Administrative Code

Virginia Administrative Code
12/4/2021

Chapter 40. Regulations for Prescriptive Authority for Nurse Practitioners

Part I
General Provisions

18VAC90-40-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Acute pain" means pain that occurs within the normal course of a disease or condition or as the result of surgery for which controlled substances containing an opioid may be prescribed for no more than three months.

"Boards" means the Virginia Board of Medicine and the Virginia Board of Nursing.

"Certified nurse midwife" means an advanced practice registered nurse who is certified in the specialty of nurse midwifery and who is jointly licensed by the Boards of Medicine and Nursing as a nurse practitioner pursuant to § 54.1-2957 of the Code of Virginia.

"Chronic pain" means nonmalignant pain that goes beyond the normal course of a disease or condition for which controlled substances containing an opioid may be prescribed for a period greater than three months.

"Clinical nurse specialist" means an advanced practice registered nurse who is certified in the specialty of clinical nurse specialist and who is jointly licensed by the Boards of Medicine and Nursing as a nurse practitioner pursuant to § 54.1-2957 of the Code of Virginia.

"Committee" means the Committee of the Joint Boards of Nursing and Medicine.

"FDA" means the U.S. Food and Drug Administration.

"MME" means morphine milligram equivalent.

"Nonprofit health care clinics or programs" means a clinic organized in whole or in part for the delivery of health care services without charge or when a reasonable minimum fee is charged only to cover administrative costs.

"Nurse practitioner" means an advanced practice registered nurse who has met the requirements for licensure as a nurse practitioner as stated in 18VAC90-30.

"Practice agreement" means a written or electronic agreement jointly developed by the patient care team physician and the nurse practitioner for the practice of the nurse practitioner that also describes the prescriptive authority of the nurse practitioner, if applicable. For a nurse practitioner licensed in the category of certified nurse midwife, the practice agreement is a statement jointly developed with the consulting physician or a certified nurse midwife with at least two years of clinical experience. For a nurse practitioner licensed in the category of clinical nurse specialist, the practice agreement shall be between the nurse practitioner and a consulting physician.

"Prescription Monitoring Program" means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

"SAMHSA" means the federal Substance Abuse and Mental Health Services Administration.

Statutory Authority

§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 1.1, eff. August 15, 1992; amended, Virginia Register Volume 16, Issue 21, eff. August 2, 2000; Volume 25, Issue 5, eff. December 25, 2008; Volume 31, Issue 21, eff. July 15, 2015; Volume 33, Issue 1, eff. October 5, 2016; Volume 35, Issue 21, eff. July 10, 2019; Volume 38, Issue 4, eff. November 10, 2021.

18VAC90-40-20. Authority and administration of regulations.

A. The statutory authority for this chapter is found in §§ 54.1-2957.01, 54.1-3303, 54.1-3401, and 54.1-3408 of the Code of Virginia.

B. Joint boards of nursing and medicine.

1. The Committee of the Joint Boards of Nursing and Medicine shall be appointed to administer this chapter governing prescriptive authority.

2. The boards hereby delegate to the Executive Director of the Virginia Board of Nursing the authority to issue the initial authorization to those persons who meet the requirements set forth in this chapter and to grant extensions or exemptions for compliance with continuing competency requirements as set forth in subsection E of 18VAC90-40-55. Questions of eligibility shall be referred to the committee.

3. All records and files related to prescriptive authority for nurse practitioners shall be maintained in the office of the Board of Nursing.

Statutory Authority

§§ 54.1-2400 and 54.1-2957.1 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 1.2, eff. August 15, 1992; amended, Virginia Register Volume 13, Issue 20, eff. July 23, 1997; Volume 18, Issue 15, eff. May 8, 2002; Volume 25, Issue 5, eff. December 25, 2008; Volume 36, Issue 12, eff. March 4, 2020.

Part II
Approval for Prescriptive Authority

18VAC90-40-30. Authority to prescribe, general.

A. No licensed nurse practitioner shall have authority to prescribe certain controlled substances and devices in the Commonwealth of Virginia except in accordance with this chapter and as authorized by the boards.

B. The boards shall approve prescriptive authority for applicants who meet the qualifications set forth in 18VAC90-40-40 of this chapter.

Statutory Authority

§§ 54.1-2400 and 54.1-2957.01 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 2.1, eff. August 15, 1992.

18VAC90-40-40. Qualifications for initial approval of prescriptive authority.

An applicant for prescriptive authority shall meet the following requirements:

1. Hold a current, unrestricted license as a nurse practitioner in the Commonwealth of Virginia;

2. Provide evidence of one of the following:

a. Continued professional certification as required for initial licensure as a nurse practitioner;

b. Satisfactory completion of a graduate level course in pharmacology or pharmacotherapeutics obtained as part of the nurse practitioner education program within the five years prior to submission of the application;

c. Practice as a nurse practitioner for no less than 1000 hours and 15 continuing education units related to the area of practice for each of the two years immediately prior to submission of the application; or

d. Thirty contact hours of education in pharmacology or pharmacotherapeutics acceptable to the boards taken within five years prior to submission of the application. The 30 contact hours may be obtained in a formal academic setting as a discrete offering or as noncredit continuing education offerings and shall include the following course content:

(1) Applicable federal and state laws;

(2) Prescription writing;

(3) Drug selection, dosage, and route;

(4) Drug interactions;

(5) Information resources; and

(6) Clinical application of pharmacology related to specific scope of practice.

3. Develop a practice agreement between the nurse practitioner and the patient care team physician as required in 18VAC90-40-90; and

4. File a completed application and pay the fees as required in 18VAC90-40-70.

Statutory Authority

§§ 54.1-2400 and 54.1-2957.01 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 2.2, eff. August 15, 1992; amended, Virginia Register Volume 25, Issue 5, eff. December 25, 2008; Volume 31, Issue 21, eff. July 15, 2015.

18VAC90-40-50. (Repealed.)

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 2.3, eff. August 15, 1992; amended, Virginia Register Volume 13, Issue 20, eff. July 23, 1997; Volume 18, Issue 15, eff. May 8, 2002; Volume 25, Issue 5, eff. December 25, 2008; repealed, Virginia Register Volume 36, Issue 12, eff. March 4, 2020.

18VAC90-40-55. Continuing competency requirements.

A. A licensee with prescriptive authority shall meet continuing competency requirements for biennial renewal as a licensed nurse practitioner. Such requirements shall address issues such as ethical practice, an appropriate standard of care, patient safety, and appropriate communication with patients.

B. A nurse practitioner with prescriptive authority shall obtain a total of eight hours of continuing education in pharmacology or pharmacotherapeutics for each biennium in addition to the minimal requirements for compliance with subsection B of 18VAC90-30-105.

C. The nurse practitioner with prescriptive authority shall retain evidence of compliance and all supporting documentation for a period of four years following the renewal period for which the records apply.

D. The boards shall periodically conduct a random audit of their licensees to determine compliance. The nurse practitioners selected for the audit shall provide the evidence of compliance and supporting documentation within 30 days of receiving notification of the audit.

E. The boards may delegate to the committee the authority to grant an extension or an exemption for all or part of the requirements for circumstances beyond the control of the licensee, such as temporary disability, mandatory military service, or officially declared disasters.

Statutory Authority

§§ 54.1-2400 and 54.1-2957.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 15, eff. May 8, 2002; amended, Virginia Register Volume 25, Issue 5, eff. December 25, 2008; Volume 36, Issue 12, eff. March 4, 2020.

18VAC90-40-60. (Repealed.)

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 2.4, eff. August 15, 1992; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 18, Issue 15, eff. May 8, 2002; Volume 25, Issue 5, eff. December 25, 2008; Volume 31, Issue 21, eff. July 15, 2015; repealed, Virginia Register Volume 36, Issue 12, eff. March 4, 2020.

18VAC90-40-70. Fees for prescriptive authority.

The following fees have been established by the boards:

1. Initial issuance of prescriptive authority

$35

2. Handling fee for returned check or dishonored credit or debit card

$50

Statutory Authority

§§ 54.1-2400 and 54.1-2957.1 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 2.5, eff. August 15, 1992; amended, Virginia Register Volume 17, Issue 13, eff. April 11, 2001; Volume 22, Issue 12, eff. March 22, 2006; Volume 27, Issue 20, eff. July 6, 2011; Volume 33, Issue 18, eff. May 31, 2017; Volume 36, Issue 11, eff. March 5, 2020; Volume 36, Issue 12, eff. March 4, 2020.

18VAC90-40-80. (Repealed.)

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 3.1, eff. August 15, 1992; repealed, Virginia Register Volume 16, Issue 21, eff. August 2, 2000.

Part III
Practice Requirements

18VAC90-40-90. Practice agreement.

A. With the exceptions listed in subsection E of this section, a nurse practitioner with prescriptive authority may prescribe only within the scope of the written or electronic practice agreement with a patient care team physician.

B. At any time there are changes in the patient care team physician, authorization to prescribe, or scope of practice, the nurse practitioner shall revise the practice agreement and maintain the revised agreement.

C. The practice agreement shall contain the following:

1. A description of the prescriptive authority of the nurse practitioner within the scope allowed by law and the practice of the nurse practitioner.

2. An authorization for categories of drugs and devices within the requirements of § 54.1-2957.01 of the Code of Virginia.

3. The signature of the patient care team physician who is practicing with the nurse practitioner or a clear statement of the name of the patient care team physician who has entered into the practice agreement.

D. In accordance with § 54.1-2957.01 of the Code of Virginia, a physician shall not serve as a patient care team physician to more than six nurse practitioners with prescriptive authority at any one time.

E. Exceptions.

1. A nurse practitioner licensed in the category of certified nurse midwife and holding a license for prescriptive authority may prescribe in accordance with a written or electronic practice agreement with a consulting physician or with a certified nurse midwife who has practiced for at least two years prior to entering into a practice agreement. A nurse practitioner in the category of certified nurse midwife who has qualified for autonomous practice as set forth in 18VAC90-30-87 may prescribe without a practice agreement.

2. A nurse practitioner licensed in the category of a clinical nurse specialist and holding authorization for prescriptive authority may prescribe in accordance with a written or electronic practice agreement with a consulting physician or may prescribe Schedule VI controlled substances without the requirement for inclusion of such prescriptive authority in a practice agreement.

3. A nurse practitioner who is licensed in a category other than certified nurse midwife, certified registered nurse anesthetist, or clinical nurse specialist, and who has met the qualifications for autonomous practice as set forth in 18VAC90-30-86 may prescribe without a practice agreement with a patient care team physician.

Statutory Authority

§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 3.2, eff. August 15, 1992; amended, Virginia Register Volume 16, Issue 21, eff. August 2, 2000; Volume 25, Issue 5, eff. December 25, 2008; Volume 31, Issue 21, eff. July 15, 2015; Volume 33, Issue 1, eff. October 5, 2016; Volume 36, Issue 22, eff. July 22, 2020; Volume 38, Issue 4, eff. November 10, 2021.

18VAC90-40-100. (Repealed.)

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 3.3, eff. August 15, 1992; amended, Virginia Register Volume 13, Issue 20, eff. July 23, 1997; Volume 19, Issue 7, eff. January 15, 2003; Volume 24, Issue 6, eff. January 11, 2008; Volume 25, Issue 5, eff. December 25, 2008; repealed, Virginia Register Volume 31, Issue 21, eff. July 15, 2015.

18VAC90-40-110. Disclosure.

A. The nurse practitioner shall include on each prescription issued or dispensed his signature and the Drug Enforcement Administration (DEA) number, when applicable. If the nurse practitioner's practice agreement authorizes prescribing of only Schedule VI drugs and the nurse practitioner does not have a DEA number, he shall include the prescriptive authority number as issued by the boards.

B. The nurse practitioner shall disclose to patients at the initial encounter that he is a licensed nurse practitioner. Such disclosure may be included on a prescription pad or may be given in writing to the patient.

C. The nurse practitioner shall disclose, upon request of a patient or a patient's legal representative, the name of the patient care team physician and information regarding how to contact the patient care team physician.

Statutory Authority

§§ 54.1-2400 and 54.1-2957.1 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 3.4, eff. August 15, 1992; amended, Virginia Register Volume 19, Issue 7, eff. January 15, 2003; Volume 31, Issue 21, eff. July 15, 2015; Volume 36, Issue 12, eff. March 4, 2020.

18VAC90-40-120. Dispensing.

A nurse practitioner may dispense only those manufacturers' samples of drugs that are included in the written or electronic practice agreement.

Statutory Authority

§§ 54.1-2400, 54.1-2957, and 54.1-2957.01 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 3.5, eff. August 15, 1992; amended, Virginia Register Volume 16, Issue 21, eff. August 2, 2000; Volume 19, Issue 7, eff. January 15, 2003; Volume 34, Issue 9, eff. February 8, 2018.

18VAC90-40-121. Prescribing for self or family.

A. Treating or prescribing shall be based on a bona fide practitioner-patient relationship, and prescribing shall meet the criteria set forth in § 54.1-3303 of the Code of Virginia.

B. A nurse practitioner shall not prescribe a controlled substance to himself or a family member, other than Schedule VI as defined in § 54.1-3455 of the Code of Virginia, unless the prescribing occurs in an emergency situation or in isolated settings where there is no other qualified practitioner available to the patient, or it is for a single episode of an acute illness through one prescribed course of medication.

C. When treating or prescribing for self or family, the nurse practitioner shall maintain a patient record documenting compliance with statutory criteria for a bona fide practitioner-patient relationship.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 5, eff. December 25, 2008.

Part IV
Discipline

18VAC90-40-130. Grounds for disciplinary action.

A. The boards may deny approval of prescriptive authority, revoke or suspend authorization, or take other disciplinary actions against a nurse practitioner who:

1. Exceeds his authority to prescribe or prescribes outside of the written or electronic practice agreement with the patient care team physician or, for certified nurse midwives, the practice agreement with the consulting physician;

2. Has had his license as a nurse practitioner suspended, revoked, or otherwise disciplined by the boards pursuant to 18VAC90-30-220; or

3. Fails to comply with requirements for continuing competency as set forth in 18VAC90-40-55.

B. Unauthorized use or disclosure of confidential information received from the Prescription Monitoring Program shall be grounds for disciplinary action.

Statutory Authority

§§ 54.1-2400 and 54.1-2957 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 and VR465-12-1 § 4.1, eff. August 15, 1992; amended, Virginia Register Volume 18, Issue 15, eff. May 8, 2002; Volume 25, Issue 5, eff. December 25, 2008; Volume 26, Issue 25, eff. September 15, 2010; Volume 31, Issue 21, eff. July 15, 2015; Volume 33, Issue 1, eff. October 5, 2016.

18VAC90-40-140. Administrative proceedings.

A. Except as provided for delegation of proceedings to an agency subordinate in 18VAC90-30-240, the Committee of the Joint Boards of Nursing and Medicine shall conduct all hearings prescribed herein and shall take action on behalf of the boards.

B. The nurse practitioner with prescriptive authority shall be subjective to the grounds for disciplinary action set forth in 18VAC90-30-220.

C. When the license of a nurse practitioner has been suspended or revoked by the joint boards, prescriptive authority shall be suspended pending a hearing simultaneously with the institution of proceedings for a hearing.

D. Any violation of law or of this chapter may result in disciplinary action including the revocation or suspension of prescriptive authority and may also result in additional sanctions imposed on the license of the nurse practitioner by the joint boards or upon the license of the registered nurse by the Board of Nursing.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from VR495-03-1 § 4.2, eff. August 15, 1992; amended, Virginia Register Volume 23, Issue 12, eff. March 21, 2007; Volume 25, Issue 5, eff. December 25, 2008.

Part V
Management of Acute Pain

18VAC90-40-150. Evaluation of the patient for acute pain.

A. The requirements of this part shall not apply to:

1. The treatment of acute pain related to (i) cancer, (ii) sickle cell, (iii) a patient in hospice care, or (iv) a patient in palliative care;

2. The treatment of acute pain during an inpatient hospital admission or in a nursing home or an assisted living facility that uses a sole source pharmacy; or

3. A patient enrolled in a clinical trial as authorized by state or federal law.

B. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. If an opioid is considered necessary for the treatment of acute pain, the practitioner shall give a short-acting opioid in the lowest effective dose for the fewest possible days.

C. Prior to initiating treatment with a controlled substance containing an opioid for a complaint of acute pain, the prescriber shall perform a history and physical examination appropriate to the complaint, query the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia, and conduct an assessment of the patient's history and risk of substance misuse as a part of the initial evaluation.

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.

18VAC90-40-160. Treatment of acute pain with opioids.

A. Initiation of opioid treatment for patients with acute pain shall be with short-acting opioids.

1. A prescriber providing treatment for a patient with acute pain shall not prescribe a controlled substance containing an opioid in a quantity that exceeds a seven-day supply as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the medical record. This shall also apply to prescriptions of a controlled substance containing an opioid upon discharge from an emergency department.

2. An opioid prescribed as part of treatment for a surgical procedure shall be for no more than 14 consecutive days in accordance with manufacturer's direction and within the immediate perioperative period, unless extenuating circumstances are clearly documented in the medical record.

B. Initiation of opioid treatment for all patients shall include the following:

1. The practitioner shall carefully consider and document in the medical record the reasons to exceed 50 MME per day.

2. Prior to exceeding 120 MME per day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist.

3. Naloxone shall be prescribed for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME per day, or concomitant benzodiazepine are present.

C. Due to a higher risk of fatal overdose when opioids are used with 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.

D. Buprenorphine is not indicated for acute pain in the outpatient setting, except when a prescriber who has obtained a SAMHSA waiver is treating pain in a patient whose primary diagnosis is the disease of addiction.

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.

18VAC90-40-170. Medical records for acute pain.

The medical record shall include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan, and the medication prescribed or administered to include the date, type, dosage, and quantity prescribed or administered.

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.

Part VI
Management of Chronic Pain

18VAC90-40-180. Evaluation of the chronic pain patient.

A. The requirements of this part shall not apply to:

1. The treatment of chronic pain related to (i) cancer, (ii) sickle cell, (iii) a patient in hospice care, or (iv) a patient in palliative care;

2. The treatment of chronic pain during an inpatient hospital admission or in a nursing home or an assisted living facility that uses a sole source pharmacy; or

3. A patient enrolled in a clinical trial as authorized by state or federal law.

B. Prior to initiating management of chronic pain with a controlled substance containing an opioid, a medical history and physical examination, to include a mental status examination, shall be performed and documented in the medical record, including:

1. The nature and intensity of the pain;

2. Current and past treatments for pain;

3. Underlying or coexisting diseases or conditions;

4. The effect of the pain on physical and psychological function, quality of life, and activities of daily living;

5. Psychiatric, addiction, and substance misuse histories of the patient and any family history of addiction or substance misuse;

6. A urine drug screen or serum medication level;

7. A query of the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia;

8. An assessment of the patient's history and risk of substance misuse; and

9. A request for prior applicable records.

C. Prior to initiating opioid analgesia for chronic pain, the practitioner shall discuss with the patient the known risks and benefits of opioid therapy and the responsibilities of the patient during treatment to include securely storing the drug and properly disposing of any unwanted or unused drugs. The practitioner shall also discuss with the patient an exit strategy for the discontinuation of opioids in the event they are not effective.

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.

18VAC90-40-190. Treatment of chronic pain with opioids.

A. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids.

B. In initiating opioid treatment for all patients, the practitioner shall:

1. Carefully consider and document in the medical record the reasons to exceed 50 MME per day;

2. Prior to exceeding 120 MME per day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist;

3. Prescribe naloxone for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME per day, or concomitant benzodiazepine are present; and

4. Document the rationale to continue opioid therapy every three months.

C. Buprenorphine mono-product in tablet form shall not be prescribed for chronic pain.

D. Due to a higher risk of fatal overdose when opioids, including buprenorphine, are given 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. The practitioner shall regularly evaluate for opioid use disorder and shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation for treatment if indicated.

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.

18VAC90-40-200. Treatment plan for chronic pain.

A. The medical record shall include a treatment plan that states measures to be used to determine progress in treatment, including pain relief and improved physical and psychosocial function, quality of life, and daily activities.

B. The treatment plan shall include further diagnostic evaluations and other treatment modalities or rehabilitation that may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

C. The prescriber shall record in the medical records the presence or absence of any indicators for medication misuse or diversion and take appropriate action.

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.

18VAC90-40-210. Informed consent and agreement for treatment of chronic pain.

A. The practitioner shall document in the medical record informed consent, to include risks, benefits, and alternative approaches, prior to the initiation of opioids for chronic pain.

B. There shall be a written treatment agreement, signed by the patient, in the medical record that addresses the parameters of treatment, including those behaviors that will result in referral to a higher level of care, cessation of treatment, or dismissal from care.

C. The treatment agreement shall include notice that the practitioner will query and receive reports from the Prescription Monitoring Program and permission for the practitioner to:

1. Obtain urine drug screen or serum medication levels, when requested; and

2. Consult with other prescribers or dispensing pharmacists for the patient.

D. Expected outcomes shall be documented in the medical record including improvement in pain relief and function or simply in pain relief. Limitations and side effects of chronic opioid therapy shall be documented 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.

18VAC90-40-220. Opioid therapy for chronic pain.

A. The practitioner shall review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health at least every three months.

B. Continuation of treatment with opioids shall be supported by documentation of continued benefit from the prescribing. If the patient's progress is unsatisfactory, the practitioner shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

C. Practitioners shall check the Prescription Monitoring Program at least every three months after the initiation of treatment.

D. The practitioner shall order and review a urine drug screen or serum medication levels at the initiation of chronic pain management and thereafter randomly at the discretion of the practitioner but at least once a year.

E. The practitioner shall regularly evaluate for opioid use disorder and shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation for treatment if indicated.

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.

18VAC90-40-230. Additional consultation.

A. When necessary to achieve treatment goals, the prescriber shall refer the patient for additional evaluation and treatment.

B. When a practitioner makes the diagnosis of opioid use disorder, treatment for opioid use disorder shall be initiated or the patient shall be referred for evaluation and 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.

18VAC90-40-240. Medical records.

The prescriber shall keep current, accurate, and complete records in an accessible manner and readily available for review to include:

1. The medical history and physical examination;

2. Past medical history;

3. Applicable records from prior treatment providers or any documentation of attempts to obtain those records;

4. Diagnostic, therapeutic, and laboratory results;

5. Evaluations and consultations;

6. Treatment goals;

7. Discussion of risks and benefits;

8. Informed consent and agreement for treatment;

9. Treatments;

10. Medications, including date, type, dosage and quantity prescribed, and refills;

11. Patient instructions; and

12. Periodic reviews.

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.

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. Nurse practitioners 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 nurse practitioner 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.

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.

FORMS (18VAC90-40).

Application for Prescriptive Authority for Licensed Nurse Practitioners (rev. 6/11).

Prescriptive Authority for Licensed Nurse Practitioners Practice Agreement (rev. 3/11).

Application for Reinstatement of Prescriptive Authority (rev. 7/07).

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