Bill Text: NY S05914 | 2023-2024 | General Assembly | Amended


Bill Title: 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.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Engrossed) 2024-05-16 - referred to higher education [S05914 Detail]

Download: New_York-2023-S05914-Amended.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                         5914--B

                               2023-2024 Regular Sessions

                    IN SENATE

                                     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:

     1    Section 1. Section 6802 of the education law is amended  by  adding  a
     2  new subdivision 30 to read as follows:
     3    30. "Automated dispensing device (ADD)" shall mean a mechanical system
     4  used  in  nursing  homes and residential health care facilities licensed
     5  pursuant to article twenty-eight of the public health law  and  hospices
     6  certified pursuant to article forty of the public health law, that pack-
     7  ages  and labels patient specific medication or multiple medications for
     8  the purposes of administration by a health care professional licensed to
     9  administer medications by the state of New York based on a  prescription
    10  or order that has completed final verification by a licensed pharmacist.
    11    § 2. The education law is amended by adding a new section 6809 to read
    12  as follows:
    13    §  6809.  Automated  storage  and  dispensing  of  medications. 1. For
    14  purposes of this section, "automated dispensing device (ADD)" shall have
    15  the same meaning as subdivision thirty of  section  sixty-eight  hundred
    16  two of this article.
    17    2.  The  ADD  and its contents shall remain the property of a pharmacy
    18  registered  under  this  article.    The  pharmacy  shall  maintain  all
    19  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

     1  of the state.  Pharmacies  utilizing  automated  dispensing  devices  as
     2  permitted  under  this  section  for  routine  medication  dispensing of
     3  controlled substances  shall  obtain  a  machine-specific  federal  Drug
     4  Enforcement Administration (DEA-ADD) registration number, and the appro-
     5  priate New York state licensing.
     6    3.   The pharmacy shall maintain records on site at the pharmacy (hard
     7  copy or electronic) for not less  than  ten  years,  including  but  not
     8  limited to:
     9    a.  documentation  of  the  approval  for use and placement of the ADD
    10  received from the department and/or the board of pharmacy;
    11    b. delivery manifests or similar electronic documentation  that  moni-
    12  tors  the  transport  of  controlled substances between the pharmacy and
    13  ADD;
    14    c. ADD cleaning and maintenance logs or similar documentation;
    15    d. records and/or electronic data of  all  events  involving  the  ADD
    16  including but not limited to:
    17    (i) identity of all personnel who access the contents;
    18    (ii) location of the system accessed;
    19    (iii) type of transaction with date/time stamp;
    20    (iv) name, strength, dosage form, and quantity of the accessed medica-
    21  tion;
    22    (v)  name  or  other identifier of the patient for whom the medication
    23  was ordered;
    24    (vi) reconciliation of all controlled substance inventories  at  least
    25  monthly.
    26    4.    The prepackaged cartridges or containers may be sent to a remote
    27  site to be loaded into such machine by personnel designated by the phar-
    28  macist-in-charge provided:
    29    a. the individual cartridges or containers  are  transported  to  such
    30  remote site in a secure, tamper-evident container; and
    31    b.  the automated pharmacy system uses bar-coding, microchip, or other
    32  technologies to ensure that the containers are accurately loaded in  the
    33  automated pharmacy system.
    34    5.  Access  to  an  ADD shall be restricted to authorized pharmacy and
    35  facility nursing licensed personnel,  registered  pharmacy  technicians,
    36  and  pharmacy  aides  as  established  by the facility administration in
    37  conjunction with the pharmacist-in-charge.   A list of  such  authorized
    38  personnel  shall  be maintained at all times within the system and shall
    39  be reviewed and updated periodically.
    40    6. All medications, including controlled substances shall be dispensed
    41  from an automated dispensing device pursuant to a valid, patient-specif-
    42  ic prescription or order.
    43    7.   The pharmacy  and  the  facility  shall  implement  and  maintain
    44  adequate  and  appropriate  policies,  procedures  and quality assurance
    45  programs to ensure safety, accuracy, security,  accountability,  patient
    46  confidentiality,  and  functionality  with respect to administration and
    47  usage of ADD.
    48    8. The ADD will be monitored at the facility continuously by video and
    49  under visual supervision by a pharmacist during the loading process.
    50    9. Any losses of medication shall be reported in accordance  with  the
    51  requirements of the servicing pharmacy's licensing body.
    52    §  3.  This  act  shall take effect on the sixtieth day after it shall
    53  have become a law.
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