(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, 2024
Structure New York Laws
6801 - Definition of Practice of Pharmacy.
6801-A - Collaborative Drug Therapy Management Demonstration Program.
6803 - Practice of Pharmacy and Use of Title "Pharmacist".
6804 - State Board of Pharmacy.
6805 - Requirements for a Professional License.
6807 - Exempt Persons; Special Provisions.
6808 - Registering and Operating Establishments.
6808-A - Identification of Pharmacists.
6808-B - Registration of Nonresident Establishments.
6811-A - Certain Drugs to Be Clearly Marked or Labeled.
6811-B - Door-to-Door Distribution of Drugs Prohibited.
6811-C - Patient Notification of Recalled Drugs.
6815 - Adulterating, Misbranding and Substituting.
6816 - Omitting to Label Drugs, or Labeling Them Wrongly.
6816-A - When Substitution Is Required.
6818 - Adulterated and Misbranded Cosmetics.
6819 - Regulations Making Exceptions.
6820 - Certification of Coal-Tar Colors for Drugs and Cosmetics.
6821 - Poison Schedules; Register.
6822 - Examinations and Investigations.
6824 - Injunction Proceedings.
6825 - Proof Required in Prosecution for Certain Violations.
6826 - Drug Retail Price Lists.
6826-A - Reducing Certain Copayments.
6827 - Mandatory Continuing Education.
6828 - Certificates of Administration.
6830 - Standardized Patient-Centered Data Elements.
6831 - Special Provisions Relating to Outsourcing Facilities.