Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-500 - Licensed emergency medical services (EMS) agencies

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