S T A T E   O F   N E W   Y O R K
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    S. 2985                                                  A. 4579

                       2011-2012 Regular Sessions

                      S E N A T E - A S S E M B L Y

                            February 4, 2011
                               ___________

IN  SENATE -- Introduced by Sens. LAVALLE, DeFRANCISCO, FUSCHILLO, GRIF-
  FO, LARKIN, LITTLE, RANZENHOFER -- read twice and ordered printed, and
  when printed to be committed to the Committee on Higher Education

IN ASSEMBLY -- Introduced by M. of  A.  CANESTRARI,  GOTTFRIED,  COLTON,
  ENGLEBRIGHT,  PAULIN, BURLING, LIFTON, ORTIZ, BROOK-KRASNY, GABRYSZAK,
  SCHROEDER, MAYERSOHN, CASTELLI, SPANO, GUNTHER, SCHIMEL, JAFFEE, WEIS-
  ENBERG, HOYT -- Multi-Sponsored by -- M.  of  A.  AMEDORE,  BENEDETTO,
  BOYLAND,  BRENNAN,  BUTLER, CONTE, CROUCH, CYMBROWITZ, DESTITO, GALEF,
  GANTT, HAWLEY, HEVESI, JACOBS,  LATIMER,  LAVINE,  V. LOPEZ,  LUPARDO,
  MAGEE, MARKEY, McDONOUGH, McENENY, J. MILLER, MORELLE, PEOPLES-STOKES,
  PHEFFER,  PRETLOW, RAIA, REILLY, ROSENTHAL, SAYWARD, THIELE, WRIGHT --
  read once and referred to the Committee on Higher Education

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:

  Section  1.  Subdivision  1  of  section 6801 of the education law, as
amended by chapter 563 of the laws  of  2008,  is  amended  to  read  as
follows:
  1. The practice of the profession of pharmacy is defined as the admin-
istering,  preparing,  compounding,  preserving,  or  the  dispensing of
drugs, medicines and therapeutic devices on the basis  of  prescriptions
or  other  legal authority, AND COLLABORATIVE DRUG THERAPY MANAGEMENT IN
ACCORDANCE WITH THE PROVISIONS OF SECTION SIXTY-EIGHT HUNDRED  ONE-A  OF
THIS ARTICLE.
  S  1-a.  Section 6801 of the education law, as added by chapter 987 of
the laws of 1971, is amended to read as follows:
  S 6801. Definition of practice of  pharmacy.    The  practice  of  the
profession  of  pharmacy  is  defined  as  the  preparing,  compounding,
preserving, or  the  dispensing  of  drugs,  medicines  and  therapeutic
devices  on  the  basis  of  prescriptions or other legal authority, AND

              

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD06072-01-1

S. 2985                             2                            A. 4579

COLLABORATIVE DRUG THERAPY MANAGEMENT IN ACCORDANCE WITH THE  PROVISIONS
OF SECTION SIXTY-EIGHT HUNDRED ONE-A OF THIS ARTICLE.
  S  2.  The  education law is amended by adding a new section 6801-a to
read as follows:
  S 6801-A. COLLABORATIVE DRUG THERAPY MANAGEMENT DEMONSTRATION PROGRAM.
1.  AS USED IN THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE  FOLLOW-
ING MEANINGS:
  A.  "COLLABORATIVE DRUG THERAPY MANAGEMENT" SHALL MEAN THE PERFORMANCE
OF 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 DISEASE STATE, 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 WRITTEN ORDER OR PROTOCOL MADE BY THE PATIENT'S  PHYSI-
CIAN,  WHICH  MAY INCLUDE ADJUSTING DRUG STRENGTH, FREQUENCY OF ADMINIS-
TRATION 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 SUBSTI-
TUTION  IS  EXPRESSLY  AUTHORIZED  IN THE WRITTEN ORDER OR PROTOCOL. THE
PHARMACIST SHALL BE REQUIRED  TO  IMMEDIATELY  ENTER  INTO  THE  PATIENT
RECORD  ANY  CHANGE  OR  CHANGES  MADE TO THE PATIENT'S DRUG THERAPY AND
SHALL USE ANY REASONABLE MEANS OR METHOD ESTABLISHED BY THE FACILITY  OR
THE  DEPARTMENT TO NOTIFY ANY OF 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 CLINICAL LABORATORY TESTS RELATED TO THE
DRUG THERAPY MANAGEMENT FOR THE SPECIFIC DISEASE OR DISEASE STATE SPECI-
FIED WITHIN THE PROTOCOL; AND
  (III) ONLY IF SPECIFICALLY AUTHORIZED BY THE 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 COLLECT-
ING AND REVIEWING OF PATIENT HISTORIES, AND ORDERING OR CHECKING PATIENT
VITAL SIGNS, INCLUDING PULSE, TEMPERATURE, BLOOD PRESSURE  AND  RESPIRA-
TION.
  B.  "WRITTEN  AGREEMENT  OR  PROTOCOL"  SHALL MEAN A WRITTEN DOCUMENT,
PURSUANT TO AND CONSISTENT WITH ANY APPLICABLE STATE OR FEDERAL REQUIRE-
MENTS, THAT ADDRESSES A SPECIFIC  DISEASE  OR  DISEASE  STATE  AND  THAT
DESCRIBES  THE NATURE AND SCOPE OF COLLABORATIVE DRUG THERAPY MANAGEMENT
TO BE UNDERTAKEN BY THE PHARMACIST, IN COLLABORATION  WITH  THE  PARTIC-
IPATING PHYSICIAN, IN ACCORDANCE WITH THE PROVISIONS OF THIS SECTION.
  C.  "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 OR DISEASE STATE THAT IS THE SUBJECT OF THE
COLLABORATIVE DRUG THERAPY MANAGEMENT.
  D. "FACILITY" SHALL MEAN A TEACHING HOSPITAL, INCLUDING ANY DIAGNOSTIC
CENTER,  TREATMENT  CENTER,  OR  HOSPITAL-BASED  OUTPATIENT  DEPARTMENT,
HOWEVER,  FOR  THE  PURPOSES  OF  THIS  SECTION, RESIDENTIAL HEALTH CARE
FACILITIES AND NURSING HOMES SHALL BE EXCLUDED. FOR THE PURPOSES OF THIS

S. 2985                             3                            A. 4579

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.
  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 MANAGE-
MENT, 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 PHAR-
MACY 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 FACILI-
TY, WHICH INVOLVES CONSULTATION WITH PHYSICIANS  WITH  RESPECT  TO  DRUG
THERAPY AND MAY INCLUDE A RESIDENCY AT A FACILITY INVOLVING SUCH CONSUL-
TATION; 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 EXPERI-
ENCE,  OF WHICH AT LEAST ONE YEAR OF SUCH EXPERIENCE SHALL INCLUDE CLIN-
ICAL 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.
  C. 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  JUDG-
MENT  BY  THE  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 PARTIC-
IPATE IN COLLABORATIVE DRUG THERAPY MANAGEMENT SHALL BE DISCLOSED TO ANY
PATIENT  WHO  IS  ELIGIBLE TO RECEIVE COLLABORATIVE DRUG THERAPY MANAGE-
MENT. 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 COLLA-
BORATIVE 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 PRAC-
TICE OF PHARMACY NOR BE DEEMED TO LIMIT THE AUTHORITY OF PHARMACISTS AND

S. 2985                             4                            A. 4579

PHYSICIANS  TO  ENGAGE  IN  MEDICATION MANAGEMENT PRIOR TO THE EFFECTIVE
DATE OF THIS SECTION AND TO THE EXTENT AUTHORIZED BY LAW.
  S  3.  Subdivision 2 of section 6827 of the education law, as added by
chapter 311 of the laws of 1996, is amended to read as follows:
  2. During each triennial registration period an applicant  for  regis-
tration  shall  complete  a  minimum  of  forty-five hours of acceptable
formal continuing education, as specified in subdivision  four  of  this
section,  provided that no more than twenty-two hours of such continuing
education shall consist of self-study courses.   ANY PHARMACIST  PARTIC-
IPATING IN COLLABORATIVE DRUG THERAPY MANAGEMENT PURSUANT TO SECTION SIX
THOUSAND  EIGHT  HUNDRED  ONE-A  OF THIS ARTICLE SHALL COMPLETE AT LEAST
FIVE HOURS OF ACCEPTABLE FORMAL CONTINUING  EDUCATION  IN  THE  AREA  OR
AREAS  OF  PRACTICE  GENERALLY RELATED TO ANY COLLABORATIVE DRUG THERAPY
MANAGEMENT PROTOCOLS  TO WHICH THE PHARMACIST MAY BE SUBJECT. Any  phar-
macist  whose  first  registration  date following the effective date of
this section occurs less than three years from such effective date,  but
on or after January first, nineteen hundred ninety-eight, shall complete
continuing  education  hours  on a prorated basis at the rate of one and
one-quarter hours per month for  the  period  beginning  January  first,
nineteen  hundred  ninety-seven up to the first registration date there-
after.  A licensee who has not satisfied the mandatory continuing educa-
tion requirements shall not be issued a triennial  registration  certif-
icate  by  the  department  and  shall  not  practice unless and until a
conditional registration certificate is issued as provided for in subdi-
vision three of this section. Continuing education  hours  taken  during
one triennium may not be transferred to a subsequent triennium.
  S  4. The department of education, in consultation with the department
of health, shall prepare or shall  arrange  for  the  preparation  of  a
report  on  the  implementation of collaborative drug therapy management
(CDTM) in New York state. The report shall be submitted to  the  speaker
of the assembly and the temporary president of the senate and the chairs
of  the  senate  and  assembly higher education committees at least four
months prior to the expiration of this act. The report shall review  the
extent to which CDTM was implemented in New York state and shall examine
whether  and  the extent to which CDTM contributed to the improvement of
quality of care for patients, reduced  the  risk  of  medication  error,
reduced  unnecessary  health care expenditures, and was otherwise in the
public interest. The  report  may  make  recommendations  regarding  the
extension,  alteration and/or expansion of these provisions and make any
other recommendations related to the implementation of CDTM pursuant  to
this act.
  S 5. This act shall take effect on the one hundred twentieth day after
it shall have become a law and shall expire 3 years after such effective
date  when  upon  such  date  the provisions of this act shall be deemed
repealed; provided, however, that the amendments  to  subdivision  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 subdivision  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 is authorized and directed to be made and
completed on or before such effective date.