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) "Cross-coverage" means an agreement between an Ohio-licensed physician and another Ohio licensed physician or healthcare provider acting within the scope of their professional license under which the physician provides medical services for an active patient, as that term is defined in paragraph (D) of rule this rule, of the other physician or healthcare provider who is temporarily unavailable to conduct the evaluation of the patient.

(1) This type of agreement includes on-call coverage for after hours and weekends.

(2) The medical evaluation required by paragraph (C) of rule 4731-11-09 of the Administrative Code may be a limited evaluation conducted through interaction with the patient.

(D) For purposes of paragraph (D) of rule 4731-11-09 of the Administrative Code, "active patient" as that term is used in paragraph (C) of this rule, means that within the previous twenty-four months the physician or other healthcare provider acting within the scope of their professional license conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine as that term is defined in 21 C.F.R. 1300.04, in effect as of the effective date of this rule.

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

(F) "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.

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

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

(I) "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.

(J) "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;

(4) Subspecialty certification in addiction medicine from the American board of preventive medicine; or

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

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

(L) "Acute pain" means pain that normally fades with healing, is related to tissue damage, significantly alters a patient's typical function and is expected to be time limited.

(M) "Minor" has the same meaning as in section 3719.061 of the Revised Code.

(N) "Morphine equivalent daily dose (MED)" means a conversion of various opioid analgesics to a morphine equivalent dose by the use of accepted conversion tables provided by the state of Ohio board of pharmacy at: http://www.ohiopmp.gov/ (effective 2017).

(O) "Extended-release or long-acting opioid analgesic" means an opioid analgesic that:

(1) Has United States food and drug administration approved labeling indicating that it is an extended-release or controlled release formulation;

(2) Is administered via a transdermal route; or

(3) Contains methadone.

(P) "Opioid analgesic" has the same meaning as in section 3719.01 of the Revised Code and means a controlled substance that has analgesic pharmacologic activity at the opioid receptors of the central nervous system, including but not limited to the following drugs and their varying salt forms or chemical congeners: buprenorphine, butorphanol, codeine (including acetaminophen and other combination products), dihydrocodeine, fentanyl, hydrocodone (including acetaminophen combination products), hydromorphone, meperidine, methadone, morphine sulfate, oxycodone (including acetaminophen, aspirin, and other combination products), oxymorphone, tapentadol, and tramadol.

(Q) "Hospice care program" has the same meaning as in section 3712.01 of the Revised Code.

(R) "Palliative care" has the same meaning as in section 3712.01 of the Revised Code.

(S) "Terminal condition" has the same meaning as in section 2133.01 of the Revised Code.

Cite as Ohio Admin. Code 4731-11-01

Effective: 8/31/2017
Five Year Review (FYR) Dates: 1/31/2020
Promulgated Under: 119.03
Statutory Authority: 4731.05, 3719.062
Rule Amplifies: 3719.062 , 4731.74, 4731.22
Prior Effective Dates: 11/17/86, 10/31/98, 9/1/00, 1/31/15, 3/23/17

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 the rules promulgated thereunder, rules 4729-5-30 and 4729-5-13 of the Administrative 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.

Cite as Ohio Admin. Code 4731-11-02

Effective: 8/31/2017
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, 12/31/15

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

Cite as Ohio Admin. Code 4731-11-03

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

Cite as Ohio Admin. Code 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.

Cite as Ohio Admin. Code 4731-11-04.1

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].

Cite as Ohio Admin. Code 4731-11-05

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

Cite as Ohio Admin. Code 4731-11-06

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

Cite as Ohio Admin. Code 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.

Cite as Ohio Admin. Code 4731-11-08

Five Year Review (FYR) Dates: 08/17/2016 and 08/17/2021
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22
Prior Effective Dates: 11/11/98, 3/15/01, 9/30/08

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

(A) Except as provided in paragraph (D) of this rule, a physician shall not prescribe, personally furnish, otherwise provide, or cause to be provided, any controlled substance to a person on whom the physician has never conducted a physical examination.

(B) Except as provided in paragraph (C) of this rule, a physician shall not prescribe, personally furnish, otherwise provide, or cause to be provided, any prescription drug that is not a controlled substance to a person on whom the physician has never conducted a physical examination.

(C) A physician may prescribe, personally furnish, otherwise provide, or cause to be provided a prescription drug that is not a controlled substance to a person on whom the physician has never conducted a physical examination and who is at a location remote from the physician by complying with all of the following requirements:

(1) The physician shall establish the patient's identity and physical location;

(2) The physician shall obtain the patient's informed consent for treatment through a remote examination;

(3) The physician shall request the patient's consent and, if granted, forward the medical record to the patient's primary care provider or other health care provider, if applicable, or refer the patient to an appropriate health care provider or health care facility;

(4) The physician shall, through interaction with the patient, complete a medical evaluation that is appropriate for the patient and the condition with which the patient presents and that meets the minimal standards of care, which may include portions of the evaluation having been conducted by other Ohio licensed healthcare providers acting within the scope of their professional license;

(5) The physician shall establish or confirm, as applicable, a diagnosis and treatment plan, which includes documenation of the necessity for the utilization of a prescription drug. The diagnosis and treatment plan shall include the identification of any underlying conditions or contraindications to the recommended treatment;

(6) The physician shall document in the patient's medical record the patient's consent to treatment through a remote evaluation, pertinent history, evaluation, diagnosis, treatment plan, underlying conditions, any contraindications, and any referrals to appropriate health care providers, including primary care providers or health care facilities;

(7) The physician shall provide appropriate follow-up care or recommend follow-up care with the patient's primary care provider, other appropriate health care provider, or health care facility in accordance with the minimal standards of care;

(8) The physician shall make the medical record of the visit available to the patient;

(9) The physician shall use appropriate technology that is sufficient for the physician to conduct all steps in this paragraph as if the medical evaluation occurred in an in-person visit.

(D) A physician may prescribe, personally furnish, otherwise provide, or cause to be provided a prescription drug that is a controlled substance to a person on whom the physician has not conducted a physical examination and who is at a location remote from the physician in any of the following situations:

(1) The person is an active patient, as that term is defined in paragraph (D) of rule 4731-11-01 of the Administrative Code, of an Ohio licensed physician or other health care provider who is a colleague of the physician and the drugs are provided pursuant to an on call or cross coverage arrangement between them and the physician complies with all steps of paragraph (C) of this rule;

(2) The patient is physically located in a hospital or clinic registered with the United States drug enforcement administration to personally furnish or provide controlled substances, when the patient is being treated by an Ohio licensed physician or other healthcare provider acting in the usual course of their practice and within the scope of their professional license and who is registered with the United States drug enforcement administration to prescribe or otherwise provide controlled substances in Ohio.

(3) The patient is being treated by, and in the physical presence of, an Ohio licensed physician or healthcare provider acting in the usual course of their practice and within the scope of their professional license, and who is registered with the United States drug enforcement administration to prescribe or otherwise provide controlled substances in Ohio.

(4) The physician has obtained from the administrator of the United States drug enforcement administration a special registration to prescribe or otherwise provide controlled substances in Ohio.

(5) The physician is the medical director, hospice physician, or attending physician for a hospice program licensed pursuant to Chapter 3712. of the Revised Code and both of the following conditions are met:

(a) The controlled substance is being provided to a patient who is enrolled in that hospice program, and

(b) The prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.

(6) The physician is the medical director of, or attending physician at, an institutional facility, as that term is defined in rule 4729-17-01 of the Administrative Code, and both of the following conditions are met:

(a) The controlled substance is being provided to a person who has been admitted as an inpatient to or is a resident of an institutional facilty, and

(b) The prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.

(E) Nothing in this rule shall be construed to imply that one in-person physician examination demonstrates that a prescription has been issued for a legitimate medical purpose within the course of professional practice.

(F) 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, 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; or

(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.

(G) For purposes of this rule, "informed consent" means a process of communication between a patient and physician discussing the risks and benefits of, and alternatives to, treatment through a remote evaluation that results in the patient's agreement or signed authorization to be treated through an evaluation conducted through appropriate technology when the physician is in a location remote from the patient.

(H) This rule shall not apply to any prescribing situations specifically authorized by the Revised Code or Administrative Code.

(I) For purposes of this rule, "patient" means a person for whom the physician provides healthcare services or the person's representative.

Replaces: 4731-11-09

Cite as Ohio Admin. Code 4731-11-09

Effective: 3/23/2017
Five Year Review (FYR) Dates: 03/23/2022
Promulgated Under: 119.03
Statutory Authority: 4731.05 ; 4731.74
Rule Amplifies: 4731.22 ; 4731.74
Prior Effective Dates: 10/1/99; 8/31/06; 11/30/10

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

Cite as Ohio Admin. Code 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.

Cite as Ohio Admin. Code 4731-11-12

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

4731-11-13 Prescribing of opiate analgesics for acute pain.

(A) For the treatment of acute pain, the physician shall comply with the following:

(1) Extended-release or long-acting opioid analgesics shall not be prescribed for treatment of acute pain;

(2) Before prescribing an opioid analgesic, the physician shall first consider non- opioid treatment options. If opioid analgesic medications are required as determined by a history and physical examination, the physician shall prescribe for the minimum quantity and potency needed to treat the expected duration of pain, with a presumption that a three-day supply or less is frequently sufficient and that limiting the duration of opioid use to the necessary period will decrease the likelihood of subsequent chronic use or dependence;

(3) In all circumstances where opioid analgesics are prescribed for acute pain:

(a) Except as provided in paragraph (B) of this rule, the duration of the first opioid analgesic prescription for the treatment of an episode of acute pain shall be:

(i) For adults, not more than a seven-day supply with no refills;

(ii) For minors, not more than a five-day supply with no refills. A physician shall comply with section 3719.061 of the Revised Code, including but not limited to obtaining from the parent, guardian, or another adult who is authorized to consent to the minor's medical treatment written consent prior to prescribing an opioid analgesic to a minor;

(iii) The seven-day limit for adults and five-day limit for minors may be exceeded for pain that is expected to persist for longer than seven days based on the pathology causing the pain. In this circumstance, the reason that the limits are being exceeded and the reason that a non-opioid medication was not appropriate to treat the patient's conditions shall be documented in the patient's medical record. The number of days of the prescription shall not exceed the amount required to treat the expected duration of the pain as noted in paragraph (A) (2) of this rule; and

(iv) If a patient is allergic to or otherwise unable to tolerate the initially prescribed opioid medication, a prescription for a different, appropriate opioid may be issued at any time during the initial seven or five-day dosing period and shall be subject to all other provisions of this rule. The allergy and/or intolerance shall be documented in the patient's medical record. The patient or the minor patient's parent, guardian or another adult who is authorized to consent to the minor's medical treatment must be provided education of the safe disposal of the unused medication.

(b) The patient, or a minor's parent or guardian, shall be advised of the benefits and risks of the opioid analgesic, including the potential for addiction, and the advice shall be documented in the patient's medical record; and

(c) The total morphine equivalent dose (MED) of a prescription for opioid analgesics for treatment of acute pain shall not exceed an average of thirty MED per day, except when all of the following apply:

(i) The patient suffers from medical conditions, surgical outcomes or injuries of such severity that pain cannot be managed within the thirty MED average limit as determined by the treating physician based upon prevailing standards of medical care, such as:

(a) Traumatic crushing of tissue;

(b) Amputation;

(c) Major orthopedic surgery;

(d) Severe burns

(ii) The physician determines that exceeding the thirty MED average limit is necessary based on the physician's clinical judgment and the patient's needs.

(iii) The physician shall document in the patient's medical record the reason for exceeding the thirty MED average and the reason it is the lowest dose consistent with the patient's medical condition.

(iv) Only the prescribing physician for the conditions in paragraph (A)(3) (c)(i) of this rule may exceed the thirty MED average. The prescribing physician shall be held singularly accountable for prescriptions that exceed the thirty MED average.

(v) In circumstances when the thirty MED average is exceeded, the dose shall not exceed the dose required to treat the severity of the pain as noted in paragraph (A) (2) of this rule.

(d) Prescriptions that exceed the five or seven day supply or thirty MED average daily dose are subject to additional review by the state medical board. The dosage, days supplied, and condition for which the opioid analgesic is prescribed will be considered as part of this additional review.

(B) The requirements of paragraph (A) of this rule apply to treatment of acute pain and do not apply when an opioid analgesic is prescribed:

(1) To an individual who is a hospice patient or in a hospice care program;

(2) To an individual receiving palliative care;

(3) To an individual who has been diagnosed with a terminal condition; or

(4) To an individual who has cancer or another condition associated with the individual's cancer or history of cancer.

(C) This rule does not apply to prescriptions for opioid analgesics for the treatment of opioid addiction utilizing a schedule III, IV or V controlled substance narcotic that is approved by the federal drug administration for opioid detoxification or maintenance treatment.

(D) This rule does not apply to inpatient prescriptions as defined in Chapter 4729. of the Revised Code.

Cite as Ohio Admin. Code 4731-11-13

Effective: 8/31/2017
Five Year Review (FYR) Dates: 08/31/2022
Promulgated Under: 119.03
Statutory Authority: 3719.062, 4731.05
Rule Amplifies: 3719.062