18 Va. Admin. Code § 110-20-490

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

Section 18VAC110-20-490 - [Effective until 2/11/2026] Automated devices for dispensing and administration of drugs

A. A hospital, state facility as defined in § 37.2-100 of the Code of Virginia that is established pursuant to Title 37.2 of the Code of Virginia, facility as defined in § 37.2-100 of the Code of Virginia that is licensed by the Department of Behavioral Health and Developmental Services and provides site-based crisis stabilization services, or other facility authorized by the board may use automated drug dispensing systems and remote dispensing systems for the dispensing and administration of drugs pursuant to § 54.1-3301 of the Code of Virginia and §§ 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. Unless prohibited under federal law, a remote dispensing system that solely stores drugs labeled and verified by the provider pharmacist for patients to obtain medication may be placed within close proximity of a permitted pharmacy or at a location issued a controlled substance registration pursuant to § 54.1-3420.2 of the Code of Virginia in a secure area under constant surveillance to ensure security of drugs, confidentiality of protected health information, and appropriate recordkeeping.

B. Policy and procedure manual; access codes.

1. Proper use of the automated drug dispensing system and remote dispensing system and means of compliance with requirements shall be set forth in the pharmacy's policy and procedure manual, which shall include provisions for granting and terminating user access.

2. Personnel allowed access to an automated drug dispensing system and remote dispensing system shall have a specific access code or other means to record the identity of the person accessing the device. The device may verify access codes using biometric identification or other coded identification after the initial log-on in order to eliminate sharing or theft of access codes.

3. If a key may be used to access the automated drug dispensing system or remote dispensing system and the provider pharmacy is not located within the facility, a key may be maintained in the possession of the director of nursing or an individual designated by the director of nursing who is licensed to administer medications.

C. Distribution of drugs from the pharmacy.

1. Except when the automated drug dispensing system or remote dispensing system is used exclusively for administration of drugs for emergencies, a pharmacy located outside of the hospital or facility it services shall first obtain a controlled substance registration issued in the name of the pharmacy at the address of the hospital or facility and a registration from the Drug Enforcement Administration, if required, prior to stocking controlled substances in Schedules II through VI.

2. 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. Pharmacies using a remote dispensing device that only stores patient-specific dispensed drugs for patients to obtain medication may place pharmacist-verified dispensed drug into the device.

3. Prior to removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated drug dispensing system or remote dispensing system. The delivery record shall include the date; drug name, dosage form, and strength; quantity; hospital or facility unit and a unique identifier for the specific device receiving the drug; initials of the person loading the automated drug dispensing system or remote dispensing system; and initials of the pharmacist checking the drugs to be removed from the pharmacy and the delivery record for accuracy.

4. 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 pharmacist in charge, who shall be responsible for ensuring reconciliation of the discrepancy or properly reporting of a loss.

D. Distribution and dispensing of drugs from the device.

1. Automated drug dispensing and remote dispensing systems shall be capable of producing a hard-copy record of distribution that shall show patient name, drug name and strength, dose withdrawn, date and time of withdrawal from the device, and identity of person withdrawing the drug. The record shall be filed in chronological order from date of issue or maintained electronically.

2. If an automated drug dispensing system or remote dispensing system 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.

3. 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.

4. 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 B on the label, medication envelope, or the medication run report.

5. 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 to ensure accuracy of the dispensed drug.

E. Discrepancy reports. A discrepancy report for all Schedules II through V drugs and any drugs of concern, as defined in § 54.1-3456.1 of the Code of Virginia, shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be initiated or 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.

F. Reviews and audits.

1. The PIC or the PIC's designee shall conduct at least a monthly review for compliance with written policy and procedures that are consistent with § 54.1-3434.02A of the Drug Control Act for security and use of the automated dispensing system and remote dispensing system, to include procedures for timely termination of access codes when applicable, accuracy of distribution and dispensing from the device, and proper recordkeeping.

2. The PIC or the PIC's designee shall conduct at least a monthly audit to review distribution and dispensing 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 drug recorded as removed from the pharmacy was diverted rather than placed in the proper device.

b. If a pharmacy has an ongoing method for perpetually monitoring drugs in Schedules II through V to ensure drugs dispensed from the pharmacy have been loaded into the device and not diverted, such as with the use of perpetual inventory management software, then the audit required in this subsection may be limited to the discrepancies or exceptions as identified by the method for perpetually monitoring the drugs.

3. The PIC or the PIC's designee shall conduct at least a monthly audit to review the dispensing and administration records of Schedules II through V drugs from each automated drug dispensing system and remote dispensing system as follows:

a. The audit shall include a review of administration and dispensing records, if applicable, for each device per month for possible diversion by fraudulent charting. The review 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.

b. 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.

c. The PIC or the PIC's designee shall be exempt from requirements of this audit if reconciliation software that provides a statistical analysis is used to generate reports at least monthly. The statistical analysis shall be based on:

(1) Peer-to-peer comparisons of use for that unit or department; and

(2) Monitoring of overrides and unresolved discrepancies.

d. The report shall be used to identify suspicious activity, which includes usage beyond three standard deviations in peer-to-peer comparisons. A focused audit of the suspicious activity and individuals associated with the activity shall be performed whenever suspicious activity is identified from the reports.

4. The PIC or the PIC's designee shall maintain a record of compliance with the reviews and audits in accordance with subsection H of this section.

G. Inspections. 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. The PIC or the PIC's designee shall maintain documentation of the inspection in accordance with subsection H of this section. With the exception of a monthly physical review of look-alike and sound-alike drugs stored within matrix drawers or open access areas within the device, such monthly inspection shall not require physical inspection of the device if the device is capable of and performs the following:

1. At least daily monitoring of refrigerator or freezer storage with documented temperature ranges, variances, and resolutions;

2. Automatic identification and isolation of the location of each drug within the device using a machine readable product identifier, such as barcode technology, and generation of a report verifying the applicable settings;

3. Electronic tracking of drug expiration dates and generation of proactive reports allowing for the replacement of drugs prior to the expiration date; and

4. Electronic detection of the opening of the device, identification of the person accessing the device, automatic denial of access to the device during malfunctions and mechanical errors, and generation of reports of any malfunction and mechanical error.

H. Records.

1. All records required by this section shall be 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 or facility except manual Schedule VI distribution records, reports auditing for indications of suspicious activity, and focused audits, all of which 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.

2. Distribution and delivery records and required initials may be generated or maintained electronically provided:

a. 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.

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

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

3. Schedules II through V distribution and delivery records may also be stored off site or electronically in compliance with requirements of subdivision 1 of this subsection and if authorized by DEA or in federal law or regulation.

4. Hard-copy distribution, dispensing, and administration records that are printed and reviewed in conducting required audits may be maintained at an offsite 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 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 § 110-20-490

Derived from VR530-01-1 §10.7, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 14, Issue 8, eff. February 4, 1998; Volume 15, Issue 21, eff. August 4, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 27, Issue 11, eff. March 17, 2011; Amended, Virginia Register Volume 30, Issue 10, eff. February 12, 2014; Amended, Virginia Register Volume 36, Issue 06, eff. 12/11/2019; 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.