Includes nurse practitioners as a provider of services for purposes of collaborative drug therapy management; makes the authorization for pharmacists to perform such management permanent.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A1321
SPONSOR: Seawright TITLE OF BILL:
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 amending
the education law relating to authorizing pharmacists to perform colla-
borative drug therapy management with physicians in certain settings, in
relation to making the authorization for pharmacists to perform collabo-
rative drug therapy management permanent
PURPOSE OR GENERAL IDEA OF BILL:
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 consul-
tation 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.
DIFFERENCE BETWEEN ORIGINAL AND AMENDED VERSION (IF APPLICABLE)
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 manage-
ment. The existing law authorizes pharmacists and physicians, pursuant
to protocols entered between them, to adjust and manage a drug regimen
of a patient, including adjusting drug strength, frequency of adminis-
tration and route of administration. If authorized by the proto- col,
the substitution of a different drug may also be permitted. In addition,
requirements relating to follow-up with the patient's treating physi-
cians, the qualifications of the pharmacists and various other require-
ments 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, eval-
uate and implement drug therapies for patients in certain settings. The
current law only applies to teaching hospitals and their affiliated
outpatient and freestanding clinics.
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 prac-
titioners to engage in collaborative agreements with pharma- cists.
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 informa-
tion on ADRs suggests that these earlier estimates may under- state the
problem. A recent comprehensive study of medication errors estimated
that as many as 2.7 million medication errors occur each year in hospi-
tals 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, but they are also 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 medi-
cation 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 contrib-
ution 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.
PRIOR LEGISLATIVE HISTORY:
2023-24: A9702 (Seawright) referred to higher education/ S4043 (Rivera)
Referred to Higher Education
2021-22: A1036 (Seawright) referred to higher education/ S04689
(LaValle) Referred to Higher Education
2017-18: A10196 (Seawright) Referred to Higher Education Committee/
54296 (LaValle) Ordered to Third Reading
2015-16: S280 (LaValle) Referred to Higher Education Committee 2011
Chapter 21 of the Laws of 2011
FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS:
None.
EFFECTIVE DATE:
This act shall take effect on the one hundred twentieth day after It
shall have become a law; provided that, effective immediately, the addi-
tion, amendment and/or repeal of any rule or regulation necessary for
the implementation of this act on its effective date are authorized and
directed to be made and completed on or before such effective date.
STATE OF NEW YORK
________________________________________________________________________
1321
2025-2026 Regular Sessions
IN ASSEMBLY
January 9, 2025
___________
Introduced by M. of A. SEAWRIGHT, STIRPE, LUPARDO, BUTTENSCHON, FORREST
-- read once and referred 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:
1 Section 1. Section 6801-a of the education law, as amended by chapter
2 238 of the laws of 2015, is amended to read as follows:
3 § 6801-a. Collaborative drug therapy management [demonstration
4 program]. 1. As used in this section, the following terms shall have
5 the following meanings:
6 a. "Board" shall mean the state board of pharmacy as established by
7 section sixty-eight hundred four of this article.
8 b. "Clinical services" shall mean the collection and interpretation of
9 patient data for the purpose of initiating, modifying and monitoring
10 drug therapy with associated accountability and responsibility for
11 outcomes in a direct patient care setting.
12 c. "Collaborative drug therapy management" shall mean the performance
13 of clinical services by a pharmacist relating to the review, evaluation
14 and management of drug therapy to a patient, who is being treated by a
15 physician or nurse practitioner for a specific disease or associated
16 disease states, in accordance with a written agreement or protocol with
17 a voluntarily participating physician or nurse practitioner and in
18 accordance with the policies, procedures, and protocols of the facility.
19 Such agreement or protocol as entered into by the physician or nurse
20 practitioner and a pharmacist, may include, and shall be limited to:
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02944-01-5
A. 1321 2
1 (i) adjusting or managing a drug regimen of a patient, pursuant to a
2 patient specific order or protocol made by the patient's physician or
3 nurse practitioner, which may include adjusting drug strength, frequency
4 of administration or route of administration. Adjusting the drug regimen
5 shall not include substituting or selecting a different drug which
6 differs from that initially prescribed by the patient's physician or
7 nurse practitioner unless such substitution is expressly authorized in
8 the written order or protocol. The pharmacist shall be required to imme-
9 diately document in the patient record changes made to the patient's
10 drug therapy and shall use any reasonable means or method established by
11 the facility to notify the patient's other treating physicians or nurse
12 practitioners with whom [he or she] such pharmacist does not have a
13 written agreement or protocol regarding such changes. The patient's
14 physician or nurse practitioner may prohibit, by written instruction,
15 any adjustment or change in the patient's drug regimen by the pharma-
16 cist;
17 (ii) evaluating and, only if specifically authorized by the protocol
18 and only to the extent necessary to discharge the responsibilities set
19 forth in this section, ordering disease state laboratory tests related
20 to the drug therapy management for the specific disease or disease state
21 specified within the written agreement or protocol; and
22 (iii) only if specifically authorized by the written agreement or
23 protocol and only to the extent necessary to discharge the responsibil-
24 ities set forth in this section, ordering or performing routine patient
25 monitoring functions as may be necessary in the drug therapy management,
26 including the collecting and reviewing of patient histories, and order-
27 ing or checking patient vital signs, including pulse, temperature, blood
28 pressure and respiration.
29 d. "Facility" shall mean: (i) a [teaching hospital or general] hospi-
30 tal, [including any diagnostic center, treatment center, or hospital-
31 based outpatient department] as defined in subdivision one of section
32 twenty-eight hundred one of the public health law; or (ii) a nursing
33 home with an on-site pharmacy staffed by a licensed pharmacist;
34 provided, however, for the purposes of this section the term "facility"
35 shall not include dental clinics, dental dispensaries, residential
36 health care facilities and rehabilitation centers.
37 [For the purposes of this section, a "teaching hospital" shall mean a
38 hospital licensed pursuant to article twenty-eight of the public health
39 law that is eligible to receive direct or indirect graduate medical
40 education payments pursuant to article twenty-eight of the public health
41 law.] In addition, a facility may also include up to fifteen community-
42 practice sites, selected by the department in consultation with the
43 department of health, where pharmacists and physicians or nurse practi-
44 tioners may propose to enter into collaborative arrangements, pursuant
45 to the provisions of this section. Such sites shall be selected based
46 upon a review of applications submitted to the department by such phar-
47 macists and physicians or nurse practitioners, which demonstrate that
48 the applicants can satisfy the requirements of this section.
49 e. "Physician" or "nurse practitioner" shall mean the physician or
50 nurse practitioner selected by or assigned to a patient, who has primary
51 responsibility for the treatment and care of the patient for the disease
52 and associated disease states that are the subject of the collaborative
53 drug therapy management.
54 f. "Written agreement or protocol" shall mean a written document,
55 pursuant to and consistent with any applicable state or federal require-
56 ments, that addresses a specific disease or associated disease states
A. 1321 3
1 and that describes the nature and scope of collaborative drug therapy
2 management to be undertaken by the pharmacists, in collaboration with
3 the participating physician or nurse practitioner in accordance with the
4 provisions of this section.
5 2. a. A pharmacist who meets the experience requirements of paragraph
6 b of this subdivision and who is either employed by or otherwise affil-
7 iated with a facility or is participating with a community-practice site
8 selected pursuant to paragraph d of subdivision one of this section
9 shall be permitted to enter into a written agreement or protocol with a
10 physician or nurse practitioner authorizing collaborative drug therapy
11 management, subject to the limitations set forth in this section, within
12 the scope of such employment [or], affiliation or participation.
13 b. A participating pharmacist must:
14 (i)(A) have been awarded either a master of science in clinical phar-
15 macy or a doctor of pharmacy degree;
16 (B) maintain a current unrestricted license; and
17 (C) have a minimum of two years experience, of which at least one year
18 of such experience shall include clinical experience in a health facili-
19 ty, which involves consultation with physicians or nurse practitioners
20 with respect to drug therapy and may include a residency at a facility
21 involving such consultation; or
22 (ii)(A) have been awarded a bachelor of science in pharmacy;
23 (B) maintain a current unrestricted license; and
24 (C) within the last seven years, have a minimum of three years experi-
25 ence, of which at least one year of such experience shall include clin-
26 ical experience in a health facility, which involves consultation with
27 physicians or nurse practitioners with respect to drug therapy and may
28 include a residency at a facility involving such consultation; and
29 (iii) meet any additional education, experience, or other requirements
30 set forth by the department in consultation with the board.
31 c. Notwithstanding any provision of law, nothing in this section shall
32 prohibit a licensed pharmacist from engaging in clinical services asso-
33 ciated with collaborative drug therapy management, in order to gain
34 experience necessary to qualify under clause (C) of subparagraph (i) or
35 (ii) of paragraph b of this subdivision, provided that such practice is
36 under the supervision of a pharmacist that currently meets the refer-
37 enced requirement, and that such practice is authorized under the writ-
38 ten agreement or protocol with the physician or nurse practitioner.
39 d. Notwithstanding any provision of this section, nothing herein shall
40 authorize the pharmacist to diagnose disease. In the event that a treat-
41 ing physician or nurse practitioner may disagree with the exercise of
42 professional judgment by a pharmacist, the judgment of the treating
43 physician or nurse practitioner shall prevail.
44 3. The physician or nurse practitioner who is a party to a written
45 agreement or protocol authorizing collaborative drug therapy management
46 shall be employed by or otherwise affiliated with the same facility with
47 which the pharmacist is also employed or affiliated.
48 4. The existence of a written agreement or protocol on collaborative
49 drug therapy management and the patient's right to choose to not partic-
50 ipate in collaborative drug therapy management shall be disclosed to any
51 patient who is eligible to receive collaborative drug therapy manage-
52 ment. Collaborative drug therapy management shall not be utilized unless
53 the patient or the patient's authorized representative consents, in
54 writing, to such management. If the patient or the patient's authorized
55 representative consents, it shall be noted on the patient's medical
56 record. If the patient or the patient's authorized representative who
A. 1321 4
1 consented to collaborative drug therapy management chooses to no longer
2 participate in such management, at any time, it shall be noted on the
3 patient's medical record. In addition, the existence of the written
4 agreement or protocol and the patient's consent to such management shall
5 be disclosed to the patient's primary physician or nurse practitioner
6 and any other treating physician or nurse practitioner or healthcare
7 provider.
8 5. Participation in a written agreement or protocol authorizing colla-
9 borative drug therapy management shall be voluntary, and no patient,
10 physician or nurse practitioner, pharmacist, or facility shall be
11 required to participate.
12 6. Nothing in this section shall be deemed to limit the scope of prac-
13 tice of pharmacy nor be deemed to limit the authority of pharmacists and
14 physicians or nurse practitioners to engage in medication management
15 prior to the effective date of this section and to the extent authorized
16 by law.
17 § 2. Section 5 of chapter 21 of the laws of 2011 amending the educa-
18 tion law relating to authorizing pharmacists to perform collaborative
19 drug therapy management with physicians in certain settings, as amended
20 by section 2 of part P of chapter 57 of the laws of 2024, is amended to
21 read as follows:
22 § 5. This act shall take effect on the one hundred twentieth day after
23 it shall have become a law[, provided, however, that the provisions of
24 sections two, three, and four of this act shall expire and be deemed
25 repealed July 1, 2026]; provided, however, that the amendments to subdi-
26 vision 1 of section 6801 of the education law made by section one of
27 this act shall be subject to the expiration and reversion of such subdi-
28 vision pursuant to section 8 of chapter 563 of the laws of 2008, when
29 upon such date the provisions of section one-a of this act shall take
30 effect; provided, further, that effective immediately, the addition,
31 amendment and/or repeal of any rule or regulation necessary for the
32 implementation of this act on its effective date are authorized and
33 directed to be made and completed on or before such effective date.
34 § 3. This act shall take effect on the one hundred twentieth day after
35 it shall have become a law. Effective immediately, the addition, amend-
36 ment and/or repeal of any rule or regulation necessary for the implemen-
37 tation of this act on its effective date are authorized to be made and
38 completed on or before such effective date.
