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 §§
54.1-3401 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show patient name, drug name and strength, dose withdrawn, dose to be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
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.