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This entry was published on 2014-09-22
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SECTION 3343-A
Prescription monitoring program registry
Public Health (PBH) CHAPTER 45, ARTICLE 33, TITLE 4
§ 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.