201 KAR 9:016reg. Restrictions on use of amphetamine and amphetamine-like anorectic controlled substances

      Section 1. Definitions. (1) "Board" is defined in KRS 311.550(1).

      (2) "Body mass index" means the weight of the patient in kilograms divided by the height in meters, squared.

      (3) "Schedule II amphetamine or amphetamine-like controlled substance" means:

      (a) Amphetamine, its salts, optical isomers, and salts of optical isomers; or

      (b) Methylphenidate.

      (4) "Schedule III or IV amphetamine-like controlled substance" means a drug classified as a stimulant pursuant to:

      (a) 902 KAR 55:025, Section 2; or

      (b) 902 KAR 55:030 Section 1.

 

      Section 2. Prior to prescribing, ordering, dispensing, administering, selling, supplying, or giving a Schedule II, III or IV amphetamine or amphetamine-like controlled substance, a physician shall take into account the:

      (1) Drug’s potential for abuse;

      (2) Possibility that a drug may lead to dependence;

      (3) Possibility a patient will obtain the drug for a nontherapeutic use;

      (4) Possibility a patient will distribute it to others; and

      (5) Potential illicit market for the drug.

 

      Section 3. Schedule II Amphetamine or Amphetamine-like Controlled Substances. (1) The patient’s record shall denote the diagnosis that justifies treatment with a Schedule II amphetamine or amphetamine-like controlled substance.

      (2) A Schedule II amphetamine or amphetamine-like controlled substance shall be used to treat only:

      (a) Narcolepsy;

      (b) Attention deficit/hyperactive disorder;

      (c) Resistant depressive disorder in combination with other antidepressant medications, or if alternative antidepressants and other therapeutic modalities are contraindicated;

      (d) Drug-induced brain dysfunction;[or]

      (e) A diagnosis for which the clinical use of the Schedule II amphetamine or amphetamine-like controlled substance is investigational and the investigative protocol has been submitted, reviewed, and approved by the board prior to the clinical use of the drug; or

      (f) An adult patient with a moderate to severe binge-eating disorder, if diagnosed according to criteria set forth in the Diagnostic and Statistical Manual of Mental Disorders at the time of diagnosis.

      (3) A Schedule II amphetamine or amphetamine-like controlled substance shall not be utilized to treat obesity.

 

      Section 4. Treatment of Obesity with a Schedule III or IV Amphetamine-like Controlled Substance. (1) Prior to prescribing, administering, dispensing, ordering, selling, supplying, or giving a Schedule III or IV amphetamine-like controlled substance to treat obesity in a patient sixteen (16) years of age or older, the physician shall:

      (a) Establish a physician/patient relationship;

      (b) Determine that the patient is obese or overweight with medical risk factors and is a proper candidate for weight reduction treatment;

      (c) Determine and record the extent of prior anorectics or other controlled substances used by the patient. The prescribing physician shall obtain and review a KASPER report for the twelve (12) month period immediately preceding the patient encounter, before prescribing or dispensing controlled substances to the patient;

      (d) Determine that the patient has either:

      1. A body mass index of twenty-seven (27) or more, unless the body mass index is twenty-five (25) to twenty-seven (27) and the patient has a co-morbidity such as a cardiovascular disease, diabetes mellitus, dyslipidemia, hypertension, or sleep apnea;

      2. Body fat greater than or equal to thirty (30) percent in females or greater than or equal to twenty-five (25) percent in males;

      3. Current body weight greater than or equal to 120 percent of a well documented, long-standing, healthy weight that the patient maintained after age eighteen (18);

      4. A waist-hip ratio or waist circumference at a level indicating that the individual is known to be at increased cardiovascular or co-morbidity risk because of abdominal visceral fat; or

      5. Presence of a co-morbid condition or conditions aggravated by the patient’s excessive adiposity; and

      (e) Provide the patient with carefully prescribed diet, together with counseling on exercise, behavior modification, and other appropriate supportive and collateral therapies.

      (2) During treatment for obesity, a physician shall:

      (a) Maintain a physician/patient relationship throughout the treatment process;

      (b) Maintain an adequate patient record in accordance with subsection (4) of this section; and

      (c) Justify in the patient record the use of any Schedule III or IV amphetamine-like controlled substance beyond three (3) months. Before the physician continues the use of a substance beyond three (3) months, the physician shall obtain and review a current KASPER report.

      (3) A physician shall terminate the use of Schedule III or IV amphetamine-like controlled substances if:

      (a) The patient does not demonstrate weight loss and does not attempt to comply with exercise and dietary changes;

      (b) The body mass index of the patient without a co-morbid condition is less than twenty-seven (27) and the percentage of body fat is normal at less than thirty (30) percent in females or less than twenty-five (25) percent in males;

      (c) The body mass index of the patient with a co-morbid condition is less than twenty-five (25) and the percentage of body fat is normal at less than thirty (30) percent in females or less than twenty-five (25) percent in males;

      (d) The patient has regained the weight lost, using sympathomimetics as part of a complete program and reuse of the medication does not produce loss of the weight gain to help maintain a minimum of five (5) percent weight loss; or

      (e) The patient has obtained a Schedule III or IV amphetamine-like controlled substance from another physician without the prescriber’s knowledge and consent.

      (4) The board shall consider the following factors in reviewing the adequacy of a patient record:

      (a) Medical history, including:

      1. Illnesses, with particular emphasis on cardiovascular diseases;

      2. Surgery;

      3. Lifestyle;

      4. Medications, including controlled substances;

      5. Eating habits;

      6. Exercise;

      7. Weight gain or loss;

      8. Prior efforts at weight control or reduction;

      9. Prior treatment compliance;

      10. Menstruation or pregnancy; and

      11. Psychiatric history with particular reference to depression, paranoia, psychosis, or chemical dependency;

      (b) Social history;

      (c) Family history;

      (d) Complete physical examination;

      (e) Evaluation of laboratory tests including:

      1. CBC;

      2. Fasting blood sugar;

      3. Thyroid panel or TSH;

      4. Lipid profile;

      5. Serum potassium;

      6. Liver function test; and

      7. Renal function test;

      (f) An informed consent signed by the patient that cites the limitations and risk of anorectic treatment including potential dependency or psychiatric illness;

      (g)1. A signed agreement that the patient has voluntarily agreed to:

      a. Have one (1) prescribing physician for controlled substances;

      b. Use one (1) pharmacy to fill prescriptions for controlled substances;

      c. Not have early refills on the prescriptions for controlled substances; and

      d. Provide full disclosure of other medications taken; or

      2. Documentation that:

      a. The physician requested the patient sign an agreement meeting the requirements of subparagraph 1 of this paragraph;

      b. The patient declined to sign the agreement; and

      c. Indicates the physician’s clinical reasons for prescribing, or continuing to prescribe, a Schedule III or IV amphetamine-like controlled substance to the patient, in light of the patient’s refusal to sign the agreement; and

      (h) A record of each office visit, including:

      1. The patient's weight;

      2. The patient's blood pressure;

      3. The patient's pulse;

      4. The presence or absence of medication side effects or complications;

      5. The doses of medications prescribed;

      6. The patient's body mass index; and

      7. Evaluation of the patient’s compliance with the total treatment regimen.

 

      Section 5. Waiver. For a legitimate medical purpose, a physician may apply in writing for a written waiver of any requirement in this administrative regulation. The board may issue a waiver with terms and conditions it deems appropriate.

 

      Section 6. Failure to comply with the requirements of this administrative regulation shall constitute dishonorable, unethical, or unprofessional conduct by a physician which is apt to deceive, defraud, or harm the public under KRS 311.595(9) and 311.597.

 

PRESTON P. NUNNELLEY, M.D., President

      APPROVED BY AGENCY: March 29, 2016

      FILED WITH LRC: March 30, 2016 at 11 a.m.

      PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on May 24, 2016 at 9:00 a.m. at the offices of the Kentucky Board of Medical Licensure, 310 Whittington Parkway, Suite 1B, Louisville, Kentucky 40222. Individuals interested in being heard at this hearing shall notify this agency in writing by May 17, 2016, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through May 31, 2016. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.

      CONTACT PERSON: Leanne K. Diakov, General Counsel, Kentucky Board of Medical Licensure, 310 Whittington Parkway, Suite 1B, Louisville, Kentucky 40222, phone [phone], fax [phone].

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact Person: Leanne K. Diakov

      (1) Provide a brief summary of:

      (a) What this administrative regulation does: This administrative regulation establishes restrictions on use of amphetamine and amphetamine-like anorectic controlled substances.

      (b) The necessity of this administrative regulation: This regulation is necessary to establish restrictions on use of amphetamine and amphetamine-like anorectic controlled substances.

      (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of KRS 311.565(1)(a) which authorizes the Board to promulgate regulations to prevent empiricism and regulate the practice of medicine/osteopathy in the Commonwealth of Kentucky.

      (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation acts specifically to establish restrictions on use of amphetamine and amphetamine-like anorectic controlled substances.

      (2) If this is an amendment to an existing regulation, provide a brief summary of:

      (a) How the amendment will change this existing administrative regulation: The amendment expands the approved use of Schedule II amphetamine and amphetamine-like anorectic controlled substances to treat binge-eating disorders in accordance with new Federal Drug Administration standards so that Kentuckians can have access to this treatment.

      (b) The necessity of the amendment to this administrative regulation: The amendment is necessary to expand the approved use of Schedule II amphetamine and amphetamine-like anorectic controlled substances to treat binge-eating disorders in accordance with new Federal Drug Administration standards so that Kentuckians can have access to this treatment.

      (c) How the amendment conforms to the content of the authorizing statutes: This amendment conforms to the content of KRS 311.565(1)(a) which authorizes the Board to promulgate regulations to prevent empiricism and regulate the practice of medicine/osteopathy in the Commonwealth of Kentucky.

      (d) How the amendment will assist in the effective administration of the statutes: This amendment acts specifically to establish restrictions on use of Schedule II amphetamine and amphetamine-like anorectic controlled substances.

      (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: This amendment will affect all physicians licensed in Kentucky who prescribe Schedule II amphetamine and amphetamine-like anorectic controlled substances.

      (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this regulation, if new, or by the change, if it is an amendment, including:

      (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: Physicians licensed in Kentucky who prescribe Schedule II amphetamine and amphetamine-like anorectic controlled substances will not have to take any action, but they will be able to use Schedule II amphetamine and amphetamine-like anorectic controlled substances to treat binge-eating disorders with some patients.

      (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There is no cost associated with the requirements of this administrative regulation known to the board.

      (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): They will be able to use Schedule II amphetamine and amphetamine-like anorectic controlled substances to treat binge-eating disorders with some patients.

      (5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

      (a) Initially: None

      (b) On a continuing basis: None

      (6) What is the source of funding to be used for the implementation and enforcement of this administration regulation: None

      (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No increase of fees or funding will be necessary.

      (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees: This regulation does not establish any fees nor does it directly or indirectly increase any fees.

      (9) TIERING: Is tiering applied? Tiering was not appropriate in this administrative regulation because the administrative regulation applies equally to all those individuals regulated by it.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

      (1) What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? The Kentucky Board of Medical Licensure will be impacted by this administrative regulation.

      (2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 311.565(1)(a)

      (3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect. None

      (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? None

      (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? None

      (c) How much will it cost to administer this program for the first year? None

      (d) How much will it cost to administer this program for subsequent years? None

      Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

      Revenues (+/-):

      Expenditures (+/-):

      Other Explanation:

Notation

      RELATES TO: KRS 311.550, 311.595(9), 311.597

      STATUTORY AUTHORITY: KRS 311.565(1)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 311.565(1)(a) authorizes the board to promulgate administrative regulations to regulate the conduct of licensees. KRS 311.595(9) and 311.597 authorize disciplinary action against licensees for specified offenses. This administrative regulation establishes the requirements governing the use of amphetamine and amphetamine-like anorectic controlled substances.