N.Y. Comp. Codes R. & Regs. tit. 10 § 80.63

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.63 - Prescribing

(a) A prescription as defined by the Public Health Law means:

(1) an official New York State prescription;

(2) an electronic prescription;

(3) an oral prescription; or

(4) an out-of-state prescription, which means a prescription issued in lieu of an official prescription by a practitioner in another state who is licensed by that state to prescribe controlled substances.

(b) The use of preprinted prescriptions which indicate the controlled substance or the strength, dosage and/or quantity of the controlled substance is prohibited. Such prohibition shall not apply to printed prescriptions generated by means of a computer or an electronic medical record system, provided such printed prescriptions are generated at the time a practitioner prescribes a controlled substance for a patient.

(c)

(1) Prior to prescribing for or dispensing to a patient any controlled substance listed on schedule II, III, or IV of section 3306 of the Public Health Law, every practitioner shall consult the prescription monitoring program registry for the purpose of reviewing that patient's controlled substance history. The patient's controlled substance history shall be obtained from the prescription monitoring program registry no more than 24 hours prior to the practitioner prescribing or dispensing any controlled substance to that patient. A practitioner shall document such consultation in the patient's medical chart or, if the practitioner does not consult the prescription monitoring program registry, the practitioner shall document in the patient's medical chart the reason such consultation was not performed. Such documentation shall include the specific exception listed in paragraph (2) of this subdivision.

(i) When such consultation is not performed due to circumstances specified in subparagraph (2)(vii) of this subdivision, the practitioner shall further document in the patient's medical chart the conditions, occurrences, or circumstances that caused such consultation in a timely manner to be unreasonable. Such documentation shall include a description of the barrier(s) to accessing the registry, and the efforts made by the practitioner to contact other designees.

(ii) When such consultation is not performed due to circumstances specified in subparagraph (2)(viii) of this subdivision, the practitioner shall further document in the patient's medical chart a description of the circumstances supporting the practitioner's conclusion that consultation of the registry would adversely impact the patient's ability to obtain a prescription in a timely manner and the relationship between that delay and the patient's medical condition.

(2) The duty to consult the prescription monitoring program registry shall not apply to:

(i) veterinarians;

(ii) a practitioner dispensing pursuant to Public Health Law section 3351(3);

(iii) a practitioner administering a controlled substance, as defined in Public Health Law section 3302(2);

(iv) a practitioner prescribing or ordering a controlled substance pursuant to Public Health Law section 3342(1) for a patient of an institutional dispenser as defined by Public Health Law section 3302 for use on the premises of, or during an emergency transfer from, the institutional dispenser;

(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 Public Health Law section 4002;

(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 Public Health Law section 3343-a, 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 circumstances under which consultation of the registry would, as determined by the practitioner, result in a patient's inability to obtain a prescription in a timely manner, thereby adversely impacting the medical condition of such patient, provided that the quantity of the controlled substance does not exceed a five-day supply if the controlled substance were used in accordance with the directions for use;

(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 defined in section 80.64 of this Part. In the instance of a temporary technological or electrical failure, a practitioner shall, without undue delay, seek to correct any cause for the failure that is reasonably within his or her control; or

(x) a practitioner to whom the commissioner has granted a waiver from the requirement to consult the registry. A waiver may be issued by the commissioner based upon a showing by a practitioner that his or her ability to consult the registry in accordance with this section is unduly burdened by:

(a) technological limitations that are not reasonably within the control of the practitioner; or

(b) other exceptional circumstance demonstrated by the practitioner.

The practitioner's showing shall include a sworn statement of facts detailing the circumstances in support of a waiver, and should be accompanied by any and all other information which would be relevant to the commissioner's determination. As part of the application for a waiver, the practitioner shall also provide any information which would tend to negate the need for a waiver. A waiver shall be granted by the commissioner for a specified period of time, but in no event for more than one year. Subsequent waivers shall be applied for in the same manner and shall be subject to the same requirements as the original waiver. A practitioner who has been granted a waiver shall notify the department in writing within five business days upon gaining the capability to consult the prescription monitoring program registry. Without regard to the original expiration date, the waiver granted to the practitioner shall terminate within a reasonable period of time as determined by the department, allowing for the practitioner to make accommodations to begin consulting the prescription monitoring program registry.

(3) A practitioner may authorize a designee to consult the prescription monitoring program registry on his or her behalf, provided that 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. A practitioner may only appoint a designee if:

(i) such designee is located in the State of New York when accessing the prescription monitoring program registry;

(ii) the designee is employed by the same professional practice or is under contract with such practice. For purposes of this subparagraph, professional practice shall include, but not be limited to, an institutional dispenser where the designating practitioner is employed, under contract, or otherwise has privileges or authorization to practice;

(iii) the practitioner takes reasonable steps to ensure or has actual knowledge that such designee is sufficiently competent in the use of the registry and that such designee is aware of and conforms to all relevant Federal and State privacy statutes;

(iv) 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 the practitioner remains responsible for any breach of confidentiality; and

(v) the practitioner selects and maintains all active designees authorized to access the prescription monitoring program registry in a format acceptable to the department. Upon a designee's relinquishment or termination of employment or authorization as a designee, a designating practitioner shall immediately notify the department, in a fashion deemed appropriate by the commissioner, of the revocation of the designee's authorization to access the prescription monitoring program registry on the designating practitioner's behalf.

(4) 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. A pharmacist may designate another pharmacist or a pharmacy intern as defined by section 6806 of the Education Law to consult the prescription monitoring program registry on the pharmacist's behalf, provided that:

(i) such designee is located in the State of New York when accessing the prescription monitoring program registry and is employed by the same pharmacy or is under contract with such pharmacy; and

(ii) the designating pharmacist selects and maintains all active designees authorized to access the prescription monitoring program registry in a format acceptable to the department. Upon relinquishment or termination of employment or authorization as a designee, a designating pharmacist shall immediately notify the department, in a fashion deemed appropriate by the commissioner, of the revocation of the designee's authorization to access the prescription monitoring program registry on the designating pharmacist's behalf.

(d)

(1) No controlled substance prescription shall be issued prior to examination of the patient by the practitioner except as otherwise permitted by this subdivision.

(2) Once the initial examination has been completed, the frequency and necessity for future examinations prior to prescribing, either for the same acute or chronic condition, will be made by the practitioner utilizing generally accepted medical standards, including taking into account the drug to be prescribed and the patient's condition, history and disposition toward the use of controlled substances.

(3) In the temporary absence of the initial prescriber, an authorized practitioner may issue a controlled substance prescription for a patient as part of a continuing therapy if the practitioner:

(i) had direct access to the patient's medical records and such records warrant continued controlled substance prescribing; or

(ii) had direct and adequate consultation with the initial prescriber, who assures the necessity of continued controlled substance prescribing and with which the practitioner concurs. If the patient record is not available, the practitioner shall document the activity for his or her own record and shall transmit to the initial prescriber the prescription information. The initial prescriber shall include the prescription information in the patient's record.

(4) A practitioner may prescribe a controlled substance to his or her patient after review of the patient's record if the record contains the result of an examination performed by a consulting physician or hospital and such record warrants the prescribing.

(5) If a patient develops a new condition that would warrant the issuance of a prescription for a controlled substance, a practitioner may issue such prescription prior to performing an examination if:

(i) the prescribing practitioner has a previously established practitioner/patient relationship with the patient;

(ii) an emergency exists; and

(iii) the prescription does not exceed a five day supply as determined by the directions for use. An emergency means that the immediate administration of the drug is necessary for the proper treatment of the patient and that no alternative treatment is available. If the practitioner prescribes such substance orally, the practitioner must comply with the requirements of sections 80.68 and 80.70 of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.63