NY State Senate Bill 2023-S5914A

Senate Bill S5914A

2023-2024 Legislative Session

Relates to the automated storage and dispensing of controlled substances using an automated dispensing device

download bill text pdf

Current Bill Status - In Senate Committee Higher Education Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 04, 2024	print number 5914b
Jan 04, 2024	amend and recommit to higher education
Jan 03, 2024	referred to higher education returned to senate died in assembly
May 17, 2023	referred to higher education delivered to assembly passed senate
May 15, 2023	advanced to third reading
May 10, 2023	2nd report cal.
May 09, 2023	1st report cal.811
Apr 26, 2023	print number 5914a
Apr 26, 2023	amend (t) and recommit to higher education
Mar 22, 2023	referred to higher education

Votes

- May 17, 2023 - Floor Vote
  S5914A
  
  60
  
  Aye
  
  1
  
  Nay
  
  0
  
  Absent
  
  2
  
  Excused
  
  0
  
  Abstained
  - - Floor Vote: May 17, 2023
      
      aye (60)
      
      Addabbo Jr.
      
      Ashby
      
      Bailey
      
      Borrello
      
      Breslin
      
      Brisport
      
      Brouk
      
      Canzoneri-Fitzpatrick
      
      Chu
      
      Cleare
      
      Comrie
      
      Felder
      
      Fernandez
      
      Gallivan
      
      Gianaris
      
      Gonzalez
      
      Griffo
      
      Harckham
      
      Helming
      
      Hinchey
      
      Hoylman-Sigal
      
      Jackson
      
      Kavanagh
      
      Kennedy
      
      Krueger
      
      Lanza
      
      Liu
      
      Mannion
      
      Martinez
      
      Martins
      
      Mattera
      
      May
      
      Mayer
      
      Murray
      
      Myrie
      
      O'Mara
      
      Oberacker
      
      Ortt
      
      Palumbo
      
      Parker
      
      Persaud
      
      Ramos
      
      Rhoads
      
      Rivera
      
      Rolison
      
      Ryan
      
      Salazar
      
      Sanders Jr.
      
      Scarcella-Spanton
      
      Sepúlveda
      
      Serrano
      
      Skoufis
      
      Stavisky
      
      Stec
      
      Stewart-Cousins
      
      Tedisco
      
      Thomas
      
      Webb
      
      Weber
      
      Weik
      
      nay (1)
      
      Walczyk
      
      excused (2)
      
      Cooney
      
      Gounardes
  May 9, 2023 - Higher Education Committee Vote
  S5914A
  
  11
  
  Aye
  
  0
  
  Nay
  
  0
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Higher Education Committee Vote: May 9, 2023
      
      aye (11)
      
      Breslin
      
      Chu
      
      Gounardes
      
      Griffo
      
      Jackson
      
      Liu
      
      Murray
      
      Oberacker
      
      Rivera
      
      Stavisky
      
      Webb

Bill Amendments

Original

B (Active)

2023-S5914 - Details

See Assembly Version of this Bill:: A2132
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6802, add §6809, Ed L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S8474, A10784
2021-2022: S4102, A2463, A5512

2023-S5914 - Summary

Relates to the automated storage and dispensing of controlled substances using an automated dispensing device at licensed nursing homes, residential health care facilities and hospices.

2023-S5914 - Sponsor Memo

                                 
BILL NUMBER: S5914

SPONSOR: CHU
 
TITLE OF BILL:

An act to amend the education law and the public health law, in relation
to the automated storage and dispensing of controlled substances using
an automated dispensing device

 
PURPOSE:

Permits the use of Automated Dispensing Devices (ADD) within health care
facilities.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section One: Amends section 6802 of the education law to define auto-
mated dispensing devices (ADD) as mechanical systems used in nursing
homes, residential health care facilities, and hospices that packages
and labels patient specific medication or multiple medications for the
purposes of administration by a health care professional based on a
prescription.

Section Two: Amends the education law by adding a new section 6809,
which outlines the processes and procedures of loading an ADD, distrib-
uting medication through an ADD, as well as any directing policy guid-
ance for health care facilities.

Section Three: sets the effective date.

 
JUSTIFICATION:

Automated dispensing devices (ADD)s prevent delays in first-dose deliv-
ery, loss of doses, and medication diversion, while also increasing
patient safety by providing a good balance of security, accessibility,
and inventory control. With Automated Dispensing Devices, all medica-
tions are packaged resident specific, one shift (8 hours) at a time, as
opposed to the current "30 day supply" paid for by Medicaid. This means
Medicaid is only paying for medication tablets actually packaged, not
the full prescription up front.

Nurses need updated tools to assist with patient care and ADDs are that
new technology. They streamline the nurse-pharmacy process thus enabling
nurses to be more available for direct patient care.

ADDs remove human error in dispensing to the greatest extent practica-
ble, particularly when it comes to reading doctors' handwritten
instructions. Additionally, they save health care professional time by
ending end of-shift medication counts.

 
LEGISLATIVE HISTORY:

2021-2022: S4102A (SAVINO) / A5512A (Dinowitz) - Passed Senate / Died in
Assembly

2020: S8474 (SAVINO) / A10784 (Dinowitz): Passed Senate / Died in Assem-
bly

 
FISCAL IMPLICATIONS:
None.

 
EFFECTIVE DATE:
60 days after signed into law.

2023-S5914 - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5914
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              March 22, 2023
                                ___________
 
 Introduced  by  Sen.  CHU  --  read  twice and ordered printed, and when
   printed to be committed to the Committee on Higher Education
 
 AN ACT to amend the education law and the public health law, in relation
   to the automated storage and dispensing of controlled substances using
   an automated dispensing device

   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 a
 new subdivision 29 to read as follows:
   29. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
 DESIGNED FOR USE IN HEALTH CARE FACILITIES ALLOWING  FOR  COMPUTER-CONT-
 ROLLED  STORAGE,  PACKAGING  AND  DISPENSING  OF  DRUGS  AND  DEVICES TO
 LICENSED HEALTH CARE PROFESSIONALS NEAR THE POINT OF CARE.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   § 280-D. AUTOMATED STORAGE AND DISPENSING OF CONTROLLED SUBSTANCES. 1.
 FOR PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)"  SHALL
 MEAN  A  MECHANICAL  SYSTEM  DESIGNED  FOR USE IN HEALTH CARE FACILITIES
 ALLOWING FOR COMPUTER-CONTROLLED STORAGE, PACKAGING  AND  DISPENSING  OF
 DRUGS  AND  DEVICES TO LICENSED HEALTH CARE PROFESSIONALS NEAR THE POINT
 OF CARE.
   2. NOTWITHSTANDING ANY PROVISION OF LAW, RULE  OR  REGULATION  TO  THE
 CONTRARY,  LICENSED HEALTH CARE FACILITIES THROUGHOUT THE STATE SHALL BE
 PERMITTED TO USE AUTOMATED DISPENSING  DEVICES  TO  STORE,  PACKAGE  AND
 DISPENSE  MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES, AS AUTHORIZED BY
 SUCH FACILITY'S LICENSING BODY.
   3. THE ADD AND ITS CONTENTS SHALL REMAIN THE PROPERTY OF THE PHARMACY.
   4. LICENSED  HEALTH  CARE  FACILITIES  SHALL  IMPLEMENT  AND  MAINTAIN
 ADEQUATE  AND  APPROPRIATE  POLICIES,  PROCEDURES  AND QUALITY ASSURANCE
 PROGRAMS TO ENSURE SAFETY, ACCURACY, SECURITY,  ACCOUNTABILITY,  PATIENT
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-01-3
 S. 5914                             2

 
 CONFIDENTIALITY  AND FUNCTIONALLY WITH RESPECT TO THE ADMINISTRATION AND
 USAGE OF AUTOMATED DISPENSING DEVICES.
   5.  ACCESS  TO AN AUTOMATED DISPENSING DEVICE WITHIN A LICENSED HEALTH
 CARE FACILITY SHALL BE RESTRICTED TO AUTHORIZED LICENSED PERSONNEL,  AND
 A  LIST  OF  SUCH  AUTHORIZED PERSONNEL SHALL BE MAINTAINED AT ALL TIMES
 WITHIN THE SYSTEM AND SHALL BE REVIEWED AND UPDATED PERIODICALLY.
   6. ALL MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES SHALL BE DISPENSED
 FROM AN AUTOMATED DISPENSING DEVICE PURSUANT TO A VALID, PATIENT-SPECIF-
 IC PRESCRIPTION OR ORDER.
   7. THE SERVICING PHARMACY SHALL MAINTAIN RECORDS ON-SITE FOR A  PERIOD
 OF  NOT  LESS  THAN  FIVE  YEARS  WITH  RESPECT  TO THE USE OF AUTOMATED
 DISPENSING DEVICES. SUCH RECORDS SHALL INCLUDE:
   (A) DOCUMENTATION OF THE APPROVAL FOR USE AND PLACEMENT  OF  AN  AUTO-
 MATED  DISPENSING DEVICE BY SUCH LICENSED HEALTH CARE FACILITY FROM SUCH
 FACILITY'S LICENSING BODY, IF APPLICABLE;
   (B) THE LOCATION OF ALL AUTOMATED DISPENSING  DEVICES  BEING  USED  AT
 SUCH FACILITY;
   (C) DELIVERY MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION WHICH MONI-
 TORS  THE TRANSPORT OF CONTROLLED SUBSTANCES BETWEEN THE SERVICING PHAR-
 MACY AND THE AUTOMATED DISPENSING DEVICE;
   (D) AUTOMATED DISPENSING DEVICE  MAINTENANCE  AND  CLEANING  LOGS,  OR
 SIMILAR DOCUMENTATION;
   (E)  DOCUMENTATION OR ELECTRONIC DATA OF ALL EVENTS INVOLVING AN AUTO-
 MATED DISPENSING DEVICE, INCLUDING, BUT NOT LIMITED TO:
   (I) THE IDENTITY OF PERSONNEL WHO HAVE ACCESSED THE CONTENTS  OF  SUCH
 DEVICE;
   (II) THE LOCATION OF THE DEVICE ACCESSED;
   (III) THE TYPE OF TRANSACTION, INCLUDING A DATE AND TIME STAMP;
   (IV) THE NAME, STRENGTH, DOSAGE FORM AND QUANTITY OF AN ACCESSED PROD-
 UCT;
   (V)  THE  NAME  OR  OTHER  IDENTIFIER  OF  THE  PATIENT  FOR  WHOM THE
 CONTROLLED SUBSTANCE WAS ORDERED; AND
   (VI) RECONCILIATION OF ALL INVENTORY ACTIVITIES.
   8. ANY LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE  WITH  THE
 REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
   9.  SERVICING  PHARMACIES  UTILIZING  AUTOMATED  DISPENSING DEVICES IN
 LICENSED HEALTH CARE FACILITIES FOR ROUTINE MEDICATION  DISPENSING,  FOR
 EMERGENCY MEDICATION KITS OR OTHER SIMILAR APPROVED USE, SHALL BE LOADED
 BY EITHER A:
   (A) PHARMACY TECHNICIAN, PHARMACY INTERN, OR PHARMACIST; OR
   (B) LICENSED NURSE.
   10.  SERVICING  PHARMACIES  UTILIZING  AUTOMATED DISPENSING DEVICES IN
 LICENSED HEALTH CARE FACILITIES FOR  ROUTINE  MEDICATION  DISPENSING  OF
 CONTROLLED  SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL DRUG
 ENFORCEMENT AGENCY (DEA) REGISTRATION NUMBER, AND APPROPRIATE  NEW  YORK
 STATE LICENSING.
   11.  SERVICING  PHARMACIES  UTILIZING  AUTOMATED DISPENSING DEVICES IN
 LICENSED HEALTH CARE FACILITIES FOR ROUTINE MEDICATION DISPENSING  SHALL
 ENSURE THAT SUCH DEVICE IS CONTINUALLY MONITORED BY VIDEO.
   § 3. This act shall take effect immediately.

2023-S5914A - Details

See Assembly Version of this Bill:: A2132
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6802, add §6809, Ed L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S8474, A10784
2021-2022: S4102, A2463, A5512

2023-S5914A - Summary

Relates to the automated storage and dispensing of controlled substances using an automated dispensing device at licensed nursing homes, residential health care facilities and hospices.

2023-S5914A - Sponsor Memo

                                 
BILL NUMBER: S5914A

SPONSOR: CHU
 
TITLE OF BILL:

An act to amend the education law, in relation to the automated storage
and dispensing of controlled substances using an automated dispensing
device

 
PURPOSE:

Permits the use of Automated Dispensing Devices (ADD) within health care
facilities.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section one of the bill adds subdivision 29 to § 6802 of the education
law to define automated dispensing devices (ADD) as a mechanical system
used in nursing homes, residential health care facilities, and hospices
that packages and labels patient specific medication or multiple medica-
tions for the purposes of administration by a health care professional
based on a prescription or order that has completed final verification

by a licensed pharmacist.

Section two of the bill adds § 6809 the education law. Subdivision one
states "automated dispensing device (ADD)" has the same meaning as
subdivision twenty-nine of section sixty-eight hundred two of this arti-
cle.  Subdivision 2 provides that the ADD shall remain property a phar-
macy licensed in NYS, which will maintain all controls, required record
keeping and obtain all licensing required by state and federal laws.

Subdivision 3 requires record keeping by hard or electronic copy for a
minimum of five years.

Subdivision 4 sets procedures for loading of prepackaged cartridges or
containers into ADD by personnel designated by the pharmacist in charge.

Subdivision 5 sets who has access to the ADD and requires a list of
authorized personnel to be maintained within the ADD system, updated,
and reviewed periodically.

Subdivision 6 requires all medications dispensed through ADD to be
pursuant to a valid, patient-specific prescription or order.

Subdivision 7 requires the pharmacy and facility to implement and main-
tain policies, procedures, and programs to ensure safety, accuracy,
accountability, patient confidentiality, and functionality with respect
to the ADD.

Subdivision 8 requires the ADD at the facility to be continuously video
monitored by the pharmacist during loading.

Subdivision 9 requires any losses of medication to be reported according
to the requirements of the servicing pharmacists licensing body.

Section three of the bill provides the effective date.

 
JUSTIFICATION:

Automated dispensing devices (ADD)s prevent delays in first-dose deliv-
ery, loss of doses, and medication diversion, while also increasing
patient safety by providing a good balance of security, accessibility,
and inventory control. With Automated Dispensing Devices, all medica-
tions are packaged resident specific, one shift (8 hours) at a time, as
opposed to the current "30 day supply" paid for by Medicaid. This means
Medicaid is only paying for medication tablets actually packaged, not
the full prescription up front.

Nurses need updated tools to assist with patient care and ADDs are that
new technology. They streamline the nurse-pharmacy process thus enabling
nurses to be more available for direct patient care.

ADDs remove human error in dispensing to the greatest extent practica-
ble, particularly when it comes to reading doctors' handwritten
instructions. Additionally, they save health care professional time by
ending end of-shift medication counts.

 
LEGISLATIVE HISTORY:

2021-2022: S4102A (SAVINO) / A5512A (Dinowitz) - Passed Senate / Died in
Assembly

2020: S8474 (SAVINO) / A10784 (Dinowitz): Passed Senate / Died in Assem-
bly

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
60 days after signed into law.

2023-S5914A - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  5914--A
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              March 22, 2023
                                ___________
 
 Introduced  by  Sen.  CHU  --  read  twice and ordered printed, and when
   printed to be committed  to  the  Committee  on  Higher  Education  --
   committee  discharged,  bill amended, ordered reprinted as amended and
   recommitted to said committee
 
 AN ACT to amend the education law, in relation to the automated  storage
   and  dispensing of controlled substances using an automated dispensing
   device
 
   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 a
 new subdivision 29 to read as follows:
   29. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
 USED IN NURSING HOMES AND RESIDENTIAL HEALTH  CARE  FACILITIES  LICENSED
 PURSUANT  TO  ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND HOSPICES
 CERTIFIED PURSUANT TO ARTICLE FORTY OF THE PUBLIC HEALTH LAW, THAT PACK-
 AGES AND LABELS PATIENT SPECIFIC MEDICATION OR MULTIPLE MEDICATIONS  FOR
 THE PURPOSES OF ADMINISTRATION BY A HEALTH CARE PROFESSIONAL LICENSED TO
 ADMINISTER  MEDICATIONS BY THE STATE OF NEW YORK BASED ON A PRESCRIPTION
 OR ORDER THAT HAS COMPLETED FINAL VERIFICATION BY A LICENSED PHARMACIST.
   § 2. The education law is amended by adding a new section 6809 to read
 as follows:
   § 6809. AUTOMATED  STORAGE  AND  DISPENSING  OF  MEDICATIONS.  1.  FOR
 PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)" SHALL HAVE
 THE  SAME  MEANING  AS  SUBDIVISION  TWENTY-NINE  OF SECTION SIXTY-EIGHT
 HUNDRED TWO OF THIS ARTICLE.
   2. THE ADD AND ITS CONTENTS SHALL REMAIN THE PROPERTY  OF  A  PHARMACY
 REGISTERED  UNDER  THIS  ARTICLE.    THE  PHARMACY  SHALL  MAINTAIN  ALL
 CONTROLS, RECORD KEEPING AS REQUIRED BY ALL LAWS, RULES AND  REGULATIONS
 OF  THE  STATE.  PHARMACIES  UTILIZING  AUTOMATED  DISPENSING DEVICES AS
 PERMITTED UNDER  THIS  SECTION  FOR  ROUTINE  MEDICATION  DISPENSING  OF
 CONTROLLED  SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL DRUG
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-04-3

 S. 5914--A                          2
 
 ENFORCEMENT ADMINISTRATION (DEA-ADD) REGISTRATION NUMBER, AND THE APPRO-
 PRIATE NEW YORK STATE LICENSING.
   3.   THE PHARMACY SHALL MAINTAIN RECORDS ON SITE AT THE PHARMACY (HARD
 COPY OR ELECTRONIC) FOR NOT LESS THAN FIVE YEARS  AS  REQUIRED  BY  PART
 SIXTY-THREE  OF  THE  REGULATIONS OF THE COMMISSIONER, INCLUDING BUT NOT
 LIMITED TO:
   A. DOCUMENTATION OF THE APPROVAL FOR USE  AND  PLACEMENT  OF  THE  ADD
 RECEIVED FROM THE DEPARTMENT AND/OR THE BOARD OF PHARMACY;
   B.  DELIVERY  MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION THAT MONI-
 TORS THE TRANSPORT OF CONTROLLED SUBSTANCES  BETWEEN  THE  PHARMACY  AND
 ADD;
   C. ADD CLEANING AND MAINTENANCE LOGS OR SIMILAR DOCUMENTATION;
   D.  RECORDS  AND/OR  ELECTRONIC  DATA  OF ALL EVENTS INVOLVING THE ADD
 INCLUDING BUT NOT LIMITED TO:
   (I) IDENTITY OF ALL PERSONNEL WHO ACCESS THE CONTENTS;
   (II) LOCATION OF THE SYSTEM ACCESSED;
   (III) TYPE OF TRANSACTION WITH DATE/TIME STAMP;
   (IV) NAME, STRENGTH, DOSAGE FORM, AND QUANTITY OF THE ACCESSED MEDICA-
 TION;
   (V) NAME OR OTHER IDENTIFIER OF THE PATIENT FOR  WHOM  THE  MEDICATION
 WAS ORDERED;
   (VI)  RECONCILIATION  OF ALL CONTROLLED SUBSTANCE INVENTORIES AT LEAST
 MONTHLY.
   4.  THE PREPACKAGED CARTRIDGES OR CONTAINERS MAY BE SENT TO  A  REMOTE
 SITE TO BE LOADED INTO SUCH MACHINE BY PERSONNEL DESIGNATED BY THE PHAR-
 MACIST-IN-CHARGE PROVIDED:
   A.  THE  INDIVIDUAL  CARTRIDGES  OR CONTAINERS ARE TRANSPORTED TO SUCH
 REMOTE SITE IN A SECURE, TAMPER-EVIDENT CONTAINER; AND
   B. THE AUTOMATED PHARMACY SYSTEM USES BAR-CODING, MICROCHIP, OR  OTHER
 TECHNOLOGIES  TO ENSURE THAT THE CONTAINERS ARE ACCURATELY LOADED IN THE
 AUTOMATED PHARMACY SYSTEM.
   5. ACCESS TO AN ADD SHALL BE RESTRICTED  TO  AUTHORIZED  PHARMACY  AND
 FACILITY  NURSING  LICENSED  PERSONNEL, REGISTERED PHARMACY TECHNICIANS,
 AND PHARMACY AIDES AS ESTABLISHED  BY  THE  FACILITY  ADMINISTRATION  IN
 CONJUNCTION  WITH  THE PHARMACIST-IN-CHARGE.   A LIST OF SUCH AUTHORIZED
 PERSONNEL SHALL BE MAINTAINED AT ALL TIMES WITHIN THE SYSTEM  AND  SHALL
 BE REVIEWED AND UPDATED PERIODICALLY.
   6. ALL MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES SHALL BE DISPENSED
 FROM AN AUTOMATED DISPENSING DEVICE PURSUANT TO A VALID, PATIENT-SPECIF-
 IC PRESCRIPTION OR ORDER.
   7.    THE  PHARMACY  AND  THE  FACILITY  SHALL  IMPLEMENT AND MAINTAIN
 ADEQUATE AND APPROPRIATE  POLICIES,  PROCEDURES  AND  QUALITY  ASSURANCE
 PROGRAMS  TO  ENSURE SAFETY, ACCURACY, SECURITY, ACCOUNTABILITY, PATIENT
 CONFIDENTIALITY, AND FUNCTIONALITY WITH RESPECT  TO  ADMINISTRATION  AND
 USAGE OF ADD.
   8. THE ADD WILL BE MONITORED AT THE FACILITY CONTINUOUSLY BY VIDEO AND
 UNDER VISUAL SUPERVISION BY A PHARMACIST DURING THE LOADING PROCESS.
   9.  ANY  LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE WITH THE
 REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
   § 3. This act shall take effect on the sixtieth  day  after  it  shall
 have become a law.

2023-S5914B (ACTIVE) - Details

See Assembly Version of this Bill:: A2132
Current Committee:: Senate Higher Education
Law Section:: Education Law
Laws Affected:: Amd §6802, add §6809, Ed L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S8474, A10784
2021-2022: S4102, A2463, A5512

2023-S5914B (ACTIVE) - Summary

Relates to the automated storage and dispensing of controlled substances using an automated dispensing device at licensed nursing homes, residential health care facilities and hospices.

2023-S5914B (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S5914B

SPONSOR: CHU
 
TITLE OF BILL:

An act to amend the education law, in relation to the automated storage
and dispensing of controlled substances using an automated dispensing
device

 
PURPOSE:

Permits the use of Automated Dispensing Devices (ADD) within health care
facilities.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section one of the bill adds subdivision 29 to § 6802 of the education
law to define automated dispensing devices (ADD) as a mechanical system
used in nursing homes, residential health care facilities, and hospices
that packages and labels patient specific medication or multiple medica-
tions for the purposes of administration by a health care professional
based on a prescription or order that has completed final verification

by a licensed pharmacist.

Section two of the bill adds § 6809 the education law. Subdivision one
states "automated dispensing device (ADD)" has the same meaning as
subdivision twenty-nine of section sixty-eight hundred two of this arti-
cle.

Subdivision 2 provides that the ADD shall remain property a pharmacy
licensed in NYS, which will maintain all controls, required record keep-
ing and obtain all licensing required by state and federal laws.

Subdivision 3 requires record keeping by hard or electronic copy for a
minimum of ten years.

Subdivision 4 sets procedures for loading of prepackaged cartridges or
containers into ADD by personnel designated by the pharmacist in charge.

Subdivision 5 sets who has access to the ADD and requires a list of
authorized personnel to be maintained within the ADD system, updated,
and reviewed periodically.

Subdivision 6 requires all medications dispensed through ADD to be
pursuant to a valid, patient-specific prescription or order.

Subdivision 7 requires the pharmacy and facility to implement and main-
tain policies, procedures, and programs to ensure safety, accuracy,
accountability, patient confidentiality, and functionality with respect
to the ADD.

Subdivision 8 requires the ADD at the facility to be continuously video
monitored by the pharmacist during loading.

Subdivision 9 requires any losses of medication to be reported according
to the requirements of the servicing pharmacists licensing body.

Section three of the bill provides the effective date.

 
JUSTIFICATION:

Automated dispensing devices (ADD)s prevent delays in first-dose deliv-
ery, loss of doses, and medication diversion, while also increasing
patient safety by providing a good balance of security, accessibility,
and inventory control. With Automated Dispensing Devices, all medica-
tions are packaged resident specific, one shift (8 hours) at a time, as
opposed to the current "30 day supply" paid for by Medicaid. This means
Medicaid is only paying for medication tablets actually packaged, not
the full prescription up front.

Nurses need updated tools to assist with patient care and ADDs are that
new technology. They streamline the nurse-pharmacy process thus enabling
nurses to be more available for direct patient care.

ADDs remove human error in dispensing to the greatest extent practica-
ble, particularly when it comes to reading doctors' handwritten
instructions. Additionally, they save health care professional time by
ending end of-shift medication counts.

 
LEGISLATIVE HISTORY:

2021-2022: S4102A (SAVINO) / A5512A (Dinowitz) - Passed Senate / Died in
Assembly

2020: S8474 (SAVINO) / A10784 (Dinowitz): Passed Senate / Died in Assem-
bly

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
60 days after signed into law.

2023-S5914B (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  5914--B
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              March 22, 2023
                                ___________
 
 Introduced  by  Sen.  CHU  --  read  twice and ordered printed, and when
   printed to be committed  to  the  Committee  on  Higher  Education  --
   committee  discharged,  bill amended, ordered reprinted as amended and
   recommitted to said committee -- recommitted to the Committee on High-
   er Education in accordance with Senate Rule 6,  sec.  8  --  committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee
 
 AN  ACT to amend the education law, in relation to the automated storage
   and dispensing of controlled substances using an automated  dispensing
   device
 
   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  a
 new subdivision 30 to read as follows:
   30. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
 USED  IN  NURSING  HOMES AND RESIDENTIAL HEALTH CARE FACILITIES LICENSED
 PURSUANT TO ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW  AND  HOSPICES
 CERTIFIED PURSUANT TO ARTICLE FORTY OF THE PUBLIC HEALTH LAW, THAT PACK-
 AGES  AND LABELS PATIENT SPECIFIC MEDICATION OR MULTIPLE MEDICATIONS FOR
 THE PURPOSES OF ADMINISTRATION BY A HEALTH CARE PROFESSIONAL LICENSED TO
 ADMINISTER MEDICATIONS BY THE STATE OF NEW YORK BASED ON A  PRESCRIPTION
 OR ORDER THAT HAS COMPLETED FINAL VERIFICATION BY A LICENSED PHARMACIST.
   § 2. The education law is amended by adding a new section 6809 to read
 as follows:
   §  6809.  AUTOMATED  STORAGE  AND  DISPENSING  OF  MEDICATIONS. 1. FOR
 PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)" SHALL HAVE
 THE SAME MEANING AS SUBDIVISION THIRTY OF  SECTION  SIXTY-EIGHT  HUNDRED
 TWO OF THIS ARTICLE.
   2.  THE  ADD  AND ITS CONTENTS SHALL REMAIN THE PROPERTY OF A PHARMACY
 REGISTERED  UNDER  THIS  ARTICLE.    THE  PHARMACY  SHALL  MAINTAIN  ALL
 CONTROLS,  RECORD KEEPING AS REQUIRED BY ALL LAWS, RULES AND REGULATIONS
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00901-06-3

 S. 5914--B                          2
 
 OF THE STATE.  PHARMACIES  UTILIZING  AUTOMATED  DISPENSING  DEVICES  AS
 PERMITTED  UNDER  THIS  SECTION  FOR  ROUTINE  MEDICATION  DISPENSING OF
 CONTROLLED SUBSTANCES  SHALL  OBTAIN  A  MACHINE-SPECIFIC  FEDERAL  DRUG
 ENFORCEMENT ADMINISTRATION (DEA-ADD) REGISTRATION NUMBER, AND THE APPRO-
 PRIATE NEW YORK STATE LICENSING.
   3.   THE PHARMACY SHALL MAINTAIN RECORDS ON SITE AT THE PHARMACY (HARD
 COPY OR ELECTRONIC) FOR NOT LESS  THAN  TEN  YEARS,  INCLUDING  BUT  NOT
 LIMITED TO:
   A.  DOCUMENTATION  OF  THE  APPROVAL  FOR USE AND PLACEMENT OF THE ADD
 RECEIVED FROM THE DEPARTMENT AND/OR THE BOARD OF PHARMACY;
   B. DELIVERY MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION  THAT  MONI-
 TORS  THE  TRANSPORT  OF  CONTROLLED SUBSTANCES BETWEEN THE PHARMACY AND
 ADD;
   C. ADD CLEANING AND MAINTENANCE LOGS OR SIMILAR DOCUMENTATION;
   D. RECORDS AND/OR ELECTRONIC DATA OF  ALL  EVENTS  INVOLVING  THE  ADD
 INCLUDING BUT NOT LIMITED TO:
   (I) IDENTITY OF ALL PERSONNEL WHO ACCESS THE CONTENTS;
   (II) LOCATION OF THE SYSTEM ACCESSED;
   (III) TYPE OF TRANSACTION WITH DATE/TIME STAMP;
   (IV) NAME, STRENGTH, DOSAGE FORM, AND QUANTITY OF THE ACCESSED MEDICA-
 TION;
   (V)  NAME  OR  OTHER IDENTIFIER OF THE PATIENT FOR WHOM THE MEDICATION
 WAS ORDERED;
   (VI) RECONCILIATION OF ALL CONTROLLED SUBSTANCE INVENTORIES  AT  LEAST
 MONTHLY.
   4.    THE PREPACKAGED CARTRIDGES OR CONTAINERS MAY BE SENT TO A REMOTE
 SITE TO BE LOADED INTO SUCH MACHINE BY PERSONNEL DESIGNATED BY THE PHAR-
 MACIST-IN-CHARGE PROVIDED:
   A. THE INDIVIDUAL CARTRIDGES OR CONTAINERS  ARE  TRANSPORTED  TO  SUCH
 REMOTE SITE IN A SECURE, TAMPER-EVIDENT CONTAINER; AND
   B.  THE AUTOMATED PHARMACY SYSTEM USES BAR-CODING, MICROCHIP, OR OTHER
 TECHNOLOGIES TO ENSURE THAT THE CONTAINERS ARE ACCURATELY LOADED IN  THE
 AUTOMATED PHARMACY SYSTEM.
   5.  ACCESS  TO  AN  ADD SHALL BE RESTRICTED TO AUTHORIZED PHARMACY AND
 FACILITY NURSING LICENSED PERSONNEL,  REGISTERED  PHARMACY  TECHNICIANS,
 AND  PHARMACY  AIDES  AS  ESTABLISHED  BY THE FACILITY ADMINISTRATION IN
 CONJUNCTION WITH THE PHARMACIST-IN-CHARGE.   A LIST OF  SUCH  AUTHORIZED
 PERSONNEL  SHALL  BE MAINTAINED AT ALL TIMES WITHIN THE SYSTEM AND SHALL
 BE REVIEWED AND UPDATED PERIODICALLY.
   6. ALL MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES SHALL BE DISPENSED
 FROM AN AUTOMATED DISPENSING DEVICE PURSUANT TO A VALID, PATIENT-SPECIF-
 IC PRESCRIPTION OR ORDER.
   7.   THE PHARMACY  AND  THE  FACILITY  SHALL  IMPLEMENT  AND  MAINTAIN
 ADEQUATE  AND  APPROPRIATE  POLICIES,  PROCEDURES  AND QUALITY ASSURANCE
 PROGRAMS TO ENSURE SAFETY, ACCURACY, SECURITY,  ACCOUNTABILITY,  PATIENT
 CONFIDENTIALITY,  AND  FUNCTIONALITY  WITH RESPECT TO ADMINISTRATION AND
 USAGE OF ADD.
   8. THE ADD WILL BE MONITORED AT THE FACILITY CONTINUOUSLY BY VIDEO AND
 UNDER VISUAL SUPERVISION BY A PHARMACIST DURING THE LOADING PROCESS.
   9. ANY LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE  WITH  THE
 REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
   §  3.  This  act  shall take effect on the sixtieth day after it shall
 have become a law.

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Senate Bill S5914A

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Sponsored By

Iwen Chu

Current Bill Status - In Senate Committee Higher Education Committee

Bill Amendments

2023-S5914 - Details

2023-S5914 - Summary

2023-S5914 - Sponsor Memo

2023-S5914 - Bill Text download pdf

2023-S5914A - Details

2023-S5914A - Summary

2023-S5914A - Sponsor Memo

2023-S5914A - Bill Text download pdf

2023-S5914B (ACTIVE) - Details

2023-S5914B (ACTIVE) - Summary

2023-S5914B (ACTIVE) - Sponsor Memo

2023-S5914B (ACTIVE) - Bill Text download pdf

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