S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  6841

                       2009-2010 Regular Sessions

                          I N  A S S E M B L Y

                             March 13, 2009
                               ___________

Introduced  by  M.  of  A.  SCOZZAFAVA  -- read once and referred to the
  Committee on Higher Education

AN ACT to amend the education law, in relation to establishing the prac-
  tice of telepharmacy

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Section 6802 of the education law is amended by adding four
new subdivisions 23, 24, 25 and 26 to read as follows:
  23.  "REMOTE  SITE"  MEANS  A  PHARMACY STAFFED BY REGISTERED PHARMACY
TECHNICIANS WITH ACCESS TO ITS MAIN PHARMACY AND REGISTERED  PHARMACISTS
BY COMPUTER LINK, VIDEO LINK AND AUDIO LINK WHILE OPEN.
  24.  "SATELLITE  CONSULTATION  SITE"  MEANS  A  TELEPHARMACY WHERE ANY
FILLED PRESCRIPTIONS READY FOR DISPENSING ARE PREPARED AT ANOTHER  PHAR-
MACY  AND  DELIVERED  TO THE SATELLITE FOR DISPENSING VIA COMPUTER LINK,
VIDEO LINK AND AUDIO LINK TO THE MAIN PHARMACY AND  A  LICENSED  PHARMA-
CIST.
  25.  "TELEPHARMACY"  MEANS  A CENTRAL PHARMACY WITH ONE OR MORE REMOTE
SITES IN WHICH ALL SITES ARE CONNECTED VIA COMPUTER LINK, VIDEO LINK AND
AUDIO LINK.
  26. "TELEPHARMACY IN HOSPITALS" MEANS A CENTRAL HOSPITAL PHARMACY WITH
ONE OR MORE REMOTE SITES IN WHICH ALL SITES ARE CONNECTED  VIA  COMPUTER
LINK, VIDEO LINK AND AUDIO LINK.
  S 2. The education law is amended by adding a new section 6829 to read
as follows:
  S  6829.  TELEPHARMACY.  1.  A  REMOTE  SITE SHALL COMPLY WITH SECTION
SIXTY-EIGHT HUNDRED EIGHT OF THIS ARTICLE,  GOVERNING  REQUIREMENTS  FOR
PERMIT  TO OPERATE A PHARMACY. THE REMOTE SITE IS CONSIDERED TO BE UNDER
THE PERSONAL CHARGE OF THE PHARMACIST AT THE CENTRAL PHARMACY.
  2. A REMOTE SITE SHALL  BE  CONNECTED  TO  ITS  CENTRAL  PHARMACY  VIA
COMPUTER  LINK,  VIDEO  LINK AND AUDIO LINK. A REMOTE SITE SHALL USE ITS

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD08513-01-9

              

A. 6841                             2

CENTRAL PHARMACY'S CENTRAL PROCESSING UNIT, INCLUDING, BUT  NOT  LIMITED
TO:
  (A)  CONSECUTIVE  PRESCRIPTION  NUMBERS  AND  ALL PRESCRIPTION RECORDS
SHALL BE MAINTAINED AT THE CENTRAL PHARMACY;
  (B) PRESCRIPTIONS FILLED AT THE REMOTE SITE SHALL  BE  DISTINGUISHABLE
ON RECORDS FROM THOSE FILLED AT THE CENTRAL PHARMACY;
  (C)  DAILY  REPORTS MUST BE SEPARATED FOR THE CENTRAL PHARMACY AND THE
REMOTE SITE, BUT SHALL BE MAINTAINED AT THE CENTRAL PHARMACY;
  (D) PHARMACIES SHALL BE ABLE TO GENERATE LABELS FROM THE CENTRAL PHAR-
MACY OR AT THE REMOTE SITE; AND
  (E) ALL PRESCRIPTIONS DISTRIBUTED AT THE  REMOTE  SITE  SHALL  HAVE  A
LABEL  THAT  MEETS REQUIREMENTS SET FORTH IN SECTION SIXTY-EIGHT HUNDRED
ELEVEN-A OF THIS ARTICLE ATTACHED TO THE FINAL DRUG CONTAINER BEFORE THE
PHARMACIST VERIFIES THE DISPENSING PROCESS.
  3.  A  PHARMACIST  AT  THE  CENTRAL  PHARMACY   SHALL   APPROVE   EACH
PRESCRIPTION BEFORE IT LEAVES THE REMOTE SITE, INCLUDING, BUT NOT LIMIT-
ED TO:
  (A) DISPENSING IS CONSIDERED TO BE DONE AT THE CENTRAL PHARMACY;
  (B)  BOTH  THE PHARMACIST'S AND THE TECHNICIAN'S INITIALS SHALL APPEAR
ON THE FILL SCREEN, PATIENT PROFILE AND LABEL; AND
  (C) A PHARMACIST SHALL COMPARE VIA VIDEO LINK THE STOCK  BOTTLE,  DRUG
DISPENSED  AND  STRENGTH. THE ENTIRE LABEL SHALL BE CHECKED FOR ACCURACY
ON THE VIDEO LINK.
  4. COUNSELING SHALL BE ACCOMPLISHED BY  A  PHARMACIST  VIA  VIDEO  AND
AUDIO  LINK.  THE  PHARMACIST SHALL COUNSEL THE PATIENT OR THE PATIENT'S
AGENT ON ALL NEW PRESCRIPTIONS AND REFILLS.
  5. A PHARMACIST SHALL COMPLETE MONTHLY INSPECTIONS OF THE REMOTE SITE.
INSPECTION CRITERIA SHALL BE INCLUDED IN THE POLICIES AND PROCEDURES FOR
THE SITE. THE INSPECTION REPORTS SHALL  BE  MAINTAINED  UNTIL  THE  NEXT
STATE BOARD OF PHARMACY INSPECTION.
  6.  THE  REMOTE  SITE  SHALL HAVE A PRESCRIPTION INVENTORY. CONTROLLED
SUBSTANCES SHALL BE KEPT AT THE REMOTE SITE.
  (A) IF CONTROLLED SUBSTANCES ARE KEPT, THE REMOTE SITE SHALL BE REGIS-
TERED WITH THE DRUG ENFORCEMENT ADMINISTRATION AND SHALL OBTAIN ITS  OWN
DRUG ENFORCEMENT ADMINISTRATION NUMBER.
  (B)  ALL RECORDS SHALL BE STORED AT THE CENTRAL PHARMACY, EXCEPT THOSE
REQUIRED BY DRUG ENFORCEMENT ADMINISTRATION TO BE AT THE  DRUG  ENFORCE-
MENT ADMINISTRATION REGISTERED SITE.
  (C)  POLICIES  AND  PROCEDURES SHALL BE IMPLEMENTED TO ENSURE THE SAFE
AND EFFECTIVE DISTRIBUTION OF PHARMACEUTICAL PRODUCTS  AND  DELIVERY  OF
REQUIRED  PHARMACEUTICAL  CARE; INCLUDING, BUT NOT LIMITED TO AN ONGOING
REVIEW OF INCIDENT REPORTS AND  OUTCOMES,  WITH  APPROPRIATE  CORRECTIVE
ACTION TAKEN WHEN NECESSARY, TO ENSURE THERE IS NO ABNORMAL FREQUENCY OF
ERRORS IN DISPENSING DRUGS OR DEVICES.
  7. DISPENSING AND CONSULTATION MAY BE DONE WHEN THE REGISTERED PHARMA-
CY TECHNICIAN IS NOT PRESENT, UNDER THE FOLLOWING CIRCUMSTANCES:
  (A)  THE  PRESCRIPTION  HAS  BEEN  PREPARED BY THE REGISTERED PHARMACY
TECHNICIAN AND CHECKED BY THE LICENSED PHARMACIST;
  (B) THE PRESCRIPTION AREA IS LOCKED;
  (C)  A  SEPARATE  LOCKED  DRAWER  OR   CABINET   IS   MAINTAINED   FOR
PRESCRIPTIONS READY FOR DISPENSING;
  (D)  A  LOG  IS  MAINTAINED  BY  THE REGISTERED PHARMACY TECHNICIAN OF
PRESCRIPTIONS PLACED IN THE LOCKED DRAWER OR CABINET;
  (E) A RECORD SHALL BE MADE BY THE PHARMACIST AS TO THE DATE  AND  TIME
AT WHICH DISPENSING AND COUNSELING OCCURS;

A. 6841                             3

  (F)  SUPPORTIVE  PERSONNEL,  TRAINED  IN THE USE OF THE AUDIO LINK AND
VIDEO LINK, TO THE LICENSED PHARMACIST,  ARE  ON  HAND,  TO  ASSIST  THE
PATIENTS; AND
  (G)  THE  PATIENTS  RECEIVE  THEIR  PRESCRIPTIONS AS SUCH PATIENTS ARE
BEING COUNSELED BY THE LICENSED PHARMACIST.
  8. THE PERMITHOLDER OR THE PHARMACIST IN CHARGE OF THE CENTRAL PHARMA-
CY SHALL APPLY FOR A PERMIT FOR THE REMOTE SITE. A  TELEPHARMACY  PERMIT
IS HEREBY ESTABLISHED FOR THE PURPOSE OF CONDUCTING A TELEPHARMACY. SUCH
PERMITS  ARE ISSUED TO A REMOTE SITE CONNECTED TO A CENTRAL PHARMACY VIA
COMPUTER LINK, VIDEO LINK AND AUDIO LINK.
  9. TO THE EXTENT OF A CONFLICT WITH ANY PROVISION OF THIS ARTICLE, THE
PROVISIONS OF THIS ARTICLE GOVERN WITH RESPECT  TO  A  TELEPHARMACY  AND
REMOTE SITE OPERATING IN COMPLIANCE WITH THIS CHAPTER.  WITH THE FOLLOW-
ING CONDITIONS, THIS SECTION IS AN EXCEPTION TO THE FOLLOWING RULES:
  (A)  THE REMOTE SITE SHALL HAVE A REGISTERED PHARMACY TECHNICIAN PRES-
ENT AND A WORKING COMPUTER, VIDEO AND AUDIO LINK TO A PHARMACIST AT  THE
CENTRAL  PHARMACY  TO HAVE THE PRESCRIPTION AREA OPEN. THE COMMUNICATION
LINK SHALL BE CHECKED DAILY AND THE REMOTE SITE PHARMACY SHALL BE CLOSED
IF SUCH LINK MALFUNCTIONS, UNLESS A PHARMACIST IS AT THE REMOTE SITE.
  (I) THE TECHNICIAN SHALL BE REGISTERED WITH THE STATE BOARD OF PHARMA-
CY.
  (II) THE TECHNICIAN SHALL BE A GRADUATE OF AN APPROVED PHARMACY  TECH-
NICIAN  EDUCATION PROGRAM OR MUST MAKE APPLICATION TO THE STATE BOARD OF
PHARMACY, WHICH DEMONSTRATES KNOWLEDGE AND EXPERIENCE IN PREPARATION  OF
PRESCRIPTIONS FOR DISPENSING AND WORKING WITH  PATIENTS.
  (III)  A  PHARMACIST  MAY  OVERSEE  NO MORE THAN FOUR REMOTE SITES. AS
DISPENSING IS CONSIDERED DONE BY THE PHARMACIST, THE PHARMACIST SHALL BE
HELD RESPONSIBLE FOR AND HELD ACCOUNTABLE FOR THE REMOTE SITE.
  (B) THE PHARMACY TECHNICIAN MAY UNLOCK THE  PRESCRIPTION  AND  STORAGE
AREAS.    WHILE  THE  TECHNICIAN  IS  ON DUTY, THE PRESCRIPTION AREA MAY
REMAIN OPEN.
  (C) THE INPUT OF DRUG INFORMATION SHALL BE DONE BY A PHARMACIST AT THE
MAIN PHARMACY OR IF ENTERED BY THE TECHNICIAN AT THE REMOTE SITE,  SHALL
BE VERIFIED BY A PHARMACIST.
  (I)  NEW  PRESCRIPTIONS  MAY  BE  RECEIVED AT THE CENTRAL PHARMACY AND
ENTERED THERE WITH A LABEL PRINTING AT THE REMOTE SITE; AND
  (II) NEW PRESCRIPTIONS RECEIVED AT THE REMOTE SITE MAY BE ENTERED INTO
THE COMPUTER SYSTEM THERE WITH ALL  VERIFICATION,  INTERACTION  CHECKING
AND  PROFILE  REVIEW THE RESPONSIBILITY OF THE PHARMACIST AT THE CENTRAL
PHARMACY.
  10. THE STATE BOARD OF PHARMACY MAY SUSPEND IMMEDIATELY THE PERMIT  OF
ANY TELEPHARMACY IF A DANGER TO THE PUBLIC EXISTS.
  11.  THERE  SHALL  BE  ESTABLISHED TELEPHARMACY SATELLITE CONSULTATION
SITES WHICH SHALL:
  (A) HAVE NO PRESCRIPTION INVENTORY;
  (B) ALLOW ONLY FILLED PRESCRIPTIONS, FILLED AT THE  CENTRAL  PHARMACY,
WITH FINAL PATIENT LABELING ATTACHED;
  (C) BE CONTROLLED BY SUPPORTIVE PERSONNEL WHO HAVE BEEN TRAINED IN THE
USE  OF THE PATIENT COUNSELING AUDIO LINKS AND VIDEO LINKS NECESSARY FOR
THE DISPENSING AND CONSULTATION TO OCCUR;
  (D) HAVE THE SUPPORTIVE PERSONNEL NECESSARY TO ASSIST THE  PATIENT  IN
ACCESSING THE PHARMACIST VIA THE AUDIO LINK AND VIDEO LINK;
  (E)  ACCEPT  PRESCRIPTION REFILL REQUESTS COMMUNICATED TO SUCH SITE BY
THE PATIENT OR THE PATIENT'S AGENT;

A. 6841                             4

  (F) ACCEPT ORIGINAL WRITTEN PRESCRIPTIONS BROUGHT TO SUCH SITES BY THE
PATIENT OR THE PATIENT'S AGENT FOR FAXING, SCANNING AND TRANSMITTING  TO
THE CENTRAL PHARMACY;
  (G) NOT RECEIVE A PRESCRIPTION OR REFILL COMMUNICATED FROM PRACTITION-
ERS AT SUCH SITES;
  (H)  MAINTAIN  BY THE PHARMACIST SECURITY OF FILLED PRESCRIPTIONS BY A
SEPARATE LOCKED DRAWER OR CABINET; AND
  (I) HAVE A RECORD BY THE PHARMACIST AS TO THE DATE AND TIME  AT  WHICH
DISPENSING AND COUNSELING OCCURRED.
  12.  IN  A  HOSPITAL WHICH IS UTILIZING TELEPHARMACY, PURSUANT TO THIS
SECTION, NO PRESCRIPTION ORDER MAY BE RELEASED FOR ADMINISTRATION  TO  A
PATIENT  UNTIL  APPROVED  BY A PHARMACIST VIA THE AUDIO LINK, VIDEO LINK
AND COMPUTER LINK. THE POLICY AND PROCEDURES OF  THE  HOSPITAL  PHARMACY
SHALL  ADDRESS ALL ASPECTS OF THE TELEPHARMACY OPERATION, INCLUDING, BUT
NOT LIMITED TO, THE CONTROL OF THE PHARMACY BY THE  REGISTERED  PHARMACY
TECHNICIAN IN THE ABSENCE OF THE PHARMACIST.
  13.  TELEPHARMACY SATELLITE REMOTE DISPENSING MACHINE SITES SHALL HAVE
PRESCRIPTION INVENTORY, WHICH IS  SECURED  IN  AN  AUTOMATED  DISPENSING
DEVICE CONNECTED TO THE CENTRAL PROCESSING UNIT AT THE CENTRAL PHARMACY.
  A  PHARMACIST  SHALL  APPROVE  ALL  PRESCRIPTION  ORDERS  BEFORE  SUCH
PRESCRIPTIONS ARE RELEASED FROM THE AUTOMATED DISPENSING DEVICE.
  DISPENSING AND COUNSELING ARE PERFORMED BY THE LICENSED PHARMACIST  AT
THE CENTRAL SITE VIA AUDIO LINK AND VIDEO LINK.
  S  3.  This act shall take effect immediately.  Effective immediately,
the addition, amendment and/or repeal of any rule or  regulation  neces-
sary  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.