURSE PRACTITIONER unless such  substitution  is  expressly
authorized  in  the  written  order or protocol. The pharmacist shall be
required to immediately enter into 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 department to  notify
any  of  the  patient's other treating physicians OR NURSE PRACTITIONERS
with whom he or she does  not  have  a  written  agreement  or  protocol
regarding  such  changes.  The patient's physician OR NURSE PRACTITIONER
may prohibit, by written instruction, any adjustment or  change  in  the
patient's drug regimen by the pharmacist;
  (ii)  evaluating  and, only if specifically authorized by the protocol
and only to the extent necessary to discharge the  responsibilities  set
forth in this section, ordering clinical laboratory tests related to the
drug therapy management for the specific disease or disease state speci-
fied within the protocol; and
  (iii)  only if specifically authorized by the protocol and only to the
extent necessary to discharge the responsibilities  set  forth  in  this
section,  ordering or performing routine patient monitoring functions as
may be necessary in the drug therapy management, including the  collect-
ing and reviewing of patient histories, and ordering or checking patient
vital  signs,  including pulse, temperature, blood pressure and respira-
tion.
  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  OR  NURSE  PRACTITIONER,  in  accordance  with   the
provisions of this section.
  c. "Physician OR NURSE PRACTITIONER" shall mean the physician 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.
  d.  "Facility"  shall mean a [teaching] hospital, [including any diag-
nostic center, treatment center, or  hospital-based  outpatient  depart-
ment, however, for the purposes of this section, residential health care
facilities  and  nursing homes shall be excluded] AS DEFINED BY SUBDIVI-
SION ONE OF SECTION TWENTY-EIGHT HUNDRED ONE OF THE PUBLIC  HEALTH  LAW.
[For  the  purposes  of this section, a "teaching hospital" shall mean a
hospital licensed pursuant to article twenty-eight of the public  health
law  that  is  eligible  to  receive direct or indirect graduate medical
education payments pursuant to article twenty-eight of the public health
law.] IN ADDITION, A FACILITY MAY ALSO INCLUDE UP TO FIFTEEN  COMMUNITY-
PRACTICE  SITES,  SELECTED  BY  THE  DEPARTMENT IN CONSULTATION WITH THE
DEPARTMENT OF HEALTH, WHERE PHARMACISTS AND PHYSICIANS OR NURSE  PRACTI-
TIONERS  MAY  PROPOSE TO ENTER INTO COLLABORATIVE ARRANGEMENTS, PURSUANT
TO THE PROVISIONS OF THIS SECTION. SUCH SITES SHALL  BE  SELECTED  BASED
UPON  A REVIEW OF APPLICATIONS SUBMITTED TO THE DEPARTMENT BY SUCH PHAR-
MACISTS AND PHYSICIANS OR NURSE PRACTITIONERS,  WHICH  DEMONSTRATE  THAT
THE APPLICANTS CAN SATISFY THE REQUIREMENTS OF THIS SECTION.
  2.  a. A pharmacist who meets the experience requirements of paragraph
b of this subdivision and who is EITHER employed by or otherwise  affil-
iated with a facility OR IS PARTICIPATING WITH A COMMUNITY-PRACTICE SITE
SELECTED  PURSUANT  TO  PARAGRAPH  D  OF SUBDIVISION ONE OF THIS SECTION
shall be permitted to enter into a written agreement or protocol with  a

S. 5400                             3

physician  OR  NURSE PRACTITIONER authorizing collaborative drug therapy
management, subject to the limitations set forth in this section, within
the scope of such employment [or], affiliation OR PARTICIPATION.
  b. A participating pharmacist must:
  (i)(A)  have been awarded either a master of science in clinical phar-
macy or a doctor of pharmacy degree;
  (B) 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 facili-
ty, which involves consultation with physicians OR  NURSE  PRACTITIONERS
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 OR NURSE PRACTITIONERS with respect to drug therapy  and  may
include a residency at a facility involving such consultation.
  c. Notwithstanding any provision of this section, nothing herein shall
authorize the pharmacist to diagnose disease. In the event that a treat-
ing  physician  OR  NURSE PRACTITIONER may disagree with the exercise of
professional judgment by the pharmacist, the judgment  of  the  treating
physician OR NURSE PRACTITIONER shall prevail.
  3.  The  physician  OR  NURSE PRACTITIONER who is a party to a written
agreement or protocol authorizing collaborative drug therapy  management
IN  A FACILITY SETTING shall be employed by or otherwise affiliated with
the same facility with which the pharmacist is also employed  or  affil-
iated.
  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  OR  NURSE  PRACTITIONER
and  any  other  treating  physician OR NURSE PRACTITIONER or healthcare
provider.
  5. Participation in a written agreement or protocol authorizing colla-
borative drug therapy management shall be  voluntary,  and  no  patient,
physician, NURSE PRACTITIONER, pharmacist, or facility shall be required
to participate.
  6. Nothing in this section shall be deemed to limit the scope of prac-
tice of pharmacy nor be deemed to limit the authority of pharmacists and
physicians  OR  NURSE  PRACTITIONERS  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

S. 5400                             4

drug therapy management with physicians in certain settings  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 3 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
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 on the one hundred twentieth day after
it shall have become a law; provided 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.

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Senate Bill S5400

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Sponsored By

Kenneth P. LaValle