S T A T E O F N E W Y O R K
________________________________________________________________________
6197
2011-2012 Regular Sessions
I N A S S E M B L Y
March 9, 2011
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Introduced by M. of A. BLANKENBUSH, CROUCH, McLAUGHLIN -- Multi-Spon-
sored by -- M. of A. PALMESANO -- 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.
LBD09379-01-1
A. 6197 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. 6197 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. 6197 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.