Q: What must a practitioner do to be authorized to prescribe buprenorphine products in Kentucky?
A: The rules that govern physician and physician assistant prescribing can be found in the regulations of the Kentucky Board of Medical Licensure. The rules that govern APRNs can be found in the regulations of the Kentucky Board of Nursing. The substance abuse and mental health services administration (SAMHSA), a branch of the Department of Health and Human Services coordinates the federal response to substance abuse prevention and treatment and drafts the federal rules governing the prescription of buprenorphine products.
A licensed physician, physician’s assistant or APRN must:
- Obtain and maintain in good standing a data X waiver and license issued by the DEA to prescribe buprenorphine products for the treatment of opioid use disorder in the Commonwealth of Kentucky.
- Possess a certification for the completion of a buprenorphine certified course from SAMSHA.
For Physicians and Physician Assistants only: For each three (3) year continuing education cycle, each DEA-licensed prescriber of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone shall complete at least twelve (12) hours of continuing medical education.
201 KAR 9:270 (1)(1), 201 KAR 20:065(2)(1), and 21 U.S.C. § 823(g)(2).
Q: How do I verify that a provider issuing a buprenorphine prescription for a patient possesses the data X waiver?
A: Those practitioners who possess the X waiver will be identified on the prescription via an “X” located in the DEA registration number verification line along with the practitioner’s DEA number, however, an X in the DEA registration number does not guarantee the provider actually possesses a waiver in good standing. It is always best to use the tool below to confirm practitioner authority.
Pharmacists may also use the Buprenorphine Pharmacy Lookup to verify a practitioner's certification to prescribe buprenorphine for the treatment of opioid use disorder.
You may also use DEA’s online validation tool to determine waiver status.
Q: How must a prescription for buprenorphine products be transmitted to pharmacies?
A: Beginning January 1, 2021, no practitioner shall issue any prescription for a controlled substance unless the prescription is made by electronic prescription from the practitioner issuing the prescription to the pharmacy. Exceptions to this requirement are set forth in KRS 218A.182.
A pharmacist who receives a written, oral, or faxed prescription for a controlled substance shall not be required to verify that the prescription falls under one of the exceptions in KRS 218A.182. Moreover, if the practitioner has obtained an EPCS waiver from CHFS, they are not required at this time to utilize an electronic prescription. Pharmacists may continue to dispense otherwise valid written, oral, or faxed prescriptions that are consistent with current laws and regulations.
The exceptions to the electronic prescription requirement for controlled substances, includes:
(a) By veterinarians;
(b) In circumstances where electronic prescribing is not available due to temporary technological or electrical failure;
(c) By a practitioner to be dispensed by a pharmacy located outside the state;
(d) When the prescriber and dispenser are the same entity;
(e) That include elements that are not supported by the most recently implemented version of the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard;
(f) By a practitioner for a drug that contains certain elements that cannot be incorporated as required by the United States Food and Drug Administration with electronic prescribing, including extemporaneous compounding;
(g) By a practitioner allowing for the dispensing of a nonpatient specific prescription under a standing order, approved protocol for drug therapy, or collaborative drug management or comprehensive medication management, in response to a public health emergency;
(h) By a practitioner prescribing a drug under a research protocol;
(i) By practitioners who have received a waiver or a renewal thereof, from the requirement to use electronic prescribing due to economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner. The initial waiver and each subsequent waiver renewal shall not exceed one (1) year per waiver or waiver renewal;
(j) By a practitioner under circumstances where, notwithstanding the practitioner's present ability to make an electronic prescription as required by this subsection, the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and delay would adversely impact the patient's medical condition;
(k) By a practitioner for an individual who receives hospice care; or
(l) By a practitioner for an individual who is a resident of a nursing facility.
Q: Can a prescription for buprenorphine-containing products be transferred for the purpose of refill dispensing?
A: Yes, the transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. (Title 21 CFR 1306.25)
A transfer must be communicated directly between two licensed pharmacists and transfers via oral, paper, or electronic prescriptions are subject to the requirements set forth in Title 21 CFR 1306.25. A controlled substance prescription that has never been dispensed may not be transferred, with the following exception. If pharmacies have a common database, and have an operating system that works in real time, a controlled substance prescription that has never been filled may be “forwarded” not transferred to another pharmacy within the common database. (http://www.ncbop.org/PDF/LMillerDEAGuidanceTransferofOnFileCSPrescriptions.pdf)
Q: When may a refill of a prescription for buprenorphine-containing products be authorized? How many times may a prescription for buprenorphine products be refilled?
A: A prescription for buprenorphine products shall not be filled or refilled more than six (6) months after the date issued.
MD/DO: A prescription may be written with up to a maximum of five (5) refills and be refilled no more than five (5) times.
APRN/PA: A prescription may be written with up to a maximum thirty (30) day supply without refills. The dosing and quantity supply of buprenorphine-containing products per prescription varies in accordance to the patient’s treatment plan. (201 KAR 20:065)
Under title 21 of the code of federal regs § 1306.23, the partial filling of a schedule III is permissible so long as each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after 6 months after the date on which the prescription was issued.
A prescription can be renewed by the practitioner and a new prescription that is written, electronic, or oral, shall be required. (KRS 218A.180) (KRS 314.011(8))
Q: When may Buprenorphine-Mono-Products be prescribed for medically supervised withdrawal or as a maintenance treatment for a patient diagnosed with opioid use disorder?
A: Pursuant to KBML and KBN prescribing standards, buprenorphine-Mono-Product shall not be prescribed for medically supervised withdrawal or as a maintenance treatment for a patient diagnosed with opioid use disorder unless the patient is pregnant, has demonstrated hypersensitivity to naloxone, the Buprenorphine-Mono-Product is administered under supervision in a physician’s office or other healthcare facility, or the patient is transitioning from methadone to buprenorphine, limited to a period of no longer than a week. This applies to physicians, PA’s, and APRN’s. 201 KAR 9:270 (2)(2) and 201 KAR 20:065 (3)(2).
Q: To address an extraordinary and acute medical need, can buprenorphine-containing products be prescribed to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants, or other opioids without consultation?
A: Yes. A practitioner may prescribe or dispense buprenorphine products to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants, or other opioids, without consultation in order to address an extraordinary and acute medical need not to exceed a combined period of thirty (30) days. 201 KAR 9:270 (2)(3)(b) and 201 KAR 20:065 (3)(3)(b).
Q: When is a psychiatry/addictionology consultation required before prescribing buprenorphine-containing products?
A: Buprenorphine products shall not be prescribed or dispensed to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants or other opioids, without consultation of a physician who is certified by the American Board of Addiction Medicine, the American Board of Preventive Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry. (201 KAR 9:270 (2)(3)(a))
APRN’s shall not prescribe buprenorphine products to a patient who is also being prescribed benzodiazepines, other sedative hypnotics, stimulants or other opioids, without consultation of a physician certified in addiction medicine or psychiatry as required by 201 KAR 9:270, an APRN certified in addiction therapy by the Addictions Nursing Certification Board, American Academy of Health Care Providers in the Addictive Disorders or National Certification Commission for Addiction Specialists, or a psychiatric-mental health nurse practitioner. (201 KAR 20:065 (3)(3)(a))
Q: Are there limits on the quantities and dosages per day of buprenorphine-containing product that can be prescribed by a physician or physician assistant?
A: A physician or PA shall prescribe to the patient an amount of buprenorphine product that is necessary to minimize craving and opiate withdrawal, is to be taken no more than once daily, is only able to supply the patient until the next visit and does not produce opiate sedation. 201 KAR 9:270 (2)(4)(e)(2). This does not apply to APRNs.
EXCEPTIONS for once daily dosing:
- If the patient is pregnant, the product is to be taken no more than twice daily.
- If the patient is receiving a daily dosage of less than 16mg, the product is to be taken no more than twice daily.
- If the patient is simultaneously engaged in cancer treatment, hospice or palliative care, the product is to be taken bid or tid.
- If the patient is undergoing a major surgery or has suffered a significant physical trauma, the product shall be taken bid or tid for up to fourteen (14) days. 201 KAR 9:270 (2)(4)(e)(2)(c).
A physician who is unable to conform to the professional standards for prescribing buprenorphine products due to circumstances beyond the physician’s control, or if the physician makes a professional determination that it is not appropriate to comply with a specific standard, may prescribe buprenorphine in accordance with SAMHSA guidelines if the physician documents those circumstances in the patient’s record and only prescribes buprenorphine products to the patient when the patient record appropriately justifies the prescribing. 201 KAR 9:270(4)(2).
Q: Are there limits on the quantities and dosages per day of buprenorphine-containing product that can be prescribed by an APRN?
An APRN shall prescribe to the patient the amount of buprenorphine product that is necessary to minimize craving and opiate withdrawal, does not produce opiate sedation, is only able to supply the patient until the next visit and does not exceed FDA-approved dosage limit and/or a maximum of thirty (30) days. 201 KAR 20:065 (2)(4)(e).
Q: What kind of information must be present on a prescription for a buprenorphine-containing product for it to be valid?
A: All prescriptions for controlled substances shall include the full name and address of the patient, drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, registration number and “X” number of the practitioner. KRS 218A.180(5), 21 CFR § 1306.05
NOTE: When reporting to KASPER, you must report the actual DEA number, not the data waiver (“X” number).
Q: What record keeping requirement is required for pharmacists filling buprenorphine-containing products?
A: A pharmacist refilling any prescription shall record on the prescription or other equivalent record the date, the quantity, and the pharmacist’s initials. The maintenance of prescription records under the federal controlled substances laws and regulations containing substantially the same information as specified in KRS 218A.180 shall constitute compliance with the statute.
Pursuant to KRS 218A.200, controlled substance inventory records, including invoices, must be kept for five (5) years. Further, 201 KAR 2:171 requires a record of the day’s prescription data to be dated, verified, and signed by the pharmacist(s) who filled the prescription and kept for five (5) years. Original prescriptions or a record of refill, if received written or oral, shall be preserved as a hard copy for three (3) years and thereafter may be preserved as a hard copy or electronically for an additional two (2) years. Records that are received electronically may be kept electronically and shall be preserved electronically for no less than five (5) years. (201 KAR 2:171)
Q: What must be present on the label of the dispensing container for a buprenorphine-containing product?
A: The pharmacist filling a written, facsimile, electronic, or oral prescription for a controlled substance shall affix to the package a label showing the date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner and directions for use and cautionary statements, if any, contained in such prescription or required by law. (Title 21 CFR 1306.14 (a))
Q: What quantity of buprenorphine-containing medications may a PA prescribe to a patient?
A: Prescriptions issued by a physician assistant for Schedule III controlled substances, as described in KRS 218A.080, shall be limited to a thirty (30) day supply without any refill.
Q: When a pharmacy dispenses a long-acting injectable buprenorphine product, what must the pharmacy and pharmacist do to ensure compliance with federal law?
A: Currently, Sublocade is the only long-acting buprenorphine product delivered directly to the provider under the Support Act. Brixati will join this drug class in December, 2021. To ensure compliance with the REMS program, see the requirements here: https://www.sublocaderems.com/ Moreover, these long-acting injectable are governed by federal law in 21 U.S.C. 823(g).