TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Proposed Regulation

Title of Regulation: 18VAC110-21. Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians (amending 18VAC110-21-46).

Statutory Authority: §§ 54.1-2400 and 54.1-3303.1 of the Code of Virginia.

Public Hearing Information:

May 2, 2024 - 9:06 a.m. - Department of Health Professions, 9960 Mayland Drive, Suite 201, Board Room 2, Henrico, Virginia 23233.

Public Comment Deadline: June 21, 2024.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations of the Board of Pharmacy are promulgated under the general authority of § 54.1-2400 of the Code of Virginia. Section 54.1-3303.1 of the Code of Virginia sets forth the ability for pharmacists to initiate treatment for certain diseases and conditions.

Purpose: The purpose of the proposed regulation is to ensure that a pharmacist who initiates treatment for patients follows protocols that would render such treatment to be a low risk for patient harm. The rules establishing treatment protocols, appropriate notification of primary care providers, obtaining patient histories, and providing appropriate counseling of patients are necessary to ensure the health and safety of patients who receive treatment from pharmacists.

Substance: The substantive changes (i) require the pharmacist to have a bona fide pharmacist-patient relationship with the patient with whom the pharmacist initiates treatment; (ii) add nicotine replacement therapy and other tobacco-cessation therapies as drugs and therapies with which a pharmacist can initiate treatment for an adult 18 years of age or older; (iii) add a provision allowing a pharmacist to initiate treatment for patients three years of age and older by administering vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention (CDC), vaccines for COVID-19, and tests for COVID-19 and other coronaviruses; (iv) ensure that practitioners will be provided notification of initiation of treatment with a patient even if no method exists to send the notification electronically in a manner compliant with the Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.); and (v) require the treating pharmacist to obtain a patient history and, in the case of administration of vaccines to a minor, provide written notice to the minor's parent or guardian that the minor should visit a pediatrician annually.

Issues: The primary advantage to the public is access to health care for certain diseases and conditions at more locations, including a patient's local pharmacy. There are no disadvantages to the public. No primary advantages or disadvantages to the agency or the Commonwealth exist.

Department of Planning and Budget's Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. Among other changes, Chapters 790² and 791 of the 2022 Acts of Assembly expanded the conditions for which pharmacists can initiate treatment. The Board of Pharmacy (board) therefore proposes to amend the Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians to conform it with the amendments made by the legislation to the Code of Virginia.

Background. All of the proposed amendments to the regulation are essentially identical to the changes made to the Code of Virginia by the legislation.³ Those amendments include the following:

For persons 18 years of age or older, the list of drugs and devices that a pharmacist may initiate treatment with, dispense, or administer is expanded to include (i) vaccines for COVID-19; and (ii) nicotine replacement and other tobacco-cessation therapies, including controlled substances as defined in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), together with appropriate patient counseling; and

Both the legislation and the proposed regulation also added that the pharmacist must have a bona fide pharmacist-patient relationship with the person 18 years of age or older. Section 54.1-3303 of the Code of Virginia states that a bona fide practitioner-patient relationship exists "if the practitioner has (i) obtained or caused to be obtained a medical or drug history of the patient; (ii) provided information to the patient about the benefits and risks of the drug being prescribed; (iii) performed or caused to be performed an appropriate examination of the patient, either physically or by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically; and (iv) initiated additional interventions and follow-up care, if necessary, especially if a prescribed drug may have serious side effects."

In addition, for persons three years of age or older a pharmacist may initiate treatment with, dispense, or administer (i) vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention and vaccines for COVID-19; and (ii) tests for COVID-19 and other coronaviruses.

Further, a pharmacist who administers a vaccination to a minor shall provide written notice to the parent or guardian that the minor should visit a pediatrician annually.

For a patient of any age, a pharmacist who initiates treatment with or dispenses or administers a drug or device shall notify the patient's primary health care provider, even if no method exists to send the notification electronically in a manner compliant with the federal Health Insurance Portability and Accountability Act, provided that the patient consents to such notification.

Pharmacists who initiate treatment with, dispense, or administer a drug, device, controlled paraphernalia, or other supplies or equipment shall obtain a history from the patient, including questioning the patient for any known allergies, adverse reactions, contraindications, or health diagnoses or conditions that would be adverse to the initiation of treatment, dispensing, or administration.

Finally, it is established that a pharmacist may initiate treatment with, dispense, or administer drugs, devices, controlled paraphernalia, and other supplies and equipment through telemedicine services, as defined in § 38.2-3418.16 of the Code of Virginia, in compliance with all requirements of § 54.1-3303 of the Code of Virginia and consistent with the applicable standard of care.

Estimated Benefits and Costs. In terms of requirements and opportunities, the proposed amendments to the regulation are essentially identical to the amendments in the legislation. Because the statutory language already requires these changes, amending the regulation would have no impact beyond better informing readers of the regulation of those requirements and opportunities.

Businesses and Other Entities Affected. The 1,756 pharmacies in the Commonwealth and the 16,064 licensed pharmacists in the Commonwealth, as well as patients with whom they initiate treatment, are potentially affected by the legislation.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁴ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As the proposed amendments neither increase costs nor reduce net revenue for any entity, no adverse impact is indicated.

Small Businesses⁵ Affected.⁶ The proposed amendments do not adversely affect small businesses.

Localities⁷ Affected.⁸ The proposed amendments neither disproportionally affect any particular localities nor introduce costs for local governments.

Projected Impact on Employment. The proposed amendments do not affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments do not affect the use and value of private property or real estate development costs.

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¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²See https://lis.virginia.gov/cgi-bin/legp604.exe?221+sum+SB672.

³There are additional changes in the legislation that are not pertinent to the regulation.

⁴Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁵Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁶If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁷"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁸Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

Pursuant to Chapters 790 and 791 of the 2022 Acts of Assembly, the proposed amendments expand the conditions for which a pharmacist can initiate treatment. The proposed amendments (i) require the pharmacist to have a bona fide pharmacist-patient relationship with the patient with whom the pharmacist initiates treatment; (ii) add nicotine replacement therapy and other tobacco-cessation therapies as drugs and therapies with which a pharmacist can initiate treatment for an adult 18 years of age or older; (iii) allow a pharmacist to initiate treatment for patients three years of age and older by administering vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention, vaccines for COVID-19, and tests for COVID-19 and other coronaviruses; (iv) require practitioners to provide notification of initiation of treatment with a patient even if no method exists to send the notification electronically in a manner compliant with the Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.); and (v) require the treating pharmacist to obtain a patient history and, in the case of administration of vaccines to a minor, provide the minor's parent or guardian written notice that the minor should visit a pediatrician annually.

18VAC110-21-46. Initiation of treatment by a pharmacist.

A. Pursuant to § 54.1-3303.1 of the Code of Virginia, a pharmacist may initiate treatment with, dispense, or administer the following drugs and devices to persons 18 years of age or older with whom the pharmacist has a bona fide pharmacist-patient relationship:

1. Naloxone or other opioid antagonist, including such controlled paraphernalia as defined in § 54.1-3466 of the Code of Virginia as may be necessary to administer such naloxone or other opioid antagonist;

2. Epinephrine;

3. Injectable or self-administered hormonal contraceptives, provided the patient completes an assessment consistent with the United States Medical Eligibility Criteria for Contraceptive Use;

4. Prenatal vitamins for which a prescription is required;

5. Dietary fluoride supplements, in accordance with recommendations of the American Dental Association for prescribing of such supplements for persons whose drinking water has a fluoride content below the concentration recommended by the U.S. Department of Health and Human Services;

6. Drugs and devices as defined in § 54.1-3401 of the Code of Virginia, controlled paraphernalia as defined in § 54.1-3466 of the Code of Virginia, and other supplies and equipment available over the counter covered by the patient's health carrier when the patient's out-of-pocket cost is lower than the out-of-pocket cost to purchase an over-the-counter equivalent of the same drug, device, controlled paraphernalia, or other supplies or equipment;

7. Vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention or that have a current emergency use authorization from the U.S. Food and Drug Administration and vaccines for COVID-19;

8. Tuberculin purified protein derivative for tuberculosis testing; and

9. Controlled substances for the prevention of human immunodeficiency virus, including controlled substances prescribed for pre-exposure and post-exposure prophylaxis pursuant to guidelines and recommendations of the Centers for Disease Control and Prevention;

10. Nicotine replacement and other tobacco-cessation therapies, including controlled substances as defined in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), together with appropriate patient counseling; and

11. Tests for COVID-19 and other coronaviruses.

B. Notwithstanding the provisions of § 54.1-3303 of the Code of Virginia, a pharmacist may initiate treatment with, dispense, or administer the following drugs and devices to persons three years of age or older:

1. Vaccines included on the Immunization Schedule published by the Centers for Disease Control and Prevention and vaccines for COVID-19; and

2. Tests for COVID-19 and other coronaviruses.

The provisions of this subsection will become effective upon expiration of the provisions of the federal Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 related to the vaccination and COVID-19 testing of minors.

C. Pharmacists who initiate treatment with, dispense, or administer a drug or, device, controlled paraphernalia, or other supplies or equipment pursuant to subsection subsections A and B of this section shall:

1. Follow the statewide protocol adopted by the board for each drug, device, controlled paraphernalia, or other supplies or equipment.

2. Notify the patient's primary health care provider that treatment has been initiated with such drug, device, controlled paraphernalia, or other supplies or equipment or that such drug, device, controlled paraphernalia, or other supplies or equipment have been dispensed or administered to the patient, provided that the patient consents to such notification. No pharmacist shall limit the ability of notification to be sent to the patient's primary care provider by requiring use of email that is secure or compliant with the federal Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.) (HIPAA). If the patient does not have a primary health care provider, the pharmacist shall counsel the patient regarding the benefits of establishing a relationship with a primary health care provider and, upon request, provide information regarding primary health care providers, including federally qualified health centers, free clinics, or local health departments serving the area in which the patient is located. If the pharmacist is initiating treatment with, dispensing, or administering injectable or self-administered hormonal contraceptives, the pharmacist shall counsel the patient regarding seeking preventative care, including (i) routine well-woman visits, (ii) testing for sexually transmitted infections, and (iii) pap smears. If the pharmacist is administering a vaccine pursuant to this section, the pharmacist shall report such administration to the Virginia Immunization Information System in accordance with the requirements of § 32.1-46.01 of the Code of Virginia.

3. Maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:

a. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or the patient's personal representative; or

b. Records that are required by contractual obligation or federal law to be maintained for a longer period of time.

4. Perform the activities in a manner that protects patient confidentiality and complies with the Health Insurance Portability and Accountability Act, 42 USC § 1320d et seq HIPAA.

5. Obtain a history from the patient, including questioning the patient for any known allergies, adverse reactions, contraindications, or health diagnoses or conditions that would be adverse to the initiation of treatment, dispensing, or administration.

6. If administering a vaccination to a minor pursuant to subdivision B 1 of this section, provide written notice to the minor's parent or guardian that the minor should visit a pediatrician annually.

D. A pharmacist may initiate treatment with, dispense, or administer drugs, devices, controlled paraphernalia, and other supplies and equipment pursuant to this section through telemedicine services, as defined in § 38.2-3418.16 of the Code of Virginia, in compliance with all requirements of § 54.1-3303 of the Code of Virginia and consistent with the applicable standard of care.