Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-425, 18VAC110-20-500; adding 18VAC110-20-505).

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

Effective Date: December 7, 2022.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Summary:

The amendments for 18VAC110-20-425 allow any interested hospital to use technology commonly referred to as medication carousels to store and guide the selection of drugs to be dispensed or removed from the pharmacy. A pharmacist will not be required to manually check the accuracy of a drug removed from the carousel by a pharmacy technician when the technology is used in compliance with the regulation to verify accuracy. Because medication carousels rely on the use of barcode scanning to verify drug accuracy, certain safeguards are included in the proposed amendments regarding a verification check by a pharmacist for the accuracy of the barcode assignment to an individual drug.

The amendments also add a new section, 18VAC110-20-505, to incorporate another technology already approved for innovative pilot programs: the use of radio-frequency identification (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency medical services personnel or other kits used as floor stock throughout a hospital. The responsibilities of a pharmacist and the duties of a pharmacy technician in the use of RFID technology are included in the amendments.

Changes to the proposed regulation include (i) waiving the requirement for scanning by a nurse or person authorized to administer in an emergent event when a delay would cause imminent harm and (ii) allowing a hospital that does not have the capacity for the drug to be verified for accuracy by scanning each unit, to allow a patient-specific drug to first be verified by two pharmacy technicians and after such verification, requiring a nurse or other person authorized to administer to scan each drug unit prior to administration.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

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.

8. 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.

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.

18VAC110-20-500. Licensed emergency medical services (EMS) agencies program.

A. The pharmacy may prepare a kit for a licensed EMS agency provided:

1. The PIC of the hospital pharmacy shall be responsible for all prescription drugs and Schedule VI controlled devices contained in this kit. A Except as authorized in 18VAC110-20-505, a pharmacist shall check each kit after filling and initial the filling record certifying the accuracy and integrity of the contents of the kit.

2. The kit is sealed, secured, and stored in such a manner that it will deter theft or loss of drugs and devices and aid in detection of theft or loss.

a. The hospital pharmacy shall have a method of sealing the kits such that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The pharmacy shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

c. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy may be used.

3. Drugs and devices may be administered by an EMS provider upon an oral or written order or standing protocol of an authorized medical practitioner in accordance with § 54.1-3408 of the Code of Virginia. Oral orders shall be reduced to writing by the EMS provider and shall be signed by a medical practitioner. Written standing protocols shall be signed by the operational medical director for the EMS agency. A current copy of the signed standing protocol shall be maintained by the pharmacy participating in the kit exchange. The EMS provider shall make a record of all drugs and devices administered to a patient.

4. When the drug kit has been opened, the kit shall be returned to the pharmacy and exchanged for an unopened kit. The record of the drugs administered shall accompany the opened kit when exchanged. An accurate record shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year. A pharmacist, pharmacy technician, or nurse shall reconcile the Schedule II, III, IV, or V drugs in the kit at the time the opened kit is returned. A record of the reconciliation, to include any noted discrepancies, shall be maintained by the pharmacy for a period of two years from the time of exchange. The theft or any other unusual loss of any Schedule II, III, IV, or V controlled substance shall be reported in accordance with § 54.1-3404 of the Code of Virginia.

5. Accurate records of the following shall be maintained by the pharmacy on the exchange of the drug kit for a period of one year:

a. The record of filling and verifying the kit to include the drug contents of the kit, the initials of the pharmacist verifying the contents, the date of verification, a record of an identifier if a seal is used, and the assigned expiration date for the kit, which shall be no later than the expiration date associated with the first drug or device scheduled to expire.

b. The record of the exchange of the kit to include the date of exchange and the name of EMS agency and EMS provider receiving the kit.

6. Destruction of partially used Schedules II, III, IV, and V drugs shall be accomplished by two persons, one of whom shall be the EMS provider and the other shall be a pharmacist, nurse, prescriber, pharmacy technician, or a second EMS provider. Documentation shall be maintained in the pharmacy for a period of two years from the date of destruction.

7. The record of the drugs and devices administered shall be maintained as a part of the pharmacy records pursuant to state and federal regulations for a period of not less than two years.

8. Intravenous and irrigation solutions provided by a hospital pharmacy to an emergency medical services agency may be stored separately outside the kit.

9. Any drug or device showing evidence of damage or tampering shall be immediately removed from the kit and replaced.

10. In lieu of exchange by the hospital pharmacy, the PIC of the hospital pharmacy may authorize the exchange of the kit by the emergency department. Exchange of the kit in the emergency department shall only be performed by a pharmacist, nurse, or prescriber if the kit contents include Schedule II, III, IV, or V drugs.

B. A licensed EMS agency may obtain a controlled substances registration pursuant to § 54.1-3423 D of the Code of Virginia for the purpose of performing a one-to-one exchange of Schedule VI drugs or devices.

1. The controlled substances registration may be issued to a single agency or to multiple agencies within a single jurisdiction.

2. The controlled substances registration issued solely for this intended purpose does not authorize the storage of drugs within the agency facility.

3. Pursuant to § 54.1-3434.02 of the Code of Virginia, the EMS provider may directly obtain Schedule VI drugs and devices from an automated drug dispensing device.

4. If such drugs or devices are obtained from a nurse, pharmacist, or prescriber, it shall be in accordance with the procedures established by the pharmacist-in-charge, which shall include a requirement to record the date of exchange, name of licensed person providing drug or device, name of the EMS agency and provider receiving the drug or device, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.

5. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs or devices, Schedule II, III, IV, or V drugs shall remain in a separate, sealed container and shall only be exchanged in accordance with provisions of subsection A of this section.

18VAC110-20-505. Use of radio-frequency identification.

A hospital pharmacy may use radio-frequency identification (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency medical services pursuant to 18VAC110-20-500 or other kits used as floor stock throughout the hospital under the following conditions:

1. A pharmacist shall be responsible for performing and verifying the accuracy of the following tasks:

a. The addition, modification, or deletion of drug information into the RFID database for assignment of a RFID tag to an individual drug; and

b. The development of the contents of the kit in the RFID database and the associated drug-specific RFID tags.

2. A pharmacy technician may place the RFID tag on the drugs, and a pharmacist shall verify that all drugs have been accurately tagged prior to storing the drugs in the pharmacy's inventory.

3. A pharmacy technician may remove RFID-tagged drugs from the pharmacy's inventory whose RFID tags have been previously verified for accuracy by a pharmacist and place the drugs into the kit's container. A pharmacy technician may then place the container into the pharmacy's device that reads the RFID tags to verify if the correct drugs have been placed into the container as compared to the list of the kit's contents in the RFID database.

4. A pharmacist shall perform a daily random check for verification of the accuracy of 5.0% of all kits prepared that day utilizing the RFID technology. A manual or electronic record from which information can be readily retrieved, shall be maintained that includes:

a. The date of verification;

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

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

5. Pharmacies engaged in RFID tagging of drugs shall be exempt from the requirements in subsection C of 18VAC110-20-490, subsection A of 18VAC110-20-460, and subsection A of 18VAC110-20-355.

6. All records required by this subsection shall be maintained for a period of one year from the date of verification by the pharmacist.