2023 New York Laws › PBH - Public Health › Article 33 - Controlled Substances › Title 4 - Dispensing to Ultimate Users › 3343-A - Prescription Monitoring Program Registry.

§  3343-a.  Prescription monitoring program registry. 1. Establishment
of system. (a) The commissioner shall, in accordance with the provisions
of this  section,  establish  and  maintain  an  electronic  system  for
collecting,   monitoring   and   reporting  information  concerning  the
prescribing and dispensing of controlled substances, to be known as  the
prescription  monitoring  program  registry.  The registry shall include
information reported by pharmacies on a real time basis, as set forth in
subdivision four of section thirty-three hundred  thirty-three  of  this
article.
(b) The registry shall include, for each person to whom a prescription
for  controlled  substances  has  been  dispensed,  all patient-specific
information covering such period of time as is  deemed  appropriate  and
feasible  by  the  commissioner, but no less than six months and no more
than five years. Such patient-specific  information  shall  be  obtained
from  the  prescription  information  reported by pharmacies pursuant to
subdivision four of section thirty-three hundred  thirty-three  of  this
article and by practitioners who dispense pursuant to subdivision six of
section  thirty-three  hundred  thirty-one of this article, and shall be
processed and included in the registry by the department  without  undue
delay.  For  purposes  of  this  article, "patient-specific information"
means information pertaining to  individual  patients  included  in  the
registry,  which  shall include the following information and such other
information as is required by the department in regulation:
(i) the patient's name;
(ii) the patient's residential address;
(iii) the patient's date of birth;
(iv) the patient's gender;
(v) the date on which the prescription was issued;
(vi) the date on which the controlled substance was dispensed;
(vii) the metric quantity of the controlled substance dispensed;
(viii)  the  number  of  days  supply  of  the  controlled   substance
dispensed;
(ix) the name of the prescriber;
(x)  the  prescriber's  identification number, as assigned by the drug
enforcement administration;
(xi) the name or identifier of the drug that was dispensed; and
(xii) the payment method.
(c) The registry shall be secure, easily accessible  by  practitioners
and  pharmacists,  and  compatible  with  the electronic transmission of
prescriptions for controlled substances,  as  required  by  section  two
hundred  eighty-one of this chapter, and section sixty-eight hundred ten
of the education law, and any regulations promulgated pursuant  thereto.
To the extent practicable, implementation of the electronic transmission
of  prescriptions  for  controlled  substances shall serve to streamline
consultation  of  the  registry  by  practitioners  and   reporting   of
prescription   information   by   pharmacists.  The  registry  shall  be
interoperable with other similar registries operated by federal or state
governments, to the extent deemed appropriate by the  commissioner,  and
subject  to the provisions of section thirty-three hundred seventy-one-a
of this article.
(d) The department shall establish and implement such protocols as are
reasonably  necessary  to  ensure  that  information  contained  in  the
registry  is  maintained  in  a  secure  and  confidential manner and is
accessible only by practitioners, pharmacists or their designees for the
purposes established in subdivisions two and three of this  section,  or
as  otherwise set forth in sections thirty-three hundred seventy-one and
thirty-three hundred seventy-one-a of this article. Such protocols shall
include a mechanism for the department to monitor and record  access  to

the  registry,  which shall identify the authorized individual accessing
and each controlled substance history accessed.
2.   Duty   to   consult  prescription  monitoring  program  registry;
practitioners. (a) Every practitioner  shall  consult  the  prescription
monitoring  program  registry  prior  to  prescribing  or dispensing any
controlled substance listed  on  schedule  II,  III  or  IV  of  section
thirty-three hundred six of this article, for the purpose of reviewing a
patient's  controlled  substance  history as set forth in such registry;
provided, however, that  nothing  in  this  section  shall  preclude  an
authorized  practitioner, other than a veterinarian, from consulting the
registry at his or her option prior to  prescribing  or  dispensing  any
controlled  substance.  The duty to consult the registry shall not apply
to:
(i) veterinarians;
(ii) a  practitioner  dispensing  pursuant  to  subdivision  three  of
section thirty-three hundred fifty-one of this article;
(iii) a practitioner administering a controlled substance;
(iv) a practitioner prescribing or ordering a controlled substance for
use  on  the  premises of an institutional dispenser pursuant to section
thirty-three hundred forty-two of this title;
(v) a practitioner prescribing a controlled substance in the emergency
department  of  a  general  hospital,  provided  that  the  quantity  of
controlled substance prescribed does not exceed a five day supply if the
controlled  substance  were  used  in accordance with the directions for
use;
(vi) a practitioner prescribing a controlled substance  to  a  patient
under  the care of a hospice, as defined by section four thousand two of
this chapter;
(vii) a practitioner when:
(A) it is not reasonably possible for the practitioner to  access  the
registry in a timely manner;
(B)  no  other  practitioner  or  designee  authorized  to  access the
registry, pursuant to paragraph (b) of this subdivision,  is  reasonably
available; and
(C)  the quantity of controlled substance prescribed does not exceed a
five day supply if the controlled substance were used in accordance with
the directions for use;
(viii) a practitioner acting in compliance with regulations  that  may
be  promulgated  by  the  commissioner  as  to circumstances under which
consultation of the registry would result in a  patient's  inability  to
obtain  a  prescription  in a timely manner, thereby adversely impacting
the medical condition of such patient;
(ix) a situation where the registry is not operational  as  determined
by the department or where it cannot be accessed by the practitioner due
to  a  temporary  technological  or  electrical failure, as set forth in
regulation; or
(x) a practitioner who has been granted a waiver due to  technological
limitations   that   are  not  reasonably  within  the  control  of  the
practitioner, or other  exceptional  circumstance  demonstrated  by  the
practitioner,  pursuant  to  a process established in regulation, and in
the discretion of the commissioner.
(b) For purposes of this  section,  a  practitioner  may  authorize  a
designee  to consult the prescription monitoring program registry on his
or her behalf, provided that: (i) the designee so authorized is employed
by the same  professional  practice  or  is  under  contract  with  such
practice;  (ii)  the  practitioner takes reasonable steps to ensure that
such designee is sufficiently competent in  the  use  of  the  registry;
(iii)  the  practitioner remains responsible for ensuring that access to

the registry by the designee  is  limited  to  authorized  purposes  and
occurs  in a manner that protects the confidentiality of the information
obtained from the registry, and remains responsible for  any  breach  of
confidentiality;  and (iv) the ultimate decision as to whether or not to
prescribe  or  dispense  a  controlled  substance   remains   with   the
practitioner  and  is  reasonably  informed  by  the relevant controlled
substance  history  information  obtained   from   the   registry.   The
commissioner  shall  establish  in regulation reasonable parameters with
regard to a practitioner's ability to authorize  designees  pursuant  to
this  section,  which  shall  include  processes  necessary to allow the
department to: (A) grant access to the registry in a  reasonably  prompt
manner  to  as  many designees as are authorized by practitioners, up to
the  number  deemed  appropriate  by  the  commissioner  for  particular
professional  practices  or  types of practices, taking into account the
need to maintain security  of  the  registry  and  the  patient-specific
information  maintained therein, and the objective of minimizing burdens
to  practitioners  to  the  extent   practicable;   (B)   require   that
practitioners  notify  the department upon terminating the authorization
of  any  designee;  and  (C)  establish  a  mechanism  to  prevent  such
terminated  designees from accessing the registry in a reasonably prompt
manner following such notification.
3. Authority to  consult  prescription  monitoring  program  registry;
pharmacists.  (a)  A  pharmacist may consult the prescription monitoring
program registry in order to review the controlled substance history  of
an  individual  for  whom  one  or  more  prescriptions  for  controlled
substances is presented to such pharmacist.
(b) For purposes of this section, a pharmacist may  designate  another
pharmacist, a pharmacy intern, as defined by section sixty-eight hundred
six of the education law, or other individual as may be permitted by the
commissioner  in  regulation,  to  consult  the  prescription monitoring
program registry on the pharmacist's behalf, provided that such designee
is employed by  the  same  pharmacy  or  is  under  contract  with  such
pharmacy.  The  commissioner  shall  establish  in regulation reasonable
parameters with regard to a pharmacist's ability to authorize  designees
pursuant  to  this  section,  which shall include processes necessary to
allow the  department  to:  (A)  grant  access  to  the  registry  in  a
reasonably  prompt  manner  to  as  many  designees as are authorized by
pharmacists, up to the number deemed appropriate by the commissioner for
particular pharmacies, taking into account the need to maintain security
of the registry and the patient-specific information maintained therein,
and the objective of minimizing burdens to  pharmacists  to  the  extent
practicable;  (B)  require  that  pharmacists notify the department upon
terminating the authorization of  any  designee;  and  (C)  establish  a
mechanism  to  prevent  such  terminated  designees  from  accessing the
registry in a reasonably prompt manner following such notification.
4. Immunity. No practitioner or pharmacist, and no  person  acting  on
behalf  of  such  practitioner  or  pharmacist  as  permitted under this
section, acting with reasonable care and in good faith shall be  subject
to  civil  liability  arising  from  any false, incomplete or inaccurate
information submitted  to  or  reported  by  the  registry  or  for  any
resulting  failure  of  the  system  to accurately or timely report such
information; provided, however, that nothing in this  subdivision  shall
be  deemed  to  alter  the  obligation  to submit or report prescription
information to the department as otherwise set forth in this article  or
in regulations promulgated pursuant thereto.
5.  Guidance to practitioners and pharmacists. The commissioner shall,
in consultation with the commissioner of education, provide guidance  to
practitioners,  pharmacists,  and  pharmacies regarding the purposes and

uses of the registry established by this section and the means by  which
practitioners  and  pharmacists  can  access the registry. Such guidance
shall  reference  educational  information  available  pursuant  to  the
prescription  pain  medication awareness program established pursuant to
section thirty-three hundred nine-a of this article.
6.  Individual  access  to   controlled   substance   histories.   The
commissioner  shall establish procedures by which an individual may: (a)
request  and  obtain  his  or  her  own  controlled  substances  history
consisting   of   patient-specific   information   or,   in  appropriate
circumstances, that of a patient who lacks capacity to make health  care
decisions  and  for whom the individual has legal authority to make such
decisions and would have legal  access  to  the  patient's  health  care
records;  or  (b)  seek  review  of  any  part  of his or her controlled
substances history or, in appropriate circumstances, that of  a  patient
who  lacks  capacity  to  make  health  care  decisions and for whom the
individual has legal authority to make such  decisions  and  would  have
legal  access to the patient's health care records, that such individual
disputes. Such procedures  shall  require  the  department  to  promptly
revise   any  information  accessible  through  the  registry  that  the
department  determines  to  be  inaccurate.  Such  procedures  shall  be
described  on  the department's website and included with the controlled
substances history provided to an individual pursuant to a request  made
under  this  subdivision  or under subparagraph (iv) of paragraph (a) of
subdivision two of section  thirty-three  hundred  seventy-one  of  this
article.
7.  Department  analysis  of  data.  The department shall periodically
analyze data contained in the prescription monitoring  program  registry
to identify information that indicates that a violation of law or breach
of  professional  standards may have occurred and, as warranted, provide
any relevant information to  appropriate  entities  as  permitted  under
section thirty-three hundred seventy-one of this article. The department
shall  keep  a  record  of  the information provided, including, but not
limited to, the specific information provided and the  agency  to  which
such  information  was  provided,  including  the  name and title of the
person to whom such information was provided  and  an  attestation  from
such person that he or she has authority to receive such information.
8.  Funding  the  prescription  monitoring  program  registry. (a) The
commissioner shall make reasonable efforts to apply for monies available
from the federal government and other institutions, to the extent deemed
appropriate by the commissioner, and  use  any  monies  so  obtained  to
supplement  any  other  monies  made  available for the purposes of this
title.
(b) Operation of the registry established by this section shall not be
funded, in whole or in part,  by  fees  imposed  specifically  for  such
purposes  upon practitioners, pharmacists, designees or patients subject
to this section.
9. Rules and regulations. The commissioner shall promulgate such rules
and regulations as are necessary to effectuate the  provisions  of  this
section,  in  consultation  with  the work group established pursuant to
subdivision  three  of  section  thirty-three  hundred  nine-a  of  this
article.