Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VIII - Unit Dose Dispensing Systems › Section 18VAC110-20-425 - Robotic pharmacy systems

Current through Register Vol. 40, No. 24, July 15, 2024
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.