Ohio Buprenorphine Regulations & Office-Based Opioid Treatment
To prevent forms of misuse, the State Medical Board of Ohio has placed tight regulations on buprenorphine. For example, prescribers must complete continuing medical education, establish a comprehensive treatment plan, and adhere to the FDA’s recommended dosages.
Opioid use disorder (also called opioid addiction or opioid dependence) is a serious disease that makes you feel unable to stop using opioids.
Unfortunately, some people misuse buprenorphine by taking it to decrease withdrawal symptoms between opioid doses. Some also misuse it to get high, although that’s less common. To prevent misuse, the State Medical Board of Ohio has tightly regulated the medication.
Prescribing Buprenorphine In Ohio
According to the State Medical Board of Ohio, only qualifying physicians may prescribe buprenorphine products. A qualifying physician is any physician who is board-certified in addiction psychiatry and has completed eight hours of approved training.
The Comprehensive Addiction and Recovery Act of 2016 also allows physician assistants and nurse practitioners to prescribe buprenorphine, but only if they obtain a waiver.
Buprenorphine prescribers may treat up to 30 patients with the drug at one time. Once the prescriber completes the Controlled Substance Act training (also called “X-waiver training”), they may treat up to 100 patients at one time.
After treating 100 patients for one year, the physician may treat up to 275 patients if they obtain additional credentials or if they practice in a qualified practice setting as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Office-Based Opioid Treatment (OBOT)
Many providers prescribe buprenorphine to people who are currently enrolled in inpatient opioid treatment programs (OTPs). Others prescribe the drug in an outpatient setting. This is called office-based opioid treatment (OBOT).
To provide OBOT, Ohio physicians must comply with the following regulations:
The Physician Must Follow An Approved Treatment Protocol
The physician must provide OBOT while following an approved treatment protocol. These protocols include:
- The SAMHSA Treatment Improvement Protocol
- The American Society of Addiction Medicine (ASAM) National Practice Guideline
The Physician Must Complete Continuing Medical Education (CME)
The physician must complete at least eight hours of category 1 continuing medical education (CME) related to drug abuse and addiction.
Category 1 CME is training that helps physicians maintain and increase their skills. Physicians who prescribe buprenorphine must complete this training every two years.
The Physician Must Assess The Patient
Before prescribing buprenorphine, the physician must perform an assessment of the patient that includes:
- medical, psychiatric, and substance abuse history
- family history and psychosocial supports
- mental status exam
- physical examination
- urine drug screen or oral fluid drug testing
- pregnancy test, if applicable
- testing for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
- testing for tuberculosis and sexually transmitted diseases in at-risk patients
The physician must also review the patient’s prescription information in the Ohio Automated Rx Reporting System (OARRS). This system tracks the distribution of controlled substances to Ohioans.
The Physician Must Establish A Comprehensive Treatment Plan
The physician must create a personalized, comprehensive treatment plan for the patient. The treatment plan must include a psychosocial needs assessment, supportive counseling, links to existing family supports, and referral to community services.
It must also include at least one of the following interventions:
- cognitive behavioral therapy
- community reinforcement approach
- contingency management/motivational incentives
- motivational interviewing
- behavioral couples counseling
If the patient refuses these interventions, the physician must require the patient to participate in a twelve-step program or self-help recovery program.
The Physician Must Prescribe Naloxone Alongside Buprenorphine
The physician must offer the patient naloxone.
Naloxone is an opioid antagonist, which means it blocks the effects of opioids. It’s often used to prevent opioid overdose deaths. Physicians prescribe it alongside buprenorphine to reduce the risk of people misusing buprenorphine to get high.
The Physician Must Understand Potential Drug Interactions
Patients face a higher risk of overdose if they use buprenorphine alongside certain other prescription drugs, including other opioids, benzodiazepines, and sedative-hypnotics. Thus, the physician should only prescribe these drugs when it’s medically necessary.
They must also educate the patient on the risks of using these drugs at the same time.
The Physician Must Adhere To The FDA’s Recommended Dosages
The physician must prescribe a dosage recommended by the United States Food and Drug Administration (FDA).
During the first ninety days of treatment, the physician must prescribe no more than a two-week supply of buprenorphine. After the ninetieth day of treatment, the physician must prescribe no more than a thirty-day supply.
When starting a patient on the drug, the physician must see the patient at least once a week to monitor progress.
If you or someone you love struggles with substance abuse, please reach out to Ohio Recovery Center. Our board-certified healthcare providers offer medical detox, medication-assisted treatment, and other drug addiction treatment services to help you or your loved one stay sober.
- Ohio Laws & Administrative Rules — Rule 4731-33-03 | Office-based treatment for opioid addiction https://codes.ohio.gov/ohio-administrative-code/rule-4731-33-03
- Ohio Laws & Administrative Rules — Rule 4731-33-01 | Definitions https://codes.ohio.gov/ohio-administrative-code/rule-4731-33-01
- State of Ohio Board of Pharmacy — Guidance Document on DEA X-Waiver Changes for Buprenorphine Prescribing https://www.pharmacy.ohio.gov/Documents/Pubs/Special/ControlledSubstances/Guidance%20Document%20on%20DEA%20X-Waiver%20Changes%20for%20Buprenorphine%20Prescribing.pdf
- Substance Abuse and Mental Health Services Administration — Understanding the Final Rule for a Patient Limit of 275 https://www.samhsa.gov/sites/default/files/programs_campaigns/medication_assisted/understanding-patient-limit275.pdf
- Substance Abuse and Mental Health Services Administration — What is Buprenorphine? https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/buprenorphine