18 Va. Admin. Code § 110-20-591

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

Section 18VAC110-20-591 - [Effective until 2/19/2026] Allowances for emergency medical services agencies to obtain drugs

A. This section contains specific provisions by which an EMS agency may obtain drugs for administration.

B. Unless prohibited by federal law, a pharmacy may prepare a kit for an EMS agency, provided:

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

2. The kit containing drugs in Schedules II through V is sealed, secured, and stored in such a manner that will deter theft or loss of drugs and aid in detection of theft or loss. Kits containing only drugs in Schedule VI are not required to be sealed but must be secured in a manner to deter theft or loss.

a. The 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. 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 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 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 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 pharmacy to an emergency medical services agency may be stored separately outside the kit.

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

10. In lieu of exchange by a 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, prescriber, or pharmacy technician if the kit contents include Schedule II, III, IV, or V drugs.

11. Drug kits shall be secured on the EMS vehicle or other EMS vehicle at all times, unless the vehicle is incapable of maintaining appropriate drug storage temperature or is out of service. The EMS agency is not required to obtain a controlled substances registration pursuant to § 54.1-3423D of the Code of Virginia to participate in a pharmacy kit exchange in accordance with this section unless the EMS agency needs to temporarily store a secured drug kit within the EMS building when a vehicle is incapable of maintaining appropriate drug storage temperature or is out of service and the EMS agency does not otherwise serve as a designated location of a current, active controlled substances registration. An alarm system consistent with requirements in 18VAC110-20-710 is not required under these conditions.

C. An EMS agency or regional EMS council that has been issued a controlled substances registration pursuant to 18VAC110-20-690 G and a registration from DEA in accordance with federal law may receive drugs in Schedules II through VI and deliver or transfer the drugs to any designated location of the registered EMS agency headquarters or regional EMS council. Delivery of the drugs shall not constitute wholesale distribution.

D. For sites that are not designated locations of the entity providing the drug, nothing shall preclude a hospital, EMS agency, or regional EMS council from transferring or distributing drugs in Schedule VI to another EMS agency, regional EMS council, or a designated location of either entity during a shortage of drugs or in an emergency.

E. A hospital, EMS agency, regional EMS council, and designated locations may deliver drugs in Schedules II through V to each other consistent with federal law in the event of shortages of such drugs, a public health emergency, or a mass casualty event. All entities transferring, delivering, and receiving drugs shall comply with recordkeeping requirements listed in 18VAC110-20-721.

F. In compliance with federal law, a hospital pharmacy may provide drugs to a hospital-owned EMS agency operating as an extension of the hospital pharmacy's DEA registration.

G. If an EMS agency that is not hospital owned has obtained a controlled substances registration and a DEA registration in accordance with federal law, a pharmacy may provide that EMS agency drugs for restocking an EMS vehicle or other EMS vehicle, provided all of the following criteria are met:

1. The registered or designated location of the agency operating the EMS vehicle or other EMS vehicle maintains the record of receipt of drugs in accordance with state and federal law.

2. The pharmacy maintains a record of the delivery to the EMS agency in accordance with state and federal law.

3. If the EMS vehicle or other EMS vehicle is primarily situated at a designated location of an EMS agency, the designated location notifies the registered location of the agency within 72 hours of the EMS vehicle or other EMS vehicle receiving drugs in Schedules II through V.

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

5. If such drugs 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 the drug, name of the EMS agency and provider receiving the drug, and assigned expiration date. Such record shall be maintained by the pharmacy for one year from the date of exchange.

6. If an EMS agency is performing a one-to-one exchange of Schedule VI drugs, such Schedule VI drugs shall remain in a separate container.

H. Schedule VI drugs stored on an EMS vehicle or other EMS vehicle are not required to be stored in a sealed kit, but must be stored in a manner to deter theft or loss. Drugs in Schedules II through V stored on a ground EMS vehicle, other EMS vehicle, or EMS vehicle that is a licensed fixed-wing aircraft shall be stored in a sealed, secured kit or device within a locked cabinet that is accessible from the patient compartment of the vehicle. Drugs in Schedules II through V stored on an EMS vehicle that is a licensed rotary aircraft shall be stored in a sealed, secured kit or device to deter theft or loss.

1. The method of sealing the kits shall ensure that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

2. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing. The EMS registered agency headquarters, regional EMS council, or designated location sealing and resealing the kit shall maintain a record of the seal identifiers when placed on a kit and maintain the record for a period of one year.

3. In lieu of a seal, a kit with a built-in mechanism preventing resealing or relocking once opened except by EMS personnel may be used.

I. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall implement a process to review expiration dates no less often than every three months to ensure drugs are not administered beyond the expiration date.

J. Registered EMS agency headquarters, regional EMS councils, and designated locations of the registered EMS agency headquarters or regional EMS councils shall perform drug inventories and report drug theft or unusual loss to the board in accordance with § 54.1-3404 of the Code of Virginia.

K. Registered EMS agency headquarters and regional EMS councils shall audit the security of the drug storage location and perform a random audit of Schedules II through V drugs and required recordkeeping for accuracy at least every six months at each designated location under the controlled substances registration. Documentation verifying the completion of the audit for each designated location shall be maintained at the registered EMS agency headquarters or regional EMS council for two years from the date performed.

18 Va. Admin. Code § 110-20-591

Derived from Virginia Register Volume 41, Issue 2, eff. 8/20/2024, exp. 2/19/2026 (Emergency).

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