Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-540).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 27, 2016.

Effective Date: August 11, 2016.

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 in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) that are reasonable and necessary to administer effectively the regulatory system.

Purpose: The purpose of the planned regulatory action is to address an urgent problem. Omnicare, a CVS Health Company, provides long-term care pharmacy services to a diverse population of skilled nursing patients in Virginia to include subacute care for children. Specifically, the children in these facilities suffer from complex physical and neurological diseases and experience frequent seizures. As a result, nurses assigned to these pediatric units need immediate access to diazepam rectal gel in their emergency boxes. Limiting the access to this critical medication will most certainly threaten a successful patient outcome up to and including the survival of the patient. Unfortunately, current pharmacy regulation 18VAC110-20-550 does not allow a CIV rectal gel to be included in the contents allowed in the emergency box. The company requested the amendment to allow pharmacists to meet the needs of this fragile population. The request for limited access to the drug was approved to protect the health and safety of patients in a long-term care facility. Because 18VAC110-20-590 authorizes correctional facilities that employ one or more full-time physicians, nurses, or physician assistants to obtain an emergency kit in accordance with 18VAC110-20-540, patients in correctional facilities may also benefit from the inclusion of this drug in an emergency kit.

Rationale for Using Fast-Track Rulemaking Process: This action will not be controversial as it is limited to making a small dosage of a drug that can be lifesaving available in an emergency situation.

Substance: 18VAC110-20-540 is amended to allow a provider pharmacist, in consultation with medical and nursing staff, to include diazepam rectal gel in an emergency kit maintained in a long-term care facility. The amendment will also allow inmates in correctional facilities to potentially benefit from inclusion of this drug since 18VAC110-20-590 allows for an emergency kit under certain circumstances, consistent with 18VAC110-20-540.

Issues: The advantage to the public is availability of a drug that may be lifesaving to a small group of patients. There are no disadvantages to the public. There are no advantages or disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to amend this regulation to allow a provider pharmacist, in consultation with medical and nursing staff, to include diazepam rectal gel in an emergency kit maintained in a long-term care facility.

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

Estimated Economic Impact. The Regulations Governing the Practice of Pharmacy specify that pharmacists may prepare an emergency kit for a long-term care facility in which access to the kit is restricted to a licensed nurse, pharmacist, or prescriber under certain conditions.¹ The current regulation limits the contents of the kit to "drugs for administration by injection or inhalation only, except that Nitroglycerin SL may be included." The Board proposes to additionally allow diazepam rectal gel in the kit. Diazepam rectal gel is used in emergency situations to stop cluster seizures (episodes of increased seizure activity) in people who are taking other medications to treat epilepsy (seizures).²

Children and adults in long-term care facilities who suffer from complex physical and neurological diseases and experience frequent seizures would benefit from having immediate access to diazepam rectal gel in the facilities' emergency boxes. Under the current regulation the gel can only be obtained by prescription as needed. The proposed amendment will be beneficial in that it will likely help improve patient outcomes for patients having seizures by allowing for immediate access to the gel. Since the regulation authorizes correctional facilities that employ one or more full-time physicians, nurses, or physician assistants to obtain an emergency kit in accordance with the regulation, patients in correctional facilities may also benefit from the inclusion of this drug in an emergency kit. Since there is no apparent cost to the proposed amendment, the proposed addition of diazepam rectal gel to the allowable contents of emergency kits for long-term facilities creates a net benefit.

Businesses and Entities Affected. The proposed amendment potentially affects 162 skilled nursing facilities in the Commonwealth,³ as well as correctional facilities.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment does not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendment does not have significant effect on the use and value of private property.

Real Estate Development Costs. The proposed amendment does not affect real estate development costs.

Small Businesses:

Definition. Pursuant 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."

Costs and Other Effects. The proposed amendment does not significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendment does not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendment does not adversely affect businesses.

Localities. The proposed amendment does not adversely affect localities.

Other Entities. The proposed amendment does not adversely affect other entities.

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¹http://law.lis.virginia.gov/admincode/title18/agency110/chapter20
/section540/

²Source: U.S. National Library of Medicine (https://www.nlm.nih.gov/medlineplus/druginfo/meds/a605033.html)

³The number of affected facilities was estimated by Omnicare, a CVS Health Company, which supplies the facilities.

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 amendments allow a provider pharmacist, in consultation with medical and nursing staff, to include diazepam rectal gel in an emergency kit maintained in a long-term care facility.

18VAC110-20-540. Emergency drug kit.

The pharmacist providing services may prepare an emergency kit for a long-term care facility in which access to the kit is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the kit and only under the following conditions:

1. The contents of the emergency kit shall be of such a nature that the absence of the drugs would threaten the survival of the patients.

2. The contents of the kit shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the institutions and shall be limited to drugs for administration by injection or inhalation only, except that Nitroglycerin SL and diazepam rectal gel may be included.

3. The kit is sealed in such a manner that it will preclude any possible loss of the drug.

a. The dispensing pharmacy must have a method of sealing such kits 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 and/or, resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box or kit and maintain the record until such time as the seal is replaced.

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

4. The kit shall have a form to be filled out upon opening the kit and removing contents to write the name of the person opening the kit, the date, time and name and quantity of item(s) items removed. The opened kit is maintained under secure conditions and returned to the pharmacy within 72 hours for replenishing.

5. Any drug used from the kit shall be covered by a prescription, signed by the prescriber, when legally required, within 72 hours.