VACo recently received several updates regarding the transition of the prescription drug box program in Virginia. On October 9, 2024, the U.S. Food and Drug Administration (FDA) issued an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners, extending the compliance date for one year to November 27, 2025. It’s expected that the U.S. Drug Enforcement Agency’s (DEA) anticipated enforcement of the Protection of Patient Access to Emergency Medications Act may be released sometime in 2025.
On October 28, 2024, the Virginia Regional EMS Medication Kit Transition Workgroup met to discuss the extension. The workgroup proposed an April 15, 2025, drug box program transition date. On October 30, 2024, the Virginia Society of Health-System Pharmacists and Virginia Hospital and Healthcare Association agreed to extend the transition deadline to the proposed April 15, 2025, date. However, should the DEA publish its final rule for the Protection of Patient Access to Emergency Medications Act with an enforcement date before April 15, 2025, the transition date will be adjusted to the earlier of the two dates.
More information can be found on a memorandum provided by the Old Dominion Emergency Medical Services Alliance.
As previously reported, VACo encourages members to continue to coordinate with their EMS providers and area hospital pharmacies to seek opportunities to reduce cost burdens in the process of shifting responsibilities for the drug box program to local governments.
VACo also contacted the Opioid Abatement Authority (OAA) on whether OAA funds could be used to help fund transition costs associated with the new standards of the prescription drug box program. According to the OAA, this would not be an approved use of OAA funds, and for localities to use their direct settlement funds would not meet the OAA’s voluntary gold standard as this expense is an unfunded mandate on EMS agencies to continue their current level of operations. It is not a new or expanded opioid abatement strategy. The OAA Board has a policy statement that addresses the use of opioid settlement funds for EMS, Fire, and law enforcement related expenses,
If your county or EMS providers are still struggling to implement changes to the prescription drug box program as a result of the new regulations or are facing delays in the approval of waivers submitted to the FDA, VACo encourages you to contact members of your congressional delegation for assistance. A useful compilation of additional information and resources provided by the Peninsulas EMS Councils can be found here.
VACo will continue to engage on this issue and provide updates as they become available.
VACo Contact: Jeremy R. Bennett