S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6462
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                              April 29, 2021
                                ___________
 
 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:
 
   Section  1.  The  public health law is amended by adding a new section
 280-d to read as follows:
   § 280-D. USE OF ANTIPSYCHOTIC DRUGS ON ELDERLY PATIENTS WITH DEMENTIA.
 1. AS USED IN THIS SECTION:
   (A) "OFF  LABEL"  MEANS  A  MEDICAL  PRACTICE  IN  WHICH  A  PHYSICIAN
 PRESCRIBES A DRUG FOR A DIFFERENT MEDICAL PURPOSE THAN THE ONE FOR WHICH
 SUCH DRUG IS APPROVED FOR;
   (B) "BLACK BOX WARNING" MEANS A WARNING ISSUED BY THE FEDERAL FOOD AND
 DRUG  ADMINISTRATION  AND PLACED ON THE PACKAGE INSERT OF A PRESCRIPTION
 DRUG THAT MAY BE FATAL OR CAUSE SERVER SIDE EFFECTS;
   (C)  "CHEMICAL  RESTRAINT"  MEANS  WHEN  AN  ANTIPSYCHOTIC  DRUG  THAT
 PROVIDES  NO  MEDICAL  BENEFIT TO A PATIENT WITH DEMENTIA AND IS USED TO
 SEDATE SUCH PATIENT, CONTROL SUCH PATIENT'S BEHAVIOR  OR  RESTRICT  SUCH
 PATIENT'S MOVEMENT;
   (D)  "ANTIPSYCHOTIC  DRUG" MEANS ANY TYPICAL OR ATYPICAL ANTIPSYCHOTIC
 DRUG THAT IS INTENDED TO BE USED ON PATIENTS WITH  MENTAL  ILLNESS  THAT
 REQUIRE  A BLACK BOX WARNING AND SHALL INCLUDE BUT NOT BE LIMITED TO THE
 FOLLOWING:
   (I) TYPICAL ANTIPSYCHOTIC DRUGS: HALOPERIDOL, LOXAPINE,  THIORIDAZINE,
 MOLINDONE,  THIOTHIXENE,  FLUPHENAZINE, TRIFLUOPERAZINE, CHLORPROMAZINE,
 PERPHENAZINE, OR PROMOZIDE; OR
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD11120-01-1

              

 S. 6462                             2
 
   (II) ATYPICAL ANTIPSYCHOTIC DRUGS: ARIPIPRAZOLE, LUMAPETERONE, CLOZAR-
 IL, ILOPERIDONE, ZIPRASIDONE, PALIPERIDONE, LURASIDONE,  BREXIPIPRAZOLE,
 RISPERIDONE, ASENAPINE, QUETIAPINE, CARIPRAZINE, OR OLANZAPINE; AND
   (E) "PATIENT" MEANS AN ELDERLY INDIVIDUAL WITH DEMENTIA WHO IS:
   (I)  A  RESIDENT  OF  A RESIDENTIAL HEALTH CARE FACILITY AS DEFINED IN
 ARTICLE TWENTY-EIGHT OF THIS CHAPTER OR AN ADULT CARE FACILITY CERTIFIED
 UNDER SECTION FOUR HUNDRED SIXTY-ONE-B OF THE SOCIAL SERVICES LAW; OR
   (II) IN THE CARE OF A HOSPITAL AS DEFINED IN ARTICLE  TWENTY-EIGHT  OF
 THIS CHAPTER, A FACILITY AS DEFINED IN ARTICLE TWENTY OF THIS CHAPTER OR
 ANY OTHER HEALTH CARE FACILITY WHO CARE FOR INDIVIDUALS WITH DEMENTIA.
   2.  NO  ANTIPSYCHOTIC  DRUG THAT CONTAINS A BLACK BOX WARNING SHALL BE
 USED FOR AN OFF LABEL PURPOSE ON A PATIENT KNOWN TO HAVE DEMENTIA OR  TO
 CHEMICALLY  RESTRAIN  A  PATIENT KNOWN TO HAVE DEMENTIA. AN ORDER FOR AN
 ANTIPSYCHOTIC DRUG MAY ONLY BE ISSUED IN AN EMERGENCY SITUATION AND BY A
 HEALTH CARE PROFESSIONAL WHO SPECIALIZES IN DEMENTIA OR IS  SPECIFICALLY
 TRAINED  IN  THE  TREATMENT  OF  DEMENTIA  PATIENTS IF SUCH A PATIENT IS
 AGITATED AND WHERE IT IS  REASONABLY  NECESSARY  TO  PROTECT  THE  LIFE,
 HEALTH  OR  SAFETY  OF  THE PATIENT OR ANOTHER PERSON. WHERE AN ORDER IS
 MADE UNDER THIS SUBDIVISION, THE HEALTH CARE  PROFESSIONAL  SHALL  IMME-
 DIATELY  RECORD  THE  USE  OF THE ANTIPSYCHOTIC DRUG, THE REASON FOR THE
 USE, AND THE DOSAGE, IN THE PATIENT'S MEDICAL RECORD; AND SHALL PROMPTLY
 NOTIFY THE PATIENT OR THE PATIENT'S LAWFUL REPRESENTATIVE WHO WOULD HAVE
 HAD THE AUTHORITY TO CONSENT THAT SUCH DRUG WITH A BLACK BOX WARNING WAS
 USED AND ANY FAMILY MEMBER REQUIRED TO BE NOTIFIED  UNDER  THIS  SECTION
 AND RECORD SUCH NOTIFICATIONS IN THE PATIENT'S MEDICAL RECORD.
   3.  THIS SECTION DOES NOT INCREASE THE LAWFUL SCOPE OF PRACTICE OF ANY
 HEALTH CARE PROFESSIONAL AND DOES NOT DIMINISH OR IMPAIR ANY REQUIREMENT
 FOR OR REGULATION OF CONSENT TO HEALTH CARE  TREATMENT.  A  HEALTH  CARE
 PROFESSIONAL WHO FAILS TO COMPLY WITH THE PROVISIONS OF THIS SECTION MAY
 BE  FOUND  GUILTY  OF  PROFESSIONAL  MISCONDUCT  PURSUANT TO ARTICLE ONE
 HUNDRED THIRTY-ONE-A OF THE EDUCATION LAW.
   4. THE COMMISSIONER MAY MAKE RULES OR  REGULATIONS  TO  IMPLEMENT  THE
 PROVISIONS OF THIS SECTION.
   §  2.  Section  6530  of  the education law is amended by adding a new
 subdivision 51 to read as follows:
   51. FAILING TO COMPLY WITH  THE  PROVISIONS  OF  SECTION  TWO  HUNDRED
 EIGHTY-D OF THE PUBLIC HEALTH LAW.
   §  3.  This  act shall take effect on the thirtieth day after it shall
 have become a law. Effective immediately, the addition, amendment and/or
 repeal of any rule or regulation necessary  for  the  implementation  of
 this  act  on its effective date are authorized to be made and completed
 on or before such effective date.