For decades, EMS providers throughout the Commonwealth obtained drugs for use by EMS personnel in a unique manner. EMS providers exchanged partially used drug boxes or “kits" to multiple participating hospital pharmacies, which in turn supplied EMS providers with new drug kits to use in EMS vehicles. For many years this exchange performed an important part of emergency service provision in Virginia, which is also uniquely reliant upon volunteer EMS providers, as it allowed 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 U.S. Drug Enforcement Administration (“DEA"), the kit exchange process was not fully compliant with DEA requirements as drugs were not exclusively transferred between DEA registrants or provided to an EMS agency working as an extension of a specific hospital DEA registration. Therefore, the tracking and ownership of controlled substances was historically challenging and created potential liability for hospital pharmacies.

Federal legislation passed in 2017 known as the Protecting Patient Access to Emergency Medications Act, subsequent proposed regulations published by DEA, and FDA’s announcement of its intention to enforce certain requirements of the Drug Supply Chain Security Act, 21 U.S.C. § 351 et seq. (“DSCSA"), resulted in a determination by hospital pharmacies in late 2023 that the hospitals could no longer legally participate in an emergency drug kit exchange process with EMS agencies as of November 27, 2024. Beginning in January 2024, stakeholder meetings were convened, by the Virginia Department of Health EMS Medical Direction Committee and the Virginia Regional EMS Medication Kit Transition Workgroup, to discuss a transition plan. After significant input from stakeholders, the Board of Pharmacy adopted emergency regulations in a specially convened meeting to create a new model consistent with the federal law and DEA’s proposed regulations. The emergency regulations became effective on August 20, 2024. Concurrently, regional EMS councils worked diligently with EMS agencies in their regions to determine the optimal model to obtain and transfer drugs for use in emergency drug kits. The Board developed a virtual inspection process for expeditiously performing initial inspections prior to issuing 300 controlled substance registrations to EMS agencies and approving over 700 designated locations. In October 2024, FDA announced a DSCSA exemption from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug, and Cosmetic Act for eligible trading partners which extended until November 27, 2025. Based on this announcement, hospital pharmacies agreed to continue providing emergency drug kits, if needed, until April 15, 2025, with the understanding that both EMS and hospital pharmacy stakeholders would actively continue to complete the transition.

While current and future challenges exist, most stakeholders agree that the transition for how EMS agencies receive and handle emergency drug kits in Virginia has gone well. One hospital pharmacist reported that she could not recall a hospital project, short of building a new hospital, in which so much time was invested with involvement from multiple disciplines, health system leadership, and the convening of dozens and dozens of meetings. Strong collaboration from stakeholders and state and federal partners was invaluable during this transition.