18 Va. Admin. Code § 110-20-425

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

Section 18VAC110-20-425 - Robotic pharmacy systems

A. Consistent with 18VAC110-20-420, a pharmacy providing services to a hospital or a long-term care facility and operating a robotic pharmacy system that dispenses drugs in barcoded unit dose or compliance packaging is exempted from 18VAC110-20-270 C, provided the accuracy of the final dispensed prescription product complies with a written quality assurance plan and requirements of this chapter. The following requirements for operation of a robotic pharmacy system shall apply:

1. Pharmacists shall review for accuracy and appropriateness of therapy all data entry of prescription orders into the computer operating the system.

2. The packaging, repackaging, stocking, and restocking of the robotic pharmacy system shall be performed by pharmacy technicians or pharmacists.

3. Pharmacists shall verify and check for the accuracy of all drugs packaged or repackaged for use by the robot by a visual check of both labeling and contents prior to stocking the drugs in the robotic pharmacy system. A repackaging record shall be maintained in accordance with 18VAC110-20-355 A, and the verifying pharmacist shall initial the record. Packaging and labeling, including the appropriate beyond-use date, shall conform to requirements of this chapter and current USP-NF standards.

4. A written policy and procedure must be maintained and complied with and shall include at a minimum procedures for ensuring:

a. Accurate packaging and repackaging of all drugs for use in the robotic pharmacy system, to include properly labeled barcodes, and method for ensuring pharmacist verification of all packaged and repacked drugs compliant with this chapter and assigned barcodes;

b. Accurate stocking and restocking of the robotic pharmacy system;

c. Removing expired drugs;

d. Proper handling of drugs that may be dropped by the robotic pharmacy system;

e. Performing routine maintenance of robotic pharmacy system as indicated by manufacturer's schedules and recommendations;

f. Accurate dispensing of drugs via robotic pharmacy system for cart fills, first doses, and cart fill updates during normal operation and during any scheduled or unscheduled downtime;

g. Accurate recording of any scheduled or unanticipated downtime with an explanation of the problem to include the time span of the downtime and the resolution;

h. Appropriately performing an analysis to investigate, identify, and correct sources of discrepancies or errors associated with the robotic pharmacy system; and

i. Maintaining quality assurance reports.

5. All manual picks shall be checked by pharmacists.

6. If it is identified that the robot selected an incorrect medication, the pharmacy shall identify and correct the source of discrepancy or error in compliance with the pharmacy's policies and procedures prior to resuming full operations of the robot. An investigation of the cause of the event shall be completed, and the outcome of the corrective action plan shall be summarized and documented in a readily retrievable format.

7. Quarterly quality assurance reports demonstrating the accuracy of the robot shall be maintained. At a minimum, these reports shall include a summary indicating the date and description of all discrepancies that include discrepancies involving the packaging, repackaging, and dispensing of drugs via the robotic pharmacy system found during that quarter plus a cumulative summary since initiation of the robotic pharmacy system.

B. Intravenous admixture robotics may be utilized to compound drugs in compliance with § 54.1-3410.2 of the Code of Virginia and 18VAC110-20-321; however, a pharmacist shall verify the accuracy of all compounded drugs pursuant to 18VAC110-20-270 B.

C. Medication carousels functioning with or without a robotic pharmacy system in a hospital may be utilized to store and guide the selection of drugs to be dispensed or removed from the pharmacy under the following conditions:

1. The entry of drug information into the barcode database for assignment of a barcode to an individual drug shall be performed by a pharmacist who shall verify the accuracy of the barcode assignment.

2. A pharmacist is not required to verify the accuracy of a patient-specific drug removed from a medication carousel if:

a. The entry of the order for a patient-specific drug into the pharmacy's dispensing software is verified by a pharmacist for accuracy and is electronically transmitted to the medication carousel; and

b. The patient-specific drug removed from the medication carousel by a pharmacy technician is verified for accuracy by the pharmacy technician who shall scan each drug unit removed from the medication carousel prior to dispensing, and a nurse or other person authorized to administer the drug scans each drug unit using barcode technology to verify the accuracy of the drug prior to administration of the drug to the patient. The requirement for scanning by a nurse or other person authorized to administer is waived in an emergent event when a delay would cause imminent harm to the patient; or

c. The patient-specific drug is checked by two pharmacy technicians if a hospital does not have the capability for the drug to be verified for accuracy by scanning each drug unit. The first pharmacy technician removing the patient-specific drug from the medication carousel shall perform a visual inspection of each drug unit for accuracy and then double check the accuracy by scanning an individual unit of each drug. A second, different pharmacy technician shall perform a separate visual inspection of each drug unit and scan an individual unit of each drug for final verification. A nurse or other person authorized to administer the drug shall scan each drug unit prior to administration, unless the drug is being administered to treat an emergent event when a delay would cause imminent harm to the patient.

3. A pharmacist is not required to verify the accuracy of the drug removed from the medication carousel by a pharmacy technician if that drug is intended to be placed into an automated drug dispensing system as defined in § 54.1-3401 of the Code of Virginia or distributed to another entity legally authorized to possess the drug if:

a. The list of drugs to be removed from the medication carousel for loading or replenishing an individual automated dispensing system is electronically transmitted to the medication carousel; and

b. The drug removed from the medication carousel is verified for accuracy by the pharmacy technician by scanning each drug unit removed from the medication carousel prior to leaving the pharmacy and delivering the drug to the automated drug dispensing system or distributed to another entity, and a nurse or other person authorized to administer the drug scans each drug unit using barcode technology to verify the accuracy of the drug prior to administration of the drug to the patient. If the drug is placed into an automated drug dispensing system located within a hospital, or the entity receiving the distributed drug, wherein a nurse or other person authorized to administer the drug will not be able to scan each drug unit using barcode technology to verify the accuracy of the drug prior to patient administration, then a second verification for accuracy shall be performed by a pharmacy technician by scanning each drug unit at the time of placing the drugs into the automated dispensing system; or

c. The drug intended for restocking an automated dispensing device is checked by two pharmacy technicians if the hospital does not have the capability for scanning each drug unit. The first pharmacy technician removing the drug for restocking from the medication carousel shall perform a visual inspection of each drug unit for accuracy and then double check the accuracy by scanning an individual unit of each drug of the automated dispensing device restock order prior to leaving the pharmacy. A second, different pharmacy technician shall perform a separate visual inspection of each drug unit and scan an individual unit for each drug of the restock order for final verification at the time of placing the drug into the automated dispensing device. A nurse or other person authorized to administer the drug shall scan each drug unit prior to administration, unless the drug is being administered to treat an emergent event where a delay would cause imminent harm to the patient.

4. A pharmacist shall verify the accuracy of all drugs that are manually removed from the medication carousel by a pharmacy technician without the use of barcode scanning technology to verify the accuracy of the selection of the drug product prior to dispensing those drugs or those drugs leaving the pharmacy.

5. A pharmacist shall perform a daily random check for verification of the accuracy of 5.0% of drugs prepared that day utilizing the medication carousel technology. A manual or electronic record, from which information can be readily retrieved, shall be maintained and shall include:

a. The date of verification;

b. A description of all discrepancies identified, if any; and

c. The initials of the pharmacist verifying the accuracy of the process.

D. All records required by this section shall be maintained at the address of the pharmacy for a minimum of two years. 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 of the board.

18 Va. Admin. Code § 110-20-425

Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; amended, Virginia Register Volume 25, Issue 24, eff. September 2, 2009; Volume 29, Issue 25, eff. September 26, 2013; Amended, Virginia Register Volume 36, Issue 06, eff. 12/11/2019; Amended, Virginia Register Volume 39, Issue 6, eff. 12/7/2022.

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