18 Va. Admin. Code § 110-20-555

Current through Register Vol. 41, No. 6, November 4, 2024

Section 18VAC110-20-555 - [Effective until 2/11/2026] Use of automated dispensing devices and remote dispensing devices in nursing homes

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 and remote 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 or remote 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 pharmacy that is not located within the nursing home it services shall obtain a controlled substances registration issued in the name of the pharmacy at the address of the nursing home and a registration from the Drug Enforcement Administration, if required, prior to stocking drugs in Schedules II through VI, unless the automated drug dispensing system or remote dispensing 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. Access to the automated drug dispensing system or remote dispensing system shall be restricted to a licensed nurse, pharmacist, or prescriber or a registered pharmacy technician pursuant to designation by the PIC or pharmacist on duty.

4. Removal of drugs from any automated drug dispensing system or remote 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 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 drug dispensing system or remote dispensing system 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 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.

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of distribution and dispensing, if applicable, that shall show patient name, drug name and strength, dose or quantity withdrawn, dose to be administered, if applicable, date and time of withdrawal from the device, and identity of person withdrawing the drug.

5. Drugs placed in automated drug dispensing systems 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. Drugs authorized pursuant to § 54.1-3434.02 of the Code of Virginia may be placed into and removed from automated drug dispensing systems or remote dispensing systems. Pharmacies servicing remote dispensing systems that package and label drugs for a specific patient may repackage drugs into bulk bins that are verified for accuracy by a pharmacist pursuant to 18VAC110-20-355. Drugs intended to be administered by the patient or a person not licensed to administer drugs must fully comply with the labeling requirements in §§ 54.1-3410 and 54.1-3463 of the Code of Virginia and board regulations. Directions for use may only be abbreviated when drugs are administered exclusively by persons licensed to administer drugs.

7. Prior to the removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated drug dispensing system and remote dispensing system, 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.

8. 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.

9. 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.

10. 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 drug dispensing system or remote dispensing system 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.

11. Remote dispensing systems that dispense patient-specific drugs into an envelope shall satisfy compliance with 18VAC110-20-340 if the medication is assigned an expiration date of no more than 48 hours from the date of the packaging in an envelope and is not self-administered.

12. Remote dispensing systems that dispense multiple medications into a single container for a specific patient shall include a medication description as set forth in 18VAC110-20-340 on the label, medication envelope, or the medication run report.

13. Pharmacist verification of a patient-specific dispensed drug as required in 18VAC110-20-270 from a remote dispensing system is waived if a pharmacist verified the drug placed in the bulk bin that is placed in the device and the device incorporates sufficient technology assistance to ensure accuracy of the dispensed drug.

14. The PIC of the provider pharmacy or the PIC's designee shall conduct at least a monthly audit to review distribution, administration, and dispensing, if applicable, of Schedules II through V drugs from each automated drug dispensing system and remote dispensing system 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 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 § 54.1-3404E of the Drug Control Act.

c. The audit shall include a review of a sample of administration and dispensing records, if applicable, from each device per month for possible diversion by fraudulent charting. A sample shall include all Schedules II through V drugs administered and dispensed 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 or dispensed.

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, dispensing, 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.

15. Automated drug dispensing systems and remote dispensing systems 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.

16. Personnel allowed access to an automated drug dispensing system or remote dispensing system shall have a specific access code that records the identity of the person accessing the device.

17. The PIC of the pharmacy providing services to the nursing home shall establish, maintain, and ensure compliance with written policy and procedure for the accurate stocking and proper storage of drugs in the automated drug dispensing system and remote dispensing system, accountability for and security of all drugs maintained in the 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 ensuring compliance with the requirements of this chapter. The manual shall be capable of being accessed at both the pharmacy and the nursing home.

18. 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 off site or electronically as described in subdivisions 18 a and 18 b of this section if authorized by DEA or in federal law or regulation.

d. Hard-copy distribution, administration, and dispensing records that are printed and reviewed in conducting required audits may be maintained off site 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 drug dispensing system or remote dispensing system being audited, the time period covered by the audit and review, and the initials of all reviewers.

18 Va. Admin. Code § 110-20-555

Derived from Virginia Register Volume 15, Issue 8, eff. February 3, 1999; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Amended, Virginia Register Volume 35, Issue 03, eff. 10/31/2018; Amended, Virginia Register Volume 41, Issue 01, eff. 8/12/2024, exp. 2/11/2026 (Emergency).

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