N.Y. Public Health Law § 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 four 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.