After a lengthy hearing process, the State Medical Board rule on physician use of controlled substances to treat dependence or addiction was adopted by the State Medical Board on January 14 and filed on January 16. The rule, also referred to as the buprenorphine rule (4731-11-12), is effective on Saturday, January 31, 2015.
The rule went through two separate review and revision processes through the State Medical Board, and hearings of the Common Sense Initiative and the Ohio General Assembly’s Joint Committee on Agency Rule Review. The Ohio Academy of Family Physicians participated in negotiations during the entire process.
- Prior to providing office-based opioid treatment, the physician must conduct an assessment of the patient that meets the requirements of the rule.
- The physician must practice in accordance with one of the protocols listed in the rule, and the diagnosis of an opioid disorder must be made utilizing the criteria in the DSM, 4th or 5th edition.
- The physician must develop an individualized treatment plan for the patient, require the patient to actively participate in appropriate behavioral counseling or treatment for addiction, and provide ongoing toxicological testing.
- The physician’s prescribing of the medication must comply with requirements that include, but are not limited to, prescribing only drugs specifically approved by the Food and Drug Administration for use in maintenance and detoxification treatment, prescribing no more than 16 milligrams of medication daily for a patient unless specified requirements are met, and accessing the Ohio Automated Rx Reporting System for each patient no less frequently than every 90 days.
- The physician must complete Category I continuing medical education (CME) related to substance abuse and addiction every two years, which will be accepted as part of the CME requirement for license renewal.
The requirements of the rule do not apply to the treatment of a pregnant patient during the pregnancy and for two months thereafter.
Violation of the rule subjects the physician to disciplinary action by the Medical Board.
- Effective Friday, March 20, 2015, Ohio Revised Code (ORC) 4729.291 states a prescriber may not do either of the following:
- In any thirty-day period, personally furnish to or for patients, taken as a whole, controlled substances containing buprenorphine in an amount that exceeds a total of 2,500 (two thousand five hundred) dosage units; or
- In any seventy-two-hour period, personally furnish to or for a patient an amount of a controlled substance containing buprenorphine that exceeds the amount necessary for the patient’s use in a 72–hour period.
- Effective Wednesday, April 1, 2015, ORC 4729.541 will require the following business entities to hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, and dispense controlled substances containing buprenorphine that are used for the purpose of treating drug dependence or addiction:
- A limited liability company if the entity has a sole shareholder who is a licensed health professional authorized to prescribe drugs and is authorized to provide the professional services being offered by the entity; or
- A limited liability company, a partnership or a limited liability partnership, or a professional association, if, to be a shareholder, member, or partner, an individual is required to be licensed, certified, or otherwise legally authorized under Title 47 of the ORC to perform the professional service provided by the entity and each such individual is a licensed health professional authorized to prescribe drugs.
Please review the Ohio State Board of Pharmacy’s to help with implementation of this new law.