NY Educ L § 6801-A (2021)
2021 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, 2022