Virginia EMS Drug Kit Transition & Compliance Overview

EMS Drug Kit Transition Webinars Series February 05, 2025 Office of Emergency Medical Service Virginia Department of Health February 05, 2025

Regulation & Compliance Enforcement Review Ronald D. Passmore, NRP, TS-C Director Regulation and Compliance Enforcement Division Office of Emergency Medical Services Virginia Department of Health

Compliance Considerations Regulations do not require an EMS agency to provide any specific medications other than oxygen. Regulations do require the agency to provide all medications indicated by agency specific protocols. EMS Drug Kit must match agency treatment protocols. This flexibility allows agency leadership and Medical Director to determine what medications the agency will provide Example If a licensed EMS agency decides to not carry medications - the EMS agency Medical Director must authorize agency specific, medication free, protocols.

Regulation & Compliance Enforcement Team Ron Passmore, NRP Division Director 804-888-9131 Marybeth Mizell,- Staff Support (Physicians & DDNR) 804-888-9130 Katie Hodges,-Staff Support (Background Investigations) 804-888-9133 Paul Fleenor, NRP Field Supervisor Virginia West Team Steve McNeer, EMT-I Field Investigator Central Virginia Chad Gregg, EMT-I Field Investigator Coastal Virginia Doug Layton, EMT-P Field Investigator Shenandoah Virginia Lenny Mascaro EMT-P, - Field Investigator Northern Virginia Scotty Williams, EMT-P Field Investigator Highlands Virginia Ron Kendrick, EMT-I Field Investigator Appalachian Virginia

Additional Questions? Contact your local EMS Program Representative, or contact Ron Passmore 804-888-9130 ron.passmore@vdh.virginia.gov

Virginia Board of Pharmacy EMS Inspections Wendy Ashworth, Senior Inspector Beth O Halloran, Deputy Executive Director

Virginia Board of Pharmacy EMS Inspections Inspection Cycle for Controlled Substance Registration (CSR) Holders Common Deficiencies Securing Drugs on EMS Vehicles Required Audits Additional Recordkeeping Requirements *Not Inclusive of All Board Regulations

Inspection Cycle and Process Facility inspection prior to receiving a Controlled Substance Registration Unannounced routine inspection of registered location and designated locations in approximately one year Every two years following the first routine inspection CSRs must be renewed every year by the last day of February

Commonly Cited Deficiencies 18VAC110-20-700 Unauthorized access to drugs No list of supervising practitioner-approved drugs Stocking drugs in schedules not approved under the CSR Not notifying the Board of a change to the Supervising Practitioner and/or Responsible Party within 14 days No documentation of supervising practitioner established procedures and training for compliance with all requirements of law and regulation, including storage, security, and recordkeeping.

Commonly Cited Deficiencies (continued) 18VAC110-20-710 Expired drugs found in working stock Alarm not operational Drugs not being maintained in accordance with USP guidelines for temperature control 18VAC110-20-720 and 54.1-3404 Biennial inventory incomplete or not being performed Records of receipt of Schedule II-V drugs missing signature and/or date received Records of Schedule II drugs not being maintained separately from all other records

Securing Drugs on an EMS Vehicle 18VAC110-20-591 Schedule VI drugs are not required to be in a kit but must be stored in a manner to deter theft or loss Schedule II-V drugs must be stored in a sealed, secured kit or device within a locked cabinet accessible from the patient compartment of vehicle. Seals must not be re-sealable , have a unique numeric or alphanumeric identifier. Record of the kit identifiers must be maintained for up to 1 year at each location In lieu of a seal, may use a kit with built-in mechanism preventing re-sealing or re-locking once opened.

Audits for CSR Registered Locations and Designated Locations 18VAC110-20-591 All locations where drugs are maintained must have a process to review expiration dates at least every 3 months and remove drug from working stock if expired. Security and access to drug storage alarm also required for designated locations stocking Schedule II-V drugs unless temporarily storing a kit while vehicle is being serviced or incapable of maintaining appropriate storage temperature. Registered location must perform random audit at each designated location for accuracy of Schedule II-V drugs and required recordkeeping. Must be performed at least every 6 months.

CSR Registrants Using RFID 18VAC110-20-505 Supervising practitioner or responsible party shall be responsible for performing and verifying the accuracy of the following tasks: Addition, modification, deletion of drug information in database for assignment of RFID tag to an individual drug Development of contents of the kit in RFID database and associated drug-specific RFID tags Responsible party or designee shall be responsible for: Verifying that all drugs have been accurately tagged prior to storing the drugs in the pharmacy's inventory Perform a weekly random check for verification of the accuracy of 5.0% of all kits prepared that week (ex. 20 kits prepared audit 1 kit) Documented proof of audit Date Description of discrepancies Initials of individual who performed the check

Additional Recordkeeping 18VAC110-20-720 Inventories and administration records Schedule II must be maintained separately from all other records Theft and/or loss ( 54.1-3404) Protocols, practice guidelines, practice agreements Audits of designated locations Records of all drugs received, administered, disposed of, deliveries between registered locations and designated locations, standing or verbal orders issued or adopted

Additional Recordkeeping 18VAC110-20-721 Written standing protocols signed by OMD Oral orders reduced to writing by EMS provider and signed by OMD Record of all drugs administered, and destruction of drug partially administered Destruction of partially used Sch II-V drugs must be accomplished by 2 persons, one who must be the EMS provider and the other may be a pharmacist, nurse, prescriber, pharmacy technician or second EMS provider. Drugs that are expired or unwanted must be transferred to another entity authorized to possess or provide for proper destruction of such drugs.

Additional Recordkeeping 18VAC110-20-721 Records of acquisition of all drugs, distribution of all drugs, delivery of all drugs between designated location and registered location must include: Drug name Finished form (ex 10 mg tab) Number of units or volume in commercial container (ex -100 tab bottle) Number of containers acquired, distributed, or delivered Date of acquisition, distribution, or delivery Name, address and, if appropriate, DEA reg number of person for whom the drug was acquired, distributed, or delivered Name and title of person acquiring , distributing, or delivering the drug.

Online Access to Laws, Regulations, and Inspection Report **This presentation in not inclusive of all requirements** Virginia Board of Pharmacy emergency regulations and applicable state laws may be accessed at https://www.dhp.virginia.gov/Boards/Pharmacy/Practitione rResources/LawsRegulations/ CSR inspection report may be accessed at https://www.dhp.virginia.gov/Boards/Pharmacy/Practitione rResources/FormsandApplications/ Not all sections of the inspection report are relevant to EMS facilities