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Changes in federal laws governing how emergency medical services agencies are allowed to dispense drugs have left Isle of Wight County with a four-month window to bring its Fire and Rescue service up to code.

In 2013, Congress enacted the Drug Supply Chain Security Act, which set an enforcement date of Nov. 27 of this year for the required electronic tracking of prescription drug containers stored and dispensed by EMS agencies.

Virginia’s current practice, which will no longer be allowed, is for ambulance crews to exchange used containers for Schedule II through VI drugs for unopened ones on a one-for-one basis at hospitals.

According to Isle of Wight Fire and Rescue Chief Garry Windley, the law changed to eliminate the possibility of losing track of used drugs should the containers be returned to a different hospital than the one from which they originated.

Instead, agencies will be required to purchase their own drug kits and store them at their stations. That requires a Virginia Board of Pharmacy fee and costly security modifications for each station that serves as a dispensary.

Windley estimates it will cost over $113,000 to outfit the county’s Isle of Wight and Windsor volunteer rescue stations and ambulances. The biggest expense is the purchase of safes that use radio frequency identification, or RFID, tags to keep track of their contents. The 15 safes alone – one for each station and 13 mobile safes that can be mounted inside ambulances – will cost over $56,000. The six-figure total also includes $6,500 for medication inventory software, $4,000 in security upgrades at the two stations to comply with U.S. Drug Enforcement Agency regulations, and the cost of the drug kits and the drugs themselves.

The total also includes the $120 cost of a Virginia Board of Pharmacy controlled substances registration, or CSR, and $888 for a DEA license, which a 2017 amendment by Congress to the Controlled Substances Act is now requiring of EMS agencies.

Windley said the CSR application is ready to send this month but is waiting on the installation of the safes, as part of the approval process is for each station to pass an in-person inspection. Once each station has its CSR in place, Isle of Wight Fire and Rescue can apply for its DEA license, Windley said. Once both licenses are in place, Isle of Wight can apply to the U.S. Food and Drug Administration for a certificate authorizing the county to purchase drugs, which Windley said will entail hiring someone as Isle of Wight’s designated coordinator for the federal controlled substance ordering system.

The costly and confusing process has, according to Windley, been compounded by conflicting information from federal and state sources and a shakeup at the Virginia Office of EMS.

“We’re trying to navigate the ever-changing information that we get,” Windley told Isle of Wight County supervisors on July 11. “Every meeting we go to … we hear something else that we have to do to meet the regulations. We’re not getting anything really from the Office of EMS; we’re having to go out and find it ourselves.”

The Office of EMS, according to its budget request from earlier this year, has its hands full tracking down $33 million in unpaid bills, including $6.6 million in missed payments to localities. According to the budget document, the state office is funded solely through the “4 for Life” program that collects $6.25 per vehicle registration. Each fee collected is supposed to allocate $2 toward a $12.5 million transfer to Virginia’s General Fund. The budget request notes that in June 2023 when funds needed to meet the $12.5 million transfer were unavailable, an internal audit found “financial irregularities” going back “several years.” The state Office of EMS director, Gary Brown, retired last year amid the ongoing state and federal investigations, which, according to the budget request, now include the U.S. Attorney’s Office.

“We have not seen a decrease in state funding,” Windley said. “However, we may have been entitled to more than we received, which is what is being audited by multiple state and federal agencies to determine if more money should be distributed to localities.”

It wasn’t until May 2 that the Board of Pharmacy adopted emergency regulations for EMS agencies, and those, according to Windley, were based on proposed DEA regulations from 2020 that ultimately weren’t adopted. Prior to that date, “EMS agencies had no guidelines to know what was required for security, purchasing, record-keeping and distribution,” Windley said.

The Office of EMS, according to its spokeswoman, Marian Hunter, has been coordinating with a working group and the Virginia Board of Pharmacy on emergency regulations.

“The Virginia Regional Medication Kit Transition Workgroup has been meeting since December of 2023 to develop recommendations and tools to assist EMS agencies transition from hospital stocked regional EMS Medication Kits exchanged one-for-one with EMS agencies to an alternative that is compliant with the FDA’s Drug Supply Chain Security Act enforcement date of November 27, 2024, a federal regulation not known to EMS before last November, Hunter said.

The working group, which consists of representatives from Virginia’s regional EMS councils, the state office, Board of Pharmacy and other stakeholders, has branched into teams tasked with addressing licensure, policies, purchasing of drugs and financial assistance, Hunter said.

Despite the conflicting and in some cases lack of information, Windley said he’s “confident that we are ahead of the curve.”

“Most agencies in the region and state still do not have a plan or funding to meet the requirements of this unfunded mandate,” he said. “We have the support of county administration and the Board of Supervisors, which is what other agencies are struggling with.”

According to County Administrator Randy Keaton, a large portion of the six-figure cost Windley quoted can be funded with undesignated capital reserve funds. Keaton said revenues from what Isle of Wight bills health insurance companies, ranging from $450 to $800 for basic or advanced life support, plus $11.25 per mile a patient is transported by ambulance, came in roughly $185,000 above what the county had budgeted for the 2023-24 fiscal year that ended June 30. But one component the higher-than-expected EMS revenues won’t cover is the cost of hiring a dedicated employee to oversee the in-house distribution of drugs.