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A06848 Summary:

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A06848 Floor Votes:

A06848 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
            S. 3292--A                                            A. 6848--A
            Cal. No. 68
 
                               2009-2010 Regular Sessions
 
                SENATE - ASSEMBLY
 
                                     March 13, 2009
                                       ___________
 
        IN  SENATE  -- Introduced by Sens. LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN,
          FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORA-
          TO, RANZENHOFER, SERRANO, SEWARD, STACHOWSKI, VOLKER -- read twice and
          ordered printed, and when printed to be committed to the Committee  on

          Higher  Education  -- recommitted to the Committee on Higher Education
          in accordance with Senate Rule 6, sec. 8 --  reported  favorably  from
          said committee, ordered to first and second report, ordered to a third
          reading,  passed  by  Senate  and delivered to the Assembly, recalled,
          vote reconsidered, restored to  third  reading,  amended  and  ordered
          reprinted, retaining its place in the order of third reading
 
        IN  ASSEMBLY  --  Introduced  by M. of A. CANESTRARI, GOTTFRIED, COLTON,
          ENGLEBRIGHT, PAULIN, BURLING,  LIFTON,  ORTIZ,  FIELDS,  BROOK-KRASNY,
          GORDON,   GABRYSZAK,   SKARTADOS,   SCHROEDER,   MAYERSOHN,   BRODSKY,
          HYER-SPENCER, CASTELLI, SPANO, GUNTHER, STIRPE, SCHIMEL, JAFFEE, WEIS-
          ENBERG, HOYT -- Multi-Sponsored by -- M. of A. ALFANO, AMEDORE, BARRA,
          BENEDETTO,  BOYLAND,  BRENNAN,  BUTLER,  CHRISTENSEN,  CONTE,  CROUCH,

          CYMBROWITZ,  DelMONTE,  DESTITO, GALEF, GANTT, HAWLEY, HEVESI, JACOBS,
          JOHN, KOON, LATIMER, LAVINE, V. LOPEZ, LUPARDO, MAGEE,  MARKEY,  McDO-
          NOUGH,  McENENY, J. MILLER, MORELLE, PEOPLES-STOKES, PHEFFER, PRETLOW,
          QUINN, RAIA, REILLY, ROSENTHAL, SAYWARD, THIELE, WRIGHT --  read  once
          and  referred  to  the Committee on Higher Education -- recommitted to
          the Committee on Higher Education in accordance with Assembly Rule  3,
          sec.  2  --  committee  discharged, bill amended, ordered reprinted as
          amended and recommitted to said committee
 
        AN ACT to amend the education law, in relation  to  authorizing  pharma-
          cists to perform collaborative drug therapy management with physicians
          in  certain  settings  and providing for the repeal of such provisions
          upon expiration thereof
 
          The People of the State of New York, represented in Senate and  Assem-

        bly, do enact as follows:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02624-03-0
        S. 3292--A                          2                         A. 6848--A
 
     1    Section  1.  Subdivision  1  of  section 6801 of the education law, as
     2  amended by chapter 563 of the laws  of  2008,  is  amended  to  read  as
     3  follows:
     4    1. The practice of the profession of pharmacy is defined as the admin-
     5  istering,  preparing,  compounding,  preserving,  or  the  dispensing of
     6  drugs, medicines and therapeutic devices on the basis  of  prescriptions
     7  or  other  legal authority, and collaborative drug therapy management in

     8  accordance with the provisions of section sixty-eight hundred  one-a  of
     9  this article.
    10    §  1-a.  Section 6801 of the education law, as added by chapter 987 of
    11  the laws of 1971, is amended to read as follows:
    12    § 6801. Definition of practice of  pharmacy.    The  practice  of  the
    13  profession  of  pharmacy  is  defined  as  the  preparing,  compounding,
    14  preserving, or  the  dispensing  of  drugs,  medicines  and  therapeutic
    15  devices  on  the  basis  of  prescriptions or other legal authority, and
    16  collaborative drug therapy management in accordance with the  provisions
    17  of section sixty-eight hundred one-a of this article.
    18    §  2.  The  education law is amended by adding a new section 6801-a to
    19  read as follows:
    20    § 6801-a. Collaborative drug therapy management demonstration program.

    21  1.  As used in this section, the following terms shall have the  follow-
    22  ing meanings:
    23    a.  "Collaborative drug therapy management" shall mean the performance
    24  of services by a pharmacist  relating  to  the  review,  evaluation  and
    25  management  of  drug  therapy  to  a  patient, who is being treated by a
    26  physician for a specific disease or disease state, in accordance with  a
    27  written agreement or protocol with a voluntarily participating physician
    28  and  in  accordance  with the policies, procedures, and protocols of the
    29  facility.  Such agreement or protocol as entered into by  the  physician
    30  and a pharmacist, may include, and shall be limited to:
    31    (i)  adjusting  or managing a drug regimen of a patient, pursuant to a

    32  patient specific written order or protocol made by the patient's  physi-
    33  cian,  which  may include adjusting drug strength, frequency of adminis-
    34  tration or route of administration. Adjusting the drug regimen shall not
    35  include substituting or selecting a different drug  which  differs  from
    36  that initially prescribed by the patient's physician unless such substi-
    37  tution  is  expressly  authorized  in the written order or protocol. The
    38  pharmacist shall be required  to  immediately  enter  into  the  patient
    39  record  any  change  or  changes  made to the patient's drug therapy and
    40  shall use any reasonable means or method established by the facility  or
    41  the  department to notify any of the patient's other treating physicians

    42  with whom he or she does  not  have  a  written  agreement  or  protocol
    43  regarding such changes. The patient's physician may prohibit, by written
    44  instruction,  any  adjustment or change in the patient's drug regimen by
    45  the pharmacist;
    46    (ii) evaluating and, only if specifically authorized by  the  protocol
    47  and  only  to the extent necessary to discharge the responsibilities set
    48  forth in this section, ordering clinical laboratory tests related to the
    49  drug therapy management for the specific disease or disease state speci-
    50  fied within the protocol; and
    51    (iii) only if specifically authorized by the protocol and only to  the
    52  extent  necessary  to  discharge  the responsibilities set forth in this

    53  section, ordering or performing routine patient monitoring functions  as
    54  may  be necessary in the drug therapy management, including the collect-
    55  ing and reviewing of patient histories, and ordering or checking patient
        S. 3292--A                          3                         A. 6848--A
 
     1  vital signs, including pulse, temperature, blood pressure  and  respira-
     2  tion.
     3    b.  "Written  agreement  or  protocol"  shall mean a written document,
     4  pursuant to and consistent with any applicable state or federal require-
     5  ments, that addresses a specific  disease  or  disease  state  and  that
     6  describes  the nature and scope of collaborative drug therapy management

     7  to be undertaken by the pharmacist, in collaboration  with  the  partic-
     8  ipating physician, in accordance with the provisions of this section.
     9    c.  "Physician" shall mean the physician, selected by or assigned to a
    10  patient, who has primary responsibility for the treatment  and  care  of
    11  the  patient for the disease or disease state that is the subject of the
    12  collaborative drug therapy management.
    13    d. "Facility" shall mean a teaching hospital, including any diagnostic
    14  center,  treatment  center,  or  hospital-based  outpatient  department,
    15  however,  for  the  purposes  of  this  section, residential health care
    16  facilities and nursing homes shall be excluded. For the purposes of this

    17  section, a "teaching hospital" shall mean a hospital  licensed  pursuant
    18  to  article  twenty-eight  of  the public health law that is eligible to
    19  receive direct or indirect graduate medical education payments  pursuant
    20  to article twenty-eight of the public health law.
    21    2.  a. A pharmacist who meets the experience requirements of paragraph
    22  b of this subdivision and who is employed  by  or  otherwise  affiliated
    23  with  a facility shall be permitted to enter into a written agreement or
    24  protocol with a physician authorizing collaborative drug therapy manage-
    25  ment, subject to the limitations set forth in this section,  within  the
    26  scope of such employment or affiliation.
    27    b. A participating pharmacist must:

    28    (i)(A)  have been awarded either a master of science in clinical phar-
    29  macy or a doctor of pharmacy degree;
    30    (B) maintain a current unrestricted license; and
    31    (C) have a minimum of two years experience, of which at least one year
    32  of such experience shall include clinical experience in a health facili-
    33  ty, which involves consultation with physicians  with  respect  to  drug
    34  therapy and may include a residency at a facility involving such consul-
    35  tation; or
    36    (ii)(A) have been awarded a bachelor of science in pharmacy;
    37    (B) maintain a current unrestricted license; and
    38    (C) within the last seven years, have a minimum of three years experi-
    39  ence,  of which at least one year of such experience shall include clin-

    40  ical experience in a health facility, which involves  consultation  with
    41  physicians with respect to drug therapy and may include a residency at a
    42  facility involving such consultation.
    43    c. Notwithstanding any provision of this section, nothing herein shall
    44  authorize  the  pharmacist  to  diagnose  disease.   In the event that a
    45  treating physician may disagree with the exercise of professional  judg-
    46  ment  by  the  pharmacist,  the judgment of the treating physician shall
    47  prevail.
    48    3. The physician who is a party to a  written  agreement  or  protocol
    49  authorizing  collaborative  drug therapy management shall be employed by
    50  or otherwise affiliated with the same facility with which the pharmacist
    51  is also employed or affiliated.

    52    4. The existence of a written agreement or protocol  on  collaborative
    53  drug therapy management and the patient's right to choose to not partic-
    54  ipate in collaborative drug therapy management shall be disclosed to any
    55  patient  who  is  eligible to receive collaborative drug therapy manage-
    56  ment. Collaborative drug therapy management shall not be utilized unless
        S. 3292--A                          4                         A. 6848--A
 
     1  the patient or the  patient's  authorized  representative  consents,  in
     2  writing,  to such management. If the patient or the patient's authorized
     3  representative consents, it shall be  noted  on  the  patient's  medical
     4  record.    If the patient or the patient's authorized representative who

     5  consented to collaborative drug therapy management chooses to no  longer
     6  participate  in  such  management, at any time, it shall be noted on the
     7  patient's medical record.   In addition, the existence  of  the  written
     8  agreement or protocol and the patient's consent to such management shall
     9  be  disclosed  to the patient's primary physician and any other treating
    10  physician or healthcare provider.
    11    5. Participation in a written agreement or protocol authorizing colla-
    12  borative drug therapy management shall be  voluntary,  and  no  patient,
    13  physician, pharmacist, or facility shall be required to participate.
    14    6. Nothing in this section shall be deemed to limit the scope of prac-

    15  tice of pharmacy nor be deemed to limit the authority of pharmacists and
    16  physicians  to  engage  in  medication management prior to the effective
    17  date of this section and to the extent authorized by law.
    18    § 3. Subdivision 2 of section 6827 of the education law, as  added  by
    19  chapter 311 of the laws of 1996, is amended to read as follows:
    20    2.  During  each triennial registration period an applicant for regis-
    21  tration shall complete a  minimum  of  forty-five  hours  of  acceptable
    22  formal  continuing  education,  as specified in subdivision four of this
    23  section, provided that no more than twenty-two hours of such  continuing
    24  education  shall  consist of self-study courses.  Any pharmacist partic-
    25  ipating in collaborative drug therapy management pursuant to section six

    26  thousand eight hundred one-a of this article  shall  complete  at  least
    27  five  hours  of  acceptable  formal  continuing education in the area or
    28  areas of practice generally related to any  collaborative  drug  therapy
    29  management  protocols  to which the pharmacist may be subject. Any phar-
    30  macist whose first registration date following  the  effective  date  of
    31  this  section occurs less than three years from such effective date, but
    32  on or after January first, nineteen hundred ninety-eight, shall complete
    33  continuing education hours on a prorated basis at the rate  of  one  and
    34  one-quarter  hours  per  month  for  the period beginning January first,
    35  nineteen hundred ninety-seven up to the first registration  date  there-
    36  after.  A licensee who has not satisfied the mandatory continuing educa-

    37  tion  requirements  shall not be issued a triennial registration certif-
    38  icate by the department and  shall  not  practice  unless  and  until  a
    39  conditional registration certificate is issued as provided for in subdi-
    40  vision  three  of  this section. Continuing education hours taken during
    41  one triennium may not be transferred to a subsequent triennium.
    42    § 4. The department of education, in consultation with the  department
    43  of  health,  shall  prepare  or  shall  arrange for the preparation of a
    44  report on the implementation of collaborative  drug  therapy  management
    45  (CDTM)  in  New York state. The report shall be submitted to the speaker
    46  of the assembly and the temporary president of the senate and the chairs
    47  of the senate and assembly higher education  committees  at  least  four
    48  months  prior to the expiration of this act. The report shall review the

    49  extent to which CDTM was implemented in New York state and shall examine
    50  whether and the extent to which CDTM contributed to the  improvement  of
    51  quality  of  care  for  patients,  reduced the risk of medication error,
    52  reduced unnecessary health care expenditures, and was otherwise  in  the
    53  public  interest.  The  report  may  make  recommendations regarding the
    54  extension, alteration and/or expansion of these provisions and make  any
    55  other  recommendations related to the implementation of CDTM pursuant to
    56  this act.
        S. 3292--A                          5                         A. 6848--A
 
     1    § 5. This act shall take effect on the one hundred twentieth day after
     2  it shall have become a law and shall expire 3 years after such effective
     3  date when upon such date the provisions of  this  act  shall  be  deemed

     4  repealed;  provided,  however,  that  the amendments to subdivision 1 of
     5  section  6801 of the education law made by section one of this act shall
     6  be subject to the expiration and reversion of such subdivision  pursuant
     7  to section 8 of chapter 563 of the laws of 2008, when upon such date the
     8  provisions  of  section  one-a  of this act shall take effect; provided,
     9  further, that effective  immediately,  the  addition,  amendment  and/or
    10  repeal  of  any  rule  or regulation necessary for the implementation of
    11  this act on its effective date is authorized and directed to be made and
    12  completed on or before such effective date.