S T A T E O F N E W Y O R K ________________________________________________________________________ 5091 2015-2016 Regular Sessions I N A S S E M B L Y February 12, 2015 ___________ Introduced by M. of A. BLANKENBUSH, LAVINE, CROUCH -- 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: 1 Section 1. Section 6802 of the education law is amended by adding four 2 new subdivisions 27, 28, 29 and 30 to read as follows: 3 27. "REMOTE SITE" MEANS A PHARMACY STAFFED BY REGISTERED PHARMACY 4 TECHNICIANS WITH ACCESS TO ITS MAIN PHARMACY AND REGISTERED PHARMACISTS 5 BY COMPUTER LINK, VIDEO LINK AND AUDIO LINK WHILE OPEN. 6 28. "SATELLITE CONSULTATION SITE" MEANS A TELEPHARMACY WHERE ANY 7 FILLED PRESCRIPTIONS READY FOR DISPENSING ARE PREPARED AT ANOTHER PHAR- 8 MACY AND DELIVERED TO THE SATELLITE FOR DISPENSING VIA COMPUTER LINK, 9 VIDEO LINK AND AUDIO LINK TO THE MAIN PHARMACY AND A LICENSED PHARMA- 10 CIST. 11 29. "TELEPHARMACY" MEANS A CENTRAL PHARMACY WITH ONE OR MORE REMOTE 12 SITES IN WHICH ALL SITES ARE CONNECTED VIA COMPUTER LINK, VIDEO LINK AND 13 AUDIO LINK. 14 30. "TELEPHARMACY IN HOSPITALS" MEANS A CENTRAL HOSPITAL PHARMACY WITH 15 ONE OR MORE REMOTE SITES IN WHICH ALL SITES ARE CONNECTED VIA COMPUTER 16 LINK, VIDEO LINK AND AUDIO LINK. 17 S 2. The education law is amended by adding a new section 6832 to read 18 as follows: 19 S 6832. TELEPHARMACY. 1. A REMOTE SITE SHALL COMPLY WITH SECTION 20 SIXTY-EIGHT HUNDRED EIGHT OF THIS ARTICLE, GOVERNING REQUIREMENTS FOR 21 PERMIT TO OPERATE A PHARMACY. THE REMOTE SITE IS CONSIDERED TO BE UNDER 22 THE PERSONAL CHARGE OF THE PHARMACIST AT THE CENTRAL PHARMACY. 23 2. A REMOTE SITE SHALL BE CONNECTED TO ITS CENTRAL PHARMACY VIA 24 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. LBD08720-01-5 A. 5091 2 1 CENTRAL PHARMACY'S CENTRAL PROCESSING UNIT, INCLUDING, BUT NOT LIMITED 2 TO: 3 (A) CONSECUTIVE PRESCRIPTION NUMBERS AND ALL PRESCRIPTION RECORDS 4 SHALL BE MAINTAINED AT THE CENTRAL PHARMACY; 5 (B) PRESCRIPTIONS FILLED AT THE REMOTE SITE SHALL BE DISTINGUISHABLE 6 ON RECORDS FROM THOSE FILLED AT THE CENTRAL PHARMACY; 7 (C) DAILY REPORTS MUST BE SEPARATED FOR THE CENTRAL PHARMACY AND THE 8 REMOTE SITE, BUT SHALL BE MAINTAINED AT THE CENTRAL PHARMACY; 9 (D) PHARMACIES SHALL BE ABLE TO GENERATE LABELS FROM THE CENTRAL PHAR- 10 MACY OR AT THE REMOTE SITE; AND 11 (E) ALL PRESCRIPTIONS DISTRIBUTED AT THE REMOTE SITE SHALL HAVE A 12 LABEL THAT MEETS REQUIREMENTS SET FORTH IN SECTION SIXTY-EIGHT HUNDRED 13 ELEVEN-A OF THIS ARTICLE ATTACHED TO THE FINAL DRUG CONTAINER BEFORE THE 14 PHARMACIST VERIFIES THE DISPENSING PROCESS. 15 3. A PHARMACIST AT THE CENTRAL PHARMACY SHALL APPROVE EACH 16 PRESCRIPTION BEFORE IT LEAVES THE REMOTE SITE, INCLUDING, BUT NOT LIMIT- 17 ED TO: 18 (A) DISPENSING IS CONSIDERED TO BE DONE AT THE CENTRAL PHARMACY; 19 (B) BOTH THE PHARMACIST'S AND THE TECHNICIAN'S INITIALS SHALL APPEAR 20 ON THE FILL SCREEN, PATIENT PROFILE AND LABEL; AND 21 (C) A PHARMACIST SHALL COMPARE VIA VIDEO LINK THE STOCK BOTTLE, DRUG 22 DISPENSED AND STRENGTH. THE ENTIRE LABEL SHALL BE CHECKED FOR ACCURACY 23 ON THE VIDEO LINK. 24 4. COUNSELING SHALL BE ACCOMPLISHED BY A PHARMACIST VIA VIDEO AND 25 AUDIO LINK. THE PHARMACIST SHALL COUNSEL THE PATIENT OR THE PATIENT'S 26 AGENT ON ALL NEW PRESCRIPTIONS AND REFILLS. 27 5. A PHARMACIST SHALL COMPLETE MONTHLY INSPECTIONS OF THE REMOTE SITE. 28 INSPECTION CRITERIA SHALL BE INCLUDED IN THE POLICIES AND PROCEDURES FOR 29 THE SITE. THE INSPECTION REPORTS SHALL BE MAINTAINED UNTIL THE NEXT 30 STATE BOARD OF PHARMACY INSPECTION. 31 6. THE REMOTE SITE SHALL HAVE A PRESCRIPTION INVENTORY. CONTROLLED 32 SUBSTANCES SHALL BE KEPT AT THE REMOTE SITE. 33 (A) IF CONTROLLED SUBSTANCES ARE KEPT, THE REMOTE SITE SHALL BE REGIS- 34 TERED WITH THE DRUG ENFORCEMENT ADMINISTRATION AND SHALL OBTAIN ITS OWN 35 DRUG ENFORCEMENT ADMINISTRATION NUMBER. 36 (B) ALL RECORDS SHALL BE STORED AT THE CENTRAL PHARMACY, EXCEPT THOSE 37 REQUIRED BY DRUG ENFORCEMENT ADMINISTRATION TO BE AT THE DRUG ENFORCE- 38 MENT ADMINISTRATION REGISTERED SITE. 39 (C) POLICIES AND PROCEDURES SHALL BE IMPLEMENTED TO ENSURE THE SAFE 40 AND EFFECTIVE DISTRIBUTION OF PHARMACEUTICAL PRODUCTS AND DELIVERY OF 41 REQUIRED PHARMACEUTICAL CARE; INCLUDING, BUT NOT LIMITED TO AN ONGOING 42 REVIEW OF INCIDENT REPORTS AND OUTCOMES, WITH APPROPRIATE CORRECTIVE 43 ACTION TAKEN WHEN NECESSARY, TO ENSURE THERE IS NO ABNORMAL FREQUENCY OF 44 ERRORS IN DISPENSING DRUGS OR DEVICES. 45 7. DISPENSING AND CONSULTATION MAY BE DONE WHEN THE REGISTERED PHARMA- 46 CY TECHNICIAN IS NOT PRESENT, UNDER THE FOLLOWING CIRCUMSTANCES: 47 (A) THE PRESCRIPTION HAS BEEN PREPARED BY THE REGISTERED PHARMACY 48 TECHNICIAN AND CHECKED BY THE LICENSED PHARMACIST; 49 (B) THE PRESCRIPTION AREA IS LOCKED; 50 (C) A SEPARATE LOCKED DRAWER OR CABINET IS MAINTAINED FOR 51 PRESCRIPTIONS READY FOR DISPENSING; 52 (D) A LOG IS MAINTAINED BY THE REGISTERED PHARMACY TECHNICIAN OF 53 PRESCRIPTIONS PLACED IN THE LOCKED DRAWER OR CABINET; 54 (E) A RECORD SHALL BE MADE BY THE PHARMACIST AS TO THE DATE AND TIME 55 AT WHICH DISPENSING AND COUNSELING OCCURS; A. 5091 3 1 (F) SUPPORTIVE PERSONNEL, TRAINED IN THE USE OF THE AUDIO LINK AND 2 VIDEO LINK, TO THE LICENSED PHARMACIST, ARE ON HAND, TO ASSIST THE 3 PATIENTS; AND 4 (G) THE PATIENTS RECEIVE THEIR PRESCRIPTIONS AS SUCH PATIENTS ARE 5 BEING COUNSELED BY THE LICENSED PHARMACIST. 6 8. THE PERMITHOLDER OR THE PHARMACIST IN CHARGE OF THE CENTRAL PHARMA- 7 CY SHALL APPLY FOR A PERMIT FOR THE REMOTE SITE. A TELEPHARMACY PERMIT 8 IS HEREBY ESTABLISHED FOR THE PURPOSE OF CONDUCTING A TELEPHARMACY. SUCH 9 PERMITS ARE ISSUED TO A REMOTE SITE CONNECTED TO A CENTRAL PHARMACY VIA 10 COMPUTER LINK, VIDEO LINK AND AUDIO LINK. 11 9. TO THE EXTENT OF A CONFLICT WITH ANY PROVISION OF THIS ARTICLE, THE 12 PROVISIONS OF THIS ARTICLE GOVERN WITH RESPECT TO A TELEPHARMACY AND 13 REMOTE SITE OPERATING IN COMPLIANCE WITH THIS CHAPTER. WITH THE FOLLOW- 14 ING CONDITIONS, THIS SECTION IS AN EXCEPTION TO THE FOLLOWING RULES: 15 (A) THE REMOTE SITE SHALL HAVE A REGISTERED PHARMACY TECHNICIAN PRES- 16 ENT AND A WORKING COMPUTER, VIDEO AND AUDIO LINK TO A PHARMACIST AT THE 17 CENTRAL PHARMACY TO HAVE THE PRESCRIPTION AREA OPEN. THE COMMUNICATION 18 LINK SHALL BE CHECKED DAILY AND THE REMOTE SITE PHARMACY SHALL BE CLOSED 19 IF SUCH LINK MALFUNCTIONS, UNLESS A PHARMACIST IS AT THE REMOTE SITE. 20 (I) THE TECHNICIAN SHALL BE REGISTERED WITH THE STATE BOARD OF PHARMA- 21 CY. 22 (II) THE TECHNICIAN SHALL BE A GRADUATE OF AN APPROVED PHARMACY TECH- 23 NICIAN EDUCATION PROGRAM OR MUST MAKE APPLICATION TO THE STATE BOARD OF 24 PHARMACY, WHICH DEMONSTRATES KNOWLEDGE AND EXPERIENCE IN PREPARATION OF 25 PRESCRIPTIONS FOR DISPENSING AND WORKING WITH PATIENTS. 26 (III) A PHARMACIST MAY OVERSEE NO MORE THAN FOUR REMOTE SITES. AS 27 DISPENSING IS CONSIDERED DONE BY THE PHARMACIST, THE PHARMACIST SHALL BE 28 HELD RESPONSIBLE FOR AND HELD ACCOUNTABLE FOR THE REMOTE SITE. 29 (B) THE PHARMACY TECHNICIAN MAY UNLOCK THE PRESCRIPTION AND STORAGE 30 AREAS. WHILE THE TECHNICIAN IS ON DUTY, THE PRESCRIPTION AREA MAY 31 REMAIN OPEN. 32 (C) THE INPUT OF DRUG INFORMATION SHALL BE DONE BY A PHARMACIST AT THE 33 MAIN PHARMACY OR IF ENTERED BY THE TECHNICIAN AT THE REMOTE SITE, SHALL 34 BE VERIFIED BY A PHARMACIST. 35 (I) NEW PRESCRIPTIONS MAY BE RECEIVED AT THE CENTRAL PHARMACY AND 36 ENTERED THERE WITH A LABEL PRINTING AT THE REMOTE SITE; AND 37 (II) NEW PRESCRIPTIONS RECEIVED AT THE REMOTE SITE MAY BE ENTERED INTO 38 THE COMPUTER SYSTEM THERE WITH ALL VERIFICATION, INTERACTION CHECKING 39 AND PROFILE REVIEW THE RESPONSIBILITY OF THE PHARMACIST AT THE CENTRAL 40 PHARMACY. 41 10. THE STATE BOARD OF PHARMACY MAY SUSPEND IMMEDIATELY THE PERMIT OF 42 ANY TELEPHARMACY IF A DANGER TO THE PUBLIC EXISTS. 43 11. THERE SHALL BE ESTABLISHED TELEPHARMACY SATELLITE CONSULTATION 44 SITES WHICH SHALL: 45 (A) HAVE NO PRESCRIPTION INVENTORY; 46 (B) ALLOW ONLY FILLED PRESCRIPTIONS, FILLED AT THE CENTRAL PHARMACY, 47 WITH FINAL PATIENT LABELING ATTACHED; 48 (C) BE CONTROLLED BY SUPPORTIVE PERSONNEL WHO HAVE BEEN TRAINED IN THE 49 USE OF THE PATIENT COUNSELING AUDIO LINKS AND VIDEO LINKS NECESSARY FOR 50 THE DISPENSING AND CONSULTATION TO OCCUR; 51 (D) HAVE THE SUPPORTIVE PERSONNEL NECESSARY TO ASSIST THE PATIENT IN 52 ACCESSING THE PHARMACIST VIA THE AUDIO LINK AND VIDEO LINK; 53 (E) ACCEPT PRESCRIPTION REFILL REQUESTS COMMUNICATED TO SUCH SITE BY 54 THE PATIENT OR THE PATIENT'S AGENT; A. 5091 4 1 (F) ACCEPT ORIGINAL WRITTEN PRESCRIPTIONS BROUGHT TO SUCH SITES BY THE 2 PATIENT OR THE PATIENT'S AGENT FOR FAXING, SCANNING AND TRANSMITTING TO 3 THE CENTRAL PHARMACY; 4 (G) NOT RECEIVE A PRESCRIPTION OR REFILL COMMUNICATED FROM PRACTITION- 5 ERS AT SUCH SITES; 6 (H) MAINTAIN BY THE PHARMACIST SECURITY OF FILLED PRESCRIPTIONS BY A 7 SEPARATE LOCKED DRAWER OR CABINET; AND 8 (I) HAVE A RECORD BY THE PHARMACIST AS TO THE DATE AND TIME AT WHICH 9 DISPENSING AND COUNSELING OCCURRED. 10 12. IN A HOSPITAL WHICH IS UTILIZING TELEPHARMACY, PURSUANT TO THIS 11 SECTION, NO PRESCRIPTION ORDER MAY BE RELEASED FOR ADMINISTRATION TO A 12 PATIENT UNTIL APPROVED BY A PHARMACIST VIA THE AUDIO LINK, VIDEO LINK 13 AND COMPUTER LINK. THE POLICY AND PROCEDURES OF THE HOSPITAL PHARMACY 14 SHALL ADDRESS ALL ASPECTS OF THE TELEPHARMACY OPERATION, INCLUDING, BUT 15 NOT LIMITED TO, THE CONTROL OF THE PHARMACY BY THE REGISTERED PHARMACY 16 TECHNICIAN IN THE ABSENCE OF THE PHARMACIST. 17 13. TELEPHARMACY SATELLITE REMOTE DISPENSING MACHINE SITES SHALL HAVE 18 PRESCRIPTION INVENTORY, WHICH IS SECURED IN AN AUTOMATED DISPENSING 19 DEVICE CONNECTED TO THE CENTRAL PROCESSING UNIT AT THE CENTRAL PHARMACY. 20 A PHARMACIST SHALL APPROVE ALL PRESCRIPTION ORDERS BEFORE SUCH 21 PRESCRIPTIONS ARE RELEASED FROM THE AUTOMATED DISPENSING DEVICE. 22 DISPENSING AND COUNSELING ARE PERFORMED BY THE LICENSED PHARMACIST AT 23 THE CENTRAL SITE VIA AUDIO LINK AND VIDEO LINK. 24 S 3. This act shall take effect immediately. Effective immediately, 25 the addition, amendment and/or repeal of any rule or regulation neces- 26 sary for the implementation of this act on its effective date is author- 27 ized and directed to be made and completed on or before such effective 28 date.