A Except as provided in 18VAC110-20-490(D), a pharmacist shall check all Schedule II-VI drugs delivered to a hospital unit as floor-stock before the drugs leave the pharmacy and shall initial or sign manually or electronically the record of distribution verifying the accuracy of the distribution.
B. A delivery receipt shall be obtained for Schedule II through V drugs supplied as floor stock. This record shall include the date, drug name and strength, quantity, hospital unit receiving drug and the manual or electronic signatures of the dispensing pharmacist and the receiving nurse.
C. A record of disposition/administration shall be used to document administration of Schedule II through V drugs when a floor stock system is used for such drugs. The record shall be returned to the pharmacy within three months of its issue. The PIC or his designee shall:
1. Match returned records with delivery receipts to verify that all records are returned;
2. Periodically audit returned administration records for completeness as to patient's names, dose, date and time of administration, signature or initials of person administering the drug, and date the record is returned;
3. Verify that all additions to inventory are recorded, that all additions to and deductions from inventory are correctly calculated, that sums carried from one record to the next are correctly recorded, and periodically verify that doses documented on administration records are reflected in the medical record; and
4. Initial the returned record.
D. All records required by this section shall be filed chronologically by date of issue, and retained for two years from the date of return at the address of the pharmacy. Schedule VI records may be maintained in offsite storage or 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. Schedule II-V records may only be stored offsite or electronically as described in this subsection if authorized by DEA or in federal law or regulation. The filing requirements of 18VAC110-20-240 A 1 for separation of Schedule II records shall be met for administration records if the Schedule II drugs are listed in a separate section on a page that contains other schedules 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 applicable.
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, which shall include provisions for granting and terminating user access.
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. The delivery record 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 Schedules 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 ensuring reconciliation of the discrepancy or properly reporting of a loss.
D. Distribution of drugs from a central warehouser or wholesale distributor.
Notwithstanding subsection (C)(1), a central warehouser or wholesale distributor may distribute Schedule VI drugs to hospitals to be placed in specific automated dispensing devices under the following conditions:
1. A pharmacist licensed in Virginia, employed by or otherwise working at the central warehouser or wholesale distributor, shall verify the accuracy of all Schedule VI drugs to be placed in specific automated dispensing devices within the hospital prior to delivery of the drugs directly to the hospital pharmacy;
2. A pharmacist at the hospital pharmacy shall not be required to: (i) verify the accuracy of these drugs prior to leaving the hospital pharmacy for delivery to the hospital unit as floor stock as required in 18VAC110-20-460(A), or (ii) initial the delivery record as required in 18VAC110-20-490(C)(1).
3. The central warehouser or wholesale distributor shall maintain a record of all Schedule VI drugs distributed to a hospital for placement in a specific automated dispensing device. The record shall include the date; drug name, dosage form, and strength; quantity; hospital name; hospital unit and a unique identifier for the specific automated dispensing device receiving the drug; and initials of the pharmacist employed by or working at the central warehouser or wholesale distributor who is responsible for verifying the drugs for accuracy;
4. The central warehouser or wholesale distributor shall provide an invoice to each hospital pharmacy indicating the drugs delivered to the hospital to be placed in a specific automated dispensing device;
5. A pharmacist or pharmacy technician at each hospital shall load the drugs into the specific automated dispensing device, each unit should be scanned, and the hospital pharmacy shall maintain a record which consists of the initials of the person loading the automated dispensing device;
6. A pharmacist licensed in Virginia, employed by or otherwise working at the warehouser or wholesale distributor, shall perform barcode linking of any drug to the related drug files in the hospital information system and automated dispensing device;
7. Each hospital receiving drugs from the central warehouser or wholesale distributor shall maintain at least a 90% barcode scanning rate for restocking automated dispensing devices. If the scanning rate for restocking the automated dispensing device is less than 90% for any quarter, the pharmacy at the hospital shall immediately reinstitute a 100% pharmacist verification process at the receiving pharmacy until a 90% scanning rate for a subsequent quarter is achieved and documented; and
8. The hospital pharmacy receiving such services from a central warehouser or wholesale distributor shall maintain quarterly reports containing the hospital's restocking barcode scanning rate, bedside barcode scanning rate, and any errors in drug product received from the central warehouser or wholesale distributor.
DE. Distribution of drugs from the device.
1. Automated dispensing devices in hospitals 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 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.
EF. 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 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. FG. 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.
2. The PIC or his designee shall conduct at least a monthly audit to review distribution of Schedules II through V drugs from each automated dispensing device 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 his designee shall conduct at least a monthly audit to review the dispensing and administration records of Schedules II through V drugs from each automated dispensing device as follows:
a. The audit shall include a review of administration records for each device per month for possible diversion by fraudulent charting. The review shall include all Schedules II through V drugs administered for a time period of not less than 24 consecutive hours during the audit period.
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.
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 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.
GH. 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.
1. All records required by this section shall be maintained for a period of not less than two years. Records required to be maintained by the pharmacy shall be maintained at the address of the pharmacy providing services to the hospital
except manual . Records required to be maintained by the warehouser or wholesale distributor shall be maintained at the address of the applicable facility. Manual Schedule VI distribution records, reports auditing for indications of suspicious activity, and focused audits, all of which and records required to be maintained by the warehouser or wholesale distributor distributing Schedule VI drugs to specific automated dispensing devices 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 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.