Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 9 - Board of Medical Licensure › Section 201 KAR 9:260 - Professional standards for prescribing, dispensing, and administering controlled substances

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				218A.172,
				218A.205,
				311.530-311.620,
				311.990,
				311.840-311.862
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				311.565(1)(a) authorizes the
				board to promulgate administrative regulations to regulate the conduct of its
				licensees.
				KRS
				218A.205(3)(a) and (b)
				require the board, in consultation with the Kentucky Office of Drug Control
				Policy, to establish mandatory prescribing and dispensing standards related to
				controlled substances, and in accordance with the Centers for Disease Control
				and Prevention (CDC) guidelines, to establish a prohibition on a practitioner
				issuing a prescription for a Schedule II controlled substance for more than a
				three (3) day supply if intended to treat pain as an acute medical condition,
				unless an exception applies.
				KRS
				311.842(1)(b) requires that
				the board promulgate administrative regulations establishing professional
				standards for prescribing and administering controlled substances by physician
				assistants. This administrative regulation establishes the professional
				standards for prescribing and dispensing controlled substances for any licensee
				authorized to prescribe, dispense, or administer controlled substances.
Section 1. Applicability.
(1) Any licensee who is authorized to
			 prescribe, dispense, or administer a controlled substance shall comply with the
			 standards of acceptable and prevailing medical practice for prescribing,
			 dispensing, or administering a controlled substance established in this
			 administrative regulation.
(2) A
			 physician assistant shall only prescribe or administer a controlled substance
			 to the extent delegated by the supervising physician in the applications
			 required under
			 KRS
			 311.854 and
			 311.858.
			 This administrative regulation, including any exemptions stated herein, shall
			 not alter the prescribing limits established in
			 KRS
			 311.858 or the requirements for delegation
			 from a supervising physician established in
			 KRS
			 311.854.
(a) Any change in the supervising physician
			 application, including changes in practice address, scope of practice, or scope
			 of delegated prescriptive authority, required under
			 KRS
			 311.854 and
			 311.858
			 shall be reported in writing to the board within ten (10) days of the
			 change.
(b) If the physician
			 assistant's supervising physician changes or the supervising physician becomes
			 restricted or suspended from the practice of medicine or osteopathy, the
			 physician assistant shall cease prescribing or administering controlled
			 substances until the restriction or suspension is terminated or a new
			 supervising physician is approved.
(c) Prescribing or administering controlled
			 substances without the applications required under
			 KRS
			 311.854 and
			 311.858
			 shall constitute a violation of this administrative regulation and shall be
			 grounds for an emergency order of restriction or suspension.
(3) The professional standards
			 established in this administrative regulation shall not apply to prescribing,
			 dispensing, or administering a controlled substance:
(a) To a patient as part of the patient's
			 hospice or end-of-life treatment;
(b) To a patient admitted to a licensed
			 hospital as an inpatient, outpatient, or observation patient, during and as
			 part of a normal and expected part of the patient's course of care at that
			 hospital;
(c) To a patient for the
			 treatment of pain associated with cancer or with the treatment of
			 cancer;
(d) To a patient who is a
			 registered resident of a long-term-care facility as defined in
			 KRS
			 216.510;
(e) During the effective period of any period
			 of disaster or mass casualties that has a direct impact upon the physician's
			 practice;
(f) In a single dose to
			 relieve the anxiety, pain, or discomfort experienced by that patient submitting
			 to a diagnostic test or procedure;
(g) That has been classified as a Schedule V
			 controlled substance;
(h) That is a
			 Schedule II controlled substance as part of a narcotic treatment program
			 licensed by the Cabinet for Health and Family Services;
(i) Within seven (7) days of an initial
			 prescribing or dispensing under subsection (1) of this section if the
			 prescribing or dispensing:
1. Is done as a
			 substitute for the initial prescribing or dispensing;
2. Cancels any refills for the initial
			 prescription; and
3. Requires the
			 patient to dispose of any remaining unconsumed medication;
(j) Within ninety (90) days of an initial
			 prescribing or dispensing under subsection (1) of this section if the
			 prescribing or dispensing is done by another physician in the same practice or
			 in an existing coverage arrangement, if done for the same patient for the same
			 medical condition;
(k) To a
			 research subject enrolled in a research protocol approved by an institutional
			 review board that has an active federalwide assurance number from the United
			 States Department for Health and Human Services, Office for Human Research
			 Protections if the research involves single, double, or triple blind drug
			 administration or is additionally covered by a certificate of confidentiality
			 from the National Institutes of Health; or
(l)
1. To a
			 patient immediately prior to, during, or within the fourteen (14) days
			 following:
a. A major surgery, being any
			 operative or invasive procedure or a delivery; or
b. A significant trauma, being any acute
			 blunt, blast, or penetrating bodily injury that has a risk of death, physical
			 disability, or impairment; and
2. The usage does not extend beyond fourteen
			 (14) days.