TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Proposed Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-555).

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

Public Hearing Information:

June 25, 2024 - 9:06 a.m. - Department of Health Professions, 9960 Mayland Drive, Suite 201, Board Room Four, Henrico, Virginia 23233.

Public Comment Deadline: August 16, 2024.

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 of the Board of Pharmacy are promulgated under § 54.1-2400 of the Code of Virginia, which authorizes health regulatory boards to promulgate regulations that are reasonable and necessary to effectively administer the regulatory system.

Purpose: The board determined that the petitioner correctly identified a potential hazard in the storage of stat or emergency use medications under 18VAC110-20-540 or 18VAC110-20-550. Stat or emergency use drugs stored in an automatic dispensing device (ADD) would contain an electronic record of access to those drugs, while the current tackle-box style storage systems do not. For some facilities, such as nursing homes, ADDs are not used because the only drugs stored on the premises are stat or emergency use medication. Patient and drug security may be increased through utilization of ADDs when exempted from certain requirements that would unacceptably delay the administration of life-saving drugs for patients.

Additionally, the change as adopted by the board treats stat drugs and drugs that would be kept in an emergency drug kit the same in that the drugs may be accessed prior to receiving electronic authorization from the pharmacist. Under current language, stat drugs are treated differently from drugs that would be in an emergency drug kit when these drugs are stored in an ADD. Drugs that would be in an emergency drug kit may be accessed prior to receiving electronic authorization from the pharmacist, while stat drugs may not.

Substance: The amendments remove the reference to drugs that would be stocked in a stat drug box from the requirements of subdivision 4 a of 18VAC110-20-555. Subdivision 4 c of 18VAC110-20-555 is amended to include drugs that would be included in a stat drug box, thereby treating drugs that would be contained in a stat drug box the same as drugs that would be kept in an emergency kit.

Issues: The primary advantage to the public is security of the drug supply in that diversion of stat-use or emergency medications will be less likely while preserving quick access to these medications. There are no disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

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. In response to a petition for rulemaking,² the Board of Pharmacy (board) proposes to allow nursing homes to use stat drugs from an automated dispensing device (ADD), prior to receiving electronic authorization from the pharmacist, provided that delay in use of the drug could harm the patient.

Background. Generally, nursing homes contract with a pharmacy for the drugs their residents need. The traditional delivery of drugs from the pharmacy to the nursing home is usually accomplished by a courier service with which the pharmacy contracts. The courier service delivery could either be on a regular schedule, or also on demand, depending on the urgency of the need. In addition, the pharmacy always makes a stat box and an emergency box of drugs available at the nursing home. Stat drugs are those in which a delay in initiating therapy may result in harm to the patient such as antibiotics; and emergency drugs are those used for life threatening emergencies, such as an inhaler. The stat and emergency drug boxes are traditionally similar to tackle-boxes secured with a plastic seal. The pharmacy restocks these boxes by replacing opened kits with sealed kits on a regular basis. Both containers are sealed and contain drugs that have already been prescribed for the patient,³ but their presence in a nursing home allows therapy to be initiated "prior to the receipt of ordered drugs from the pharmacy." As an alternative to these boxes, stat or emergency drugs may be made available at nursing homes through an ADD. The use of ADDs in nursing homes for dispensing drugs has become increasingly more common. An ADD is a secured dispensing machine about the size of a small refrigerator with electronic connectivity to the pharmacy. The regulation already allows ADDs to be used in nursing homes, and the drugs in an ADD are replenished by a pharmacy technician who travels to the nursing home to restock it. Currently, the regulation allows a nurse to access a traditional tackle-box stat box containing stat drugs without prior electronic authorization from a pharmacist. However, under the current language a nurse may not access such drugs from an ADD without prior electronic authorization from the pharmacy. The petitioner brought to the attention of the board the discrepancy wherein the prior authorization requirement is based on how the drugs are stored, which the board acknowledged and affirmed. The board now proposes to exempt the stat drugs from prior pharmacist authorization requirement when they are accessed through an ADD.

Estimated Benefits and Costs. The proposed changes remove the prior authorization requirement if a stat drug is dispensed from an ADD, provided that "a delay in administration of the drug could result in harm to the patient." As mentioned, ADD is an alternative or supplemental way of storing and delivering stat and emergency drugs at nursing homes. The removal of the prior authorization requirement would make use of ADDs more attractive for stat drug distribution at nursing homes as it would eliminate an administrative inconvenience. According to Department of Health Professions (DHP), the cost of a simple ADD varies between $4,000 and $7,000, but a more technologically sophisticated ADD could cost as much as $30,000 to $100,000. Since the use of an ADD is optional, and pharmacies rather than nursing homes would most likely purchase them and keep at the nursing homes, a pharmacy would start using an ADD only if the benefits of an ADD exceed its costs. Thus, we can reliably infer that the proposed changes do not create any additional compliance costs for the pharmacies contracted with nursing homes.

To the extent pharmacies shift their stat drug delivery at nursing homes toward use of ADDs, several indirect effects could be expected. For example, the board concluded that patient and drug security may both be increased through utilization of ADDs because stat or emergency use drugs stored in an ADD would contain an electronic record of access to those drugs, while the current tackle-box style storage systems do not.⁴ The board also notes that the removal of prior authorization requirement would speed up the ability to access stat drugs from an ADD and thus benefit the patients. As a result, diversion of stat-use medications would be less likely while preserving quick access to these medications. Also, a shift away from courier drug delivery would reduce the need for courier services and increase demand for pharmacy technicians. Finally, makers of ADDs would likely see an increase in demand for their machines to the extent pharmacies start using them in response to the proposed changes.

Businesses and Other Entities Affected. The proposed changes would primarily effect nursing homes, the pharmacies with which they contract, and their residents who use stat drugs. According to Virginia Department of Health, there are nearly 300 licensed nursing homes containing over 33,000 beds.⁵ None of the affected entities appear to be disproportionately affected.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁶ 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 noted, the proposed changes would make use of ADDs more attractive by removing prior authorization from the pharmacy when dispensing a stat drug for urgent use and the use of ADDs is optional. Thus, no direct adverse impact is indicated.

Small Businesses⁷ Affected.⁸ The proposed amendments do not adversely affect small businesses.

Localities⁹ Affected.¹⁰ The proposed amendments apply to affected entities in all localities in Virginia.

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

Effects on the Use and Value of Private Property. Although the proposed changes may incentivize the use of ADDs for stat drug distribution at nursing homes, no direct impact on the use and value of private property or real estate development costs is expected.

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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.

² https://townhall.virginia.gov/l/viewpetition.cfm?petitionid=361.

³ See page 9 at https://townhall.virginia.gov/l/GetFile.cfm?File=30\4694\7885\Agency Statement_DHP_7885_v1.pdf.

⁴ See page 2 at https://townhall.virginia.gov/l/GetFile.cfm?File=30\5966\9953\Agency Statement_DHP_9953_v3.pdf.

⁵ https://www.vdh.virginia.gov/licensure-and-certification/division-of-long-term-care-services/.

⁶ Pursuant 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.

⁷ Pursuant 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."

⁸ If 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.

⁹ "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.

¹⁰ Section 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:

The proposed amendments (i) remove the prior authorization requirement if a stat drug is dispensed from an automatic dispensing device (ADD), provided that a delay in administration of the drug could result in harm to the patient; and (ii) include drugs that would be included in a stat drug box, thereby treating drugs that would be contained in a stat drug box the same as drugs that would be kept in an emergency kit. This action is in response to a petition for rulemaking.

18VAC110-20-555. Use of automated dispensing devices.

Nursing homes licensed pursuant to Chapter 5 (§ 32.1-123 et seq.) of Title 32.1 of the Code of Virginia may use automated drug dispensing systems, as defined in § 54.1-3401 of the Code of Virginia, upon meeting the following conditions:

1. Drugs placed in an automated drug dispensing system in a nursing home shall be under the control of the pharmacy providing services to the nursing home, the pharmacy shall have online communication with and control of the automated drug dispensing system, and access to any drug for a patient shall be controlled by the pharmacy.

2. A nursing home without an in-house pharmacy shall obtain a controlled substances registration prior to using an automated dispensing system, unless the system is exclusively stocked with drugs that would be kept in a stat-drug box pursuant to 18VAC110-20-550 or an emergency drug kit pursuant to 18VAC110-20-540 and are solely administered for stat or emergency administration.

3. For facilities not required to obtain a controlled substance registration, access to the automated dispensing device shall be restricted to a licensed nurse, pharmacist, or prescriber, or a registered pharmacy technician for the purpose of stocking or reloading.

4. Removal of drugs from any automated drug dispensing system for administration to patients can only be made pursuant to a valid prescription or lawful order of a prescriber under the following conditions:

a. A No drug, including a drug that would be stocked in a stat-drug box pursuant to subsection B of 18VAC110-20-550, may not be administered to a patient from an automated dispensing device until a pharmacist has reviewed the prescription order and electronically authorized the access of that drug for that particular patient in accordance with the order.

b. The PIC of the provider pharmacy shall ensure that a pharmacist who has online access to the system is available at all times to review a prescription order as needed and authorize administering pursuant to the order reviewed.

c. Drugs that would be stocked in an emergency drug kit pursuant to 18VAC110-20-540 or a stat drug box pursuant to subsection B of 18VAC110-20-550 may be accessed prior to receiving electronic authorization from the pharmacist, provided that the absence of the drugs would threaten the survival of the patients patient or that a delay in administration of the drug could result in harm to the patient.

d. Automated dispensing devices shall be capable of producing a hard-copy record of distribution that shall show patient name, drug name and strength, dose withdrawn, dose to be administered, date and time of withdrawal from the device, and identity of person withdrawing the drug.

5. Drugs placed in automated dispensing devices shall be in the manufacturer's sealed original unit dose or unit-of-use packaging or in repackaged unit-dose containers in compliance with the requirements of 18VAC110-20-355 relating to repackaging, labeling, and records.

6. Prior to the removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated dispensing device, which shall include the date; drug name, dosage form, and strength; quantity; nursing home; a unique identifier for the specific device receiving drugs; and initials of the pharmacist checking the order of drugs to be removed from the pharmacy and the records of distribution for accuracy.

7. At the direction of the PIC, drugs may be loaded in the device by a pharmacist or a pharmacy technician adequately trained in the proper loading of the system.

8. At the time of loading, the delivery record for all Schedules II through VI drugs shall be signed by a nurse or other person authorized to administer drugs from that specific device, and the record returned to the pharmacy.

9. At the time of loading any Schedules II through V drug, the person loading will verify that the count of that drug in the automated dispensing device is correct. Any discrepancy noted shall be recorded on the delivery record and immediately reported to the PIC, who shall be responsible for reconciliation of the discrepancy or the proper reporting of a loss.

10. The PIC of the provider pharmacy or his the PIC's designee shall conduct at least a monthly audit to review distribution and administration of Schedules II through V drugs from each automated dispensing device as follows:

a. The audit shall reconcile records of all quantities of Schedules II through V drugs dispensed from the pharmacy with records of all quantities loaded into each device to detect whether any drugs recorded as removed from the pharmacy were diverted rather than being placed in the proper device.

b. A discrepancy report shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be resolved by the PIC or his the PIC's designee within 72 hours of the time the discrepancy was discovered or, if determined to be a theft or an unusual loss of drugs, shall be immediately reported to the board in accordance with § 54.1-3404 E of the Drug Control Act.

c. The audit shall include a review of a sample of administration records from each device per month for possible diversion by fraudulent charting. A sample shall include all Schedules II through V drugs administered for a time period of not less than 24 consecutive hours during the audit period.

d. The audit shall include a check of medical records to ensure that a valid order exists for a random sample of doses recorded as administered.

e. The audit shall also check for compliance with written procedures for security and use of the automated dispensing devices, accuracy of distribution from the device, and proper recordkeeping.

f. The hard copy distribution and administration records printed out and reviewed in the audit shall be initialed and dated by the person conducting the audit. If nonpharmacist personnel conduct the audit, a pharmacist shall review the record and shall initial and date the record.

11. Automated dispensing devices shall be inspected monthly by pharmacy personnel to verify proper storage, proper location of drugs within the device, expiration dates, the security of drugs and validity of access codes.

12. Personnel allowed access to an automated dispensing device shall have a specific access code which that records the identity of the person accessing the device.

13. The PIC of the pharmacy providing services to the nursing home shall establish, maintain, and assure ensure compliance with written policy and procedure for the accurate stocking and proper storage of drugs in the automated drug dispensing system, accountability for and security of all drugs maintained in the automated drug dispensing system, preventing unauthorized access to the system, tracking access to the system, complying with federal and state regulations related to the storage and dispensing of controlled substances, maintaining patient confidentiality, maintaining required records, and assuring ensuring compliance with the requirements of this chapter. The manual shall be capable of being accessed accessible at both the pharmacy and the nursing home.

14. All records required by this section shall be filed in chronological order from date of issue and maintained for a period of not less than two years. Records shall be maintained at the address of the pharmacy providing services to the nursing home, except:

a. Manual Schedule VI distribution records may be maintained in offsite storage or electronically as an electronic image that provides an exact image of the document that is clearly legible, provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

b. Distribution and delivery records and required signatures may be generated or maintained electronically, provided:

(1) The system being used has the capability of recording an electronic signature that is a unique identifier and restricted to the individual required to initial or sign the record.

(2) The records are maintained in a read-only format that cannot be altered after the information is recorded.

(3) The system used is capable of producing a hard-copy printout of the records upon request.

c. Schedules II through V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 14 a and 14 b of this section if authorized by DEA or in federal law or regulation.

d. Hard-copy distribution and administration records that are printed and reviewed in conducting required audits may be maintained offsite or electronically, provided that (i) they can be readily retrieved upon request; provided (ii) they are maintained in a read-only format that does not allow alteration of the records; and provided (iii) a separate log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.