Part VII. Prescribing of Buprenorphine
18VAC90-40-250. General provisions.
A. Practitioners engaged in office-based opioid addiction treatment with buprenorphine shall have obtained a waiver from SAMHSA and the appropriate U.S. Drug Enforcement Administration registration.
B. Practitioners shall abide by all federal and state laws and regulations governing the prescribing of buprenorphine for the treatment of opioid use disorder.
C. Advanced practice registered nurses who have obtained a SAMHSA waiver shall only prescribe buprenorphine for opioid addiction pursuant to a practice agreement with a SAMHSA-waivered doctor of medicine or doctor of osteopathic medicine unless the advanced practice registered nurse has been authorized by the boards for autonomous practice.
D. Practitioners engaged in medication-assisted treatment shall either provide counseling in their practice or refer the patient to a mental health service provider, as defined in § 54.1-2400.1 of the Code of Virginia, who has the education and experience to provide substance misuse counseling. The practitioner shall document provision of counseling or referral in the medical record.
Statutory Authority
§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 35, Issue 21, eff. July 10, 2019; amended, Virginia Register Volume 40, Issue 4, eff. November 8, 2023.
18VAC90-40-260. Patient assessment and treatment planning.
A. A practitioner shall perform and document an assessment that includes a comprehensive medical and psychiatric history, substance misuse history, family history and psychosocial supports, appropriate physical examination, urine drug screen, pregnancy test for women of childbearing age and ability, a check of the Prescription Monitoring Program, and, when clinically indicated, infectious disease testing for human immunodeficiency virus, hepatitis B, hepatitis C, and tuberculosis.
B. The treatment plan shall include the practitioner's rationale for selecting medication assisted treatment, patient education, written informed consent, how counseling will be accomplished, and a signed treatment agreement that outlines the responsibilities of the patient and the practitioner.
Statutory Authority
§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 35, Issue 21, eff. July 10, 2019.
18VAC90-40-270. Treatment with buprenorphine.
A. Buprenorphine without naloxone (buprenorphine mono-product) shall not be prescribed except:
1. When a patient is pregnant;
2. When converting a patient from methadone or buprenorphine mono-product to buprenorphine containing naloxone for a period not to exceed seven days;
3. In formulations other than tablet form for indications approved by the FDA; or
4. For patients who have a demonstrated intolerance to naloxone; such prescriptions for the mono-product shall not exceed 3.0% of the total prescriptions for buprenorphine written by the prescriber, and the exception shall be clearly documented in the patient's medical record.
B. Buprenorphine mono-product tablets may be administered directly to patients in federally licensed opioid treatment programs. With the exception of those conditions listed in subsection A of this section, only the buprenorphine product containing naloxone shall be prescribed or dispensed for use off site from the program.
C. The evidence for the decision to use buprenorphine mono-product shall be fully documented in the medical record.
D. Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.
E. Prior to starting medication-assisted treatment, the practitioner shall perform a check of the Prescription Monitoring Program.
F. During the induction phase, except for medically indicated circumstances as documented in the medical record, patients should be started on no more than eight milligrams of buprenorphine per day. The patient shall be seen by the prescriber at least once a week.
G. During the stabilization phase, the prescriber shall increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.
H. Practitioners shall take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill counts, and checks of the Prescription Monitoring Program. The practitioner shall also require urine drug screens or serum medication levels at least every three months for the first year of treatment and at least every six months thereafter.
I. Documentation of the rationale for prescribed doses exceeding 16 milligrams of buprenorphine per day shall be placed in the medical record. Dosages exceeding 24 milligrams of buprenorphine per day shall not be prescribed.
J. The practitioner shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a mental health service provider, as defined in § 54.1-2400.1 of the Code of Virginia, who has the education and experience to provide substance misuse counseling.
Statutory Authority
§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 35, Issue 21, eff. July 10, 2019.
18VAC90-40-280. Special populations.
A. Pregnant women may be treated with the buprenorphine mono-product, usually 16 milligrams per day or less.
B. Patients younger than the age of 16 years shall not be prescribed buprenorphine for addiction treatment unless such treatment is approved by the FDA.
C. The progress of patients with chronic pain shall be assessed by reduction of pain and functional objectives that can be identified, quantified, and independently verified.
D. Practitioners shall (i) evaluate patients with medical comorbidities by history, physical exam, and appropriate laboratory studies and (ii) be aware of interactions of buprenorphine with other prescribed medications.
E. Practitioners shall not undertake buprenorphine treatment with a patient who has psychiatric comorbidities and is not stable. A patient who is determined by the practitioner to be psychiatrically unstable shall be referred for psychiatric evaluation and treatment prior to initiating medication-assisted treatment.
Statutory Authority
§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 35, Issue 21, eff. July 10, 2019.
18VAC90-40-290. Medical records for opioid addiction treatment.
A. Records shall be timely, accurate, legible, complete, and readily accessible for review.
B. The treatment agreement and informed consent shall be maintained in the medical record.
C. Confidentiality requirements of 42 CFR Part 2 shall be followed.
Statutory Authority
§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 35, Issue 21, eff. July 10, 2019.