2012 New York Consolidated Laws
PBH - Public Health
Article 33 - CONTROLLED SUBSTANCES
Title 4 - (3330 - 3345) 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.
    * NB Effective August 27, 2013