Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-490).

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: March 2, 2011.

Effective Date: March 17, 2011.

Agency Contact: Caroline Juran, RPh, Acting 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.

Section 54.1-3307 of the Code of Virginia provides the specific statutory authority for the Board of Pharmacy to regulate the practice of pharmacy including regulations pertaining to the safety and integrity of drugs.

Purpose: The petitioner who requested elimination of the requirement for nurses to sign for medications loaded into automated dispensing devices noted the requirement takes nurses away from patient care duties, which is clinically irresponsible as the nursing shortage continues. Hospital pharmacies utilize activity reports to verify that medications were actually loaded into the devices, and those reports provide a reliable source of accountability. Allowing nurses to stay focused on patient care without the distraction of other duties is essential to protect the health and safety of patients in hospitals.

Rationale for Using Fast-Track Process: This action is in response to a petition for rulemaking initially published in April 2009. In response to the petition, there were 31 comments in favor of eliminating the signing requirements; there were no comments in opposition. There were no comments on the Notice of Intended Regulatory Action during the 30-day comment period from October 26, 2009, to November 25, 2009. The members of the board unanimously agreed that the requirement could be eliminated because the log for the automated dispensing system establishes an adequate safeguard and acted to eliminate the requirement in subsection B of 18VAC110-20-490.

Since all comments have been supportive of the action and the board members have determined that there is no controversy and no public safety issue, the action is being submitted under the fast-track rulemaking process.

Substance: The fast-track action amends 18VAC110-20-490 to eliminate the requirement for a nurse or other person authorized to administer drugs to sign the delivery record of an automated dispensing device and allow a hospital to utilize the activity reports from the device as a check on medications loaded into the machine.

Issues: The advantage to the public is the elimination of a task that currently requires the attention of nurses on the floor in a hospital and takes them away from a focus on patient care. There is no value added to the signing task, and public safety will not be compromised by elimination of the task. There are no disadvantages to the public. Hospital pharmacies utilize activity reports to verify that drugs were actually loaded into the dispensing device; those reports are more reliable and provide needed accountability.

There are no advantages or disadvantage to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy proposes to no longer require that, at the time of loading automated drug dispensing devices in hospitals, the delivery record for all Schedule II through V drugs be signed by a nurse or other person authorized to administer drugs from that specific device.

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

Estimated Economic Impact. Pursuant to §§ 54.1-3301, 54.1-3401, and 54.1-3434.02 of the Code of Virginia and under specified conditions, hospitals may use automated devices for the dispensing and administration of drugs. One of the conditions under the current regulations is as follows: "At the time of loading, the delivery record for all Schedule II through V 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." The Board proposes to eliminate this condition. According to the Department of Health Professions, hospital pharmacies utilize activity reports to verify that medications were actually loaded into the devices and those reports provide a reliable source of accountability. Further, the time that nurses currently spend signing these records could be more productively used by providing direct care to patients. Thus the proposal to eliminate the nurse signature requirement should provide a net benefit.

Businesses and Entities Affected. The proposed elimination of the nurse signature requirement affects hospital pharmacies and nurses whose work currently involves interactions with hospital pharmacies, as well as hospital patients.

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

Projected Impact on Employment. The proposed elimination of the nurse signature requirement is unlikely to significantly affect total employment, but will allow nurses to use their time more productively.

Effects on the Use and Value of Private Property. The proposed elimination of the nurse signature requirement will allow nurses to use their time more productively at private hospitals (as well as at public hospitals).

Small Businesses: Costs and Other Effects. The proposed amendments do not significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not significantly affect small businesses.

Real Estate Development Costs. The proposed amendments do not significantly affect real estate development costs.

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 regulations to eliminate a requirement for nurses in hospitals to sign the delivery record of an automated dispensing device.

Summary:

In response to a petition for rulemaking, the Board of Pharmacy has amended its regulations pertaining to automated devices in hospitals for dispensing and administration of drugs to use the activity reports rather than having a nurse or other licensed person sign for loading and delivery of the drugs to the hospital floor.

18VAC110-20-490. Automated devices for dispensing and administration of drugs.

A hospital may use automated devices for the dispensing and administration of drugs pursuant to § 54.1-3301 of the Code of Virginia and §§ 54.3401 54.1-3401 and 54.1-3434.02 of the Drug Control Act and in accordance with 18VAC110-20-270, 18VAC110-20-420, or 18VAC110-20-460 as applicable. The following conditions shall apply:

1. Prior to 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; hospital unit and a unique identifier for the specific device receiving the drug; initials of the person loading the automated dispensing device; and initials of the pharmacist checking the drugs to be removed from the pharmacy and the delivery record for accuracy.

2. At the time of loading, the delivery record for all Schedule II through V 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.

3. 2. At the time of loading any Schedule 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 pharmacist in charge, who shall be responsible for reconciliation of the discrepancy or properly reporting of a loss.

4. 3. Automated dispensing devices in hospitals shall be capable of producing a hard-copy record of distribution which 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. 4. The PIC or his designee shall conduct at least a monthly audit to review distribution and administration of Schedule II through V drugs from each automated dispensing device as follows:

a. The audit shall reconcile records of all quantities of Schedule 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 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 Schedule II-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.

6. 5. If an automated dispensing device is used to obtain drugs for dispensing from an emergency room, a separate dispensing record is not required provided the automated record distinguishes dispensing from administration and records the identity of the physician who is dispensing.

7. 6. 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.

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

9. 8. Proper use of the automated dispensing devices and means of compliance with requirements shall be set forth in the pharmacy's policy and procedure manual.

10. 9. 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 hospital 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 records are 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. Schedule II-V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 10 9 a and 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 at an off-site location or electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format that does not allow alteration of the records; and provided 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.