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.
STATE OF NEW YORK
________________________________________________________________________
3048
2019-2020 Regular Sessions
IN ASSEMBLY
January 28, 2019
___________
Introduced by M. of A. SEAWRIGHT -- 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.
LBD04907-01-9
A. 3048 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 does not have a written agreement or
13 protocol regarding such changes. The patient's physician or nurse prac-
14 titioner may prohibit, by written instruction, any adjustment or change
15 in the patient's drug regimen by the pharmacist;
16 (ii) evaluating and, only if specifically authorized by the protocol
17 and only to the extent necessary to discharge the responsibilities set
18 forth in this section, ordering disease state laboratory tests related
19 to the drug therapy management for the specific disease or disease state
20 specified within the written agreement or protocol; and
21 (iii) only if specifically authorized by the written agreement or
22 protocol and only to the extent necessary to discharge the responsibil-
23 ities set forth in this section, ordering or performing routine patient
24 monitoring functions as may be necessary in the drug therapy management,
25 including the collecting and reviewing of patient histories, and order-
26 ing or checking patient vital signs, including pulse, temperature, blood
27 pressure and respiration.
28 d. "Facility" shall mean: (i) a [teaching hospital or general] hospi-
29 tal, [including any diagnostic center, treatment center, or hospital-
30 based outpatient department] as defined in subdivision one of section
31 twenty-eight hundred one of the public health law; or (ii) a nursing
32 home with an on-site pharmacy staffed by a licensed pharmacist;
33 provided, however, for the purposes of this section the term "facility"
34 shall not include dental clinics, dental dispensaries, residential
35 health care facilities and rehabilitation centers.
36 [For the purposes of this section, a "teaching hospital" shall mean a
37 hospital licensed pursuant to article twenty-eight of the public health
38 law that is eligible to receive direct or indirect graduate medical
39 education payments pursuant to article twenty-eight of the public health
40 law.] In addition, a facility may also include up to fifteen community-
41 practice sites, selected by the department in consultation with the
42 department of health, where pharmacists and physicians or nurse practi-
43 tioners may propose to enter into collaborative arrangements, pursuant
44 to the provisions of this section. Such sites shall be selected based
45 upon a review of applications submitted to the department by such phar-
46 macists and physicians or nurse practitioners, which demonstrate that
47 the applicants can satisfy the requirements of this section.
48 e. "Physician" or "nurse practitioner" shall mean the physician or
49 nurse practitioner selected by or assigned to a patient, who has primary
50 responsibility for the treatment and care of the patient for the disease
51 and associated disease states that are the subject of the collaborative
52 drug therapy management.
53 f. "Written agreement or protocol" shall mean a written document,
54 pursuant to and consistent with any applicable state or federal require-
55 ments, that addresses a specific disease or associated disease states
56 and that describes the nature and scope of collaborative drug therapy
A. 3048 3
1 management to be undertaken by the pharmacists, in collaboration with
2 the participating physician or nurse practitioner in accordance with the
3 provisions of this section.
4 2. a. A pharmacist who meets the experience requirements of paragraph
5 b of this subdivision and who is either employed by or otherwise affil-
6 iated with a facility or is participating with a community-practice site
7 selected pursuant to paragraph d of subdivision one of this section
8 shall be permitted to enter into a written agreement or protocol with a
9 physician or nurse practitioner authorizing collaborative drug therapy
10 management, subject to the limitations set forth in this section, within
11 the scope of such employment [or], affiliation or participation.
12 b. A participating pharmacist must:
13 (i)(A) have been awarded either a master of science in clinical phar-
14 macy or a doctor of pharmacy degree;
15 (B) maintain a current unrestricted license; and
16 (C) have a minimum of two years experience, of which at least one year
17 of such experience shall include clinical experience in a health facili-
18 ty, which involves consultation with physicians or nurse practitioners
19 with respect to drug therapy and may include a residency at a facility
20 involving such consultation; or
21 (ii)(A) have been awarded a bachelor of science in pharmacy;
22 (B) maintain a current unrestricted license; and
23 (C) within the last seven years, have a minimum of three years experi-
24 ence, of which at least one year of such experience shall include clin-
25 ical experience in a health facility, which involves consultation with
26 physicians or nurse practitioners with respect to drug therapy and may
27 include a residency at a facility involving such consultation; and
28 (iii) meet any additional education, experience, or other requirements
29 set forth by the department in consultation with the board.
30 c. Notwithstanding any provision of law, nothing in this section shall
31 prohibit a licensed pharmacist from engaging in clinical services asso-
32 ciated with collaborative drug therapy management, in order to gain
33 experience necessary to qualify under clause (C) of subparagraph (i) or
34 (ii) of paragraph b of this subdivision, provided that such practice is
35 under the supervision of a pharmacist that currently meets the refer-
36 enced requirement, and that such practice is authorized under the writ-
37 ten agreement or protocol with the physician or nurse practitioner.
38 d. Notwithstanding any provision of this section, nothing herein shall
39 authorize the pharmacist to diagnose disease. In the event that a treat-
40 ing physician or nurse practitioner may disagree with the exercise of
41 professional judgment by a pharmacist, the judgment of the treating
42 physician or nurse practitioner shall prevail.
43 3. The physician or nurse practitioner who is a party to a written
44 agreement or protocol authorizing collaborative drug therapy management
45 shall be employed by or otherwise affiliated with the same facility with
46 which the pharmacist is also employed or affiliated.
47 4. The existence of a written agreement or protocol on collaborative
48 drug therapy management and the patient's right to choose to not partic-
49 ipate in collaborative drug therapy management shall be disclosed to any
50 patient who is eligible to receive collaborative drug therapy manage-
51 ment. Collaborative drug therapy management shall not be utilized unless
52 the patient or the patient's authorized representative consents, in
53 writing, to such management. If the patient or the patient's authorized
54 representative consents, it shall be noted on the patient's medical
55 record. If the patient or the patient's authorized representative who
56 consented to collaborative drug therapy management chooses to no longer
A. 3048 4
1 participate in such management, at any time, it shall be noted on the
2 patient's medical record. In addition, the existence of the written
3 agreement or protocol and the patient's consent to such management shall
4 be disclosed to the patient's primary physician or nurse practitioner
5 and any other treating physician or nurse practitioner or healthcare
6 provider.
7 5. Participation in a written agreement or protocol authorizing colla-
8 borative drug therapy management shall be voluntary, and no patient,
9 physician or nurse practitioner, pharmacist, or facility shall be
10 required to participate.
11 6. Nothing in this section shall be deemed to limit the scope of prac-
12 tice of pharmacy nor be deemed to limit the authority of pharmacists and
13 physicians or nurse practitioners to engage in medication management
14 prior to the effective date of this section and to the extent authorized
15 by law.
16 § 2. Section 5 of chapter 21 of the laws of 2011 amending the educa-
17 tion law relating to authorizing pharmacists to perform collaborative
18 drug therapy management with physicians in certain settings, as amended
19 by section 5 of part DD of chapter 57 of the laws of 2018, is amended to
20 read as follows:
21 § 5. This act shall take effect on the one hundred twentieth day after
22 it shall have become a law[, provided, however, that the provisions of
23 sections two, three, and four of this act shall expire and be deemed
24 repealed July 1, 2020]; provided, however, that the amendments to subdi-
25 vision 1 of section 6801 of the education law made by section one of
26 this act shall be subject to the expiration and reversion of such subdi-
27 vision pursuant to section 8 of chapter 563 of the laws of 2008, when
28 upon such date the provisions of section one-a of this act shall take
29 effect; provided, further, that effective immediately, the addition,
30 amendment and/or repeal of any rule or regulation necessary for the
31 implementation of this act on its effective date are authorized and
32 directed to be made and completed on or before such effective date.
33 § 3. This act shall take effect on the one hundred twentieth day after
34 it shall have become a law. Effective immediately, the addition, amend-
35 ment and/or repeal of any rule or regulation necessary for the implemen-
36 tation of this act on its effective date are authorized to be made and
37 completed on or before such effective date.
