§ 3343-A — Prescription monitoring program registry

New York § 3343-A

• Jurisdiction: New York
• Law PBH: Public Health
• Title 4: Dispensing to Ultimate Users
• Art. 33: Controlled Substances

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§ 3343-a. Prescription monitoring program registry. 1. Establishment\nof system. (a) The commissioner shall, in accordance with the provisions\nof this section, establish and maintain an electronic system for\ncollecting, monitoring and reporting information concerning the\nprescribing and dispensing of controlled substances, to be known as the\nprescription monitoring program registry. The registry shall include\ninformation reported by pharmacies on a real time basis, as set forth in\nsubdivision four of section thirty-three hundred thirty-three of this\narticle.\n (b) The registry shall include, for each person to whom a prescription\nfor controlled substances has been dispensed, all patient-specific\ninformation covering such period of time as is deemed appropriate and\nfeasible by the commissioner, but no less than six months and no more\nthan five years. Such patient-specific information shall be obtained\nfrom the prescription information reported by pharmacies pursuant to\nsubdivision four of section thirty-three hundred thirty-three of this\narticle and by practitioners who dispense pursuant to subdivision six of\nsection thirty-three hundred thirty-one of this article, and shall be\nprocessed and included in the registry by the department without undue\ndelay. For purposes of this article, "patient-specific information"\nmeans information pertaining to individual patients included in the\nregistry, which shall include the following information and such other\ninformation as is required by the department in regulation:\n (i) the patient's name;\n (ii) the patient's residential address;\n (iii) the patient's date of birth;\n (iv) the patient's gender;\n (v) the date on which the prescription was issued;\n (vi) the date on which the controlled substance was dispensed;\n (vii) the metric quantity of the controlled substance dispensed;\n (viii) the number of days supply of the controlled substance\ndispensed;\n (ix) the name of the prescriber;\n (x) the prescriber's identification number, as assigned by the drug\nenforcement administration;\n (xi) the name or identifier of the drug that was dispensed; and\n (xii) the payment method.\n (c) The registry shall be secure, easily accessible by practitioners\nand pharmacists, and compatible with the electronic transmission of\nprescriptions for controlled substances, as required by section two\nhundred eighty-one of this chapter, and section sixty-eight hundred ten\nof the education law, and any regulations promulgated pursuant thereto.\nTo the extent practicable, implementation of the electronic transmission\nof prescriptions for controlled substances shall serve to streamline\nconsultation of the registry by practitioners and reporting of\nprescription information by pharmacists. The registry shall be\ninteroperable with other similar registries operated by federal or state\ngovernments, to the extent deemed appropriate by the commissioner, and\nsubject to the provisions of section thirty-three hundred seventy-one-a\nof this article.\n (d) The department shall establish and implement such protocols as are\nreasonably necessary to ensure that information contained in the\nregistry is maintained in a secure and confidential manner and is\naccessible only by practitioners, pharmacists or their designees for the\npurposes established in subdivisions two and three of this section, or\nas otherwise set forth in sections thirty-three hundred seventy-one and\nthirty-three hundred seventy-one-a of this article. Such protocols shall\ninclude a mechanism for the department to monitor and record access to\nthe registry, which shall identify the authorized individual accessing\nand each controlled substance history accessed.\n 2. Duty to consult prescription monitoring program registry;\npractitioners. (a) Every practitioner shall consult the prescription\nmonitoring program registry prior to prescribing or dispensing any\ncontrolled substance listed on schedule II, III or IV of section\nthirty-three hundred six of this article, for the purpose of reviewing a\npatient's controlled substance history as set forth in such registry;\nprovided, however, that nothing in this section shall preclude an\nauthorized practitioner, other than a veterinarian, from consulting the\nregistry at his or her option prior to prescribing or dispensing any\ncontrolled substance. The duty to consult the registry shall not apply\nto:\n (i) veterinarians;\n (ii) a practitioner dispensing pursuant to subdivision three of\nsection thirty-three hundred fifty-one of this article;\n (iii) a practitioner administering a controlled substance;\n (iv) a practitioner prescribing or ordering a controlled substance for\nuse on the premises of an institutional dispenser pursuant to section\nthirty-three hundred forty-two of this title;\n (v) a practitioner prescribing a controlled substance in the emergency\ndepartment of a general hospital, provided that the quantity of\ncontrolled substance prescribed does not exceed a five day supply if the\ncontrolled substance were used in accordance with the directions for\nuse;\n (vi) a practitioner prescribing a controlled substance to a patient\nunder the care of a hospice, as defined by section four thousand two of\nthis chapter;\n (vii) a practitioner when:\n (A) it is not reasonably possible for the practitioner to access the\nregistry in a timely manner;\n (B) no other practitioner or designee authorized to access the\nregistry, pursuant to paragraph (b) of this subdivision, is reasonably\navailable; and\n (C) the quantity of controlled substance prescribed does not exceed a\nfive day supply if the controlled substance were used in accordance with\nthe directions for use;\n (viii) a practitioner acting in compliance with regulations that may\nbe promulgated by the commissioner as to circumstances under which\nconsultation of the registry would result in a patient's inability to\nobtain a prescription in a timely manner, thereby adversely impacting\nthe medical condition of such patient;\n (ix) a situation where the registry is not operational as determined\nby the department or where it cannot be accessed by the practitioner due\nto a temporary technological or electrical failure, as set forth in\nregulation; or\n (x) a practitioner who has been granted a waiver due to technological\nlimitations that are not reasonably within the control of the\npractitioner, or other exceptional circumstance demonstrated by the\npractitioner, pursuant to a process established in regulation, and in\nthe discretion of the commissioner.\n (b) For purposes of this section, a practitioner may authorize a\ndesignee to consult the prescription monitoring program registry on his\nor her behalf, provided that: (i) the designee so authorized is employed\nby the same professional practice or is under contract with such\npractice; (ii) the practitioner takes reasonable steps to ensure that\nsuch designee is sufficiently competent in the use of the registry;\n(iii) the practitioner remains responsible for ensuring that access to\nthe registry by the designee is limited to authorized purposes and\noccurs in a manner that protects the confidentiality of the information\nobtained from the registry, and remains responsible for any breach of\nconfidentiality; and (iv) the ultimate decision as to whether or not to\nprescribe or dispense a controlled substance remains with the\npractitioner and is reasonably informed by the relevant controlled\nsubstance history information obtained from the registry. The\ncommissioner shall establish in regulation reasonable parameters with\nregard to a practitioner's ability to authorize designees pursuant to\nthis section, which shall include processes necessary to allow the\ndepartment to: (A) grant access to the registry in a reasonably prompt\nmanner to as many designees as are authorized by practitioners, up to\nthe number deemed appropriate by the commissioner for particular\nprofessional practices or types of practices, taking into account the\nneed to maintain security of the registry and the patient-specific\ninformation maintained therein, and the objective of minimizing burdens\nto practitioners to the extent practicable; (B) require that\npractitioners notify the department upon terminating the authorization\nof any designee; and (C) establish a mechanism to prevent such\nterminated designees from accessing the registry in a reasonably prompt\nmanner following such notification.\n 3. Authority to consult prescription monitoring program registry;\npharmacists. (a) A pharmacist may consult the prescription monitoring\nprogram registry in order to review the controlled substance history of\nan individual for whom one or more prescriptions for controlled\nsubstances is presented to such pharmacist.\n (b) For purposes of this section, a pharmacist may designate another\npharmacist, a pharmacy intern, as defined by section sixty-eight hundred\nsix of the education law, or other individual as may be permitted by the\ncommissioner in regulation, to consult the prescription monitoring\nprogram registry on the pharmacist's behalf, provided that such designee\nis employed by the same pharmacy or is under contract with such\npharmacy. The commissioner shall establish in regulation reasonable\nparameters with regard to a pharmacist's ability to authorize designees\npursuant to this section, which shall include processes necessary to\nallow the department to: (A) grant access to the registry in a\nreasonably prompt manner to as many designees as are authorized by\npharmacists, up to the number deemed appropriate by the commissioner for\nparticular pharmacies, taking into account the need to maintain security\nof the registry and the patient-specific information maintained therein,\nand the objective of minimizing burdens to pharmacists to the extent\npracticable; (B) require that pharmacists notify the department upon\nterminating the authorization of any designee; and (C) establish a\nmechanism to prevent such terminated designees from accessing the\nregistry in a reasonably prompt manner following such notification.\n 4. Immunity. No practitioner or pharmacist, and no person acting on\nbehalf of such practitioner or pharmacist as permitted under this\nsection, acting with reasonable care and in good faith shall be subject\nto civil liability arising from any false, incomplete or inaccurate\ninformation submitted to or reported by the registry or for any\nresulting failure of the system to accurately or timely report such\ninformation; provided, however, that nothing in this subdivision shall\nbe deemed to alter the obligation to submit or report prescription\ninformation to the department as otherwise set forth in this article or\nin regulations promulgated pursuant thereto.\n 5. Guidance to practitioners and pharmacists. The commissioner shall,\nin consultation with the commissioner of education, provide guidance to\npractitioners, pharmacists, and pharmacies regarding the purposes and\nuses of the registry established by this section and the means by which\npractitioners and pharmacists can access the registry. Such guidance\nshall reference educational information available pursuant to the\nprescription pain medication awareness program established pursuant to\nsection thirty-three hundred nine-a of this article.\n 6. Individual access to controlled substance histories. The\ncommissioner shall establish procedures by which an individual may: (a)\nrequest and obtain his or her own controlled substances history\nconsisting of patient-specific information or, in appropriate\ncircumstances, that of a patient who lacks capacity to make health care\ndecisions and for whom the individual has legal authority to make such\ndecisions and would have legal access to the patient's health care\nrecords; or (b) seek review of any part of his or her controlled\nsubstances history or, in appropriate circumstances, that of a patient\nwho lacks capacity to make health care decisions and for whom the\nindividual has legal authority to make such decisions and would have\nlegal access to the patient's health care records, that such individual\ndisputes. Such procedures shall require the department to promptly\nrevise any information accessible through the registry that the\ndepartment determines to be inaccurate. Such procedures shall be\ndescribed on the department's website and included with the controlled\nsubstances history provided to an individual pursuant to a request made\nunder this subdivision or under subparagraph (iv) of paragraph (a) of\nsubdivision two of section thirty-three hundred seventy-one of this\narticle.\n 7. Department analysis of data. The department shall periodically\nanalyze data contained in the prescription monitoring program registry\nto identify information that indicates that a violation of law or breach\nof professional standards may have occurred and, as warranted, provide\nany relevant information to appropriate entities as permitted under\nsection thirty-three hundred seventy-one of this article. The department\nshall keep a record of the information provided, including, but not\nlimited to, the specific information provided and the agency to which\nsuch information was provided, including the name and title of the\nperson to whom such information was provided and an attestation from\nsuch person that he or she has authority to receive such information.\n 8. Funding the prescription monitoring program registry. (a) The\ncommissioner shall make reasonable efforts to apply for monies available\nfrom the federal government and other institutions, to the extent deemed\nappropriate by the commissioner, and use any monies so obtained to\nsupplement any other monies made available for the purposes of this\ntitle.\n (b) Operation of the registry established by this section shall not be\nfunded, in whole or in part, by fees imposed specifically for such\npurposes upon practitioners, pharmacists, designees or patients subject\nto this section.\n 9. Rules and regulations. The commissioner shall promulgate such rules\nand regulations as are necessary to effectuate the provisions of this\nsection, in consultation with the work group established pursuant to\nsubdivision three of section thirty-three hundred nine-a of this\narticle.\n