Chapter 4731-11 Controlled Substances

4731-11-01 Definitions.

As used in Chapter 4731-11 of the Administrative Code:

(A) "Controlled substance" means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V pursuant to the provisions of Chapter 3719. of the Revised Code.

(B) "Controlled substance stimulant" means any drug, compound, mixture, preparation, or substance which is classified as a stimulant in controlled substance schedule II, III, or IV listed in section 3719.41 of the Revised Code, or which is classified as a stimulant in controlled substances schedule II, III, or IV pursuant to section 3719.43 or 3719.44 of the Revised Code.

(C) "Utilize a controlled substance or controlled substance stimulant" means to prescribe, administer, dispense, supply, sell or give a controlled substance or controlled substance stimulant.

(D) "Recognized contraindication" means any contraindication to the use of a drug which is listed in the United States food and drug administration (hereinafter, "F.D.A.") approved labeling for the drug, or which the board determines to be accepted as a contraindication.

(E) "The board" means the state medical board of Ohio.

(F) "BMI" means body mass index, calculated as a person's weight in kilograms divided by height in meters squared.

(G) "Physician" means an individual holding a certificate under Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery and practicing within his or her scope of practice as defined by section 4731.51 of the Revised Code.

(H) "Board certified addictionologist or addiction psychiatrist" means a medical doctor or doctor of osteopathic medicine and surgery who holds one of the following certifications:

(1) Subspecialty board certification in addiction psychiatry from the American board of psychiatry and neurology;

(2) Board certification in addiction medicine from the American board of addiction medicine;

(3) Certification from the American society of addiction medicine; or

(4) Board certification with additional qualification in addiction medicine from the American osteopathic association.

(I) "Office based opioid treatment", or "OBOT", means treatment of opioid addiction utilizing a schedule III, IV or V controlled substance narcotic.

(J) "Opioid treatment program", or "OTP", sometimes referred to as a "methadone clinic", means a program licensed by the state to administer or dispense schedule II controlled substance narcotics in the maintenance or detoxification treatment of opioid addiction.

Effective: 1/31/2015
Five Year Review (FYR) Dates: 10/20/2014 and 01/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 47431.22
Prior Effective Dates: 11/17/86, 10/31/98, 9/1/00

4731-11-02 General provisions.

(A) A physician shall not utilize a controlled substance other than in accordance with all of the provisions of this chapter of the Administrative Code.

(B) A physician shall not utilize a controlled substance without taking into account the drug's potential for abuse, the possibility the drug may lead to dependence, the possibility the patient will obtain the drug for a nontherapeutic use or to distribute to others, and the possibility of an illicit market for the drug.

(C) A physician shall complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients. Patient medical records shall accurately reflect the utilization of any controlled substances in the treatment of a patient and shall indicate the diagnosis and purpose for which the controlled substance is utilized, and any additional information upon which the diagnosis is based.

(D) A physician shall obey all applicable provisions of sections 3719.06, 3719.07, 3719.08 and 3719.13 of the Revised Code, and all applicable provisions of federal law governing the possession, distribution, or use of controlled substances.

(E) Violations of this rule:

(1) A violation of any provision of this rule, as determined by the board, shall constitute any or all of the following: "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; and "a departure from, or the failure to conform to, minimal standards of care of similar physicians 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) A violation of paragraph (C) of this rule shall further constitute "selling, prescribing, giving away, 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.

Replaces: 4731-11-02

Effective: 12/31/2015
Five Year Review (FYR) Dates: 12/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 11/17/86;9/1/00; 9/30/08

4731-11-03 Utilization of anabolic steroids, schedule II controlled substance cocaine hydrochloride, and schedule II controlled substance stimulants.

(A) A physician shall not:

(1) Utilize anabolic steroids, growth hormones, testosterone or its analogs, human chorionic gonadotropin ("HCG"), or other hormones for the purpose of enhancing athletic ability.

(2) Utilize the schedule II controlled substance cocaine hydrochloride for a purpose other than one of the following:

(a) As a topical anesthetic in situations in which it is properly indicated; or

(b) For in-office diagnostic testing for pupillary disorders.

(3) Utilize a schedule II controlled substance stimulant in any of the following circumstances:

(a) For purposes of weight reduction or control;

(b) When the physician knows or has reason to believe that a recognized contra-indication to its use exists; or

(c) In the treatment of a patient who the physician knows or should know is pregnant, except if the following criteria are met:

(i) After the physician's medical assessment the physician and patient determine that the benefits of treating the patient with a schedule II controlled substance stimulant outweigh the risks, and

(ii) The basis for the determination is documented in the patient record.

(B) Utilizing a schedule II controlled subtance stimulant:

(1) Before initiating treatment utilizing a schedule II controlled substance stimulant, the physician shall perform all of the following:

(a) Obtain a thorough history;

(b) Perform an appropriate physical examination of the patient; and

(c) Rule out the existence of any recognized contra-indications to the use of the controlled subtance stimulant to be utilized.

(2) A physician may utilize a schedule II controlled substance stimulant only for one of the following purposes:

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

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

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

(d) The differential diagnostic psychiatric evaluation of depression;

(e) The treatment of depression shown to be refractory to other therapeutic modalities, including pharmacologic approaches, such as antidepressants;

(f) As adjunctive therapy in the treatment of the following:

(i) Chronic severe pain;

(ii) Closed head injuries;

(iii) Cancer-related fatigue;

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

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

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

(g) The treatment of binge eating disorder.

(3) 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 perform both of the following;

(a) 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; and

(b) Actively monitor such patient for signs and symptoms of drug abuse and drug dependency.

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

(1) "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;

(2) "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;

(3) "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.

Replaces: 4731-11-02, 4731-11-03, 4731-11-05

Effective: 12/31/2015
Five Year Review (FYR) Dates: 12/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 11/17/86; 10/31/98; 9/1/00, 4/30/2009

4731-11-04 Controlled substances: Utilization of short term anorexiants for weight reduction.

(A) A physician shall utilize a schedule III or IV controlled substance short term anorexiant for purposes of weight reduction only if it has an F.D.A. approved indication for this purpose and then only in accordance with all of the provisions of this rule.

(B) Before initiating treatment for weight reduction utilizing any schedule III or IV controlled substance short term anorexiant, the physician shall complete all of the following requirements:

(1) The physician shall review the physician's own records of prior treatment or review the records of prior treatment by another treating physician, dietician, or weight-loss program to determine the patient's past efforts to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, intensive behavioral therapy, and exercise, without the utilization of controlled substances, and that the treatment has been ineffective.

(2) The physician shall complete and document the findings of all of the following:

(a) Obtain a thorough history;

(b) Perform an appropriate physical examination of the patient;

(c) Determine the patient's BMI;

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

(e) Assess and document the patient's freedom from signs of drug or alcohol abuse, and the presence or absence of contraindications and adverse side effects.

(f) Access OARRS for the patient's prescription history during the preceding twelve month period and document in the patient's record the receipt and assessment of the report received; and

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

(3) The physician shall not initiate treatment utilizing a controlled substance short term 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 related 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;

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

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

(e) The review of the physician's own records of prior treatment or review of records of prior treatment provided by another physician, dietician, or weight-loss program indicate that the patient made less than a substantial good faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, intensive behavioral therapy, and exercise without the utilization of controlled substances.

(C) A physician may utilize a schedule III or IV controlled substance short term anorexiant, that bears appropriate F.D.A. approved labeling for weight loss, in the treatment of obesity as an adjunct, in a regimen of weight reduction based on caloric restriction, provided that:

(1) The physician shall personally meet face-to-face with the patient, at a minimum, every thirty days when controlled substances are being utilized for weight reduction, and shall record in the patient record information demonstrating the patient's continuing efforts to lose weight, the patient's dedication to the treatment program and response to treatment, and the presence or absence of contraindications, adverse effects, and indicators of possible substance abuse that would necessitate cessation of treatment utilizing controlled substances.

(2) The controlled substance short term anorexiant is prescribed strictly in accordance with the F.D.A. approved labeling. If the F.D.A. approved labeling of the controlled substance short term anorexiant being utilized for weight loss states that it is indicated for use for "a few weeks," the total course of treatment using that controlled substance shall not exceed twelve weeks. That time period includes any interruption in treatment that may be permitted under paragraph (C)(3) of this rule.

(3) A physician shall not initiate a course of treatment utilizing a controlled substance short term anorexiant for purposes of weight reduction if the patient has received any controlled substance for purposes of weight reduction within the past six months. However, the physician may resume utilizing a controlled substance short term anorexiant following an interruption of treatment of more than seven days if the interruption resulted from one or more of the following:

(a) Illness of or injury to the patient justifying a temporary cessation of treatment; or

(b) Unavailability of the physician; or

(c) Unavailability of the patient, if the patient has notified the physician of the cause of the patient's unavailability.

(4) After initiating treatment, the physician may elect to switch to a different controlled substance short term anorexiant for weight loss based on sound medical judgment, but the total course of treatment for any short term anorexiant combination of controlled substances each of which is indicated for "a few weeks" shall not exceed twelve weeks.

(5) The physician shall not initiate or shall discontinue utilizing all controlled substance short term anorexiants for purposes of weight reduction immediately upon ascertaining or having reason to believe:

(a) That 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 relating to the patient's use of drugs or alcohol;

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

(c) That the patient has failed to lose weight while under treatment with a controlled substance or controlled substances over a period of thirty days during the current course of treatment, which determination shall be made by weighing the patient at least every thirtieth day, except that a patient who has never before received treatment for obesity utilizing any controlled substance who fails to lose weight during the first thirty days of the first such treatment attempt may be treated for an additional thirty days;

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

(e) That the physician knows or should know the patient is pregnant.

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

(1) "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;

(2) "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

(3) "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.

Replaces: 4731-11-04

Effective: 2/29/2016
Five Year Review (FYR) Dates: 02/28/2021
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 11/17/86; 10/31/98; 6/30/00

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

4731-11-05 [Rescinded].

Effective: 12/31/2015
Five Year Review (FYR) Dates: 07/01/2015
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 2/1/88, 9/1/00

4731-11-06 Waivers for new uses. [Rescinded].

Rescinded eff 9-30-08

4731-11-07 Research utilizing controlled substances.

The provisions of this chapter of the Administrative Code shall not apply to or in any way prohibit research conducted under the auspices of an accredited medical school, or research which meets both of the following conditions:

(A) The U.S. food and drug administration has approved an investigational new drug ("IND") application for the research or has notified the researchers that the proposed study is exempt from the "IND" regulations; and

(B) The research is conducted in conformance with the approval granted by either of the following:

(1) An institutional review board of a hospital or medical center accredited by the "Joint Commission," "Healthcare Facilities Accreditation Program" or other accrediting body approved by the board; or

(2) An institutional review board accredited by the association for the accreditation of human research protection programs.

Replaces: 4731-11-07

Effective: 9/30/2015
Five Year Review (FYR) Dates: 09/30/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 12/1/94

4731-11-08 Utilizing controlled substances for self and family members.

(A) Accepted and prevailing standards of care presuppose a professional relationship between a patient and physician when the physician is utilizing controlled substances. By definition, a physician may never have such a relationship with himself or herself. Thus, a physician may not self-prescribe or self-administer controlled substances. This paragraph does not prohibit a physician from obtaining a schedule V controlled substance for personal use in conformance with state and federal laws, in the same manner that a non-physician may obtain a schedule V controlled substance.

(B) Accepted and prevailing standards of care require that a physician maintain detached professional judgment when utilizing controlled substances in the treatment of family members. A physician shall utilize controlled substances when treating a family member only in an emergency situation which shall be documented in the patient's record.

(C) For purposes of this rule, "family member" means a spouse, parent, child, sibling or other individual in relation to whom a physician's personal or emotional involvement may render that physician unable to exercise detached professional judgment in reaching diagnostic or therapeutic decisions.

Effective: 09/30/2008
R.C. 119.032 review dates: 06/06/2008 and 09/30/2013
Promulgated Under: 119.03
Statutory Authority: 4731.05, 4731.052
Rule Amplifies: 4731.22, 4731.052
Prior Effective Dates: 11/11/98; 3/15/01

4731-11-09 Prescribing to persons not seen by the physician.

(A) Except in institutional settings, on call situations, cross coverage situations, situations involving new patients, protocol situations, situations involving nurses practicing in accordance with standard care arrangements, and hospice settings, as described in paragraphs (D) and (E) of this rule, a physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any controlled substance to a person who the physician has never personally physically examined and diagnosed.

(B) Except in institutional settings, on call situations, cross coverage situations, situations involving new patients, protocol situations, situations involving nurses practicing in accordance with standard care arrangements, and hospice settings, as described in paragraphs (D) and (E) of this rule, a physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any dangerous drug which is not a controlled substance to a person who the physician has never personally physically examined and diagnosed, except in accordance with one of the following requirements:

(1) The physician is providing care in compliance with both of the following:

(a) The care provided is in consultation with another physician who:

(i) Has an ongoing professional relationship with the patient; and

(ii) Has agreed to supervise the patient's use of the drug or drugs to be provided.

(b) The care provided meets all applicable standards of care and all applicable statutory and regulatory requirements.

(2) The psychiatrist is providing telepsychiatry to one patient per session who is located at the Ohio office of an Ohio licensed physician or a community mental health clinic certified by the Ohio department of mental health, and all of the following requirements are met:

(a) The psychiatrist has reviewed records from a physical examination of the patient that was conducted by a physician licensed under Chapter 4731. of the Revised Code within a reasonable period of time prior to the telepsychiatry visit;

(b) A licensed healthcare professional is available during the telepsychiatry visit to provide various physical findings in accordance with the licensed healthcare professional's scope of practice that the psychiatrist may need to complete an adequate assessment;

(c) The psychiatrist agrees to do both of the following:

(i) Be available to consult with another physician who has an ongoing professional relationship with the patient; and

(ii) Supervise the patient's use of the drug or drugs prvided;

(d) The psychiatrist's care of the patient meets all applicable standards of care and all applicable statutory and regulatory requirements.

(C) A physician shall not advertise or offer, or permit the physician's name or certificate to be used in an advertisement or offer, to provide any dangerous drug in a manner that would violate paragraph (A) or paragraph (B) of this rule.

(D) Paragraphs (A) and (B) of this rule do not apply to or prohibit the provision of drugs to a person who is admitted as an inpatient to or is a resident of an institutional facility. For purposes of this rule, "institutional facility" has the same meaning as in rule 4729-17-01 of the Administrative Code. This paragraph does not authorize or legitimize practices that would violate other applicable standards or legal requirements.

(E) Paragraphs (A) and (B) of this rule do not apply to or prohibit:

(1) The provision of controlled substances or dangerous drugs by a physician to a person who is a patient of a colleague of the physician, if the drugs are provided pursuant to an on call or cross coverage arrangement between the physicians;

(2) The provision of controlled substances or dangerous drugs by a physician to a person who the physician has accepted as a patient, if the physician has scheduled or is in the process of scheduling an appointment to examine the patient and the drugs are intended to be used pending that appointment;

(3) The provision of controlled substances or dangerous drugs by emergency medical squad personnel, nurses, or other appropriately trained and licensed individuals, in accordance with protocols approved by the state board of pharmacy pursuant to rule 4729-5-01 of the Administrative Code; or

(4) The provision of controlled substances or dangerous drugs by a nurse practicing in accordance with a standard care arrangement that meets the requirements of Chapter 4723. of the Revised Code and rules promulgated by the board of nursing pursuant thereto.

(5) The provision of controlled substances or dangerous drugs by a physician who is a medical director or hospice physician of a hospice program licensed pursuant to Chapter 3712. of the Revised Code, to a patient who is enrolled in that hospice program.

This paragragh does not authorize or legitimize practices that would violate other applicable standards or legal requirements.

(F) For purposes of this rule, "controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(G) For purposes of this rule, "dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(H) 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, prescribing, giving away, 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.

(I) For purposes of this rule:

(1) "Licensed healthcare professional" means any of the following:

(a) An individual licensed under Chapter 4731. of the Revised Code to practice allopathic medicine and surgery or osteopathic medicine and surgery;

(b) A physician assistant licensed under Chapter 4730. of the Revised Code who is practicing in compliance with all applicable statutory and rule requirements; and

(c) A nurse licensed under Chapter 4723. of the Revised Code who is practicing in compliance with all applicable statutory and rule requirements.

(2) "Psychiatrist" means an individual licensed under Chapter 4731. of the Revised Code to practice allopathic medicine and surgery or osteopathic medicine and surgery who has successfully completed an approved psychiatry training program, as specified in the accreditation requirements that must be met to qualify as graduate medical education under section 4731.091 of the Revised Code.

(3) "Telepsychiatry" means the provision of psychiatric care via real-time, adequate resolution audio and video telecommunications when all of the following requirements are met:

(a) Videoconferencing picture resolution, at a minimum, shall have a data rate of 30 frames per second (fps), with each frame containing 288 lines and 352 pixels per line.

(b) Systems shall have a minimum of 384 kilobytes per second (Kbps) of bandwidth, and the provider site shall have the capacity to zoom and to follow the patient at the remote site.

Effective: 11/30/2010
R.C. 119.032 review dates: 08/31/2001
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 10/1/99, 8/31/06

4731-11-11 Standards and procedures for review of "Ohio Automated Rx Reporting System" (OARRS).

(A) For purposes of this rule:

(1) :"Delegate" means an authorized representative who is registered with the Ohio board of pharmacy to obtain an OARRS report on behalf of a physician;

(2) "OARRS" means the "Ohio Automated Rx Reporting System" drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(3) "OARRS report" means a report of information related to a specified patient generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(4) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.

(5) "Reported drugs" means all the drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to section 4729.75 of the Revised Code, including controlled substances in schedules II, III, IV, and V.

(B) Standards of care:

(1) The accepted and prevailing minimal standards of care require that when prescribing or personally furnishing a reported drug, a physician shall take into account all of the following:

(a) The potential for abuse of the reported drug;

(b) The possibility that use of the reported drug may lead to dependence;

(c) The possibility the patient will obtain the reported drug for a nontherapeutic use or distribute it to other persons; and

(d) The potential existence of an illicit market for the reported drug.

(2) In considering whether a prescription for or the personally furnishing of a reported drug is appropriate for the patient, the physician shall use sound clinical judgment and obtain and review an OARRS report consistent with the provisions of this rule.

(C) A physician shall obtain and review an OARRS report to help determine if it is appropriate to prescribe or personally furnish an opioid analgesic, benzodiazepine, or reported drug to a patient as provided in this paragraph and paragraph (F) of this rule:

(1) A physician shall obtain and review an OARRS report before prescribing or personally furnishing an opiate analgesic or benzodiazepine to a patient, unless an exception listed in paragraph (G) of this rule is applicable.

(2) A physician shall obtain and review an OARRS report when a patient's course of treatment with a reported drug other than an opioid analgesic or benzodiazepine has lasted more than ninety days, unless an exception listed in paragraph (G) of this rule is applicable.

(3) A physician shall obtain and review an OARRS report when any of the following red flags pertain to the patient:

(a) Selling prescription drugs;

(b) Forging or altering a prescription;

(c) Stealing or borrowing reported drugs;

(d) Increasing the dosage of reported drugs in amounts that exceed the prescribed amount;

(e) Suffering an overdose, intentional or unintentional;

(f) Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;

(g) Having been arrested, convicted, or received diversion or intervention in lieu of conviction for a drug related offense while under the physician's care;

(h) Receiving reported drugs from multiple prescribers, without clinical basis;

(i) Traveling with a group of other patients to the physician's office where all or most of the patients request controlled substance prescriptions;

(j) Traveling an extended distance or from out of state to the physician's office;

(k) Having a family member, friend, law enforcement officer, or health care professional express concern related to the patient's use of illegal or reported drugs;

(l) A known history of chemical abuse or dependency;

(m) Appearing impaired or overly sedated during an office visit or exam;

(n) Requesting reported drugs by street name, color, or identifying marks;

(o) Frequently requesting early refills of reported drugs;

(p) Frequently losing prescriptions for reported drugs;

(q) A history of illegal drug use;

(r) Sharing reported drugs with another person; or

(s) Recurring visits to non-coordinated sites of care, such as emergency departments, urgent care facilities, or walk-in clinics to obtain reported drugs.

(D) A physician who decides to utilize an opioid analgesic, benzodiazepine, or other reported drug in any of the circumstances within paragraphs (C)(2) and (C)(3) of this rule, shall take the following steps prior to issuing a prescription for or personally furnishing the opioid analgesic, benzodiazepine, or other reported drug:

(1) Review and document in the patient record the reasons why the physician believes or has reason to believe that the patient may be abusing or diverting drugs;

(2) Review and document in the patient's record the patient's progress toward treatment objectives over the course of treatment;

(3) Review and document in the patient record the functional status of the patient, including activities for daily living, adverse effects, analgesia, and aberrant behavior over the course of treatment;

(4) Consider using a patient treatment agreement including more frequent and periodic reviews of OARRS reports and that may also include more frequent office visits, different treatment options, drug screens, use of one pharmacy, use of one provider for the prescription or personally furnishing of reported drugs, and consequences for non-compliance with the terms of the agreement. The patient treatment agreement shall be maintained as part of the patient record; and

(5) Consider consulting with or referring the patient to a substance abuse specialist.

(E) Frequency for follow-up OARRS reports:

(1) For a patient whose treatment with an opioid analgesic or benzodiazepine lasts more than ninety days, a physician shall obtain and review and OARRS report for the patient at least every ninety days during the course of treatment, unless an exception listed in paragraph (G) of this rule is applicable.

(2) For a patient who is treated with a reported drug other than an opioid analgesic or benzodiazepine for a period lasting more than ninety days, the physician shall obtain and review and OARRS report for the patient at least annually following the initial OARRS report obtained and reviewed pursuant to paragraph (C)(2) of this rule until the course of treatment utilizing the reported drug has ended, unless an exception in paragraph (G) of this rule is applicable.

(F) When a physician or their delegate requests an OARRS report in compliance with this rule, a physician shall document receipt and review of the OARRS report in the patient record, as follows:

(1) Initial reports requested shall cover at least the twelve months immediately preceding the date of the request:

(2) Subsequent reports requested shall, at a minimum, cover the period from the date of the last report to present;

(3) If the physician practices primarily in a county of this state that adjoins another state, the physician or their delegate shall also request a report of any information available in the drug database that pertains to prescriptions issued or drugs furnished to the patient in the state adjoining that county; and

(4) If an OARRS report regarding the patient is not available, the physician shall document in the patient's record the reason that the report is not available and any efforts made in follow-up to obtain the requested information.

(G) A physician shall not be required to review and assess an OARRS report when prescribing or personally furnishing an opioid analgesic, benzodiazepine, or other reported drug under the following circumstances, unless a physician believes or has reason to believe that a patient may be abusing or diverting reported drugs:

(1) The reported drug is prescribed or personally furnished to a hospice patient in a hospice care program as those terms are defined in section 3712.01 of the Revised Code, or any other patient diagnosed as terminally ill;

(2) The reported drug is prescribed for administration in a hospital, nursing home, or residential care facility;

(3) The reported drug is prescribed or personally furnished in an amount indicated for a period not to exceed seven days;

(4) The reported drug is prescribed or personally furnished for the treatment of cancer or another condition associated with cancer; and

(5) The reported drug is prescribed or personally furnished to treat acute pain resulting from a surgical or other invasive procedure or a delivery.

Replaces: 4731-11-11

Effective: 12/31/2015
Five Year Review (FYR) Dates: 12/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05, 4731.055
Rule Amplifies: 4731.055
Prior Effective Dates: 11/30/11

4731-11-12 Office based opioid treatment.

(A) For the purposes of this rule:

(1) "Office Based Opioid Treatment," or "OBOT," means treatment of opioid addiction utilizing a "Schedule III, IV, or V" controlled substance narcotic.

(2) "Board certified addictionologist or addiction psychiatrist" means a medical doctor or doctor of osteopathic medicine and surgery who holds one of the following certifications:

(a) Subspecialty board certification in addiction psychiatry from the American board of psychiatry and neurology;

(b) Board certification in addiction medicine from the American board of addiction medicine;

(c) Certification from the American society of addiction medicine; or

(d) Board certification with additional qualification in addiction medicine from the American osteopathic association.

(B) A physician shall provide OBOT in compliance with all of the provisions of this rule.

(1) The physician shall comply with all federal and state laws applicable to OBOT;

(2) Prior to providing OBOT, the physician shall conduct an assessment meeting the following requirements:

(a) The assessment shall include, at a minimum, an appropriate history and physical, mental status exam, substance use history, appropriate lab tests, pregnancy test for women of childbearing years, toxicology tests for drugs and alcohol, and "hepatitis B" and "hepatitis C" screens.

(b) For other than the toxicology tests for drugs and alcohol, appropriate history, substance abuse history, hepatitis "B" and "C" screens and the pregnancy test, the physician may satisfy the assessment requirements by reviewing records from a physical examination of the patient that was conducted by a physician within a reasonable period of time prior to the visit. For purposes of this paragraph, "physician" means an individual holding a certificate under Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery and practicing within his or her scope of practice as defined by section 4731.51 of the Revised Code, or an individual practicing in another state where the individual holds an active and unrestricted license to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery and practicing within his or her scope of practice.

(3) The physician shall practice in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance and tapering. Acceptable protocols are any of the following:

(a) "Clinical Guidelines For the Use of Buprenorphine in the Treatment of Opioid Addiction" protocol approved by the substance abuse and mental health services administration in 2004, (available from the substance abuse and mental health services administration website at http://samhsa.gov/);

(b) The low dose protocol approved by the Ohio department of alcohol and drug addiction services in or about 2011 (available from the Ohio department of mental health and addiction services website at http://mha.ohio.gov/ ); or

(c) Any protocol for OBOT approved by the Ohio department of mental health and addiction services and available from the Ohio department of mental health and addiction services website at http://mha.ohio.gov.

(4) The physician shall diagnose an opioid disorder utilizing the criteria contained in the diagnostic and statistical manual of mental disorders, 4th or 5th edition.

(5) The physician shall develop an individualized treatment plan for each patient

(6) The physician shall require each patient to actively participate in appropriate behavioral counseling or treatment for their addiction and shall document at each visit that the patient is attending sufficient behavioral health treatment.

(a) The physician shall maintain meaningful interactions with the qualified chemical dependency professional, addiction treatment provider, or other behavioral health professional who is treating the patient.

(b) If the physician is a psychiatrist, board certified addictionologist, or board certified addiction psychiatrist, the physician may personally provide behavioral health treatment for the addiction.

(c) If the physician determines that the patient cannot reasonably be required to obtain professional treatment or if the patient has successfully completed professional treatment, the physician shall require the patient to actively participate in a recovery care program such as alcoholics anonymous, narcotics anonymous, or other appropriate twelve step program, and to document attendance at program meetings.

(i) For at least the first year the physician shall require the patient to attend the meetings at least three times weekly.

(ii) Following the first year, the physician shall determine the frequency with which the patient shall be required to attend the meetings.

(iii) The physician shall document in the patient record the reasons that the patient cannot reasonably be required to obtain professional treatment.

(7) The physician shall provide OBOT utilizing a drug product that has been specifically approved by the United States food and drug administration for use in maintenance and detoxification treatment. A physician shall not provide OBOT utilizing a drug product that has not been specifically approved by the United States food and drug administration for use in maintenance and detoxification treatment.

(8) The physician shall comply with all of the following:

(a) During the first twelve months of treatment, the physician shall not prescribe, personally furnish, or administer more than a thirty day supply of OBOT medications at one time.

(b) The physician shall personally meet with and evaluate the patient at each visit during the first twelve months of OBOT, and shall document an assessment and plan for continuing treatment.

(c) After twelve months of OBOT, the physician shall personally meet with and evaluate the patient at least every three months, unless more frequent meetings are indicated.

(9) The physician shall not provide OBOT to a patient whom the physician knows or should know is receiving other controlled substances for more than twelve consecutive weeks on an outpatient basis from any provider, without having consulted with a board certified addictionologist or addiction psychiatrist, who has recommended the patient receive OBOT. If the physician is a board certified addictionologist or addiction psychiatrist, the consultation is not required.

(10) The physician shall not prescribe, personally furnish, or administer greater than 16 milligrams of buprenorphine per day to a patient, except in one of the following situations:

(a) The dosage greater than 16 milligrams was established before the effective date of this rule;

(b) The physician is a board certified addictionologist or addiction psychiatrist and has determined that a dosage greater than 16 milligrams is required for the patient, and has documented patientspecific reasons for the need for a dosage greater than 16 milligrams in the patient's record; or

(c) The physician has consulted with a board certified addictionologist or addiction psychiatrist who has recommended a dosage greater than 16 milligrams and that fact is documented in the patient's medical record.

(11) The physician shall access OARRS for each patient no less frequently than every ninety days, and shall document receipt and assessment of the information received.

(12) ) The physician shall provide ongoing toxicological testing in compliance with all of the following:

(a) The physician shall assure that any inoffice kit used is "Clinical Laboratory Improvement Amendments" waived.

(b) The physician shall require toxicological testing be performed at least monthly for the first six months, then randomly at least once every three months thereafter.

(c) The physician may accept the results of toxicological testing performed by a treatment program or pursuant to a court order to satisfy the requirements of paragraph (B)(12)(b) of this rule.

(d) A screen is failed if the result is inconsistent with the treatment plan. A physician shall address failed screens in a clinically appropriate manner.

(13) Each physician who provides OBOT shall complete at least eight hours of "Category I" continuing medical education relating to substance abuse and addiction every two years. Courses completed in compliance with this rule shall be accepted toward meeting the physician's "Category I" continuing medical education requirement for biennial renewal of the physician's certificate.

(C) Notwithstanding the provisions of this rule, a physician may provide OBOT to a pregnant patient during the term of her pregnancy and for two months thereafter, in compliance with the minimal standards of care.

(D) A violation of any provision of this rule, as determined by the board, shall constitute any or all of the following violations:

(1) "Failure to maintain minimal standards applicable to the selection or administration of drugs," and "failure to employ acceptable scientific methods in the selection of drugs or other modalities for treatment of disease," as those clauses are used in division (B)(2) of section 4731.22 of the Revised Code, and " a departure from, or the failure to conform to, minimal standards of care of similar physicians 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) A violation of paragraph (B)(7) of this rule shall further constitute "selling, prescribing, giving away, 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.

Effective: 1/31/2015
Five Year Review (FYR) Dates: 01/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22