NY State Senate Bill 2019-S9047

Senate Bill S9047

2019-2020 Legislative Session

Directs the commissioner of health to promulgate and implement rules authorizing the use of automated patient dispensing and storage systems

download bill text pdf

Archive: Last Bill Status - In Senate Committee Rules 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

Please enter your contact information

First Name

Last Name

Email Address

A valid email address is required.

Home address is used to determine the senate district in which you reside. Your support or opposition to this bill is then shared immediately with the senator who represents you.

Optional services from the NY State Senate:

Create an account. An account allows you to officially support or oppose key legislation, sign petitions with a single click, and follow issues, committees, and bills that matter to you. When you create an account, you agree to this platform's terms of participation.

Include a custom message for your Senator? (Optional)

Enter a message to your senator. Many New Yorkers use this to share the reasoning behind their support or opposition to the bill. Others might share a personal anecdote about how the bill would affect them or people they care about.

Actions

View Actions

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Oct 13, 2020	referred to rules

2019-S9047 (ACTIVE) - Details

Current Committee:: Senate Rules
Law Section:: Education Law
Laws Affected:: Amd §6808, Ed L; add §280-d, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S58

2019-S9047 (ACTIVE) - Summary

Directs the commissioner of health, in consultation with the commissioner of education, the commissioner of mental health, the state board of pharmacy and the commissioner of corrections and community supervision, to promulgate and implement rules and regulations authorizing the use of automated patient dispensing and storage systems for distribution of prescription and non-prescription drugs and medical devices.

2019-S9047 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S9047

SPONSOR: PERSAUD
 
TITLE OF BILL:

An act to amend the education law and the public health law, in relation
to directing the commissioner of health, in consultation with the
commissioner of education, the commissioner of mental health, the state
board of pharmacy and the commissioner of corrections and community
supervision, to promulgate and implement rules and regulations authoriz-
ing the use of automated patient dispensing and storage systems for
distribution of prescription and non-prescription drugs and medical
devices

 
PURPOSE OR GENERAL IDEA OF BILL:

The purpose of the bill is to direct the commissioner of health to
promulgate and implement rules authorizing the use of automated patient
dispensing and storage systems.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1. Subdivision 1 of section 6808 of the education law, as
amended by section 2 of part D of chapter 60 of the laws of 2014, is
amended to read as follows: no person, firm, corporation or association
shall possess drugs prescriptions or poisons for the purpose of
compounding, dispensing, retailing, wholesaling, or manufacturing, or
shall offer drugs, prescriptions or poisons for sale at retail or whole-
sale unless registered by the department as a pharmacy, wholesaler,
manufacturer or outsourcing facility; provided, however, that the
provisions of this section shall not prohibit the dispensing and/or
storage of prescriptions, drugs or medical devices through the use of an
automated patient dispensing and storage system as provided in section
two hundred eighty-d of the public health law and rules and regulations
promulgated pursuant to such section.

 
JUSTIFICATION:

This bill facilitates patient safety, pharmacist commitment to direct
patient care, cost reduction and incorporating rapid innovation of tech-
nology into a safe medication process.

Recently, Texas and South Carolina modified their pharmacy rules to
allow for the use of prescription pick-up kiosks, automated storage,
dispensing, and delivery systems amid the COVID-19 pandemic.

According to one of the research that was done by the New York Times, on
January 31, 2020, there have been numerous life threatened errors made
by overworked and burned-out pharmacists who had to meet corporate
unreasonable and unsafe metrics. Pharmacists across the U.S. go through
a great deal of struggle to fill prescriptions, give flu shots, answer
phones, work the registers, tend to patients and drive -through, call
doctors and insurance companies. A New York Times research found that
many mistakes made by overworked pharmacists were not accessible to the
public because companies often made the victims or; their families sign
a confidentiality agreement before the settlements.

The automated dispenser makes it convenient to send prescriptions
directly from a doctor's office to a pharmacist who can scan the
patient's file, refill the order, and put it into the dispenser for pick
up. The automated drug-dispensing machine can be efficient in reducing
the risk of medication contamination; the medications are stored in a
safe and sterile environment.

The Army has tested automated drug dispensing systems and believes that
they can benefit sick soldiers being deployed. States such as Califor-
nia, Virginia, and Illinois are currently using the automated patient
dispensing system. The state of Florida allows Pharmaceutical kiosks in
long-term-care facilities, correctional institutions, hospices, and
hospitals. In-house pharmacists can focus on direct patient care while
the kiosks provide remote pharmacist consultation when needed.

Researchers have done studies regarding the importance of automated
prescription dispensers on school campuses, nursing home facilities,
long-term care facilities, hospitals, and in-house pharmacies.

Research by PubMed Central (PMC), a free full-text archive of biomedical
and life sciences journal literature, at the U.S. National Institutes of
Health's National Library of Medicine concluded:  "automated dispensing
machines eliminate the dispensing of unused "as-needed" or (PRN) doses,
which in Latin means pro re nata, thereby decreasing the potential for
administration errors that can arise if more doses than needed are
dispensed and available for administration." The automated dispensing
machine is beneficial, and it improves customer service. It allows phar-
macists to devote more time to patient care services such as; answering
questions about prescriptions and provide primary preventive care.

The automated dispenser will allow Pharmacists the ability to track and
monitor the drug usage pattern. Such data will be easily accessible and
can be shared with other healthcare professionals when needed.

 
PRIOR LEGISLATIVE HISTORY:

None

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
This act shall take effect immediately.

2019-S9047 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9047
 
                             I N  S E N A T E
 
                             October 13, 2020
                                ___________
 
 Introduced  by  Sen. PERSAUD -- read twice and ordered printed, and when
   printed to be committed to the Committee on Rules
 
 AN ACT to amend the education law and the public health law, in relation
   to directing the commissioner of  health,  in  consultation  with  the
   commissioner  of  education,  the  commissioner  of mental health, the
   state board of pharmacy and the commissioner of corrections and commu-
   nity supervision, to promulgate and implement  rules  and  regulations
   authorizing  the  use  of  automated  patient  dispensing  and storage
   systems for distribution of prescription  and  non-prescription  drugs
   and medical devices
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1.  Subdivision 1 of section 6808 of  the  education  law,  as
 amended  by  section  2  of part D of chapter 60 of the laws of 2014, is
 amended to read as follows:
   1. No person, firm, corporation or association  shall  possess  drugs,
 prescriptions  or  poisons  for  the purpose of compounding, dispensing,
 retailing,  wholesaling,  or  manufacturing,  or  shall   offer   drugs,
 prescriptions  or  poisons for sale at retail or wholesale unless regis-
 tered by the department  as  a  pharmacy,  wholesaler,  manufacturer  or
 outsourcing  facility;  PROVIDED,  HOWEVER,  THAT THE PROVISIONS OF THIS
 SECTION  SHALL  NOT  PROHIBIT   THE   DISPENSING   AND/OR   STORAGE   OF
 PRESCRIPTIONS,  DRUGS OR MEDICAL DEVICES THROUGH THE USE OF AN AUTOMATED
 PATIENT DISPENSING AND STORAGE SYSTEM AS PROVIDED IN SECTION TWO HUNDRED
 EIGHTY-D OF THE PUBLIC HEALTH LAW AND RULES AND REGULATIONS  PROMULGATED
 PURSUANT TO SUCH SECTION.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   §  280-D.  AUTOMATED  PATIENT  DISPENSING  AND STORAGE SYSTEMS. 1. THE
 COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER  OF  EDUCATION,  THE
 COMMISSIONER  OF  MENTAL  HEALTH,  THE  STATE  BOARD OF PHARMACY AND THE
 COMMISSIONER OF CORRECTIONS AND COMMUNITY SUPERVISION, SHALL  PROMULGATE
 RULES  AND  REGULATIONS  TO AUTHORIZE THE LICENSING AND USE OF AUTOMATED
 PATIENT DISPENSING AND STORAGE SYSTEMS AS PROVIDED IN THIS SECTION WHICH
 SHALL INCLUDE, BUT NOT BE LIMITED TO, REQUIRING THAT THE OPERATOR OF  AN
 AUTOMATED  PATIENT  DISPENSING  AND  STORAGE SYSTEM HOLDS A REGISTRATION

 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD17292-04-0

 S. 9047                             2

 FROM THE  FEDERAL  DRUG  ENFORCEMENT  AGENCY  FOR  THE  DISTRIBUTION  OF
 CONTROLLED SUBSTANCES.
   2. DEFINITIONS. AS USED IN THIS SECTION:
   (A)  "AUTOMATED  DRUG  DELIVERY  SYSTEM"  OR "ADDS" MEANS A MECHANICAL
 SYSTEM THAT PERFORMS OPERATIONS OR ACTIVITIES, OTHER THAN COMPOUNDING OR
 ADMINISTRATION, RELATIVE TO THE STORAGE, DISPENSING, OR DISTRIBUTION  OF
 DRUGS.  AN  ADDS  SHALL  COLLECT,  CONTROL, AND MAINTAIN ALL TRANSACTION
 INFORMATION TO ACCURATELY TRACK THE MOVEMENT OF DRUGS INTO  AND  OUT  OF
 THE SYSTEM FOR SECURITY, ACCURACY, AND ACCOUNTABILITY.
   (B) "AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM" OR "APDSS" MEANS
 AN  ADDS  FOR STORAGE AND DISPENSING OF DRUGS DIRECTLY TO PATIENTS OR TO
 MEDICAL PERSONNEL FOR PROMPT  ADMINISTRATION  TO  PATIENTS  PURSUANT  TO
 PRIOR AUTHORIZATION BY A PHARMACIST.
   (C) "COVERED ENTITY" MEANS:
   (I)  A  "COVERED ENTITY" AS DEFINED IN SECTION 256B OF TITLE 42 OF THE
 UNITED STATES CODE; AND
   (II) A  CORRECTIONAL  FACILITY  AS  DEFINED  IN  SECTION  TWO  OF  THE
 CORRECTION LAW.
   (D)  "DRUG" MEANS A CONTROLLED SUBSTANCE AS DEFINED IN SECTION THIRTY-
 THREE HUNDRED SIX OF THE PUBLIC HEALTH LAW, A NON-PRESCRIPTION  DRUG  OR
 OVER-THE-COUNTER MEDICATION OR SUPPLY, AND/OR A MEDICAL DEVICE.
   (E)  "PATIENT"  MEANS  AN  INDIVIDUAL  FOR  WHOM  MEDICATION  HAS BEEN
 PRESCRIBED BY ANY PERSON AUTHORIZED TO PRESCRIBE MEDICATION PURSUANT  TO
 ARTICLE  ONE HUNDRED THIRTY-ONE, ONE HUNDRED THIRTY-ONE-B OR ONE HUNDRED
 FORTY-ONE OF THE EDUCATION LAW.
   3. PURSUANT TO THE RULES AND REGULATIONS AUTHORIZED BY SUBDIVISION ONE
 OF THIS SECTION, IF ALL OF THE FOLLOWING CONDITIONS ARE MET, A  PHARMACY
 LOCATED IN THE STATE MAY PROVIDE PHARMACY SERVICES THROUGH THE USE OF AN
 AUTOMATED  PATIENT  DISPENSING SYSTEM TO:  (I) THE PATIENTS OF A COVERED
 ENTITY THROUGH AN APDSS LOCATED ON THE PREMISES OF THE COVERED ENTITY OR
 ON THE PREMISES OF MEDICAL  PROFESSIONAL  PRACTICES  UNDER  CONTRACT  TO
 PROVIDE  MEDICAL  SERVICES TO COVERED ENTITY PATIENTS, WHICH NEED NOT BE
 THE SAME LOCATION AS THE  PHARMACY;  AND  (II)  INDIVIDUAL  PATIENTS  AS
 DESCRIBED IN SUBDIVISION FIVE OF THIS SECTION:
   (A) THE PHARMACY OBTAINS A LICENSE FROM THE STATE BOARD OF PHARMACY TO
 OPERATE  THE APDSS AT THE COVERED ENTITY OR AN AFFILIATED SITE, OR AT OR
 ADJACENT TO THE PHARMACY, AS APPLICABLE. AS PART OF THE APPLICATION, THE
 PHARMACY SHALL PROVIDE THE ADDRESS AT WHICH THE APDSS  SHALL  BE  PLACED
 AND,  IF  THE APDSS IS TO BE INSTALLED AT A COVERED ENTITY, IDENTIFY THE
 COVERED ENTITY. A SEPARATE LICENSE SHALL BE REQUIRED FOR  EACH  LOCATION
 AND  SHALL BE RENEWED ANNUALLY CONCURRENT WITH THE PHARMACY LICENSE. THE
 APPLICATION AND RENEWAL FEE SHALL BE THREE HUNDRED DOLLARS  AND  MAY  BE
 INCREASED  TO  FIVE  HUNDRED  DOLLARS.    THE STATE BOARD OF PHARMACY IS
 AUTHORIZED TO LOWER THE RENEWAL FEE TO NOT LESS THAN TWO HUNDRED DOLLARS
 IF A LOWER FEE LEVEL WILL PROVIDE SUFFICIENT RESOURCES  TO  SUPPORT  THE
 REGULATORY ACTIVITIES.
   (B)  THE PHARMACY PROVIDING THE PHARMACY SERVICES TO THE PATIENTS OF A
 COVERED ENTITY, INCLUDING, UNLESS OTHERWISE PROHIBITED BY ANY OTHER LAW,
 PATIENTS ENROLLED IN THE MEDICARE AND MEDICAID PROGRAMS, SHALL BE  UNDER
 CONTRACT  WITH  THAT  COVERED  ENTITY TO PROVIDE THOSE PHARMACY SERVICES
 THROUGH THE USE OF THE APDSS.
   (C) DRUGS STORED IN AN APDSS SHALL BE PART OF  THE  INVENTORY  OF  THE
 PHARMACY PROVIDING PHARMACY SERVICES TO THE PATIENTS AND DRUGS DISPENSED
 FROM  THE APDSS SHALL BE CONSIDERED TO HAVE BEEN DISPENSED BY THAT PHAR-
 MACY.

 S. 9047                             3

   (D) THE PHARMACY SHALL MAINTAIN RECORDS OF THE ACQUISITION AND  DISPO-
 SITION  OF  DRUGS  STORED  IN  THE  APDSS  SEPARATE  FROM OTHER PHARMACY
 RECORDS.
   (E)  THE PHARMACY SHALL BE SOLELY RESPONSIBLE FOR THE SECURITY, OPERA-
 TION, AND MAINTENANCE OF THE APDSS; PROVIDED,  HOWEVER,  THAT  AN  APDSS
 INSTALLED  AT  A  CORRECTIONAL  FACILITY SHALL BE DEEMED TO BE UNDER THE
 DUAL SECURITY AND CONTROL OF THE PHARMACY AND THE CORRECTIONAL FACILITY.
   (F) THE PHARMACY SHALL PROVIDE TRAINING REGARDING  THE  OPERATION  AND
 USE OF THE APDSS TO BOTH PHARMACY AND COVERED ENTITY PERSONNEL USING THE
 SYSTEM.
   (G)  THE  OPERATION  OF  THE APDSS SHALL BE UNDER THE SUPERVISION OF A
 PHARMACIST LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIRTY-SEVEN OF  THE
 EDUCATION LAW ACTING ON BEHALF OF THE PHARMACY PROVIDING SERVICES TO THE
 PATIENTS  OF  THE  COVERED ENTITY. THE PHARMACIST NEED NOT BE PHYSICALLY
 PRESENT AT THE SITE OF THE APDSS AND MAY SUPERVISE THE SYSTEM  ELECTRON-
 ICALLY.
   (H)  THE STATE BOARD OF PHARMACY MAY ISSUE A LICENSE FOR THE OPERATION
 OF AN APDSS AT AN ADDRESS FOR WHICH IT HAS ISSUED ANOTHER SITE  LICENSE,
 INCLUDING  BUT  NOT  LIMITED  TO  DRIVE-THROUGH PHARMACY AREAS AND OTHER
 AREAS ADJACENT TO THE PHYSICAL LOCATION OCCUPIED BY A PHARMACY.
   (I) THE STATE BOARD OF PHARMACY, WITHIN THIRTY DAYS AFTER  RECEIPT  OF
 AN  APPLICATION  FOR  AN  APDSS  LICENSE,  SHALL CONDUCT A PRE-LICENSURE
 INSPECTION AT THE PROPOSED LOCATION OF  THE  APDSS.  RELOCATION  OF  THE
 APDSS  SHALL REQUIRE A NEW APPLICATION FOR LICENSURE.  REPLACEMENT OF AN
 APDSS SHALL REQUIRE NOTICE TO SUCH BOARD WITHIN THIRTY DAYS.
   (J) THE APDSS LICENSE SHALL BE CANCELED BY OPERATION  OF  LAW  IF  THE
 UNDERLYING  PHARMACY  LICENSE  IS  NOT  CURRENT, VALID, AND ACTIVE. UPON
 REISSUANCE OR REINSTATEMENT OF THE UNDERLYING PHARMACY  LICENSE,  A  NEW
 APPLICATION  FOR  AN APDSS LICENSE SHALL BE SUBMITTED TO THE STATE BOARD
 OF PHARMACY, IF SO REQUIRED BY SUCH BOARD.
   (K) A PHARMACY THAT HOLDS AN APDSS  LICENSE  SHALL  ADVISE  THE  STATE
 BOARD  OF  PHARMACY IN WRITING WITHIN THIRTY DAYS IF USE OF THE APDSS IS
 DISCONTINUED.
   4. (A) AN  AUTOMATED  PATIENT  DISPENSING  AND  STORAGE  SYSTEM  SHALL
 COLLECT, CONTROL, AND MAINTAIN ALL TRANSACTION INFORMATION TO ACCURATELY
 TRACK  THE  MOVEMENT  OF  DRUGS INTO AND OUT OF THE SYSTEM FOR SECURITY,
 ACCURACY, AND ACCOUNTABILITY.
   (B) TRANSACTION INFORMATION SHALL BE MADE READILY AVAILABLE IN A DOWN-
 LOADABLE FORMAT FOR REVIEW AND INSPECTION BY INDIVIDUALS  AUTHORIZED  BY
 LAW TO REVIEW SUCH INFORMATION. THESE RECORDS SHALL BE MAINTAINED BY THE
 PHARMACY FOR A MINIMUM OF THREE YEARS.
   5.  DRUGS  FROM AN AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM MAY
 BE DISPENSED DIRECTLY TO A PATIENT FROM A DRIVE-THROUGH  PHARMACY  AISLE
 OR  OTHER  LOCATION  ADJACENT  TO  THE PHYSICAL LOCATION OCCUPIED BY THE
 PHARMACY, IF ALL OF THE FOLLOWING REQUIREMENTS ARE MET:
   (A) THE PHARMACY DEVELOPS, IMPLEMENTS, AND  ANNUALLY  REVIEWS  WRITTEN
 POLICIES AND PROCEDURES WITH RESPECT TO ALL OF THE FOLLOWING:
   (I)  THE  PHARMACY  MAINTAINS  THE SECURITY OF THE APDSS AND THE DRUGS
 WITHIN THAT APDSS;
   (II) THE PHARMACY DETERMINES AND APPLIES INCLUSION CRITERIA  REGARDING
 WHICH  DRUGS  ARE  APPROPRIATE  FOR PLACEMENT IN THE APDSS AND FOR WHICH
 PATIENTS;
   (III) THE PHARMACY ENSURES THAT PATIENTS ARE AWARE  THAT  CONSULTATION
 WITH  A PHARMACIST IS AVAILABLE FOR ANY PRESCRIPTION MEDICATION, INCLUD-
 ING THOSE DELIVERED VIA THE APDSS;

 S. 9047                             4

   (IV) THE PHARMACY DESCRIBES THE ASSIGNMENT OF RESPONSIBILITIES TO, AND
 TRAINING OF, PHARMACY PERSONNEL, AND OTHER PERSONNEL USING THE APDSS  AT
 THE  LOCATION WHERE THE APDSS IS PLACED, REGARDING MAINTENANCE AND FILL-
 ING PROCEDURES FOR THE APDSS;
   (V)  THE  PHARMACY  ORIENTS  PARTICIPATING  PATIENTS ON THE USE OF THE
 APDSS, NOTIFYING PATIENTS WHEN EXPECTED PRESCRIPTION MEDICATIONS ARE NOT
 AVAILABLE IN THE APDSS, AND ENSURING THAT PATIENT USE OF THE APDSS  DOES
 NOT INTERFERE WITH DELIVERY OF DRUGS; AND
   (VI)  THE  PHARMACY ENSURES DELIVERY OF DRUGS TO PATIENTS EXPECTING TO
 RECEIVE THEM FROM THE APDSS IN THE EVENT THE AUTOMATED PATIENT  DISPENS-
 ING AND STORAGE SYSTEM IS DISABLED OR MALFUNCTIONS.
   (B)  THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL ONLY BE
 USED FOR PATIENTS WHO HAVE SIGNED A WRITTEN CONSENT DEMONSTRATING  THEIR
 INFORMED CONSENT TO RECEIVE PRESCRIBED DRUGS FROM AN APDSS AND WHOSE USE
 OF  THE APDSS MEET THE CRITERIA PURSUANT TO PARAGRAPH A OF THIS SUBDIVI-
 SION.
   (C) THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL  HAVE  A
 MEANS TO IDENTIFY EACH PATIENT AND ONLY RELEASE THE IDENTIFIED PATIENT'S
 DRUGS TO THE PATIENT OR THE PATIENT'S AGENT.
   (D) A PHARMACIST SHALL PERFORM ALL CLINICAL SERVICES CONDUCTED AS PART
 OF  THE DISPENSING PROCESS, INCLUDING, BUT NOT LIMITED TO, DRUG UTILIZA-
 TION REVIEW AND CONSULTATION.
   (E) DRUGS SHALL BE DISPENSED FROM THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM ONLY UPON AUTHORIZATION FROM A PHARMACIST AFTER THE PHAR-
 MACIST HAS REVIEWED THE  PRESCRIPTION  AND  THE  PATIENT'S  PROFILE  FOR
 POTENTIAL CONTRAINDICATED AND ADVERSE DRUG REACTIONS.
   (F)  ALL  DRUGS  DISPENSED  FROM  THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM FOR THE FIRST TIME SHALL BE ACCOMPANIED BY A CONSULTATION
 CONDUCTED BY A PHARMACIST LICENSED PURSUANT TO ARTICLE ONE HUNDRED THIR-
 TY-SEVEN OF THE EDUCATION LAW IN ONE OF THE FOLLOWING  MANNERS:  (I)  IN
 PERSON;  (II)  THROUGH  A  DRIVE-THROUGH PRESCRIPTION DISPENSING WINDOW;
 (III) VIA A TELECOMMUNICATIONS LINK THAT HAS TWO-WAY AUDIO AND VIDEO; OR
 (IV) THROUGH A TELEPHONE CALL BETWEEN THE PHARMACIST AND THE PATIENT  OR
 THE  PATIENT'S  APPOINTED  REPRESENTATIVE WITH THE PRESCRIBING PHYSICIAN
 PRESENT FOR THE DURATION OF THE CALL.
   (G) THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL  INCLUDE
 A  NOTICE,  PROMINENTLY  POSTED  ON THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM, THAT PROVIDES THE NAME, ADDRESS, AND TELEPHONE NUMBER OF
 THE PHARMACY THAT HOLDS THE AUTOMATED  PATIENT  DISPENSING  AND  STORAGE
 SYSTEM LICENSE FOR THAT APDSS.
   (H)  THE  LABELS  ON  ALL  DRUGS  DISPENSED  BY  THE AUTOMATED PATIENT
 DISPENSING AND STORAGE SYSTEM SHALL COMPLY WITH ALL NEW YORK  STATE  AND
 FEDERAL  REQUIREMENTS FOR LABELLING OF DRUGS PRESCRIBED AND DISPENSED IN
 THIS STATE.
   (I) ANY COMPLAINT, ERROR, OR OMISSION INVOLVING THE AUTOMATED  PATIENT
 DISPENSING  AND  STORAGE SYSTEM SHALL BE REVIEWED AS PART OF THE PHARMA-
 CY'S QUALITY ASSURANCE PROGRAM.
   (J) THE STATE BOARD OF PHARMACY SHALL NOT ISSUE A PHARMACY  MORE  THAN
 FIFTEEN  LICENSES  FOR  AUTOMATED  PATIENT DISPENSING AND STORAGE SYSTEM
 UNITS UNDER THIS SECTION. THE STATE BOARD OF PHARMACY  MAY  ADOPT  REGU-
 LATIONS  TO  REDUCE THE NUMBER OF APDSS LICENSES THAT MAY BE ISSUED TO A
 PHARMACY.
   (K) THE  PHARMACY  HOLDING  THE  LICENSE  FOR  THE  AUTOMATED  PATIENT
 DISPENSING AND STORAGE SYSTEM SHALL MAINTAIN THE POLICIES AND PROCEDURES
 DEVELOPED  PURSUANT  TO  PARAGRAPH A OF THIS SUBDIVISION FOR THREE YEARS
 AFTER THE LAST DATE OF USE OF THAT APDSS.

 S. 9047                             5
 
   6. ACCESS TO THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL
 BE CONTROLLED AND TRACKED USING AN IDENTIFICATION OR PASSWORD SYSTEM  OR
 BIOSENSOR. A SYSTEM THAT IS ACCESSED VIA A PASSWORD SYSTEM SHALL INCLUDE
 A CAMERA THAT RECORDS A PICTURE OF THE INDIVIDUAL ACCESSING THE MACHINE.
 PICTURE  RECORDS SHALL BE MAINTAINED FOR A MINIMUM OF ONE HUNDRED EIGHTY
 DAYS.
   7. THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM  SHALL  MAKE  A
 COMPLETE  AND  ACCURATE RECORD OF ALL TRANSACTIONS THAT WILL INCLUDE ALL
 USERS ACCESSING THE APDSS AND ALL DRUGS ADDED TO, OR REMOVED  FROM,  THE
 APDSS.
   8.  THE STOCKING OF AN AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM
 SHALL BE PERFORMED BY A PHARMACIST.  IF  THE  APDSS  UTILIZES  REMOVABLE
 POCKETS,  CARDS,  DRAWERS,  SIMILAR TECHNOLOGY, OR UNIT OF USE OR SINGLE
 DOSE CONTAINERS AS DEFINED BY THE UNITED STATES PHARMACOPEIA, THE STOCK-
 ING SYSTEM MAY BE DONE OUTSIDE OF THE APDSS  AND  BE  DELIVERED  TO  THE
 FACILITY IF ALL OF THE FOLLOWING CONDITIONS ARE MET:
   (A) THE TASK OF PLACING DRUGS INTO THE REMOVABLE POCKETS, CARDS, DRAW-
 ERS,  SIMILAR  TECHNOLOGY,  OR  UNIT OF USE OR SINGLE DOSE CONTAINERS IS
 PERFORMED BY A PHARMACIST, OR BY AN  INTERN  PHARMACIST  OR  A  PHARMACY
 TECHNICIAN WORKING UNDER THE DIRECT SUPERVISION OF A PHARMACIST LICENSED
 PURSUANT TO ARTICLE ONE HUNDRED THIRTY-SEVEN OF THE EDUCATION LAW.
   (B) THE REMOVABLE POCKETS, CARDS, DRAWERS, SIMILAR TECHNOLOGY, OR UNIT
 OF  USE  OR  SINGLE DOSE CONTAINERS ARE TRANSPORTED BETWEEN THE PHARMACY
 AND THE APDSS IN A SECURE TAMPER-EVIDENCE CONTAINER.
   (C) THE PHARMACY, IN CONJUNCTION WITH THE COVERED ENTITY,  HAS  DEVEL-
 OPED  POLICIES  AND  PROCEDURES  TO  ENSURE  THAT THE REMOVABLE POCKETS,
 CARDS, DRAWERS, SIMILAR TECHNOLOGY,  OR  UNIT  OF  USE  OR  SINGLE  DOSE
 CONTAINERS ARE PROPERLY PLACED INTO THE AUTOMATED PATIENT DISPENSING AND
 STORAGE SYSTEM.
   9. REVIEW OF THE DRUGS CONTAINED WITHIN, AND THE OPERATION AND MAINTE-
 NANCE  OF,  THE AUTOMATED PATIENT DISPENSING AND STORAGE SYSTEM SHALL BE
 DONE IN ACCORDANCE WITH LAW AND SHALL BE THE RESPONSIBILITY OF THE PHAR-
 MACY. THE REVIEW SHALL BE CONDUCTED ON A MONTHLY BASIS BY  A  PHARMACIST
 AND  SHALL  INCLUDE  A PHYSICAL INSPECTION OF THE DRUGS IN THE APDSS, AN
 INSPECTION OF THE APDSS MACHINE FOR CLEANLINESS, AND  A  REVIEW  OF  ALL
 TRANSACTION  RECORDS  IN ORDER TO VERIFY THE SECURITY AND ACCOUNTABILITY
 OF THE APDSS.
   10. A PHARMACY HOLDING AN AUTOMATED  PATIENT  DISPENSING  AND  STORAGE
 SYSTEM  LICENSE  SHALL  COMPLETE  AN  ANNUAL  SELF-ASSESSMENT, PERFORMED
 PURSUANT TO RULES AND REGULATIONS PROMULGATED PURSUANT TO THIS  SECTION,
 EVALUATING  THE PHARMACY'S COMPLIANCE WITH THE EDUCATION LAW RELATING TO
 THE USE OF THE AUTOMATED PATIENT  DISPENSING  AND  STORAGE  SYSTEM.  ALL
 INFORMATION  REGARDING  OPERATION, MAINTENANCE, COMPLIANCE, ERROR, OMIS-
 SIONS, OR COMPLAINTS PERTAINING TO THE APDSS SHALL BE  INCLUDED  IN  THE
 SELF-ASSESSMENT.
   11.  THE  PHARMACY  SHALL  COMPLY  WITH  ALL RECORDKEEPING AND QUALITY
 ASSURANCE REQUIREMENTS PURSUANT TO THIS SECTION AND ARTICLE ONE  HUNDRED
 THIRTY-SEVEN OF THE EDUCATION LAW AND SHALL MAINTAIN THOSE RECORDS WITH-
 IN  THE  PHARMACY  HOLDING  THE  APDSS LICENSE AND SEPARATELY FROM OTHER
 PHARMACY RECORDS.
   12. RULES AND REGULATIONS PROVIDING  FOR  THE  IMPLEMENTATION  OF  THE
 PROVISIONS OF THIS SECTION WITHIN THE FACILITIES OF ALL COVERED ENTITIES
 SHALL  BE IMPLEMENTED WITHIN THREE HUNDRED SIXTY-FIVE DAYS OF THE EFFEC-
 TIVE DATE OF THIS SECTION.
   § 3. This act shall take effect immediately.

Comments

Open Legislation is a forum for New York State legislation. All comments are subject to review and community moderation is encouraged.

Comments deemed off-topic, commercial, campaign-related, self-promotional; or that contain profanity, hate or toxic speech; or that link to sites outside of the nysenate.gov domain are not permitted, and will not be published. Attempts to intimidate and silence contributors or deliberately deceive the public, including excessive or extraneous posting/posts, or coordinated activity, are prohibited and may result in the temporary or permanent banning of the user. Comment moderation is generally performed Monday through Friday. By contributing or voting you agree to the Terms of Participation and verify you are over 13.

Create an account. An account allows you to sign petitions with a single click, officially support or oppose key legislation, and follow issues, committees, and bills that matter to you. When you create an account, you agree to this platform's terms of participation.