Chapter 4731-11 | Controlled Substances

Rule 4731-11-01 | Definitions.

• Effective: October 31, 2020
• Promulgated Under: 119.03

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 and Chapter 4729:9-1 of the Administrative 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 Chapter 4729:9-1 of the Administrative Code, or which is classified as a stimulant in controlled substances schedule II, III, or IV pursuant to Chapter 4729:9-1 of the Administrative 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 (OBOT)" "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 and not more than six weeks in duration.

(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: https://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" means an irreversible, incurable, and untreatable condition caused by disease, illness, or injury from which, to a reasonable degree of medical certainty as determined in accordance with reasonable medical standards by a physician who has examined the patient, both of the following apply:

(1) There can be no recovery.

(2) Death is likely to occur within a relatively short time if life-sustaining treatment is not administered.

(T) "Medication therapy management" has the same meaning as in rule 4729:5-12-01 of the Administrative Code.

(U) "Subacute pain" means pain that has persisted after reasonable medical efforts have been made to relieve it and continues either episodically or continuously for more than six weeks but less than twelve weeks following initial onset of pain. It may be the result of underlying medical disease or condition, injury, medical or surgical treatment, inflammation, or unknown cause.

(V) "Chronic pain" means pain that has persisted after reasonable medical efforts have been made to relieve it and continues either episodically or continuously for twelve or more weeks following initial onset of pain. It may be the result of an underlying medical disease or condition, injury, medical treatment, inflammation, or unknown cause. "Chronic pain" does not include pain associated with a terminal condition or with a progressive disease that, in the normal course of progression, may reasonably be expected to result in a terminal condition.

(W) "Board certification in hospice and palliative care" means either of the following:

(1) Subspecialty certification in hospice and palliative medicine granted by a certification board that is a member of the American board of medical specialties.

(2) Certification of added qualification in hospice and palliative medicine by the American osteopathic association bureau of medical specialties.

(X) "Board certification in hematology" means specialty or subspecialty certification in hematology or a related hematology specialty or subspecialty by a certification board that is a member of the American board of medical specialties or by the American ostepathic association bureau of medical specialties.

(Y) "Board certification in oncology" means specialty or subspecialty certification in oncology or a related oncology specialty or subspecialty by a certification board that is a member of the American board of medical specialties or American osteopathic association bureau of medical specialties.

(Z) "Board certification in pain medicine" means any of the following:

(1) Current subspecialty certification in pain medicine by a member board of the American board of medical specialties, or current certificate of added qualification in pain medicine by the American osteopathic association bureau of osteopathic specialists;

(2) Current board certification by the American board of pain medicine; or

(3) Current board certification by the American board of interventional pain physicians.

Supplemental Information

Authorized By: 4731.052, 4731.05 , 4730.39, 3719.062
Amplifies: 3719.062 , 4731.74, 4731.052, 4730.39
Five Year Review Date: 10/31/2025
Prior Effective Dates: 11/17/1986

Rule 4731-11-02 | General provisions.

• Effective: December 23, 2018
• Promulgated Under: 119.03

(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, all prescription issuance rules adopted under Chapter 4729. 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.

Last updated February 28, 2023 at 12:49 PM

Supplemental Information

Authorized By: 4730.39, 4731.05
Amplifies: 3719.06, 3719.07, 3719.08, 3719.13, 4730.39, 4731.22
Five Year Review Date: 5/27/2026

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

• Effective: February 28, 2023
• Promulgated Under: 119.03

(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 substance 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 and mental status examination of the patient; and

(c) Rule out the existence of any recognized contra-indications to the use of the controlled substance 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 attention deficit hyperactivity disorder and/or related disorders;

(c) The treatment of major or mild neurocognitive disorder due to traumatic brain injury or substance/medication-induced major or mild neurocognitive disorder;

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

(e) As adjunctive therapy in the treatment of chronic pain, as defined in rule 4731-11-01 of the Administrative Code. :

(f) 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.

Last updated February 28, 2023 at 8:47 AM

Supplemental Information

Authorized By: 4731.05
Amplifies: 4731.22
Five Year Review Date: 2/28/2028
Prior Effective Dates: 4/30/2009

Rule 4731-11-04 | Controlled substances for the treatment of obesity.

• Effective: February 28, 2023
• Promulgated Under: 119.03

(A) A prescriber may utilize a schedule III or IV controlled substance for the treatment of obesity 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 obesity utilizing any schedule III or IV controlled substance, the prescriber shall complete all of the following requirements:

(1) The prescriber shall review the prescriber's own records of prior treatment or review the records of prior treatment by another treating physician, prescriber, dietitian, 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 nutritional counseling, intensive behavioral therapy, and exercise, without the utilization of controlled substances, and that the treatment has been ineffective.

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

(a) Obtain a thorough history;

(b) Perform an appropriate 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 prescriber shall not initiate treatment utilizing a controlled substance for the treatment of obesity 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 prescriber 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 prescriber's directions;

(c) The prescriber 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, including type 2 diabetes, cardio vascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, nonalcoholic fatty liver disease, osteoarthritis, insulin resistance, metabolic syndrome, pre-diabetes, or major depression;

(e) The patient has any condition that would contraindicate the use of the controlled substance to be utilized;

(f) The prescriber shall document in the patient's record the rationale for initiation or re-initiation of treatment utilizing a controlled substance for chronic obesity.

(C) A prescriber may utilize a schedule III or IV controlled substance that bears appropriate F.D.A. approved labeling for weight loss, in the treatment of obesity as an adjunct, to a lifestyle intervention, such as caloric restriction, provided that:

(1) The prescriber shall assess the patient, at a minimum, once in the first three months of utilization of controlled substances 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 prescriber may personally furnish controlled substances for weight reduction or chronic weight management. For any controlled substance that is personally furnished, the prescriber shall not exceed a total of two thousand five hundred dosage units in any thirty-day period and shall not in any seventy-two hour period, personally furnish an amount that exceeds the amount necessary for the patient's use in a seventy-two hour period. Dosage unit means any of the following:

(a) A single pill, capsule, ampule, or tablet;

(b) In the case of a liquid solution, one milliliter;

(c) In the case of a cream, lotion or gel, one gram; or

(d) Any other form of administration available as a single unit.

(3) The prescriber shall not personally furnish or prescribe additional controlled substances to treat obesity for a patient who has not achieved a weight loss of at least five per cent of the patient's initial weight, during the initial three months of treatment using controlled substances to treat obesity.

(4) The prescriber may personally furnish or prescribe controlled substances to treat obesity when the prescriber observes and records that the patient significantly benefits from the controlled substances and has no serious adverse effects related to the drug regimen. A patient significantly benefits from the controlled substances when weight is reduced or when weight loss is maintained and any existing co-morbidity is reduced.

(a) The prescriber shall assess the patient at least once every three months and shall obtain the patient's weight, blood pressure, and heart rate. The findings shall be entered in the patient's record.

(b) For the continuation of schedule III or IV controlled substances designated as FDA short term use controlled substances beyond three months, the patient must maintain a five per cent weight reduction. The prescriber shall document the patient's weight loss or maintenance in the record.

(c) The prescriber shall document the patient's progress with the treatment plan.

(d) The prescriber shall access OARRS in accordance with rules 4731-11-11 and 4730-2-10 of the Administrative Code.

(5) The prescriber shall discontinue utilizing all controlled substances for purposes of weight reduction immediately upon ascertaining or having reason to believe:

(a) That the patient has made any false or misleading statement to the prescriber 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 not responded by achieving less than five per cent weight reduction after three months while under treatment with a controlled substance or controlled substances;

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

(e) That the patient demonstrates any signs that the controlled substance is not safe for or well tolerated by the patient; or

(f) That the prescriber 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) 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.

Last updated February 28, 2023 at 8:47 AM

Supplemental Information

Authorized By: 4731.05
Amplifies: 4731.22
Five Year Review Date: 2/28/2028
Prior Effective Dates: 10/31/1998, 6/30/2000, 2/29/2016

Rule 4731-11-07 | Research utilizing controlled substances.

• Effective: September 30, 2015
• Promulgated Under: 119.03

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.

Last updated February 28, 2023 at 12:50 PM

Supplemental Information

Authorized By: 4731.05
Amplifies: 4731.22
Five Year Review Date: 5/27/2026
Prior Effective Dates: 12/1/1994

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

• Effective: September 30, 2008
• Promulgated Under: 119.03

(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.

Last updated February 28, 2023 at 12:50 PM

Supplemental Information

Authorized By: 4731.05, 4731.052
Amplifies: 4731.22, 4731.052
Five Year Review Date: 5/27/2026
Prior Effective Dates: 3/15/2001

Rule 4731-11-09 | Controlled substance and telehealth prescribing.

• Effective: February 28, 2023
• Promulgated Under: 119.03

(A) As used in this rule:

(1) "Hospice care" means the care of a hospice patient as that term is defined in section 3712.01 of the Revised Code.

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

(3) "Medication assisted treatment" and "substance use disorder" have the same meanings as in rule 4731-33-01 of the Administrative Code.

(4) "Mental health condition" means any mental health condition, illness, or disorder as determined by the diagnostic criteria in the "Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision" (DSM-5-TR). This is a well-known and readily available text. It may be found at libraries, bookstores, on the internet at www.appi.org, or at the state medical board's office.

(5) "Emergency situation" means a situation involving an "emergency medical condition" as that term is defined in section 1753.28 of the Revised Code.

(B) A physician, or a physician assistant who holds a valid prescriber number issued by the state medical board and who has been granted physician-delegated prescriptive authority shall comply with the requirements of federal law governing prescription drugs that are controlled substances to prescribe, personally furnish, otherwise provide, or cause to be provided a prescription drug that is a controlled substance to a person.

(C) When the physician, or physician assistant who holds a valid prescriber number issued by the state medical board and who has been granted physician-delegated prescriptive authority prescribes, personally furnishes, otherwise provides, or causes to be provided a prescription drug that is a controlled substance during the provision of telehealth services, the physician or physician assistant shall comply with all requirements in rule 4731-37-01 of the Administrative Code.

(D) The physician, or physician assistant who holds a valid prescriber number issued by the state medical board and who has been granted physician-delegated prescriptive authority shall conduct a physical examination of a new patient as part of an initial in-person visit before prescribing a schedule II controlled substance to the patient except as provided in paragraph (E) of this rule.

(E) As an exception to paragraph (D) of this rule, a physician or physician assistant may prescribe a controlled substance to a new patient as part of the provision of telehealth services for any of the following patient medical conditions and situations:

(1) The medical record of a new patient indicates that the patient is receiving hospice or palliative care;

(2) The patient has a substance use disorder, and the controlled substance is FDA approved for and prescribed for medication assisted treatment or to treat opioid use disorder.

(3) The patient has a mental health condition and the controlled substance prescribed is prescribed to treat that mental health condition;

(4) The physician or physician assistant determines in their clinical judgment that the new patient is in an emergency situation provided that the following occurs:

(a) The physician or physician assistant prescribes only the amount of a schedule II controlled substance to cover the duration of the emergency or an amount not to exceed a three-day supply whichever is shorter;

(b) After the emergency situation ends, the physician or physician assistant conducts the physical examination as part of an initial in-person visit before any further prescribing of a drug that is a schedule II controlled substance; or

(5) The prescribing of a controlled substance through telehealth services is being done under an exception permitted by federal law governing prescription drugs that are controlled substances.

(F) When prescribing a controlled substance through the provision of telehealth services under one of the exceptions in paragraph (E) of this rule, the physician or physician assistant shall document one of the reasons listed in paragraph (E) for the prescribing in the medical record of the new patient in addition to the documentation already required to meet the standard of care in rule 4731-37-01 of the Administrative Code.

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

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

(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; or

(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; or

(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.

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

Last updated February 28, 2023 at 8:47 AM

Supplemental Information

Authorized By: 4743.09, 4731.74, 4731.05
Amplifies: 4731.22, 4731.74, 4731.741, 4743.09, 4730.25, 4730.60.
Five Year Review Date: 2/28/2028
Prior Effective Dates: 3/23/2017

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

• Effective: September 30, 2021
• Promulgated Under: 119.03

(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 4729:8-2-01 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.

Last updated September 30, 2021 at 8:34 AM

Supplemental Information

Authorized By: 4731.05, 4731.055
Amplifies: 4731.055
Five Year Review Date: 9/30/2026
Prior Effective Dates: 11/30/2011, 12/31/2015

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

• Effective: August 31, 2017
• Promulgated Under: 119.03

(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.

Supplemental Information

Authorized By: 3719.062, 4731.05
Amplifies: 3719.062
Five Year Review Date: 8/31/2022

Rule 4731-11-14 | Prescribing for subacute and chronic pain.

• Effective: July 31, 2023
• Promulgated Under: 119.03

(A) Prior to treating, or continuing to treat subacute or chronic pain with an opioid analgesic, the physician shall first consider and document non-medication and non-opioid treatment options.

(1) 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 and improve the patient's ability to function.

(2) The physician shall comply with the requirements of rule 4731-11-02 of the Administrative Code.

(B) Before prescribing an opioid analgesic for subacute or chronic pain, the physician shall complete or update and document in the patient record assessment activities to assure the appropriateness and safety of the medication including:

(1) History and physical examination including review of previous treatment and response to treatment, patient's adherence to medication and non-medication treatment, and screening for substance misuse or substance use disorder;

(2) Laboratory or diagnostic testing or documented review of any available relevant laboratory or diagnostic test results. If evidence of substance misuse or substance use disorder exists, diagnostic testing shall include urine drug screening;

(3) Review the results of an OARRS check in compliance with rule 4731-11-11 of the Administrative Code;

(4) A functional pain assessment which includes the patient's ability to engage in work or other purposeful activities, the pain intensity and its interference with activities of daily living, quality of family life and social activities, and the physical activity of the patient;

(5) A treatment plan based upon the clinical information obtained, to include all of the following components:

(a) Diagnosis;

(b) Objective goals for treatment;

(c) Rationale for the medication choice and dosage; and

(d) Planned duration of treatment and steps for further assessment and follow-up.

(6) Discussion with the patient or guardian regarding:

(a) Benefits and risks of the medication, including potential for addiction and risk of overdose; and

(b) The patient's responsibility to safely store and appropriately dispose of the medication.

(7) The physician shall offer a prescription for an overdose reversal drug to the patient receiving an opioid analgesic prescription under any of the following circumstances:

(a) The patient has a history of prior opioid overdose;

(b) The dosage prescribed exceeds a daily average of eighty MED or at lower doses if the patient is co-prescribed a benzodiazepine, sedative hypnotic drug, carisprodol, tramadol, or gabapentin; or

(c) The patient has a concurrent substance use disorder.

(C) Prior to increasing the opioid dosage to a daily average of fifty MED or greater the physician shall complete and document the following in the patient's medical record:

(1) The physician shall review and update the assessment completed in paragraph (B) of this rule, if needed. The physician may rely on an appropriate assessment completed within a reasonable time if the physician is satisfied that he or she may rely on that information for purposes of meeting the further requirements of this chapter of the Administrative Code;

(2) The physician shall update or formulate a new treatment plan, if needed;

(3) The physician shall obtain from the patient or the patient's guardian written informed consent which includes discussion of all of the following:

(a) Benefits and risks of the medication, including potential for addiction and risk of overdose.

(b) The patient's responsibility to safely store and appropriately dispose of the medication.

(4) Except when the patient was prescribed an average daily dosage that exceeded fifty MED before the effective date of this rule, the physician who is neither a specialist in the area of the body affected by the pain nor a pain management specialist shall document consideration of the following:

(a) Consultation with a specialist in the area of the body affected by the pain;

(b) Consultation with a pain management specialist;

(c) Obtaining a medication therapy management review by a pharmacist; and

(d) Consultation with a specialist in addiction medicine or addiction psychiatry, if aberrant behaviors indicating medication misuse or substance use disorder are noted.

(5) The physician shall consider offering a prescription for an overdose reversal drug to mitigate risk of overdose.

(D) Prior to increasing the opioid dosage to a daily average of eighty MED or greater, the physician shall complete all of the following:

(1) Enter into a written pain treatment agreement with the patient that outlines the physician's and patient's responsibilities during treatment and requires the patient or patient guardian's agreement to all of the following provisions:

(a) Permission for drug screening and release to speak with other practitioners concerning the patient's condition or treatment;

(b) Cooperation with pill counts or other checks designed to assure compliance with the treatment plan and to minimize the risk of misuse or diversion;

(c) The understanding that the patient shall only receive opioid medications from the physician treating the chronic pain unless there is written agreement among all of the prescribers of opioids outlining the responsibilities and boundaries of prescribing for the patient; and

(d) The understanding that the dosage may be tapered if not effective or if the patient does not abide by the treatment agreement.

(2) Offer a prescription for an overdose reversal drug to the patient as described in paragraph (B) of this rule.

(3) Except when the patient was prescribed an average daily dosage that exceeded eighty MED before the effective date of this rule, the physician who is neither a specialist in the area of the body affected by the pain nor a pain management specialist shall obtain at least one of the following based upon the patient's clinical presentation:

(a) Consultation with a specialist in the area of the body affected by the pain;

(b) Consultation with a pain management specialist;

(c) Obtain a medication therapy management review; or

(d) Consultation with a specialist in addiction medicine or addiction psychiatry if aberrant behavior indicating medication misuse or substance use disorder may be present.

(E) The physician shall not prescribe a dosage that exceeds an average of one hundred twenty MED per day. This prohibition shall not apply in the following circumstances:

(1) The physician holds board certification in pain medicine, board certification in hospice and palliative care, board certification in hematology, or board certification in oncology;

(2) The physician has received a written recommendation for a dosage exceeding an average of one hundred twenty MED per day from a board certified pain medicine physician or board certified hospice and palliative care physician who based the recommendation on a face-to-face visit and examination of the patient. The prescribing physician shall maintain the written recommendation in the patient's record; or

(3) The patient was receiving an average daily dose of one hundred twenty MED or more prior to the effective date of this rule. The physician shall follow the steps in paragraph (E)(2) of this rule prior to escalating the patient's dose.

(F) During the course of treatment with an opioid analgesic at doses below the average of fifty MED per day, the physician shall provide periodic follow-up assessment and documentation of the patient's functional status, the patient's progress toward treatment objectives, indicators of possible addiction, drug abuse or drug diversion and the notation of any adverse drug effects.

(G) During the course of treatment with an opioid analgesic at doses at or above the average of fifty MED per day, the physician shall complete and document in the patient record the following no less than every three months:

(1) Review of the course of treatment and the patient's response and adherence to treatment.

(2) The assessment shall include a review of any complications or exacerbation of the underlying condition causing the pain through appropriate interval history, physical examination, any appropriate diagnostic tests, and specific treatments to address the findings.

(3) The assessment of the patient's adherence to treatment including any prescribed non-pharmacological and non-opioid treatment modalities;

(4) Rationale for continuing opioid treatment and nature of continued benefit, if present.

(5) The results of an OARRS check in compliance with rule 4731-11-11 of the Administrative Code.

(6) Screening for medication misuse or substance use disorder. Urine drug screen should be obtained based on clinical assessment of the physician with frequency based upon presence or absence of aberrant behaviors or other indications of addiction or drug abuse.

(7) Evaluation of other forms of treatment and the tapering of opioid medication if continued benefit cannot be established.

(H) This rule does not apply to the physician who prescribes an opioid in any of the following situations:

(1) The medication is for a patient in hospice care.

(2) The patient has terminal cancer or another terminal condition, as that term is defined in rule 4731-11-01 of the Administrative Code.

(I) This rule does not apply to inpatient prescriptions as defined in rule 4729-17-01 of the Administrative Code.

Last updated July 31, 2023 at 8:24 AM

Supplemental Information

Authorized By: 3719.062, 4731.05, 4731.052, 4730.39, 4730.07
Amplifies: 3719.062, 4731.052, 4730.39
Five Year Review Date: 12/23/2023