Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-550).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 23, 2009.

Effective Date: January 7, 2010.

Agency Contact: Elizabeth Scott Russell, 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 scotti.russell@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia establishes the general powers and duties of health regulatory boards, including the Board of Pharmacy, and the board's responsibility to promulgate regulations. The specific authority to control prescription drugs in the Commonwealth 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 purpose of the amended regulation is to address a public health need in many nursing homes that have become "sub-acute hospitals." Nursing homes are seeing an increased number of acute patients with many health complications. Many are admitted postsurgically after an orthopedic procedure (hip replacement, etc.), and the adequate and timely administration of pain medication is critical to their well-being and recovery. Patients who have their pain controlled have fewer complications and heal faster. Patients may be admitted when the pharmacy is not open, and it may take many hours for the prescriber's order to be filled by the provider pharmacy and delivered to the facility for administration. In the best of circumstances, there is a gap of time between the patient's arrival at the nursing home and the delivery of prescription pain medication from the provider pharmacy. By amending the current regulation, the board has addressed this issue in a manner that is responsive to patient health needs but also retains safeguards against diversion and medication error. Only persons licensed to administer, dispense, or prescribe may access a stat-drug box, and a valid prescription or order from a prescriber must be received prior to removal of any drug from the stat-drug box.

Rationale for Using Fast-Track Process: The amendment is being sought by a coalition of nursing homes, provider pharmacies, and professional associations serving the long-term care industry. There is a sense of urgency about the need for the amendment to alleviate pain and enhance patient comfort and recovery, and there is consensus about the language being proposed. No opposition is expected.

Substance: The substantive provision is deletion of the prohibition against the stat-drug box in a long-term care facility containing Schedule II drugs.

Issues: The primary advantage to the public is that the inclusion of Schedule II drugs in a stat-drug box in a long-term care facility will allow facilities and physicians to ensure their patients receive pain medications appropriately and expeditiously. There are no disadvantages to the public. Any concern about diversion is addressed by the security measures and accountability required, and only licensed nurses, pharmacists, or prescribers can access drugs in a stat-drug box. There are no advantages or disadvantages to the agency or the Commonwealth.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to allow long term care facilities to keep a stock of Schedule II drugs so that new patients can receive prescribed pain medication in a timely manner. The Board also proposes to allow long term care facilities to stock greater quantities of Schedule III through V drugs so that they are on hand to be used as prescribed for patients.

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

Estimated Economic Impact. Current regulations allow long term care facilities to keep up to five doses of each therapeutic class of Schedule III through V drugs in a locked stat-drug box. These drugs are there for patients who might suffer harm if the taking of prescribed medication is delayed because provider pharmacies need time to fill and deliver prescriptions.

The Board proposes to increase the number of medication doses that can be kept in the stat-drug box, to 20 solid dosage units per schedule, and to allow Schedule II drugs to be kept in the stat-drug box. No entities are likely to incur any costs on account of these regulatory changes as they do not mandate any change in current practice. Patients in long term care facilities are likely to benefit from these changes in several ways. First, increasing the number of doses of any given medication that can be kept in a stat-drug box will allow more patients to be given prescribed drugs in a time frame that is therapeutically indicated. Second, patients who are in need of Schedule II medications (mainly for treatment of pain) will be able to receive those medications from the stat-drug box rather than waiting in pain for their prescriptions to be filled and delivered.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that all long term care facilities with nursing staff licensed to dispense prescribed medications, as well as patients to whom medication will be dispensed, are affected by these proposed regulations. The Department of Health currently licenses 276 such facilities.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. This regulatory action will likely have no impact on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory action will likely have no effect on the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Small businesses in the Commonwealth are unlikely to incur any costs on account of this regulatory action.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. 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 Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the 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. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget on fast-track amendments to regulations for the stat-drug boxes in long-term care facilities.

Summary:

The amendments allow a stat-drug box in a long-term care facility to contain doses of Schedule II drugs for the relief of acute pain and offer more flexibility in the drugs that are maintained in a stat-drug box, depending on the needs of patients in the facility.

18VAC110-20-550. Stat-drug box.

An additional drug box called a stat-drug box may be prepared by a pharmacy to provide for initiating therapy prior to the receipt of ordered drugs from the pharmacy. Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the stat-drug box. Additionally, a valid prescription or lawful order of a prescriber must exist prior to the removal of any drug from the stat-drug box. A stat-drug box shall be subject to the following conditions:

1. The box is sealed in such a manner that will preclude the loss of drugs.

a. The dispensing pharmacy must have a method of sealing such boxes so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box and maintain the record until such time as the seal is replaced.

c. In lieu of seals, a box with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.

2. The box shall have a form to be filled out upon opening the box and removing contents to write the name of the person opening the box, the date, the time, and the name and quantity of item(s) removed. When the stat-drug box has been opened, it is returned to the pharmacy.

3. There shall be a listing of the contents of the box maintained in the pharmacy and also attached to the box in the facility. This same listing shall become a part of the policy and procedure manual of the facility served by the pharmacy.

4. The drug listing on the box shall bear an expiration date for the box. The expiration date shall be the day on which the first drug in the box will expire.

5. The contents of the box shall be limited to those drugs in which a delay in initiating therapy may result in harm to the patient.

a. The listing of drugs contained in the stat-drug box shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the long-term care facility.

b. The stat-drug box shall contain no Schedule II drugs.

c. b. The stat-drug box shall contain no more than one 20 solid dosage units per schedule of Schedule III II through V drug in each therapeutic class and no more than five doses of each drugs except that one unit of liquid, not to exceed 30 ml, may be substituted for a solid dosage unit. If the unit of a liquid that may contain more than one dose is removed from the stat-drug box pursuant to a patient order, the remainder shall be stored with that patient's other drugs, may be used for subsequent doses administered to that patient, and shall not be administered to any other patient.