Bill Text: NY S08474 | 2019-2020 | General Assembly | Introduced

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Bill Title: Relates to the automated storage and dispensing of controlled substances using an automated dispensing device.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Engrossed - Dead) 2020-07-22 - referred to higher education [S08474 Detail]

Download: New_York-2019-S08474-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                          8474

                    IN SENATE

                                      June 3, 2020
                                       ___________

        Introduced  by  Sen.  SAVINO -- 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 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 29 to read as follows:
     3    29. "Automated dispensing device (ADD)" shall mean a mechanical system
     4  designed for use in health care facilities allowing  for  computer-cont-
     5  rolled  storage,  packaging  and  dispensing  of  drugs  and  devices to
     6  licensed health care professionals near the point of care.
     7    § 2. The public health law is amended by adding a new section 280-d to
     8  read as follows:
     9    § 280-d. Automated storage and dispensing of controlled substances. 1.
    10  For purposes of this section, "automated dispensing device (ADD)"  shall
    11  mean  a  mechanical  system  designed  for use in health care facilities
    12  allowing for computer-controlled storage, packaging  and  dispensing  of
    13  drugs  and  devices to licensed health care professionals near the point
    14  of care.
    15    2. Notwithstanding any provision of law, rule  or  regulation  to  the
    16  contrary,  licensed health care facilities throughout the state shall be
    17  permitted to use automated dispensing  devices  to  store,  package  and
    18  dispense  medications, including controlled substances, as authorized by
    19  such facility's licensing body.
    20    3. The ADD and its contents shall remain the property of the pharmacy.
    21    4. Licensed  health  care  facilities  shall  implement  and  maintain
    22  adequate  and  appropriate  policies,  procedures  and quality assurance
    23  programs to ensure safety, accuracy, security,  accountability,  patient
    24  confidentiality  and functionally with respect to the administration and
    25  usage of automated dispensing devices.
    26    5. Access to an automated dispensing device within a  licensed  health
    27  care  facility shall be restricted to authorized licensed personnel, and

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD16526-02-0
        S. 8474                             2

     1  a list of such authorized personnel shall be  maintained  at  all  times
     2  within the system and shall be reviewed and updated periodically.
     3    6. All medications, including controlled substances shall be dispensed
     4  from an automated dispensing device pursuant to a valid, patient-specif-
     5  ic prescription or order.
     6    7.  The servicing pharmacy shall maintain records on-site for a period
     7  of not less than five  years  with  respect  to  the  use  of  automated
     8  dispensing devices. Such records shall include:
     9    (a)  documentation  of  the approval for use and placement of an auto-
    10  mated dispensing device by such licensed health care facility from  such
    11  facility's licensing body, if applicable;
    12    (b)  the  location  of  all automated dispensing devices being used at
    13  such facility;
    14    (c) delivery manifests or similar electronic documentation which moni-
    15  tors the transport of controlled substances between the servicing  phar-
    16  macy and the automated dispensing device;
    17    (d)  automated  dispensing  device  maintenance  and cleaning logs, or
    18  similar documentation;
    19    (e) documentation or electronic data of all events involving an  auto-
    20  mated dispensing device, including, but not limited to:
    21    (i)  the  identity of personnel who have accessed the contents of such
    22  device;
    23    (ii) the location of the device accessed;
    24    (iii) the type of transaction, including a date and time stamp;
    25    (iv) the name, strength, dosage form and quantity of an accessed prod-
    26  uct;
    27    (v) the  name  or  other  identifier  of  the  patient  for  whom  the
    28  controlled substance was ordered; and
    29    (vi) reconciliation of all inventory activities.
    30    8.  Any  losses of medication shall be reported in accordance with the
    31  requirements of the servicing pharmacy's licensing body.
    32    9. Servicing pharmacies  utilizing  automated  dispensing  devices  in
    33  licensed  health  care facilities for routine medication dispensing, for
    34  emergency medication kits or other similar approved use, shall be loaded
    35  by either a:
    36    (a) pharmacy technician, pharmacy intern, or pharmacist; or
    37    (b) licensed nurse.
    38    10. Servicing pharmacies utilizing  automated  dispensing  devices  in
    39  licensed  health  care  facilities  for routine medication dispensing of
    40  controlled substances  shall  obtain  a  machine-specific  federal  Drug
    41  Enforcement  Agency  (DEA) registration number, and appropriate New York
    42  state licensing.
    43    11. Servicing pharmacies utilizing  automated  dispensing  devices  in
    44  licensed  health care facilities for routine medication dispensing shall
    45  ensure that such device is continually monitored by video.
    46    § 3. This act shall take effect immediately.