N.Y. Education Law § 6801-a: Collaborative drug therapy management demonstration program

* § 6801-a. Collaborative drug therapy management demonstration

program. 1. As used in this section, the following terms shall have the

following meanings:

a. "Board" shall mean the state board of pharmacy as established by

section sixty-eight hundred four of this article.

b. "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.

c. "Collaborative drug therapy management" shall mean the performance

of clinical services by a pharmacist relating to the review, evaluation

and management of drug therapy to a patient, who is being treated by a

physician for a specific disease or associated disease states, in

accordance with a written agreement or protocol with a voluntarily

participating physician and in accordance with the policies, procedures,

and protocols of the facility. Such agreement or protocol as entered

into by the physician 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 order or protocol made by the patient's physician,

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 physician unless such substitution

is expressly authorized in the written order or protocol. The pharmacist

shall be required to immediately document in the patient record changes

made to the patient's drug therapy and shall use any reasonable means or

method established by the facility to notify 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;

(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 disease state laboratory tests related

to the drug therapy management for the specific disease or disease state

specified within the written agreement or protocol; and

(iii) only if specifically authorized by the written agreement or

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 collecting and reviewing of patient

histories, and ordering or checking patient vital signs, including

pulse, temperature, blood pressure and respiration.

d. "Facility" shall mean: (i) a teaching hospital or general hospital,

including any diagnostic center, treatment center, or hospital-based

outpatient department as defined in section twenty-eight hundred one of

the public health law; or (ii) a nursing home with an on-site pharmacy

staffed by a licensed pharmacist; provided, however, for the purposes of

this section the term "facility" shall not include dental clinics,

dental dispensaries, residential health care facilities and

rehabilitation centers.

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.

e. "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 and associated disease states that are 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

requirements, that addresses a specific disease or associated disease

states and that describes the nature and scope of collaborative drug

therapy management to be undertaken by the pharmacists, in collaboration

with the participating physician 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

management, subject to the limitations set forth in this section, within

the scope of such employment or affiliation.

b. A participating pharmacist must:

(i)(A) have been awarded either a master of science in clinical

pharmacy 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

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

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; and

(iii) meet any additional education, experience, or other requirements

set forth by the department in consultation with the board.

c. Notwithstanding any provision of law, nothing in this section shall

prohibit a licensed pharmacist from engaging in clinical services

associated with collaborative drug therapy management, in order to gain

experience necessary to qualify under clause (C) of subparagraph (i) or

(ii) of paragraph b of this subdivision, provided that such practice is

under the supervision of a pharmacist that currently meets the

referenced requirement, and that such practice is authorized under the

written agreement or protocol with the physician.

d. Notwithstanding any provision of this section, nothing herein shall

authorize the pharmacist to diagnose disease. In the event that a

treating physician may disagree with the exercise of professional

judgment by a pharmacist, the judgment of the treating physician 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

participate in collaborative drug therapy management shall be disclosed

to any patient who is eligible to receive collaborative drug therapy

management. 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.

5. Participation in a written agreement or protocol authorizing

collaborative drug therapy management shall be voluntary, and no

patient, physician, pharmacist, or facility 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.

* NB Repealed July 1, 2030