Based on federal regulatory changes associated with the Drug Supply Chain Security Act, 21 U.S.C. § 351 et seq. (DSCSA), and the Protecting Patient Access to Emergency Medications Act, 21 U.S.C. § 823, hospitals have indicated that they will no longer provide and exchange drug kits with Emergency Medical Service (EMS) providers as of November 27, 2024, the date the U.S. Food and Drug Administration (FDA) has indicated that it will begin enforcing additional requirements of the DSCSA impacting hospital pharmacies. This unique program to Virginia, also known colloquially as prescription drug boxes, has, for years, performed an important part of emergency service provision in Virginia, which is also uniquely reliant upon volunteer EMS providers, as it allows EMS vehicles to ensure they are fully stocked to provide needed drugs to patients in transport or at accident sites. While seemingly condoned by the Drug Enforcement Administration (DEA), the Virginia Board of Pharmacy (BOP) has opined that kit exchange process is not fully compliant with DEA requirements as drugs are not exclusively transferred between DEA registrants or provided to an EMS agency working as an extension of a specific hospital DEA registration. This could upend existing local EMS practices and impose significant financial and/or staffing burdens upon local governments.
According to guidance from the Virginia Regional EMS Medication Kit Transition Workgroup Report of February 2024, the DSCSA regulations, also known as “Track and Trace,” provide a carve out for EMS agencies regarding mandated tracking and reporting. Hospitals can provide medications to an EMS agency if they can transfer ownership and provide transaction information, transaction histories and transaction statements upon request. Compliance is not possible with the current regional drug box exchange system utilized by many EMS councils where a box is not owned by/transferred to any single agency or hospital, the medications in the box have originated from multiple hospitals, and where there is no origin information accompanying any of the medications in the box.
Once made aware of these potential changes, VACo notified County Administrators in April of 2024 about the need to engage with the BOP as well as working with our representative on the State EMS Advisory Board to try to mitigate the potential impact of any regulatory changes. The State EMS Advisory Board formed a Virginia Regional EMS Medication Kit Transition Workgroup, the final report of which may be accessed here.
The BOP and EMS stakeholders had previously worked together to align regulations with new federal requirements and provide a solution to ensure EMS providers can provide drugs to patients as needed. To do so, many EMS agencies must obtain controlled substance registrations (“CSR”) and subsequent registration from the DEA to purchase their own drug stock and transfer to associated EMS stations. The unique nature of emergency medical services requires the Board of Pharmacy to implement regulatory changes to ensure the process of obtaining CSRs and complying with drug requirements is not impractical or overly onerous on EMS entities while conforming to federal allowances for obtaining a DEA registration.
Based on feedback provided during the public comment period, in May of 2024, the Board of Pharmacy unanimously passed the proposed regulatory changes as Emergency Regulations, initiating a Notice of Intent for Regulatory Action. The regulations still must undergo an administrative review process, involving the Office of the Attorney General, Department of Planning and Budget, and Governor, which may take approximately 10 weeks to complete. Emergency regulations are temporary and must be replaced with permanent regulations. The BOP also repealed their previous Guidance Document 110-4, Virginia Board of Pharmacy Emergency Medical Services Drug Kits, as some of the guidance is now inconsistent with language adopted by the board prior to the May 2024 meeting. Some of the changes approved include:
- Allowing EMS agencies within a jurisdiction to be served by a single EMS Agency with a CSR/DEA license.
- Allowing EMS agencies within a region to be served by the Regional Council with a single CSR license.
- Allowing for continuation of Hospital 1:1 Exchange of Schedule 6 medications assuming compliance with federal law and regulation.
- Allowing anyone with Virginia EMS certification at any level authorized to administer Medications to have access to medications under a supervising authority for the purposes of medication supply/resupply management.
- Allowing medications and controlled substances to be transported in vehicles owned by EMS agencies, Regional Councils or Jurisdictions and used by EMS agencies and Regional Councils for the purpose of medical supply/resupply management.
- Removing the requirement for alarm systems for the temporary storage of medication kits in an EMS Agency registered or designated location when the vehicle they are stored on must be removed from service for repair or maintenance and when only Schedule 6 drugs are stored in the building.
- Requiring medication kits containing Schedule 2-5 medications to be sealed.
- Conforming BOP regulations to the expected minimum regulations required by FDA and DEA for EMS.
- Other changes reconciling differences in language and clarifying meanings.
These changes adopted by BOP do much to address fundamental challenges EMS providers and local governments face in trying to comply with the federal regulations.
VACo is currently exploring additional options with state and federal partners to further reduce any administrative burdens or unfunded mandates imposed by these federal requirements, including correspondence to the FDA, DEA, and Virginia’s congressional delegation. VACo will continue to provide updates to members on this issue. A useful compilation of additional information and resources provided by the Peninsulas EMS Councils can be found here.
VACo Contact: Jeremy R. Bennett