|SAME AS||No Same As|
|Amd §6801-a, Ed L; amd §5, Chap 21 of 2011|
|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.|
|01/28/2019||referred to higher education|
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NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A3048 Revised Memo 2/4/19 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 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.   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 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 proto- col, 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, 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. 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 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 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 cost- ly to the health care system, resulting in additional and unnecessary expenditures of as much as $177 billion per year. Of this amount, seven- ty 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 addi- tional settings and the authorizing of Nurse Practitioners as collab- orating 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: 2017-18 A10196 (Seawright) Referred to Higher Education Committee/ S4296 (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.
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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 [ demonstration4 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. LBD04907-01-9A. 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 a37 hospital licensed pursuant to article twenty-eight of the public health38 law that is eligible to receive direct or indirect graduate medical39 education payments pursuant to article twenty-eight of the public health40 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 therapyA. 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 longerA. 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 of23 sections two, three, and four of this act shall expire and be deemed24 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.