Bill Text: NY S05704 | 2023-2024 | General Assembly | Introduced

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Bill Title: Limits the off label use of antipsychotic drugs with black box warnings on elderly patients with dementia; provides for professional misconduct for any health care professional who uses such drug on such patient.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2024-01-03 - REFERRED TO HEALTH [S05704 Detail]

Download: New_York-2023-S05704-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                          5704

                               2023-2024 Regular Sessions

                    IN SENATE

                                     March 13, 2023
                                       ___________

        Introduced  by  Sen.  COMRIE -- read twice and ordered printed, and when
          printed to be committed to the Committee on Health

        AN ACT to amend the public health law, in relation to limiting  the  off
          label  use  of  antipsychotic drugs with black box warnings on elderly
          patients with dementia; and to amend the education law, in relation to
          professional medical misconduct

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:

     1    Section  1.  The  public health law is amended by adding a new section
     2  280-d to read as follows:
     3    § 280-d. Use of antipsychotic drugs on elderly patients with dementia.
     4  1. As used in this section:
     5    (a) "off  label"  means  a  medical  practice  in  which  a  physician
     6  prescribes a drug for a different medical purpose than the one for which
     7  such drug is approved for;
     8    (b) "black box warning" means a warning issued by the federal Food and
     9  Drug  Administration  and placed on the package insert of a prescription
    10  drug that may be fatal or cause server side effects;
    11    (c)  "chemical  restraint"  means  when  an  antipsychotic  drug  that
    12  provides  no  medical  benefit to a patient with dementia and is used to
    13  sedate such patient, control such patient's behavior  or  restrict  such
    14  patient's movement;
    15    (d)  "antipsychotic  drug" means any typical or atypical antipsychotic
    16  drug that is intended to be used on patients with  mental  illness  that
    17  require  a black box warning and shall include but not be limited to the
    18  following:
    19    (i) Typical antipsychotic drugs: haloperidol, loxapine,  thioridazine,
    20  molindone,  thiothixene,  fluphenazine, trifluoperazine, chlorpromazine,
    21  perphenazine, or promozide; or

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD04705-01-3
        S. 5704                             2

     1    (ii) Atypical antipsychotic drugs: aripiprazole, lumapeterone, clozar-
     2  il, iloperidone, ziprasidone, paliperidone, lurasidone,  brexipiprazole,
     3  risperidone, asenapine, quetiapine, cariprazine, or olanzapine; and
     4    (e) "patient" means an elderly individual with dementia who is:
     5    (i)  a  resident  of  a residential health care facility as defined in
     6  article twenty-eight of this chapter or an adult care facility certified
     7  under section four hundred sixty-one-b of the social services law; or
     8    (ii) in the care of a hospital as defined in article  twenty-eight  of
     9  this chapter, a facility as defined in article twenty of this chapter or
    10  any other health care facility who care for individuals with dementia.
    11    2.  No  antipsychotic  drug that contains a black box warning shall be
    12  used for an off label purpose on a patient known to have dementia or  to
    13  chemically  restrain  a  patient known to have dementia. An order for an
    14  antipsychotic drug may only be issued in an emergency situation and by a
    15  health care professional who specializes in dementia or is  specifically
    16  trained  in  the  treatment  of  dementia  patients if such a patient is
    17  agitated and where it is  reasonably  necessary  to  protect  the  life,
    18  health  or  safety  of  the patient or another person. Where an order is
    19  made under this subdivision, the health care  professional  shall  imme-
    20  diately  record  the  use  of the antipsychotic drug, the reason for the
    21  use, and the dosage, in the patient's medical record; and shall promptly
    22  notify the patient or the patient's lawful representative who would have
    23  had the authority to consent that such drug with a black box warning was
    24  used and any family member required to be notified  under  this  section
    25  and record such notifications in the patient's medical record.
    26    3.  This section does not increase the lawful scope of practice of any
    27  health care professional and does not diminish or impair any requirement
    28  for or regulation of consent to health care  treatment.  A  health  care
    29  professional who fails to comply with the provisions of this section may
    30  be  found  guilty  of  professional  misconduct  pursuant to article one
    31  hundred thirty-one-a of the education law.
    32    4. The commissioner may make rules or  regulations  to  implement  the
    33  provisions of this section.
    34    §  2.  Section  6530  of  the education law is amended by adding a new
    35  subdivision 51 to read as follows:
    36    51. Failing to comply with  the  provisions  of  section  two  hundred
    37  eighty-d of the public health law.
    38    §  3.  This  act shall take effect on the thirtieth day after it shall
    39  have become a law. Effective immediately, the addition, amendment and/or
    40  repeal of any rule or regulation necessary  for  the  implementation  of
    41  this  act  on its effective date are authorized to be made and completed
    42  on or before such effective date.