KRS 218A.172: Administrative regulations on prescribing or dispensing of Schedule II

controlled substance -- Continuing course of treatment -- Recordkeeping --

Exemptions.

(1) Administrative regulations promulgated under KRS 218A.205(3) shall require that,

prior to the initial prescribing or dispensing of any Schedule II controlled substance

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 p atient'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 th e 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.

(2) (a) Administrative regulations promulgated under KRS 218A.205(3) shall require

that a practitioner prescribing or dispensing additional amounts of Schedule II

controlled substances for the same medical complaint and related symptom s

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.

(3) Administrative regulations promulgated under KRS 218A.205(3) shall require that

for each patient for whom a practitioner prescribes any Schedule II controlled

substance the practitioner shall keep accurate, readily accessible, and complete

medical records which include, as appropriate:

(a) Medical history and physical or mental health examination;

(b) Diagnostic, therapeutic, and laboratory results;

(c) Evaluations and consultations;

(d) Treatment objectives;

(e) Discussion of risk, benefits, and limitations of treatments;

(f) Treatments;

(g) Medications, including date, type, dosage, and quantity prescribed or

dispensed;

(h) Instructions and agreements; and

(i) Periodic reviews of the patient's file.

(4) 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 lic ensed 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 hos pital

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 pat ient'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

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;

(e) The prescribing of a Schedule III, IV, o r V controlled substance by a licensed

optometrist to a patient in accordance with the provisions of KRS 320.240; or

(f) 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.

(5) (a) A state licensing board promulgating administrative regulations under KRS

218A.205(3) may promulgate an administrative regulation in accordance with

KRS Chapter 13A authorizing exemptions supplemental or in ad dition 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 e vidence 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 act ions, 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.

(b) Within one (1) working day of promulgating an administrative regulation

authorizing an exemption under this section, the promulgating board shall

email 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 Innovation and 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.