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218A.172 Administrative regulations on prescribing or dispensing of
Schedule II controlled substance or Schedule III controlled substance
containing hydrocodone -- Continuing course of treatment -Recordkeeping -- Exemptions.
(1)
(2)
(3)
Administrative regulations promulgated under KRS 218A.205(3) shall require
that, prior to the initial prescribing or dispensing of any Schedule II controlled
substance or a Schedule III controlled substance containing hydrocodone to a
human patient, a practitioner shall:
(a) Obtain a medical history and conduct a physical or mental health
examination of the patient, as appropriate to the patient's medical
complaint, and document the information in the patient's medical record;
(b) Query the electronic monitoring system established in KRS 218A.202 for
all available data on the patient for the twelve (12) month period
immediately preceding the patient encounter and appropriately utilize that
data in the evaluation and treatment of the patient;
(c) Make a written plan stating the objectives of the treatment and further
diagnostic examinations required;
(d) Discuss the risks and benefits of the use of controlled substances with
the patient, the patient's parent if the patient is an unemancipated minor
child, or the patient's legal guardian or health care surrogate, including
the risk of tolerance and drug dependence; and
(e) Obtain written consent for the treatment.
(a) Administrative regulations promulgated under KRS 218A.205(3) shall
require that a practitioner prescribing or dispensing additional amounts of
Schedule II controlled substances or Schedule III controlled substances
containing hydrocodone for the same medical complaint and related
symptoms shall:
1.
Review, at reasonable intervals based on the patient's individual
circumstances and course of treatment, the plan of care;
2.
Provide to the patient any new information about the treatment; and
3.
Modify or terminate the treatment as appropriate.
(b) If the course of treatment extends beyond three (3) months, the
administrative regulations shall also require that the practitioner:
1.
Query the electronic monitoring system established in KRS
218A.202 no less than once every three (3) months for all available
data on the patient for the twelve (12) month period immediately
preceding the query; and
2.
Review that data before issuing any new prescription or refills for the
patient for any Schedule II controlled substance or a Schedule III
controlled substance containing hydrocodone.
Administrative regulations promulgated under KRS 218A.205(3) shall require
that, for each patient for whom a practitioner prescribes any Schedule II
controlled substance or a Schedule III controlled substance containing
hydrocodone, the practitioner shall keep accurate, readily accessible, and
complete medical records which include, as appropriate:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(4)
Medical history and physical or mental health examination;
Diagnostic, therapeutic, and laboratory results;
Evaluations and consultations;
Treatment objectives;
Discussion of risk, benefits, and limitations of treatments;
Treatments;
Medications, including date, type, dosage, and quantity prescribed or
dispensed;
(h) Instructions and agreements; and
(i) Periodic reviews of the patient's file.
Administrative regulations promulgated under KRS 218A.205(3) may exempt,
in whole or in part, compliance with the mandatory diagnostic, treatment,
review, and other protocols and standards established in this section for:
(a) A licensee prescribing or administering a controlled substance
immediately prior to, during, or within the fourteen (14) days following an
operative or invasive procedure or a delivery if the prescribing or
administering is medically related to the operative or invasive procedure
or the delivery and the medication usage does not extend beyond the
fourteen (14) days;
(b) A licensee prescribing or administering a controlled substance necessary
to treat a patient in an emergency situation;
(c) A licensed pharmacist or other person licensed by the Kentucky Board of
Pharmacy to dispense drugs or a licensed pharmacy;
(d) A licensee prescribing or dispensing a controlled substance:
1.
For administration in a hospital or long-term-care facility if the
hospital or long-term-care facility with an institutional account, or a
practitioner in those hospitals or facilities where no institutional
account exists, queries the electronic monitoring system established
in KRS 218A.202 for all available data on the patient or resident for
the twelve (12) month period immediately preceding the query within
twelve (12) hours of the patient's or resident's admission and places
a copy of the query in the patient's or resident's medical records
during the duration of the patient's stay at the facility;
2.
As part of the patient's hospice or end-of-life treatment;
3.
For the treatment of pain associated with cancer or with the
treatment of cancer;
4.
In a single dose to relieve the anxiety, pain, or discomfort
experienced by a patient submitting to a diagnostic test or
procedure;
5.
Within seven (7) days of an initial prescribing or dispensing under
subsection (1) of this section if the prescribing or dispensing:
a.
Is done as a substitute for the initial prescribing or dispensing;
b.
Cancels any refills for the initial prescription; and
c.
Requires the patient to dispose of any remaining unconsumed
(e)
(f)
(5)
(a)
(b)
medication;
6.
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 practitioner in the same practice or in an existing
coverage arrangement, if done for the same patient for the same
medical condition; or
7.
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 of Health and
Human Services, Office for Human Research Protections, where 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;
The prescribing of a Schedule III, IV, or V controlled substance by a
licensed optometrist to a patient in accordance with the provisions of KRS
320.240; or
The prescribing of a three (3) day supply of a Schedule III controlled
substance following the performance of oral surgery by a dentist licensed
pursuant to KRS Chapter 313.
A state licensing board promulgating administrative regulations under
KRS 218A.205(3) may promulgate an administrative regulation
authorizing exemptions supplemental or in addition to those specified in
subsection (4) of this section. Prior to exercising this authority, the board
shall:
1.
Notify the Kentucky Office of Drug Control Policy that it is
considering a proposal to promulgate an administrative regulation
authorizing exemptions supplemental or in addition to those
specified in subsection (4) of this section and invite the office to
participate in the board meeting at which the proposal will be
considered;
2.
Make a factual finding based on expert testimony as well as
evidence or research submitted to the board that the exemption
demonstrates a low risk of diversion or abuse and is supported by
the dictates of good medical practice; and
3.
Submit a report to the Governor and the Legislative Research
Commission of its actions, including a detailed explanation of the
factual and policy basis underlying the board's action. A copy of this
report shall be provided to the regulations compiler.
Within one (1) working day of promulgating an administrative regulation
authorizing an exemption under this section, the promulgating board shall
e-mail to the Kentucky Office of Drug Control Policy:
1.
A copy of the administrative regulation as filed, and all attachments
required by KRS 13A.230(1); and
2.
A request from the board that the office review the administrative
regulation in the same manner as would the Commission on Small
Business Advocacy under KRS 11.202(1)(e), and submit its report
or comments in accordance with the deadline established in KRS
13A.270(1)(c). A copy of the report or comments shall be filed with
the regulations compiler.
Effective:March 4, 2013
History: Amended 2013 Ky. Acts ch. 2, sec. 1, effective March 4, 2013. -- Created
2012 (1st Extra. Sess.) Ky. Acts ch. 1, sec. 3, effective July 20, 2012.
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