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Virginia Administrative Code (Last Updated: January 10, 2017) |
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Title 18. Professional and Occupational Licensing |
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Agency 110. Board of Pharmacy |
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Chapter 20. Regulations Governing the Practice of Pharmacy |
Section 425. Robotic pharmacy systems
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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 bar-coded 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 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;
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. Appropriately investigating, identifying and correcting sources of discrepancies or errors associated with the robotic pharmacy system; and
h. Maintaining quality assurance reports.
5. Pharmacists shall perform a daily random check of medications or compliance packaging picked by the robot for 5.0% of all patients' bins and 5.0% of all first doses or cart updates. Documentation of this check shall include the pharmacist's initials for each medication checked and a description of all discrepancies found.
6. All manual picks shall be checked by pharmacists.
7. If the robot picks an incorrect medication, the pharmacy shall immediately institute a 100% check of all doses or compliance packages and shall immediately report the error to the board. The 100% check procedure shall continue until such time as the pharmacy provides documentation to the board showing that the cause of the error has been determined and addressed and that the robot is no longer making errors, and the board allows the pharmacy to return to a reduction in checking.
8. Quarterly quality assurance reports demonstrating the accuracy of the robot shall be maintained. At a minimum, these reports shall include:
a. A summary indicating the date and description of all discrepancies that include but are not limited to 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. The total number of doses packaged or compliance packages prepared for the robotic pharmacy system and total number of doses or compliance packages picked by the robot during the quarter.
c. The total number of doses or compliance packages picked by the robot that were checked in conducting the 5.0% checks.
d. Dates and time associated with any scheduled or unanticipated downtime with an explanation of the problem to include the time span of the downtime and the resolution.
9. All unanticipated downtime shall be immediately reported to the board.
10. 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.
Historical Notes
Derived from Volume 17, Issue 07, eff. January 17, 2001; amended, Virginia Register Volume 25, Issue 24, eff. September 2, 2009; Volume 29, Issue 25, eff. September 26, 2013.