S T A T E O F N E W Y O R K
________________________________________________________________________
3591--A
2023-2024 Regular Sessions
I N S E N A T E
February 1, 2023
___________
Introduced by Sens. BRESLIN, ADDABBO -- read twice and ordered printed,
and when printed to be committed to the Committee on Health -- commit-
tee discharged, bill amended, ordered reprinted as amended and recom-
mitted to said committee
AN ACT to amend the public health law and the education law, in relation
to collaborative practice medication adherence; and to amend chapter
21 of the laws of 2011 amending the education law relating to author-
izing pharmacists to perform collaborative drug therapy management
with physicians in certain settings, in relation to making the
provisions of such chapter permanent
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. This act shall be known and may be cited as the "Collabora-
tive Practice Medication Adherence Act".
§ 2. The public health law is amended by adding a new article 29-H to
read as follows:
ARTICLE 29-H
COLLABORATIVE PRACTICE MEDICATION ADHERENCE ACT
SECTION 2999-FF. COLLABORATIVE PRACTICE MEDICATION ADHERENCE.
§ 2999-FF. COLLABORATIVE PRACTICE MEDICATION ADHERENCE. 1. DEFI-
NITIONS. AS USED IN THIS ARTICLE, THE FOLLOWING TERMS SHALL HAVE THE
FOLLOWING MEANINGS:
(A) QUALIFIED PHARMACIST. THE TERM "QUALIFIED PHARMACIST" SHALL MEAN A
PHARMACIST WHO MAINTAINS A CURRENT UNRESTRICTED LICENSE PURSUANT TO
ARTICLE ONE HUNDRED THIRTY-SEVEN OF THE EDUCATION LAW, WHO HAS A MINIMUM
OF TWO YEARS OF EXPERIENCE IN PATIENT CARE AS A PRACTICING PHARMACIST
WITHIN THE LAST FIVE YEARS, AND WHO HAS DEMONSTRATED COMPETENCY IN MEDI-
CATION ADHERENCE OF PATIENTS WITH A CHRONIC DISEASE OR DISEASES, INCLUD-
ING, BUT NOT LIMITED TO, THE COMPLETION OF ONE OR MORE PROGRAMS WHICH
ARE ACCREDITED BY THE ACCREDITATION COUNCIL FOR PHARMACY EDUCATION,
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD08609-04-3
S. 3591--A 2
RECOGNIZED BY THE EDUCATION DEPARTMENT AND ACCEPTABLE TO THE PATIENT'S
TREATING PHYSICIAN.
(B) PATIENT CARE. THE TERM "PATIENT CARE" SHALL MEAN ASSESSING THE
APPROPRIATENESS OF PRESCRIPTION AND NON-PRESCRIPTION DRUGS FOR INDIVID-
UAL PATIENTS BASED ON AN ASSESSMENT OF THE PATIENT'S MEDICATION HISTORY,
MEDICATION EXPERIENCE INCLUDING BELIEFS, CONCERNS, UNDERSTANDING AND
EXPECTATIONS, THE CLINICAL GOALS OF THERAPY, POTENTIAL DRUG-TO-DRUG
INTERACTIONS OR OTHER MEDICATION SAFETY CONCERNS, RECOMMENDATIONS FOR
ADHERENCE AND CONSULTING WITH A PATIENT OR CAREGIVER.
(C) COLLABORATIVE PRACTICE MEDICATION ADHERENCE. THE TERM "COLLABORA-
TIVE PRACTICE MEDICATION ADHERENCE" SHALL MEAN A PROGRAM CONDUCTED BY A
QUALIFIED PHARMACIST THAT ENSURES A PATIENT'S MEDICATIONS, WHETHER
PRESCRIPTION OR NONPRESCRIPTION, ARE INDIVIDUALLY ASSESSED TO DETERMINE
THAT EACH MEDICATION IS APPROPRIATE FOR THE PATIENT, EFFECTIVE FOR THE
MEDICAL CONDITION, SAFE GIVEN THE COMORBIDITIES AND OTHER MEDICATIONS
BEING TAKEN, AND ABLE TO BE TAKEN BY THE PATIENT AS INTENDED. COLLABORA-
TIVE PRACTICE MEDICATION ADHERENCE PROTOCOLS CONDUCTED BY A QUALIFIED
PHARMACIST SHALL INCLUDE SHARING OF APPLICABLE PATIENT CLINICAL INFORMA-
TION WITH THE TREATING PHYSICIAN AS SPECIFIED IN A COLLABORATIVE PRAC-
TICE MEDICATION ADHERENCE PROTOCOL.
(D) COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL. THE TERM
"COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL" SHALL MEAN A
WRITTEN DOCUMENT PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE
AND FEDERAL REQUIREMENTS, THAT IS ENTERED INTO VOLUNTARILY BY A PHYSI-
CIAN LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-ONE OF THE EDUCA-
TION LAW AND A QUALIFIED PHARMACIST WHICH ADDRESSES A CHRONIC DISEASE OR
DISEASES AS DETERMINED BY THE TREATING PHYSICIAN AND THAT DESCRIBES THE
NATURE AND SCOPE OF THE COLLABORATIVE PRACTICE MEDICATION ADHERENCE
SERVICES TO BE PERFORMED BY THE QUALIFIED PHARMACIST, IN ACCORDANCE WITH
THE PROVISIONS OF THIS ARTICLE. COLLABORATIVE PRACTICE MEDICATION ADHER-
ENCE PROTOCOLS BETWEEN LICENSED PHYSICIANS AND QUALIFIED PHARMACISTS
SHALL BE MADE AVAILABLE TO THE DEPARTMENT FOR REVIEW AND TO ENSURE
COMPLIANCE WITH THIS ARTICLE, UPON REQUEST.
2. AUTHORIZATION TO ESTABLISH COLLABORATIVE PRACTICE MEDICATION ADHER-
ENCE PROTOCOLS. A PHYSICIAN LICENSED PURSUANT TO ARTICLE ONE HUNDRED
THIRTY-ONE OF THE EDUCATION LAW SHALL BE AUTHORIZED TO VOLUNTARILY
ESTABLISH A COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL WITH A
QUALIFIED PHARMACIST TO PROVIDE COLLABORATIVE PRACTICE MEDICATION ADHER-
ENCE SERVICES FOR A PATIENT WHO HAS NOT MET CLINICAL GOALS OF THERAPY,
IS AT RISK FOR HOSPITALIZATION OR FOR WHOM THE PHYSICIAN DEEMS IT IS
NECESSARY TO RECEIVE COLLABORATIVE PRACTICE MEDICATION ADHERENCE
SERVICES. PARTICIPATION BY THE PATIENT IN COLLABORATIVE PRACTICE MEDI-
CATION ADHERENCE SERVICES SHALL BE VOLUNTARY.
3. SCOPE OF COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOLS.
UNDER A COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL, A QUALI-
FIED PHARMACIST SHALL BE PERMITTED TO:
(A) ADJUST OR MANAGE A DRUG REGIMEN OF A PATIENT, PURSUANT TO THE
PATIENT SPECIFIC ORDER OR PROTOCOL ESTABLISHED BY THE PATIENT'S TREATING
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 TREATING PHYSI-
CIAN UNLESS SUCH SUBSTITUTION IS EXPRESSLY AUTHORIZED IN THE WRITTEN
ORDER OR PROTOCOL. THE QUALIFIED PHARMACIST SHALL BE REQUIRED TO IMME-
DIATELY DOCUMENT IN THE PATIENT'S MEDICAL RECORD CHANGES MADE TO THE
PATIENT'S DRUG THERAPY. THE PATIENT'S TREATING PHYSICIAN MAY PROHIBIT,
S. 3591--A 3
BY WRITTEN INSTRUCTION, ANY ADJUSTMENT OR CHANGE IN THE PATIENT'S DRUG
REGIMEN BY THE QUALIFIED PHARMACIST;
(B) EVALUATE AND, ONLY IF SPECIFICALLY AUTHORIZED BY THE PROTOCOL AND
ONLY TO THE EXTENT NECESSARY TO DISCHARGE THE RESPONSIBILITIES SET FORTH
IN THIS ARTICLE, ORDER DISEASE STATE LABORATORY TESTS RELATED TO THE
DRUG THERAPY MANAGEMENT FOR THE SPECIFIC CHRONIC DISEASE OR DISEASES
SPECIFIED WITHIN THE WRITTEN AGREEMENT OR PROTOCOL;
(C) ONLY IF SPECIFICALLY AUTHORIZED BY THE WRITTEN ORDER OR PROTOCOL
AND ONLY TO THE EXTENT NECESSARY TO DISCHARGE THE RESPONSIBILITIES SET
FORTH IN THIS ARTICLE, ORDER OR PERFORM ROUTINE PATIENT MONITORING FUNC-
TIONS 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,
WEIGHT AND RESPIRATION; AND
(D) ACCESS THE COMPLETE PATIENT MEDICAL RECORD MAINTAINED BY THE
TREATING PHYSICIAN WITH WHOM THE QUALIFIED PHARMACIST HAS THE COLLABORA-
TIVE PRACTICE MEDICATION ADHERENCE PROTOCOL AND DOCUMENT ANY ADJUSTMENTS
MADE PURSUANT TO THE PROTOCOL IN THE PATIENT'S MEDICAL RECORD AND SHALL
NOTIFY THE PATIENT'S TREATING PHYSICIAN OF ANY ADJUSTMENTS IN A TIMELY
MANNER ELECTRONICALLY OR BY OTHER MEANS.
(E) UNDER NO CIRCUMSTANCES, SHALL THE QUALIFIED PHARMACIST BE PERMIT-
TED TO DELEGATE COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES TO
ANY OTHER LICENSED PHARMACIST OR OTHER PHARMACY PERSONNEL.
4. MEDICATION ADJUSTMENTS. ANY MEDICATION ADJUSTMENTS MADE BY THE
QUALIFIED PHARMACIST PURSUANT TO THE COLLABORATIVE PRACTICE MEDICATION
ADHERENCE PROTOCOL INCLUDING ADJUSTMENTS IN DRUG STRENGTH, FREQUENCY OR
ROUTE OF ADMINISTRATION, OR INITIATION OF A DRUG WHICH DIFFERS FROM THAT
INITIALLY PRESCRIBED AND AS DOCUMENTED IN THE PATIENT'S MEDICAL RECORD
SHALL BE DEEMED AN ORAL PRESCRIPTION AUTHORIZED BY AN AGENT OF THE
PATIENT'S TREATING PHYSICIAN AND SHALL BE DISPENSED CONSISTENT WITH
SECTION SIXTY-EIGHT HUNDRED TEN OF THE EDUCATION LAW. FOR THE PURPOSES
OF THIS ARTICLE, A PHARMACIST WHO IS NOT AN EMPLOYEE OF THE PHYSICIAN
MAY BE AUTHORIZED TO SERVE AS AN AGENT OF THE PHYSICIAN.
5. REFERRALS. A PHYSICIAN LICENSED PURSUANT TO ARTICLE ONE HUNDRED
THIRTY-ONE OF THE EDUCATION LAW WHO HAS RESPONSIBILITY FOR THE TREATMENT
AND CARE OF A PATIENT FOR A CHRONIC DISEASE OR DISEASES AS DETERMINED BY
THE PHYSICIAN MAY REFER THE PATIENT TO A QUALIFIED PHARMACIST FOR COLLA-
BORATIVE PRACTICE MEDICATION ADHERENCE SERVICES, PURSUANT TO THE COLLA-
BORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL THAT THE PHYSICIAN HAS
ESTABLISHED WITH THE QUALIFIED PHARMACIST. THE PROTOCOL AGREEMENT SHALL
AUTHORIZE THE PHARMACIST TO SERVE AS AN AGENT OF THE PHYSICIAN AS
DEFINED BY THE PROTOCOL. SUCH REFERRAL SHALL BE DOCUMENTED IN THE
PATIENT'S MEDICAL RECORD.
6. PATIENT PARTICIPATION. PARTICIPATION IN COLLABORATIVE PRACTICE
MEDICATION ADHERENCE SERVICES SHALL BE VOLUNTARY, AND NO PATIENT, PHYSI-
CIAN OR PHARMACIST SHALL BE REQUIRED TO PARTICIPATE. THE REFERRAL OF A
PATIENT FOR COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES AND THE
PATIENT'S RIGHT TO CHOOSE TO NOT PARTICIPATE SHALL BE DISCLOSED TO THE
PATIENT. COLLABORATIVE PRACTICE MEDICATION ADHERENCE SERVICES SHALL NOT
BE UTILIZED UNLESS THE PATIENT OR THE PATIENT'S AUTHORIZED REPRESEN-
TATIVE CONSENTS, IN WRITING, TO SUCH SERVICES. SUCH CONSENT SHALL BE
NOTED IN THE PATIENT'S MEDICAL RECORD. IF THE PATIENT OR THE PATIENT'S
AUTHORIZED REPRESENTATIVE WHO CONSENTED CHOOSES TO NO LONGER PARTICIPATE
IN SUCH SERVICES, AT ANY TIME, THE SERVICES SHALL BE DISCONTINUED AND IT
SHALL BE NOTED IN THE PATIENT'S MEDICAL RECORD.
S. 3591--A 4
§ 3. The education law is amended by adding a new section 6801-b to
read as follows:
§ 6801-B. COLLABORATIVE PRACTICE MEDICATION ADHERENCE. 1. AS USED IN
THIS SECTION:
(A) "COLLABORATIVE PRACTICE MEDICATION ADHERENCE" SHALL MEAN A PROGRAM
FOR THE MANAGEMENT OF CHRONIC DISEASE OR DISEASES THAT ENSURES A
PATIENT'S MEDICATIONS, WHETHER PRESCRIPTION OR NONPRESCRIPTION, ARE
INDIVIDUALLY ASSESSED TO DETERMINE THAT EACH MEDICATION IS APPROPRIATE
FOR THE PATIENT, EFFECTIVE FOR THE MEDICAL CONDITION, SAFE GIVEN THE
COMORBIDITIES AND OTHER MEDICATIONS BEING TAKEN, AND ABLE TO BE TAKEN BY
THE PATIENT AS INTENDED; AND
(B) "COLLABORATIVE PRACTICE MEDICATION ADHERENCE PROTOCOL" SHALL MEAN
A WRITTEN DOCUMENT, PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE
OR FEDERAL REQUIREMENTS, THAT IS ENTERED INTO VOLUNTARILY BY A PHYSICIAN
LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-ONE OF THIS TITLE AND A
LICENSED PHARMACIST WHO MEETS THE QUALIFICATION REQUIREMENTS SPECIFIED
IN ARTICLE TWENTY-NINE-H OF THE PUBLIC HEALTH LAW WHICH ADDRESSES A
CHRONIC DISEASE OR DISEASES AS DETERMINED BY THE PHYSICIAN AND THAT
DESCRIBES THE NATURE AND SCOPE OF THE COLLABORATIVE PRACTICE MEDICATION
ADHERENCE SERVICE TO BE PERFORMED BY THE QUALIFIED PHARMACIST. COLLABO-
RATIVE PRACTICE MEDICATION ADHERENCE PROTOCOLS BETWEEN LICENSED PHYSI-
CIANS AND QUALIFIED PHARMACISTS SHALL BE MADE AVAILABLE TO THE DEPART-
MENT FOR REVIEW AND TO ENSURE COMPLIANCE WITH THIS ARTICLE, UPON
REQUEST.
2. A LICENSED PHARMACIST QUALIFIED PURSUANT TO ARTICLE TWENTY-NINE-H
OF THE PUBLIC HEALTH LAW IS AUTHORIZED TO SERVE AS AN AGENT OF THE
PHYSICIAN WHEN EXECUTING THE TERMS OF THE WRITTEN COLLABORATIVE PRACTICE
MEDICATION ADHERENCE PROTOCOL AS ESTABLISHED BY THE LICENSED PHYSICIAN
FOR THE MANAGEMENT OF PATIENTS WITH A CHRONIC DISEASE OR DISEASES.
§ 4. Section 5 of chapter 21 of the laws of 2011 amending the educa-
tion law relating to authorizing pharmacists to perform collaborative
drug therapy management with physicians in certain settings, as amended
by section 5 of part CC of chapter 57 of the laws of 2022, is amended to
read as follows:
§ 5. This act shall take effect on the one hundred twentieth day after
it shall have become a law[, provided, however, that the provisions of
sections two, three, and four of this act shall expire and be deemed
repealed July 1, 2024]; provided, however, that the amendments to subdi-
vision 1 of section 6801 of the education law made by section one of
this act shall be subject to the expiration and reversion of such subdi-
vision pursuant to section 8 of chapter 563 of the laws of 2008, when
upon such date the provisions of section one-a of this act shall take
effect; provided, further, that effective immediately, the addition,
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.
§ 5. This act shall take effect immediately, provided that sections
one and two of this act shall take effect on the one hundred eightieth
day after it shall have become a law. 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 to
be made and completed on or before such effective date.
