Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-590).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 1, 2015.

Effective Date: July 16, 2015.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific authority to control prescription drugs is found in Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Purpose: The goal of the amended regulation is a less burdensome requirement for drugs in correctional facilities that will facilitate more efficient medical care for the patients who are inmates in those facilities. In modifying 18VAC110-20-590, the board adopted a requirement for floor stock of controlled substances that have little or no potential for abuse or diversion. Therefore, the proposed change will accommodate better patient care without jeopardizing public health and safety.

Rationale for Using Fast-Track Process: The board has opted to use the fast-track rulemaking process because the amended regulation (i) is less restrictive, (ii) was supported unanimously and without discussion by board members, and (iii) will not be controversial.

Substance: The substantive change to existing regulation is an allowance for a correctional facility to be able to maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. Such stock must be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

Issues: The primary advantage of the regulatory action is cost and time savings to correctional facilities and provider pharmacies as they strive to meet the medical needs of inmates in the system. The purpose for the requirement can be accomplished with a less burdensome and costly regulation that ensures public protection. There are no disadvantages to the public. There are no advantages or disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to allow correctional facilities to maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed and administered by authorized persons.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The Board proposes to allow correctional facilities to maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed and administered by authorized persons. Currently, correctional facilities can maintain these drugs only in a stat-drug box.

This change is in response to a request from the Department of Corrections (DOC). According to DOC staff, the fiscal benefit of being able to stock these drugs is not significant. However, the Board expects more efficient medical care of the patients who are inmates in those facilities. In addition, the Board believes these substances have little or no potential for abuse or diversion. Therefore, the proposed change is expected to accommodate better patient care without jeopardizing public health and safety.

Businesses and Entities Affected. The proposed change will primarily affect correctional facilities with clinics in Virginia. According to DOC, approximately 50 prisons, correctional units, and community correctional centers may be affected. In addition, there are 64 local jails, 4 juvenile correctional centers, and 24 juvenile detention homes that may be affected.

Localities Particularly Affected. The regulation applies throughout the Commonwealth.

Projected Impact on Employment. The proposed change is unlikely to affect employment.

Effects on the Use and Value of Private Property. The proposed change is unlikely to affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed change is unlikely to affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed change is unlikely to adversely affect small businesses.

Real Estate Development Costs. The proposed change is unlikely to affect real estate development costs.

Legal Mandate. General: 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 Number 14 (2010). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulation would apply,

• the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected,

• the projected costs to affected businesses or entities to implement or comply with the regulation, and

• the impact on the use and value of private property.

Small Businesses: If the proposed regulation will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• 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,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• 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, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC110-20, Regulations Governing the Practice of Pharmacy.

Summary:

The proposed amendments allow a correctional facility to maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and to be administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. The floor stock must be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

18VAC110-20-590. Drugs in correctional facilities.

A. All prescription drugs at any correctional facility shall be obtained only on an individual prescription basis from a pharmacy and subject to the following conditions:

1. Notwithstanding the allowances in subsections B, C, and D of this section, prescription drugs shall be obtained only on an individual prescription basis.

2. All prepared drugs shall be maintained in a suitable locked storage area with only the person responsible for administering the drugs having access.

2. 3. Complete and accurate records shall be maintained of all drugs received, administered and discontinued. The administration record shall show the:

a. Patient name;

b. Drug name and strength;

c. Number of dosage units received;

d. Prescriber's name; and

e. Date, time and signature of the person administering the individual dose of drug.

3. 4. All unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Such drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within 30 days of discontinuance.

a. The provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability.

b. The drug administration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility.

c. Drugs may be returned to pharmacy stock in compliance with the provisions of 18VAC110-20-400.

d. Other drugs shall be disposed of or destroyed by the provider pharmacy in accordance with local, state, and federal regulations.

4. 5. Alternatively, drugs for destruction may be forwarded by a pharmacist directly from the correctional facility to a returns company after performing the audit required by subdivision 3 4 a of this subsection and ensuring the proper maintenance of the administration records.

B. Emergency and stat-drug box. An emergency box and a stat-drug box may be prepared for a correctional facility served by the pharmacy pursuant to 18VAC110-20-540 and 18VAC110-20-550 provided that the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, or physician assistants.

C. Prescription A correctional facility may maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and shall be administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

D. Except for drugs in an emergency box, stat-drug box, or a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline, prescription drugs, including but not limited to vaccines, may be floor-stocked only at a medical clinic or surgery center that is part of a correctional facility and that is staffed by one or more prescribers during the hours of operation, provided the clinic first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and 18VAC110-20-720.