NY Pub Health L § 3343-A (2021)
2021 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.