4731-11-04.1 Controlled substances: utilization for chronic weight management.

(A) A physician shall determine whether to utilize a controlled substance anorexiant for purposes of chronic weight management as an adjunct to a reduced calorie diet and increased physical activity. The determination shall be made in compliance with the provisions of this rule.

(1) Before initiating treatment utilizing any controlled substance anorexiant, the physician shall complete all of the following requirements:

(a) Obtain a thorough history;

(b) Perform a physical examination of the patient;

(c) Determine the patient's BMI;

(d) Review the patient's attempts to lose weight in the past for indications that the patient has made a substantial good faith effort to lose weight in a regimen for weight reduction based on caloric restriction, nutritional counseling, intensive behavioral therapy, and exercise without the utilization of controlled substance anorexiants. The review shall include available records from the physician's own prior treatment of the patient, prior treatment provided by another physician, prior participation in a weight-loss program, or prior treatment by a dietitian;

(e) Rule out the existence of any recognized contraindications to the use of the controlled substance anorexiant to be utilized;

(f) Assess and document the patient's freedom from signs of drug or alcohol abuse;

(g) Access OARRS and document in the patient's record the receipt and assessment of the information received; and

(h) Develop and record in the patient record a treatment plan that includes, at a minimum, a diet and exercise program for weight loss.

(2) The physician shall not initiate treatment utilizing a controlled substance anorexiant upon ascertaining or having reason to believe any one or more of the following:

(a) The patient has a history of, or shows a propensity for, alcohol or drug abuse, or has made any false or misleading statement to the physician or physician assistant relating to the patient's use of drugs or alcohol;

(b) The patient has consumed or disposed of any controlled substance other than in strict compliance with the treating physician's directions; or

(c) The physician knows or should know the patient is pregnant.

(3) The physician shall not initiate treatment utilizing a controlled substance anorexiant if any of the following conditions exist:

(a) The patient has an initial BMI of less than thirty, unless the patient has an initial BMI of at least twenty seven with comorbid factors.

(b) The review of the patient's attempts to lose weight in the past indicates that the patient has not made a substantial good faith effort to lose weight in a regimen for weight reduction based on caloric restriction, nutritional counseling, intensive behavioral therapy, and exercise without the utilization of controlled substance anorexiants. The review shall include available records from the physician's own prior treatment of the patient, prior treatment provided by another physician, prior participation in a weight-loss program, or prior treatment by a dietitian.

(4) The physician shall prescribe the controlled substance anorexiant strictly in accordance with the F.D.A. approved labeling;

(5) Throughout the course of treatment with any controlled substance anorexiant the physician shall comply with rule 4731-11-11 of the Administrative Code and the physician assistant shall comply with rule 4730-2-10 of the Administrative Code.

(B) A physician shall provide treatment utilizing a controlled substance anorexiant for weight management in compliance with paragraph (A) of this rule and the following:

(1) The physician shall meet face-to-face with the patient for the initial visit and at least every thirty days during the first three months of treatment. If the F.D.A. approved labeling for the controlled substance anorexiant requires induction of treatment at one dose and an increase to a higher dose after a stated period of less than thirty days, the physician may give the patient a prescription for the higher dose at the initial visit and the first thirty day period then starts from the date the prescription for the higher dose may be filled.

(2) Following the initial visit and two follow-up visits, the treatment may be continued under one of the following means:

(a) The physician may authorize refills for the controlled substance anorexiant up to five times within six months after the initial prescription date;

(b) The treatment may be provided by a physician assistant in compliance with this rule, the supervisory plan or policies of the healthcare facility, and the physician assistant formulary adopted by the board.

(3) When treatment for chronic weight management is provided by a physician assistant, the following requirements apply:

(a) The supervising physician shall personally review the medical records of each patient to whom the physician assistant has prescribed a controlled substance anorexiant following each visit; and

(b) A physician assistant shall not initiate utilization of a different controlled substance anorexiant, but may recommend such change for the supervising physician's initiation.

(4) A physician shall discontinue utilizing any controlled substance anorexiant immediately upon ascertaining or having reason to believe:

(a) That the patient has repeatedly failed to comply with the physician's treatment recommendations; or

(b) That the patient is pregnant.

(C) A violation of any provision of this rule, as determined by the board, shall constitute the following as applicable:

(1) For a physician:

(a) "Failure to maintain minimal standards applicable to the selection or administration of drugs," as that clause is used in division (B)(2) of section 4731.22 of the Revised Code;

(b) "Selling, giving away, personally furnishing, prescribing, or administering drugs for other than legal and legitimate therapeutic purposes," as that clause is used in division (B)(3) of section 4731.22 of the Revised Code; and

(c) "A departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code.

(2) For a physician assistant:

(a) "A departure from, or failure to conform to, minimal standards of care of similar physician assistants under the same or similar circumstances, regardless of whether actual injury to a patient is established," as that clause is used in division (B)(19) of section 4730.25 of the Revised Code;

(b) "Failure to comply with the requirements of this chapter, Chapter 4731. of the Revised Code, or any rules adopted by the board," as that clause is used in division (B)(2) of section 4730.25 of the Revised Code; and

(c) "Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of this chapter, Chapter 4731. of the Revised Code, or the rules adopted by the board," as that clause is used in division (B)(3) of section 4730.25 of the Revised Code.

Effective: 12/31/2015
Five Year Review (FYR) Dates: 12/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22