Titles of Regulations: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-150).

18VAC110-21. Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians (adding 18VAC110-21-46).

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

Public Hearing Information:

February 7, 2022 - 8:45 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Commonwealth Conference Center, Suite 201, Board Room 2, Henrico, VA 23233.

Public Comment Deadline: March 4, 2022.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific statutory mandate for regulations governing the initiation of treatment by pharmacists with certain drugs and devices is found in § 54.1-3303.1 of the Code of Virginia.

Purpose: The purpose of the regulation is to ensure that a pharmacist who initiates treatment for patients follows a protocol that would render such dispensing to be low risk for patient harm. The rules establishing protocols, appropriate notification of primary care providers, maintenance of records, and patient privacy are necessary to ensure this activity protects the health and safety of patients who receive such treatment from pharmacists.

Substance: The substantive provision in the proposed regulation is the addition of 18VAC110-21-46, which sets out the listing of drugs and devices a pharmacist is authorized to initiate under § 54.1-3303.1 of the Code of Virginia and the requirements for such initiation of treatment, including adherence to established protocols, notification to medical providers, maintenance of records, and protection of patient privacy.

Issues: The advantage to the public will be access to certain prescription drugs and devices directly from a pharmacist rather than being required to go to a health care practitioner with prescriptive authority and incur additional cost. There should be no disadvantages to the public. A pharmacist who follows the protocols established for initiation of treatment would be providing drugs and devices that are considered to be low risk for any patient harm. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 731 of the 2020 Acts of Assembly (legislation), an emergency regulation became effective on January 3, 2021, that allows pharmacists to dispense and administer certain drugs and devices to persons 18 years of age or older in accordance with specified requirements.

The emergency regulation will expire on July 2, 2022. Also pursuant to the legislation, the Board of Pharmacy proposes to replace the emergency regulation with an identical permanent regulation.

Background. Amongst other new text, Chapter 731 added the following to the Code of Virginia:

"§ 54.1-3303.1. Initiating of treatment with and dispensing and administering of controlled substances by pharmacists.

A. Notwithstanding the provisions of § 54.1-3303, a pharmacist may initiate treatment with, dispense, or administer the following drugs and devices to persons 18 years of age or older in accordance with a statewide protocol developed by the Board in collaboration with the Board of Medicine and the Department of Health and set forth in regulations of the Board:

1. Naloxone or other opioid antagonist, including such controlled paraphernalia, as defined in § 54.1-3466, 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; and

6. Medications 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."

The proposed regulation is essentially identical to the legislative text. As instructed by the legislation, statewide protocols were developed by the Board in collaboration with the Board of Medicine and the Department of Health for all of the drugs and devices listed. These protocols are currently posted on the Board's website.¹

Chapter 731 also added the following to § 54.1-3303.1.

"B. A pharmacist who initiates treatment with or dispenses or administers a drug or device pursuant to this section shall notify the patient's primary health care provider that the pharmacist has initiated treatment with such drug or device or that such drug or device has been dispensed or administered to the patient, provided that the patient consents to such notification. 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."

Again, the proposed regulation is essentially identical to the legislative text.

Estimated Benefits and Costs. By mirroring the legislation, the proposed regulation essentially confers the same benefits found in the statute. Namely, by allowing pharmacists to dispense and administer the specified drugs and devices, patients potentially benefit in three ways: 1) saving the time required to obtain and go to a doctor's appointment in order to get a prescription, 2) saving the fees associated with the doctor's appointment, and 3) reducing the cost of obtaining medications 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.

Naloxone is an opioid antagonist used for the complete or partial reversal of opioid overdose, including respiratory depression.² Epinephrine is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.³ Enabling pharmacists to administer these drugs without a physician's prescription could potentially be lifesaving in some circumstances.

The protocols jointly created with the Board of Medicine and the Department of Health for the pharmacists to follow should help minimize risk that pharmacists would improperly initiate treatment with, dispense, or administer the specified drugs and devices. The requirement in the new § 54.1-3303.1 that the pharmacist who initiates treatment with or dispenses or administers the specified drugs or devices notifies the patient's primary health care provider, provided that the patient consents to such notification, should help continuity of care. Likewise, the requirements that if: 1) the patient does not have a primary health care provider, the pharmacist counsels 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, and 2) the pharmacist is initiating treatment with, dispensing, or administering injectable or self-administered hormonal contraceptives, the pharmacist counsels the patient regarding seeking preventative care, including (i) routine well-woman visits, (ii) testing for sexually transmitted infections, and (iii) pap smears, should help encourage patients to pursue and find appropriate ongoing health care services.

Businesses and Other Entities Affected. There are approximately 8,600 licensed pharmacists with a Virginia address and 1,789 pharmacies in the Commonwealth.⁴ It is unclear how many pharmacists and pharmacies will choose to provide this service to their patients. Only those that elect to initiate treatment for patients would be affected by the legislation and proposed amendments to the regulation.

Since the administering of the specified drugs and devices would be optional for pharmacists, the proposal does not produce any costs.

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

Localities⁶ Affected.⁷ Localities with comparatively high opioid addiction rates may be particularly affected in that pharmacists could administer naloxone to someone brought into their pharmacy experiencing an opioid overdose. The proposal does not introduce costs for local governments.

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

Effects on the Use and Value of Private Property. The legislation and the proposed regulation would likely spur some pharmacists to dispense and administer some, in not all of the drugs and devices specified in the legislation and proposed regulation. This may have a moderate positive impact on the value of the associated pharmacies. The proposed amendments do not affect real estate development costs.

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¹See https://www.dhp.virginia.gov/Pharmacy/

²Source: www.rxlist.com

³Source: www.webmd.com

⁴Source: Department of Health Professions

⁵Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

⁶"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.

⁷§ 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 of the Department of Planning and Budget.

Summary:

Pursuant to Chapter 713 of the 2020 Acts of Assembly, the proposed amendments (i) list drugs and devices that may be initiated by a pharmacist for a patient older than 18 years of age and (ii) provide the protocol to notify a primary care provider, maintain patient records, and protect patient privacy.

18VAC110-20-150. Physical standards for all pharmacies.

A. The prescription department shall not be less than 240 square feet. The patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines shall not be considered a part of the minimum 240 square feet. The total area shall be consistent with the size and scope of the services provided.

B. Access to stock rooms, rest rooms, and other areas other than an office that is exclusively used by the pharmacist shall not be through the prescription department. A rest room in the prescription department, used exclusively by pharmacists and personnel assisting with dispensing functions, may be allowed provided there is another rest room outside the prescription department available to other employees and the public. This subsection shall not apply to prescription departments in existence prior to November 4, 1993.

C. The pharmacy shall be constructed of permanent and secure materials. Trailers or other moveable facilities or temporary construction shall not be permitted.

D. The entire area of the location of the pharmacy practice, including all areas where drugs are stored, shall be well lighted and well ventilated; the proper storage temperature shall be maintained to meet USP-NF specifications for drug storage.

E. The prescription department counter work space shall be used only for the compounding and dispensing of drugs and necessary recordkeeping.

F. A sink with hot and cold running water shall be within the prescription department. A pharmacy issued a limited-use permit that does not stock prescription drugs as part of its operation is exempt from this requirement.

G. Adequate refrigeration facilities equipped with a monitoring thermometer for the storage of drugs requiring cold storage temperature shall be maintained within the prescription department if the pharmacy stocks such drugs.

H. A pharmacy stocking drugs requiring cold storage temperature shall record the temperature daily and adjust the thermostat as necessary to ensure an appropriate temperature range. The record shall be maintained manually or electronically for a period of two years.

I. The physical settings of a pharmacy in which a pharmacist initiates treatment with, dispenses, or administers drugs and devices pursuant to § 54.1-3303.1 of the Code of Virginia and 18VAC110-21-46 shall protect patient confidentiality and comply with the Health Insurance Portability and Accountability Act, 42 USC § 1320d et seq.

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:

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; and

6. Medications 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.

B. Pharmacists who initiate treatment with, dispense, or administer a drug or device pursuant to subsection A of this section shall:

1. Follow the statewide protocol adopted by the board for each drug or device.

2. Notify the patient's primary health care provider that treatment has been initiated with such drug or device or that such drug or device has been dispensed or administered to the patient, provided that the patient consents to such notification. 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.

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.