201 KAR 25:090. Prescribing and dispensing controlled

substances.

 

      RELATES TO: KRS 218A.205, 218A.172

      STATUTORY AUTHORITY: KRS 218A.205(3)(a), 311.410(4)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.205(3)(a)

requires the board to establish standards for prescribing controlled

substances. KRS 218A.172 requires the board to promulgate administrative

regulations governing the prescribing or dispensing of any Schedule II

controlled substance or a Schedule III controlled substance containing hydrocodone.

This administrative regulation establishes the standards for prescribing or

dispensing controlled substances.

 

      Section 1. Prescribing or dispensing a controlled

substance. (1) This administrative regulation governs the prescribing and

dispensing of controlled

substances

listed in Schedule

II through V as classified in KRS 218A.060, 218A.070, 218A.080, 218A.090,

218A.100, 218A.110, 218A.120, and 218A.130.

      (2) If initially prescribing or

dispensing a controlled substance, a licensee shall:

      (a) Obtain a complete medical history and

conduct a physical examination of the patient;

      (b) Complete a written treatment plan which

states the objectives of the treatment underlying the prescription of the controlled

substance and which includes an outline of any further diagnostic examinations

that may be required;

      (c) Discuss the risks and benefits of the

use of controlled substances with the patient or the patient’s legal guardian

or health care surrogate, including the risk of tolerance and drug dependence;

      (d) Verify that the patient is the person

that he or she has identified himself or herself as being by requiring the

person to produce proper government issued identification;

      (e) Query the Kentucky All-Schedule

Prescription Electronic Reporting System (KASPER) for all information available

on the patient if prescribing controlled substances that are included in:

      1. Schedule II;

      2. Schedule III; and

      3. The following from Schedule IV:

      a. Ambien;

      b. Anorexics;

      c. Ativan;

      d. Klonopin;

      e. Librium;

      f. Nubain;

      g. Oxazepam;

      h. Phentermine;

      i. Soma;

      j. Stadol;

      k. Stadol NS;

      l. Tramadol;

      m. Valium;

      n. Versed; and

      o. Xanax;

      (f) Obtain consent for the treatment from

the patient in writing; and

      (g) Document the patient’s file as

required by Section 2 of this administrative regulation.

      (3) If it is necessary to continue the

prescription or dispensation of a controlled substance after the initial supply

is completed, a licensee shall:

      (a) Conduct, at reasonable intervals

under the circumstances presented, all clinically indicated steps;

      (b) Review the course of treatment that

he initially prepared to determine if any changes are required;

      (c) Provide any new information about the

course of treatment or any changes made to the patient;

      (d) Query KASPER for all information

available on the patient no less than once every three months for all available

data on the patient to review that data before issuing any new prescription or

refill for the patient for controlled substance specified in subsection (2)(e)

of this section; and

      (e) Document the patient’s file as

required by Section 2 of this administrative regulation.

 

      Section 2. Podiatric medical records for

patients being prescribed controlled substance shall include at a minimum:

      (1) The patient’s name;

      (2) The patient’s date of birth;

      (3) The information concerning the patient’s

medical history and physical examination required by Section 1 of this

administrative regulation;

      (4) The podiatrist’s diagnosis of the

patient’s condition;

      (5) The procedures and treatments to be

undertaken and their objectives;

      (6) The date of the procedures or

treatments;

      (7) (Whether local or general anesthetics

were used, including the type and the amount administered;

      (8) Diagnostic, therapeutic, and

laboratory results;

      (9) The findings and recommendations of

any other evaluations or consultations;

      (10) All medications administered or

prescribed by the podiatrist, including the date, type, dosage, and quantity administered

or prescribed;

      (11) Any post-treatment instructions from

the podiatrist; and

      (12) Documentation that the KASPER query

required by Section 3 of this administrative regulation was completed.

 

      Section 3. If a prescription for a

controlled substance is written, a podiatrist shall:

      (1) Obtain and document in the patient’s

podiatric medical record the information concerning the patient’s medical

history and physical examination required by Section 1 of this administrative

regulation;

      (2) Query the Kentucky All-Scheduled

Prescription Electronic Reporting System (KASPER) for all available data on the

patient if the controlled substance is one specified in Section 1(2)(e) of this

administrative regulation and record the results of the query in the patient’s

record;

      (3) 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

      (4) Obtain consent for the treatment from

the patient in writing.

 

      Section 4. Dispensing Schedule II or

Schedule III controlled substances containing hydrocodone. (1) A licensee shall

not dispense more than a forty-eight (48) hour supply of Schedule II or Schedule

III controlled substances containing hydrocodone.

      (2) If a patient continues to present

with pain after the initial supply has been completed and the podiatrist

believes that an additional prescription for a controlled substance is

medically appropriate, the podiatrist shall at a minimum:

      (a) Follow the requirements of Section 1

of this administrative regulation; and

      (b) Prescribe only that amount of the

controlled substance that is appropriate under accepted and prevailing practice

standards.

 

      Section 5. Authority to prescribe

controlled substances. (1) A podiatrist licensed by the board may prescribe any

medicine necessary for the treatment of a patient that comes within the practice

of podiatry as defined by KRS 311.380(2), including Schedule II and Schedule III

controlled substances containing hydrocodone, if the licensee:

      (a) Has obtained a license number from

the Drug Enforcement Administration;

      (b) Registers with and utilizes the

Kentucky All-Schedule Prescription Electronic Reporting System (KASPER) as required

by KRS 218A.202;

      (c) Follows the requirements of this

administrative regulation; and

      (d) Meets all the requirements for

utilizing KASPER promulgated by the Cabinet as well as the requirements set

forth in KRS 218A.202.

      (2) A licensed podiatrist shall not

prescribe or dispense:

      (a) With the intent or knowledge that a

medication will be used or is likely to be used for any purpose other than one

that is necessary for medical treatment or therapeutic use;

      (b) With the intent to evade any law

governing the sale, use, or disposition of the medication;

      (c) When the licensee knows or has reason

to know that the abuse of the controlled substance is occurring or may result therefrom;

and

      (d) In amounts that the licensee knows or

has reason to know, under the circumstance, that the amount prescribed is excessive

under accepted and prevailing practice standards.

      (3) After a hearing conducted under KRS

Chapter 13B and 201 KAR 25:051, the board shall fine a licensee who otherwise

has the authority to prescribe controlled substances, but who has failed to register

for an account with KASPER, an amount not less than $250 per prescription for

each prescription that individual has written while not properly registered.

(39 Ky.R. 676; 1391; eff. 2-1-2013.)