18VAC110-20-490. Automated devices for dispensing and administration of drugs.
A. A hospital may use automated devices for the
dispensing and administration of drugs pursuant to § 54.1-3301 of the Code of
Virginia and §§ 54.1-3401 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
The following conditions shall apply:
B. Policy and procedure manual; access codes.
1. 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.
2. Personnel allowed access to an automated dispensing device shall have a specific access code that records 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.
C. Distribution of drugs from the pharmacy.
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 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.
D. Distribution of drugs from the device.
3. 1. 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show patient name, drug name and strength, dose withdrawn, dose to be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. The record shall be filed in chronological
order from date of issue.
2. 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.
E. Discrepancy reports. 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.
F. Reviews and audits.
1. The PIC or his designee shall conduct at least a monthly review for compliance with written policy and procedures that are consistent with § 54.1-3434.02 A of the Drug Control Act for security and use of the automated dispensing devices, to include procedures for timely termination of access codes when applicable, accuracy of distribution from the device, and proper recordkeeping.
4. 2. 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.
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 If a pharmacy has an ongoing method
for perpetually monitoring drugs in Schedule 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 his designee shall conduct at least a monthly audit to review administration of Schedule II through V drugs from each automated dispensing device as follows:
c. a. 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 The review shall
include all Schedule II-V 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. b. 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. 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.
c. The PIC or his 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, but is not limited to, 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 his designee shall maintain a record of compliance with the reviews and audits in accordance with subsection H of this section.
6. G. Inspections. 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. The PIC or his 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 their 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.
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. 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. 9. 1. 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 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. b. 2. Distribution and delivery records and
required signatures initials may be generated or maintained
electronically provided: (1) 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. (2) b. The records are maintained in a read-only
format that cannot be altered after the information is recorded. (3) c. The system used is capable of producing a
hard-copy printout of the records upon request. c. 3. Schedule II-V II through V
distribution and delivery records may only also be stored offsite
or electronically as described in subdivisions 9 a and b of this section
in compliance with requirements of subdivision 1 of this subsection and
if authorized by DEA or in federal law or regulation. d. 4. 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.