4731-11-03 Schedule II controlled substance stimulants.

 

 

 

4731-11-03                  Schedule II controlled substance stimulants.

 

 

 

(A)    A physician shall not utilize a schedule II controlled substance stimulant for any purpose except:

 

(1)   The treatment of narcolepsy, idiopathic hypersomnia, and hypersomnias due to medical conditions known to cause excessive sleepiness;

 

(2)    The treatment orof abnormal behavioral syndrome (attention deficit disorder, hyperkinetic syndrome), and/or related disorders of childhood;

 

(3)   The treatment of drug-induced or trauma-induced brain dysfunction;

 

(4)   The differential diagnostic psychiatric evaluation of depression;

 

(5)     The treatment of depression shown to be refractory to other therapeutic modalities, including pharmacologic approaches, such as tricyclic antidepressants and MAO inhibitors;

 

(6)   As adjunctive therapy in the treatment of the following:chronic severe pain or depression, in the terminal stages of diseases which are accompanied by severe pain;

 

(a) Chronic severe pain;

 

(b) Closed head injuries;

 

(c) Cancer-related fatigue;

 

(d)Fatigue experienced during the terminal stages of disease;

 

(e) Depression experienced during the terminal stages of disease; or

 

(f)Intractable pain, as defined in rule 4731-21-01 of the Administrative Code.

 

(7)The clinical investigation of the effects of such drugs, in which case the physician shall submit to the board a written investigative protocol for its review and approval before the investigation has begun. The investigation shall be conducted in strict compliance with the investigative protocol, and the physician shall, within sixty days following the conclusion of the investigation, submit to the board a written report detailing the findings and conclusions of the investigation.

 

(B)   A physician shall not utilize a schedule II controlled substance stimulant for purposes

 

 

 

of weight reduction or control.

(C)   A physician may utilize a schedule II controlled substance stimulant when properly indicated for any purpose listed in paragraph (A) of this rule, provided that all of the following conditions are met:

(1)   Before initiating treatment utilizing a schedule II controlled substance stimulant, the physician obtains a thorough history, performs a thorough physical examination of the patient, and rules out the existence of any recognized contraindications to the use of the controlled substance stimulant to be utilized.

(2)    The physician shall not utilize any schedule II controlled substance stimulant when he knows or has reason to believe that a recognized contra-indication to its use exists.

(3)   The physician shall not utilize any schedule II controlled substance stimulant in the treatment of a patient who he knows or should know is pregnant.

(4)   Upon ascertaining or having reason to believe that the patient has a history of or shows a propensity for alcohol or drug abuse, or that the patient has consumed or disposed of any controlled substance other than in strict compliance with the treating physician's directions, the physician shall reappraise the desirability of continued utilization of schedule II controlled substance stimulants and shall document in the patient record the factors weighed in deciding to continue their use. The physician shall actively monitor such a patient for signs and symptoms of drug abuse and drug dependency.

(D)   A violation of any provision of this rule, as determined by the board, shall constitute "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; "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 "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.

Effective:                                                     04/30/2009

R.C. 119.032 review dates:                         06/06/2008 and 04/30/2014

CERTIFIED ELECTRONICALLY

Certification

04/17/2009

Date

Promulgated Under:                           119.03

Statutory Authority:                           4731.05

Rule Amplifies:                                  4731.22

Prior Effective Dates:                         11/17/86; 10/31/98; 9/1/00