Ohio has experienced an epidemic of prescription drug abuse and dependence, specifically involving opioid controlled substances. Because of this epidemic, more physicians are offering opioid maintenance treatment for persons suffering from addiction. Suboxone, a combination of buprenorphine and naloxone, has assisted in countless recoveries from opioid addiction, but regrettably, Ohio has likewise seen a rise in diversion and misuse of Suboxone and other buprenorphine products.
As a result, the State Medical Board of Ohio (“Board”) recently released proposed administrative rules concerning the provision of office-based treatment of opioid addiction using buprenorphine products such as Suboxone. Such rules, while not yet adopted, would be added to the Board’s rules pertaining to controlled substances, Chapter 4731-11 of the Ohio Administrative Code.
In order to prescribe Suboxone and buprenorphine products for the purpose of opioid maintenance treatment, a physician must apply and qualify for a special registration under the Drug Addition Treatment Act of 2000 (see 21 U.S.C. 823(g)). An approved physician is then provided with a unique registration number that must be included on every prescription. Under federal law, an approved physician cannot treat more than 100 patients for opioid maintenance treatment and must attest that he or she has the capacity to refer addiction treatment patients for appropriate counseling and other non-pharmacologic therapies.
Under the Board’s proposed administrative rules, before a physician can provide office based opioid maintenance treatment to a patient, the physician must complete and document a history and physical; perform a mental status exam; document a substance use history; and conduct appropriate lab tests, including but not limited to a pregnancy test for women of childbearing years, toxicology tests for drugs and alcohol, and screens for Hepatitis B and C. Thereafter, the physician must do the following:
- Practice in accordance with accepted treatment protocols for assessment, induction, stabilization, maintenance and tapering (see http://samhsa.gov/ and http://mha.ohio.gov/for further information);
- Diagnose an opioid disorder under the criteria established in the 4th or 5th editions of the Diagnostic and Statistical Manual of Mental Disorders;
- Develop an individualized treatment plan, to include the patient’s participation in behavioral health treatment and/or twelve step program such as Alcoholics Anonymous or Narcotics Anonymous;
- See the patient at least every three months, and refrain from prescribing, administering or personally furnishing Suboxone and other buprenorphine products in greater than 30-day supplies, and except for certain circumstances, in amounts that exceed 16 milligrams per day; and
- Conduct monthly reviews of OARRS and toxicology testing.
The treatment of opioid addiction is indeed challenging and complex. Ohio physicians who are appropriately registered and engage in office based opioid treatment should be cognizant of the proposed rules, and should implement measures to anticipate such changes and ensure compliance with state and federal rules and regulations.