This section applies to physicians per Kentucky Board of Medical Licensure regulation 201 KAR 9:270. This does not apply to APRN prescribing of buprenorphine. Buprenorphine and buprenorphine/naloxone physician prescribing regulation 201 KAR 9:270, what a pharmacist should know:
1. Physician must have an X DEA number. The X DEA number and the regular DEA number of the physician must be on the prescription. An X DEA number does not make the physician an addictionologist. Addictionology is a Board Certified Specialty. The X DEA number can be verified at http://buprenorphine.samhsa.gov/ .
2. Physician cannot prescribe buprenorphine single entity products or buprenorphine with naloxone combination products for off labeled use. The only indication is for addiction. This does not apply to transdermal products (Butrans) or buccal films (Belbuca).
3. Buprenorphine single entity products may only be prescribed to pregnant females, patients with a documented hypersensitivity to naloxone or the injectable may be administered in a physician’s office or healthcare facility. Physicians may not prescribe buprenorphine single entity products because they are less expensive or because that is the only product covered by the patient’s insurance.
4. Concurrent prescribing of benzodiazepines, other sedative hypnotics, stimulants or opioids is prohibited without the consult of a Board Certified Addictionologist or Board Certified Psychiatrist.
5. Concurrent prescribing of benzodiazepines, other sedative hypnotics, stimulants or opioids is permitted without a consult by a Board Certified Addictionolgist or Board Certified Psychiatrist for extraordinary or acute medical needs for a period of not greater than 30 days (for example a surgery or child birth).
6. Buprenorphine single entity products and buprenorphine with naloxone combination products are dosed once daily.
Other information in the regulation to be aware of but is not the responsibility of the pharmacist to enforce:
1. The regulation sets treatment guidelines regarding how often a patient is to be seen.
2. If the patient is on a dose greater than 16mg/day (or equivalent, depending on the product) for longer than 12 months, the prescriber must get a consult from a Board Certified Addictionologist or Board Certified Psychiatrist.
3. The physician shall have a documented plan for lost or stolen medication and shall not automatically replace the medication and may require the patient to report the stolen medication to law enforcement, if deemed necessary by the physician.
4. Every 3 months the patient shall be evaluated by the physician to determine the appropriate dose.
5. Every 12 months the physician will evaluate and document the need for the patient to continued treatment at the established dose.
6. Physician shall request a KASPER initially and every 3 months while treating the patient.
7. Patient will have at least 8 drug screens per year, with 2 of the screens including “pill counts.”
APRN Prescribing of Buprenorphine:
The 2016 Comprehensive Addiction and Recovery Act (CARA) extended the prescribing of buprenorphine in office-based settings to APRNs, who may obtain a DATA waiver number (an X DEA) to treat up to 30 patients after completing 24 hours of required training.
Use this link for the Kentucky Board of Nursing regulation, 201 KAR 20:065, Professional standards for prescribing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone by APRNs for medication treatment for opioid use disorder. Please contact the Kentucky Board of Nursing with any questions.