2023 New York Laws › EDN - Education › Title 8 - The Professions › Article 137 - Pharmacy › 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, 2026