N.Y. Pub. Health Law § 3343-A

Current through 2024 NY Law Chapter 553

Section 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.

N.Y. Pub. Health Law § 3343-A